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urokinase

Generic Name: urokinase (URE oh KYE nase)

Brand names: Abbokinase, Kinlytic, Abbokinase Open-Cath

What is urokinase?

Urokinase is a man-made product developed using a protein that occurs naturally in the kidneys. Urokinase is a thrombolytic agent that works by dissolving blood clots.

Urokinase is used to treat blood clots in the lungs.

Urokinase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about urokinase?

You should not use this medication if you are allergic to urokinase, or if you have internal bleeding, a brain tumor or aneurysm, hemophilia or other bleeding disorder, arterial hypertension, or if you have had a recent stroke, surgery, organ transplant, or medical emergency .

Before you receive urokinase, tell your doctor if you have liver or kidney disease, diabetes, heart problems, if you are pregnant or recently gave birth, a history of stroke or stomach bleeding.

Tell your caregivers at once if you have a serious side effect such as easy bruising or bleeding, blood in your stools, coughing up blood, chest pain, sudden problems with vision or speech, swelling, discoloration of your fingers or toes, severe stomach pain, weak or shallow breathing, fever, chills, or flu symptoms.

Before you receive urokinase, tell your doctor if you are using a blood thinner such as warfarin (Coumadin), aspirin or an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), and others, or any medication used to prevent blood clots such as Kabikinase, Plavix, Ticlid, Persantine, Streptase, and others.

What should I discuss with my health care provider before I receive urokinase?

You should not use this medication if you are allergic to urokinase, or if you have:

internal bleeding;

a brain tumor;

a brain aneurysm (dilated blood vessel);

a bleeding or blood clotting disorder (such as hemophilia);

a condition called arterial hypertension;

if you have had a recent medical emergency requiring CPR (cardiopulmonary resuscitation);

if you have had a stroke, brain surgery, or spinal surgery within in the past 2 months.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you receive urokinase, tell your doctor if you have:

a history of stroke;

severe liver or kidney disease;

eye problems caused by diabetes;

an infection of the lining of your heart (also called bacterial endocarditis);

a blood clot of your heart;

a recent history of stomach or intestinal bleeding;

if you are pregnant or have had a baby within the past 10 days; or

if you have had surgery or an organ transplant within the past 10 days.

FDA pregnancy category B. Urokinase is not expected to be harmful to an unborn baby. However, your doctor should know if you are pregnant before you receive this medication. It is not known whether urokinase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Urokinase is made from human kidney cells and albumin (part of the blood) and it may contain viruses and other infectious agents that can cause disease. Although donated human blood is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is urokinase given?

Urokinase is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

Urokinase is given slowly, usually over a period of 12 hours, using a continuous infusion pump.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving urokinase.

What happens if I miss a dose?

Since urokinase is given by a healthcare professional in a clinical setting, you are not likely to miss a dose.

What happens if I overdose?

Because urokinase is given in a controlled clinical setting, an overdose is not expected to occur.

What should I avoid while receiving urokinase?

Avoid taking aspirin or ibuprofen (Motrin, Advil) to treat a fever shortly after you have received urokinase. These medications can increase your risk of bleeding. Ask your doctor about other methods of treating a fever.

Urokinase side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

easy bruising or bleeding (nosebleeds, bleeding gums, bleeding from a wound, incision, catheter, or needle injection );

bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

sudden headache or problems with speech, vision, or balance;

fever, chills, flu symptoms, nausea, vomiting, back pain, or stomach pain;

drowsiness, confusion, mood changes, increased thirst, loss of appetite;

swelling, weight gain, feeling short of breath;

urinating less than usual or not at all;

red or purple discoloration of fingers or toes;

weak or shallow breathing, blue-colored lips or fingernails;

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure); or

pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Urokinase Dosing Information

Usual Adult Dose for Myocardial Infarction:

Lysis of coronary artery thrombi:
Prior to beginning urokinase, a bolus of heparin 2500 to 10,000 units IV once should be given. Prior heparin administration should be considered when calculating the heparin dose.

Systemic thrombolytic administration:
1 to 2 million intl units administered IV once over 15 to 30 minutes. The rate of infusion is limited by side effects (fever, chills, rigors), and may need to be decreased in some patients. Doses up to 3 million intl units have been used to treat acute myocardial infarction (AMI).

To determine the response to urokinase, the manufacturer recommends serial angiography every 15 minutes. Maximal coronary artery opening usually occurs 15 to 30 minutes after opening begins.

Direct intracoronary artery infusion:
Following the heparin bolus, urokinase may be infused into the occluded artery at a rate of 6000 intl units/min for up to 2 hours, with an average total dose of 500,000 intl units administered.

Alternatively, some studies have reported administering urokinase infusions at a rate of 20,000 to 25,000 intl units/min for 10 to 20 minutes up to a total dose of 250,000 to 500,000 intl units. It has not been established that intracoronary administration of urokinase during evolving transmural AMI results in salvage of myocardial tissue, nor that it reduces mortality.

Heparin therapy (without a loading dose) is recommended when the thrombin time has decreased to less than twice the normal control value.

Usual Adult Dose for Pulmonary Embolism:

Initial: 4400 intl units/kg ideal body weight (IBW) administered as an IV bolus over 10 minutes.

Maintenance: 4400 intl units/kg (IBW) /hour administered as a continuous IV infusion for 12 hours.

Heparin therapy (without a loading dose) is recommended when the thrombin time has decreased to less than twice the normal control value.

Usual Adult Dose for Deep Vein Thrombosis:

Initial: 4400 intl units/kg ideal body weight (IBW) administered as an IV bolus over 10 minutes.

Maintenance: 4400 intl units/kg (IBW) /hour administered as a continuous IV infusion for 72 hours. Treatment may be needed for as long as 10 to 14 days in selected patients.

Heparin therapy (without a loading dose) is recommended when the thrombin time has decreased to less than twice the normal control value.

Usual Adult Dose for Thrombotic/Thromboembolic Disorder:

IV catheter clearance:
When the following procedure is used for thrombolysis of a central venous catheter, the patient should be asked to hold his/her breath at end-exhalation any time the catheter is not connected to IV tubing, a heparin lock, or a syringe (to avoid air embolism).

Once a clot is suspected (after gentle aspiration of the affected catheter with a 10 mL syringe), 5000 intl units urokinase in a 1 mL tuberculin syringe may be slowly and gently injected, using only an amount equivalent to the volume of the catheter. A 5 or 10 mL syringe may be used to gently aspirate from the catheter every 5 minutes. If the catheter is not open within 30 minutes, the catheter may be capped allowing urokinase to dwell inside for 30 to 60 minutes before again attempting to aspirate. A second injection may be necessary in resistant cases.

Once patency is restored, aspiration and removal of 5 mL of blood is recommended to remove all drug and clot residual. Flushing the catheter with normal saline injection is then recommended.

What other drugs will affect urokinase?

The following drugs can interact with urokinase. Tell your doctor if you are using any of these:

a blood thinner such as warfarin (Coumadin);

aspirin or an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others; or

medication used to prevent blood clots, such as alteplase (Activase), anistreplase (Eminase), clopidogrel (Plavix), dipyridamole (Persantine), streptokinase (Kabikinase, Streptase), or ticlopidine (Ticlid).

