Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide

Prescription

Handelsnamen: Phenohytro

Darreichungsform

Tablet

Applikationsweg

ORAL

Hersteller

Winder Laboratories, LLC

About This Medication

DESCRIPTION PHENOHYTRO ® ELIXIR Grape Flavored each 5 mL (teaspoonful) oral-administered dose of elixir contains: Phenobarbital, USP ( WARNING: may be habit forming) 16.2 mg Hyoscyamine Sulfate, USP 0.1037 mg Atropine Sulfate, USP 0.0194 mg Scopolamine Hydrobromide, USP 0.0065 mg Alcohol not more than 23.8% INACTIVE INGREDIENTS Purified water, glycerin, sorbitol, ethyl alcohol, sucrose, sodium saccharin, artificial grape flavor, FD&C Red No. 3, FD&C Blue No. 1.

Wirkstoffe

Wirkstoff	Stärke
Atropine Sulfate	-
Hyoscyamine Sulfate	-
Phenobarbital	-
Scopolamine Hydrobromide	-

Indikationen und Anwendung

INDICATIONS AND USAGE Based on the National Academy of Sciences-National Research Council's review of this drug and/or other information, FDA has classified the following indications as "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. 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.

Dosierung und Verabreichung

DOSAGE AND ADMINISTRATION Adults One or two teaspoonfuls of PHENOHYTRO ® ELIXIR three or four times a day according to conditions and severity of symptoms. Pediatric patients may be dosed every 4 to 6 hours. Starting Dosage Body Weight q4h q6h 10 lb. (4.5 kg) 0.5 mL 0.75 mL 20 lb. (9.1 kg) 1.0 mL 1.5 mL 30 lb. (13.6 kg) 1.5 mL 2.0 mL 50 lb. (22.7 kg) 1/2 tsp 3/4 tsp 75 lb. (34 kg) 3/4 tsp 1 tsp 100 lb. (45.4kg) 1 tsp 1 1/2 tsp

Side Effects Overview

ADVERSE REACTIONS Call your doctor for medical advice about side effects. Adverse reactions associated with anticholinergics and/or anticonvulsants are: dry mouth; tachycardia; urinary hesitancy and retention; palpitation; blurred vision; prolonged pupil dilation; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, hives and/or other dermal manifestations; decreased sweating; impotence; suppression of lactation; constipation; bloated feeling and musculoskeletal pain. Elderly patients may react with symptoms of excitement, agitation and drowsiness to even small doses of the drug. Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions. To report SUSPECTED ADVERSE REACTIONS, contact Winder Laboratories, LLC at 1-770-307-0702, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Warnhinweise und Vorsichtsmaßnahmen

WARNINGS Heat prostration can occur with belladonna alkaloids in high temperatures. Diarrhea may be an early symptom of incomplete intestinal obstruction, particularly in patients with ileostomy or colostomy. In this instance, treatment with this drug could be harmful. PHENOHYTRO ® ELIXIR may produce drowsiness and blurred vision. The patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery. Phenobarbital may decrease the effect of anticoagulants, and larger doses of the anticoagulant may be necessary for optimal effect. When phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. Phenobarbital may be habit forming and should not be administered to patients who are susceptible to addiction or to those with a history of physical and/or psychological drug dependence. Barbiturates should be used with caution in patients with hepatic dysfunction.

Kontraindikationen

CONTRAINDICATIONS PHENOHYTRO ® ELIXIR is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in patients with acute intermittent porphyria and in those patients in which phenobarbital produces restlessness and/or excitement. PHENOHYTRO ® ELIXIR is also contraindicated in patients with glaucoma, obstructive uropathy; paralytic ileus; myasthenia gravis; intestinal atony; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; hiatal hernia associated with reflux esophagitis; obstructive disease of the gastrointestinal tract; or severe ulcerative colitis.

Frequently Asked Questions

INDICATIONS AND USAGE Based on the National Academy of Sciences-National Research Council's review of this drug and/or other information, FDA has classified the following indications as "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. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC / ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL …

DOSAGE AND ADMINISTRATION Adults One or two teaspoonfuls of PHENOHYTRO ® ELIXIR three or four times a day according to conditions and severity of symptoms. Pediatric patients may be dosed every 4 to 6 hours. Starting Dosage Body Weight q4h q6h 10 lb. (4.5 kg) 0.5 mL 0.75 mL 20 lb. (9.1 kg) 1.0 mL 1.5 mL 30 lb. (13.6 kg) 1.5 mL 2.0 mL 50 lb. (22.7 kg) 1/2 tsp 3/4 tsp 75 lb. (34 kg) 3/4 tsp 1 …

WARNINGS Heat prostration can occur with belladonna alkaloids in high temperatures. Diarrhea may be an early symptom of incomplete intestinal obstruction, particularly in patients with ileostomy or colostomy. In this instance, treatment with this drug could be harmful. PHENOHYTRO ® ELIXIR may produce drowsiness and blurred vision. The patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery. Phenobarbital may decrease the effect of anticoagulants, and larger …

CONTRAINDICATIONS PHENOHYTRO ® ELIXIR is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in patients with acute intermittent porphyria and in those patients in which phenobarbital produces restlessness and/or excitement. PHENOHYTRO ® ELIXIR is also contraindicated in patients with glaucoma, obstructive uropathy; paralytic ileus; myasthenia gravis; intestinal atony; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; hiatal hernia associated with reflux esophagitis; obstructive disease of the gastrointestinal …

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide drug label (National Library of Medicine)
• openFDA — Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 1046787 (NLM Normalized Drug Names)
• NDC Directory — Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide (FDA National Drug Code)

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Datenquellen: DailyMed (NLM), openFDA, MFDS