Donnatal Tablets

Donnatal (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide) Tablets is a combination of natural belladonna alkaloids and a barbiturate used as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal tablets may also be useful as adjunctive therapy in the treatment of duodenal ulcer. Common side effects of Donnatal include:

• dry mouth
• difficulty urinating or urinary retention
• blurred vision
• rapid heart rate
• heart palpitations
• dilated pupils
• vision problems
• loss of taste sense
• headache
• nervousness
• drowsiness
• weakness
• dizziness
• insomnia
• nausea
• vomiting
• impotence
• decreased production of breast milk in nursing women
• constipation
• bloating
• muscle pain
• severe allergic reaction (including anaphylaxis)
• hives and other skin problems, and
• decreased sweating

The adult dose of Donnatal is one or two tablets three or four times a day according to the patient's condition and severity. Donnatal may interact with anticoagulants. Tell your doctor all medications and supplements you use. During pregnancy, Donnatal should be taken only if prescribed; it may harm a fetus. It is unknown if the drugs in Donnatal pass into breast milk. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Donnatal.

Our Donnatal (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Donnatal Tablets Consumer Information

Phenobarbital may cause a severe allergic reaction. Stop taking phenobarbital and get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, eyes, lips, tongue, or throat.

Call your doctor at once if you have:

• weak or shallow breathing;
• unusual pain anywhere in your body (especially in the neck, shoulder, or arms);
• a red blood cell disorder--pale skin, muscle weakness, diarrhea, weight loss, rapid heart rate, tongue swelling, numbness or tingling in your hands or feet, feeling short of breath; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Side effects such as confusion, depression, or excitement may be more likely in older adults and those who are ill or debilitated.

Common side effects may include:

• drowsiness, lack of energy;
• dizziness or spinning sensation;
• depressed mood;
• feeling restless or excited (especially in children or older adults);
• drunk feeling; or
• "hangover" effect (drowsiness the day after taking phenobarbital).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Donnatal Tablets (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Tablets)

 

Donnatal Tablets Professional Information

SIDE EFFECTS

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 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.

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 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 (see WARNINGS).

Dependence

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

Read the entire FDA prescribing information for Donnatal Tablets (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Tablets)

&Copy; Donnatal Tablets Patient Information is supplied by Cerner Multum, Inc. and Donnatal Tablets Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.