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

Loperamide Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION



DESCRIPTION







CLINICAL PHARMACOLOGY




INDICATIONS & USAGE



CONTRAINDICATIONS





  • ●in patients with acute dysentery, which is characterized by blood in stools and high fever,
  • ●in patients with acute ulcerative colitis,
  • ●in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter,
  • ●in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics.

WARNINGS







PRECAUTIONS

General


INFORMATION FOR PATIENTS




DRUG INTERACTIONS




CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Teratogenic Effects

Pregnancy category C


Non-teratogenic Effects


NURSING MOTHERS



PEDIATRIC USE




ADVERSE REACTIONS

Clinical Trial Data













**
Postmarketing Experience


Skin and Subcutaneous Tissue Disorders


Immune System Disorders


Gastrointestinal Disorders


Renal and Urinary Disorders


Nervous System Disorders


General Disorders and Administrative Site Conditions



DRUG ABUSE AND DEPENDENCE

Abuse


Dependence


OVERDOSAGE







DOSAGE & ADMINISTRATION




Acute Diarrhea

Adults


Children








Chronic Diarrhea

Children


Adults



Children Under 2 Years


Elderly


Renal Impairment


Hepatic Impairment


HOW SUPPLIED




STORAGE AND HANDLING





PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL














Loperamide Hydrochloride

Loperamide Hydrochloride CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:24236-083(NDC:0093-0311)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE 2 mg

Inactive Ingredients

Ingredient Name Strength
MAGNESIUM STEARATE
DIMETHICONE
GELATIN
FERROSOFERRIC OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
lactose monohydrate
STARCH, CORN
SHELLAC
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
brown 14 mm TEVA;0311 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24236-083-04 14 in 1 BLISTER PACK
2 NDC:24236-083-15 15 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073192 2011-11-16


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Be sure to consult your doctor before taking any medication!
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