Orifral
Orifral Uses, Dosage, Side Effects, Food Interaction and all others data.
Orifral shows antiepileptic properties in various types of seizures. The exact mechanism of Orifral 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 | Orifral |
| Generic | Sodium Valproate |
| Weight | 250mg/5ml |
| Type | Syrup |
| Therapeutic Class | Primary anti-epileptic drugs |
| Manufacturer | Raazee Theraputics (pvt) Ltd, |
| Available Country | Pakistan |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Orifral 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
Orifral 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:
Orifral is for intravenous use only. Use of Orifral 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.
Orifral 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 Orifral (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
Orifral is a non specific inhibitor of drug metabolism. Phenobarbital, Phenytoin, Warfarin, Aspirin etc. interacts with Orifral.
Pregnancy & Breastfeeding use
Orifral crosses the placenta in humans which may lead to neural tube defects such as anencephaly and spina bifida if exposed in the first trimester. Orifral may excrete in breast milk. So treatment with Orifral may cause harm to new born baby.
Contraindication
Orifral is contra-indicated in patients with known hypersensitivity of Orifral, 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 Orifral
FAQ
What is Orifral used for?
Orifral 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 Orifral?
Many people can take Orifral safely for many months or years. However, there are potential side effects that can happen over a long time. Long-term treatment with Orifral can cause osteoporosis and osteopenia.
How long does it take for sodium valproate to work?
Orifral 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 Orifral?
The common side effects of Orifral 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 Orifral?
Orifral 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 Orifral?
You can take Orifral 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 Orifral?
If you're taking Orifral 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 Orifral 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 Orifral safe during pregnancy?
Orifral 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 Orifral prevention programme.
Is Orifral safe during breastfeeding?
If your doctor or health visitor says your baby is healthy you can take Orifral while breastfeeding.
Orifral 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 Orifral?
Once your condition is under control, you'll usually need to keep taking Orifral for many years.
Is Orifral safe to take it for a long time?
Many people can take Orifral safely for many months or years.
However, there are potential side effects that can happen over a long time. Long-term treatment with Orifral can cause osteoporosis and osteopenia.
What will happen when I come off Orifral?
Do not stop taking Orifral 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 Orifral 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 Orifral gradually.
Can I drink alcohol with Orifral?
Drinking alcohol while taking Orifral 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 Orifral affect my fertility?
Orifral can reduce fertility in both men and women. Once you stop taking this medicine, your fertility will return.In men Orifral has been reported to cause infertility.
Will Orifral affect my contraception?
Orifral 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 Orifral you must use contraception. Your doctor will put you on Prevent, the valproate pregnancy prevention programme.
Can I drive after taking Orifral?
You may feel sleepy, tired or dizzy when you first start taking Orifral. 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 Orifral?
Taking too much Orifral can lead to symptoms such as: feeling or being sick, headaches or feeling dizzy,muscle weakness.
What happen If I missed Orifral?
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 Orifral 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 Orifral?
You should not use Orifral if you are allergic to it.
