Nutramid5 mg/5 ml

Metoclopramide hydrochloride is a dopamine-receptor blocking antiemetic and prokinetic medicine used for:

• Relief of symptomatic, documented gastroesophageal reflux disease (GERD) in adults who have not responded to conventional therapy, for a short-term course
• Acute and recurrent diabetic gastroparesis (delayed stomach emptying) - relief of associated symptoms such as nausea, vomiting, bloating, and early fullness after eating
• Prevention and treatment of nausea and vomiting, including chemotherapy-induced and postoperative nausea and vomiting, in certain clinical settings, often given by injection
• Facilitating small bowel intubation in radiological examinations, and stimulating gastric emptying to assist in certain barium studies, in some clinical protocols

Metoclopramide carries an important boxed warning regarding the risk of tardive dyskinesia with long-term use, and treatment duration is deliberately limited as a result (see Precautions).

Contains Nutramid 5 mg/5 ml as the active ingredient, available as oral tablets (commonly 5 mg and 10 mg), orally disintegrating tablets, oral solution (commonly 5 mg per 5 mL), and injection (commonly 5 mg/mL, in vials or pre-filled syringes).

Metoclopramide is a widely used medicine that relieves nausea, vomiting, and symptoms of delayed stomach emptying by blocking dopamine receptors and speeding up the movement of the stomach and upper intestine. It is available as tablets, an oral solution, and an injection, and is used both for short-term symptom relief and for specific gastrointestinal motility conditions. Because of a recognized risk of a serious, potentially irreversible movement disorder called tardive dyskinesia with prolonged use, metoclopramide carries a boxed warning and treatment is generally limited to no more than 12 weeks.

Therapeutic Class: Antiemetic / Gastrointestinal Prokinetic Agent

Metoclopramide crosses the blood-brain barrier and blocks dopamine D2 receptors both in the chemoreceptor trigger zone (the brain's vomiting centre) and in the gastrointestinal tract, where it also enhances the response to acetylcholine, increasing the tone and amplitude of gastric contractions and relaxing the pyloric sphincter and duodenal bulb - together speeding gastric emptying and transit through the small bowel, without affecting gastric, biliary, or pancreatic secretions.

• Oral tablets and solution are generally taken 30 minutes before meals and at bedtime
• Orally disintegrating tablets should be placed on the tongue and allowed to dissolve, without water
• Injection is given by a healthcare professional, by intravenous or intramuscular route, depending on the clinical situation
• Use the lowest effective dose for the shortest possible duration, and periodically reassess the ongoing need for treatment with your prescriber

The following should be assessed by a healthcare professional before combining with metoclopramide:

• Other dopamine-blocking medicines (such as antipsychotics): combined use increases the risk of extrapyramidal symptoms, including tardive dyskinesia; generally avoided together.
• Sedating medicines, alcohol, and opioids: may increase drowsiness and central nervous system depression when combined with metoclopramide.
• Medicines affecting gut motility (such as anticholinergics or opioids): may antagonize metoclopramide's prokinetic effect.
• Drugs requiring a specific absorption window (such as digoxin): metoclopramide's effect on gastric emptying may reduce absorption of digoxin from the stomach.
• Insulin: because metoclopramide accelerates gastric emptying, timing of food absorption relative to insulin dosing may need adjustment in diabetic patients, coordinated with the treating physician.
• Serotonergic medicines (such as SSRIs): metoclopramide has some serotonergic activity and may add to serotonin syndrome risk when combined with other serotonergic drugs, though this interaction is less prominent than with other agents.

Common side effects

• Drowsiness or fatigue
• Restlessness or nervousness
• Diarrhoea
• Headache

Serious side effects (require prompt medical attention)

• Tardive dyskinesia (boxed warning): repetitive, involuntary movements of the face and body (such as lip smacking, grimacing, tongue movements), which risk increases with duration and total cumulative dose of treatment; discontinue metoclopramide immediately if signs or symptoms develop, since this movement disorder is often irreversible even after stopping the medicine.
• Acute dystonic reactions: sudden, involuntary muscle spasms (particularly of the face, neck, or eyes), more common in children and young adults, and typically occurring shortly after starting treatment or with higher doses.
• Parkinsonian-like symptoms: tremor, rigidity, shuffling gait - risk increases with dose, particularly in elderly patients.
• Neuroleptic malignant syndrome (rare): high fever, muscle rigidity, altered consciousness, and autonomic instability - a rare but life-threatening reaction requiring emergency treatment.
• Depression, including rare reports of suicidal ideation, has been associated with metoclopramide use.
• Signs of a severe allergic reaction: rash, swelling, difficulty breathing.

