Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide

Description

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-(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: (C 17 H 23 NO 3 ) 2 ∙ H 2 SO 4 ∙ 2H 2 O 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: (C 34 H 46 N 2 O 6 ∙ H 2 O 4 S ∙ H 2 O 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)-(1 α ,2 β ,4 β ,5 α ,7 β )]-. It has the following structural formula: C 17 H 21 NO 4 ∙ BrH ∙ 3H 2 O M.W. 438.31 Chemical Structure Chemical...

What Is Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide Used For?

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.

Dosage and Administration

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 (Adverse Reactions)

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.

Contraindications

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.

Pregnancy and Breastfeeding

PREGNANCY PREGNANCY CATEGORY C Animal reproduction studies have not been conducted with PHENOHYTRO ® ELIXIR. It is not known whether PHENOHYTRO ® ELIXIR can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PHENOHYTRO ® ELIXIR should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, exercise caution when administering PHENOHYTRO ® ELIXIR to a nursing woman.

Overdosage

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.

How Supplied

HOW 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. STORAGE CONDITIONS AVOID FREEZING Store PHENOHYTRO ® ELIXIR 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. Use safety closures when dispensing this product unless otherwise directed by a physician or requested by purchaser. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN THE CASE OF OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Contains color additives, including FD&C Yellow No. 5 (tartrazine).