Donnatal

What is Donnatal?

DESCRIPTION Donnatal ® Elixir - Grape Each 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 Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1.

Uses of Donnatal

Established uses

• 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 indications as follows: "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.
• Final classification of the less-than-effective indications requires further investigation.
• 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.

How to take Donnatal

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. Use a pediatric dosing device or oral syringe to measure the dose. Starting Dosage Body weight Every 4 hours Every 6 hours 10 lb. (4.5 kg) 0.5 mL 0.75 mL 20 lb. (9.1 kg) 1 mL 1.5 mL 30 lb. (13.6 kg) 1.5 mL 2 mL 50 lb. (22.7 kg) 2.5 mL 3.75 mL 75 lb. (34 kg) 3.75 mL 5 mL 100 lb. (45.4 kg) 5 mL 7.5 mL

Dosage

Follow the dose prescribed by your doctor or pharmacist. The ranges below are general information, not a personal prescription.

Adults

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. Use a pediatric dosing device or oral syringe to measure the dose. Starting Dosage Body weight Every 4 hours Every 6 hours 10 lb. (4.5 kg) 0.5 mL 0.75 mL 20 lb. (9.1 kg) 1 mL 1.5 mL 30 lb. (13.6 kg) 1.5 mL 2 mL 50 lb. (22.7 kg) 2.5 mL 3.75 mL 75 lb. (34 kg) 3.75 mL 5 mL 100 lb. (45.4 kg) 5 mL 7.5 mL

Side effects of Donnatal

Common

• ADVERSE REACTIONS Adverse reactions may include xerostomia;
• urinary hesitancy and retention;
• blurred vision;
• tachycardia;
• palpitation;
• mydriasis;

Warnings and who should not take it

Who should NOT take Donnatal?

• 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;

Warnings and precautions

• WARNINGS Donnatal® Elixir can cause fetal harm when administered to a pregnant woman.
• Animal reproduction studies have not been conducted with Donnatal® Elixir.
• If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
• 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.

Overdose

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.

Safety at a glance

Children and elderly

Interactions

Medicine and medicine

• Drug Interactions 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.

Frequently asked questions