Donnatal .0194 mg/1
PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE · TABLET · Advanz Pharma (US) Corp.
Donnatal is a tablet containing phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide at .0194 mg/1, taken oral. Manufactured by Advanz Pharma (US) Corp..
Key Facts
- Brand Name
- Donnatal
- Generic Name
- PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
- NDC Code (Product)
59212-425- Manufacturer
- Advanz Pharma (US) Corp.
- Strength
- .0194 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Marketing Start
- 12/30/1980
Recall History
West-ward Pharmaceutical Corp.
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.
Safecor Health, LLC
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Rx PAK
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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.
Dosage & Administration
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
Warnings
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. 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 f…
Contraindications
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; 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.
Drug Interactions
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.
Adverse Reactions
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. 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…
Frequently Asked Questions
What is Donnatal used for?
Donnatal contains PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE. It is a tablet taken oral. Consult your doctor for specific uses.
Is Donnatal a controlled substance?
Yes, Donnatal is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Donnatal?
The generic name for Donnatal is PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE. There are 3 other brand versions of PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE.
What is the NDC code for Donnatal .0194 mg/1?
The NDC (National Drug Code) for Donnatal .0194 mg/1 is 59212-425, listed by Advanz Pharma (US) Corp..