Drugs Details

Drugs Info of Hiprex, Mandelamine, Urex
Drugs Details
  • Drugs Type  : Multum
  • Date : 2nd Feb 2015 12:11 am
  • Brand Name : Hiprex, Mandelamine, Urex
  • Generic Name : methenamine (Pronunciation: meh THEH na meen)
Descriptions

Each yellow capsule-shaped tablet contains 1 g Methenamine Hippurate which is the Hippuric Acid Salt of Methenamine (hexamethylene tetramine). The tablet also contains inactive ingredients. FD&C Yellow No. 5 (tartrazine, see PRECAUTIONS), Magnesium Stearate, Povidone, and Saccharin Sodium.

What are the possible side effects of methenamine (Hiprex, Mandelamine, Urex)?

If you experience any of the following serious side effects, stop taking methenamine and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives;
  • lower back or side pain;
  • blood in urine; or
  • increasingly painful or difficult urination.

Other, less serious side effects may be more likely to occur. Continue to take methenamine and talk to your doctor if you experience

  • nausea or upset...

Read All Potential Side Effects and See Pictures of Hiprex »

What are the precautions when taking methenamine hippurate (Hiprex)?

Before taking methenamine, tell your doctor or pharmacist if you are allergic to it; or to formaldehyde; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, dehydration.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and the effect on a...

Read All Potential Precautions of Hiprex »


This monograph has been modified to include the generic and brand name in many instances.

Indications

HIPREX (methenamine hippurate) is indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of HIPREX (methenamine hippurate) and other antibacterial drugs, HIPREX (methenamine hippurate) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Dosage Administration

1 tablet (1.0 g) twice daily (morning and night) for adults and pediatric patients over 12 years of age. 1/2 to 1 tablet (0.5 to 1.0 g) twice daily (morning and night) for pediatric patients 6 to 12 years of age. Since the antibacterial activity of HIPREX (methenamine hippurate) is greater in acid urine, restriction of alkalinizing foods and medications is desirable. If necessary, as indicated by urinary pH and clinical response, supplemental acidification of the urine should be instituted. The efficacy of therapy should be monitored by repeated urine cultures.

How Supplied

1-gram scored, capsule-shaped yellow tablets debossed MERRELL 277 in bottles of 100 (NDC 0068-0277-61)

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Rev. March 2006. Manufactured for: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807. FDA revision date: 11/21/05


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Minor adverse reactions have been reported in less than 3.5% of patients treated. These reactions have included nausea, upset stomach, dysuria, and rash.

Read the Hiprex (methenamine hippurate) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided.

Read the Hiprex Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Large doses of methenamine (8 grams daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.

Precautions

Prescribing HIPREX (methenamine hippurate) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

  1. Care should be taken to maintain an acid pH of the urine, especially when treating infections due to urea-splitting organisms such as Proteus and strains of Pseudomonas.
  2. In a few instances in one study, the serum transaminase levels were slightly elevated during treatment but returned to normal while the patients were still taking HIPREX (methenamine hippurate) . Because of this report, it is recommended that liver function studies be performed periodically on patients taking the drug, especially those with liver dysfunction.
  3. Use in Pregnancy: In early pregnancy the safe use of HIPREX (methenamine hippurate) is not established. In the last trimester, safety is suggested, but not definitely proved. No adverse effects on the fetus were seen in studies in pregnant rats and rabbits. HIPREX (methenamine hippurate) taken during pregnancy can interfere with laboratory tests of urine estriol (resulting in unmeasurably low values) when acid hydrolysis is used in the laboratory procedure. This interference is due to the presence in the urine of methenamine and/or formaldehyde. Enzymatic hydrolysis, in place of acid hydrolysis, will circumvent this problem.
  4. This product contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Geriatric Use

Clinical studies of HIPREX (methenamine hippurate) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

HIPREX (methenamine hippurate) is contraindicated in patients with renal insufficiency and severe hepatic insufficiency (see CONTRAINDICATIONS).


This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provider.

ContrainDications

HIPREX (methenamine hippurate tablets USP) is contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. Methenamine preparations should not be given to patients taking sulfonamides because some sulfonamides may form an insoluble precipitate with formaldehyde in the urine.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Actions

Microbiology: HIPREX (methenamine hippurate tablets USP) has antibacterial activity because the methenamine component is hydrolyzed to formaldehyde in acid urine. Hippuric acid, the other component, has some antibacterial activity and also acts to keep the urine acid. The drug is generally active against E. coli, enterococci and staphylococci. Enterobacter aerogenes is generally resistant. The urine must be kept sufficiently acid for urea-splitting organisms such as Proteus and Pseudomonas to be inhibited.

