Ipnopan

Pharmacological properties

Ipnopan contains Levetiracetam, an antiepileptic, belonging to a new group of drugs derived from pyrrolidone. (α-ethyl-2-oxo-1-pyrrolidone acetamide s-enantiomer), without chemical relationship with existing antiepileptic active ingredients.

Its site of action is the SV2A protein in the brain synaptic vesicle. This protein plays a substantial role in the release of neurotransmitters essential for normal neuronal activity in the brain and spinal cord.

Therapeutic indications

Ipnopan is indicated as monotherapy in the treatment of epileptic seizures, either focal or generalized: juvenile myoclonic epilepsy, in the treatment of primary generalized tonic-clonic seizures in adults and adolescents over 12 years of age with Idiopathic Generalized Epilepsy.


Contraindications

Hypersensitivity reactions to Levetiracetam or other derivatives of pyrrolidone or any of its excipients.

Side Effects

 

They are infrequent at the recommended doses; Drowsiness and asthenia have been described in some patients. Other very rare side effects are dizziness, emotional lability, insomnia, tremors, ataxia, digestive disturbances, and skin rash. Headache and chest pain have also been described.

Drug interactions

Studies have shown that Levetiracetam does not influence plasma levels of Carbamazepine, Phenytoin, Primidone, Valproate, Digoxin or Warfarin. The total absorption of Levetiracetam is not reduced by food, but it slows down. There are no studies on the interaction of Levetiracetam with alcohol.

Cautions

In patients with renal failure, the daily dose should be adjusted according to the creatinine index. Moderate liver failure requires no adjustment. According to current clinical practice, if it is necessary to discontinue therapy with Levetiracetam, it is recommended to withdraw it gradually. (in adults: 500 mg reductions 2 times a day every 2 to 4 weeks; in children: the dose decrease should not exceed 10 mg / kg 2 times a day every 2 weeks.

Use in children younger than 4 years: Ipnopan is not recommended for use in children younger than 4 years, due to a paucity of data on safety and efficacy in this age group.

Use during pregnancy and lactation:

There are no adequate data on the use of Levetiracetam in pregnant women. Animal studies have shown reproductive toxicity. The potential risk to humans is unknown. Levetiracetam should not be used during pregnancy unless clearly necessary.

Levetiracetam is excreted in human breast milk. Therefore breastfeeding is not recommended. However, if you need treatment with Levetiracetam while breastfeeding, the risk / benefit of treatment should be evaluated considering the importance of breastfeeding.

Effects on ability to drive vehicles and operate machinery

No studies on the effects on the ability to drive vehicles and operate machinery have been performed. Due to possible differences in individual sensitivities, some patients may experience drowsiness or other symptoms related to the central nervous system, at the start of treatment or after an increase in dose. Therefore, caution is recommended in such patients when performing delicate tasks, driving vehicles or operating machinery.

Warnings

Sale by prescription. Keep out of reach of children.

Composition

Ipnopan Oral Solution

Levetiracetam     100 mg

C.S.P Excipients     1 ml

Ipnopan Caplets

Levetiracetam     500 mg

C.S.P Excipients     1 coated caplet


Posology and administration

Ipnopan caplets should be ingested with a sufficient amount of liquid, with or without food. Monotherapy: Adults and adolescents from 16 years of age: the recommended initial dose is 250 mg 2 times a day, which should be increased to the initial therapeutic dose of 500 mg 2 times a day after 2 weeks of treatment. The dose can be increased by 250 mg twice a day every 2 weeks depending on the response to treatment. The maximum dose corresponds to 1500 mg 2 times a day.

Ipnopan oral solution can be diluted in a glass with water and can be administered with or without food. The daily dosage is divided into equal doses divided into two doses a day.

Children from 4 to 11 years old and adolescents (from 12 to 17 years old) weighing less than 50 kg:

The initial therapeutic dose is 10mg / kg twice a day.

Depending on the clinical response and tolerability, the dose can be increased up to 30 mg / kg twice a day. Dose changes should not exceed 10 mg / kg increments or decrements twice daily every other week. The lowest effective dose should be used. The dose for children weighing 50 kg or more is the same as for adults.

The doctor will indicate the pharmaceutical form and the appropriate concentration according to weight and dose.

WeightInitial dose:
10 mg / kg twice a day
Maximum dose:
30 mg / kg twice a day
15 kg150 mg twice a day (1.5 ml)450 mg twice a day (4.5 ml)
20 kg200 mg twice a day (2 ml)600 mg twice a day (6 ml)
25 kg250 mg twice a day (2.5 ml)750 mg twice a day (7.5 ml)
From 50 kg (2)500 mg twice a day (5 ml)1500 mg twice a day (15 ml)


Presentation

Ipnopan – 500: Box containing 3 blisters with 10 coated caplets each.

Ipnopan Oral Solution: Box containing 1 bottle with 120 ml of solution.

 


Storage Recommendations

Store below 30 °C. Protect  from light.