Pepcid

Name: Pepcid

Why is this medication prescribed?

Famotidine injection is used in people who are hospitalized to treat certain conditions in which the stomach produces too much acid or to treat ulcers (sores in the lining of the stomach or intestine) that were not successfully treated with other medications. Famotidine injection is also used on a short-term basis in people who cannot take oral medication

  • to treat ulcers,
  • to prevent ulcers from returning after they have healed,
  • to treat gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube between the throat and the stomach]),
  • and to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas and small intestine that caused increased production of stomach acid).

Famotidine injection is in a class of medications called H2 blockers. It works by decreasing the amount of acid made in the stomach.

How to use

This medication is injected into a vein as directed by your doctor. The dosage and length of treatment are based on your medical condition and response to treatment. In children, dosage may also be based on body weight.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before injecting each dose, clean the injection site with rubbing alcohol. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Tell your doctor if your condition persists or worsens.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Since famotidine reduces the amount of acid in your stomach, it may also change the absorption of certain medications and affect how they work. Some examples of affected drugs include atazanavir, dasatinib, delavirdine, certain azole antifungals (such as itraconazole, ketoconazole), among others. Ask your doctor or pharmacist if any of the medications you take are affected by famotidine and how to manage this interaction.Check the labels on all your medicines because they may contain aspirin or aspirin-like NSAIDs (e.g., ibuprofen, naproxen) that can cause stomach irritation/ulcers. Ask your doctor or pharmacist about the safe use of these products. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day), should be continued. Consult your doctor for more details.This medication and other H2 blockers (e.g., cimetidine, ranitidine, nizatidine) are available both over-the-counter and by prescription. Do not take them at the same time.

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.

Warnings

No information provided

Pepcid Overview

Pepcid is both an over-the-counter and a prescription medication used to treat conditions of the stomach, esophagus, and intestines. The over-the-counter form is used to treat and prevent heartburn, acid indigestion, and sour or upset stomach. The prescription form is used to treat ulcers, GERD, erosive esophagitis, and other conditions.

Pepcid comes as a tablet and a suspension (liquid) to be taken by mouth. It is usually taken once daily at bedtime or 1 to 4 times a day. Take 15 to 60 minutes before eating foods or drinking beverages that may cause heartburn.

Common side effects of Pepcid include headache, constipation, and diarrhea. Pepcid can also cause dizziness. Do not drive or operate heavy machinery until you know how this medication will affect you.

Manufacturer

  • Marathon Pharmaceuticals, LLC

  • Salix Pharmaceuticals, Inc.

  • Valeant Pharmaceuticals, Inc.

Introduction

Histamine H2 receptor antagonist.1 3 4 6 23 46 48 114

Proper Use of famotidine

This section provides information on the proper use of a number of products that contain famotidine. It may not be specific to Pepcid. Please read with care.

Take this medicine 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 this medicine 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 this medicine 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 this medicine. 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 this medicine, 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.

How do I store and/or throw out Pepcid?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Clinical pharmacology in pediatric patients

Pharmacokinetics

Table 6 presents pharmacokinetic data from clinical trials and a published study in pediatric patients (<1 year of age; N=27) given famotidine I.V. 0.5 mg/kg and from published studies of small numbers of pediatric patients (1-15 years of age) given famotidine intravenously. Areas under the curve (AUCs) are normalized to a dose of 0.5 mg/kg I.V. for pediatric patients 1-15 years of age and compared with an extrapolated 40 mg intravenous dose in adults (extrapolation based on results obtained with a 20 mg I.V. adult dose).

aValues are presented as means ± SD unless indicated otherwise.
bMean value only.
cSingle center study.
dMulticenter study.

  Table 6
Pharmacokinetic Parametersa of Intravenous Famotidine
 

  Age
(N=number of patients)

   

  Area Under the Curve (AUC)
(ng-hr/mL)

   

  Total Clearance (Cl)
(L/hr/kg)

   

  Volume of Distribution (Vd)
(L/kg)

   

  Elimination Half-life (T1/2)
(hours)

  0-1 monthc (N=10)

 

  NA

 

  0.13 ± 0.06

 

  1.4 ± 0.4

 

  10.5 ± 5.4

  0-3 monthsd (N=6)

 

  2688 ± 847

 

  0.21 ± 0.06

 

  1.8 ± 0.3

 

  8.1 ± 3.5

  >3-12 monthsd (N=11)

 

  1160 ± 474

 

  0.49 ± 0.17

 

  2.3 ± 0.7

 

  4.5 ± 1.1

  1-11 yrs (N=20)

 

  1089 ± 834

 

  0.54 ± 0.34

 

  2.07 ± 1.49

 

  3.38 ± 2.60

  11-15 yrs (N=6)

 

  1140 ± 320

 

  0.48 ± 0.14

 

  1.5 ± 0.4

 

  2.3 ± 0.4

  Adult (N=16)

 

  1726b

 

  0.39 ± 0.14

 

  1.3 ± 0.2

 

  2.83 ± 0.99

Plasma clearance is reduced and elimination half-life is prolonged in pediatric patients 0-3 months of age compared to older pediatric patients. The pharmacokinetic parameters for pediatric patients, ages >3 months-15 years, are comparable to those obtained for adults.

