Motilon Syrup 5 mg/5 ml

Motilon Syrup

Generic Name: Metoclopramide Hydrochloride

Strength: 5 mg/5 ml

Dosage Form: Syrup

Manufacturer: Synovia Pharma PLC

Indications

Pharmacology

Metoclopramide blocks dopamine receptors and in higher doses, it also blocks serotonin receptors in chemoreceptor trigger zone of the CNS. It enhances the response to acetylcholine of tissue in upper GI tract causing enhanced motility and accelerated gastric emptying w/o stimulating gastric, biliary, or pancreatic secretions. It also increases lower esophageal sphincter tone.

Dosage Information

Metoclopramide Spray:

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) for 2 to 8 weeks, depending on symptomatic response.

Adults 65 years of age and older: Metoclopramide 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 Metoclopramide 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum four times daily) for 2 to 8 weeks, depending on symptomatic response.

Metoclopramide tablet:

Gastroesophageal Reflux: Administer Metoclopramide continuously or intermittently:

• Continuous: Administer 10 to 15 mg, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks.
• Intermittent: Single doses up to 20 mg prior to provoking situation.

Acute and Recurrent Diabetic Gastroparesis: Administer 10 mg, 30 minutes before each meal and at bedtime (maximum of 40 mg per day) for 2 to 8 weeks.

Metoclopramide injection:

For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis): If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with Metoclopramide Injection (IM or IV). Doses of 10 mg may be administered slowly by the intravenous route over a 1- to 2-minute period. Administration of Metoclopramide Injection (metoclopramide injection, USP) up to 10 days may be required before symptoms subside, at which time oral administration of metoclopramide may be instituted. The physician should make a thorough assessment of the risks and benefits prior to prescribing further metoclopramide treatment.

For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy: Intravenous infusions should be made slowly over a period of not less than 15 minutes, 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses. The initial two doses should be 2 mg/kg if highly emetogenic drugs such as cisplatin or dacarbazine are used alone or in combination. For less emetogenic regimens, 1 mg/kg per dose may be adequate.

For the Prevention of Postoperative Nausea and Vomiting: Metoclopramide Injection should be given intramuscularly near the end of surgery. The usual adult dose is 10 mg; however, doses of 20 mg may be used.

Side Effects

Most common adverse reactions (≥5%) are: dysgeusia, headache, and fatigue.

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 Reglan and seek immediate medical attention.  

Depression and suicidal ideation/suicide: Avoid use.

Metoclopramide Spray:

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) for 2 to 8 weeks, depending on symptomatic response.

Adults 65 years of age and older: Metoclopramide 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 Metoclopramide 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum four times daily) for 2 to 8 weeks, depending on symptomatic response.

Metoclopramide tablet:

Gastroesophageal Reflux: Administer Metoclopramide continuously or intermittently:

• Continuous: Administer 10 to 15 mg, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks.
• Intermittent: Single doses up to 20 mg prior to provoking situation.

Acute and Recurrent Diabetic Gastroparesis: Administer 10 mg, 30 minutes before each meal and at bedtime (maximum of 40 mg per day) for 2 to 8 weeks.

Metoclopramide injection:

For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis): If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with Metoclopramide Injection (IM or IV). Doses of 10 mg may be administered slowly by the intravenous route over a 1- to 2-minute period. Administration of Metoclopramide Injection (metoclopramide injection, USP) up to 10 days may be required before symptoms subside, at which time oral administration of metoclopramide may be instituted. The physician should make a thorough assessment of the risks and benefits prior to prescribing further metoclopramide treatment.

For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy: Intravenous infusions should be made slowly over a period of not less than 15 minutes, 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses. The initial two doses should be 2 mg/kg if highly emetogenic drugs such as cisplatin or dacarbazine are used alone or in combination. For less emetogenic regimens, 1 mg/kg per dose may be adequate.

For the Prevention of Postoperative Nausea and Vomiting: Metoclopramide Injection should be given intramuscularly near the end of surgery. The usual adult dose is 10 mg; however, doses of 20 mg may be used.

Most common adverse reactions (≥5%) are: dysgeusia, headache, and fatigue.

Pregnancy Category B. Reproduction studies performed in rats, mice and rabbits by the IM, IV, subcutaneous (SC), and oral routes at maximum levels ranging from 12 to 250 times the human dose have demonstrated no impairment of fertility or significant harm to the fetus due to metoclopramide. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: Metoclopramide is excreted in human milk. Caution should be exercised when metoclopramide is administered to a nursing mother.

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 Reglan and seek immediate medical attention.  

Depression and suicidal ideation/suicide: Avoid use.