This list is not complete and there may be other drugs that can interact with urokinase. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More urokinase resources

Urokinase Side Effects (in more detail)
Urokinase Dosage
Urokinase Use in Pregnancy & Breastfeeding
Urokinase Drug Interactions
Urokinase Support Group
0 Reviews for Urokinase - Add your own review/rating

urokinase Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

Urokinase Monograph (AHFS DI)

Kinlytic Prescribing Information (FDA)

Compare urokinase with other medications

Deep Vein Thrombosis
Heart Attack
Pulmonary Embolism
Thrombotic/Thromboembolic Disorder

Where can I get more information?

Your doctor or pharmacist can provide more information about urokinase.

See also: urokinase side effects (in more detail)

Urso

Pronunciation: ERR-so-DIE-ole
Generic Name: Ursodiol
Brand Name: Examples include Actigall and Urso

Urso is used for:

Treating and preventing gallstones. It may also be used for other conditions as determined by your doctor.

Urso is a bile acid naturally found in the body. It works by dissolving the cholesterol that makes gallstones and inhibiting production of cholesterol in the liver and absorption in the intestines, which helps to decrease the formation of gallstones. It can also reduce the amount of other bile acids that can be harmful to liver cells when levels are elevated.

Do NOT use Urso if:

you are allergic to any ingredient in Urso

Contact your doctor or health care provider right away if any of these apply to you.

Before using Urso:

Some medical conditions may interact with Urso. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have obstruction or inflammation of the bile duct, inflammation of the gallbladder, inflammation of the pancreas, or bleeding from the veins in the esophagus

Some MEDICINES MAY INTERACT with Urso. Tell your health care provider if you are taking any other medicines, especially any of the following:

Estrogens (eg, premarin, oral contraceptives) because they may decrease Urso's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Urso may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Urso:

Use Urso as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Urso by mouth with food or milk.

Do not take an antacid that has aluminum in it or a bile acid sequestrant (eg, cholestyramine, colestipol) within 1 hour before or 2 hours after you take Urso.

If you miss a dose of Urso, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Urso.

Important safety information:

It may take several months for Urso to work. Do not stop taking Urso without checking with your doctor.

Lab tests, including liver function, may be performed while you use Urso. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Urso should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Urso while you are pregnant. It is not known if Urso is found in breast milk. If you are or will be breast-feeding while you use Urso, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Urso:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dry skin; gas; headache; indigestion; metallic taste; muscle or joint pain; nausea; skin rash; stomach pain; swelling; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Urso side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea.

Proper storage of Urso:

Store Urso at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Urso out of the reach of children and away from pets.

General information:

If you have any questions about Urso, please talk with your doctor, pharmacist, or other health care provider.

Urso is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Urso. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Urso resources

Urso Side Effects (in more detail)
Urso Use in Pregnancy & Breastfeeding
Drug Images
Urso Drug Interactions
Urso Support Group
3 Reviews for Urso - Add your own review/rating

Urso Concise Consumer Information (Cerner Multum)

Urso Prescribing Information (FDA)

Urso Advanced Consumer (Micromedex) - Includes Dosage Information

Ursodiol Prescribing Information (FDA)

Ursodiol Professional Patient Advice (Wolters Kluwer)

Ursodiol Monograph (AHFS DI)

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Biliary Cirrhosis
Gallbladder Disease
Nonalcoholic Fatty Liver Disease

Urised

Generic Name: atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid (Oral route)

AT-roe-peen SUL-fate, hye-oh-SYE-a-meen SUL-fate, meth-EN-a-meen, METH-i-leen BLOO, FEN-il sal-I-si-late, ben-ZOE-ik AS-id

Commonly used brand name(s)

In the U.S.

Prosed EC

Trac Tabs

Urised

Available Dosage Forms:

Tablet

Tablet, Enteric Coated

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Atropine

Chemical Class: Salicylate, Non-Aspirin

Uses For Urised

Atropine , hyoscyamine , methenamine , methylene blue, phenyl salicylate , and benzoic acid combination medicine is an anticholinergic, anti-infective, and analgesic. It is given by mouth to help relieve the discomfort caused by urinary tract infections; however, it will not cure the infection itself. This combination medicine may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

Before Using Urised

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Unusual excitement, nervousness, restlessness or irritability, and unusual warmth, dryness, and flushing of skin are more likely to occur in children, who are usually more sensitive to the effects of atropine and hyoscyamine (contained in this combination medicine). Also, when atropine and hyoscyamine are given to children during hot weather, a rapid increase in body temperature may occur. In infants and children, especially those with spastic paralysis or brain damage, this medicine may be more likely to cause severe side effects.

Geriatric

Confusion or memory loss, constipation, difficult urination, excitement, agitation, drowsiness, or dryness of mouth may be more likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of atropine and hyoscyamine. Also, this combination medicine may cause eye pain in patients who have untreated glaucoma.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Benzoic Acid

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Methylene BlueBenzyl BenzoateMethenamineAtropineHyoscyamine

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ambenonium

Amitriptyline

Amoxapine

Bupropion

Citalopram

Clomipramine

Desipramine

Desvenlafaxine

Doxepin

Duloxetine

Escitalopram

Fluoxetine

Fluvoxamine

Imipramine

Isocarboxazid

Linezolid

Maprotiline

Mirtazapine

Nortriptyline

Paroxetine

Phenelzine

Potassium

Protriptyline

Selegiline

Sertraline

Tranylcypromine

Trimipramine

Venlafaxine

Vilazodone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Buspirone

Nefazodone

Trazodone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Arbutamine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid

This section provides information on the proper use of a number of products that contain atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid. It may not be specific to Urised. Please read with care.

While you are taking this combination medicine, it is important for your urine to be acidic. To do this, your doctor may recommend that you eat more protein and such foods as cranberries (especially cranberry juice with vitamin C added), plums, or prunes. You should avoid foods that make the urine more alkaline, such as most fruits (especially citrus fruits and juices), milk, and other dairy products.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Each dose should be taken with a full glass (8 ounces) of water or other liquid (except citrus juices and milk). Drink plenty of water or other liquids every day, unless otherwise directed by your doctor. Drinking enough liquids will help your kidneys work better and lessen your discomfort.

To help clear up your infection completely, keep taking this medicine for the full time of treatment even if you begin to feel better after a few days. Do not miss any doses.

In order for this medicine to work well, your urine must be acid (pH 5.5 or below). To make sure that your urine is acid:

Before you start taking this medicine, check your urine with phenaphthazine paper or another test to see if it is acid. If you have any questions about this, check with your health care professional.

You may need to change your diet; however, check with your doctor first if you are on a special diet (for example, for diabetes). To help make your urine more acid you should avoid most fruits (especially citrus fruits and juices), milk and other dairy products, and other foods which make the urine more alkaline. Eating more protein and foods such as cranberries (especially cranberry juice with vitamin C added), plums, or prunes may also help. If your urine is still not acid enough, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For relief of urinary tract symptoms:
  - Adults and children 12 years of age and older—1 to 2 tablets four times a day.
  - Children 6 to 12 years of age—Dose must be determined by the doctor.
  - Children up to 6 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Urised

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

These medicines may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking this medicine.

This medicine may cause some people to have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not able to see well. If your vision continues to be blurred, check with your doctor.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take this medicine within 2 or 3 hours of taking antacids or medicine for diarrhea. Taking antacids or antidiarrhea medicines and this medicine too close together may prevent this medicine from working properly.

