PB Hyos Elixir
Related Posts "PB Hyos Elixir":
phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
Dosage Form: oral elixir
PB Hyos Elixir DESCRIPTION:
Each 5 mL (teaspoonful) of elixir contains:
Artificial Grape Flavor, Ethyl Alcohol, FDC Blue #1, FDC Red #40, Glycerin, Purified Water USP, Sodium Saccharin, Sorbitol Solution 70%, and Sucrose.CLINICAL PHARMACOLOGY:
This drug combination provides peripheral anticholinergic/antispasmodic action and mild sedation.INDICATIONS AND USAGE:
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:
PB Hyos 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.
Heat prostration can occur with belladonna alkaloids in high temperatures.
GENERAL: Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension.
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.
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.DOSAGE AND ADMINISTRATION:
The dosage of PB Hyos Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
PB Hyos Elixir is a purple colored, grape flavored liquid. 1 Pint (16 fl oz.) bottles NDC 49769-395-16.
Below represents the current labeling being used:
phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide elixir Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49769-395 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 16.2 mg in 5 mL HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.1037 mg in 5 mL ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 0.0194 mg in 5 mL SCOPOLAMINE HYDROBROMIDE (SCOPOLAMINE) SCOPOLAMINE HYDROBROMIDE 0.0065 mg in 5 mL Inactive Ingredients Ingredient Name Strength ALCOHOL FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN WATER SACCHARIN SODIUM SORBITOL SUCROSE Product Characteristics Color purple Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 49769-395-16 473 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/01/2010 10/31/2012
Labeler - Kylemore Pharmaceuticals, LLC (831892471) Revised: 03/2011Kylemore Pharmaceuticals, LLC
More PB Hyos Elixir resources PB Hyos Elixir Side Effects (in more detail) PB Hyos Elixir Dosage PB Hyos Elixir Use in Pregnancy & Breastfeeding PB Hyos Elixir Drug Interactions PB Hyos Elixir Support Group 0 Reviews for PB Hyos - Add your own review/rating Compare PB Hyos Elixir with other medications Duodenal Ulcer Enterocolitis Irritable Bowel Syndrome
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