Other in vitro and in vivo tests did not demonstrate genotoxicity. - Anti-neoplastic agents: tyrosine kinase inhibitors, ifosfamide (+ risk of increased neurotoxicity of ifosfamide due to increased metabolism induced by primidone). It is available in brand and generic versions. Vitamin D supplementation may be needed during long-term primidone therapy (see section 4.8).Exceptionally, as with phenytoin and phenobarbital, megaloblastic anaemia may develop requiring discontinuation of primidone. • Risk of decreased plasma concentrations due to increased metabolism induced by primidone for:- Antivirals: cobicistat, daclatasvir, dasabuvir, ledipasvir, nelfinavir, rilpivirine, ombitasvir+paritaprevir, sofosbuvir, telaprevir. Get contact details and address | ID: 16173164255 What Mysoline looks like and contents of the pack Mysoline 50 mg Tablets are white uncoated tablets for oral use. Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of primidone.Patients should be advised of the signs and symptoms and monitored closely for skin reactions.The highest risk for occurrence of SJS or TEN is within the first weeks of treatment.If symptoms or signs of SJS or TEN (e.g. In an acute and severe form, withdrawal of treatment is required.Other adverse reactions, observed during post-marketing setting, may include:Frequencies are defined as: very rare (< 1/10,000), not known (cannot be estimated from the available data).Allergic reactions particularly affecting the skin which can include maculopapular, morbilliform or scarlatiniform rashes.Megaloblastic anemia*, leucopenia, thrombocytopenia, lymphadenopathyElevation in hepatic enzymes, including gamma-glutamyl transferase (gamma GT) and alkaline phosphataseSevere cutaneous adverse reactions : Stevens-Johnson síndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported (see section 4.4)Hypersensitivity syndrome: multisystemic reactions often with fever, rash, hypereosniphilia and liver injuryDecreased bone density, osteopenia, osteoporosis and fractures in patients on long term therapy*** * Exceptionally, as with phenytoin and phenobarbital, primidone can cause megaloblastic anaemia requiring discontinuation of primidone.

• Concomitant use with certain classes of medicinal products (see section 4.5)Primidone is not efficient for the treatment of absences and myoclonic fits which may be sometimes aggravated.Due to its sedative effect, it is recommended to initiate treatment of primidone with the lowest dose in the evening, and then with a stepwise approach (see section 4.2).Primidone should be given with caution and may be required in reduced dosage in children, the elderly, debilitated patients or those with impaired renal, hepatic or respiratory function.Primidone has the potential to harm the foetus (see section 4.6).Introduction of an anti-epileptic drug may be rarely followed by recrudescence of the crises or by occurrence of new type of crisis for the patient, independently of the fluctuations observed in some epilepsy. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for primidone.Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. The risk of carcinogenicity to humans is unknown.Animal studies have shown that primidone is teratogenic and impairs post-natal development at doses considered to be clinically relevant. After prolonged administration there is a potential for tolerance, dependence and a withdrawal reaction on abrupt cessation of treatment.Primidone is an enzymatic inducer (CYP450) which may increase the catabolism of vitamin D. A dose-dependent increase in the risk of osteomalacia has been observed during therapy with primidone, which may predispose to the development of bone disease. Day 10 to maintenance: 250 mg three times a day. Treatment must always be planned on an individual basis. Eligibility requirements vary for each program.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. For this reason, pregnant patients should be given Vitamin K1 through the last month of pregnancy up to the time of delivery.
• Risk of decreased primidone plasma concentrations and risk of lack of efficacy for: For most adults and children 8 years of age and over, the usual maintenance dosage is three to four 250 mg MYSOLINE tablets in divided doses (250 mg three times a day or four times a day).

• Given its beneficial effect in other situations, supplementation with folic acid can be suggested before and during pregnancy.
progressive skin rash often with blisters or mucosal lesions) are present, primidone treatment should be discontinued.The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Premier Medical Agency - Offering Mysoline Tablets, Packaging Type: Sachet at Rs 75/pack in Nagpur, Maharashtra. * The drugs affecting the nervous system also have increased risk of additive CNS depression.Primidone is suspected to have caused serious birth defects when administered during pregnancy. This drug is less popular than comparable drugs.