Urised Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Blurred vision

eye pain

skin rash or hives

Symptoms of overdose

Blood in urine and/or stools

diarrhea

dizziness

drowsiness (severe)

fast heartbeat

flushing or redness of face

headache (severe or continuing)

lower back pain

pain or burning while urinating

ringing or buzzing in the ears

shortness of breath or troubled breathing

sweating

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Difficult urination (more common with large doses taken over a prolonged period of time)

dryness of mouth, nose, or throat

nausea or vomiting

stomach upset or pain (more common with large doses taken over a prolonged period of time)

This medicine may cause your urine and/or stools to turn blue or blue-green. This is to be expected while you are taking this medicine.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Urised side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Urised resources

Urised Side Effects (in more detail)
Urised Use in Pregnancy & Breastfeeding
Urised Drug Interactions
Urised Support Group
1 Review for Urised - Add your own review/rating

Urised MedFacts Consumer Leaflet (Wolters Kluwer)

Darcalma Concise Consumer Information (Cerner Multum)

Darcalma Prescribing Information (FDA)

Darpaz Prescribing Information (FDA)

Phosenamine Prescribing Information (FDA)

Phosphasal Prescribing Information (FDA)

Prosed/DS MedFacts Consumer Leaflet (Wolters Kluwer)

Urelle Prescribing Information (FDA)

Uribel Prescribing Information (FDA)

Urimax Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Uritact-EC Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Ustell Prescribing Information (FDA)

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Urinary Tract Infection

Urobiotic

Dosage Form: Capsules

Each capsule contains

Oxytetracycline hydrochloride equivalent to. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250 mg

oxytetracycline

Sulfamethizole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250 mg

Phenazopyridine hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mg

Inert ingredients in the formulation are: hard gelatin capsules (which may contain Green 3, Yellow 6, Yellow 10 and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch.

ACTIONS

Urobiotic-250 is a product designed for use specifically in urinary tract infections.

Terramycin® (oxytetracycline HCl) is a widely used antibiotic with clinically proved activity against gram-positive and gram-negative bacteria, rickettsiae, spirochetes, large viruses, and certain protozoa. Terramycin is well tolerated and well absorbed after oral administration. It diffuses readily through the placenta and is present in the fetal circulation. It diffuses into the pleural fluid, and under some circumstances, into the cerebrospinal fluid. Oxytetracycline HCl appears to be concentrated in the hepatic system and is excreted in the bile. It is excreted in the urine and in the feces, in high concentrations, in a biologically active form.

Sulfamethizole is a chemotherapeutic agent active against a number of important gram-positive and gram-negative bacteria. This sulfonamide is well absorbed, has a low degree of acetylation, and is extremely soluble. Because of these features and its rapid renal excretion, sulfamethizole has a low order of toxicity and provides prompt and high concentrations of the active drug in the urinary tract.

Phenazopyridine is an orally absorbed agent which produces prompt and effective local analgesia and relief of urinary symptoms by virtue of its rapid excretion in the urinary tract. These effects are confined to the genitourinary system and are not accompanied by generalized sedation or narcosis.

INDICATIONS

Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications as follows:

"Lacking substantial evidence of effectiveness as a fixed combination":

Urobiotic-250 is indicated in the therapy of a number of genitourinary infections caused by susceptible organisms. These infections include the following: pyelonephritis, pyelitis, ureteritis, cystitis, prostatitis, and urethritis.

Since both Terramycin and sulfamethizole provide effective levels in blood, tissue, and urine, Urobiotic-250 provides a multiple antimicrobial approach at the site of infection. Both antibacterial components are active against the most common urinary pathogens, including Escherichia coli, Pseudomonas aeruginosa, Aerobacter aerogenes, Streptococcus faecalis, Streptococcus hemolyticus, and Micrococcus pyogenes. Urobiotic-250 is particularly useful in the treatment of infections caused by bacteria more sensitive to the combination than to either component alone. The combination is also of value in those cases with mixed infections, and in those instances where the causative organism is unknown pending laboratory isolation.

Final classification of the less than effective indications requires further investigation. Clinical studies to substantiate the efficacy of Urobiotic 250 are ongoing. Completion of these ongoing studies will provide data for final classification of these indications.

Contraindications

This drug is contraindicated in individuals who have shown hypersensitivity to any of its components.

This drug, because of the sulfonamide component, should not be used in patients with a history of sulfonamide sensitivities, and in pregnant females at term.

Warnings

If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulation of the drug and possible liver toxicity. Under such conditions, lower than usual doses are indicated and if therapy is prolonged, tetracycline serum level determinations may be advisable.

Oxytetracycline HCl, which is one of the ingredients of Urobiotic-250, may form a stable calcium complex in any bone-forming tissue with no serious harmful effects reported thus far in humans. However, use of oxytetracycline during tooth development (last trimester of pregnancy, neonatal period and early childhood) may cause discoloration of the teeth (yellow-grey-brownish). This effect occurs mostly during long term use of the drug but it also has been observed in usual short treatment courses.

Because of its sulfonamide content, this drug should be used only after critical appraisal in patients with liver damage, renal damage, urinary obstruction, or blood dyscrasias. Deaths have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, and other blood dyscrasias associated with sulfonamide administration. When used intermittently, or for a prolonged period, blood counts and liver and kidney function tests should be performed.

Certain hypersensitive individuals may develop a photodynamic reaction precipitated by exposure to direct sunlight during the use of this drug. This reaction is usually of the photoallergic type which may also be produced by other tetracycline derivatives. Individuals with a history of photosensitivity reactions should be instructed to avoid exposure to direct sunlight while under treatment with this or other tetracycline drugs, and treatment should be discontinued at first evidence of skin discomfort.

NOTE: Reactions of a photoallergic nature are exceedingly rare with Terramycin (oxytetracycline HCl). Phototoxic reactions are not believed to occur with Terramycin.

Precautions

As with all antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate specific therapy should be instituted. This drug should be used with caution in persons having histories of significant allergies and/or asthma.

Adverse Reactions

Glossitis, stomatitis, proctitis, nausea, diarrhea, vaginitis, and dermatitis, as well as reactions of an allergic nature, may occur during oxytetracycline HCl therapy, but are rare. If adverse reactions, individual idiosyncrasy, or allergy occur, discontinue medication. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule forms of drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (See Dosage and Administration.)

With oxytetracycline therapy bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving full therapeutic dosages. These conditions disappeared rapidly when the drug was discontinued.

As in all sulfonamide therapy, the following reactions may occur: nausea, vomiting, diarrhea, hepatitis, pancreatitis, blood dyscrasias, neuropathy, drug fever, skin rash, injection of the conjunctiva and sclera, petechiae, purpura, hematuria and crystalluria. The dosage should be decreased or the drug withdrawn, depending upon the severity of the reaction.

Urobiotic Dosage and Administration

Urobiotic-250 is recommended in adults only. A dose of 1 capsule four times daily is suggested. In refractory cases 2 capsules four times a day may be used.

Therapy should be continued for a minimum of seven days or until bacteriologic cure in acute urinary tract infections.

Administration of adequate amounts of fluid along with capsule forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (SeeAdverse Reactions.)

To aid absorption of the drug, it should be given at least one hour before or two hours after eating. Aluminum hydroxide gel given with antibiotics has been shown to decrease their absorption and is contraindicated.

SUPPLY

Urobiotic-250 capsules: bottles of 50 (NDC 0049-0920-50), and unit dose packages of 100 (10 × 10's) (NDC 0049-0920-41).

