Ácido Valpróico APS

Ácido Valpróico APS Uses, Dosage, Side Effects, Food Interaction and all others data.

Ácido Valpróico APS shows antiepileptic properties in various types of seizures. The exact mechanism of Ácido Valpróico APS is not yet established. However it is suggested that its activity is related to increased brain levels of Gama Amino Butyric Acid (GABA).

Ácido Valpróico APS
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Ácido Valpróico APS
Generic	Sodium Valproate
Type
Therapeutic Class	Primary anti-epileptic drugs
Manufacturer	GENERIS FARMACÉUTICA, SA
Available Country	Portugal
Last Updated:	September 19, 2023 at 7:00 am

Uses

Ácido Valpróico APS 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

Ácido Valpróico APS 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:

Ácido Valpróico APS is for intravenous use only. Use of Ácido Valpróico APS 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.

Ácido Valpróico APS 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 Ácido Valpróico APS (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

Ácido Valpróico APS is a non specific inhibitor of drug metabolism. Phenobarbital, Phenytoin, Warfarin, Aspirin etc. interacts with Ácido Valpróico APS.

Pregnancy & Breastfeeding use

Ácido Valpróico APS crosses the placenta in humans which may lead to neural tube defects such as anencephaly and spina bifida if exposed in the first trimester. Ácido Valpróico APS may excrete in breast milk. So treatment with Ácido Valpróico APS may cause harm to new born baby.

Contraindication

Ácido Valpróico APS is contra-indicated in patients with known hypersensitivity of Ácido Valpróico APS, 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

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FAQ

What is Ácido Valpróico APS used for?

Ácido Valpróico APS 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 Ácido Valpróico APS?

Many people can take Ácido Valpróico APS safely for many months or years. However, there are potential side effects that can happen over a long time. Long-term treatment with Ácido Valpróico APS can cause osteoporosis and osteopenia.

How long does it take for sodium valproate to work?

Ácido Valpróico APS 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 Ácido Valpróico APS?

The common side effects of Ácido Valpróico APS 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 Ácido Valpróico APS?

Ácido Valpróico APS 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 Ácido Valpróico APS?

You can take Ácido Valpróico APS 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 Ácido Valpróico APS?

If you're taking Ácido Valpróico APS 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 Ácido Valpróico APS 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 Ácido Valpróico APS safe during pregnancy?

Ácido Valpróico APS 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 Ácido Valpróico APS prevention programme.

Is Ácido Valpróico APS safe during breastfeeding?

If your doctor or health visitor says your baby is healthy you can take Ácido Valpróico APS while breastfeeding.
Ácido Valpróico APS 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 Ácido Valpróico APS?

Once your condition is under control, you'll usually need to keep taking Ácido Valpróico APS for many years.

Is Ácido Valpróico APS safe to take it for a long time?

Many people can take Ácido Valpróico APS safely for many months or years.
However, there are potential side effects that can happen over a long time. Long-term treatment with Ácido Valpróico APS can cause osteoporosis and osteopenia.

What will happen when I come off Ácido Valpróico APS?

Do not stop taking Ácido Valpróico APS 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 Ácido Valpróico APS 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 Ácido Valpróico APS gradually.

Can I drink alcohol with Ácido Valpróico APS?

Drinking alcohol while taking Ácido Valpróico APS 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 Ácido Valpróico APS affect my fertility?

Ácido Valpróico APS can reduce fertility in both men and women. Once you stop taking this medicine, your fertility will return.In men Ácido Valpróico APS has been reported to cause infertility.

Will Ácido Valpróico APS affect my contraception?

Ácido Valpróico APS 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 Ácido Valpróico APS you must use contraception. Your doctor will put you on Prevent, the valproate pregnancy prevention programme.

Can I drive after taking Ácido Valpróico APS?

You may feel sleepy, tired or dizzy when you first start taking Ácido Valpróico APS. 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 Ácido Valpróico APS?

Taking too much Ácido Valpróico APS can lead to symptoms such as: feeling or being sick, headaches or feeling dizzy,muscle weakness.

What happen If I missed Ácido Valpróico APS?

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 Ácido Valpróico APS once a day ,take the forgotten dose as soon as you remember unless it's within a few hours of the next dose.