Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Dailymed
Generic: phenobarbital, hyoscyamine sulfate, atropine sulfate and scopolamine hydrobromide is used for the treatment of Tissue Adhesions Asthma Bradycardia Colitis, Ulcerative Heart Arrest Heart Block Intestinal Obstruction Iris Diseases Kidney Diseases Lens Diseases Liver Diseases Megacolon, Toxic Myasthenia Gravis Poisoning Sinoatrial Block Stomach Ulcer Tachycardia Thyrotoxicosis Ureteral Obstruction Uveitis Xerostomia Glaucoma, Angle-Closure Mydriasis Drug-Related Side Effects and Adverse Reactions Abnormalities, Drug-Induced Urinary Bladder, Neurogenic Colic Glaucoma Hyperhidrosis Ileal Diseases Intraoperative Complications Muscle Rigidity Peptic Ulcer Rhinitis Shock, Hemorrhagic Sialorrhea Spasm Tremor Urethral Obstruction Myocardial Ischemia Gastroparesis Irritable Bowel Syndrome Airway Obstruction Seizures, Febrile Epilepsies, Partial Epilepsy, Tonic-Clonic Hyperbilirubinemia Porphyrias Pregnancy Liver Failure Epilepsy, Benign Neonatal Amnesia Colonic Diseases Diverticulitis Dysentery Facial Paralysis Hemorrhage Motion Sickness Nausea Parkinson Disease, Postencephalitic Rhinitis, Vasomotor Vomiting Iridocyclitis
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Description
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets
Each Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablet 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
Dibasic Calcium Phosphate Dihydrate, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Stearic Acid, Silicon Dioxide Colloidal, Magnesium Stearate.
Clinical Pharmacology
This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.
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.
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 exclient.
Warnings
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets can cause fetal harm when administered to a pregnant woman. Animal reproduction studies have not been conducted with Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets. 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.
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets 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.
Precautions
General
Use with caution in patients with:
- autonomic neuropathy
- hepatic or renal disease
- hyperthyroidism
- coronary heart disease
- congestive heart failure
- cardiac arrhythmias
- tachycardia
- hypertension
Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer.
Do not rely on the use of the drug in the presence of complication of biliary tract disease.
Theoretically, with overdosage, a curare-like action may occur.
Information for Patients
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets 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.
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy
Animal reproduction studies have not been conducted with Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks (see WARNINGS).
Nursing Mothers
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 Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets are administered to a nursing woman.
Geriatric Use
Elderly patients may react with symptoms of exclient, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.
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 chronic use of phenobarbital.
Phenobarbital may produce exclient in some patients, rather than a sedative effect.
To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or 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.
Overdosage
The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be used.
Dosage And Administration
The dosage of Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets - Adults: One or two Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets three or four times a day according to condition and severity of symptoms.
How Supplied
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets are supplied as: white, D-shaped, flat faced beveled edge tablets embossed “D” on one side and debossed “DONNATAL” on the other side.
- Bottles of 100 tablets- NDC 50742-667-01.
Store at 20°- 25°C (68°- 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
DEA EXEMPT PRODUCT
Manufactured for:
Ingenus Pharmaceuticals, LLC
Orlando, FL 32839-6408
Revised: 05/2021
LF-122302-01
MPL-095
Package Label.principal Display Panel
NDC 50742-667-01
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets
Each tablet contains:
Phenobarbital, USP ………………………….……… 16.2 mg
Hyoscyamine Sulfate, USP ………………….…… 0.1037 mg
Atropine Sulfate, USP ……………………………. 0.0194 mg
Scopolamine Hydrobromide, USP ……………….. 0.0065 mg
Rx Only
100 Tablets
Â
Ingenus
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