Medications and Drugs
GENERIC NAME: hyoscyamine sulfate, atropine sulfate,
scopolamine sulfate and phenobarbital
BRAND NAME: Donnatal
DRUG CLASS AND MECHANISM: Donnatal is a medicine which
combines
naturally occurring belladonna alkaloids (atropine, scopolamine
and
hyoscyamine) with phenobarbital. This provides multiple
effects, including
reduction of bowel spasms caused by overly active nerves and
mild
sedation.
PRESCRIPTION: yes
GENERIC AVAILABLE: yes
PREPARATIONS: Capsules: 16.2 mg phenobarbital,
0.1037
hyoscyamine sulfate, 0.0194 mg atropine sulfate, and 0.0065 mg
scopolamine
hydrobromide. Tablets: 16.2 mg phenobarbital, 0.1037 mg
hyoscyamine sulfate, 0.0194 mg atropine sulfate, and 0.065 mg
scopolamine
hydrobromide or, 32.4 mg phenobarbital and the same amount of
the other
components as the regular Donnatal tablets. Sustained
release tablets:
48.6 mg phenobarbital, 0.311 mg hyoscyamine sulfate, 0.0582 mg
atropine
sulfate, and 0.0195 mg scopolamine hydrobromide (Donnatal Extentabs).
Elixir (per 5ml): 16.2 mg phenobarbital, 0.1037 mg
hyoscyamine
sulfate, 0.0194 mg atropine sulfate, and 0.0065 mg scopolamine
hydrobromide.
STORAGE: Store at controlled room temperature between
15-30C
(59-86F)
PRESCRIBED FOR: Donnatal is used in the treatment of
abdominal
pain, bloating and cramps in patients with irritable bowel
syndrome. It is
also used in patients with acute inflammation of the stomach and
intestines (gastroenteritis), in reducing pain and diarrhea. It
is
frequently used as additional therapy in patients with duodenal
ulcer.
DOSING: May be taken with or without food. The dosage is
adjusted to the individual patient to assure control of
symptoms with a
minimum of side effects.
DRUG INTERACTIONS: Caution is advised in patients with
glaucoma,
myasthenia gravis and urinary obstruction as symptoms of these
conditions
may worsen with the use of Donnatal. Patients with an unstable
cardiac
status, severe ulcerative colitis and acute intermittent
porphyria should
avoid Donnatal. Elderly patients may experience adverse
neurological
effects even from small doses.
PREGNANCY: Pregnant women should use Donnatal only when
the
expected benefit outweighs the potential risks, because the
effect on the
unborn fetus is unknown.
NURSING MOTHERS: Caution should be exercised when giving Donnatal to nursing mothers.
SIDE EFFECTS: Adverse reactions include dry eyes, dry
mouth and
urinary hesitancy and retention. Blurred vision, rapid heart
rates,
palpitations may also occur. Headache, nervousness, drowsiness,
and
dizziness can also be seen.
Reference: FDA Prescribing Information
Last Editorial Review: 11/23/1998
Report Problems to the Food and Drug Administration
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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