General MedicationsNASALBlack Box

GIMOTI

METOCLOPRAMIDE HYDROCHLORIDE

Standard Dose

2 DOSAGE AND ADMINISTRATION Administration See the full prescribing information for complete information on administration. ( 2.1 ) Recommended Dosage Adults less than 65 years of age: The recommended dosage is 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum of 4 sprays daily). ( 2.2 ) Adults 65 years of age and older: GIMOTI is not recommended in geriatric patients as initial therapy. Geriatric patients receiving an alternative metoclopramide product at a stable dosage of 10 mg four times daily can be switched to GIMOTI 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum four times daily). ( 2.2 , 8.5 ) 2.1 Important Administration and Storage Instructions One spray in one nostril administers the appropriate dose. Before administering the first dose from a bottle, prime the pump by pressing down on the finger flange and releasing 10 sprays in the air. Place the spray nozzle tip under one nostril and lean the head slightly forward so the tip of spray nozzle is aimed away from the septum and toward the back of the nose. Close the other nostril with the other index finger. Move spray pump upwards so the tip of the nozzle is in the nostril. To ensure a full dose, hold the bottle upright while pressing down firmly and completely on finger flange and release while inhaling slowly through the open nostril. Remove spray pump nozzle tip from nostril and exhale slowly through the mouth. Wipe the spray nozzle with a clean tissue. Missed or Incomplete Doses If uncertain that the spray entered the nose, do not repeat the dose. Take the next dose at the scheduled time. If a dose is missed, take the next dose of GIMOTI at the regularly scheduled time. Do not make up for the missed dose or double the next dose. Storage Discard GIMOTI 4 weeks after opening even if the bottle contains unused drug. 2.2 Recommended Dosage Adults Less Than 65 Years of Age The recommended dosage of GIMOTI for the treatment of acute and recurrent diabetic gastroparesis in adults is 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum of four times daily). Adults 65 Years of Age and Older Elderly patients may be more sensitive to the adverse effects of metoclopramide and require a lower starting dosage [see Warnings and Precautions ( 5.1 )] . GIMOTI is not recommended in geriatric patients as initial therapy. Geriatric patients receiving an alternative metoclopramide product at a stable dosage of 10 mg four times daily can be switched to GIMOTI 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum four times daily). Treatment Duration Use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatment. Avoid treatment with metoclopramide, including GIMOTI, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD [see Warnings and Precautions ( 5.1 )] .

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

Summary

Indications and usage 1 INDICATIONS AND USAGE GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

GIMOTI is a dopamine-2 (D 2 ) antagonist indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1 ) Limitations of Use : GIMOTI is not recommended for use in: pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. ( 1 , 8.4 ) moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions. ( 1 , 5.9 , 7.1 ) Limitations of Use : GIMOTI is not recommended for use in: pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4 )]. moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions [see Warnings and Precautions ( 5.9 )].

