Napilex
Napilex Uses, Dosage, Side Effects, Food Interaction and all others data.
Napilex shows antiepileptic properties in various types of seizures. The exact mechanism of Napilex 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 | Napilex |
| Generic | Sodium Valproate |
| Type | Liquid, Syrup |
| Therapeutic Class | Primary anti-epileptic drugs |
| Manufacturer | Mankind Pharmaceuticals Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Napilex 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
Napilex 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:
Napilex is for intravenous use only. Use of Napilex 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.
Napilex 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 Napilex (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
Napilex is a non specific inhibitor of drug metabolism. Phenobarbital, Phenytoin, Warfarin, Aspirin etc. interacts with Napilex.
Pregnancy & Breastfeeding use
Napilex crosses the placenta in humans which may lead to neural tube defects such as anencephaly and spina bifida if exposed in the first trimester. Napilex may excrete in breast milk. So treatment with Napilex may cause harm to new born baby.
Contraindication
Napilex is contra-indicated in patients with known hypersensitivity of Napilex, 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 Napilex
FAQ
What is Napilex used for?
Napilex 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 Napilex?
Many people can take Napilex safely for many months or years. However, there are potential side effects that can happen over a long time. Long-term treatment with Napilex can cause osteoporosis and osteopenia.
How long does it take for sodium valproate to work?
Napilex 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 Napilex?
The common side effects of Napilex 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 Napilex?
Napilex 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 Napilex?
You can take Napilex 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 Napilex?
If you're taking Napilex 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 Napilex 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 Napilex safe during pregnancy?
Napilex 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 Napilex prevention programme.
Is Napilex safe during breastfeeding?
If your doctor or health visitor says your baby is healthy you can take Napilex while breastfeeding.
Napilex 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 Napilex?
Once your condition is under control, you'll usually need to keep taking Napilex for many years.
Is Napilex safe to take it for a long time?
Many people can take Napilex safely for many months or years.
However, there are potential side effects that can happen over a long time. Long-term treatment with Napilex can cause osteoporosis and osteopenia.
What will happen when I come off Napilex?
Do not stop taking Napilex 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 Napilex 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 Napilex gradually.
Can I drink alcohol with Napilex?
Drinking alcohol while taking Napilex 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 Napilex affect my fertility?
Napilex can reduce fertility in both men and women. Once you stop taking this medicine, your fertility will return.In men Napilex has been reported to cause infertility.
Will Napilex affect my contraception?
Napilex 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 Napilex you must use contraception. Your doctor will put you on Prevent, the valproate pregnancy prevention programme.
Can I drive after taking Napilex?
You may feel sleepy, tired or dizzy when you first start taking Napilex. 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 Napilex?
Taking too much Napilex can lead to symptoms such as: feeling or being sick, headaches or feeling dizzy,muscle weakness.
What happen If I missed Napilex?
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 Napilex 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 Napilex?
You should not use Napilex if you are allergic to it.
