METOCLOPRAMIDE Hydrochloride

METOCLOPRAMIDE HYDROCHLORIDE- metoclopramide hydrochloride tablet, orally disintegrating
Lupin Pharmaceuticals,Inc.

WARNING TARDIVE DYSKINESIA

  • Metoclopramide Orally Disintegrating Tablets can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1)].
  • Discontinue Metoclopramide Orally Disintegrating Tablets in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after Metoclopramide Orally Disintegrating Tablets is stopped [see Warnings and Precautions (5.1)].
  • Avoid treatment with Metoclopramide Orally Disintegrating Tablets for longer than 12 weeks because of the increased risk of developing TD with longer-term use [see Warnings and Precautions (5.1), Dosage and Administration (2.2, 2.3)].

1 INDICATIONS AND USAGE

Metoclopramide Orally Disintegrating Tablets is indicated in adults for the:

  • Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy.
  • Relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis).

Limitations of Use:

Metoclopramide Orally Disintegrating Tablets is not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms and the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4)]

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

  • Avoid treatment with Metoclopramide Orally Disintegrating Tablets for longer than 12 weeks because of the increased risk of developing TD with longer-term use [see Dosage and Administration ( 2.2, 2.3), Warnings and Precautions ( 5.1)].
  • Take on an empty stomach at least 30 minutes before eating [see Clinical Pharmacology ( 12.3)]. Do not repeat dose if inadvertently taken with food.
  • 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.
  • Place the tablet on the tongue and allow it to disintegrate (takes approximately one minute) and swallow the granules without water [see Clinical Pharmacology ( 12.3)].

2.2 Dosage for GERD

Metoclopramide Orally Disintegrating Tablets may be administered continuously or intermittently in patients with symptomatic GERD who fail to respond to conventional therapy:

Continuous Dosing

The recommended adult dosage of Metoclopramide Orally Disintegrating Tablets is 10 to 15 mg four times daily for 4 to 12 weeks. The treatment duration is determined by endoscopic response. Administer the dosage thirty minutes before each meal and at bedtime. The maximum recommended daily dosage is 60 mg.

Table 1 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors.

Intermittent Dosing

If symptoms only occur intermittently or at specific times of the day, administer Metoclopramide Orally Disintegrating Tablets in single dose up to 20 mg prior to the provoking situation. Consider dosage reductions for the populations and situations in Table 1.

Table 1 Recommended Metoclopramide Orally Disintegrating Tablets Dosage in Patients with Gastroesophageal Reflux
Recommended Dosage Maximum Recommended Daily Dosage
Adult patients 10 to 15 mg four times daily (thirty minutes before each meal and at bedtime) 60 mg
Mild hepatic impairment (Child-Pugh A)
Elderly patients1 [see Use in Specific Populations ( 8.5)] 5 mg four times daily (thirty minutes before each meal and at bedtime)
Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations ( 8.7)] 5 mg four times daily (thirty minutes before each meal and at bedtime), or 10 mg taken three times daily 30 mg
CYP2D6 poor metabolizers [see Use in Specific Populations ( 8.9)]
Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [see Drug Interactions ( 7.1)]
Moderate or severe renal impairment (creatinine clearance less than or equal to 60 mL/minute) [see Use in Specific Populations ( 8.6)]
Patients with End-Stage Renal Disease (ESRD) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations ( 8.6)] 5 mg four times daily (thirty minutes before each meal and at bedtime) or 10 mg twice daily 20 mg
1 Elderly patients may be more sensitive to the therapeutic or adverse effects of Metoclopramide Orally Disintegrating Tablets; therefore, consider a lower starting dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 to 15 mg four times daily based upon response and tolerability.

2.3 Dosage for Acute and Recurrent Diabetic Gastroparesis (Gastric Stasis)

The recommended adult dosage for the relief of symptoms associated with diabetic gastroparesis (gastric stasis) is 10 mg four times daily for 2 to 8 eight weeks, depending on symptomatic response. Avoid Metoclopramide Orally Disintegrating Tablets treatment for greater than 12 weeks [see Warnings and Precautions (5.1)] . Administer the dosage at least 30 minutes before each meal and at bedtime. The maximum recommended daily dosage is 40 mg.

Table 2 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors.

If patients with diabetic gastroparesis have severe nausea or vomiting and are unable to take oral Metoclopramide Orally Disintegrating Tablets tablets, consider starting therapy with metoclopramide injection given intramuscularly or intravenously for up to 10 days (see the prescribing information for metoclopramide injection). After patients are able to take oral therapy, switch to Metoclopramide Orally Disintegrating Tablets tablets.

Table 2 Recommended Metoclopramide Orally Disintegrating Tablets Dosage in Patients with Acute and Recurrent Diabetic Gastroparesis
Recommended Dosage Maximum Recommended Daily Dosage
Adult patients 10 mg four times daily (thirty minutes before each meal and at bedtime) 40 mg
Mild hepatic impairment (Child-Pugh A)
Elderly patients [see Use in Specific Populations ( 8.5)] 5 mg1 four times daily (thirty minutes before each meal and at bedtime)
Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations ( 8.7)] 5 mg four times daily (thirty minutes before each meal and at bedtime) 20 mg
CYP2D6 poor metabolizers [see Use in Specific Populations ( 8.9)]
Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [see Drug Interactions ( 7.1)]
Moderate or severe renal impairment (creatinine clearance less than or equal to 60 mL/minute) [see Use in Specific Populations ( 8.6)]
Patients with End-Stage Renal Disease (ESRD) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations ( 8.6)] 5 mg twice daily 10 mg
1 Elderly patients may be more sensitive to the therapeutic or adverse effects of Metoclopramide Orally Disintegrating Tablets; therefore, consider a lower dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 mg four times daily based upon response and tolerability.

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