Famotidine (oral)

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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
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.

### NonGuideline-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.

### NonGuideline-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

## 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 20-25C (68-77F)
- Protect from moisture and light

# Images

## Drug Images

## Package and Label Display Panel

# 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