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Mysoline 250mg 50 Tabs, Primidone

INDICATIONS: Anticonvulsant.

Primidone is indicated for the control of grand mal and psychomotor epilepsy for (temporal lobe). It is also valuable for controlling focal or Jacksonian seizures, myoclonic seizures and akinetic attacks.

Contraindications

Primidone is contraindicated: In patients with acute intermittent porphyria, liver failure, nephritis, hyperthyroidism, diabetes mellitus, or anemia.

In patients with hypersensitivity to primidone, phenobarbital, or any component of the formula.

During pregnancy because it may have teratogenic effects similar to those of phenytoin.

Special Precautions: Abrupt withdrawal of anticonvulsant medication may precipitate status epilepticus.

The total daily dose should not exceed 2 g.

Primidone, like other anticonvulsants, may induce the production of liver enzymes, and although there is insufficient evidence to suggest a causal relationship, there is theoretical risk of liver damage.

Primidone may also affect the metabolism of vitamin D, which can predispose to the development of bone disease.

Since therapy is usually longer for prolonged periods, a complete blood count and a test of sequential multiple analysis 12 (A-12 SM) must be performed every 6 months.

Primidone like other anticonvulsants, may induce the production of liver enzymes, and although there is insufficient evidence to suggest a causal relationship, there is a theoretical risk of liver damage.

Primidone may also affect the metabolism of vitamin D, which can predispose to the development of bone disease.

Be administered with caution and reduced doses to children, elderly or debilitated patients and those with impaired kidney function, liver or respiratory.

Primidone is a potent CNS depressant and is partly metabolized to phenobarbital. After prolonged administration, the possibility of a reaction suspension, dependence and tolerance, if treatment is stopped suddenly.

The patient should be warned that primidone, as with other anticonvulsants, may depress psychomotor skills for operating machinery or vehicles.

DOSAGE AND ADMINISTRATION: Oral.

Dosage in adults: patients older than 8 years of age who have not received prior treatment, can initiate primidone therapy according to the following scheme:

Days 1-3: 100-125 mg at bedtime.

Days 4-6: 100-125 mg twice a day.

Days 7-9: 100-125 mg three times a day.

Day 10 to maintenance: 250 mg three times a day.

For most adults and children over 8 years of age, the usual dose for maintenance is 750 or 1,000 mg per day in divided doses. If required, the dose may be increased to 1.250 or 1.500 mg per day, but the daily dose should not exceed 2 g.

The dosage should be individualized to provide maximum benefit. In some cases, the determination of the levels of serum primidone may be necessary for optimal dosage adjustment. The clinically effective serum level is between 5-12 mg / ml.

In patients already receiving other anticonvulsants, primidone administration should be initiated at 100-125 mg at bedtime and gradually increased to maintain the drug while the other decreases gradually. This regimen should be continued until satisfactory dosage level is reached for the combination, or until another dose is withdrawn completely. If required only treatment with primidone, the transition from concomitant therapy should not be completed in less than 2 weeks.

Pediatric Dose: For children under 8 years old should use the following procedure:

Days 1-3: 50 mg before bedtime.

Days 4-6: 50 mg twice a day.

Days 7-9: 100 mg twice a day.

Day 10 to maintenance: 125 mg three times daily or 250 mg three times a day.

For children under 8 years of age, the usual maintenance dosage is 125-250 mg three times daily or 10-25 mg / kg / day in divided doses.

REPRESENTATIONS AND MANAGEMENT OF ACCIDENTAL OVERDOSE OR INTAKE: primidone overdose with CNS depression leads to varying degrees, depending on the dose ingested, may include ataxia, loss of consciousness, respiratory depression and coma.

For your treatment will include the emptying of stomach contents and measures to support vital functions. There is no specific treatment.

Crystalluria has been reported after acute overdosage with primidone in a small number of cases reported. This condition was associated with serum concentrations of primidone greater than 80 ug / ml. Since two tests have found evidence of kidney damage associated with the formation of crystals in vivo. In patients at risk is recommended vigorous hydration with forced alkaline diuresis or not, with the aim to reduce the possibility of renal toxicity and improve drug elimination.

PRESENTATION: Box of 50 tablets.
Name of the medication:Mysoline
Comparative brand name: Mysoline
Active substance: Primidone
Presentation: Tablets
Concentration: 250 mg
Time release: No
Laboratory: Psicofarma, S.A. de C.V
Bottle with 50 pills
Made in: Mexico