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This document provides guidance on the drug Famotidine, outlining the FDA's recommendations for studies related to its bioequivalence and testing requirements.
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Who needs Guidance on Famotidine?

01
Patients prescribed famotidine for conditions like GERD, ulcers, or heartburn.
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Healthcare providers needing a guideline for prescribing famotidine.
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Pharmacists involved in medication counseling for famotidine.
04
Individuals looking for information on famotidine for educational purposes.
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Geriatric. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of famotidine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving famotidine.
Take famotidine exactly as directed. Do not take more or less of it or take it more often or for a longer time than prescribed by your doctor. Shake the liquid well for 5 to 10 seconds before each use to mix the medicine evenly. Swallow the tablets and capsules with a full glass of water.
The Food and Drug Administration (FDA or Agency) has determined that PEPCID (famotidine) tablet, 20 milligrams (mg) and 40 mg, was not withdrawn from sale for reasons of safety or effectiveness.
Active gastric ulcer: The typical dosage of famotidine for patients with gastric ulcers is 40 mg orally, taken at bedtime for a maximum of 8 weeks. Alternatively, an IV dosage of 20 mg every 12 hours can be considered.
Famotidine can be taken with or without food. To prevent heartburn and acid indigestion, take famotidine 15-60 minutes before eating food or drinking beverages that can cause indigestion. Do not take more than 2 tablets in 24 hours unless directed by your doctor. Follow all directions on the product package.
Common side effects include headache, dizziness, constipation, or diarrhea. Before using famotidine, tell your health care provider about any health conditions you have and all medicines you take.
The US Food and Drug Administration and Health Canada have issued a warning to change the dose and dosing intervals of famotidine in patients with severe or moderate renal failure. Famotidine, a histamine H2 receptor antagonist used mainly to treat peptic ulcer disease, is excreted almost exclusively by the kidneys.

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Guidance on Famotidine provides information and recommendations regarding the use, dosage, and safety of Famotidine, a medication commonly used to treat conditions such as acid reflux and ulcers.
Healthcare professionals, pharmaceutical companies, and researchers involved in the prescribing, manufacturing, or studying of Famotidine are required to file Guidance on Famotidine.
To fill out Guidance on Famotidine, individuals must follow the prescribed format, ensuring to include necessary information such as patient details, dosage instructions, and any relevant clinical data.
The purpose of Guidance on Famotidine is to ensure safe and effective use of the medication, providing essential information to healthcare practitioners and patients.
Information that must be reported includes patient demographics, clinical indications for use, dosage and administration details, adverse effects, and any relevant laboratory data.
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