Prescription Drug Name:

Ranitidine Tablets, USP film coated, Strides Shasun Limited, PRESCRIBING INFORMATION

ID:

6fa9833a-4a04-3744-e053-2a91aa0a061f

Code:

34391-3

DESCRIPTION


id: 6fa9833a-4a09-3744-e053-2a91aa0a061f
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

The active ingredient in ranitidine tablets, USP 150 mg and 300 mg is ranitidine hydrochloride (HCl), USP, a histamine H
2-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 C
13H
22N
4O
3S.HCl, representing a molecular weight of 350.87.

Ranitidine HCl USP is a white to pale yellow crystalline powder that is soluble in water. It has a slightly bitter taste and sulfur-like odor.

Each ranitidine tablets, USP 150 mg for oral administration contains 168 mg of ranitidine HCl USP equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients magnesium stearate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, hypromellose, titanium dioxide, triacetin, and iron oxide red.

Each ranitidine tablets, USP 300 mg for oral administration contains 336 mg of ranitidine HCl USP equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients magnesium stearate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, hypromellose, titanium dioxide, triacetin, and iron oxide red.

CLINICAL PHARMACOLOGY


id: 6fa9833a-4a0a-3744-e053-2a91aa0a061f
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

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

INDICATIONS & USAGE


id: 6fa9833a-4a0b-3744-e053-2a91aa0a061f
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Ranitidine tablets, USP is indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Trials 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. Trials 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 trials 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: 6fa9833a-4a0c-3744-e053-2a91aa0a061f
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Ranitidine tablets, USP is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients ( see PRECAUTIONS).

ADVERSE REACTIONS


id: 6fa9833a-4a0e-3744-e053-2a91aa0a061f
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. Central Nervous System:

Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received. Cardiovascular:

As with other H
2-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats. Gastrointestinal:

Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis. Hepatic:

There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, ranitidine should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred. Rare cases of hepatic failure have also been reported. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intravenously 4 times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously 4 times daily for 5 days. Musculoskeletal:

Rare reports of arthralgias and myalgias. Hematologic:

Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported. Endocrine:

Controlled studies in animals and man have shown no stimulation of any pituitary hormone by ranitidine and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when ranitidine has been substituted. However, occasional cases of impotence and loss of libido have been reported in male patients receiving ranitidine, but the incidence did not differ from that in the general population. Rare cases of breast symptoms and conditions, including galactorrhea and gynecomastia, have been reported in both males and females. Integumentary:

Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis. Respiratory:

A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H
2RAs) compared with patients who had stopped H
2RA treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07 to 2.48). However, a causal relationship between use of H
2RAs and pneumonia has not been established. Other:

Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine.

OVERDOSAGE


id: 6fa9833a-4a0f-3744-e053-2a91aa0a061f
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/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 LD
50 values in mice and rats were 77 and 83 mg/kg, respectively.

DOSAGE & ADMINISTRATION


id: 6fa9833a-4a10-3744-e053-2a91aa0a061f
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Active Duodenal Ulcer:

The current recommended adult oral dosage of ranitidine tablets for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared to the other in a particular patient population have yet to be demonstrated ( see Clinical Trials: Active Duodenal Ulcer). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US trials, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.

Antacid should be given as needed for relief of pain ( see CLINICAL PHARMACOLOGY: Pharmacokinetics). Maintenance of Healing of Duodenal Ulcers:

The current recommended adult oral dosage is 150 mg at bedtime. Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome):

The current recommended adult oral dosage is 150 mg twice daily. In some patients it may be necessary to administer ranitidine 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease. Benign Gastric Ulcer: The current recommended adult oral dosage is 150 mg twice daily. Maintenance of Healing of Gastric Ulcers: The current recommended adult oral dosage is 150 mg at bedtime. GERD: The current recommended adult oral dosage is 150 mg twice daily. Erosive Esophagitis: The current recommended adult oral dosage is 150 mg 4 times daily. Maintenance of Healing of Erosive Esophagitis: The current recommended adult oral dosage is 150 mg twice daily.

HOW SUPPLIED


id: 6fa9833a-4a11-3744-e053-2a91aa0a061f
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Ranitidine tablets, USP 150 mg (ranitidine HCl USP equivalent to 150 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with “S   on one side and plain on the other side.                                                                                                                                                                                                                                                                             429”    

                                                                                      

They are available in bottles of 60 (NDC 64380-803-03), 100 (NDC 64380-803-06), 500 (NDC 64380-803-07) and 1000 (NDC 64380-803-08) tablets. Ranitidine tablets, USP 300 mg (ranitidine HCl USP equivalent to 300 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with “S on one side and plain on the other side.                                                                                                                                                                                                                                                                              430” 

                                                                            They are available in bottles of 30 (NDC 64380-804-04), 100 (NDC 64380-804-06) and 250 (NDC 64380-804-38) tablets. Store at 20° to 25° C (68° and 77° F); excursions permitted between 15° and 30° C (59° and 86° F) [see USP Controlled Room Temperature]. Protect from light. Replace cap securely after each opening.

Manufactured by:

Strides Shasun Limited,

Unit II, R.S. No: 32, 33/11 and 34/2, PIMS Road,

Periyakalapet, Puducherry-605 014, India.

Revised: November 2016

PRINCIPAL DISPLAY PANEL


id: 6fa989fc-0fe7-beab-e053-2a91aa0a1044
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

DRUG: RanitidineImmediate release Immediate release GENERIC: Ranitidine DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 70518-0004-0 NDC: 70518-0004-1 NDC: 70518-0004-2 COLOR: brown SHAPE: ROUND SCORE: No score SIZE: 10 mm IMPRINT: S;429 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 180 in 1 BOTTLE PLASTIC PACKAGING: 60 in 1 BOTTLE PLASTIC ACTIVE INGREDIENT(S): RANITIDINE HYDROCHLORIDE 150mg in 1 INACTIVE INGREDIENT(S): FERRIC OXIDE RED
TITANIUM DIOXIDE
HYPROMELLOSES
TRIACETIN
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE