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Metozolv

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Metozolv ODT

INDICATIONS

Symptomatic Gastroesophageal Reflux Disease

METOZOLV ODT is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy.

Diabetic Gastroparesis (Diabetic Gastric Stasis)

METOZOLV ODT is indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis) in adults.

Important Limitations

METOZOLV ODT is indicated for adults only. Therapy should not exceed 12 weeks in duration. The safety and effectiveness in pediatric patients have not been established.

DOSAGE AND ADMINISTRATION

Important Instructions for Use

Take on an empty stomach at least 30 minutes before eating since food can decrease the peak concentrations of drug in the bloodstream and/or the time it takes to achieve the maximum drug level in the bloodstream [see CLINICAL PHARMACOLOGY]. Do not repeat dose if inadvertently taken with food.

Since the tablet absorbs moisture rapidly, only remove each dose from the packaging just prior to taking. Handle the tablet with dry hands and place on the tongue. If the tablet should break or crumble while handling, discard and remove a new tablet.

METOZOLV ODT disintegrates on the tongue in approximately one minute (with a range of 10 seconds to 14 minutes). METOZOLV ODT is designed to be taken without liquid; however, the effect on the pharmacokinetics of METOZOLV ODT taken with liquid is unknown.

Symptomatic Gastroesophageal Reflux Disease

For the relief of symptomatic, documented gastroesophageal reflux disease (GERD), therapy should not exceed 12 weeks in duration.

Take 10 mg to 15 mg dose of METOZOLV ODT up to four times daily (e.g., at least 30 minutes before each meal and at bedtime). Doses may vary depending upon the symptoms being treated and the clinical response. If symptoms only occur intermittently or at specific times of the day, metoclopramide may be used in single doses up to 20 mg prior to the symptoms rather than continuous treatment.

Since there is a poor correlation between symptomatic relief and healing of esophageal lesions, any therapy directed at esophageal lesions is best confirmed by endoscopic evaluation. Although experience with the effects of metoclopramide on esophageal erosions and ulcerations is limited, healing was documented in a controlled trial using four times daily therapy at 15 mg/dose. Prolonged treatment ( > 12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to counterbalance the risks to the patient of developing tardive dyskinesia. [see WARNINGS AND PRECAUTIONS]

Diabetic Gastroparesis (Diabetic Gastric Stasis)

For the relief of symptoms associated with diabetic gastroparesis (diabetic gastric stasis), therapy of two to eight weeks is recommended. Therapy should not exceed 12 weeks in duration.

Take a 10 mg dose of METOZOLV ODT up to four times a day (e.g., at least 30 minutes before each meal and at bedtime).

The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of METOZOLV ODT may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection.

Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, METOZOLV ODT therapy should be reinstituted at the earliest manifestation.

Renal Impairment

Some patients, such as the elderly or those with impaired kidney function (creatinine clearance below 40 mL/min) may be more sensitive to the therapeutic dose or the adverse effects of metoclopramide. Therefore, these patients should start therapy at a lower dose (approximately half the recommended dosage) and the dose should be titrated according to their overall clinical response and/or adverse event profile. Dialysis is not likely to be an effective method of drug removal in overdose situations.

HOW SUPPLIED

Dosage Forms and Strengths

5 mg Tablets: Each white round 5 mg tablet is debossed with "5" on one side and plain on the other.
10 mg Tablets
: Each white round 10 mg tablet is debossed with "10" on one side and plain on the other.

5 mg Tablets: Available in blister pack with 10 tablets individually sealed in a foil-backed unit-dose container; a carton contains 10 cards (NDC 65649-431-02).

10 mg Tablets: Available in blister pack with 10 tablets individually sealed in a foil-backed unit-dose container; a carton contains 10 cards (NDC 65649-432-02).

Tablets should be stored at controlled room temperature, between 20°C and 25°C (68°F and 77°F).

Manufactured by: Catalent UK Swindon Zydis Limited Swindon, UK, Manufactured for: Salix Pharmaceuticals, Inc. Raleigh, NC 27615.

Last reviewed on RxList: 10/17/2011
This monograph has been modified to include the generic and brand name in many instances.

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