UltrametTablet

Generic

Metoclopramide Hydrochloride

Indications

The small intestine is intubated. Premedication for upper gastrointestinal tract radiologic examination, Chemotherapy-induced nausea and vomiting prophylaxis, Cancer chemotherapy or radiotherapy can cause nausea and vomiting. Diabetic gastric stasis, Gastro-oesophageal reflux illness, Diabetic gastric stasis, Diabetic gastric stasis, Diabetic gastric stasis, Diabetic gastric stasis, Diabetic gastric stasis, Dia Postoperative nausea and vomiting prevention

Pharmacology

Metoclopramide inhibits dopamine receptors and, at higher doses, serotonin receptors in the CNS's chemoreceptor trigger zone. It improves tissue in the upper GI tract's response to acetylcholine, resulting in increased motility and faster gastric emptying without increasing gastric, biliary, or pancreatic secretions. It also raises the tone of the lower esophageal sphincter.

Dosage & Administration

Oral-

Gastroesophageal Reflux: Administer Reglan 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.

Dosage Adjustment in Specific Populations: For gastroesophageal reflux and acute and recurrent diabetic gastroparesis, in patients with moderate or severe hepatic or renal impairment, and cytochrome P450 2D6 (CYP2D6) poor metabolizers.

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, 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 doses in excess of 10 mg, Metoclopramide Injection, should be diluted in 50 mL of a parenteral solution. The preferred parenteral solution is Sodium Chloride Injection (normal saline), which when combined with Metoclopramide Injection, can be stored frozen for up to 4 weeks.

Metoclopramide Injection, is degraded when admixed and frozen with Dextrose­5% in Water. Metoclopramide Injection, diluted in Sodium Chloride Injection, Dextrose­5% in Water, Dextrose ­5% in 0.45% Sodium Chloride, Ringer's Injection, or Lactated Ringer's Injection may be stored up to 48 hours (without freezing) after preparation if protected from light. All dilutions may be stored unprotected from light under normal light conditions up to 24 hours after preparation. If acute dystonic reactions should occur, inject 50 mg diphenhydramine hydrochloride intramuscularly, and the symptoms usually will subside.

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. To Facilitate Small Bowel Intubation. If the tube has not passed the pylorus with conventional maneuvers in 10 minutes, a single dose (undiluted) may be administered slowly by the intravenous route over a 1 to 2 minute period.

The recommended single use is:

• Pediatric patients above 14 years of age and adults: 10 mg metoclopramide base.
• Pediatric patients (6 to 14 years of age): 2.5 to 5 mg metoclopramide base;
• Pediatric patients (under 6 years of age): 0.1 mg/kg metoclopramide base.

Should be taken on an empty stomach. Take ½ hr before meals.

Interaction

Anticholinergics and morphine derivatives have an antagonistic impact. CNS depressants increase the potency of sedative effects. Extrapyramydal problems are increased when combined with other neuroleptics. Serotonergic medications may raise the risk of serotonin syndrome (e.g. SSRIs). Digoxin bioavailability may be reduced. Increases the bioavailability of ciclosporin. Mivacurium and suxamethonium's neuromuscular inhibiting effects may be prolonged. Strong CYP2D6 inhibitors result in higher exposure levels (e.g. fluoxetine). Atovaquone plasma concentrations may be reduced.

Contraindications

GI bleeding, mechanical blockage, or GI perforation; proven or suspected pheochromocytoma; neuroleptic or metoclopramide-induced tardive dyskinesia; epilepsy, Parkinson's disease; history of methaemoglobinaemia with metoclopramide or NADH cytochrome-b5 deficiency Concurrent usage with levodopa or dopaminergic agonists is not recommended.

Side Effects

Extrapyramidal symptoms (typically acute dystonic reactions); parkinsonism; tardive dyskinesia; restlessness, drowsiness, dizziness, anxiety, confusion, tremor; hallucinations (rare); depression with suicidal ideation; hypotension, HTN, GI disturbances, dyspnea, visual disturbances, urinary frequency and incontinence, headache; hypersensitivity reactions (rash, bronchospasm, angioe IV: Cardiac conduction problems, flushing of the face and upper body on a temporary basis (high dose).

Pregnancy & Lactation

Category B: Either animal reproduction studies have shown no risk to the fetus but no controlled studies in pregnant women have been conducted, or animal reproduction studies have shown an adverse effect (other than a decrease in fertility) that has not been confirmed in controlled studies in pregnant women in the first trimester (and there is no evidence of a risk in later trimesters).

Precautions & Warnings

Patients with underlying neurological conditions, cardiac conduction disturbances, uncorrected electrolyte imbalance, bradycardia. Renal and hepatic impairment. Elderly, childn. Pregnancy and lactation.

Therapeutic Class

Anti-emetic drugs, Prokinetic drugs

Storage Conditions

Store between 20-25°C. Protect from light.

Pharmaceutical Name

Ultra Pharma Ltd.