Mysoline 250mg Tablets

Mysoline 250mg, encompassing the active ingredient Primidone, is an antiepileptic medication tailored for the treatment of epilepsy, seizures, and essential tremors. This pharmaceutical solution offers a pathway to control involuntary shaking movements, ensuring patients can lead a more stable and comfortable life.

Key Features and Clinical Use:

● Active Ingredient:

 

Each Mysoline tablet contains 250mg of Primidone, a pivotal component in managing epileptic seizures and essential tremors.

● Treatment Spectrum:

 

Mysoline is proficient in addressing various seizure types and is particularly effective against involuntary shaking movements, enhancing patients’ quality of life.

● Administration:

 

Tailored for oral consumption, Mysoline should be ingested with water, maintaining adherence to prescribed doses for optimal therapeutic outcomes.

Mysoline 250mg 30 Tablet Pack:

The medication is marketed in a “30s” pack, providing a convenient quantity for patients undergoing treatment. This packaging ensures a consistent supply, pivotal for maintaining regular medication intake.

Pricing Insight:

The Mysoline 250 mg price in Pakistan is Rs.2500 as of 29th April, 2024.

Side Effects and Cautions:

While Mysoline is a cornerstone in seizure management, patients may encounter side effects such as visual disturbances, coordination disorders, and gastrointestinal discomfort. Its use requires careful consideration in individuals with existing health conditions affecting the lungs, liver, and kidneys.

Potential Side Effects

Common (may affect up to 1 in 10 people):

• Feeling tired, coordination issues, vision problems, eye rolling
• Nausea

Uncommon (may affect up to 1 in 100 people):

• Headaches, dizziness
• Vomiting
• Allergic skin reactions

Rare (may affect up to 1 in 1,000 people):

• Decreased levels of certain blood cells (red or white blood cells, or platelets) or swollen lymph nodes.
• Changes in mood or behavior, libido changes.
• Joint or bone pain, Dupuytren’s contracture (hand tissue thickening causing finger curling), osteomalacia (softening of bones due to vitamin D deficiency).
• Exfoliative dermatitis (skin redness and peeling), lupus erythematosus (inflammation affecting skin, joints, lungs, kidneys, heart, or liver).
• Increased liver enzyme levels (gamma GT, alkaline phosphatase).

Very rare (may affect up to 1 in 10,000 people):

• Potentially life-threatening skin rashes like Stevens-Johnson syndrome or toxic epidermal necrolysis.

Not known (frequency cannot be estimated from available data):

• Allergic reactions including fever, rash, increased blood cell counts (eosinophils), and elevated liver enzymes.
• Reports of bone disorders like osteopenia, osteoporosis, and fractures. If on long-term antiepileptic medication, have a history of osteoporosis, or take steroids, consult your doctor or pharmacist.
• Loss of appetite, fatigue.
• Potentially life-threatening skin rashes like drug rash with eosinophilia and systemic symptoms. (“Mysoline 250 mg Tablets primidone”)

Usage Recommendations:

For achieving the best results, Mysoline 250 mg 30 tablets pack should be taken as directed by a healthcare provider, with doses adjusted according to individual health status and treatment response. It’s crucial not to alter or discontinue the medication without professional guidance.

Dosage and Administration

Dosage

 

Treatment should always be tailored to individual needs. While PRIMIDONE alone may suffice for many patients, for some, it may need to be combined with other anti-convulsants.

Primidone is typically administered twice daily. Begin with 125mg once daily in the late evening. Increase the daily dose by 125mg every three days until reaching 500mg daily. Subsequently, increase the daily dose by 250mg in adults or 125mg in children under 9 years old every three days until seizure control is achieved or the maximum tolerated dose is reached. This maximum dose can be as high as 1,500mg per day in adults and 1,000mg per day in children.

 

Average daily maintenance doses:

 

• Children up to 2 years: 250mg to 500mg per day
• Children 2 to 5 years: 500mg to 750mg per day
• Children 6 to 9 years: 750mg to 1,000mg per day
• Adults and children over 9 years: 750mg to 1,500mg per day.

The total daily dose is typically divided into two equal amounts, one in the morning and the other in the evening. In some cases, a larger dose may be given when seizures are more frequent, such as administering most or all of the daily dose at night for nocturnal seizures or slightly increasing the dose during specific events like menstruation.

 

Patients on other anti-convulsants

 

If a patient’s seizures are not well controlled with current anti-convulsants or if there are troublesome side effects, Primidone may be added to or replace existing treatment. Primidone can be gradually introduced alongside the current treatment. Once a beneficial effect is observed and the Primidone dosage reaches at least half the estimated requirement, withdrawal from the previous treatment can be attempted gradually over two weeks. During this period, it may be necessary to increase Primidone dosage to maintain control.

Withdrawal of previous treatment should not be too rapid to avoid status epilepticus. When phenobarbitone was a significant part of previous treatment, both its withdrawal and substitution with Primidone should occur earlier to prevent excessive drowsiness from affecting the accurate assessment of Primidone dosage.

 

Women who could become pregnant:

 

Primidone undergoes extensive metabolism to phenobarbital. Therefore, consideration of information regarding phenobarbital is necessary. Phenobarbital may pose risks to a developing fetus if taken during pregnancy, potentially increasing the likelihood of congenital malformations by approximately 2- to 3-fold.

 

The use of primidone is not recommended in women who could become pregnant unless the potential benefits are deemed to outweigh the risks after considering alternative treatment options. Such women should be fully informed about the potential risks to a developing fetus if primidone is taken during pregnancy. Before starting treatment with primidone, a pregnancy test to exclude pregnancy should be considered in women who could become pregnant.

 

Women who could become pregnant should use highly effective contraception during treatment with primidone and for two months after the last dose. Due to enzyme induction, primidone (as well as its main metabolite, phenobarbital) may reduce the effectiveness of oral contraceptive drugs containing estrogen and/or progesterone. Therefore, women who could become pregnant should be advised to use alternative contraceptive methods.

 

Women who are planning to become pregnant should consult their physician beforehand to receive adequate counseling and discuss alternative treatment options before discontinuing contraception.

 

Women who could become pregnant should be advised to notify their doctor immediately if they become pregnant or suspect they may be pregnant while taking primidone. (“Health Products Regulatory Authority 16 September 2021 CRN00CGYX Page 1 of 15 Summary of Product Characteristics”)

Breast Feeding:

Consult your doctor before nursing while using mysoline. Mysoline can enter breast milk and potentially impact your infant. If you choose to breastfeed, monitor your baby closely. Should your baby exhibit excessive drowsiness and difficulty waking up, consult your doctor before breastfeeding again. (“MYSOLINE® Consumer Medicine Information (CMI) summary”)

Method of Administration

Tablets are taken orally with water.

Maximum Tolerated Daily Dose

2000mg. (“NEW ZEALAND DATA SHEET”)