Pregnancy

Metoclopramide has been used in pregnancy, including for severe nausea and vomiting, but should be used only if a doctor determines the benefit outweighs the potential risk, since safety data specific to this indication and the developing fetus require individualized clinical judgment.

Breastfeeding

Metoclopramide passes into breast milk and may increase milk production; use during breastfeeding should be discussed with a healthcare professional, particularly given the potential for sedation or extrapyramidal effects in the nursing infant with maternal use.

• Tardive dyskinesia risk (boxed warning): use the lowest effective dose for the shortest duration; avoid treatment beyond 12 weeks for GERD, and avoid longer-term use for gastroparesis where possible, given the cumulative dose- and duration-related risk of this often-irreversible movement disorder; risk is higher in elderly patients, particularly women.
• Discontinue immediately if signs or symptoms of tardive dyskinesia (repetitive, involuntary movements) develop.
• Depression and suicidal ideation: monitor for mood changes, particularly in patients with a history of depression.
• Neuroleptic malignant syndrome: discontinue immediately if this is suspected and provide prompt intensive supportive care.
• Use with caution in patients with a history of epilepsy or those on other drugs likely to cause extrapyramidal reactions, given increased seizure and movement disorder risk.
• Use with caution in elderly patients, who should receive the lowest effective dose and be monitored for parkinsonian-like symptoms.

Overdose may cause drowsiness, confusion, extrapyramidal reactions (such as dystonic movements or tremor), and, in severe cases, seizures or cardiovascular effects. Suspected overdose requires prompt medical evaluation; treatment is generally supportive, provided in a medical facility, and extrapyramidal symptoms may be managed with anticholinergic, antihistaminic, or antiparkinsonian medicines as directed by the treating physician.

Store tablets and oral solution at room temperature (15-30°C), protected from light and moisture. Store injectable ampoules/vials as directed on the product label, protected from light; discard any unused reconstituted or diluted portion according to the manufacturer's stability instructions.

• Elderly: Greater risk of parkinsonian-like symptoms and tardive dyskinesia; use the lowest effective dose, and discontinue promptly if such symptoms develop.
• Children: Dystonic and other extrapyramidal reactions are more common in children than adults; dosing is weight-based and should be carefully individualized by the treating physician.
• Renal impairment: Dose reduction is generally required, as metoclopramide is substantially eliminated by the kidneys.
• Hepatic impairment: Use with caution; dose adjustment may be needed.

For symptomatic GERD, treatment should not exceed 12 weeks. For diabetic gastroparesis, treatment beyond 12 weeks should be avoided where possible; if longer-term use is judged unavoidable by the treating physician, the ongoing need for treatment should be reassessed periodically, and the patient monitored routinely for signs of tardive dyskinesia. For acute nausea/vomiting indications (such as postoperative or chemotherapy-related use), treatment is typically short-term, limited to the acute clinical situation.

Drug Class: Dopamine D2-receptor antagonist (with additional 5-HT4 agonist and 5-HT3 antagonist activity)

Metoclopramide works through two complementary actions: in the brain, it blocks dopamine receptors in the area that triggers nausea and vomiting, directly reducing these symptoms; in the gastrointestinal tract, it increases the strength and coordination of stomach contractions and relaxes the valve between the stomach and small intestine, helping food move through the digestive system more quickly - which is particularly useful in diabetic gastroparesis, where the stomach empties too slowly.

Metoclopramide is used in children for certain nausea and vomiting indications, with weight-based dosing individualized by the treating physician. Dystonic and other extrapyramidal reactions occur more frequently in children than in adults, so use requires particular caution, close monitoring, and the lowest effective dose for the shortest necessary duration.