Sodium valproate apollo Sodium valproate apollo Sodium valproate

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1 Sodium valproate apollo Sodium valproate apollo Sodium valproate CAS Number : Molecular Formula : C8H15NaO2 Molecular Weight : g/mol Systematic (IUPAC) : sodium 2-propylpentanoate Uses Sodium valproate is used to treat all types of epilepsy in adults and children. It is an anti-epileptic drug also know as an anticonvulsant.

2 It is used to calm or stabilise the electrical activity in the brain of patients with epilepsy. In general this drug is used to control or stabilize the rapid electrical activity that occurs in the brain if you suffer from epilepsy. This activity or over stimulation of the brain can trigger seizures (fits). By reducing this activity, sodium valproate can prevent the seizures from occurring. Benefits of being on this drug can include preventing seizures caused by epilepsy, and for some patients the control of seizures may be good enough to allow them to hold a driving licence. Listed below are the typical uses of sodium valproate. Control of all types of epilepsy (generalised, partial or other epilepsy) On occasion your doctor may prescribe this medicine to treat a condition not on the above list. Such conditions are listed below. The intravenous form of sodium valproate may be given for the treatment of epileptic patients who temporarily cannot take oral medication. How often do I take it? This medication can be taken orally as tablets, crushable tablets, or as a solution (liquid), usually twice a day. If taking it as a liquid, it should not be diluted or taken with any other liquid. Uncoated (crushable) tablets can be crushed before swallowing, if needed. Sodium valproate is available as controlled release tablet that may be taken once or twice daily. For children, or adults with swallowing difficulties, it is supplied as microgranules (a controlled release version in a powder form) that can be taken once or twice daily. Sodium

3 valproate is also available as a tablet with a protective coating (known as enteric coated tablets) that stops the tablet from dissolving before it reaches the intestine (gut). It does not dissolve in the stomach. This form of tablet is supplied if you find you feel sick when taking other oral forms of sodium valproate. Oral sodium valproate should be taken with or after food. Take this medication by mouth usually once or twice each day, with or after food. Use this medication regularly or for duration of prescription in order to get the most benefit from it. Remember to use it at the same time each day - unless specifically told otherwise by your doctor. It may take some time before the full benefit of this drug takes effect, depending on the dose given and the severity of the condition. Sodium valproate is also available for intravenous injection. This is generally used because you are temporarily unable to swallow oral medication (for example after a surgical operation or if unconscious). This will be prepared and injected by your doctor or other health carer. Certain medical conditions may require different dosage instructions as directed by your doctor. What dose? Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines. Do I need to avoid anything? Sodium valproate may increase the effect of some other medications, such as anticoagulants (medicines used for

4 thinning the blood, such as warfarin), zidovudine (used to treat HIV), temozolomide (used to treat cancer, most commonly brain tumours), antidepressants (including monoamine oxidase inhibitors, such as moclobemide, selegiline, linezolid), and medicines used to treat emotional and mental conditions (such as diazepam and olanzapine). Some medications may increase the chance of getting side effects. These include aspirin and other drugs used to treat fits. Some medications may interfere with the way sodium valproate works, either increasing or decreasing its effect. These include drugs for treating malaria (such as mefloquine and chloroquine), cimetidine (used to treat stomach ulcers), some antibiotics, such as imipenem, meropenem, and erythromycin, and colestyramine, used to treat high levels of cholesterol in the blood. Sodium valproate may control fits well enough that some patients may be able to hold a driving licence. However, it may cause temporary drowsiness, particularly if taken together with a benzodiazepine (a type of sedative). If you are affected in this way, you should not drive or operate machinery. Consult your doctor or pharmacist for more details. When can I stop? It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop. Side Effects Known side effects: Nausea Gastric irritation Diarrhoea

5 Weight gain Hyperammonaemia (you have too much ammonia in your blood) Thrombocytopenia (low levels of platelets in your blood, which may mean you bruise easily) Transient hair loss (regrowth may be curly) Increased alertness Aggression Hyperactivity Behavioural disturbances Ataxia (lack of coordination of muscle movements) Tremor Vasculitis Stop taking sodium valproate and tell your doctor immediately if you develop any of the following symptoms: Signs of allergic reaction, such as rash, red skin, blistering of the lips, eyes or mouth, or skin peeling Problems of the liver or pancreas, which may show, for example, as feeling and being sick many times, being very tired, sleepy and weak, stomach pain, jaundice (yellowing of the skin or whites of the eyes), loss of appetite, or generally feeling unwell. Bruising more easily or getting more infections than usual Blood clotting problems (bleeding for longer than normal), or bruising or bleeding for no reason Changes in mood, loss of memory, lack of concentration, and deep loss of consciousness (coma) Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

6 A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue, or blistering or bleeding of the skin around the lips, eyes, nose, mouth and genitals. A skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid could be signs of a serious allergy called erythema multiforme. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Precautions Before taking sodium valproate tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: porphyria (a rare inherited blood disorder), acute or severe liver problems, or a family history of liver problems. Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following: liver disorders, kidney disorders, the immune disorder systemic lupus erythematosus, or diabetes, or during pregnancy, or if you have hyperammonaemia (you have too much ammonia in your blood). Before having surgery, tell your doctor or dentist that you are taking this medication.