Bioavailability studies of 8 pediatric patients (11-15 years of age) showed a mean oral bioavailability of 0.5 compared to adult values of 0.42 to 0.49. Oral doses of 0.5 mg/kg achieved AUCs of 645 ± 249 ng-hr/mL and 580 ± 60 ng-hr/mL in pediatric patients <1 year of age (N=5) and in pediatric patients 11-15 years of age, respectively, compared to 482 ± 181 ng-hr/mL in adults treated with 40 mg orally.

Pharmacodynamics

Pharmacodynamics of famotidine were evaluated in 5 pediatric patients 2-13 years of age using the sigmoid Emax model. These data suggest that the relationship between serum concentration of famotidine and gastric acid suppression is similar to that observed in one study of adults (Table 7).

 *Serum concentration of famotidine associated with 50% maximum gastric acid reduction. Values are presented as means ± SD.

  Table 7
Pharmacodynamics of famotidine using the sigmoid Emax model
 

 

 EC50 (ng/mL)*
 

  Pediatric Patients

  26 ± 13

   

 

  Data from one study

 

  a) healthy adult subjects

  26.5 ± 10.3

  b) adult patients with upper GI bleeding

  18.7 ± 10.8

Five published studies (Table 8) examined the effect of famotidine on gastric pH and duration of acid suppression in pediatric patients. While each study had a different design, acid suppression data over time are summarized as follows:

aValues reported in published literature.
bMeans ± SD.
cMean (95% confidence interval).

  Table 8

 Dosage

 Route

 Effecta

 Number of Patients (age range)

  0.5 mg/kg, single dose

  I.V.

  gastric pH >4 for 19.5 hours (17.3, 21.8)c

  11 (5-19 days)

  0.3 mg/kg, single dose

  I.V.

  gastric pH >3.5 for 8.7 ± 4.7b hours

  6 (2-7 years)

  0.4-0.8 mg/kg

  I.V.

  gastric pH >4 for 6-9 hours

  18 (2-69 months)

  0.5 mg/kg, single dose

  I.V.

  a >2 pH unit increase above baseline in gastric pH for >8 hours

  9 (2-13 years)

  0.5 mg/kg b.i.d.

  I.V.

  gastric pH >5 for 13.5 ± 1.8b hours

  4 (6-15 years)

  0.5 mg/kg b.i.d.

  oral

  gastric pH >5 for 5.0 ± 1.1b hours

  4 (11-15 years)

The duration of effect of famotidine I.V. 0.5 mg/kg on gastric pH and acid suppression was shown in one study to be longer in pediatric patients <1 month of age than in older pediatric patients. This longer duration of gastric acid suppression is consistent with the decreased clearance in pediatric patients <3 months of age (see Table 6).

Pepcid Dosage and Administration

Duodenal Ulcer

Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use Pepcid at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

Benign Gastric Ulcer

Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

Gastroesophageal Reflux Disease (GERD)

The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

See PRECAUTIONS, Pediatric Patients <1 year of age.

The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

Dosage for Pediatric Patients 1-16 years of age

See PRECAUTIONS, Pediatric Patients 1-16 years of age.

The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

The dosage of Pepcid in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

Concomitant Use of Antacids

Antacids may be given concomitantly if needed.

Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of Pepcid is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of Pepcid may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

Based on the comparison of pharmacokinetic parameters for Pepcid in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

Important information

You should not use Pepcid if you are allergic to famotidine or similar medications such as ranitidine (Zantac), cimetidine (Tagamet), or nizatidine (Axid).

Before taking Pepcid, tell your doctor if you have kidney or liver disease, a history of Long QT syndrome, stomach cancer or other problems, or asthma, COPD, or other breathing problems.

Pepcid may be only part of a complete program of treatment that also includes changes in diet or lifestyle habits. Follow your doctor's instructions very closely.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What is famotidine?

Famotidine a histamine-2 blockers. Famotidine works by decreasing the amount of acid the stomach produces.

Famotidine is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. Famotidine also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

Famotidine may also be used for purposes not listed in this medication guide.

Important Information

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What other drugs will affect famotidine?

Other drugs may interact with famotidine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 13.01.

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