Kipromax

*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

with levetiracetam for patients during dialysis. 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 with levetiracetam for patients during dialysis. 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 case 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 growth of your child or appearance of unexpected abrupty contact your physican.

• 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 machine, patients may feel somnolence at the begining

of the treatment or when dose is increased so do not drive or use machine till you can.

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 effect but not everybody gets them, the most common and the

Common side effects: Nasopharyngitis, anorexia, depression , aggression ,anxiety , insomnia , nervousness,

somnolence, headache, convulsion, dizziness, tremor, vertigo, cough, abdominal pain , nausea ,vomiting, diarrhea,

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.

Infections ,hyponatremia ,completed suicide, personality disorder, thinking abnormal, dyskinesia, pancreatitis,

hepatitis, Steven-Johnsen syndrome, toxic epidermal necrolysis and erythema multiform.

OVERDOSAGE :

Symptoms that may 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 500mg, 750mg, 1000mg tablets : Store below 30°C, in a dry place.

PRESENTATION :

Kipromax solution : pack of 100 ml .

Kipromax 500mg, 750mg, 1000mg tablets : pack of 30 tablets and hospital pack of different size.

012-06-178 05/19

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 seizures 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 a monotherapy : In the treatment of partial onset seizures with or without secondary generalization in adults and

adolescents from age 16 with newly diagnosed epilepsy.

- As adjunctive therapy :

1- In partial onset seizures with or without secondary generalization in adults ,adolescents ,children and infants starting

from one month with epilepsy.

2- In myoclonic seizures in adults and adolescents from 12 years with Juvenile myoclonic epilepsy.

3- In primary generalized tonic-clonic seizures in adults and adolescents from 12years with Idiopathic Generalized

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 to 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 to 23 months), Children (2 - 11 years) adolescents (12 - 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 10mg/kg twice daily

every 2 weeks.

Example : If the starting dose was 10mg/kg of the body weight used daily ,you are able to give your child that weigh

10kg a 100mg of Kipromax that is equivalent to 1ml of the oral solution twice a day.

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.

Formula for adults and adolescents weighing 50 kg or more

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

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

ks= 0.45 in Term infants to 1 year old; ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in

adolescent male

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

CLcr (ml/min) = (x 0.85 [140-age (year) x weight(kg)] for women)

[72 x serum creatinine (mg/dl)]

CLcr (ml/min/1.73 m2) = x 1.73 CLcr(ml/min)

BSA subject (m2)

CLcr (ml/min/1.73 m2) = Height (cm) x ks

Serum Creatinine (mg/dl)

Infants 6 to 23 months,

children and adolescents

weighing less than 50 kg

10 to 30 mg/kg

(0.10 to 0.30 ml/kg) twice daily

10 to 20 mg/kg

(0.10 to 0.20 ml/kg) twice daily

5 to 15 mg/kg

(0.05 to 0.15 ml/kg) twice daily

5 to 10 mg/kg

(0.05 to 0.10 ml/kg) twice daily

10 to 20 mg/kg

(0.10 to 0.20 ml/kg) once daily

Adults and adolescents

patients weighing

more than 50 kg

500 to 1,500 mg

twice daily

500 to 1,000 mg

twice daily

250 to 750 mg

twice daily

250 to 500 mg

twice daily

500 to 1,000 mg

once daily

Infants 1 to less

than 6 months

7 to 21 mg/kg

(0.07 to 0.21 ml/kg) twice daily

7 to 14 mg/kg

(0.07 to 0.14 ml/kg) twice daily

3.5 to 10.5 mg/kg

(0.035 to 0.105 ml/kg) twice daily

3.5 to 7 mg/kg

(0.035 to 0.07 ml/kg) twice daily

7 to 14 mg/kg

(0.07 to 0.14 ml/kg) once daily

Creatinine clearance

(ml/min/1.73m2)

> 80

50 - 79

30 - 49

< 30

-

Dose and frequency

Group

Normal

Mild

Moderate

Severe

End-stage renal disease

patients under going dialysis