Medicinal Products

EPIVIR 10 mg / mL

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Lamivudine
laboratory: Viiv Healthcare UK Ltd

Drinkable solution
Box of 1 bottle of 240 ml
All forms

Indication

Epivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children.

Dosage EPIVIR 10 mg / mL Oral solution Box of 1 bottle of 240 ml

The initial prescription must be made by a doctor experienced in the management of HIV infection.


Adults and adolescents over 12 years of age: The recommended dosage of Epivir is 300 mg daily. This dose may be administered either in two daily doses of 150 mg (15 ml) each, or in a single daily dose of 300 mg (30 ml) (see Warnings and Precautions for Use section ).

Patients switching from two doses once daily should take 150 mg (15 ml) twice daily, the day before the dose change, and then 300 mg (30 ml) the next morning. Patients who prefer a single dose at night should only take 150 mg (15 ml) in the morning and then 300 mg (30 ml) the same evening on the day of the change of dose only. For patients returning to a twice-daily dose: normally take 300 mg (30 ml) the day before the change of dosage and then 150 mg (15 ml) twice daily the next morning.


Children:

Children from 3 months to 12 years of age: The recommended dose of Epivir is 4 mg / kg twice daily, without exceeding the daily dose of 300 mg.

Children under 3 months of age: The limited data currently available are insufficient to propose a dose recommendation in this age group (see section 5.2 ).

Epivir is also available as a tablet.

Epivir can be taken during or after meals.

Renal Insufficiency: In moderate to severe renal impairment, lamivudine concentrations are increased due to decreased clearance. The dosage should therefore be adapted (see tables below):

Dosing recommendations - Adults and adolescents over 12 years:

Creatinine clearance (Cl ml / min)

Initial dose

Maintenance dose

Cl ≥ 50

150 mg (15ml)

150 mg (15 ml) twice daily

30 ≤ Cl <50

150 mg (15ml)

150 mg (15 ml) once a day

15 ≤ Cl <30

150 mg (15ml)

100 mg (10 ml) once a day

5 ≤ Cl <15

150 mg (15ml)

50 mg (5 ml) once a day

Cl <5

50 mg (5ml)

25 mg (2.5 ml) once a day


No data are available on the use of lamivudine in children with renal impairment. Based on the hypothesis of a similar correlation between creatinine clearance and lamivudine clearance in children and adults, it is recommended to reduce the dosage in children with renal impairment as a function of clearance. creatinine, in the same proportions as those recommended for adults.


Dosing recommendations - Children from 3 months to 12 years:

Clearance of creatinine

(Cl in ml / min)

Initial dose

Maintenance dose

Cl ≥ 50

4 mg / kg

4 mg / kg, twice daily

30 ≤ Cl <50

4 mg / kg

4 mg / kg, once a day

15 ≤ Cl <30

4 mg / kg

2.6 mg / kg once daily

5 ≤ Cl <15

4 mg / kg

1.3 mg / kg once daily

Cl <5

1.3 mg / kg

0.7 mg / kg, once a day

Hepatic impairment: In moderate to severe hepatic impairment, the pharmacokinetics of lamivudine are not significantly impaired. Also, no dosage adjustment is necessary in these patients, except if hepatic insufficiency is associated with renal failure.

Against indications

Hypersensitivity to the active substance or to any of the excipients.

Epivir side effects

The following side effects have been reported during treatment of HIV infection with Epivir.

Adverse effects considered to be attributable to treatment are listed below by organ class and absolute frequency. Frequencies are defined according to the following categories: very common (≥ 1/10), frequent (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare (≥ 1 / 10, 000 to <1/1000) and very rare (<1 / 10, 000). Within each category, adverse effects are presented in order of decreasing severity.

Hematological and lymphatic system disorders:

Uncommon: Neutropenia and anemia (both sometimes severe), thrombocytopenia.

Very rare: erythrocyte aplasia.

Nervous system disorders:

Common: Headache, insomnia.

Very rare: Peripheral neuropathy (or paresthesia).

Respiratory, thoracic and mediastinal disorders:

Common: Cough, nasal symptoms

Gastrointestinal disorders:

Common: Nausea, vomiting, abdominal pain or cramps, diarrhea

Rare: Pancreatitis, elevation of amylase.

Hepatobiliary disorders:

Uncommon: Transient elevation of liver enzymes (ASAT, ALAT).

Rare: Hepatitis.

Skin and subcutaneous tissue disorders:

Common: Rash, alopecia.

Rare: Angioedema.

Musculoskeletal and systemic disorders:

Common: Arthralgia, muscular disorders.

Rare: Rhabdomyolysis.

General disorders and administration site defects:

Frequent: Fatigue, malaise, fever.

Cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been observed after nucleoside analogues (see Warnings and Precautions ).

Combination antiretroviral therapy has been associated with a redistribution of body fat (lipodystrophy) in HIV-infected patients, including loss of subcutaneous peripheral and facial adipose tissue, increased body fat intra-abdominal and visceral, breast hypertrophy and accumulation of fat at the cervical level (buffalo hump).

Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia and hyperlactataemia (see Warnings and Precautions section ).

In HIV-infected patients with severe immune deficiency at the time of initiation of antiretroviral combination therapy, an inflammatory reaction to asymptomatic or residual opportunistic infections may occur (see Warnings and Precautions section). employment ).

Cases of osteonecrosis have been reported, particularly in patients with known risk factors, advanced HIV-related disease, or combination therapy with long-term antiretrovirals. Their frequency of occurrence is not known (see section Warnings and Precautions ).

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