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

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Cimetidine

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

CIMETIDINE DESCRIPTION


Cimetidine




Solubility Characteristics



CLINICAL PHARMACOLOGY




Antisecretory Activity

1) Acid Secretion

Nocturnal


Food Stimulated





24-Hour Mean H+ Activity


Chemically Stimulated




2) Pepsin


3) Intrinsic Factor


Other

Lower Esophageal Sphincter Pressure and Gastric Emptying


PHARMACOKINETICS




CLINICAL TRIALS

Duodenal Ulcer


Active Duodenal Ulcer


*
*




Maintenance Therapy in Duodenal Ulcer





Active Benign Gastric Ulcer



**

**

Gastroesophageal Reflux Disease




Pathological Hypersecretory Conditions


INDICATIONS & USAGE


(1) Short-term treatment of active duodenal ulcer.DOSAGE AND ADMINISTRATION: Duodenal Ulcer
(2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer.
(3) Short-term treatment of active benign gastric ulcer.
(4) Erosive gastroesophageal reflux (GERD).DOSAGE AND ADMINISTRATION: GERD
(5) The treatment of pathological hypersecretory conditions

CIMETIDINE CONTRAINDICATIONS



PRECAUTIONS

General

ADVERSE REACTIONS

DRUG INTERACTIONS








CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Teratogenic Effects. Pregnancy Category B


NURSING MOTHERS



PEDIATRIC USE



Immunocompromised Patients


CIMETIDINE ADVERSE REACTIONS



Gastrointestinal


CNS



Endocrine



Hematologic


Hepatobiliary




Hypersensitivity


Renal


Cardiovascular


Musculoskeletal


Integumental


Immune Function


OVERDOSAGE






DOSAGE & ADMINISTRATION

Duodenal Ulcer

Active Duodenal Ulcer
CLINICAL PHARMACOLOGY: Antisecretory Activity: Acid SecretionCLINICAL TRIALS: Duodenal Ulcer: Active Duodenal Ulcer

PRECAUTIONS: Drug Interactions

CLINICAL TRIALS: Duodenal Ulcer: Active Duodenal Ulcer



Maintenance Therapy for Duodenal Ulcer


Active Benign Gastric Ulcer
CLINICAL TRIALS

Erosive Gastroesophageal Reflux Disease (GERD)


Pathological Hypersecretory Conditions


Dosage Adjustment for Patients with Impaired Renal Function


HOW SUPPLIED


























PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Cimetidine

Cimetidine

Cimetidine

Cimetidine TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-378(NDC:0378-0372)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CIMETIDINE CIMETIDINE 400 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE
HYPROMELLOSES
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
polyethylene glycol
povidone
STARCH, CORN
SODIUM ALGINATE
SODIUM LAURYL SULFATE
titanium dioxide
triacetin
VANILLIN
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
D&C YELLOW NO. 10

Product Characteristics

Color Size Imprint Code Shape
green 11 mm M;372 PENTAGON (5 sided)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-378-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074246 2011-07-14


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