Famotidine (oral)

Famotidine (oral)
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: Kiran Singh, M.D. [2]

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Overview

Famotidine (oral) is a gastric acid secretion inhibitor that is FDA approved for the treatment of heartburn,gastric hypersecretion, gastric ulcer,gastroesophageal reflux, indigestion. Common adverse reactions include constipation ,diarrhea, dizziness , headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Duodenal ulcer
• Esophagitis - gastroesophageal reflux disease,
• Gastric hypersecretion
• Gastric ulcer
• Gastroesophageal reflux disease
• Indigestion

Dosing

• To relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

• To prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn

• Do not use more than 2 tablets in 24 hours

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of famotidine in adult patients.

Non–Guideline-Supported Use

Indications

• Esophagitis, Maintenance
• Gastritis
• Gastrointestinal hemorrhage
• Stress ulcer
• Urticaria

Dosing

• Duodenal ulcer disease: acute, 40 mg orally once daily at bedtime or 20 mg orally twice daily
• Duodenal ulcer disease: maintenance, 20 mg orally once daily at bedtime

• Esophagitis - Gastroesophageal reflux disease, Short term treatment: 20 to 40 mg orally twice daily for up to 12 weeks

• Gastric hypersecretion: 20 to 160 mg orally every 6 h.

• Gastric ulcer, Short term treatment: acute, 40 mg orally once daily at bedtime

• Gastroesophageal reflux disease, Short-term, symptom treatment: 20 mg orally twice daily for up to 6 wks

• Indigestion: 10 to 20 mg orally twice daily

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indication

• Duodenal ulcer
• Esophagitis - gastroesophageal reflux disease,
• Gastric hypersecretion
• Gastric ulcer
• Gastroesophageal reflux disease
• Indigestion

Dosing

Children 12 years and over:

• To relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

• To prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn

• Do not use more than 2 tablets in 24 hours

Children under 12 years: ask a doctor

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Famotidine in pediatric patients.

Non–Guideline-Supported Use

Indications

• Stress ulcer; Prophylaxis

Dosage

• Duodenal ulcer disease: (over 1 y old) 0.5 mg/kg/day orally at bedtime or divided twice daily; max dose 40 mg/day

• Gastric ulcer, Short term treatment: (over 1 y old) 0.5 mg/kg/day orally at bedtime or divided twice daily; max dose 40 mg/day

Contraindications

There is limited information regarding Famotidine (oral) Contraindications in the drug label.

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. if you have kidney disease, except under the advice and supervision of a doctor with other acid reducers

Ask a doctor before use if you have

• Had heartburn over 3 months. This may be a sign of a more serious condition.

• Heartburn with lightheadedness, sweating, or dizziness

• Chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

• Frequent chest pain

• Frequent wheezing, particularly with heartburn

• Unexplained weight loss

• Nausea or vomiting
• Stomach pain

Stop use and ask a doctor if

• Your heartburn continues or worsens
• You need to take this product for more than 14 days

If pregnant or breast-feeding,

• Ask a health professional before use.

Keep out of reach of children.

• In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

Common

• Gastrointestinal: constipation, diarrhea
• Neurologic: dizziness, headache

Serious

• Dermatologic: Stevens-Johnson syndrome (very rare ), toxic epidermal necrolysis (very rare )
• Gastrointestinal: necrotizing enterocolitis in fetus OR newborn
• Immunologic: anaphylaxis (infrequent ), angioedema (infrequent )
• Musculoskeletal: rhabdomyolysis
• Neurologic: seizure (rare )
• Respiratory: Interstitial pneumonia (infrequent ), nosocomial pneumonia

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Famotidine (oral) in the drug label.

Drug Interactions

There is limited information regarding Famotidine (oral) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Famotidine (oral) in women who are pregnant.
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Famotidine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Famotidine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Famotidine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Famotidine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Famotidine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Famotidine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Famotidine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Famotidine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Famotidine in patients with hepatic impairment.

Females of Reproductive Potential and Males

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

Immunocompromised Patients

There is no FDA guidance one the use of Famotidine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Monitoring of Famotidine in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Famotidine in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Famotidine in the drug label.

Pharmacology

This image is provided by the National Library of Medicine.

Mechanism of Action

There is limited information regarding Famotidine (oral) Mechanism of Action in the drug label.

Structure

There is limited information regarding Famotidine (oral) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Famotidine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Famotidine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Famotidine in the drug label.

How Supplied

There is limited information regarding Famotidine (oral) How Supplied in the drug label.

Storage

• Store at 20°-25°C (68°-77°F)
• Protect from moisture and light

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Famotidine in the drug label.

Precautions with Alcohol

• Alcohol-Famotidine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• 7 SELECT ACID CONTROLLER

Look-Alike Drug Names

There is limited information regarding Famotidine (oral) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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

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