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Drug Details

PARAMAX

• Drug Class Description
  Non-opioid analgesics / anti- emetics (antidopaminergics).
• Generic Name
  Paracetamol, metoclopramide
• Presentation
  Paramax Tablets: Paracetamol 500mg, metoclopramide hydrochloride 5mg. Paramax Sachets: Paracetamol 500mg, metoclopramide hydrochloride 5mg.
• Description
  500mg paracetamol with 5mg metoclopramide hydrochloride (calculated with reference to anhydrous substance).
• Indications
  

  Paramax is indicated for the symptomatic treatment of migraine.

• Adult Dosage
  

  Paramax should be taken at the first warning of an attack. If symptoms persist, further doses may be taken at four-hourly intervals. Total dosage in any 24-hour period should not exceed the quantity stated.

  The dosage recommendations given below should be strictly adhered to if side-effects of the dystonic type are to be avoided. It should be noted that at total daily dosage of metoclopramide, especially for adolescents and young adults, should not normally exceed 0.5mg/kg body weight.

  Usual Recommended Dosage (number of tablets/sachets)

  	Initial dose at first warning of attack	Maximum dosage in any 24-hour period
  Adults (including elderly patients) Young adults (12-19 years)	2 1	6 3

  Young adults and adolescents: Paramax should only be used after careful examination to avoid masking an underlying disorder, e.g. cerebral irritation. In the treatment of this group attention should be given primarily to bodyweight.

  Children: A presentation of Paramax suitable for the treatment of children under 12 years of age is not available.

  Paramax sachets are emptied into about ¹/₄ of a glass of water and stirred before taking.

  For oral administration only.

• Child Dosage
  Not recommended.
• Contra Indications
  

  Hypersensitivity to paracetamol, metoclopramide or any other constituents.

  Gastrointestinal haemorrhage, obstruction or perforation, since stimulation of gastrointestinal motility constitutes a risk in these situations.

  History of neuroleptic or metoclopramide-induced tardive dyskinesia.

  Confirmed epilepsy, since the frequency and severity of seizures may be increased.

  Confirmed or suspected phaeochromocytoma, because of the risk of hypertensive crisis.

  Combination with levodopa because of a mutual antagonism.

  Metoclopramide should be not be used in the immediate post-operative period (up to 3-4 days) following pyloroplasty or gut anastomosis, as vigorous gastro-intestinal contractions may adversely affect healing.

• Special Precautions
  

  Patients should not take Paramax with any other paracetamol-containing products.

  Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with (non-cirrhotic) alcoholic liver disease.

  Care should be exercised in the event of Paramax being prescribed concurrently with a phenothiazine since extra-pyramidal symptoms may occur with both products.

  Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion and hallucination occur more frequently when high doses of metoclopramide are used (see adverse reactions).

  Children, young patients and the elderly should be treated with care as they are at increased risk of extrapyramidal reactions.

  Symptomatic treatment of extrapyramidal reactions may be necessary (benzodiazepines in children and/or anticholinergic anti-parkinsonian drugs in adults).

  If vomiting persists the patient should be re-assessed to exclude the possibility of an underlying disorder, e.g. cerebral irritation.

  Care should be exercised in patients being treated with other centrally active drugs.

  Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex with hyperthermia, muscle rigidity, extrapyramidal symptoms, altered mental status and autonomic dysfunction, may occur. The management of NMS should include

  1) immediate discontinuation of the product,

  2) intensive symptomatic treatment and medical monitoring, and

  3) treatment of any concomitant serious medical problems for which specific treatments are available.

  Methemoglobinemia which could be related to NADH cytochrome b5 reductase deficiency has been reported. In such cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated.

  Care should be exercised when using Paramax in patients with a history of atopy (including asthma) or porphyria.

• Interactions
  

  Contraindicated combination:

  Levodopa: Levodopa and metoclopramide have a mutual antagonism

  Combination to be avoided:

  Alcohol: Alcohol potentiates the sedative effect of metoclopramide.

