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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
A total of 86 subjects entered three studies with METOZOLV ODT; 12 subjects entered a pilot bioavailability study (BA); 44 subjects entered a bioequivalence (BE) study, and 30 subjects entered a food-effect study. The adverse reactions from the BE and food-effect study are summarized in Table 1. The pilot BA study data are not included because it was performed with a formulation different from the METOZOLV ODT formulation.
The adverse experience profile seen with METOZOLV ODT was similar to metoclopramide tablets. Thirty-three (33) adverse reactions were reported after receiving METOZOLV ODT and 30 adverse reactions were reported after receiving metoclopramide tablets.
Table 1: Adverse Reactions in BE and Food-Effect Study in
≥ 2% of Subjects
|Adverse Reaction|| METOZOLV
| Metoclopramide tablets
|Nausea||4 (4.2 %)||4 (5.6 %)|
|Fatigue||2(2.1%)||2 (2.8 %)|
|Headache||5 (5.2 %)||3 (4.2 %)|
|Somnolence||2(2.1%)||2 (2.8 %)|
|Dizziness||1(1.0%)||3 (4.2 %)|
|1 N = number of subjects that reported adverse
2 Percent (%) occurrence = N divided by number of subjects dosed with respective study drug
3 Number of subjects dosed with METOZOLV ODT: 68 under fasted conditions and 28 under fed conditions.
4 Number of subjects dosed with metoclopramide tablets: 28 under fed conditions and 44 under fasted conditions.
The most frequently reported adverse reactions (greater than 2%) associated with METOZOLV ODT were: nausea, vomiting, fatigue, somnolence and headache. The most frequently reported adverse reactions (greater than 2%) associated with metoclopramide tablets were: nausea, headache, fatigue, somnolence, and dizziness. The combined data from the fasted BE study and the food-effect study did not demonstrate any significant differences in the adverse event profile for METOZOLV ODT compared to metoclopramide tablets.
The following adverse reactions are from the cumulative post-marketing experience with metoclopramide tablets. Since the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
CNS Effects: Restlessness, drowsiness, fatigue, and lassitude occur in approximately 10% of patients receiving the most commonly prescribed dosage of 10 mg four times a day. Insomnia, headache, confusion, dizziness, or depression with suicidal ideation occurs less frequently. The incidence of drowsiness is greater at higher doses. There are isolated reports of seizures without clear-cut relationship to metoclopramide. Rarely, hallucinations have been reported.
Extrapyramidal Syndromes (EPS): Acute dystonic reactions, the most common type of EPS associated with metoclopramide, occur in approximately 0.2% of patients (1 in 500) treated with 30 to 40 mg of metoclopramide per day. Symptoms include involuntary movements of limbs, facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, opisthotonus (tetanus-like reactions), and rarely, stridor and dyspnea possibly due to laryngospasm; ordinarily these symptoms are readily reversed by diphenhydramine [see WARNINGS AND PRECAUTIONS].
Tardive dyskinesia is most frequently characterized by involuntary movements of the tongue, face, mouth, or jaw, and sometimes by involuntary movements of the trunk and/or extremities; movements may be choreoathetotic in appearance. Motor restlessness (akathisia) may include inability to sit still, pacing, and foot tapping. These symptoms may disappear spontaneously or respond to a reduction in dosage.
Neuroleptic Malignant Syndrome: Rare occurrences of Neuroleptic Malignant Syndrome (NMS) have been reported [see WARNINGS AND PRECAUTIONS].
Gastrointestinal: Nausea, bowel disturbances, primarily diarrhea.
Hepatic: Rarely, cases of hepatotoxicity characterized by such findings as jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential.
Renal: Urinary frequency and incontinence.
Hematologic: A few cases of neutropenia, leukopenia, or agranulocytosis, generally without clear-cut relationship to metoclopramide. Methemoglobinemia in adults and especially with overdosage in neonates. Sulfhemoglobinemia in adults.
Miscellaneous: Visual disturbances. Porphyria.
Read the Metozolv ODT (metoclopramide hydrochloride orally disintegrating tablets) Side Effects Center for a complete guide to possible side effects
The effects of metoclopramide on gastrointestinal motility can impact the absorption of other drugs. The known drug-drug interactions are listed below.
Anticholinergic and Narcotic Analgesic Drugs
The effects of metoclopramide on gastrointestinal motility are antagonized by anticholinergic drugs and narcotic analgesics. Additive sedative effects can occur when metoclopramide is given with alcohol, sedatives, hypnotics, narcotics, or tranquilizers.
Monoamine Oxidase Inhibitors
Metoclopramide has been shown to release catecholamines in patients with essential hypertension suggesting that it should be used cautiously, if at all, in patients taking monoamine oxidase (MAO) inhibitors.
Absorption of drugs from the stomach may be diminished by metoclopramide (e.g., digoxin), whereas the rate and/or extent of absorption of drugs from the small bowel may be increased (e.g., acetaminophen, tetracycline, levodopa, ethanol, cyclosporine).
Because the action of metoclopramide will hasten the movement of food to the intestines and therefore the rate of absorption, insulin dosage or timing of dosage may require adjustment. Increasing movement of food to the intestines may lead to absorption of less glucose from a meal, hence less glucose in the circulation for a particular dose of administered insulin to act upon, resulting in hypoglycemia.
Antidepressants, Antipsychotics, and Neuroleptics
Concomitant use of metoclopramide should be avoided in patients taking antidepressants, antipsychotics, and/or neuroleptics that have been associated with extrapyramidal reactions such as tardive dyskinesia or Neuroleptic Malignant Syndrome (NMS) that have occurred in association with metoclopramide [see WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/17/2011
Additional Metozolv ODT Information
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