Hiprex

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Taking more of this medicine than prescribed will not make it more effective. Taking too much methenamine may cause unwanted side effects, such as bladder irritation, pain, increased urination, and blood in the urine.

Drink plenty of liquids while you are taking methenamine. Your doctor may recommend drinking certain types of liquid (such as cranberry juice) or taking other medicines to make your urine more acidic. Your doctor may also recommend increasing protein in your diet, but avoiding milk or other dairy products. Follow your doctor's instructions very closely.

You may need frequent urine tests to determine that an infection has cleared. You may also need blood tests to check your liver function.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Methenamine will not treat a viral infection such as the flu or a common cold.

Do not use methenamine to treat any condition that has not been checked by your doctor.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

You should not use methenamine if you have kidney disease, severe liver disease, if you also take a sulfa drug, or if you are dehydrated.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

• If you have an allergy to methenamine or any other part of Hiprex (methenamine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Fluid loss (dehydrated), kidney disease or liver disease.
• If you are taking a sulfa (sulfonamide) drug. Ask your doctor if you are not sure if any of your drugs are a sulfa drug.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Hiprex with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Hiprex, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Hiprex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Hiprex (methenamine).

Review Date: October 4, 2017

Hiprex 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 and other antibacterial drugs, Hiprex 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.

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

Prescribing Hiprex 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. 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 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 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.

Information for Patients

Patients should be counseled that antibacterial drugs including Hiprex should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Hiprex 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 or other antibacterial drugs in the future.

Geriatric Use

Clinical studies of Hiprex 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 is contraindicated in patients with renal insufficiency and severe hepatic insufficiency (see CONTRAINDICATIONS).

1-gram scored, capsule-shaped yellow tablets debossed MERRELL 277 in bottles of 100 (NDC 30698-277-01).

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

Distributed by:

Validus Pharmaceuticals LLC
Parsippany, NJ 07054
info@validuspharma.com
www.validuspharma.com
1-866-982-5438
(1-866-9VALIDUS)

© 2016 Validus Pharmaceuticals LLC
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(Rev January 2016)

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