Rx only

70-1636-00-9

December 1986

Urobiotic
oxytetracycline hydrochloride, sulfamethizole and phenazopyridine hydrochloride capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0049-0920
Route of Administration	ORAL	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
oxytetracycline hydrochloride (oxytetracycline)	Active	250 MILLIGRAM In 1 CAPSULE
sulfamethizole (sulfamethizole)	Active	250 MILLIGRAM In 1 CAPSULE
phenazopyridine hydrochloride (phenazopyridine)	Active	50 MILLIGRAM In 1 CAPSULE
gelatin	Inactive
Green 3	Inactive
Yellow 6	Inactive
Yellow 10	Inactive
magnesium stearate	Inactive
sodium lauryl sulfate	Inactive
starch	Inactive

Product Characteristics
Color	GREEN (Yellow) , YELLOW (Yellow)	Score	no score
Shape	CAPSULE (Capsule)	Size	22mm
Flavor		Imprint Code	Pfizer;092
Contains
Coating	false	Symbol	false

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0049-0920-50	50 CAPSULE In 1 BOTTLE	None
2	0049-0920-41	100 CAPSULE In 1 PACKAGE	None

Revised: 12/2005Roerig

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Urogesic Blue

Dosage Form: tablet
UROGESIC-BLUE™

Rx Only

Description

Each tablet contains:

	Methenamine, USP	81.6 mg
	Monobasic Sodium Phosphate, USP	40.8 mg
	Methylene Blue, USP	10.8 mg
	Hyoscyamine Sulfate, USP	0.12 mg

Inactive Ingredients include: microcrystalline cellulose, NF, mannitol, USP, croscarmellose sodium, NF, magnesium stearate, NF and lake blend blue.

HYOSCYAMINE SULFATE is an alkaloid of belladonna. Exists as a white crystalline powder. Affected by light. It is very soluble in water; freely soluble in alcohol; practically insoluble in ether.

METHENAMINE exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water; soluble in alcohol and in chloroform.

METHYLENE BLUE exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.

MONOBASIC SODIUM PHOSPHATE exists as a white crystalline powder. Its solutions are acidic to litmus. It is freely soluble in water and practically insoluble in alcohol.

Urogesic Blue - Clinical Pharmacology

HYOSCYAMINE is a parasympatholytic which relaxes smooth muscles and thus produces an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being unchanged. Its biotransformation is hepatic. Its protein binding is moderate.

METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70% to 90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. Within 24 hours it is almost completely (90%) excreted; of this amount at pH 5, approximately 20% is formaldehyde. Protein binding: some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at pH greater than 6.8.

METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed in the gastrointestinal tract and is rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged.

MONOBASIC SODIUM PHOSPHATE helps to maintain an acid pH in the urine necessary for the degradation of methenamine.

Indications and Usage for Urogesic Blue

UROGESIC-BLUE™ is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as hypermotility which accompany lower urinary tract infections and as antispasmodic. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

Contraindications

UROGESIC-BLUE™ is contraindicated in patients with a hypersensitivity to any of the ingredients. Risk-benefit should be considered when the following medical problems exist: Cardiac disease (especially cardiac arrythmias, congestive heart failure, coronary heart disease, mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

Warnings

Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs discontinue use immediately.

Precautions

Cross sensitivity and/or related problems

patients intolerant of belladonna alkaloids may be intolerant of this medication also.

Pregnancy/Reproduction

Pregnancy Category C

hyoscyamine and methenamine cross the placenta. Studies have not been done in animals or humans. It is not known whether UROGESIC-BLUE™ tablets cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. UROGESIC-BLUE™ tablets should be given to a pregnant woman only if clearly needed.

Breast-feeding

problems in humans have not been documented; however, methenamine and traces of hyoscyamine are excreted in breast milk.

Prolonged use

there have been no studies to establish the safety of prolonged use in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential.

Pediatric

infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

Geriatric

use with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness, or confusion.

Drug Interactions

because of this product's effect on gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications during concurrent use such as: urinary alkalizers; thiazide diuretics (may cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde); antimuscarinics (concurrent use may intensify antimuscarinic effects of hyoscyamine because of secondary antimuscarinic activities of these medications); antacids/antidiarrheals (may reduce absorption of hyoscyamine, concurrent use with antacids may cause urine to become alkaline reducing effectiveness of methenamine by inhibiting its conversion to formaldehyde) doses of these medications should be spaced 1 hour apart from doses of hyoscyamine; antimyasthenics (concurrent use with hyoscyamine may further reduce intestinal motility); ketoconazole (patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine oxidase (MAO) Inhibitors (concurrent use may intensify antimuscarinic side effects, opoid (narcotic) analgesics may result in increased risk of severe constipation); sulfonamides (these drugs may precipitate with formaldehyde in the urine, increasing the danger of crystalluria).

Patients should be advised that the urine may become blue to blue green and the feces may be discolored as a result of the excretion of methylene blue.

Adverse Reactions

Cardiovascular – rapid pulse, flushing

Central Nervous System – blurred vision, dizziness

Respiratory – shortness of breath or troubled breathing

Genitourinary – difficulty micturition, acute urinary retention

Gastrointestinal – dry mouth, nausea/vomiting

Drug Abuse and Dependence

A dependence on the use of UROGESIC-BLUE™ has not been reported and due to the nature of its ingredients, abuse of UROGESIC-BLUE™ is not expected.

Overdosage

Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 mg to 4 mg (0.5 mg to 1 mg in children), repeated as needed in one to two hours to reverse severe antimuscarinic symptoms. Administration of small doses of diazepam to control excitement and seizures. Artificial respiration with oxygen if needed for respiratory depression. Adequate hydration. Symptomatic treatment as necessary.

Urogesic Blue Dosage and Administration

Adults

One tablet orally 4 times per day followed by liberal fluid intake.

Older Children

Dosage must be individualized by physician. Not recommended for use in children up to 6 years of age.

How is Urogesic Blue Supplied

UROGESIC-BLUE™ are light blue to blue, oval, biconvex tablets debossed with "ED UB" with scoreline on one side and plain on the other side. Supplied in bottles of 100 tablets (NDC 0485-0051-01).

CAUTION

RX ONLY

STORAGE

Store at 25° C (77° F); excursions permitted to 15° C to 30° C (59° F to 86° F) [See USP Controlled Room Temperature]. Keep container tightly closed.

Manufactured for:

Edwards Pharmaceutical, Inc.

111 W. Mulberry St. Ripley, Mississippi 38663

Manufactured by:

Belcher Pharmaceuticals, Inc.

Largo, FL 33777

January 2010 R - 0110

PRINCIPAL DISPLAY PANEL - 100 count Tablet Bottle Label

NDC 0485-0051-01

UROGESIC-BLUE ™

URINARY ANTISEPTIC

ANTISPASMODIC

DESCRIPTION: Each tablet contains:

Methenamine, USP	81.6 mg
Monobasic Sodium Phosphate, USP	40.8 mg
Methylene Blue, USP	10.8 mg
Hyoscyamine Sulfate, USP	0.12 mg

CONTENTS: 100 TABLETS

RX ONLY

Manufactured for

EDWARDS

PHARMACEUTICAL, INC.

