Acido Valproico G.e.s.
Acido Valproico G.e.s. Uses, Dosage, Side Effects, Food Interaction and all others data.
Acido Valproico G.e.s. shows antiepileptic properties in various types of seizures. The exact mechanism of Acido Valproico G.e.s. is not yet established. However it is suggested that its activity is related to increased brain levels of Gama Amino Butyric Acid (GABA).
Trade Name | Acido Valproico G.e.s. |
Generic | Sodium Valproate |
Type | |
Therapeutic Class | Primary anti-epileptic drugs |
Manufacturer | GES GENERICOS ESPAÑOLES LABORATORIO, SA |
Available Country | Spain |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Acido Valproico G.e.s. is used for -
- Epilepsy: All types of epilepsy such as Absence seizure, Myoclonic seizure, Tonic-clonic seizure, Atonic, Mixed, simple or generalized, Secondary generalized seizure etc.
- Mania: For the treatment of manic episodes of bipolar disorders.
- Other: As an alternative treatment for febrile convulsion & migraine prophylaxis.
Dosage
Acido Valproico G.e.s. dosage
Oral:
Adults:
- Initial: 600 mg/day in 2 divided doses, preferably after food. Dose may be increased by 200mg/day at 3 days interval to a maximum of 2.5 gm daily in divided doses until control of seizure is achieved.
- Maintenance dose: Usually 1-2 gm daily (20-30 mg/kg daily).
Children (up to 20 kg):
- Initial: 20 mg/kg daily in divided doses. Dose may be increased in severe cases with proper monitoring of plasma concentration.
Children (over 20 kg):
- Initial: 400 mg/ day (irrespective of weight). Dose may be increased by 20-30 mg/ kg if required to achieve control.
Injection:
Acido Valproico G.e.s. is for intravenous use only. Use of Acido Valproico G.e.s. for periods of more than 14 days has not been studied. Patients should be switched to oral valproate products as soon as it is clinically feasible.
Acido Valproico G.e.s. should be administered as a 60 minute infusion (but not more than 20 mg/min) with the same frequency as the oral products, although plasma concentration monitoring and dosage adjustments may be necessary.
In one clinical safety study, approximately 90 patients withepilepsyand with no measurable plasma levels of valproate were given single infusions of Acido Valproico G.e.s. (up to 15 mg/kg and mean dose of 1184 mg) over 5-10 minutes (1.5-3.0 mg/kg/min). Patients generally tolerated the more rapid infusions well. This study was not designed to assess the effectiveness of these regimens.
Side Effects
Gastric irritation, nausea, ataxia & tremor; hyperammonaemia, increased appetite & weight gain; transient hair loss, oedema, thrombocytopenia, and inhibition of platelet aggregation, impaired hepatic function leading rarely to fetal hepatic failure; rashes; sedation; rarely lethargy and confusion and also increased alertness; rarely pancreatitis, leucopenia, pancytopenia, red cell hypoplasia, fibrinogen reduction; irregular periods, amenorrhoea, gynaecomastia, toxic epidermal necrolysis, hearing loss, Fancoli's syndrome, dementia, Steven's-Johnson syndrome, and vasculitis have also been reported.
Precaution
Liver function should be monitored before therapy and during first six months, especially in those patients who seem most at risk. Blood tests are recommended before surgery. Renal impaired patients, pregnant and brest feeding mother should be specially cared. Valproate is eliminated mainly through the kidney, partly in the form of ketone bodies which may lead to false statement in urine ketone test. Sudden withdrawal of therapy should be avoided
Interaction
Acido Valproico G.e.s. is a non specific inhibitor of drug metabolism. Phenobarbital, Phenytoin, Warfarin, Aspirin etc. interacts with Acido Valproico G.e.s..
Pregnancy & Breastfeeding use
Acido Valproico G.e.s. crosses the placenta in humans which may lead to neural tube defects such as anencephaly and spina bifida if exposed in the first trimester. Acido Valproico G.e.s. may excrete in breast milk. So treatment with Acido Valproico G.e.s. may cause harm to new born baby.
Contraindication
Acido Valproico G.e.s. is contra-indicated in patients with known hypersensitivity of Acido Valproico G.e.s., personal or family history of severe active liver disease, hepatic dysfunction, porphyria and known urea cycle disorder.
Storage Condition
Syrup: Store below 30° C, protected from light.
Tablet: Store below 30° C, protected from light. Keep all medicines out of the reach of children.
Innovators Monograph
You find simplified version here Acido Valproico G.e.s.
FAQ
What is Acido Valproico G.e.s. used for?
Acido Valproico G.e.s. used to treat epilepsy and bipolar disorder. It's occasionally used to prevent migraine headaches. This medicine is only available on prescription.
How safe is Acido Valproico G.e.s.?
