Each 5 mL (teaspoonful) of elixir contains: Phenobarbital, USP ............................................. 16.2 mg (WARNING: may be habit forming) Hyoscyamine Sulfate, USP .............................. 0.1037 mg Atropine Sulfate, USP ..................................... 0.0194 mg Scopolamine Hydrobromide, USP ................... 0.0065 mg Alcohol not more than 23.8%
Artificial Grape Flavor, Ethyl Alcohol, FDC Blue #1, FDC Red #40, Glycerin, Purified Water USP, Sodium Saccharin, Sorbitol Solution 70%, and Sucrose.
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.
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.
It is also contraindicated in patients with glaucoma, obstructive uropathy; paralytic ileus; myasthenia gravis; intestinal atony; unstable cardiovascular status in acute hemorrhage; hiatal hernia associated with reflux esophagitis; obstructive disease of the gastrointestinal tract; or severe ulcerative colitis.
Heat prostration can occur with belladonna alkaloids in high temperatures.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug could be harmful. PB Hyos 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 needed 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.
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.
Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer. Do not rely on the use of the drug in the presence of complication of biliary tract disease. Theoretically, with overdosage, a curare-like action may occur.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long-term studies in animals have not been performed to evaluate carcinogenic potential.
PREGNANCY CATEGORY C: Animal reproduction studies have not been conducted with PB Hyos Elixir. It is not known whether PB Hyos Elixir can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PB Hyos 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, caution should be exercised when PB Hyos Elixir is administered to a nursing woman.
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. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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.
Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.
Pediatric patients: For children age 2 and under, consult a physician for dosage and administration. Children ages 2 and over may be dosed every 4 to 6 hours.
PB Hyos Elixir is a purple colored, grape flavored liquid. 1 Pint (16 fl oz.) bottles NDC 49769-395-16.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Manufactured for: Kylemore Pharmaceuticals Port St. Joe, FL 32456 Rev. 02/10 395-10