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Belladonna and Opium

Warnings & Precautions
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WARNINGS

True addiction may result from opium usage. These preparations are not recommended for use in children.

PRECAUTIONS

Administer with caution to persons with a known idiosyncrasy to atropine or to atropine-like compounds; to persons known to be sensitive to or addicted to morphine or morphine-like drugs; to persons with cardiac disease, incipient glaucoma or prostatic hypertrophy. Caution should be used in the administration of this drug to elderly and debilitated patients and patients with increased intracranial pressure, toxic psychosis and myxedema.

Pregnancy Category C

Animal studies have not been conducted with belladonna and opium suppositories. It is also not known whether belladonna and opium suppositories can affect reproductive capacity. The active principles of belladonna and opium suppositories, atropine and morphine, are known to enter the fetal circulation. Regular use of opium alkaloids during pregnancy has resulted in addiction of the fetus leading to withdrawal symptoms in the neonate. Belladonna and opium suppositories therefore should be used by a pregnant woman with caution and only when clearly indicated.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when belladonna and opium suppositories are administered to a nursing woman.

Brand Name: Belladonna and Opium
Generic Name: Belladonna and Opium

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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