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