Donnatal

Donnatal

Donnatal Recall

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Questions & Answers

Side Effects & Adverse Reactions

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 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.

Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

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.

Donnatal® Elixir - Mint

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, Natural Mint Flavor, FD&C Yellow #5, and FD&C Blue #1.

Donnatal Manufacturers


  • Concordia Pharmaceuticals Inc.
    Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir [Concordia Pharmaceuticals Inc.]
  • Kaiser Foundation Hospitals
    Donnatal (Belladonna Alkaloids W/ Phenobarbital) Elixir [Kaiser Foundation Hospitals]
  • Rebel Distributors Corp
    Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Rebel Distributors Corp]
  • Kaiser Foundation Hospitals
    Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Kaiser Foundation Hospitals]
  • Pbm Pharmaceuticals Inc.
    Donnatal (Phenobarbital Elixir) Elixir [Pbm Pharmaceuticals Inc.]
  • Pbm Pharmaceuticals Inc.
    Donnatal (Phenobarbital Elixir) Elixir [Pbm Pharmaceuticals Inc.]
  • Pbm Pharmaceuticals Inc.
    Donnatal (Phenobarbital Elixir) Elixir [Pbm Pharmaceuticals Inc.]
  • Pbm Pharmaceuticals Inc.
    Donnatal (Phenobarbital Elixir) Elixir [Pbm Pharmaceuticals Inc.]
  • Pbm Pharmaceuticals Inc.
    Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Pbm Pharmaceuticals Inc.]
  • Avkare, Inc.
    Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Avkare, Inc.]
  • Avkare, Inc.
    Donnatal (Phenobarbital Elixir) Elixir [Avkare, Inc.]
  • Rxpak Division Of Mckesson Corporation
    Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Rxpak Division Of Mckesson Corporation]
  • Carilion Materials Management
    Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Carilion Materials Management]
  • Atlantic Biologicals Corps
    Donnatal (Phenobarbital Elixir) Elixir [Atlantic Biologicals Corps]
  • Concordia Pharmaceuticals Inc.
    Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Concordia Pharmaceuticals Inc.]

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