DESCRIPTION
id: ba2185c2-e1fe-4814-89f1-f9a231359e68
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
The active ingredient in Ranitidine Syrup (Ranitidine Oral Solution USP) is ranitidine hydrochloride (HCl) USP, 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, HCl. It has the following structure:
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.
Each 1 mL of Ranitidine Syrup (Ranitidine Oral Solution USP) contains 16.8 mg of ranitidine hydrochloride equivalent to 15 mg of ranitidine. Ranitidine Syrup (Ranitidine Oral Solution USP) also contains the inactive ingredients dibasic sodium phosphate, hydroxyethylcellulose, methylparaben, purified water, sodium chloride, sodium saccharin, spearmint flavor, sucrose and may contain monobasic sodium phosphate.
CLINICAL PHARMACOLOGY
id: bededb52-bba8-4c52-8e4a-7f7cda15b1fd
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H2-receptors, including receptors on the gastric cells. Ranitidine does not lower serum Ca++ in hypercalcemic states. Ranitidine is not an anticholinergic agent.
INDICATIONS AND USAGE
id: 2b2b2e32-30e3-48ca-9bcd-4ce423f2ae11
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Ranitidine Syrup (Ranitidine Oral Solution USP) is indicated in:
- Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
- Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.
- The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
- Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
- Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.
- Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily.
- Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily.
- Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.
Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
CONTRAINDICATIONS
id: 54c7eb4c-98d0-425f-8617-5051de24859c
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Ranitidine is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS).
ADVERSE REACTIONS
id: 93a7f4bc-e20b-4887-8aa1-111f92655b6a
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine. The relationship to therapy with ranitidine has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ranitidine.
OVERDOSAGE
id: 13d24de3-1134-4b8c-8d7f-b3938782cef7
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
There has been limited experience with overdosage. 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, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.
Studies in dogs receiving dosages of ranitidine in excess of 225 mg/kg per 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: b6a71824-df8e-4887-9c54-2ea2988dd952
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Ranitidine Syrup (Ranitidine Oral Solution USP), a clear, pale yellow, spearmint-flavored liquid, contains 16.8 mg of ranitidine hydrochloride equivalent to 15 mg of ranitidine per 1 mL of oral solution (75 mg/5 mL) in bottles of 16 fl oz (NDC 0121-0727-16) and 10 mL unit dose cups, packaged in trays of 10 (NDC 0121-4727-10).
PRINCIPAL DISPLAY PANEL – 473 mL Bottle Label
id: f45e20a6-052d-4a34-b188-c0cef3bb3f91
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 0121-0727-16
Ranitidine Syrup
(Ranitidine Oral Solution USP)
15 mg/mL
75 mg/5 mL
Each 1 mL contains: 16.8 mg of
ranitidine hydrochloride equivalent
to 15 mg of ranitidine.
Alcohol Free
Rx ONLY
16 fl oz (473 mL)
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
PRINCIPAL DISPLAY PANEL – 10 mL Cup Lid
id: b9ca8926-8b7f-4cc3-a5cd-469ea1b20f4e
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Delivers 10 mL
NDC 0121-4727-10
R
ANITIDINE
S
YRUP
(Ranitidine Oral Solution USP)
150 mg/10 mL
Each 1 mL contains 16.8 mg of Ranitidine hydrochloride
equivalent to 15 mg of ranitidine.
Store at 20° to 25°C (68° to 77°F).
(See USP Controlled Room Temperature)
Do not freeze.
FOR INSTITUTIONAL USE ONLY
Usual Dosage: See Package Insert
for Complete Dosage Recommendations.
Rx ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
