DESCRIPTION

Ranitidine HCl is a histamine H₂-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N¢-methyl-2 -nitro-1,1-ethenediamine, hydrochloride.

The empirical formula is C₁₃H₂₂N₄O₃S·HCl, representing a molecular weight of 350.87.

Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor.

Oral

Each Zantac 150 tablet for oral administration contains 168 mg of ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients FD&C yellow No. 6 aluminum lake, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, titanium dioxide, triacetin, and yellow iron oxide.

Each Zantac 300 tablet for oral administration contains 336 mg of ranitidine HCl equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients croscarmellose sodium, D&C yellow No. 10 aluminum lake, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

Zantac 150 geldose capsules and Zantac 300 geldose capsules for oral administration are soft gelatin capsules containing 168 mg of ranitidine HCl equivalent to 150 mg of ranitidine and 336 mg of ranitidine HCl equivalent to 300 mg of ranitidine, respectively, in a nonaqueous matrix of synthetic coconut oil and synthetic triglycerides. The soft gelatin capsule shell contains gelatin, sorbitol special (sorbitol and sorbitol anhydrides), glycerin, purified water, titanium dioxide, FD&C yellow No. 6, FD&C blue No. 1, and FD&C red No. 40. The capsule shell may also contain mineral oil and soybean lecithin. The capsules are printed with edible ink.

Zantac 150 EFFERdose tablets and Zantac 150 EFFERdose granules for oral administration are effervescent formulations of ranitidine that must be dissolved in water before use. Each individual tablet or the contents of a packet contain 168 mg of ranitidine HCl equivalent to 150 mg of ranitidine and the following inactive ingredients: aspartame, monosodium citrate anhydrous, povidone, and sodium bicarbonate. Each tablet also contains sodium benzoate. The total sodium content of each tablet is 183.12 mg (7.96 mEq) per 150 mg of ranitidine, and the total sodium content of each packet of granules is 173.54 mg (7.55 mEq) per 150 mg of ranitidine.

Each 1 ml of Zantac syrup contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine. Zantac syrup also contains the inactive ingredients alcohol (7.5%), butylparaben, dibasic sodium phosphate, hydroxypropyl methylcellulose, peppermint flavor, monobasic potassium phosphate, propylparaben, purified water, saccharin sodium, sodium chloride, and sorbitol.

Injection, Injection Premixed, and Injection Pharmacy Bulk Package¾Not for Direct Infusion

Ranitidine HCl Injection is a clear, colorless to yellow, nonpyrogenic liquid. The yellow color of the liquid tends to intensify without adversely affecting potency. The pH of the injection solution is 6.7 to 7.3.

Sterile Injection for Intramuscular or Intravenous Administration or Injection Pharmacy Bulk Package: Each 1 ml of aqueous solution contains ranitidine 25 mg (as the hydrochloride); phenol 5 mg as preservative; and 0.96 mg of monobasic potassium phosphate and 2.4 mg of dibasic sodium phosphate as buffers.

Injection Pharmacy Bulk Package¾Not for Direct Infusion: A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous (IV) infusion.

Sterile, Premixed Solution for Intravenous Administration in Single-Dose, Flexible Plastic Containers: Each 50 ml contains ranitidine HCl equivalent to 50 mg of ranitidine, sodium chloride 225 mg, and citric acid 15 mg and dibasic sodium phosphate 90 mg as buffers in water for injection. It contains no preservatives. The osmolarity of this solution is 180 mOsm/l (approx.), and the pH is 6.7 to 7.3.

The flexible plastic container is fabricated from a specially formulated, nonplasticized, thermoplastic co-polyester (CR3). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of the chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.

CATEGORIES, BRAND NAMES

CATEGORIES: Acid/peptic disorder; Esophagitis, erosive; Hypersecretion, gastrointestinal; Mastocytosis; Reflux, gastroesophageal; Ulcer, peptic; Zollinger-Ellison syndrome; Pregnancy Category B; FDA Approved 1983 Jun; Top 200 Drugs

FDA Drug Classes: Antihistamines; Acid/Peptic Disorders

BRAND NAMES:

