Tagamet

DRUG DESCRIPTION

Tagamet (cimetidine) is a histamine H2-receptor antagonist. Chemically it is N?-cyano-N-methyl N'-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]-ethyl]-guanidine.

The empirical formula for cimetidine is C10H16N6S and for cimetidine hydrochloride, C10H16N6SHCl; these represent molecular weights of 252.34 and 288.80, respectively.

Cimetidine contains an imidazole ring, and is chemically related to histamine.

(The liquid and injection dosage forms contain cimetidine as the hydrochloride.)

Cimetidine has a bitter taste and characteristic odor.

Solubility Characteristics : Cimetidine is soluble in alcohol, slightly soluble in water, very slightly soluble in chloroform and insoluble in ether. Cimetidine hydrochloride is freely soluble in water, soluble in alcohol, very slightly soluble in chloroform and practically insoluble in ether.

Tablets for Oral Administration : Each light green, film-coated tablet contains cimetidine as follows: 300 mg-round, debossed with the product name TAGAMET (cimetidine) , SB and 300; 400 mg-oval Tiltab® tablets, debossed with the product name TAGAMET (cimetidine) , SB and 400; 800 mg-oval Tiltab® tablets, debossed with the product name TAGAMET (cimetidine) , SB and 800. Inactive ingredients consist of cellulose, D&C Yellow No. 10, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, starch, titanium dioxide and trace amounts of other inactive ingredients.

Liquid for Oral Administration : Each 5 mL (1 teaspoonful) of clear, light orange, mint-peach flavored liquid contains cimetidine hydrochloride equivalent to cimetidine, 300 mg; alcohol, 2.8%. Inactive ingredients consist of FD&C Yellow No. 6, flavors, methylparaben, polyoxyethylene polyoxypropylene glycol, propylene glycol, propylparaben, saccharin sodium, sodium chloride, sodium phosphate, sorbitol and water.

Injection

Single-Dose Vials for Intramuscular or Intravenous Administration : Each 2 mL contains, in sterile aqueous solution (pH range 3.8 to 6), cimetidine hydrochloride equivalent to cimetidine, 300 mg; phenol, 10 mg.

Multi-Dose Vials for Intramuscular or Intravenous Administration : 8 mL (300 mg/2 mL): Each 2 mL contains, in sterile aqueous solution (pH range 3.8 to 6), cimetidine hydrochloride equivalent to cimetidine, 300 mg; phenol, 10 mg.

Single-Dose Premixed Plastic Containers for Intravenous Administration : Each 50 mL of sterile aqueous solution (pH range 5 to 7) contains cimetidine hydrochloride equivalent to 300 mg cimetidine and 0.45 grams sodium chloride.

No preservative has been added.

The plastic container is fabricated from specially formulated polyvinyl chloride. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di 2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers as well as by tissue culture toxicity studies.

ADD-Vantage®* Vials for Intravenous Administration : Each 2 mL contains, in sterile aqueous solution (pH range 3.8 to 6), cimetidine hydrochloride equivalent to cimetidine, 300 mg; phenol, 10 mg.

All of the above injection formulations are pyrogen free, and sodium hydroxide N.F. is used as an ingredient to adjust the pH.

*ADD-Vantage® is a trademark of Abbott Laboratories.

What are the possible side effects of cimetidine (Tagamet, Tagamet HB)?

Stop using cimetidine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • cough, fever, chest congestion, trouble breathing;
  • red or blistering skin rash;
  • jaundice (yellowing of the skin or eyes);
  • easy bruising or bleeding, unusual weakness;
  • feeling faint, light-headed, disoriented, or...

Read All Potential Side Effects and See Pictures of Tagamet »

What are the precautions when taking cimetidine (Tagamet)?

Before taking cimetidine, tell your doctor or pharmacist if you are allergic to it; or to other H2 blockers (e.g., famotidine, nizatidine, 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, certain lung diseases (chronic obstructive pulmonary disease-COPD), diabetes, other stomach problems (e.g., tumors).

Before taking non-prescription cimetidine for self-treatment, talk with your doctor or pharmacist first if you have any of the following symptoms. These may be signs of a more...

