Famotidine

What is Famotidine?

• Famotidine (Fluxid; Pepcid; Pepcid AC; Pepcid RPD) is a histamine-2 (H2) receptor antagonist used to treat peptic ulcer disease, gastroesophageal reflux disease, and Zollinger-Ellison syndrome.
• Over-the-counter famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks.

Famotidine

Famotidine ball-and-stick model

What are the uses of this medicine?

Famotidine (Fluxid; Pepcid; Pepcid AC; Pepcid RPD) is used in adult and pediatric patients 40 kg and greater for the treatment of:

• active duodenal ulcer (DU).
• active gastric ulcer (GU).
• symptomatic nonerosive gastroesophageal reflux disease (GERD).
• erosive esophagitis due to GERD, diagnosed by biopsy.

Famotidine is used in adults for the:

• treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
• reduction of the risk of duodenal ulcer recurrence.

How does this medicine work?

• Famotidine (fam oh' ti deen) was the third H2 blocker introduced into clinical practice in the United States and is a commonly used agent for treatment of duodenal and gastric ulcer and gastroesophageal reflux disease.
• The H2 blockers are specific antagonists of the histamine type 2 receptor, which is found on the basolateral (antiluminal) membrane of gastric parietal cells.
• The binding of famotidine to the H2 receptor results in inhibition of acid production and secretion, and improvement in symptoms and signs of acid-peptic disease.
• The H2 blockers inhibit an early, “upstream” step in gastric acid production and are less potent that the proton pump inhibitors, which inhibit the final common step in acid secretion.
• Nevertheless, the H2 blockers inhibit 24 hour gastric acid production by about 70% and are most effective in blocking basal and nocturnal acid production.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H2) receptor antagonists.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• other medications for heartburn
• dasatinib
• delavirdine mesylate
• cefditoren
• fosamprenavir
• Tizanidine

• Famotidine can reduce the absorption of other drugs, due to its effect on reducing intragastric acidity, leading to loss of efficacy of the concomitant drug.

Is this medicine FDA approved?

• Famotidine was first approved for use in the United States in 1986 and more than 3 million prescriptions for it are filled yearly.
• Famotidine is now available both by prescription and over-the-counter.
• The listed indications for famotidine are duodenal and gastric ulcer disease, gastroesophageal reflux and prevention of stress ulcers.

How should this medicine be used?

Recommended dosage: Recommended Dosage and Duration of Famotidine Tablets in Adult and Pediatric Patients 40 kg and Greater with Normal Renal Function: Active duodenal ulcer (DU):

• 40 mg once daily; or 20 mg twice daily up to 8 weeks.

Active gastric ulcer:

• 40 mg once daily up to 8 weeks.

Symptomatic nonerosive GERD:

• 20 mg twice daily up to 6 weeks.

Erosive esophagitis diagnosed by endoscopy:

• 20 mg twice daily; or 40 mg twice daily up to 12 weeks.

Pathological hypersecretory conditions:

• Starting dosage: 20 mg every 6 hours;
• Adjust dosage to individual patient needs.
• Maximum dosage 160 mg every 6 hours.

Reduction of the risk of DU recurrence:

• 20 mg once daily upto 1 year or as clinically indicated.

Dosage in Renal Impairment:

• Recommended maximum dosage of famotidine 20 mg or 40 mg tablets for patients with renal impairment, by indication.
• Use the lowest effective dose.
• Some dosage adjustments may require switching to other formulations of famotidine (e.g., oral suspension, lower dose tablet).

Administration:

• Famotidine comes as a tablet and a suspension to take by mouth.
• It is usually taken once daily at bedtime or two to four times a day.
• Over-the-counter famotidine comes as a tablet, a chewable tablet, and a capsule to take by mouth. It is usually taken once or twice a day. To prevent symptoms, it is taken 15 to 60 minutes before eating foods or drinking drinks that may cause heartburn.
• 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.
• Thoroughly chew the chewable tablets before swallowing them.
• Swallow the chewed tablet with a full glass of water.
• Do not take more than two tablets, capsules, or chewable tablets of over-the-counter famotidine in 24 hours and do not take over-the-counter famotidine for longer than 2 weeks unless your doctor tells you that you should.
• If symptoms of heartburn, acid indigestion, or sour stomach last longer than 2 weeks, stop taking over-the-counter famotidine and call your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a tablet and a suspension