Human Pharmacology: Within 1/2 hour after ingestion of a single 1-gram dose of HIPREX (methenamine hippurate) , antibacterial activity is demonstrable in the urine. Urine has continuous antibacterial activity when HIPREX (methenamine hippurate) is administered at the recommended dosage schedule of 1 gram twice daily. Over 90% of methenamine moiety is excreted in the urine within 24 hours after administration of a single 1-gram dose. Similarly, the hippurate moiety is rapidly absorbed and excreted, and it reaches the urine by both tubular secretion and glomerular filtration. This action may be important in older patients or in those with some degree of renal impairment.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients should be counseled that antibacterial drugs including HIPREX (methenamine hippurate) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When HIPREX (methenamine hippurate) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by HIPREX (methenamine hippurate) or other antibacterial drugs in the future.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

METHENAMINE - ORAL

 

(meth-EN-a-meen)

 

COMMON BRAND NAME(S): Hiprex, Mandelamine, Urex

 

USES: Methenamine is used to prevent or control returning urinary tract infections caused by certain bacteria. It is not used to treat an active infection. Other antibiotics must be used first to treat and cure the infection. Methenamine is an antibiotic that stops the growth of bacteria in urine. This medication also contains an ingredient that helps to make the urine acidic. When the urine is acidic, methenamine turns into formaldehyde to kill the bacteria.

This antibiotic is effective only against bacterial infections in the urinary tract. It will not work for other types of bacterial infections (such as in the blood) or for viral infections (such as the common cold or flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

 

HOW TO USE: Take this medication by mouth as directed by your doctor. Dosage is based on the brand of methenamine you are prescribed, your medical condition, and your response to treatment. For children, dosage is also based on age and weight.

Methenamine works better if your urine is more acidic. Your doctor may test the acidity of your urine (urine pH). If necessary, your doctor may recommend ways to increase urine acidity (such as by taking vitamin C/drinking cranberry juice, limiting foods that decrease acidity/increase alkalinity such as milk products/most fruits, adjusting alkalinizing medications). See also Drug Interactions section. Follow your doctor's instructions.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.

Continue to take this medication for the full time prescribed, even if you feel well. Skipping doses or stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection and make the bacteria more difficult to treat (resistant). Do not take more of this drug than directed because it may increase your chance of side effects.

Tell your doctor if symptoms of a urinary tract infection return (such as burning/painful/frequent urination).

Consumer Overview Side Effect

SIDE EFFECTS: Nausea, vomiting, diarrhea, abdominal cramps, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Painful or difficult urination may occur with methenamine, although less often. Report these side effects to your doctor, who may need to lower your dose of methenamine or change your treatment to make your urine less acidic.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Taking higher than recommended doses of methenamine may cause bladder irritation, painful/frequent urination, and bloody/pink urine. Tell your doctor immediately if you have any of these symptoms.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mouth sores, unusual headache, ringing in the ears, muscle cramps, swelling of the arms/legs.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Hiprex (methenamine hippurate) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking methenamine, tell your doctor or pharmacist if you are allergic to it; or to formaldehyde; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, dehydration.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also How to Use section.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: sulfonamide drugs (including sulfa antibiotics such as sulfamethizole), products that decrease the amount of acid in the urine (urinary alkalinizers such as antacids, sodium bicarbonate, potassium or sodium citrate, carbonic anhydrase inhibitors such as acetazolamide).

This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as urine tests, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor directs you to do so. A different medication may be necessary in that case.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Hiprex, Mandelamine, Urex

Generic Name: methenamine (Pronunciation: meh THEH na meen)

  • What is methenamine (Hiprex)?
  • What are the possible side effects of methenamine (Hiprex)?
  • What is the most important information I should know about methenamine (Hiprex)?
  • What should I discuss with my healthcare provider before taking methenamine (Hiprex)?
  • How should I take methenamine (Hiprex)?
  • What happens if I miss a dose (Hiprex)?
  • What happens if I overdose (Hiprex)?
  • What should I avoid while taking methenamine (Hiprex)?
  • What other drugs will affect methenamine (Hiprex)?
  • Where can I get more information?

What is methenamine (Hiprex)?

Methenamine is a urinary antiinfective medicine. Methenamine fights bacteria in the urine and bladder.

Methenamine may be used to treat and prevent urinary tract infections.

Methenamine may also be used for purposes other than those listed here.