BRAND NAMES: Achedos; Acidex; Aciloc; Acloral; Aldin; Anistal; Antagonin; Apo-Ranitidine; Apozan; Atural; Axoban; Azantac; Consec; Coralen; Curan; Eltidine; Ezopta; Galidrin; Gastrial; Gastridin; Gastrosedol; Histac; Histak; Lydin; Microtid; Neoceptin-R; Ptinolin; Quantor; Quicran; Radinat; Ranacid; Randin; Rani 2; Ranial; Raniben; Ranidil; Ranidine; Ranimex; Ranin; Raniogas; Raniplex; Ranisen; Ranital; Ranitiget; Ranix; Rantac; Rantacid; Rantin; Ratic; Raticina; Rosimol; RND; Simetac; Sostril; Taural; Ul-Pep; Ulceran; Ulceranin; Ulcex; Ulcirex; Ulsal; Ultac; Urantac; Verlost; Vesyca; Vizerul; Weichilin; Weidos; Xanidine; Zantab; Zantac; Zantadin; Zantic; Zinetac
(Foreign Brand names outside U.S. in italics)

FOREIGN BRAND AVAILABILITY:
Achedos (Peru)
Acidex (Argentina)
Aciloc (India)
Acloral (Mexico)
Aldin (India)
Anistal (Mexico)
Antagonin (Benin; Burkina-Faso; Ethiopia; Gambia; Ghana; Guinea; Ivory-Coast; Kenya; Liberia; Malawi; Mali; Mauritania; Mauritius; Morocco; Niger; Nigeria; Senegal; Seychelles; Sierra-Leone; Sudan; Tanzania; Tunia; Uganda; Zambia; Zimbabwe)
Apo-Ranitidine (Canada; New-Zealand)
Apozan (Israel)
Atural (Peru)
Axoban (Japan)
Azantac (France; Mexico)
Consec (India)
Coralen (Spain)
Curan (Korea)
Eltidine (Korea)
Ezopta (Greece)
Galidrin (Mexico)
Gastrial (Argentina)
Gastridin (Indonesia)
Gastrosedol (Argentina)
Histac (Bahrain; Benin; Burkina-Faso; Cyprus; Egypt; Ethiopia; Gambia; Ghana; Guinea; India; Iran; Iraq; Ivory-Coast; Jordan; Kenya; Kuwait; Lebanon; Liberia; Libya; Malawi; Mali; Mauritania; Mauritius; Morocco; Niger; Nigeria; Oman; Qatar; Republic-of-Yemen; Saudi-Arabia; Senegal; Seychelles; Sierra-Leone; Sudan; Syria; Tanzania; Thailand; Tunia; Uganda; United-Arab-Emirates; Zambia; Zimbabwe)
Histak (South-Africa)
Lydin (India)
Microtid (Mexico)
Neoceptin-R (Benin; Burkina-Faso; Ethiopia; Gambia; Ghana; Guinea; Ivory-Coast; Kenya; Liberia; Malawi; Mali; Mauritania; Mauritius; Morocco; Niger; Nigeria; Senegal; Seychelles; Sierra-Leone; Sudan; Tanzania; Tunia; Uganda; Zambia; Zimbabwe)
Ptinolin (Greece)
Quantor (Spain)
Quicran (Taiwan)
Radinat (Ecuador)
Ranacid (Norway)
Randin (Bahrain; Cyprus; Egypt; Iran; Iraq; Jordan; Kuwait; Lebanon; Libya; Oman; Qatar; Republic-of-Yemen; Saudi-Arabia; Syria; United-Arab-Emirates)
Rani 2 (Australia)
Ranial (India)
Raniben (Italy)
Ranidil (Italy)
Ranidine (Thailand)
Ranimex (Finland)
Ranin (Indonesia)
Raniogas (Colombia)
Raniplex (France)
Ranisen (Mexico)
Ranital (Slovenia)
Ranix (Philippines)
Rantac (India)
Rantacid (Finland)
Rantin (Indonesia)
Ratic (Thailand)
Raticina (Argentina)
Rosimol (Argentina)
RND (Taiwan)
Simetac (Hong-Kong)
Sostril (Germany)
Taural (Argentina; Costa-Rica; Dominican-Republic; Ecuador; El-Salvador; Guatemala; Honduras; Nicaragua; Panama)
Ul-Pep (Colombia)
Ulceran (Peru)
Ulceranin (Indonesia)
Ulcex (Italy)
Ulcirex (France)
Ulsal (Austria)
Ultac (India)
Urantac (Korea)
Verlost (Greece)
Vesyca (Taiwan)
Vizerul (Argentina)
Weichilin (Taiwan)
Weidos (Taiwan)
Xanidine (Thailand)
Zantab (Israel)
Zantadin (Indonesia)
Zantic (Germany; Switzerland)
Zinetac (India)

COST OF THERAPY: $99.12 (Duodenal Ulcer; Zantac Tablet; 150 mg; 2/day; 28 days)

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