Phenohytro Elixir Prescribing Information

Phenohytro Elixir Description

Phenohytro Elixir 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:

C12H12N2O3

M.W. 232.2

Hyoscyamine sulfate is a belladonna alkaloid with the chemical name Benzeneacetic acid, α-(hydroxmethyl)-, 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate. It has the following structural formula:

(C17H23NO3)2 ∙ H2SO4 ∙ 2H2O	M.W. 712.85

Atropine sulfate is belladonna alkaloid with the chemical name: Benzeneacetic acid, α-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester. It has the following structural formula:

(C34H46N2O6 ∙ H2O4S ∙ H2O	M.W. 694.83

Scopolamine hydrobromide is a belladonna alkaloid with the chemical name Benezeneacetic acid, α-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo[3.31.0.2,4]non-[7-yl ester, hydrobromide, trihydrate, [7(S)-(1α,2β,4β,5α,7β)]-. It has the following structural formula:

C17H21NO4 ∙ BrH ∙ 3H2O	M.W. 438.31

Phenohytro Elixir - Clinical Pharmacology

This drug combination provides phenobarbital combined with belladonna alkaloids in a specific, fixed ratio to provide anticholinergic/antispasmodic action and mild sedation.

Phenobarbital is a barbiturate, nonselective central nervous system depressant. It is primarily used as a sedative hypnotic and also as an anticonvulsant in subhypnotic doses.

Atropine Sulfate, Hyoscyamine Sulfate, and Scopolamine are belladonna alkaloids classified as anticholinergic, antimuscarinic drugs. They act to inhibit muscarinic actions of acetylcholine at postganglionic parasympathetic neuron effector sites. These drugs are also used as antispasmodics due to their anticholinergic action. They produce the effect in the body of reduced muscle spasms in the digestive or urinary tract, and reduced fluid secretions from certain glands or organs.

Indications and Usage for Phenohytro Elixir

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.

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.

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.

Precautions

Adverse Reactions/Side Effects

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.

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.

Phenohytro Elixir Dosage and Administration

How is Phenohytro Elixir supplied

PHENOHYTRO® ELIXIR Grape Flavored is a purple colored, grape flavored liquid.

NDC 75826-127-04 Grape Flavored in 4 oz bottles.

NDC 75826-127-16 Grape Flavored in 16 oz bottles.

PHENOHYTRO® ELIXIR Mint Flavored is a green colored, mint flavored liquid.

NDC 75826-128-04 Mint Flavored in 4 oz bottles.

NDC 75826-128-16 Mint Flavored in 16 oz bottles.

Manufactured by:
Winder Laboratories, LLC.
Winder, GA 30680

70102US10

Rev. 05/18

PRINCIPAL DISPLAY PANEL - 16 fl. oz. Bottle Label - Mint

NDC 75826-128-16
winder®
LABS

Phenohytro®
Elixir

Mint Flavored

Each 5 mL (1 teaspoonful) contains:

Phenobarbital, USP
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%

DO NOT USE IF TAMPER-EVIDENT SEAL
UNDER CAP IS BROKEN OR MISSING

Rx Only
16 fl. oz.

PRINCIPAL DISPLAY PANEL - 16 fl. oz. Bottle Label - Grape

NDC 75826-127-16
winder®
LABS

Phenohytro®
Elixir

Grape Flavored

Each 5 mL (1 teaspoonful) contains:

Phenobarbital, USP
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%

DO NOT USE IF TAMPER-EVIDENT SEAL
UNDER CAP IS BROKEN OR MISSING

Rx Only
16 fl. oz.