Ranitidine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Ranitidine Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

RANITIDINE HYDROCHLORIDE DESCRIPTION


Ranitidine Hydrochloride





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: 1. Effects on Acid Secretion:

2. Effects on Other Gastrointestinal Secretions:
Pepsin:
Intrinsic Factor:
Serum Gastrin:
Other Pharmacologic Actions:






Pediatrics:
Clinical Trials: Active Duodenal Ulcer:





Maintenance Therapy in Duodenal Ulcer:





Gastric Ulcer:



Maintenance of Healing of Gastric Ulcers:
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

PRECAUTIONS

PRECAUTIONS

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 REACTIONS



DOSAGE & ADMINISTRATION

Active Duodenal Ulcer:Clinical Trials: Active Duodenal Ulcer
CLINICAL 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



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Ranitidine Hydrochloride

Ranitidine Hydrochloride

Ranitidine Hydrochloride TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-025(NDC:53746-254)
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
CROSCARMELLOSE SODIUM
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
ferric oxide red
titanium dioxide
TRIETHYL CITRATE
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
yellow 17 mm IP254 BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-025-16 50 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077824 2012-01-12


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