Kaletra (80 mg + 20 mg) / ml oral solution
Each 1 ml of Kaletra oral solution contains 80 mg of lopinavir co-formulated with 20 mg of ritonavir as a pharmacokinetic enhancer.
Excipients with known effect:
Each 1 ml contains 356.3 mg of alcohol (42.4% v/v), 168.6 mg of high fructose corn syrup, 152.7 mg of propylene glycol (15.3% w/v) (see section 4.3), 10.2 mg of polyoxyl 40 hydrogenated castor oil and 4.1 mg of acesulfame potassium (see section 4.4).
For the full list of excipients, see section 6.1.
Oral solution
The solution is light yellow to golden.
Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years.
The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients (see sections 4.4 and 5.1).
Kaletra should be prescribed by physicians who are experienced in the treatment of HIV infection.
Posology
Adults and adolescents
The recommended dosage of Kaletra is 5 ml of oral solution (400/100 mg) twice daily taken with food.
Paediatric population (2 years of age and above)
The recommended dosage of Kaletra is 230/57.5 mg/m2 twice daily taken with food, up to a maximum dose of 400/100 mg twice daily. The 230/57.5 mg/m2 dosage might be insufficient in some children when co-administered with nevirapine or efavirenz. An increase of the dose of Kaletra to 300/75 mg/m2 should be considered in these patients. If weight-based dosing is preferred, the dosage for patients greater than or equal to 15 kg to 40 kg is 10/2.5 mg/kg twice daily when Kaletra is not co-administered with nevirapine or efavirenz. Dose should be administered using a calibrated oral dosing syringe.
The oral solution is the recommended option for the most accur
