LOPERAMIDE HYDROCHLORIDE CAPSULES U.S.P.

Antidiarrheal capsules for oral use.

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Composition

Each hard gelatin capsule contains:
Loperamide Hydrochloride U.S.P.: 2 mg
Approved colours used in capsule shell

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Indications
Loperamide hydrochloride is indicated for the control and symptomatic relief of acute non-specific diarrhoea and of chronic diarrhea associated with inflammatory bowel disease.


Dosage and Administration

Acute Diarrhea

Adults:
The recommended initial dose is 4 mg (two capsules) followed by 2mg (one capsule) after each unformed stool. Daily dosage should not exceed 16 mg (eight capsules). Clinical improvement is usually observed within 48 hours.

Children:
Loperamide hydrochloride use is not recommended for children under 2 years of age. In children 2 to 5 years of age (20 kg or less), a non-prescription liquid formulation should be used; for ages 6 to 12, either loperamide hydrochloride capsules or liquid may be used.

Chronic Diarrhea

Adults:
The recommended initial dose is 4mg (two capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled, after which the dosage of loperamide hydrochloride should be reduced to meet individual requirements. When the optimal daily dosage has been established, this amount may then be administered as a single dose or in divided doses.

Children:
Although loperamide hydrochloride has been studied in a limited number of children with chronic diarrhea, the therapeutic dose for the treatment of chronic diarrhea in a pediatric population has not been established.

Or as directed by the Physician.


Contraindications
Loperamide hydrochloride is contraindicated for children till 5 years.
Hypersensitivity to Loperamide hydrochloride or any of the ingredients.

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Presentation

10 Blisters of 10 capsules each is packed in a Carton along with the insert literature.


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