Hiprex 1 g

oval, yellow, imprinted with MERRELL 277

What are the possible side effects of methenamine (Hiprex)?

If you experience any of the following serious side effects, stop taking methenamine and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives;
  • lower back or side pain;
  • blood in urine; or
  • increasingly painful or difficult urination.

Other, less serious side effects may be more likely to occur. Continue to take methenamine and talk to your doctor if you experience

  • nausea or upset stomach;
  • decreased appetite; or
  • skin rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Hiprex (methenamine hippurate) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about methenamine (Hiprex)?

Take all of the methenamine that has been prescribed for you even if you begin to feel better. Symptoms may start to improve before the infection is completely treated.

Take each dose with a full glass of water. Plenty of fluid should be consumed while taking methenamine.

Your healthcare provider may recommend drinking additional water and/or certain fruit juices (e.g., cranberry, plum, prune) and increased protein in the diet while taking methenamine to ensure adequate hydration and acidity of the urine. It may also be recommended to avoid citrus fruits and juices (e.g., orange, grapefruit, lemon), milk and dairy products, and antacids during treatment with methenamine. These products may decrease the effectiveness of methenamine. Follow your healthcare provider's instructions.

Side Effects Centers
  • Hiprex
  • Urex

Patient Detailed How Take

What should I discuss with my healthcare provider before taking methenamine (Hiprex)?

Before taking methenamine, talk to your doctor if you

  • have liver problems;
  • have kidney problems;
  • have other medical conditions; or
  • take other medications.

You may not be able to take methenamine, or you may require a dosage adjustment or special monitoring during treatment.

Methenamine is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take methenamine without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Methenamine passes into breast milk and may affect a nursing baby. Do not take methenamine without first talking to your doctor if you are breast-feeding a baby.

How should I take methenamine (Hiprex)?

Take methenamine exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse, or pharmacist to explain them to you.

Take each dose with a full glass of water. Plenty of fluid should be consumed while taking methenamine.

Methenamine should be taken with food to reduce stomach upset.

Do not crush or chew the enteric-coated tablets. Swallow them whole. They are specially formulated to be less irritating to the stomach. Talk to your doctor if swallowing the tablets is difficult.

Shake the liquid form of methenamine well before measuring a dose. To ensure that you get the correct dose, measure the suspension with a dose-measuring spoon, dropper, or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

It is important to take methenamine at regularly scheduled intervals to get the most benefit.

Take all of the methenamine that has been prescribed for you even if you begin to feel better. Symptoms may start to improve before the infection is completely treated.

Your healthcare provider may recommend drinking additional water and/or certain fruit juices (e.g., cranberry, plum, prune) and increased protein in the diet while taking methenamine to ensure adequate hydration and acidity of the urine. It may also be recommended to avoid citrus fruits and juices (e.g., orange, grapefruit, lemon), milk and dairy products, and antacids during treatment with methenamine. These products may decrease the effectiveness of methenamine. Follow your healthcare provider's instructions.

Store methenamine at room temperature away from moisture and heat.

Side Effects Centers
  • Hiprex
  • Urex

Patient Detailed Avoid Taking

What happens if I miss a dose (Hiprex)?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose (Hiprex)?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a methenamine overdose are not known.

What should I avoid while taking methenamine (Hiprex)?

Your healthcare provider may recommend drinking additional water and/or certain fruit juices (e.g., cranberry, plum, prune) and increased protein in the diet while taking methenamine to ensure adequate hydration and acidity of the urine. It may also be recommended to avoid citrus fruits and juices (e.g., orange, grapefruit, lemon), milk and dairy products, and antacids during treatment with methenamine. These products may decrease the effectiveness of methenamine. Follow your healthcare provider's instructions.

What other drugs will affect methenamine (Hiprex)?

Do not take methenamine without first talking to your doctor if you are taking:

  • a carbonic anhydrase inhibitor such as acetazolamide (Diamox), dichlorphenamide (Daranide), or methazolamide (Glauctabs, MZM, Neptazane);
  • a sulfa product such as sulfadiazine, sulfamethoxazole (Bactrim, Septra, others), sulfasalazine (Azulfidine), and others;
  • a diuretic (water pill); or
  • a product that contains aluminum, calcium, magnesium, sodium bicarbonate, potassium or sodium citrate, or citric acid (such as antacids, vitamin or mineral pills, urinary alkalinizers, and other medications).

You may not be able to take methenamine, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with methenamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

Your pharmacist has additional information about methenamine written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.04. Revision date: 12/15/2010.

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