📌 COMPOSITION

• Each 1 ml solution contains: Levetiracetam 100 mg.
• Each F/C tablet contains: Levetiracetam 500 mg, 750 mg and 1000 mg.

📌 DESCRIPTION

Kipromax is an anticonvulsant medication that is used to treat epilepsy. It may selectively prevent seizure activity in the brain by decreasing its abnormal excitement. It is used for adults, adolescents, children and infants starting from one month old. Kipromax is rapidly absorbed after oral administration, and it is excreted majorly via urine.

📌 INDICATIONS

As monotherapy: In the treatment of partial‑onset seizures with or without secondary generalisation in adults and adolescents from age 16 with newly diagnosed epilepsy.

As adjunctive therapy:

• In partial‑onset seizures with or without secondary generalisation in adults, adolescents, children and infants starting from one month with epilepsy.
• In myoclonic seizures in adults and adolescents from 12 years with juvenile myoclonic epilepsy.
• In primary generalised tonic‑clonic seizures in adults and adolescents from 12 years with idiopathic generalised epilepsy.

📌 DOSAGE & ADMINISTRATION

Monotherapy:

• Adults and adolescents from 16 years old: As a starting dose 250 mg twice daily; dose should be increased to 500 mg twice daily after 2 weeks. It can be further increased by 250 mg twice daily every 2 weeks depending on clinical response. The maximum dose is 1500 mg twice daily.
• Children less than 16 years old: Monotherapy treatment has not been established.

As adjunctive therapy:

• Adults (≥ 18 years) and adolescents (12-17 years) weighing 50 kg or more: As a starting dose 500 mg twice daily; it can be increased up to 1500 mg twice daily depending upon clinical response and tolerability. The dose can be changed by 500 mg twice daily increased or decreased every 2-4 weeks.
• Infants (6-23 months), children (2-11 years) and adolescents (11-17 years) weighing less than 50 kg: As a starting dose 10 mg/kg (0.1 ml/kg) twice daily; the dose can be increased up to 30 mg/kg (0.3 ml/kg) twice daily depending upon clinical response and tolerability. Dose change should not exceed increased or decreased of 10 mg/kg twice daily every 2 weeks.
• Example: If the starting dose was 10 mg/kg of body weight, you are able to give your child that weighs 10 kg a 100 mg of Kipromax, equivalent to 1 ml of the oral solution twice a day. Children weighing 25 kg or less should start treatment with the oral solution.
• Infants (1-6 months): General dose is 14 mg/kg to 42 mg/kg daily divided into two doses.

Renal impairment:

For adults and adolescents, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed before starting treatment.

Formula for adults and adolescents weighing 50 kg or more:

CLcr (ml/min) = [140 - age (years)] × weight (kg) × 0.85 (for women) / [72 × serum creatinine (mg/dl)]

Then CLcr is adjusted for body surface area (BSA) as follows:

CLcr (ml/min/1.73 m²) = CLcr (ml/min) × 1.73 / BSA subject (m²)

For young adolescents, children and infants, using the following formula:

CLcr (ml/min/1.73 m²) = Height (cm) × ks / Serum Creatinine (mg/dl)

Where ks = 0.45 in term infants to 1 year old; 0.55 in children less than 13 years and in adolescent females; 0.7 in adolescent males.

Dosing adjustment for infants, children, adolescents and adults patients with renal impairment:

• For adults and adolescents patients weighing 50 kg or more a 750 mg loading dose is recommended on the first day of treatment with levetiracetam for patients during dialysis. Following dialysis, a 250 to 500 mg supplemental dose is recommended.
• Infants 1 to less than 6 months: a 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment. Following dialysis, a 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.
• Infants 6 to 23 months, children and adolescents weighing less than 50 kg: a 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment. Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.

Do not take this medication without any prescription from your doctor. In case of missing dose, do not double dose to compensate the missed dose.

📌 RESTRICTIONS ON USE

Contraindications

Hypersensitivity to levetiracetam.

Precautions

• If Kipromax has to be discontinued, it is recommended to withdraw gradually.
• In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection.
• Rare cases of decreased blood cell counts have been described at the beginning of the treatment. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorder.
• In case of impact on growth of your child or appearance of unexpected abrupt changes, contact your physician.
• Few patients taking Kipromax may experience depression or suicidal ideation. So caution should be observed.

Use in pregnancy and lactation

Kipromax is not recommended during pregnancy and breastfeeding unless it's necessary.

Effect on the ability of driving vehicles and use machines

Kipromax may affect your ability of driving vehicles and use machines. Patients may feel somnolence at the beginning of the treatment or when dose is increased, so do not drive or use machines until you are able.

📌 DRUG INTERACTIONS

• Concomitant administration of Kipromax and antiepileptic medicines increases the clearance of levetiracetam in children.
• The administration of Kipromax and methotrexate concomitantly leads to a decrease in methotrexate clearance.
• Concomitant administration of Kipromax and osmotic laxative macrogol decreases levetiracetam efficacy. So macrogol shouldn't be taken orally for one hour before and for one hour after taking Kipromax.

📌 ADVERSE EFFECTS

As any other drug, Kipromax may cause some side effects but not everybody gets them.

The most common and common side effects: Nasopharyngitis, anorexia, depression, aggression, anxiety, insomnia, nervousness, somnolence, headache, convulsion, dizziness, tremor, vertigo, cough, abdominal pain, nausea, vomiting, diarrhoea, dyspepsia, asthenia, fatigue and rash.

Uncommon side effects: Thrombocytopenia, leukopenia, weight increased or decreased, ideation or suicidal attempt, hallucination, confusion, panic attack, mood swings, amnesia, memory impairment, disturbance in attention, diplopia, vision blurred, abnormal liver function test, eczema, pruritus, muscular weakness and myalgia.

📌 OVERDOSAGE

Symptoms that may be found with overdose: Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma. After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis. Treatment of an overdose will be symptomatic and may include haemodialysis.

📌 STORAGE INSTRUCTIONS

• Kipromax solution: Store below 30°C.
• Kipromax 500 mg, 750 mg, 1000 mg tablets: Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Kipromax solution: pack of 100 ml.
• Kipromax 500 mg, 750 mg, 1000 mg tablets: pack of 30 tablets and hospital packs of different sizes.

012-06-178 05/19