Mepram         Syrup

Metoclopramide Hydrochloride 1mg/1ml

 

Usage and indications:

    • Prevention of post-operative nausea & vomiting (POVN)
    • Prevention of radiotherapy induced nausea & vomiting
    • Prevention of delayed (not acute) chemotherapy induced nausea & vomiting
    • Symptomatic treatment of nausea & vomiting including that associated with acute migraine (where it may also improve absorption of oral analgesics)

Children:

  • A second line option for the prevention of delayed chemotherapy-induced nausea & vomiting.
  • Treatment of established PONV.

Dosage and administration:

 Dosage recommendations given should be strictly followed to avoid dystonic side effect.

For adults & children, the maximum dose in 24 hours is 0.5mg/Kg of body weight.

Dosage should be at reduced levels in patients with significant renal or hepatic impairment.

Adults of 20 years and older:

The usual dose is 10mg up to three times daily. [If weigh below 60Kg see later]

Young adults and children:

Only use Metoclopramide Hydrochloride Oral Solution after examination to avoid masking an underlying disorder, such as cerebral irritation. Primary consideration must be given to body weight and treatment should be initiated at the lower dosage indicated.

The recommended dose is 0.1 to 0.15mg /Kg of body weight, up to 3 times daily.

Undesirable effects:

Blood and lymphatic system disorders:

Extremely rarely cases of red cell disorders such as methaemoglobinaemia and sulphaemoglobinaemia have been reported, particularly at high doses of metoclopramide.

If this occurs the drug should be withdrawn. Methaemoglobinaemia may be treated using methylene blue. Methaemoglobinaemia could be related to NADH cytochrome b5 reductase deficiency particularly in neonates.

Immune system disorders:

Allergic reactions may also occur. Very rarely hypersensitivity, including anaphylaxis has been reported.

Endocrine disorders:

Raised serum prolactin levels have been observed during metoclopramide therapy this may result in galactorrhoea, irregular periods and gynaecomastia.

Psychiatric disorders:

Restlessness (about 5%)

Rare: Trouble sleeping, unusual irritability and confusion

Depression has been reported extremely rarely.

Nervous system disorders:

Various extrapyramidal reactions to metoclopramide, usually of the dystonic kind, have been reported. Incidence of dystonic reactions, particularly in children and young adults, is increased if daily doses in excess of 0.5mg/kg body weight are used. Examples of dystonic reactions include: facial muscle spasm, trismus, bulbar type speech, rhythmic tongue protrusion, spasm of extraocular muscles (including oculogyric crises), unnatural positioning of head and shoulders and opisthotonos. There may also be a generalized increase in muscle tone. In most cases, the majority of these reactions occur within 36 hours of initiating treatment, they usually reverse within 24 hours of drug withdrawal. If necessary, dystonic reactions may be treated by use of an anticholinergic anti-parkinsonian drug, or a benzodiazepine.

Tardive dyskinesia, occurring during prolonged treatment, has been reported, mainly in elderly patients; such patients should be regularly reviewed. The likelihood of the occurrence of this serious side effect is increased when neuroleptic agents are used concurrently.

Very rare occurrences of neuroleptic malignant syndrome have been reported.

This syndrome is potentially fatal and comprises of hyperpyrexia, altered consciousness, muscle rigidity, autonomic instability and elevated levels of creatinine phosphokinase (CPK) and must be treated urgently (recognised treatments include dantrolene and bromocriptine). Metoclopramide should be stopped immediately if this syndrome occurs.

Extrapyramidal symptoms: Acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following administration of a single dose of the drug, particularly in children and young adults

Drowsiness (about 10%)

Rare: Dizziness (less than 1%), headache

Eye disorders:

Visual disturbances have been reported.

Cardiac disorders:

Very rare reports of abnormalities of cardiac conduction (bradycardia, asystole, heart block, sinus arrest and cardiac arrest) have been reported following intravenous administration.

Vascular disorders:

Acute hypertension may occur in patients with phaeochromocytoma. hypotension has also been reported.

Respiratory, thoracic and mediastinal disorders:

Dyspnoea may occur.

Gastrointestinal disorders:

Rare: Constipation (less than 1%), diarrhea, nausea, unusual dryness of mouth.

Skin and subcutaneous tissue disorders:

Rare: Skin rash, a small number of skin reactions such as urticaria and pruritus.

Reproductive system and breast disorders:

Rare: Breast tenderness and swelling, changes in menstruation.

General disorders and administration site conditions:

Unusual tiredness or weakness (about 10%)

 Rare: Edema (including face edema)

Warnings and precautions:

  • In order to minimize the risks of neurological & other adverse reactions, metoclorpromide is only licensed for short term use (up to 5 days). It should not be used in chronic condictions such as gastroparesis, dyspepsia or, gastro-oesophageal relflux disease nor, as adjunct in surgical & radiological procedures.
  • Given very rare reports of serious cardio vascular reactions assosicated with metoclorpromide (particularly via intravenous route), special care should be taken in populations likely to be at increased risk including: elderly patients, patients with cardiac conduction disturbances, uncorrected electrolyte imbalance or, bradycardia and, those taking other drugs known to prolong QT interval.
  • Patients who are currently taking regular metoclorpromide should have their treatment reviewed at a routine (non-urgent) medical appointment.
  • If, despite treatment, vomiting persists, the patient must be re-assessed to exclude the possibility of an underlying disorder, i.e. cerebral irritation.
  • Care should be exercised in patients being treated with other centrally acting drugs.
  • Risk-benefit should be considered in patients with: Liver disease, due to loss of conjugation; Parkinson's disease, as symptoms may be exacerbated; Severe or chronic renal failure, as the risk of extrapyramidal effects may be increased.
  • Dosage reduction is recommended.
  • Avoid alcohol.
  • Neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy.
  • Metoclopramide should be used with care in combination with other serotonergic drugs including SSRIs.
  • Care should be exercised when using metoclopramide in patients with a history of atopy (including asthma) or porphyria.
  • Extrapyramidal disorders may occur, particularly in children and young adults and/or when high doses are used.
  • Patients receiving this drug for the disorders associated with delayed gastric emptying should be reviewed at an early stage for response to treatment.
  • Metoclopramide may cause elevation of serum prolactin levels.

Excipient Warnings: This product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Methyl and propyl hydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed).

Pack: Carton box containing a glass bottle of 120ml.

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