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CONVULEX is a brand name for Valproate (also known as Valproic Acid). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Female patients: • For all female patients aged under 55 years: For the treatment of generalised, partial or other epilepsy only when there is no other effective or tolerated treatment. • For all female patients aged over 55 years: For the treatment of generalised, partial or other epilepsy. Male patients: • For all…
Verbatim from this product's MHRA label. Tap a section to expand.
Convulex capsules are for oral administration. Daily dosage requirements vary according to age and body weight. Convulex capsules may be given twice daily. 6). Valproate must be supervised by a specialist experienced in the management of epilepsy.
6). Where possible, existing female children and women of childbearing potential aged under 55 years should be switched to another treatment unless two specialists independently consider and document there is no other effective or tolerated treatment.
4). 4). Valproate should preferably be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation. 6). 6). 3).
Posology Monotherapy:
Usual requirements are as follows: a) Adults Dosage should start at 600 mg daily, followed by gradual increases (approx. 300 mg) at three day intervals until control is achieved. e. 20-30 mg/kg body weight. Where adequate control is not achieved within this range, the dose may be further increased up to 2500 mg per day.
b) Elderly Patients Although the pharmacokinetics of valproate are modified in the elderly, they have limited clinical significance and dosage should be determined by seizure control. The volume of distribution is increased in the elderly and because of decreased binding to serum albumin, the proportion of free drug is increased.
This will affect the clinical interpretation of plasma valproic acid levels. c) Paediatric population Children over 20kg Initial dosage is usually not more than 400mg/day (irrespective of weight) with spaced increases until control is achieved; this is usually within the range 20- 30mg/kg body weight per day.
Where adequate control is not achieved within this range the dose may be increased to 35mg/kg body weight per day. In children requiring doses higher than 40mg/kg/day, clinical chemistry and haematological parameters should be monitored.
Children under 20kg Initial dosage should be 20mg/kg of body weight per day; in severe cases this may be increased but only in patients in whom plasma valproic acid levels can be monitored. In children requiring doses higher than 40mg/kg/day, clinical chemistry and haematological parameters should be monitored.
d) In patients with renal insufficiency It may be necessary in patients with renal insufficiency to decrease the dosage, or to increase the dosage in patients on haemodialysis. 9). 4). 8). 4). Salicylates should not be used in children under 16 years (see aspirin/salicylate product information on Reye's syndrome).
The following CIOMS frequency rating is used, when applicable:
Very common: ≥1/10 Common: ≥1/100 to <1/10 Uncommon: ≥1/1,000 to <1/100 Rare: ≥1/10,000 to <1/1,000 Very rare: <1/10,000 Not known: Frequency cannot be estimated from the available data System organ class Very comm on Common Uncommon Rare Not known Neoplasms benign, malignant and unspecified (incl.
g. 4). 4). Gastrointestinal disorders (nausea, gastralgia, diarrhoea) frequently occur at the start of treatment. These problems can usually be overcome by taking Convulex capsules with or after food. 4). Blood and lymphatic system disorders The blood picture returned to normal when the drug was discontinued.
Isolated reduction of fibrinogen or reversible increase in bleeding time have been reported, usually without associated clinical signs and particularly with high doses (valproate has an inhibitory effect on the second phase of platelet aggregation).
6). Metabolism and nutrition disorders Cases of isolated and moderate hyperammonaemia without change in liver function tests may occur frequently, are usually transient and should not cause treatment discontinuation. However, they may present clinically as vomiting, ataxia, and increasing clouding of consciousness.
Should these symptoms occur Convulex should be discontinued. Hyperammonaemia associated with neurological symptoms has also been reported. 4). 4). Nervous system disorders Sedation has been reported occasionally, usually when in combination with other anticonvulsants.
In monotherapy it occurred early in treatment on rare occasions and is usually transient. Rare cases of lethargy occasionally progressing to stupor, sometimes with associated hallucinations or convulsions have been reported. Encephalopathy and coma have very rarely been observed.
6). Valproate must only be initiated by two specialists who independently consider and document that there is no other effective or tolerated treatment. 6). 6).
Conditions of Pregnancy Prevention Programme:
The specialist must ensure that - Individual circumstances should be evaluated in each case, involving the patient in the discussion, to support her engagement, discuss therapeutic options and ensure her understanding of the risks and the measures needed to minimise the risks.
- the potential for pregnancy is assessed for all female patients. - the patient has understood and acknowledged the risks of congenital malformations and neurodevelopmental disorders which may lead to permanent disability, including the magnitude of these risks for children exposed to valproate in utero.