Read All Potential Precautions of Tagamet »


Tagamet Consumer (continued)

SIDE EFFECTS: Headache, dizziness, drowsiness, or diarrhea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that 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 immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., agitation, confusion, depression, hallucinations), trouble urinating, muscle/joint pain, breast swelling/soreness in males, decreased sexual ability (with very high doses of this medication).

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat, cough, trouble breathing), fast/slow/irregular heartbeat, unusual tiredness, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin, change in the amount of urine.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction 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 taking cimetidine, tell your doctor or pharmacist if you are allergic to it; or to other H2 blockers (e.g., famotidine, nizatidine, 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, certain lung diseases (chronic obstructive pulmonary disease-COPD), diabetes, other stomach problems (e.g., tumors).

Before taking non-prescription cimetidine for self-treatment, talk with your doctor or pharmacist first if you have any of the following symptoms. These may be signs of a more serious condition. Consult your doctor or pharmacist immediately if you have: difficulty/pain with swallowing food, persistent nausea/vomiting, bloody vomit, vomit that looks like coffee grounds, bloody/black stools, frequent chest pain, persistent stomach pain, heartburn for more than 3 months, trouble breathing with heartburn.

If you are prescribed cimetidine or are considering non-prescription cimetidine for self-treatment, tell your doctor immediately if you have any of these other symptoms that may actually be signs of a more serious condition: heartburn combined with lightheadedness/sweating/dizziness, chest/shoulder/jaw pain (especially with trouble breathing), pain spreading to arms/neck/shoulders, unexplained weight loss.

This drug may make you dizzy or drowsy. 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.

Do not use this medication to treat children younger than 12 unless directed by the doctor.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, the elderly may be at greater risk for side effects while using this drug, especially confusion and lung infection (pneumonia).

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

Cimetidine passes into breast milk. Consult your doctor before breast-feeding.


Tagamet Patient Information Including Side Effects

Brand Names: Tagamet, Tagamet HB

Generic Name: cimetidine (Pronunciation: sye ME ti deen)

  • What is cimetidine (Tagamet)?
  • What are the possible side effects of cimetidine (Tagamet)?
  • What is the most important information I should know about cimetidine (Tagamet)?
  • What should I discuss with my healthcare provider before taking cimetidine (Tagamet)?
  • How should I take cimetidine (Tagamet)?
  • What happens if I miss a dose (Tagamet)?
  • What happens if I overdose (Tagamet)?
  • What should I avoid while taking cimetidine (Tagamet)?
  • What other drugs will affect cimetidine (Tagamet)?
  • Where can I get more information?

What is cimetidine (Tagamet)?

Cimetidine is in a group of drugs called histamine receptor antagonists. Cimetidine works by decreasing the amount of acid your stomach produces.

Cimetidine is used to treat and prevent certain types of ulcer, and to treat conditions that cause the stomach to produce too much acid. Cimetidine is also used to treat gastroesophageal reflux disease (GERD), when stomach acid backs up into the esophagus and causes heartburn.

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

What are the possible side effects of cimetidine (Tagamet)?

Stop using cimetidine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • cough, fever, chest congestion, trouble breathing;
  • red or blistering skin rash;
  • jaundice (yellowing of the skin or eyes);
  • easy bruising or bleeding, unusual weakness;
  • feeling faint, light-headed, disoriented, or confused;
  • urinating less than usual;
  • irregular heartbeat; or
  • a rash.

Less serious side effects may include:

  • feeling dizzy, depressed, or agitated;
  • breast swelling or tenderness (in men);
  • joint or muscle pain;
  • mild skin rash;
  • headache; or
  • diarrhea, nausea, or constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about cimetidine (Tagamet)?

Use this medication exactly as directed on the label, or as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not use the medication for longer than recommended.

Avoid taking antacids unless your doctor recommends them for heartburn pain. Follow your doctor's advice about the type of antacid to use and when to use it. You may not be able to take the antacid at the same time you take your dose of cimetidine.

Taking cimetidine may make you more susceptible to virus that can cause pneumonia. This has occurred most often in elderly people and in those with diabetes, a weak immune system, or chronic lung disease. Before using cimetidine, tell your doctor if you have any of these conditions.

There are many other drugs that can interact with cimetidine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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

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