DONNATAL® ELIXIR
Rx Only
DESCRIPTION: Each Donnatal� 5 mL (teaspoonful) of elixir (alcohol not
more than 23.8%) contains:
Phenobarbital, USP ................................... 16.2 mg
Hyoscyamine Sulfate, USP ........................ 0.1037 mg
Atropine Sulfate, USP ............................... 0.0194 mg
Scopolamine Hydrobromide, USP ............. 0.0065 mg
INACTIVE INGREDIENTS:
Artificial Grape Flavor, D & C Red #33, Ethyl Alcohol 95%, FD & C Blue
#1, Glycerin, Purified Water, Saccharin Sodium, Sorbitol Solution 70%,
and Sucrose.
CLINICAL PHARMACOLOGY:
This drug combination provides natural belladonna alkaloids in a specific,
fixed ratio combined with phenobarbital to provide peripheral
anticholinergic/antispasmodic action and mild sedation.
| INDICATIONS AND USAGE
Based on a review of this drug by the National Academy of Sciences- National Research Council and/or other information, FDA has classified
the following indications as ?possibly? effective:
For use as adjunctive therapy in the treatment of irritable bowel syndrome
(irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
May also be useful as adjunctive therapy in the treatment of duodenal
ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER
ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING
OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES
OR PREVENT COMPLICATIONS. |
CONTRAINDICATIONS:
Glaucoma, obstructive uropathy (for example, bladder neck obstruction
due to prostatic hypertrophy); obstructive disease of the gastrointestinal
tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus,
intestinal atony of the elderly or debilitated patient; unstable
cardiovascular status in acute hemorrhage; severe ulcerative colitis
especially if complicated by toxic megacolon; myasthenia gravis; hiatal
hernia associated with reflux esophagitis.
Donnatal� Elixir is contraindicated in patients with known hypersensitivity
to any of the ingredients. Phenobarbital is contraindicated in acute
intermittent porphyria and in those patients in whom phenobarbital
produces restlessness and/or excitement.
WARNINGS:
In the presence of a high environmental temperature, heat prostration
can occur with belladonna alkaloids (fever and heatstroke due to
decreased sweating).
Diarrhea may be an early symptom of incomplete intestinal obstruction,
especially in patients with ileostomy or colostomy. In this instance,
treatment with this drug would be inappropriate and possibly harmful.
Donnatal� Elixir may produce drowsiness or blurred vision. The patient
should be warned, should these occur, not to engage in activities
requiring mental alertness, such as operating a motor vehicle or other
machinery, and not to perform hazardous work.
Phenobarbital may decrease the effect of anticoagulants, and necessitate
larger doses of the anticoagulant for optimal effect. When the
phenobarbital is discontinued, the dose of the anticoagulant may have to
be decreased.
Phenobarbital may be habit forming and should not be administered to
individuals known to be addiction prone or to those with a history of
physical and/or psychological dependence upon drugs.
Since barbiturates are metabolized in the liver, they should be used with
caution and initial doses should be small in patients with hepatic
dysfunction.
PRECAUTIONS:
GENERAL
Use with caution in patients with: autonomic neuropathy, hepatic or renal
disease, hyperthyroidism, coronary heart disease, congestive heart
failure, cardiac arrhythmias, tachycardia, and hypertension.
Belladonna alkaloids may produce a delay in gastric emptying (antral
stasis) which would complicate the management of gastric ulcer.
Do not rely on the use of the drug in the presence of complication of
biliary tract disease. Theoretically, with overdosage, a curare-like action may occur.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:
Long-term studies in animals have not been performed to evaluate
carcinogenic potential.
PREGNANCY
PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with Donnatal�
Elixir. It is not known whether Donnatal� Elixir can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity.
Donnatal� Elixir should be given to a pregnant woman only if clearly
needed.
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 Donnatal� Elixir is administered to a nursing
woman.
ADVERSE REACTIONS:
Adverse reactions may include xerostomia; urinary hesitancy and
retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia;
increased ocular tension; loss of taste sense; headache; nervousness;
drowsiness; weakness; dizziness; insomnia; nausea; vomiting;
impotence; suppression of lactation; constipation; bloated feeling;
musculoskeletal pain; severe allergic reaction or drug idiosyncrasies,
including anaphylaxis, urticaria and other dermal manifestations; and
decreased sweating. Elderly patients may react with symptoms of
excitement, agitation, drowsiness, and other untoward manifestations to
even small doses of the drug. Phenobarbital may produce excitement in
some patients, rather than a sedative effect. In patients habituated to
barbiturates, abrupt withdrawal may produce delirium or convulsions.
OVERDOSAGE:
The signs and symptoms of overdose are headache, nausea, vomiting,
blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the
mouth, difficulty in swallowing, and CNS stimulation. Treatment should
consist of gastric lavage, emetics, and activated charcoal. If indicated,
parenteral cholinergic agents such as physostigmine or bethanechol
chloride, should be used.
DOSAGE AND ADMINISTRATION:
The dosage of Donnatal� Elixir should be adjusted to the needs of the
individual patient to assure symptomatic control with a minimum of
adverse effects.
Donnatal� Elixir. Adults: One or two teaspoonfuls of elixir three or four
times a day according to conditions and severity of symptoms.
Pediatric patients: may be dosed every 4 to 6 hours.
| |
Starting dosage |
| Body weight |
q4h |
q6h |
| 10 lb. (4.5 kg) |
0.5 mL |
0.75 mL |
| 20 lb. (9.1 kg) |
1.0 mL |
1.5 mL |
| 30 lb. (13.6 kg) |
1.5 mL |
2.0 mL |
| 50 lb. (22.7 kg) |
1/2 tsp |
3/4 tsp |
| 75 lb. (34 kg) |
3/4 tsp |
1 tsp |
| 100 lb. (45.4 kg) |
1 tsp |
1 1/2 tsp |
HOW SUPPLIED:
Donnatal� Elixir is a purple colored, grape flavored liquid.
4 fl oz (118 mL) bottles NDC 66213-423-04.
1 Pint (473 mL) bottles NDC 66213-423-16.
AVOID FREEZING
Store Donnatal� Elixir at 20� - 25�C (68� - 77�F) [see USP Controlled
Room Temperature].
Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using
a child-resistant closure. Use safety closures when dispensing this
product unless otherwise directed by a physician or requested by
purchaser.
PBM Pharmaceuticals, Inc.
Gordonsville, VA 22942
8181603
Rev 8/04
R0 |
