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REGLAN
Hyperacidity, GERD, and ulcers
Nausea
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Drug Name:

REGLAN Rx

Generic Name and Formulations:
Metoclopramide (as HCl) 5mg, +10mg; +scored tabs.

Company:
Ani Pharmaceuticals

Therapeutic Use:

Indications for REGLAN:

Symptomatic refractory GERD.

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.

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.

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.

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.

Pharmacological Class:

Dopamine-2 receptor antagonist.

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.

Generic Availability:

YES

How Supplied:

Tabs—100

Indications for REGLAN:

Relief of symptoms associated with acute and recurrent diabetic gastroparesis.

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.

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.

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.

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.

See Also:

Metoclopramide Injection

Pharmacological Class:

Dopamine-2 receptor antagonist.

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.

Generic Availability:

YES

How Supplied:

Tabs—100; Single-use vial—contact supplier

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