Ripley, MS 38663

Urogesic Blue
methenamine, sodium phosphate, monobasic, methylene blue, and hyoscyamine sulfate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0485-0051
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHENAMINE (METHENAMINE)	METHENAMINE	81.6 mg
SODIUM PHOSPHATE, MONOBASIC (SODIUM CATION)	SODIUM PHOSPHATE, MONOBASIC	40.8 mg
METHYLENE BLUE (METHYLENE BLUE)	METHYLENE BLUE	10.8 mg
HYOSCYAMINE SULFATE (HYOSCYAMINE)	HYOSCYAMINE SULFATE	0.12 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE
MANNITOL
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	OVAL (biconvex)	Size	13mm
Flavor		Imprint Code	ED;UB
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0485-0051-01	100 TABLET In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		04/30/2010

Labeler - EDWARDS PHARMACEUTICAL, INC. (195118880)

Establishment
Name	Address	ID/FEI	Operations
BELCHER PHARMACEUTIALS, INC.		175968069	MANUFACTURE, ANALYSIS, PACK, LABEL

Revised: 04/2010EDWARDS PHARMACEUTICAL, INC.

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Urogesic Blue Use in Pregnancy & Breastfeeding
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Urinary Tract Infection

urofollitropin Intramuscular, Subcutaneous, Injection

ure-oh-FOL-li-troe-pin

Commonly used brand name(s)

In the U.S.

Bravelle

Fertinex

In Canada

Fertinorm Hp

Metrodin

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Female Reproductive Agent

Pharmacologic Class: Human Follicle Stimulating Hormone

Uses For urofollitropin

Urofollitropin is a fertility drug that is identical to the hormone called follicle-stimulating hormone (FSH) that is produced naturally by the pituitary gland.

FSH is primarily responsible for stimulating growth of the ovarian follicle, which includes the developing egg, the cells surrounding the egg that produce the hormones needed to support a pregnancy, and the fluid around the egg. As the ovarian follicle grows, an increasing amount of the hormone estrogen is produced by the cells in the follicle and released into the bloodstream. Estrogen causes the endometrium (lining of the uterus) to thicken before ovulation occurs. The higher blood levels of estrogen will also provide a cue to the hypothalamus and pituitary gland to slow the production and release of FSH.

Another pituitary hormone, luteinizing hormone (LH), also helps to increase the amount of estrogen produced by the follicle cells. However, the main function of LH is to cause ovulation. The sharp rise in the blood level of LH that triggers ovulation is sometimes called the LH surge. After ovulation, the group of hormone-producing follicle cells become what is called the corpus luteum and will produce estrogen and large amounts of another hormone, progesterone. Progesterone causes the endometrium to mature so that it can support the egg after it is fertilized. If implantation of a fertilized egg does not occur, the levels of estrogen and progesterone decrease, the endometrium sloughs off, and menstruation occurs.

Urofollitropin is usually given in combination with human chorionic gonadotropin (hCG). The actions of hCG are almost identical to those of LH. It is given to simulate the natural LH surge. This results in predictable ovulation.

Urofollitropin is often used in women who have low levels of FSH and too-high levels of LH. Women with polycystic ovary syndrome usually have hormone levels such as this and are treated with urofollitropin to make up for the low amounts of FSH. Many women being treated with urofollitropin have already tried clomiphene (e.g., Serophene) and have not been able to conceive yet. Urofollitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

Urofollitropin is to be given only by or under the supervision of your doctor.

Before Using urofollitropin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For urofollitropin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to urofollitropin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of urofollitropin

Dosing

The dose of urofollitropin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of urofollitropin. If your dose is different, do not change it unless your doctor tells you to do so.

For injection dosage form:
- For becoming pregnant while having a condition called polycystic ovary syndrome:
  - Adults—75 Units injected under the skin or into a muscle once a day for seven or more days. Usually, another medicine called chorionic gonadotropin (hCG) will be given the day after the last dose. If needed, your doctor may then increase your dose of urofollitropin to 150 Units a day for another seven or more days. Higher doses may be prescribed by your doctor.
- For becoming pregnant while using other pregnancy-promoting methods (assisted reproductive technology [ART]):
  - Adults—150 Units injected under the skin or into a muscle once a day. Your treatment will probably begin on Day 2 or Day 3 after your menstrual period begins. Usually, another medicine called chorionic gonadotropin (hCG) will be given the day after the last dose.

Precautions While Using urofollitropin

It is very important that your doctor check your progress at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will likely want to monitor the development of the ovarian follicle(s) by measuring the amount of estrogen in your bloodstream and by checking the size of the follicle(s) with ultrasound examinations.

If your doctor has asked you to record your basal body temperature (BBT) daily, make sure that you do this every day. It is important that intercourse take place around the time of ovulation to give you the best chance of becoming pregnant.

urofollitropin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Abdominal or pelvic pain

bloating (mild)

redness, pain, or swelling at the injection site

Less common or rare

Abdominal or stomach pain (severe)

bloating (moderate to severe)

decreased amount of urine

feeling of indigestion

fever and chills

nausea, vomiting, or diarrhea (continuing or severe)

pelvic pain (severe)

shortness of breath

skin rash or hives

swelling of lower legs

weight gain (rapid)

Less common or rare

Breast tenderness

diarrhea (mild)

nausea

vomiting

After you stop using urofollitropin, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Abdominal or stomach pain (severe)

bloating (moderate to severe)

decreased amount of urine

feeling of indigestion

nausea, vomiting, or diarrhea (continuing or severe)

pelvic pain (severe)

shortness of breath

swelling of lower legs

weight gain (rapid)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: urofollitropin Intramuscular, Subcutaneous, Injection side effects (in more detail)

More urofollitropin Intramuscular, Subcutaneous, Injection resources

Urofollitropin Intramuscular, Subcutaneous, Injection Side Effects (in more detail)
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Female Infertility
Follicle Stimulation

Uritact-EC Delayed-Release Tablets

Pronunciation: A-troe-peen/ben-ZOE-ik AS-id/hye-oh-SYE-a-meen/meth-EN-a-meen/METH-i-leen/FEN-ill sa-LI-si-late
Generic Name: Atropine/Benzoic Acid/Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate
Brand Name: Prosed ED and Uritact-EC

Uritact-EC Delayed-Release Tablets are used for:

Treating painful and irritating symptoms of the urinary tract due to urinary tract infections or diagnostic procedures.

Uritact-EC Delayed-Release Tablets are a urinary antiseptic, urinary acidifier, analgesic, and anticholinergic combination. It works by helping to kill bacteria in the urine, decreasing pain and inflammation, and reducing muscle spasms in the urinary tract. These actions work together to help relieve discomfort while urinating.

Do NOT use Uritact-EC Delayed-Release Tablets if:

you are allergic to any ingredient in Uritact-EC Delayed-Release Tablets

you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin, other salicylate medicines, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)

you have angle-closure glaucoma, problems with your esophagus, bowel motility problems, a blockage of your bladder or bowel, severe intestinal problems (eg, ulcerative colitis), severe bleeding, flu or chickenpox, myasthenia gravis, severe kidney problems, or you are severely dehydrated

you are taking a sulfonamide (eg, sulfamethoxazole)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Uritact-EC Delayed-Release Tablets:

Some medical conditions may interact with Uritact-EC Delayed-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have constipation, diarrhea, an infection of the stomach or bowel, a hiatal hernia, or stomach ulcers

if you have nervous system problems, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, gout, influenza, Kawasaki syndrome, rheumatic disease, open-angle glaucoma, risk factors for angle-closure glaucoma, kidney or liver problems, an enlarged prostate, bladder problems, or you are unable to urinate

if you have a history of stroke or brain blood vessel problems (eg, aneurysm), an irregular heartbeat, heart blood vessel problems, congestive heart failure, heart valve problems, or other heart problems

if you are on a low-salt diet

Some MEDICINES MAY INTERACT with Uritact-EC Delayed-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticholinergics (eg, benztropine) because they may increase the risk of Uritact-EC Delayed-Release Tablets's side effects.