  Paracetamol may potentiate the effects of alcohol. Therefore, the risk of sedation and the effects of alcohol may be increased when Paramax is taken with alcohol.

  Chloramphenicol: Paracetamol may increase the elimination half-life of chloramphenicol.

  Oral contraceptives: Oral contraceptives may increase the rate of paracetamol clearance.

  Metoclopramide or domperidone: The speed of absorption of paracetamol may be increased by metoclopramide or domperidone.

  Colestyramine: The speed of absorption of paracetamol may be reduced by colestyramine.

  Warfarin and other coumarins: The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

  Combination to be taken into account:

  Anticholinergics and morphine derivatives: Anticholinergics and morphine derivatives antagonise the effects of metoclopramide on the gastrointestinal motility.

  CNS depressants (morphine derivatives, hypnotics, anxiolytics, sedative H1 antihistamines, sedative antidepressants, barbiturates, clonidine and related): Combination of CNS depressants with metoclopramide may result in potentiation of sedative effects.

  Antipsychotics: Combination of antipsychotics with metoclopramide may result in potentiation of extrapyramidal effects.

  Due to the promotion of gastric emptying and normal peristalsis caused by metoclopramide, the absorption of certain drugs may be modified:

  Digoxin: Metoclopramide decreases the gastric absorption of digoxin. Therefore, dose adjustment may be required.

  Ciclosporin: Metoclopramide increases ciclosporin bioavailability. Dose adjustment may be required. In one study, dosing requirements for ciclosporin were reduced by 20% when metoclopramide was administered concomitantly. To avoid toxicity, careful monitoring of ciclosporin plasma concentration in therefore required.

• Adverse Drug Reactions
  

  Nervous system and psychiatric disorders

  The following reactions, sometimes associated, occur more frequently when high doses are used:

  - Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia may increase following administration of a single dose particularly in children, young adults and the elderly. Although, rarely, tardive dyskinesia may be irreversible.

  The incidence of extrapyramidal symptoms in children and young adults may increase if the metoclopramide dosage exceeds 0.5mg/kg body weight/day.

  Reactions include spasm of the facial muscles, trismus, rhythmic protrusion of the tongue, a bulbar type of speech, spasm of extra-ocular muscles including oculogyric crises, unnatural positioning of the head and shoulders and opisthotonos. There may be a generalised increase in muscle tone. The majority of reactions occur within 36 hours of starting treatment and the effects usually disappear within 24 hours of withdrawal of the drug. Should treatment of a dystonic reaction be required, a benzodiazepine or an anticholinergic anti-Parkinsonian drug may be used.

  - Drowsiness, decreased level of consciousness, confusion, hallucination.

  Other reactions may occur:

  - Tardive dyskinesia, particularly in elderly patients and following or after prolonged treatment.

  - Restlessness, anxiety

  - Depression

  - Seizures

  - Neuroleptic malignant syndrome.

  Gastrointestinal disorders

  - Diarrhoea

  Blood and Lymphatic system disorders

  Metoclopramide may cause:

  - Methaemoglobinaemia which could be related to NADH cytochrome b5 reductase deficiency have been reported, particularly in neonates.

  - Sulfhaemoglobinaemia, mainly with concomitant administration of high doses of sulfur-releasing drugs.

  - Blood dyscrasias including thrombocytopenia and agranulocytosis,

  Endocrine disorders

  - Hyperprolactinaemia with (amenorrhea, galactorrhea, gynaecomastia).

  General disorders and administration site conditions

  - Very rarely hypersensitivity, including anaphylaxis has been reported.

  - Asthenia.

  - Skin rash

  Cardiac and vascular disorders

  - Hypotension.

  - Bradycardia, heart block have been reported with metoclopramide, particularly the intravenous formulation.

  Since extrapyramidal symptoms may occur with both metoclopramide and phenothiazines, care should be exercised in the event of both drugs being prescribed concurrently.