Meprobamate Tablets 400mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MEPRATE/Meprobamate Tablets 400 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Meprobamate BP 400.00 mg
3 PHARMACEUTICAL FORM
Tablets
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Short term symptomatic treatment of anxiety states where muscle tension is prominent.
4.2 Posology and method of administration
Adults: The usual dosage is 400 to 1600 mg daily in divided doses.
Higher doses are not recommended.
The Half the normal adult dose or less may be sufficient for a therapeutic
Elderly: response in the elderly.
Children: Not recommended.
Route of administration: oral
Known sensitivity to Meprobamate or related compounds such as carisoprodol or carbromal.
Acute intermittent porphyria.
Patients with a history of alcohol or drug abuse.
Acute pulmonary insufficiency.
Respiratory depression.
Breast-feeding.
4.4 Special warnings and precautions for use
Barbiturate-type dependence may occur particularly when the drug is given in higher than recommended dosages or for long periods. It may also occur on normal therapeutic dosages, particularly in individuals with emotionally unstable personalities or in others prone to alcohol or other drug dependence. Severe withdrawal reactions ranging in severity from tremulousness and insomnia to confusion, delirium tremens, convulsions and occasionally death have occurred. Regular monitoring of treatment and avoidance of routine repeat prescriptions are essential. Treatment should be withdrawn gradually.
Meprobamate may induce seizures in epileptic patients. Caution should be exercised when administering to patients with respiratory disease, muscle weakness, and hepatic and renal impairment.
4.5 Interaction with other medicinal products and other forms of interaction
Like barbiturates, meprobamate causes induction of liver enzymes so that the availability and blood levels of drugs given concurrently that are metabolised by the liver may be affected. These include the following: Coumarin-type anticoagulants; Systemic steroids (including oral contraceptives); Phenytoin; Griseofulvin; Rifampicin; Phenothiazines such as Chlorpromazine; Tricyclic antidepressants.
4.6 Pregnancy and lactation
Meprobamate passes into the breast milk and may cause drowsiness in babies or mothers taking this medicine. Meprobamate has been reported to increase the chance of birth defects if taken during the first three months of pregnancy.
Effects on ability to drive and use machines
4.7
Performance at skilled tasks and alertness may be impaired. Patients should be warned of this hazard and advised not to drive or operate machinery during treatment. These effects are potentiated by alcohol.
4.8 Undesirable effects
Drowsiness and sedation are common adverse effects. Unsteadiness, dizziness, inco-ordination, nausea, vomiting, diarrhoea, constipation, slurred speech, headache, palpitations, arrhythmia, hypotension, syncope, paraesthesiae, weakness, blurred vision, paradoxical excitement, euphoria, tachycardia may occur.
Hypersensitivity reactions have been reported in some 2% of patients, and may occur after a single tablet in patients not previously exposed to the drug. These may include skin reactions or urticaria, itchy maculopapular or erythematous skin rashes, which may be generalised or local.
Severe systemic reactions with shaking chills and fever, nausea, vomiting, hypotension and collapse have occasionally occurred. Blood disorders including thrombocytopenia, non-thrombocytopenic purpura, agranulocytosis, aplastic anaemia and pancytopenia have occurred.
Rarely reported hypersensitivity reactions include: hyperpyrexia, angioneurotic oedema, bronchospasm, oliguria, and anuria. Also, anaphylaxis, erythema multiform, exfoliative dermatitis, stomatitis proctitis, Stevens Johnson syndrome, and bullous dermatitis have been reported.
4.9 Overdose
Poisoning with Meprobamate produces shock, coma, vasomotor and respiratory collapse. Fatal doses have ranged from 12 g to 47.6 g. A regime of forced alkaline diuresis or haemodialysis to reduce blood concentrations of Meprobamate which is rapidly absorbed from the gastro-intestinal tract.
5.1 Pharmacodynamic properties
Meprobamate appears to act at multiple sites in the central nervous system including the thalamus and limbic system.
5.2 Pharmacokinetic properties
Meprobamate is well absorbed from the gastro-intestinal tract. The biotransformation of Meprobamate is hepatic. The plasma half-life is about 10 hours.
Elimination - Meprobamate is excreted in the urine and about 8 - 19% of the drug is excreted unchanged.
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize starch
Pregelatinised Maize Starch Sodium Lauryl Sulphate Sodium Starch Glycollate Magnesium Stearate Purified Water
6.2 Incompatibilities
None known 36 months all pack sizes
6.4 Special precautions for storage
Store below 25°C in a dry place.
Keep container well closed.
Protect from light.
6.5 Nature and contents of container
High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane/polythene fillers.
Pack sizes: 100 and 500.
6.6 Special precautions for disposal
No special instructions
7 MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited 11 Boumpoulinas Street,
3rd floor, 1060 Nicosia Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 33414/0058
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/02/2009
10 DATE OF REVISION OF THE TEXT
25/02/2009