Ketoconazole because it may decrease Uritact-EC Delayed-Release Tablets's effectiveness.

Monoamine oxidase inhibitors (MAOIs)or narcotic pain medicine (eg, codeine) because the risk of serious side effects may be increased.

Medicine for myasthenia gravis (eg, ambenonium), phenothiazines (eg, chlorpromazine), sulfonamides (eg, sulfamethoxazole), thiazide diuretics (eg, hydrochlorothiazide), or urinary alkalinizers (eg, sodium bicarbonate) because their effectiveness may be decreased by Uritact-EC Delayed-Release Tablets.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Uritact-EC Delayed-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Uritact-EC Delayed-Release Tablets:

Use Uritact-EC Delayed-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Uritact-EC Delayed-Release Tablets by mouth with or without food.

Swallow Uritact-EC Delayed-Release Tablets whole. Do not break, crush, or chew before swallowing.

Do not take an antacid or antidiarrheal medicine (eg, loperamide) within 1 hour before or after you take Uritact-EC Delayed-Release Tablets.

Drinking extra fluids while you are taking Uritact-EC Delayed-Release Tablets are recommended. Check with your doctor for instructions.

If you miss a dose of Uritact-EC Delayed-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Uritact-EC Delayed-Release Tablets.

Important safety information:

Uritact-EC Delayed-Release Tablets may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Uritact-EC Delayed-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.

Uritact-EC Delayed-Release Tablets may discolor the urine or stools a blue-green color. This is normal and not a cause for concern.

Uritact-EC Delayed-Release Tablets contains salicylate. Salicylates have been linked to a serious illness called Reye syndrome. Do not give Uritact-EC Delayed-Release Tablets to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.

Use Uritact-EC Delayed-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, drowsiness, and confusion.

Uritact-EC Delayed-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: It is not known if Uritact-EC Delayed-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Uritact-EC Delayed-Release Tablets while you are pregnant. Uritact-EC Delayed-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Uritact-EC Delayed-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Uritact-EC Delayed-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry mouth; flushing; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; difficulty urinating; dizziness; fast or irregular heartbeat.

See also: Uritact-EC side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Uritact-EC Delayed-Release Tablets:

Store Uritact-EC Delayed-Release Tablets between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Uritact-EC Delayed-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Uritact-EC Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

Uritact-EC Delayed-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Uritact-EC Delayed-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Uritact-EC resources

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Urinary Tract Infection

Urocit-K

potassium citrate

Dosage Form: tablet, extended release
FULL PRESCRIBING INFORMATION

Indications and Usage for Urocit-K

Renal tubular acidosis (RTA) with calcium stones

Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)].

Hypocitraturic calcium oxalate nephrolithiasis of any etiology

Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)].

Uric acid lithiasis with or without calcium stones

Potassium citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)].

Urocit-K Dosage and Administration

Dosing Instructions

Treatment with extended release potassium citrate should be added to a regimen that limits salt intake (avoidance of foods with high salt content and of added salt at the table) and encourages high fluid intake (urine volume should be at least two liters per day). The objective of treatment with Urocit®-K is to provide Urocit®-K in sufficient dosage to restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 or 7.0.

Monitor serum electrolytes (sodium, potassium, chloride and carbon dioxide), serum creatinine and complete blood counts every four months and more frequently in patients with cardiac disease, renal disease or acidosis. Perform electrocardiograms periodically. Treatment should be discontinued if there is hyperkalemia, a significant rise in serum creatinine or a significant fall in blood hemocrit or hemoglobin.

Severe Hypocitraturia

In patients with severe hypocitraturia (urinary citrate < 150 mg/day), therapy should be initiated at a dosage of 60 mEq/day (30 mEq two times/day or 20 mEq three times/day with meals or within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. In addition, urinary citrate and/or pH should be measured every four months. Doses of Urocit®-K greater than 100 mEq/day have not been studied and should be avoided.

Mild to Moderate Hypocitraturia

In patients with mild to moderate hypocitraturia (urinary citrate > 150 mg/day) therapy should be initiated at 30 mEq/day (15 mEq two times/day or 10 mEq three times/day within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. Doses of Urocit®-K greater than 100 mEq/day have not been studied and should be avoided.

Dosage Forms and Strengths

5 mEq tablets are uncoated, tan to yellowish in color, modified ball shaped, with MPC 600 debossed on one side and blank on the other

10 mEq tablets are uncoated, tan to yellowish in color, elliptical shaped, with 610 debossed on one side and MISSION on the other

15 mEq tablets are uncoated, tan to yellowish in color, modified rectangle shaped, with M15 debossed on one side and blank on the other

Contraindications

Urocit®-K is contraindicated:

In patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride).

In patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture, or those taking anticholinergic medication.

In patients with peptic ulcer disease because of its ulcerogenic potential.

In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones). The ability of Urocit®-K to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from Urocit®-K therapy might promote further bacterial growth.

In patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia.

Warnings and Precautions

Hyperkalemia

In patients with impaired mechanisms for excreting potassium, Urocit®-K administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Urocit®-K in patients with chronic renal failure, or any other condition which impairs potassium excretion such as severe myocardial damage or heart failure, should be avoided. Closely monitor for signs of hyperkalemia with periodic blood tests and ECGs.

Gastrointestinal Lesions

Because of reports of upper gastrointestinal mucosal lesions following administration of potassium chloride (wax-matrix), an endoscopic examination of the upper gastrointestinal mucosa was performed in 30 normal volunteers after they had taken glycopyrrolate 2 mg p.o. t.i.d., Urocit®-K 95 mEq/day, wax-matrix potassium chloride 96 mEq/day or wax-matrix placebo, in thrice daily schedule in the fasting state for one week. Urocit®-K and the wax-matrix formulation of potassium chloride were indistinguishable but both were significantly more irritating than the wax-matrix placebo. In a subsequent, similar study, lesions were less severe when glycopyrrolate was omitted.

Solid dosage forms of potassium chlorides have produced stenotic and/or ulcerative lesions of the small bowel and deaths. These lesions are caused by a high local concentration of potassium ions in the region of the dissolving tablets, which injured the bowel. In addition, perhaps because wax-matrix preparations are not enteric-coated and release some of their potassium content in the stomach, there have been reports of upper gastrointestinal bleeding associated with these products. The frequency of gastrointestinal lesions with wax-matrix potassium chloride products is estimated at one per 100,000 patient-years. Experience with Urocit®-K is limited, but a similar frequency of gastrointestinal lesions should be anticipated.

If there is severe vomiting, abdominal pain or gastrointestinal bleeding, Urocit®-K should be discontinued immediately and the possibility of bowel perforation or obstruction investigated.

Adverse Reactions

Postmarketing Experience

Some patients may develop minor gastrointestinal complaints during Urocit®-K therapy, such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These symptoms are due to the irritation of the gastrointestinal tract, and may be alleviated by taking the dose with meals or snacks, or by reducing the dosage. Patients may find intact matrices in their feces.

