RANITIDINE

RANITIDINE INDICATIONS AND USAGE

• 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.

RANITIDINE CONTRAINDICATIONS

PRECAUTIONS

General:

• Symptomatic response to therapy with ranitidine does not preclude the presence of gastric malignancy.
• Since ranitidine is excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function (see DOSAGE AND ADMINISTRATION). Caution should be observed in patients with hepatic dysfunction since ranitidine is metabolized in the liver.
• Rare reports suggest that ranitidine may precipitate acute porphyric attacks in patients with acute porphyria. Ranitidine should therefore be avoided in patients with a history of acute Porphyria.

Procainamide:

Warfarin:



Atazanavir:

Delavirdine:

Gefitinib:

Glipizide:

Ketoconazole:

Midazolam:

Triazolam:

Carcinogenesis, Mutagenesis, Impairment of Fertility:
Escherichia coli


Pregnancy: Teratogenic Effects:

Nursing Mothers:

Pediatric Use:



Geriatric Use:

RANITIDINE ADVERSE REACTIONS

Central Nervous System:

Cardiovascular: ₂

Gastrointestinal:

Hepatic:


Musculoskeletal:

Hematologic:

Endocrine:



Integumentary:

Respiratory:₂₂₂

Other:

OVERDOSAGE

RANITIDINE DOSAGE AND ADMINISTRATION

Active Duodenal Ulcer:Active Duodenal Ulcer



Maintenance of Healing of Duodenal Ulcers:

Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome):

Benign Gastric Ulcer:

Maintenance of Healing of Gastric Ulcers:

GERD:

Erosive Esophagitis:

Maintenance of Healing of Erosive Esophagitis:

Pediatric Use:



Treatment of Duodenal and Gastric Ulcers:

Maintenance of Healing of Duodenal and Gastric Ulcers:

Treatment of GERD and Erosive Esophagitis:

Dosage Adjustment for Patients With Impaired Renal Function:

HOW SUPPLIED

Bottles of 30	NDC 54868-4048-2
Bottles of 60	NDC 54868-4048-0
Bottles of 90	NDC 54868-4048-3
Bottles of 100	NDC 54868-4048-1
Bottles of 180	NDC 54868-4048-4

Bottles of 30	NDC 54868-4350-0
Bottles of 100	NDC 54868-4350-1

Manufactured by:



Distributed by:







Relabeling and Repackaging by:

PRINCIPAL DISPLAY PANEL

RANITIDINE RANITIDINE TABLET Product Information Product Type Human prescription drug label Item Code (Source) NDC:54868-4048(NDC:64679-906) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE RANITIDINE 150 mg Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline CROSCARMELLOSE SODIUM talc SILICON DIOXIDE MAGNESIUM STEARATE castor oil HYPROMELLOSES titanium dioxide Product Characteristics Color Size Imprint Code Shape white (white) 11 mm W906 HEXAGON (6 sided) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-4048-0 60 in 1 BOTTLE, PLASTIC 2 NDC:54868-4048-1 100 in 1 BOTTLE, PLASTIC 3 NDC:54868-4048-2 30 in 1 BOTTLE, PLASTIC 4 NDC:54868-4048-3 90 in 1 BOTTLE, PLASTIC 5 NDC:54868-4048-4 180 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075208 1999-09-21

RANITIDINE RANITIDINE TABLET Product Information Product Type Human prescription drug label Item Code (Source) NDC:54868-4350(NDC:64679-907) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE RANITIDINE 300 mg Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline CROSCARMELLOSE SODIUM talc SILICON DIOXIDE MAGNESIUM STEARATE castor oil HYPROMELLOSES titanium dioxide Product Characteristics Color Size Imprint Code Shape white (white) 16 mm W907 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-4350-0 30 in 1 BOTTLE, PLASTIC 2 NDC:54868-4350-1 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075208 2003-09-19