Donnatal Tablets

The dosage of Donnatal® Tablets should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.

Donnatal® Tablets - Adults: One or two Donnatal® Tablets three or four times a day according to condition and severity of symptoms.

How supplied

Donnatal® Tablets are supplied as: white, D-shaped, flat faced beveled edge tablets debossed “D” on one side and “Donnatal” on the other side.

Bottles of 100 tablets- NDC 59212-425-10.

Bottles of 1000 tablets- NDC 59212-425-11.

Bottles of 4 tablets- NDC 59212-425-04.

Store at 20°-25°C (68°-77°F). Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a childresistant closure.

Manufactured For: Concordia Pharmaceuticals Inc., St. Michael, Barbados BB11005. Manufactured By: IriSys, LLC, San Diego, CA 92121. Revised: March 2015

• 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;
• in patients with known hypersensitivity to any of the ingredients.

Phenobarbital (Donnatal Tablets) is contraindicated in acute intermittent porphyria and in those patients in whom Phenobarbital (Donnatal Tablets) produces restlessness and/or excitement.

Phenobarbital (Donnatal Tablets) may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the Phenobarbital (Donnatal Tablets) is discontinued, the dose of the anticoagulant may have to be decreased.

See also:
What are the possible side effects of Donnatal Tablets?

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.

Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema, and similar conditions. Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by Phenobarbital (Donnatal Tablets) and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has been associated with the chronic use of Phenobarbital (Donnatal Tablets).

Phenobarbital (Donnatal Tablets) may produce excitement in some patients, rather than a sedative effect.

To report SUSPECTED ADVERSE REACTIONS, contact Concordia Pharmaceuticals Inc. at 1-877-370-1142 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Abuse And Dependence

Abuse

Phenobarbital (Donnatal Tablets) 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.

Dependence

In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.