Drug Interactions

Potential Effects of Potassium citrate on Other Drugs

Potassium-sparing Diuretics: Concomitant administration of Urocit®-K and a potassium-sparing diuretic (such as triamterene, spironolactone or amiloride) should be avoided since the simultaneous administration of these agents can produce severe hyperkalemia.

Potential Effects of Other Drugs on Potassium citrate

Drugs that slow gastrointestinal transit time: These agents (such as anticholinergics) can be expected to increase the gastrointestinal irritation produced by potassium salts.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted. It is also not known whether Urocit®-K can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Urocit®-K should be given to a pregnant woman only if clearly needed.

Nursing Mothers

The normal potassium ion content of human milk is about 13 mEq/L. It is not known if Urocit®-K has an effect on this content. Urocit®-K should be given to a woman who is breast feeding only if clearly needed.

Pediatric Use

Safety and effectiveness in children have not been established.

Overdosage

Treatment of Overdosage: The administration of potassium salts to persons without predisposing conditions for hyperkalemia rarely causes serious hyperkalemia at recommended dosages. It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic electrocardiographic changes (peaking of T-wave, loss of P-wave, depression of S-T segment and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest.

Treatment measures for hyperkalemia include the following:

Patients should be closely monitored for arrhythmias and electrolyte changes.

Elimination of medications containing potassium and of agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements and many others.

Elimination of foods containing high levels of potassium such as almonds, apricots, bananas, beans (lima, pinto, white), cantaloupe, carrot juice (canned), figs, grapefruit juice, halibut, milk, oat bran, potato (with skin), salmon, spinach, tuna and many others.

Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.

Intravenous administration of 300-500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.

Correction of acidosis, if present, with intravenous sodium bicarbonate.

Hemodialysis or peritoneal dialysis.

Exchange resins may be used. However, this measure alone is not sufficient for the acute treatment of hyperkalemia.

Lowering potassium levels too rapidly in patients taking digitalis can produce digitalis toxicity.

Urocit-K Description

Urocit®-K is a citrate salt of potassium. Its empirical formula is K3C6H5O7 • H2O, and it has the following chemical structure:

Urocit®-K yellowish to tan, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate and 15 mEq (1620 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate.

Urocit-K - Clinical Pharmacology

Mechanism of Action

When Urocit®-K is given orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultrafilterable serum citrate. Thus, Urocit®-K therapy appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate. The increased filtered load of citrate may play some role, however, as in small comparisons of oral citrate and oral bicarbonate, citrate had a greater effect on urinary citrate.

In addition to raising urinary pH and citrate, Urocit®-K increases urinary potassium by approximately the amount contained in the medication. In some patients, Urocit®-K causes a transient reduction in urinary calcium.

The changes induced by Urocit®-K produce urine that is less conducive to the crystallization of stone-forming salts (calcium oxalate, calcium phosphate and uric acid). Increased citrate in the urine, by complexing with calcium, decreases calcium ion activity and thus the saturation of calcium oxalate. Citrate also inhibits the spontaneous nucleation of calcium oxalate and calcium phosphate (brushite).

The increase in urinary pH also decreases calcium ion activity by increasing calcium complexation to dissociated anions. The rise in urinary pH also increases the ionization of uric acid to the more soluble urate ion.

Urocit®-K therapy does not alter the urinary saturation of calcium phosphate, since the effect of increased citrate complexation of calcium is opposed by the rise in pH-dependent dissociation of phosphate. Calcium phosphate stones are more stable in alkaline urine.

In the setting of normal renal function, the rise in urinary citrate following a single dose begins by the first hour and lasts for 12 hours. With multiple doses the rise in citrate excretion reaches its peak by the third day and averts the normally wide circadian fluctuation in urinary citrate, thus maintaining urinary citrate at a higher, more constant level throughout the day. When the treatment is withdrawn, urinary citrate begins to decline toward the pre-treatment level on the first day.

The rise in citrate excretion is directly dependent on the Urocit®-K dosage. Following long-term treatment, Urocit®-K at a dosage of 60 mEq/day raises urinary citrate by approximately 400 mg/day and increases urinary pH by approximately 0.7 units.

In patients with severe renal tubular acidosis or chronic diarrheal syndrome where urinary citrate may be very low (<100 mg/day), Urocit®-K may be relatively ineffective in raising urinary citrate. A higher dose of Urocit®-K may therefore be required to produce a satisfactory citraturic response. In patients with renal tubular acidosis in whom urinary pH may be high, Urocit®-K produces a relatively small rise in urinary pH.

Clinical Studies

The pivotal Urocit®-K trials were non-randomized and non-placebo controlled where dietary management may have changed coincidentally with pharmacological treatment. Therefore, the results as presented in the following sections may overstate the effectiveness of the product.

Renal tubular acidosis (RTA) with calcium stones

The effect of oral potassium citrate therapy in a non-randomized, non-placebo controlled clinical study of five men and four women with calcium oxalate/calcium phosphate nephrolithiasis and documented incomplete distal renal tubular acidosis was examined. The main inclusion criterion was a history of stone passage or surgical removal of stones during the 3 years prior to initiation of potassium citrate therapy. All patients began alkali treatment with 60-80 mEq potassium citrate daily in 3 or 4 divided doses. Throughout treatment, patients were instructed to stay on a sodium restricted diet (100 mEq/day) and to reduce oxalate intake (limited intake of nuts, dark roughage, chocolate and tea). A moderate calcium restriction (400-800 mg/day) was imposed on patients with hypercalciuria.

X-rays of the urinary tract, available in all patients, were reviewed to determine presence of pre-existing stones, appearance of new stones, or change in the number of stones.

Potassium citrate therapy was associated with inhibition of new stone formation in patients with distal tubular acidosis. Three of the nine patients continued to pass stones during the on-treatment phase. While it is likely that these patients passed pre-existing stones during therapy, the most conservative assumption is that the passed stones were newly formed. Using this assumption, the stone-passage remission rate was 67%. All patients had a reduced stone formation rate. Over the first 2 years of treatment, the on-treatment stone formation rate was reduced from 13±27 to 1±2 per year.

Hypocitraturic calcium oxalate nephrolithiasis of any etiology

Eighty-nine patients with hypocitraturic calcium nephrolithiasis or uric acid lithiasis with or without calcium nephrolithiasis participated in this non-randomized, non-placebo controlled clinical study. Four groups of patients were treated with potassium citrate: Group 1 was comprised of 19 patients, 10 with renal tubular acidosis and 9 with chronic diarrheal syndrome, Group 2 was comprised of 37 patients, 5 with uric acid stones alone, 6 with uric acid lithiasis and calcium stones, 3 with type 1 absorptive hypercalciuria, 9 with type 2 absorptive hypercalciuria and 14 with hypocitraturia. Group 3 was comprised of 15 patients with history of relapse on other therapy and Group 4 was comprised of 18 patients, 9 with type 1 absorptive hypercalciuria and calcium stones, 1 with type 2 absorptive hypercalciuria and calcium stones, 2 with hyperuricosuric calcium oxalate nephrolithiasis, 4 with uric acid lithiasis accompanied by calcium stones and 2 with hypocitraturia and hyperuricemia accompanied by calcium stones. The dose of potassium citrate ranged from 30 to 100 mEq per day, and usually was 20 mEq administered orally 3 times daily. Patients were followed in an outpatient setting every 4 months during treatment and were studied over a period from 1 to 4.33 years. A three-year retrospective pre-study history for stone passage or removal was obtained and corroborated by medical records. Concomitant therapy (with thiazide or allopurinol) was allowed if patients had hypercalciuria, hyperuricosuria or hyperuricemia. Group 2 was treated with potassium citrate alone.

