METOCLOPRAMIDE HYDROCHLORIDE - metoclopramide hydrochloride tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46)

Available from:

GAVIS Pharmaceuticals, LLC

INN (International Name):

METOCLOPRAMIDE HYDROCHLORIDE

Composition:

METOCLOPRAMIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoclopramide Hydrochloride Orally Disintegrating Tablets are 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. Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis) in adults. Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated for adults only. Therapy should not exceed 12 weeks in duration. The safety and effectiveness in pediatric patients have not been established. Do not use metoclopramide whenever stimulation of gastrointestinal motility may be dangerous such as in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may precipitate a hypertensive crisis, most likely due to release of catecholamines from the tumor. Such hyperte

Product summary:

Metoclopramide Hydrochloride Orally Disintegrating Tablets 5 mg strength are round, white to off-white, flat faced beveled edge tablet debossed with ‘N’ on one side and “581” on the other side; it is comprised of 5 mg metoclopramide (as 5.91 mg of metoclopramide hydrochloride). These are packaged in blister cards as follows: Box of 10 (10x10s)   NDC 43386-581-30 Metoclopramide Hydrochloride Orally Disintegrating Tablets 10 mg are round, white to off-white, flat faced beveled edge tablet debossed with ‘N’ on one side and “580” on the other side; it is comprised of 10 mg metoclopramide (as 11.82 mg of metoclopramide hydrochloride). These are packaged in blister cards as follows: Box of 10 (10x10s)   NDC 43386-580-30 Tablets should be stored at controlled room temperature, between 20°C and 25°C (68°F and 77°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOCLOPRAMIDE HYDROCHLORIDE - METOCLOPRAMIDE HYDROCHLORIDE TABLET,
ORALLY
DISINTEGRATING
GAVIS PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METOCLOPRAMIDE HYDROCHLORIDE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METOCLOPRAMIDE
HYDROCHLORIDE.
METOCLOPRAMIDE HYDROCHLORIDE (METOCLOPRAMIDE HYDROCHLORIDE) TABLET,
ORALLY DISINTEGRATING
FOR ORAL USE.
INITIAL U.S. APPROVAL: 1976
WARNING: TARDIVE DYSKINESIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
TREATMENT WITH METOCLOPRAMIDE CAN CAUSE TARDIVE DYSKINESIA, A SERIOUS
MOVEMENT DISORDER THAT IS OFTEN
IRREVERSIBLE. THE RISK OF DEVELOPING TARDIVE DYSKINESIA INCREASES WITH
THE DURATION OF TREATMENT AND THE
TOTAL CUMULATIVE DOSE.
METOCLOPRAMIDE THERAPY SHOULD BE DISCONTINUED IN PATIENTS WHO DEVELOP
SIGNS OR SYMPTOMS OF TARDIVE
DYSKINESIA. THERE IS NO KNOWN TREATMENT FOR TARDIVE DYSKINESIA. IN
SOME PATIENTS, SYMPTOMS MAY LESSEN
OR RESOLVE AFTER METOCLOPRAMIDE TREATMENT IS STOPPED.
INDICATIONS AND USAGE
Metoclopramide Orally Disintegrating Tablets are a dopamine receptor
antagonist indicated for:
RELIEF OF SYMPTOMATIC GASTROESOPHAGEAL REFLUX: short-term (4 to 12
weeks) therapy for adults with symptomatic,
documented gastroesophageal reflux who fail to respond to conventional
therapy (1.1)
DIABETIC GASTROPARESIS (DIABETIC GASTRIC STASIS): the relief of
symptoms in adults associated with acute and
recurrent diabetic gastroparesis (gastric stasis) (1.2)
Important Limitations:
Therapy should not exceed 12 weeks in duration (1.3)
Metoclopramide Hydrochloride Orally Disintegrating Tablets are
recommended only for adults. The safety and
effectiveness in pediatric patients have not been established (1.3)
DOSAGE AND ADMINISTRATION
GASTROESOPHAGEAL REFULX DISEASE: 10 mg to 15 mg dose up to four times
daily at least 30 minutes before eating and
at bedtime (2.2)
DIABETIC GASTROPARESIS (DIABETIC GASTRIC STASIS): 10 mg dose four
times daily at least 30 minutes befo