Ranitidine Injection, USP

/Ranitidine Injection, USP
Ranitidine Injection, USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Ranitidine Injection, USP

ID:

a12a5556-3ba3-46c5-921f-5dd66088d86c

Code:

34391-3

DESCRIPTION


id: 84923ea2-278e-4c59-b1b9-9c47088bac4a
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

The active ingredient in ranitidine injection is ranitidine hydrochloride (HCl), 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. It has the following structure:

figure01

The molecular formula is C13H22N4O3S•HCl, representing a molecular weight of 350.87. Ranitidine hydrochloride, USP is a white to pale yellow, granular substance that is soluble in water. Ranitidine injection, USP 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 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.

CLINICAL PHARMACOLOGY


id: 524d1d8b-864a-4b66-9d84-a49b382db99f
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Ranitidine hydrochloride is a competitive, reversible inhibitor of the action of histamine at the histamine H2-receptors, including receptors on the gastric cells. Ranitidine hydrochloride does not lower serum Ca++ in hypercalcemic states. Ranitidine hydrochloride is not an anticholinergic agent.

INDICATIONS AND USAGE


id: cad700c6-bfef-4ed9-a41c-7b572e8b3fff
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Ranitidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers, or as an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication.

CONTRAINDICATIONS


id: 3a66d383-cb70-44b5-8ef8-21980073661e
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Ranitidine injection is contraindicated for patients known to have hypersensitivity to the drug.

ADVERSE REACTIONS


id: ab205e87-fc69-45f7-8271-c076f8637f20
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Transient pain at the site of IM injection has been reported. Transient local burning or itching has been reported with IV administration of ranitidine hydrochloride. The following have been reported as events in clinical trials or in the routine management of patients treated with oral or parenteral ranitidine hydrochloride. The relationship to therapy with ranitidine hydrochloride has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ranitidine hydrochloride.

OVERDOSAGE


id: fdbe0016-e93e-4c53-a613-52f71fdcad3d
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

There has been virtually no experience with overdosage with ranitidine injection and limited experience with oral doses of ranitidine. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience (see ADVERSE REACTIONS ). In addition, abnormalities of gait and hypotension have been reported. When overdosage occurs, clinical monitoring and supportive therapy should be employed. Studies in dogs receiving dosages of ranitidine hydrochloride in excess of 225 mg/kg/day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal. Intravenous LD50 values in mice and rats were 77 and 83 mg/kg, respectively.

HOW SUPPLIED


id: 93e4261f-ca39-4037-813e-b5019ac7be56
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Ranitidine Injection USP, 25 mg/mL, containing phenol 0.5% as preservative, is available as follows: NDC-65841-763-02, 2-mL single-use vials (10 Vials per carton) NDC-65841-764-06, 6-mL multi-dose vials (Single)