IMPORTANT SAFETY INFORMATION
glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); severe ulcerative colitis especially if complicated by toxic megacolon; paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; hiatal hernia associated with reflux esophagitis, myasthenia gravis; and 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.
- Donnatal can cause fetal harm when administered to a pregnant woman. 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.
- Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer.
- Donnatal 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.
- Use with caution in patients with: autonomic neuropathy; hepatic or renal disease; hyperthyroidism; coronary heart disease; congestive heart failure; cardiac arrhythmias; tachycardia; and hypertension.
- 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.
- In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.
- Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.
- Do not rely on the use of the drug in the presence of complication of biliary tract disease.
- Donnatal Elixir – Mint contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
- There is no positive evidence of human fetal risk
- 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 is administered to a nursing woman.
- Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.
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 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.
Phenobarbital may produce excitement in some patients, rather than a sedative effect.