"The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
(cimetidine hydrochloride) Liquid
(cimetidine hydrochloride) Injection
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.
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 confused;
- urinating less than...
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).
Some symptoms may actually be signs of a more serious condition. Get medical help right away if you have: heartburn with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder...
Last reviewed on RxList: 5/15/2012
This monograph has been modified to include the generic and brand name in many instances.
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