Ranitidine Hydrochloride
FULL PRESCRIBING INFORMATION: CONTENTS*
- RANITIDINE HYDROCHLORIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- RANITIDINE HYDROCHLORIDE CONTRAINDICATIONS
- PRECAUTIONS
- RANITIDINE HYDROCHLORIDE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
RANITIDINE HYDROCHLORIDE DESCRIPTION
CLINICAL PHARMACOLOGY
Pharmacokinetics: Absorption:
Distribution:
Metabolism:
Excretion:DOSAGE AND ADMINISTRATION
Geriatrics:PRECAUTIONS: Geriatric UseDOSAGE AND ADMINISTRATION: Dosage Adjustment for Patients with Impaired Renal Function
Pediatrics:
PRECAUTIONS: Pediatric UseDOSAGE AND ADMINISTRATION: Pediatric Us
Pharmacodynamics:
Antisecretory Activity:
2. Effects on Other Gastrointestinal Secretions:
Pepsin:
Intrinsic Factor:
Serum Gastrin:
Other Pharmacologic Actions:
a.
b.
c.
d.
e
f.
Pediatrics:
Clinical Trials: Active Duodenal Ulcer:
Maintenance Therapy in Duodenal Ulcer:
Gastric Ulcer:
Maintenance of Healing of Gastric Ulcers: In
Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome):
Gastroesophageal Reflux Disease (GERD):
Erosive Esophagitis:
Maintenance of Healing of Erosive Esophagitis:
INDICATIONS & USAGE
RANITIDINE HYDROCHLORIDE CONTRAINDICATIONS
PRECAUTIONSPRECAUTIONS
General:DOSAGE AND ADMINISTRATION
Laboratory Tests:
Drug Interactions:
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Pregnancy: Teratogenic Effects:
Nursing Mothers:
Pediatric Use:CLINICAL PHARMACOLOGY: PediatricsDOSADGE AND ADMINISTRATION: Pediatric Use
CLINICAL PHARMACOLOGY: Pediatrics
Geriatric Use:
CLINICAL PHARMACOLOGY: Pharmacokinetics: GeriatricsDOSAGE AND ADMINISTRATION: Dosage Adjustment for Patients with Impaired Renal Function
RANITIDINE HYDROCHLORIDE ADVERSE REACTIONS
Central Nervous System:
Cardiovascular:
Gastrointestinal:
Hepatic:
Musculoskeletal:
Hematologic:
Endocrine:
Integumentary:
Respiratory:
Other:
OVERDOSAGE
ADVERSE REACTIONSDOSAGE & ADMINISTRATION
Active Duodenal Ulcer:Clinical Trials: Active Duodenal UlcerCLINICAL PHARMACOLOGY: Pharmacokinetics
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:
CLINICAL PHARMACOLOGY: Pharmacokinetics: GeriatricsPRECAUTIONS: Geriatric Use
HOW SUPPLIED
STORAGE AND HANDLING
Store at 20- 25(68- 77(See USP Controlled Room Temperature) in a tight, light resistant container. Protect from light. Replace cap securely after each opening.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Ranitidine HydrochlorideRanitidine Hydrochloride TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