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. GIMOTI is a dopamine-2 (D 2 ) antagonist indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1 ) Limitations of Use : GIMOTI is not recommended for use in: pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. ( 1 , 8.4 ) moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions. ( 1 , 5.9 , 7.1 ) Limitations of Use : GIMOTI is not recommended for use in: pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4 )]. moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions [see Warnings and Precautions ( 5.9 )]. Dosage and administration 2 DOSAGE AND ADMINISTRATION Administration See the full prescribing information for complete information on administration. ( 2.1 ) Recommended Dosage Adults less than 65 years of age: The recommended dosage is 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum of 4 sprays daily). ( 2.2 ) Adults 65 years of age and older: GIMOTI is not recommended in geriatric patients as initial therapy. Geriatric patients receiving an alternative metoclopramide product at a stable dosage of 10 mg four times daily can be switched to GIMOTI 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum four times daily). ( 2.2 , 8.5 ) 2.1 Important Administration and Storage Instructions One spray in one nostril administers the appropriate dose. Before administering the first dose from a bottle, prime the pump by pressing down on the finger flange and releasing 10 sprays in the air. Place the spray nozzle tip under one nostril and lean the head slightly forward so the tip of spray nozzle is aimed away from the septum and toward the back of the nose. Close the other nostril with the other index finger. Move spray pump upwards so the tip of the nozzle is in the nostril. To ensure a full dose, hold the bottle upright while pressing down firmly and completely on finger flange and release while inhaling slowly through the open nostril. Remove spray pump nozzle tip from nostril and exhale slowly through the mouth. Wipe the spray nozzle with a clean tissue. Missed or Incomplete Doses If uncertain that the spray entered the nose, do not repeat the dose. Take the next dose at the scheduled time. If a dose is missed, take the next dose of GIMOTI at the regularly scheduled time. Do not make up for the missed dose or double the next dose. Storage Discard GIMOTI 4 weeks after opening even if the bottle contains unused drug. 2.2 Recommended Dosage Adults Less Than 65 Years of Age The recommended dosage of GIMOTI for the treatment of acute and recurrent diabetic gastroparesis in adults is 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum of four times daily). Adults 65 Years of Age and Older Elderly patients may be more sensitive to the adverse effects of metoclopramide and require a lower starting dosage [see Warnings and Precautions ( 5.1 )] . GIMOTI is not recommended in geriatric patients as initial therapy. Geriatric patients receiving an alternative metoclopramide product at a stable dosage of 10 mg four times daily can be switched to GIMOTI 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum four times daily). Treatment Duration Use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatment. Avoid treatment with metoclopramide, including GIMOTI, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD [see Warnings and Precautions ( 5.1 )] . Warnings and cautions 5 WARNINGS AND PRECAUTIONS Tardive dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS) : Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson's disease. If symptoms occur, discontinue GIMOTI and seek immediate medical attention. ( 5.1 , 5.2 , 5.3 , 7.1 , 7.2 ) Depression and suicidal ideation/suicide : Avoid use. ( 5.4 ) 5.1 Tardive Dyskinesia Metoclopramide, including GIMOTI, can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or

Boxed Warning

WARNING: TARDIVE DYSKINESIA Metoclopramide, including GIMOTI, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including GIMOTI, the risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions ( 5.1 )] . GIMOTI is contraindicated in patients with a history of TD. Use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatment. Immediately discontinue GIMOTI in patients who develop signs or symptoms of TD [see Warnings and Precautions ( 5.1 )] . Avoid a total duration of treatment with metoclopramide products, including GIMOTI, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD [see Warnings and Precautions ( 5.1 )] . WARNING: TARDIVE DYSKINESIA See full prescribing information for complete boxed warning . Metoclopramide, including GIMOTI, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including GIMOTI, the risk of developing TD increases with duration of treatment and total cumulative dosage. ( 5.1 ) GIMOTI is contraindicated in patients with a history of TD. ( 4 ) Use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatment. ( 2.2 , 5.1 ) Immediately discontinue GIMOTI in patients who develop signs or symptoms of TD. ( 5.1 ) Avoid a total duration of treatment with metoclopramide products, including GIMOTI, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD. ( 5.1 )

Monitoring

• 5 WARNINGS AND PRECAUTIONS Tardive dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS) : Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson's disease.
• If symptoms occur, discontinue GIMOTI and seek immediate medical attention.
• ( 5.1 , 5.2 , 5.3 , 7.1 , 7.2 ) Depression and suicidal ideation/suicide : Avoid use.
• ( 5.4 ) 5.1 Tardive Dyskinesia Metoclopramide, including GIMOTI, can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities.

Interaction Notes

• 7 DRUG INTERACTIONS Antipsychotics : Potential for additive effects, including TD, EPS, and NMS; avoid concomitant use.
• ( 7.1 ) Central nervous system (CNS) depressants : Increased risk of CNS depression.
• Avoid concomitant use and monitor for adverse reactions.
• ( 7.1 ) Monoamine oxidase (MAO) inhibitors : Increased risk of hypertension; avoid concomitant use.