7 Does alcohol intake affect this drug? No advice is given with regard to taking alcohol while on sodium valproate. Discuss with your doctor whether you should stop drinking. Children under 3 years old should not use aspirin (or other salicylate medications) while on sodium valproate because there is an increased risk of liver problems. Pregnancy and breastfeeding - please ensure you read the detailed information below Pregnancy Sodium valproate is not safe to take if you are, or are planning to become, pregnant. However, the benefit of treatment with anti-epileptics may outweigh the risk to the baby. Unplanned pregnancy is not recommended if you are being treated with sodium valproate. Women who take sodium valproate during pregnancy have a higher risk of having a baby with malformations than other women. The malformations most commonly seen are cleft lip and malformations of the heart. Sodium valproate may also cause an increased risk of defects such spina bifida. There is also a risk of your baby having delayed development. However, you should not suddenly stop anti-epileptic therapy when you are pregnant because this may lead to seizures (fits), which could have serious effects for both the mother and the baby. During pregnancy it is better to take only one anticonvulsant medication at the lowest effective dose and preferably in divided doses, because administration in several divided doses over the day and the use of a prolonged release formulation is preferable in order to avoid blood levels of sodium valproate.

8 During pregnancy, sodium valproate should not be discontinued if it has been effective. The baby should be carefully monitored (using ultrasound or other techniques, as appropriate) to detect possible malformations. First, second, and third trimester: Increased risk of congenital malformations and developmental delay (counselling and screening advised). Neonatal bleeding and neonatal liver problems have also been reported. Routine injection of vitamin K at birth counteracts the risk of neonatal bleeding. Ask your doctor or pharmacist if you have any doubts or questions about this. It is sensible to limit use of medication during pregnancy and breast-feeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation. If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist. Breast feeding Mothers taking sodium valproate may breastfeed their infants. Only small amounts of sodium valproate pass into breast milk. There have been no reports of any problems for infants breastfed by mothers taking sodium valproate. Ask your doctor or pharmacist if you have any doubts or questions about this. It is sensible to limit use of medication during pregnancy and breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in

9 individual circumstances and after a careful assessment of your specific health situation. If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist. Interactions Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: Aspirin Other medicines used to treat fits (such as phenobarbital, primidone, phenytoin, carbamazepine, lamotrigine and felbamate) Anticoagulants (medicines used for thinning the blood, such as warfarin) Zidovudine (used to treat HIV) Temozolomide (used to treat cancer, most commonly brain tumours) Antidepressants (including monoamine oxidase inhibitors) Medicines used to treat emotional and mental conditions (such as diazepam and olanzapine) Medicines for treating malaria (such as mefloquine and chloroquine) Some antibiotics, such as imipenem, meropenem, and erythromycin Cimetidine (used to treat stomach ulcers) Colestyramine, used to treat high levels of cholesterol in the blood

10 This information does not contain all possible interactions. Therefore, before using sodium valproate, tell your doctor or pharmacist of all the products you use. Overdose If you take an overdose (more sodium valproate than you should) you must tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you so the doctor knows what you have taken. The following effects may happen: feeling sick or being sick, pupils of the eye become smaller, dizziness, loss of consciousness, weak muscles and poor reflexes, breathing problems, headaches, fits (seizures), confusion, memory loss and unusual or inappropriate behaviour. If you think you, or someone you care for, might have accidentally taken more than the recommended dose of sodium valproate or intentional overdose is suspected, contact your local hospital, GP or if in the UK call NHS Direct on Missed Dose If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Warning Sodium valproate should be used with caution in: patients with liver disorders, kidney disorders, the immune disorder systemic lupus erythematosus, or diabetes, or during pregnancy, or if you have

11 hyperammonaemia (you have too much ammonia in your blood). It should not be used in: patients with porphyria (a rare inherited blood disorder), acute or severe liver problems or a family history of liver problems, or an allergy to sodium valproate. Also see list of precautions and interactions Storage Store below 30ºC in a tightly closed container. apollo asia Division APOLLO Pharmaceuticals API Manufacturers INDIA [P] Ltd. asia Division Mr.Vipin Saxena CEO Cellular: Cellular: Direct : FAX : Wireline Purchase HELPDESK: Wireline Sales HELPDESK: Wireless 24x7 HELPDESK: Blackberry Pin : 32E6500D 32E C58

12 Chat: MSN Hotmail:VipinrSaxena Skype NAME:VipinrSaxena Rocketmail:VipinrSaxena Google mail:vipinrsaxena BlackBerry:28415C58 Regd. Office :- 1104, Maker Chamber V, Nariman Point Mumbai, INDIA Pin: Industrial Office D-62, OIC India Oshiwara Industrial Centre, New Link Road, Goregoan West, Mumbai, INDIA Pin: Manufacturing Unit Address: Plot No. 117A, Village: Chamble Near MonaTona Limited.Wada, Maharashtra, PIN : INDIA

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