Ranitidine Hydrochloride Capsules

DESCRIPTION

id: 64174066-cecc-0a1b-e053-2a91aa0ab086
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

The active ingredient in Ranitidine Hydrochloride Capsules, 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 structural formula:   The molecular formula is C
₁₃H
₂₂N
₄O
₃S•HCl, representing a molecular weight of 350.87.  Ranitidine HCl is a white to pale yellow, crystalline substance that is soluble in water. It has a slightly bitter taste and sulfur-like odor.  Each Ranitidine Hydrochloride capsule, for oral administration, contains 167.4 mg or 334.8 mg of ranitidine hydrochloride equivalent to 150 mg or 300 mg of ranitidine, respectively. In addition, each capsule contains the following inactive ingredients: Microcrystalline Cellulose, Sodium Starch Glycolate, Magnesium Stearate. The capsule shells contain Black Iron Oxide, Red Iron Oxide T3469, Yellow Iron Oxide T3506, Titanium Dioxide and Gelatin. The capsule shells are imprinted with edible ink.

CLINICAL PHARMACOLOGY

id: 64174066-cecd-0a1b-e053-2a91aa0ab086
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 AND USAGE

id: 64174066-ced4-0a1b-e053-2a91aa0ab086
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

  Ranitidine 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 b.i.d.
Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg q.i.d.
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: 64174066-ced5-0a1b-e053-2a91aa0ab086
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: 64174066-cede-0a1b-e053-2a91aa0ab086
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 q.i.d. intravenously for 7 days, and in 4 of 24 subjects receiving 50 mg q.i.d. intravenously 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 gynecomastia, 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. Integumentary:  Rash, including rare cases of erythema multiforme, and, rarely, alopecia. Other:  Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, and small increases in serum creatinine.

To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email

OVERDOSAGE

id: 64174066-cedf-0a1b-e053-2a91aa0ab086
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 1000 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 AND ADMINISTRATION

id: 64174066-cee0-0a1b-e053-2a91aa0ab086
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Active Duodenal Ulcer:
  The current recommended adult oral dosage of ranitidine 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 studies, and several foreign trials have shown that 100 mg b.i.d. 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 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 a day. 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 a day.
 
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 a day.
 
Erosive Esophagitis:  The current recommended adult oral dosage is 150 mg four times a day.
 
Maintenance of Healing of Erosive Esophagitis :  The current recommended adult oral dosage is 150 mg twice a day.

HOW SUPPLIED

id: 64174066-cee2-0a1b-e053-2a91aa0ab086
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Ranitidine Hydrochloride Capsules 150 mg are Size 3, opaque light brown hard gelatin capsules imprinted “CD” and “129” in black edible ink. The capsules are supplied in bottles of 500 (NDC 42291-735-50) Ranitidine Hydrochloride Capsules 300 mg are Size 1, opaque light brown hard gelatin capsulesimprinted “CD” and “130” in black edible ink. The capsules are supplied in bottles of 500 (NDC 42291-736-50) Store at controlled room temperature 15° – 30°C (59° – 86°F) (see USP) in a dry place. Protect from light. Dispense in a tight, light resistant container. Manufactured for: AvKARE, Inc.                  Pulaski, TN 38478 Mfg. Rev. 0205 AV 11/16 (P)