In all groups, treatment that included potassium citrate was associated with a sustained increase in urinary citrate excretion from subnormal values to normal values (400 to 700 mg/day), and a sustained increase in urinary pH from 5.6-6.0 to approximately 6.5. The stone formation rate was reduced in all groups as shown in Table 1.

Table 1. Effect of Urocit®-K In Patients With Calcium Oxalate Nephrolithiasis.
Stones Formed Per Year
Group	Baseline	On Treatment	Remission*	Any Decrease
* Remission defined as "the percentage of patients remaining free of newly formed stones during treatment".
I (n=19)	12 ± 30	0.9 ± 1.3	58%	95%
II (n=37)	1.2 ± 2	0.4 ± 1.5	89%	97%
III (n=15)	4.2 ± 7	0.7 ± 2	67%	100%
IV (n=18)	3.4 ± 8	0.5 ± 2	94%	100%
Total (n=89)	4.3 ±15	0.6 ± 2	80%	98%

Uric acid lithiasis with or without calcium stones

A long-term non-randomized, non-placebo controlled clinical trial with eighteen adult patients with uric acid lithiasis participated in the study. Six patients formed only uric acid stones, and the remaining 12 patients formed mixed stones containing both uric acid and calcium salts or formed both uric acid stones (without calcium salts) and calcium stones (without uric acid) on separate occasions.

Eleven of the 18 patients received potassium citrate alone. Six of the 7 other patients also received allopurinol for hyperuricemia with gouty arthritis, symptomatic hyperuricemia, or hyperuricosuria. One patient also received hydrochlorothiazide because of unclassified hypercalciuria. The main inclusion criterion was a history of stone passage or surgical removal of stones during the 3 years prior to initiation of potassium citrate therapy. All patients received potassium citrate at a dosage of 30-80 mEq/day in three-to-four divided doses and were followed every four months for up to 5 years.

While on potassium citrate treatment, urinary pH rose significantly from a low value of 5.3 ± 0.3 to within normal limits (6.2 to 6.5). Urinary citrate which was low before treatment rose to the high normal range and only one stone was formed in the entire group of 18 patients.

REFERENCES

Pak, C. (1987). Citrate and Renal Calculi. Mineral and Electrolyte Metabolism 13, 257-266.

Pak, C. (1985). Long-Term Treatment of Calcium Nephrolithiasis with Potassium Citrate. The Journal of Urology 134, 11-19.

Preminger, G.M., K. Sakhaee, C. Skurla and C.Y.C. Pak. (1985). Prevention of Recurrent Calcium Stone Formation with Potassium Citrate Therapy in Patients with Distal Renal Tubular Acidosis. The Journal of Urology 134, 20-23.

Pak, C.Y.C., K. Sakhaee and C. Fuller. (1986). Successful Management of Uric Acid Nephrolithiasis with Potassium Citrate. Kidney International 30, 422-428.

Hollander-Rodriguez, J et al. (2006). Hyperkalemia, American Family Physician, Vol. 73/No. 2.

Greenberg, A et al. (1998). Hyperkalemia: treatment options. Semen Nephrol. Jan; 18 (1): 46-57.

How Supplied/Storage and Handling

Urocit®-K 5 mEq tablets are uncoated, tan to yellowish in color, modified ball shaped, with MPC 600 debossed on one side and blank on the other, supplied in bottles as:

NDC 0178-0600-01 Bottle of 100

Urocit®-K 10 mEq tablets are uncoated, tan to yellowish in color, elliptical shaped, with MPC 610 debossed on one side and MISSION on the other, supplied in bottles as:

NDC 0178-0610-01 Bottle of 100

Urocit®-K 15 mEq tablets are uncoated, tan to yellowish in color, modified rectangle shaped, with M15 debossed on one side and blank on the other, supplied in bottles as:

NDC 0178-0615-01 Bottle of 100

Storage: Store in a tight container.

Patient Counseling Information

Administration of Drug

Tell patients to take each dose without crushing, chewing or sucking the tablet.

Tell patients to take this medicine only as directed. This is especially important if the patient is also taking both diuretics and digitalis preparations.

Tell patients to check with the doctor if there is trouble swallowing tablets or if the tablet seems to stick in the throat.

Tell patients to check with the doctor at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.

Tell patients that their doctor will perform regular blood tests and electrocardiograms to ensure safety.

KP-503 C01 Rev 012090

MISSION PHARMACAL COMPANY, SAN ANTONIO, TX USA 78230 1355

PRINCIPAL DISPLAY PANEL - 5 mEq Bottle Label

NDC 0178-0600-01

UROCIT®-K

5 mEq

(Potassium Citrate)

Extended-release tablet

5 mEq (540 mg) per tablet

Rx only

100 Tablets

Mission

Pharmacal

PRINCIPAL DISPLAY PANEL - 10 mEq Bottle Label

NDC 0178-0610-01

UROCIT®-K

10 mEq

(Potassium Citrate)

Extended-release tablet

10 mEq (1080 mg) per tablet

Rx only

100 Tablets

Mission

Pharmacal

PRINCIPAL DISPLAY PANEL - 15 mEq Bottle Label

NDC 0178-0615-01

UROCIT®-K

15 mEq

(Potassium Citrate)

Extended-release tablet

15 mEq (1620 mg) per tablet

Rx only

100 Tablets

Mission

Pharmacal

Urocit-K
potassium citrate tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0178-0600
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
potassium citrate (potassium cation)	potassium citrate	5 meq

Inactive Ingredients
Ingredient Name	Strength
carnauba wax
magnesium stearate

Product Characteristics
Color	yellow (tan to yellowish)	Score	no score
Shape	round (modified ball)	Size	10mm
Flavor		Imprint Code	MPC;600
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0178-0600-01	100 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019071	09/01/1985

Urocit-K
potassium citrate tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0178-0610
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
potassium citrate (potassium cation)	potassium citrate	10 meq

Inactive Ingredients
Ingredient Name	Strength
carnauba wax
magnesium stearate

Product Characteristics
Color	yellow (tan to yellowish)	Score	no score
Shape	oval (ellipitcal)	Size	19mm
Flavor		Imprint Code	MPC;610;MISSION
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0178-0610-01	100 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019071	09/01/1992

Urocit-K
potassium citrate tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0178-0615
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
potassium citrate (potassium cation)	potassium citrate	15 meq

Inactive Ingredients
Ingredient Name	Strength
carnauba wax
magnesium stearate

Product Characteristics
Color	yellow (tan to yellowish)	Score	no score
Shape	rectangle (modified rectangle)	Size	20mm
Flavor		Imprint Code	M15
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0178-0615-01	100 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019071	01/27/2010

Labeler - Mission Pharmacal Company (008117095)

Establishment
Name	Address	ID/FEI	Operations
Mission Pharmacal Company		927726893	MANUFACTURE

Revised: 04/2010Mission Pharmacal Company

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Urocit-K Side Effects (in more detail)
Urocit-K Dosage
Urocit-K Use in Pregnancy & Breastfeeding
Drug Images
Urocit-K Drug Interactions
Urocit-K Support Group
0 Reviews for Urocit-K - Add your own review/rating

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Nephrolithiasis
Renal Tubular Acidosis

Monday, October 24, 2016

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