Belladonna and Opium

Each belladonna and opium suppository contains (in a water-soluble base consisting of Polyethylene Glycol 400, 1450, 8000 and Polysorbate 60):

Belladonna (16.2 mg) And Opium (30 mg)

Powdered opium 30 mg (Warning: May be habit forming.) and powdered belladonna extract 16.2 mg.

Belladonna (16.2 mg) And Opium (60 mg)

Powdered opium 60 mg (Warning: May be habit forming.) and powdered belladonna extract 16.2 mg.

This drug falls into the pharmacological/therapeutic class of narcotic analgesic/antispasmotic agents.

The pharmacologically active principles present in the belladonna extract component of belladonna and opium suppositories are:

Established Name: Atropine
Chemical Name: dl Tropyl Tropate

Established Name: Scopolamine
Chemical Name: dl Scopolamine

Opium contains more than twenty alkaloids, the principle ones being morphine (10%), narcotine (6%), papaverine (1%) and codeine (0.5%). The major pharmacologically active principle of the powdered opium component of belladonna and opium suppositories, however, is:

Name: Morphine
Chemical Name: 7, 8-Didehydro-4, 5-epoxy- 17-Methyl-morphinan-3, 6-diol

Belladonna may cause drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness and blurred vision. Opium usage may result in constipation, nausea or vomiting. Pruritis and urticaria may occasionally occur.

As with morphine and related narcotics, overdosage is characterized by respiratory depression, pinpoint pupils and coma. Respiratory depression may be reversed by intravenous administration of naloxone hydrochloride. In addition, supportive measures such as oxygenation, intravenous fluids and vasopressors should be used as indicated. As with atropine derivatives, hot, dry, flushed skin; dry mouth and hyperpyrexia may occur.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy.
• Dry mouth.
• Hard stools (constipation).
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suppository: Belladonna extract 16.2 mg and opium 30 mg; belladonna extract 16.2 mg and opium 60 mg

Pain: Rectal: One suppository 1 to 2 times daily; maximum: 4 doses/day

Store at room temperature. Do not refrigerate.

Frequency not defined.

Cardiovascular: Palpitations

Central nervous system: Dizziness, drowsiness

Dermatologic: Pruritus, urticaria

Gastrointestinal: Constipation, nausea, vomiting, xerostomia

Genitourinary: Urinary retention

Ophthalmic: Blurred vision, photophobia

Postmarketing and/or case reports (Limited to important or life-threatening): Hypogonadism (Brennan, 2013; Debono, 2011)

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how belladonna and opium will affect you.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid becoming overheated or dehydrated during exercise and in hot weather. This medication can decrease sweating and you may be more prone to heat stroke.

Drinking alcohol can increase certain side effects of belladonna and opium.