Reglan

— THERAPEUTIC CATEGORIES —
  • Hyperacidity, GERD, and ulcers
  • Nausea

Reglan Generic Name & Formulations

General Description

Metoclopramide (as HCl) 5mg, +10mg; +scored tabs.

Pharmacological Class

Dopamine-2 receptor antagonist.

See Also

    How Supplied

    Tabs—100

    Generic Availability

    YES

    Reglan Indications

    Indications

    Symptomatic refractory GERD.

    Reglan Dosage and Administration

    Adult

    Give 30mins before meals and at bedtime. Treat for 4–12 weeks. Continuous dosing: 10–15mg four times daily; max 60mg/day. Intermittent dosing: single dose up to 20mg prior to provoking situation. Elderly: 5mg four times daily; max 60mg/day. Moderate-to-severe renal or hepatic impairment, CYP2D6 poor metabolizers, concomitant strong CYP2D6 inhibitors: 5mg four times daily or 10mg three times daily; max 30mg/day. ESRD (including dialysis): 5mg four times daily or 10mg twice daily; max 20mg/day.

    Children

    Not recommended.

    Reglan Contraindications

    Contraindications

    History of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide. When stimulation of GI motility may be dangerous (eg, obstruction, perforation, or hemorrhage). Pheochromocytoma or other catecholamine-releasing paragangliomas. Epilepsy.

    Reglan Boxed Warnings

    Boxed Warning

    Tardive dyskinesia.

    Reglan Warnings/Precautions

    Warnings/Precautions

    Increased risk of TD with long-term use; avoid treatment >12 weeks. Diabetes mellitus. Discontinue if signs/symptoms of TD, extrapyramidal symptoms (EPS), parkinsonian symptoms, motor restlessness, or neuroleptic malignant syndrome (NMS) occurs. Avoid in Parkinson's disease, depression, hypertension. Cirrhosis. CHF. Renal or hepatic impairment. NADH-cytochrome b5 reductase deficiency. G6PD deficiency. CYP2D6 poor metabolizers. Elderly (esp. women). Neonates. Pregnancy. Nursing mothers: monitor infants.

    Reglan Pharmacokinetics

    See Literature

    Reglan Interactions

    Interactions

    Avoid concomitant drugs that can cause or potentially affect TD, EPS, or NMS (eg, antipsychotics). Potentiated by strong CYP2D6 inhibitors (eg, quinidine, bupropion, fluoxetine, paroxetine); reduce dose (see Adult). Increased risk of hypertension with MAOIs; avoid. Increased risk of CNS depression with alcohol, sedatives, hypnotics, opiates, anxiolytics. Antagonized by drugs that impair GI motility (eg, antidiarrheals, anticholinergics, opiates). Avoid concomitant dopaminergic drugs (eg, apomorphine, bromocriptine, levodopa, ropinirole). May potentiate succinylcholine, mivacurium, sirolimus, tacrolimus, cyclosporine; monitor and adjust dose. May antagonize digoxin (adjust dose), atovaquone, posaconazole (oral susp), fosfomycin; monitor. Concomitant insulin: monitor and adjust dose.

    Reglan Adverse Reactions

    Adverse Reactions

    Restlessness, drowsiness, fatigue, lassitude; TD, EPS, parkinsonism, akathisia, seizures, hallucinations, NMS, hypertension (discontinue if occurs), fluid retention (discontinue if occurs), hyperprolactinemia, hypersensitivity reactions.

    Reglan Clinical Trials

    See Literature

    Reglan Note

    Not Applicable

    Reglan Patient Counseling

    See Literature

    Reglan Generic Name & Formulations

    General Description

    Metoclopramide (as HCl) 5mg, +10mg; +scored tabs.

    Pharmacological Class

    Dopamine-2 receptor antagonist.

    How Supplied

    Tabs—100; Single-use vial—contact supplier

    Generic Availability

    YES

    Reglan Indications

    Indications

    Relief of symptoms associated with acute and recurrent diabetic gastroparesis.

    Reglan Dosage and Administration

    Adult

    Give 30mins before meals and at bedtime. Treat for 2–8 weeks. 10mg four times daily; max 40mg/day. Elderly: 5mg four times daily; max 40mg/day. Moderate-to-severe renal or hepatic impairment, CYP2D6 poor metabolizers, concomitant strong CYP2D6 inhibitors: 5mg four times daily; max 20mg/day. ESRD (including dialysis): 5mg twice daily; max 10mg/day.

    Children

    Not recommended.

    Reglan Contraindications

    Contraindications

    History of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide. When stimulation of GI motility may be dangerous (eg, obstruction, perforation, or hemorrhage). Pheochromocytoma or other catecholamine-releasing paragangliomas. Epilepsy.

    Reglan Boxed Warnings

    Boxed Warning

    Tardive dyskinesia.

    Reglan Warnings/Precautions

    Warnings/Precautions

    Increased risk of TD with long-term use; avoid treatment >12 weeks. Diabetes mellitus. Discontinue if signs/symptoms of TD, extrapyramidal symptoms (EPS), parkinsonian symptoms, motor restlessness, or neuroleptic malignant syndrome (NMS) occurs. Avoid in Parkinson's disease, depression, hypertension. Cirrhosis. CHF. Renal or hepatic impairment. NADH-cytochrome b5 reductase deficiency. G6PD deficiency. CYP2D6 poor metabolizers. Elderly (esp. women). Neonates. Pregnancy. Nursing mothers: monitor infants.

    Reglan Pharmacokinetics

    See Literature

    Reglan Interactions

    Interactions

    Avoid concomitant drugs that can cause or potentially affect TD, EPS, or NMS (eg, antipsychotics). Potentiated by strong CYP2D6 inhibitors (eg, quinidine, bupropion, fluoxetine, paroxetine); reduce dose (see Adult). Increased risk of hypertension with MAOIs; avoid. Increased risk of CNS depression with alcohol, sedatives, hypnotics, opiates, anxiolytics. Antagonized by drugs that impair GI motility (eg, antidiarrheals, anticholinergics, opiates). Avoid concomitant dopaminergic drugs (eg, apomorphine, bromocriptine, levodopa, ropinirole). May potentiate succinylcholine, mivacurium, sirolimus, tacrolimus, cyclosporine; monitor and adjust dose. May antagonize digoxin (adjust dose), atovaquone, posaconazole (oral susp), fosfomycin; monitor. Concomitant insulin: monitor and adjust dose.

    Reglan Adverse Reactions

    Adverse Reactions

    Restlessness, drowsiness, fatigue, lassitude; TD, EPS, parkinsonism, akathisia, seizures, hallucinations, NMS, hypertension (discontinue if occurs), fluid retention (discontinue if occurs), hyperprolactinemia, hypersensitivity reactions.

    Reglan Clinical Trials

    See Literature

    Reglan Note

    Not Applicable

    Reglan Patient Counseling

    See Literature