What is famotidine?

fam-OH-ti-deen

Commonly used brand name(s)

In the U.S.

Heartburn Relief
Pepcid
Pepcid AC

Available Dosage Forms:

Tablet
Powder for Suspension
Tablet, Chewable
Tablet, Disintegrating

Therapeutic Class: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Histamine H2 Antagonist

Uses For famotidine

Famotidine is used to treat stomach ulcers (gastric and duodenal), erosive esophagitis (heartburn or acid indigestion), and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus. It is also used to treat certain conditions where there is too much acid in the stomach (e.g., Zollinger-Ellison syndrome, endocrine tumors).

Famotidine belongs to the group of medicines known as histamine H2-receptor antagonists or H2-blockers. It works by decreasing the amount of acid produced by the stomach.

famotidine is available with your doctor's prescription and also without a prescription. For the prescription form, there is more medicine in each tablet. Your doctor will have special instructions on the proper use and dose for your medical problem.

Before Using famotidine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For famotidine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to famotidine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of famotidine in children.

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.

Pregnancy

Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking famotidine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using famotidine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine
Bepridil
Cisapride
Dronedarone
Mesoridazine
Pimozide
Piperaquine
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone

Using famotidine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amiodarone
Anagrelide
Aripiprazole
Arsenic Trioxide
Atazanavir
Bupropion
Buserelin
Clarithromycin
Clozapine
Crizotinib
Dabrafenib
Dasatinib
Degarelix
Delamanid
Delavirdine
Deslorelin
Domperidone
Escitalopram
Fluoxetine
Gonadorelin
Goserelin
Histrelin
Hydroxychloroquine
Ivabradine
Ketoconazole
Ledipasvir
Leuprolide
Metronidazole
Moxifloxacin
Nafarelin
Ondansetron
Panobinostat
Pasireotide
Pazopanib
Quetiapine
Rilpivirine
Sevoflurane
Tizanidine
Tolazoline
Triptorelin
Vandetanib
Vemurafenib
Vinflunine
Vismodegib

Using famotidine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Cefditoren Pivoxil
Cefpodoxime Proxetil
Cyclosporine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of famotidine

Take famotidine exactly as directed by your doctor or as directed on the package. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Keep using famotidine for the full time of treatment, even if you begin to feel better.

Measure the oral liquid with a marked measuring spoon or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of famotidine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of famotidine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (suspension, tablets):
- To treat stomach ulcers:
  - Adults—20 milligrams (mg) one or two times per day or 40 mg once a day at bedtime.
  - Teenagers and children above 1 year of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 0.5 milligram (mg) per kilogram (kg) of body weight per day, given as a single dose at bedtime or divided in two doses. The total dose is usually not more than 40 mg per day.
- To treat gastroesophageal reflux disease (GERD):
  - Adults—20 milligrams (mg) two times per day.
  - Teenagers and children above 1 year of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given two times per day. The total dose is usually not more than 40 mg two times per day.
  - Infants 3 months to 1 year of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given two times per day.
  - Infants younger than 3 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.5 milligram (mg) per kilogram (kg) of body weight per day, given as a single dose once a day.
- To treat erosive esophagitis (heartburn):
  - Adults—10, 20, or 40 milligrams (mg) two times per day.
  - Teenagers and children above 1 year of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given two times per day. The total dose is usually not more than 40 mg two times per day.
- To treat too much stomach acid (Zollinger-Ellison syndrome):
  - Adults—20 milligrams (mg) every 6 hours. Your doctor may adjust your dose as needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of famotidine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused oral liquid after 30 days.

Precautions While Using famotidine

It is very important that your doctor check your progress at regular visits to make sure famotidine is working properly and to check for unwanted effects.

