Phenohytro

What is Phenohytro?

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. DESCRIPTION PHENOHYTRO ® ELIXIR Mint 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 mint flavor, FD&C Yellow No. 5, FD&C Blue No. 1. Phenobarbital is a barbiturate with the chemical name 2,4,6(1H,3H,5H) -Pyrimidinetrione, 5-ethyl-5-phenyl-. It has the following structural formula: C 12 H 12 N 2 O 3 M.W. 232.2 Hyoscyamine sulfate is a belladonna alkaloid with the chemical name Benzeneacetic acid, α

Uses of Phenohytro

Established uses

• 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.

How to take Phenohytro

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

Dosage

Follow the dose prescribed by your doctor or pharmacist. The ranges below are general information, not a personal prescription.

Adults

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 of Phenohytro

Common

• 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;

Warnings and who should not take it

Who should NOT take Phenohytro?

• 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;

Warnings and precautions

• 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.

Overdose

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. Call your doctor or local Poison Control Center if overdosage is suspected. The dosage of PHENOHYTRO ® ELIXIR should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.

Safety at a glance

Frequently asked questions