Medicinal Products

EPIVIR 150 mg

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

Divisible coated tablet
Box of 1 Bottle of 60 film-coated tablets
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 150 mg Film-coated tablet scored 1 pack of 60 film-coated tablets

The initial prescription must be made by a doctor experienced in the management of HIV infection. Epivir can be given during or after meals.


The tablets should ideally be swallowed without crushing them, to ensure full dose administration. For patients unable to swallow tablets, Epivir is available as an oral solution. Another alternative is to crush the tablets and mix them with a small amount of semi-solid food or liquid, all of which must be ingested immediately (see section 5.2 Pharmacokinetic properties ).


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 each or in a single daily dose of 300 mg (see Warnings and Precautions ). The 300 mg tablet can only be used for a single daily dose.


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


Children (under 12 years old):


Since this formulation does not allow precise dosing, it is recommended to adjust the dosage per weight range for Epivir tablets. The dosing regimen for children weighing between 14 and 30 kg is primarily based on pharmacokinetic modeling, while relying on data from clinical studies.


For children weighing at least 30 kg: The dosage used in adults, 150 mg twice a day, should be administered.


For children weighing between 21 kg and 30 kg: The recommended dosage with Epivir 150 mg scored tablets is one half tablet in the morning and one tablet in the evening.

For children weighing between 14 kg and 21 kg: The recommended dosage with Epivir 150 mg scored tablets is one half tablet twice daily.


Epivir is also available as an oral solution for children over three months of age who weigh less than 14 kg or for patients unable to swallow tablets.


Children under three months of age: the available data are limited and insufficient to propose a specific dosing recommendation (see section 5.2 Pharmacokinetic properties ).

Renal Insufficiency: In moderate to severe renal impairment, lamivudine concentrations are increased due to decreased clearance. The dosage should therefore be adjusted, using the oral solution of Epivir, in patients whose creatinine clearance is less than 30 ml / min (see tables):

Dosing recommendations - Adults and adolescents weighing at least 30 kg:

Creatinine clearance (Cl ml / min)

Initial dose

Maintenance dose

Cl ≥ 50

150mg

150 mg twice daily

30 ≤ Cl <50

150mg

150 mg once a day

Cl <30

Doses less than 150 mg are necessary, the use of the oral solution is recommended.


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 aged at least 3 months and weighing less than 30 kg:

Creatinine clearance (Cl 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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