If your condition does not improve, or if it become worse, check with your doctor.

famotidine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Bleeding gums
blistering, peeling, or loosening of the skin
blood in the urine or stools
bloody, , or tarry stools
chest pain
chills
cough or hoarseness
diarrhea
fever
fever with or without chills
general feeling of tiredness or weakness
high fever
itching
joint or muscle pain
lower back or side pain
painful or difficult urination
pale skin
pinpoint red spots on the skin
red, irritated eyes
red skin lesions, often with a purple center
shortness of breath
sore throat
sores, ulcers, or white spots on the lips or in the mouth
swollen glands
unusual bleeding or bruising
unusual tiredness or weakness

Incidence not known

Abdominal or stomach pain
anxiety
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
clay-colored stools
dark urine
depression
difficulty with breathing
difficulty with swallowing
dizziness
dry mouth
fainting
false sense of well-being
fast, irregular, pounding, or racing heartbeat or pulse
headache
hives
hyperventilation
irritability
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
loss of bladder control
loss of consciousness
mood swings
nausea
nervousness
noisy breathing
personality changes
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rash
restlessness
seizures
shaking
skin rash
swelling around the eyes
tightness in the chest
total body jerking
trouble with sleeping
troubled with breathing
unpleasant breath odor
vision changes
vomiting of blood
wheezing
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Difficulty having a bowel movement (stool)

Rare

Swelling of the breasts or breast soreness in both females and males

Incidence not known

Abdominal or stomach discomfort
blemishes on the skin
change in taste or bad, unusual or unpleasant (after) taste
continuing ringing or buzzing or other unexplained noise in the ears
decreased interest in sexual intercourse
difficulty with moving
dry skin
fear
hair loss or thinning of the hair
hearing loss
hives or welts
inability to have or keep an erection
loss in sexual ability, desire, drive, or performance
mood or mental changes
muscle cramps
muscle stiffness
pimples
redness of the skin
redness of the white part of the eyes
seeing, hearing, or feeling things that are not there
sleeplessness
unable to sleep
weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How to use famotidine?

Usual Adult Dose for Duodenal Ulcer

Initial:
Parenteral: 20 mg IV every 12 hours. Alternatively, some clinicians recommend a continuous IV infusion of 3.2 mg/hour for up to 72 hours following a 10 mg IV bolus dose.

Oral: 40 mg orally once a day at bedtime or 20 mg orally twice a day.

Maintenance: 20 mg orally or IV once a day at bedtime.

Usual Adult Dose for Peptic Ulcer

Usual Adult Dose for Duodenal Ulcer Prophylaxis

20 mg orally or IV, once a day.

Usual Adult Dose for Gastric Ulcer

Parenteral: 20 mg IV every 12 hours. Alternatively, some clinicians recommend a continuous IV infusion of 3.2 mg/hour for up to 72 hours following a 10 mg IV bolus dose.

Oral: 40 mg orally once a day at bedtime or 20 mg orally twice a day.

Usual Adult Dose for Gastroesophageal Reflux Disease

Parenteral: 20 mg IV every 12 hours. Alternatively, some clinicians recommend a continuous IV infusion of 3.2 mg/hour for up to 72 hours following a 10 mg IV bolus dose.

Oral: 20 mg orally twice a day for up to 6 weeks.

Usual Adult Dose for Erosive Esophagitis

Parenteral: 20 mg IV every 12 hours. Alternatively, some clinicians recommend a continuous IV infusion of 3.2 mg/hour for up to 72 hours following a 10 mg IV bolus dose.

Oral: 20 to 40 mg orally twice a day for up to 12 weeks.

Usual Adult Dose for Zollinger-Ellison Syndrome

Parenteral: 20 mg IV every 6 hours. Alternatively, some clinicians recommend a continuous IV infusion of 3.2 mg/hour for up to 72 hours following a 10 mg IV bolus dose.

Oral:
Initial: 20 mg orally every 6 hours.
Maintenance: Dosage adjustments are made to control gastric acid secretion. Doses up to 160 mg every 6 hours have been used.

Usual Adult Dose for Pathological Hypersecretory Conditions

Usual Adult Dose for Dyspepsia

10 mg orally once or twice daily.

Usual Adult Dose for Upper GI Hemorrhage

20 mg IV every 12 hours. Alternatively, some clinicians recommend a continuous IV infusion of 3.2 mg/hour for up to 72 hours following a 10 mg IV bolus dose.