Many people can take Acido Valproico G.e.s. safely for many months or years. However, there are potential side effects that can happen over a long time. Long-term treatment with Acido Valproico G.e.s. can cause osteoporosis and osteopenia.
How long does it take for sodium valproate to work?
Acido Valproico G.e.s. may take several days to show an initial effect and in some cases may take from two to six weeks for maximum effect. Treatment is started with low doses and may be increased over a couple of weeks according to your child's response.
What are the common side effects of Acido Valproico G.e.s.?
The common side effects of Acido Valproico G.e.s. are include:
- stomach pain, feeling or being sick
- diarrhoea
- dry or sore mouth, or swollen gums
- shakes (tremors) in a part of your body, or unusual eye movements
- feeling tired or sleepy
- headache
- weight gain
- thinning hair, or changes to the colour or texture of your hair
- irregular or delayed periods
How to take Acido Valproico G.e.s.?
Acido Valproico G.e.s. comes as slow release (prolonged or sustained release) tablets, capsules and granules, gastro-resistant tablets, crushable tablets, and as a liquid.
Slow release medicine passes into your body gradually.
When is the best time to take Acido Valproico G.e.s.?
You can take Acido Valproico G.e.s. with or without food, but it's best to stick to the same way each time. Do not take it with food some days and without food on other days.
How often can I take Acido Valproico G.e.s.?
If you're taking Acido Valproico G.e.s. once a day, you can choose a time that suits you. Just try to keep to the same time every day.
If you're taking Acido Valproico G.e.s. twice a day, try to leave a gap of 10 to 12 hours between doses. For example you could take your first dose in the morning (between 7am and 8am) and your second dose in the evening (between 7pm and 8pm).
Is Acido Valproico G.e.s. safe during pregnancy?
Acido Valproico G.e.s. is not recommended in pregnancy, as it can cause birth defects and problems with your baby's learning and behaviour.
If there's a chance you could become pregnant while taking this medicine, your doctor will put you on Prevent, the Acido Valproico G.e.s. prevention programme.
Is Acido Valproico G.e.s. safe during breastfeeding?
If your doctor or health visitor says your baby is healthy you can take Acido Valproico G.e.s. while breastfeeding.
Acido Valproico G.e.s. passes into breast milk in small amounts but it's unlikely to harm your baby so you can continue breastfeeding if your doctor says you need to take it.
How long will I take Acido Valproico G.e.s.?
Once your condition is under control, you'll usually need to keep taking Acido Valproico G.e.s. for many years.
Is Acido Valproico G.e.s. safe to take it for a long time?
Many people can take Acido Valproico G.e.s. safely for many months or years.
However, there are potential side effects that can happen over a long time. Long-term treatment with Acido Valproico G.e.s. can cause osteoporosis and osteopenia.
What will happen when I come off Acido Valproico G.e.s.?
Do not stop taking Acido Valproico G.e.s. suddenly, unless your doctor tells you to.
You're unlikely to get any extra symptoms when you stop taking this medicine. However, if you're taking Acido Valproico G.e.s. for epilepsy, it's possible that you'll get seizures again once you stop taking it. You can prevent these withdrawal seizures by reducing your dose of Acido Valproico G.e.s. gradually.
Can I drink alcohol with Acido Valproico G.e.s.?
Drinking alcohol while taking Acido Valproico G.e.s. may make you feel sleepy or tired. It's best to stop drinking alcohol during the first few days, until you see how the medicine affects you.
Will Acido Valproico G.e.s. affect my fertility?
Acido Valproico G.e.s. can reduce fertility in both men and women. Once you stop taking this medicine, your fertility will return.In men Acido Valproico G.e.s. has been reported to cause infertility.
Will Acido Valproico G.e.s. affect my contraception?
Acido Valproico G.e.s. does not affect any type of contraception, including the combined pill and emergency contraception.If there's a chance you could become pregnant while taking Acido Valproico G.e.s. you must use contraception. Your doctor will put you on Prevent, the valproate pregnancy prevention programme.
Can I drive after taking Acido Valproico G.e.s.?
You may feel sleepy, tired or dizzy when you first start taking Acido Valproico G.e.s.. This may also happen if your dose has increased. If you're affected, do not drive or ride a bike until you feel more alert.
Can I take too much dose of Acido Valproico G.e.s.?
Taking too much Acido Valproico G.e.s. can lead to symptoms such as: feeling or being sick, headaches or feeling dizzy,muscle weakness.
What happen If I missed Acido Valproico G.e.s.?
If you've missed a dose, what you do next depends on whether you usually take your medicine once or twice a day. If you take Acido Valproico G.e.s. once a day ,take the forgotten dose as soon as you remember unless it's within a few hours of the next dose.
Who should not take Acido Valproico G.e.s.?
You should not use Acido Valproico G.e.s. if you are allergic to it.