This medicine is available in fallowing brand namesː

• Fluxid; Pepcid; Pepcid AC; Pepcid RPD

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache, diarrhea, dizziness, muscle aches, fatigue, drowsiness and constipation

Less common, but serious side effects may include:

• Body as a Whole: fever, asthenia, fatigue
• Cardiovascular: palpitations
• Gastrointestinal: elevated liver enzymes, vomiting, nausea, abdominal discomfort, anorexia, dry mouth
• Hematologic: thrombocytopenia
• Hypersensitivity: orbital edema, rash, conjunctival injection, bronchospasm
• Musculoskeletal: musculoskeletal pain, arthralgia
• Nervous System/Psychiatric: seizure, hallucinations, depression, anxiety, decreased libido, insomnia, somnolence
• Skin: pruritus, dry skin, flushing
• Special Senses: tinnitus, taste disorder
• Other: impotence

What special precautions should I follow?

• Central nervous system (CNS) adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy, have been reported in elderly patients and patients with moderate and severe renal impairment treated with famotidine tablets. Since famotidine blood levels are higher in patients with renal impairment than in patients with normal renal function, dosage adjustments are recommended in patients with renal impairment.
• Consider evaluation for gastric malignancy in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with famotidine tablets.
• There are limited data available on the presence of famotidine in human breast milk. There were no effects on the breastfed infant.
• Famotidine has been linked to rare instances of clinically apparent acute liver injury.
• Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation. Report new cardiac symptoms, such as palpitations, fainting and dizziness or lightheadedness immediately to a healthcare provider.
• Advise patients:
• Take famotidine tablets once daily before bedtime or twice daily in the morning and before bedtime, as recommended.
• Famotidine tablets may be taken with or without food.
• Famotidine tablets may be given with antacids.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• The types of adverse reactions in overdosage of famotidine tablets are similar to the side effects listed above.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In the event of overdosage, treatment should be symptomatic and supportive.
• Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed.
• Due to low binding to plasma proteins, famotidine is eliminated by hemodialysis.
• There is limited experience on the usefulness of hemodialysis as a treatment for famotidine tablets overdosage.

Can this medicine be used in pregnancy?

• Available data with H2-receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
• There are, however, no adequate or well-controlled studies in pregnant women.
• Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• The safety and effectiveness of famotidine tablets have been established in pediatric patients for the treatment of peptic ulcer disease (i.e., duodenal ulcer, gastric ulcer) and GERD (i.e., symptomatic nonerosive GERD, erosive esophagitis as diagnosed by endoscopy)
• In pediatric patients, the safety and effectiveness for the treatment of pathological hypersecretory conditions and reduction of risk of duodenal ulcer recurrence have not been established.
• Famotidine 20 and 40 mg tablets are not recommended for use in pediatric patients weighing less than 40 kg because these tablet strengths exceed the recommended dose for these patients.
• For pediatric patients weighing less than 40 kg, consider another famotidine formulation (e.g., oral suspension, lower dose tablet).

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• famotidine

Inactive Ingredients:

• colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide. In addition the 20 mg contains lactose monohydrate, red iron oxide and triacetin and the 40 mg contains FD&C blue No. 2 aluminum lake and FD&C yellow No. 6 aluminum lake.

Who manufactures and distributes this medicine?

Manufactured In Croatia By:

• Pliva Hrvatska d.o.o.
• Zagreb, Croatia

Manufactured For:

• Teva Pharmaceuticals USA, Inc.
• North Wales, PA

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Avoid storage of famotidine tablets at temperatures above 40°C (104°F).

The antiulcer agents in clinical use

Proton Pump Inhibitors

• Dexlansoprazole
• Esomeprazole
• Lansoprazole
• Omeprazole
• Pantoprazole
• Rabeprazole

Selective Histamine Type 2 Receptor Antagonists or H2 Blockers

• Cimetidine
• Famotidine
• Nizatidine
• Ranitidine

• Dailymed label info on Famotidine
• FDA Famotidine

Famotidine Resources
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