Usual Adult Dose for Urticaria

Study (n=25)
Less than 72 hour duration: 20 mg IM once.

Usual Pediatric Dose for Peptic Ulcer

Peptic ulcer disease:
Oral:
Children and Adolescents 1 to 16 years: 0.5 mg/kg/day once daily at bedtime or divided twice daily (maximum daily dose: 40 mg/day)
Doses up to 1 mg/kg/day have been used

Stress ulcer prophylaxis, gastric acid suppression:
IV: 0.5 to 1 mg/kg/dose every 12 hours (maximum dose: 20 mg/dose)

Hypersecretory conditions:
Oral:
Adolescents:
Initial: 20 mg every 6 hours. May increase up to 160 mg every 6 hours.

Usual Pediatric Dose for Gastroesophageal Reflux Disease

Infants 1 to 3 months:
Oral:
GERD: 0.5 mg/kg/dose once daily for up to 8 weeks
Infants 3 months to 1 year:
Oral:
GERD: 0.5 mg/kg/dose twice daily for up to 8 weeks

Children 1 to 16 years:
Oral:
GERD: 0.5 mg/kg/dose 2 times a day (doses up to 1 mg/kg/dose 2 times a day have been reported).
Maximum: 40 mg/dose

Patients unable to take oral medication:
IV:
Infants: 0.25 to 0.5 mg/kg/dose once daily
Children and Adolescents 1 to 16 years:
Initial dose: 0.25 mg/kg/dose every 12 hours (maximum dose: 20 mg/dose). Doses up to 0.5 mg/kg/dose every 12 hours have been reported.

Usual Pediatric Dose for Dyspepsia

Greater than 12 years:
Acid indigestion, heartburn, or sour stomach (OTC use): 10 to 20 mg 15 to 60 minutes before eating; not more than 2 tablets per day.

Renal Dose Adjustments

In moderate renal insufficiency (CrCl less than 50 mL/min) or severe renal insufficiency (CrCl less than 10 mL/min) the recommended dose may be cut in half or the dosing interval prolonged to 36 to 48 hours.

Liver Dose Adjustments

No adjustments recommended

Dose Adjustments

Studies in children suggest that dosing intervals of 8 hours would benefit most patients, because the observed duration of effective acid suppression (intragastric pH greater than or equal to 4) appears to be approximately 5 to 9 hours,

Precautions

Because CNS adverse effects have been reported in patients with moderate to severe renal insufficiency, a longer dose interval and/or a lower dose is necessary as indicated by clinical response.

Any gastric malignancies must be ruled out before the start of famotidine treatment, since symptom relief may delay proper and timely diagnosis.

Dialysis

No data available

Other Comments

A total of 6 to 8 weeks of famotidine therapy is usually sufficient for ulcer healing. Length of therapy for erosive esophagitis generally should not exceed 12 weeks.

Agents in this class of drugs (H2 antagonists) have not demonstrated unequivocal efficacy in the treatment of upper gastrointestinal hemorrhage, nor are they approved by the FDA for use in this setting. However, some clinicians use intravenous H2 antagonists as part of the therapeutic approach to treating upper gastrointestinal hemorrhage.

What are the side effects of famotidine?

Pepcid Side Effects

Side effects most often reported by Pepcid users are:

Headache
Dizziness
Constipation
Diarrhea

Reports show that these side effects were infrequent, however. In one clinical trial, less than 5 percent of people had headache, and less than 2 percent had dizziness, constipation, or diarrhea from taking Pepcid.

Severe Side Effects of Pepcid

Severe side effects are also rare. Those that have been reported are heart rhythm problems, jaundice, liver enzyme abnormalities, facial swelling, and grand mal seizure.

What are the precautions of famotidine?

Tablets: 10, 20, and 40 mg.
Tablets (Chewable): 10 and 20 mg.
Suspension: 40 mg per 5 ml (teaspoon). Injection: 10 mg/ml.