Methenamine and sodium salicylate

Methenamine and sodium salicylate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Methenamine and sodium salicylate is an analgesic that is FDA approved for the treatment of painful and burning urination. Common adverse reactions include hypersensitivity.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Temporarily relieves

• Painful urination
• Burning urination

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Methenamine and sodium salicylate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Methenamine and sodium salicylate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Methenamine and sodium salicylate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Methenamine and sodium salicylate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Methenamine and sodium salicylate in pediatric patients.

Contraindications

There is limited information regarding Methenamine and sodium salicylate Contraindications in the drug label.

Warnings

Reye's syndrome

• Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
• Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you age 60 or older have stomach ulcers or bleeding problems
• Take a blood thinner (anticoagulant) or steroid drug
• Take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
• Have 3 or more alcoholic drinks every day while using this product
• Take more or for a longer time than directed.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Methenamine and sodium salicylate Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Methenamine and sodium salicylate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Methenamine and sodium salicylate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Methenamine and sodium salicylate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Methenamine and sodium salicylate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Methenamine and sodium salicylate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Methenamine and sodium salicylate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Methenamine and sodium salicylate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Methenamine and sodium salicylate in geriatric settings.

Gender

There is no FDA guidance on the use of Methenamine and sodium salicylate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Methenamine and sodium salicylate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Methenamine and sodium salicylate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Methenamine and sodium salicylate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Methenamine and sodium salicylate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Methenamine and sodium salicylate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Methenamine and sodium salicylate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Methenamine and sodium salicylate and IV administrations.

Overdosage

There is limited information regarding Methenamine and sodium salicylate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Methenamine and sodium salicylate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Methenamine and sodium salicylate Mechanism of Action in the drug label.

Structure

There is limited information regarding Methenamine and sodium salicylate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Methenamine and sodium salicylate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Methenamine and sodium salicylate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Methenamine and sodium salicylate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Methenamine and sodium salicylate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Methenamine and sodium salicylate How Supplied in the drug label.

Storage

There is limited information regarding Methenamine and sodium salicylate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Methenamine and sodium salicylate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Methenamine and sodium salicylate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• CYSTEX PLUS ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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