Humibid La Guaifenesin

DESCRIPTION

Guaifenex® Gy Tablets

Each long-acting, film-coated, dye free Guaifenex® Gy Tablet contains:

    Guaifenesin ..................................................................1200 mg

Also contains: Microcrystalline cellulose, magnesium stearate and other ingredients. Film coating composed of hydroxypropyl methylcellulose, maltodextrin and polyethylene glycol.

Guaifenesin is an expectorant. Chemically, it is 3-(2-methoxyphenoxy)-1,2 propanediol

INDICATIONS

Guaifenex® Gy Tablets help loosen phlegm (mucus) and thin bronchial secretions. The result is enhanced wflow of less viscid secretions to lubricate irritated mucous membranes and increase the efficiency of the mucocilliary mechanism in removing accumulated secretions from the upper and lower airway. As a result, sinus and bronchial drainage is improved and nonproductive coughs become more productive. Guaifenex® Gy Tablets are indicated for the temporary relief of symptoms associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and allergies, when these conditions are complicated by tenacious mucus and/or mucus plugs and excess secretions.

DOSAGE AND ADMINISTRATION

Adults and pediatric patients over 12 years of age: One tablet every 12 hours, not to exceed 2 tablets (2400 mg) in 24 hours.

Pediatric patients 6 to 12 years of age: One-half (1/2) tablet every 12 hours not to exceed 1 tablet (1200 mg) in 24 hours. Tablets may be broken in half (but not crushed or chewed) without affecting the release of the medication.

HOW SUPPLIED

Guaifenex® Gy Tablets (guaifenesin 1200 mg) are supplied as white, dye free, film coated, capsule shaped tablets debossed ETHEX/ 308 right side of bisect, in bottles of 100 tablets (NDC 58177-308-04).

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

Dispense in tight container with child- resistant closure.

Protect from light and moisture.

CAUTION: Federal wlaw prohibits dispensing without prescription.

PATIENT INFORMATION

See CONTRAINDICATIONS, and PRECAUTIONS.

CLINICAL PHARMACOLOGY

Guaifenesin is an expectorant. Expectorants promote and facilitate the removal of respiratory tract secretions by increasing sputum volume and making sputum less viscous. Guaifenesin is readily absorbed from the gastrointestinal tract and is rapidly metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is beta-(2-methoxyphenoxy) lactic acid.

SIDE EFFECTS

Guaifenesin is well tolerated and has a wide margin of safety. Side effects are generally mild and infrequent. Nausea and vomiting are the most frequently occurring side effects. Dizziness, headache and rash (including urticaria) have been reported rarely.

DRUG INTERACTIONS

Laboratory Test Interactions: Guaifenesin interferes with the calorimetric determination of 5-HIAA (5-hydroxyindoleacetic acid) and VMA (vanillylmandelic acid).

WARNINGS

No information provided.

PRECAUTIONS

TO PRESERVE THE LONG-ACTING EFFECT, DO NOT CRUSH OR CHEW TABLETS BEFORE INGESTION.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available on the long term potential of guaifenesin for carcinogenesis, mutagenesis or impairment of fertility in animals or humans.

Pregnancy

Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with guaifenesin. Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, this product should not be used in pregnant patients, unless in the judgement of the physician, the potential benefits outweigh possible hazards.

Nursing Mothers

It is not known whether guaifenesin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when these products are administered to a nursing mother and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients under 6 years has not been established.

Laboratory Test Interactions

G uaifenesin interferes with the calorimetric determination of 5-HIAA (5-hydroxyindoleacetic acid) and VMA (vanillylmandelic acid).

OVERDOSE

Overdosage with guaifenesin is unlikely to produce serious toxic effects due to its wide margin of safety. When laboratory animals were administered guaifenesin in doses up to 5 grams/kg by stomach tube, no toxicity resulted. In severe cases of overdosage, the stomach should be emptied (emesis or gastric lavage) and further absorption prevented. Treatment should be directed toward supporting the patient and reversing the effects of the drugs.

CONTRAINDICATIONS

Guaifenex® Gy Tablets are contraindicated in patients hypersensitive to any of the ingredients.