Pepcid Injection

DRUG DESCRIPTION

The active ingredient in PEPCID* (famotidine) Injection Premixed and PEPCID (famotidine) Injection is a histamine H2-receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4- thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is:

PEPCID (famotidine) structural formula illustration

Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.

PEPCID Injection (famotidine injection) Premixed is supplied as a sterile solution, for intravenous use only, in plastic single dose containers. Each 50 mL of the premixed, iso-osmotic intravenous injection contains 20 mg famotidine, USP, and the following inactive ingredients: L-aspartic acid 6.8 mg, sodium chloride, USP, 450 mg, and Water for Injection. The pH ranges from 5.7 to 6.4 and may have been adjusted with additional L-aspartic acid or with sodium hydroxide.

The plastic container is fabricated from a specially designed multilayer plastic (PL 2501). Solutions are in contact with the polyethylene layer of the container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability and safety of the plastic have been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.

PEPCID (famotidine) Injection is supplied as a sterile concentrated solution for intravenous injection. Each mL of the solution contains 10 mg of famotidine and the following inactive ingredients: L-aspartic acid 4 mg, mannitol 20 mg, and Water for Injection q.s. 1 mL. The multidose injection also contains benzyl alcohol 0.9% added as preservative.

What are the precautions when taking famotidine injection (Pepcid Injection)?

Before using famotidine, tell your doctor or pharmacist if you are allergic to it; or to other acid reducers (e.g., cimetidine, ranitidine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems, kidney problems, liver problems, lung problems (e.g., asthma, chronic obstructive pulmonary disease-COPD), other stomach problems (e.g., tumors).

Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn combined with lightheadedness/sweating/dizziness, chest pain or shoulder/jaw...

Read All Potential Precautions of Pepcid Injection


Pepcid Injection Consumer (continued)

SIDE EFFECTS: Headache, constipation, diarrhea, dizziness, and pain/redness at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, fast/slow/irregular heartbeat, signs of infection (e.g., fever, persistent sore throat, cough), mental/mood changes (e.g., restlessness, confusion, depression), hearing/seeing things that are not there (hallucinations), seizure.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using famotidine, tell your doctor or pharmacist if you are allergic to it; or to other acid reducers (e.g., cimetidine, ranitidine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems, kidney problems, liver problems, lung problems (e.g., asthma, chronic obstructive pulmonary disease-COPD), other stomach problems (e.g., tumors).

Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn combined with lightheadedness/sweating/dizziness, chest pain or shoulder/jaw pain (especially with trouble breathing), pain spreading to arms/neck/shoulders, unexplained weight loss.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug. Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially confusion and dizziness.

Famotidine should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.



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