Me-PB-Hyos

Method Pharmaceuticals, Inc.

Me-PB-Hyos Tablets

FULL PRESCRIBING INFORMATION

Me-PB-Hyos Tablets
Rx Only

Rev. 04/2014

Me-PB-Hyos Tablets: Each Me-PB-Hyos Tablet contains:

Phenobarbital, USP ................................................... 16.2 mg

Hyoscyamine Sulfate, USP ................................... 0.1037 mg

Atropine Sulfate, USP ........................................... 0.0194 mg

Scopolamine Hydrobromide, USP ......................... 0.0065 mg

Starch 1500, Microcrystalline Cellulose, Silicon Dioxide, Anhydrous Lactose, Magnesium Stearate.

Based on a review of this drug by the National Academy of Sciences-National Research Council 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.

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

Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthemia gravis; hiatal hernia associated with reflux esophagitis.

Me-PB-Hyos Tablets are contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement.

In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Me-PB-Hyos Tablets may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work. Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs. Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.

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.

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

PREGNANCY CATEGORY C:

Animal reproduction studies have not been conducted with Me-PB-Hyos Tablets. It is not known whether Me-PB-Hyos Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Me-PB-Hyos Tablets should be given to a pregnant woman only if clearly needed.

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 Me-PB-Hyos Tablets is administered to a nursing woman.

Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria and other dermal manifestations; and decreased sweating. Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema and similar conditions. Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations 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.

Adverse Events:

To report an adverse event, please contact Method Pharmaceuticals Customer Service at 1-877-250-3427.

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. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be used.

The dosage of Me-PB-Hyos Tablets should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.

Me-PB-Hyos Tablets - Adults: One or two Me-PB-Hyos Tablets three or four times a day according to condition and severity of symptoms.

Me-PB-Hyos Tablets are supplied as a white, round tablet with debossed “M421” on one side.

• Bottles of 100 tablets- NDC 58657-421-01.

Store at controlled room temperature, 15-30°C (59-86°F). 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.

Also available: Me-PB-Hyos Elixir, grape flavored liquid, in 1 pint (473 mL) bottles.

Manufactured For:
Method Pharmaceuticals, LLC
Arlington, TX 76006 Rev. 04/2014

NDC 58657-421 - 0 1
Me- PB - Hyos
Tablets
100 Tablets