- the patient understands the need to undergo pregnancy testing prior to initiation of treatment and during treatment, as needed. - the patient is counselled regarding contraception, and that the patient is capable of complying with the need to use effective contraception (for further details please refer to subsection contraception of this boxed warning), without interruption during the entire duration of treatment with valproate.
- the patient understands the need for regular (at least annual) review of treatment by a specialist experienced in the management of epilepsy. - the patient understands the need to consult her general practitioner (GP) for referral to a specialist as soon as she is planning a pregnancy to ensure timely discussion and switching to another treatment prior to conception, and before contraception is discontinued.
- the patient understands the need to urgently consult her GP for urgent referral to a specialist in case of pregnancy. - the patient has received the patient guide. - the patient has acknowledged that she has understood the hazards and necessary precautions associated with valproate use (Annual Risk Acknowledgement Form).
6). 6). 1. - active liver disease, or personal or family history of severe hepatic dysfunction, especially drug related. 4). - porphyria. g. 4). 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). 5): When starting Convulex in patients already on other anticonvulsants, these should be tapered slowly; initiation of Convulex therapy should then be gradual, with target dose being reached after about 2 weeks. g. phenytoin, phenobarbital and carbamazepine.
Once known enzyme inducers have been withdrawn it may be possible to maintain seizure control on a reduced dose of Convulex. When barbiturates are being administered concomitantly and particularly if sedation is observed (particularly in children) the dosage of barbiturate should be reduced.
Optimum dosage is mainly determined by seizure control and routine measurement of plasma levels is unnecessary. 2).
These cases have often been associated with too high a starting dose or too rapid a dose escalation or concomitant use of other anti-convulsants, notably phenobarbital or topiramate. They have usually been reversible on withdrawal of treatment or reduction of dosage.
An increase in alertness may occur; this is generally beneficial but occasionally aggression, hyperactivity and behavioural deterioration have been reported. Ear and labyrinth disorders Hearing loss, either reversible or irreversible has been reported; however a cause and effect relationship has not been established.
Musculoskeletal and connective tissue disorders There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with medicinal products containing valproate. The mechanism by which valproate affects bone metabolism has not been identified.
Renal and urinary disorders There have been isolated reports of a reversible Fanconi's syndrome (a defect in […]
These conditions also apply to women who are not currently sexually active unless the specialist considers that there are compelling reasons to indicate that there is no risk of pregnancy. Female children - The specialist must ensure that parents/caregivers of female children understand the need to contact their GP once the female child using valproate experiences menarche.
Their GP will refer the patient back to the specialist. - The specialist must ensure that parents/caregivers of female children who have experienced menarche are provided with comprehensive information about the risks of congenital malformations and neurodevelopmental disorders which may lead to permanent disability including the magnitude of these risks for children exposed to valproate in utero.
- In patients who experienced menarche, the prescribing specialist must reassess the need for valproate therapy annually and consider other treatment options. If valproate is the only effective and tolerated treatment, the need for using effective contraception and all other conditions of pregnancy prevention programme should be discussed.
Every effort should be made by the specialist to switch the female children to another treatment before they reach menarche. Pregnancy test Pregnancy must be excluded before start of treatment with valproate. Treatment with valproate must not be initiated in women of child bearing potential without a negative pregnancy test (plasma pregnancy test) result, confirmed by a health care provider, to rule out unintended use in pregnancy.
Contraception Women of childbearing potential who are prescribed valproate must use effective contraception, without interruption during the entire duration of treatment with valproate. These patients must be provided with comprehensive information on pregnancy prevention and should be referred for contraceptive advice if they are not using effective contraception.
At least one effective method of contraception (preferably a user independent form such as an intra-uterine device or implant) or two complementary forms of contraception including a barrier method should be used. Individual circumstances should be evaluated in each case, when choosing the contraception method involving the patient in the discussion, to support her engagement and compliance with the chosen measures.
Even if she has amenorrhea she must follow all the advice on effective contraception. 5). Prescribers should monitor clinical response (seizure control) when initiating or discontinuing oestrogen-containing products. On the opposite, valproate does not reduce efficacy of hormonal contraceptives.
Annual treatment reviews by a specialist The specialist should at least annually review whether valproate is the most suitable treatment for the patient. The specialist should discuss and complete the annual risk acknowledgement form with the patient and/or carer at initiation and during each annual review and ensure that the patient has understood […]