EPIVIR ORAL SOLUTION 10 MG/ML

GLAXO WELLCOME OPERATIONS - UNITED KINGDOMBORA PHARMACEUTICAL SERVICES INC. (CANADA)🇸🇬 Health Sciences Authority

Approval Date: Jan 11, 1997
Approval ID: 3f992c641c8cc6df
Company: GLAXO WELLCOME OPERATIONS - UNITED KINGDOMBORA PHARMACEUTICAL SERVICES INC. (CANADA)
Type: Therapeutic

Approval Details

Approval Id: 3f992c641c8cc6df
Drug Name: EPIVIR ORAL SOLUTION 10 MG/ML
Product Name: EPIVIR ORAL SOLUTION 10 MG/ML
Approval Number: SIN09135P
Approval Date: 1997-01-11
Registrant: GLAXOSMITHKLINE PTE LTD
Licence Holder: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: SOLUTION
Dosage: Dosage and Administration Pharmaceutical Form: Oral Solution. Film-coated tablets. EPIVIR therapy should be initiated by a physician experienced in the management of HIV infection. EPIVIR can be taken with or without food. To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. For patients who are unable to swallow tablets, lamivudine is available as an oral solution. Alternatively, the tablets may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). <ul> <li>Adults, adolescents and children weighing at least 25 kg The recommended dose of EPIVIR is 300 mg daily. This may be administered as 150 mg (15 mL oral solution, 1 x 150 mg tablet) twice daily or 300 mg (30 mL oral solution, 2 x 150 mg tablets) once daily (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients changing to the once daily regimen should take 150 mg twice a day and switch to 300 mg once a day the following morning. When an evening once a day regimen is preferred, 150 mg of EPIVIR should be taken on the first morning only, followed by 300 mg in the evening. When changing back to a twice daily regimen, patients should complete the day’s treatment and start 150 mg twice a day the following morning. </li> </ul> <ul> <li>Children weighing less than 25 kg Oral Solution Children from one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily or 1 mL/kg (10 mg/kg) once daily (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Children from three months to one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily. If a twice daily regimen is not feasible, a once daily regimen (10 mg/kg/day) could be considered. It should be taken into account that data for the once daily regimen are very limited in this population (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 150 mg Scored Tablets Since an accurate dosing cannot be achieved with this formulation, dosing according to weight bands is recommended for EPIVIR tablets. Children weighing ≥ 20 kg to < 25 kg: The recommended dose is 225 mg daily. This may be administered as either 75 mg (one-half of a 150 mg tablet) taken in the morning and 150 mg (one whole 150 mg tablet) taken in the evening, or 225 mg (one and a half 150 mg tablets) taken once daily. Children weighing 14 kg to < 20 kg: The recommended dose is 150 mg daily. This may be administered as 75 mg (one-half of a 150 mg tablet) taken twice daily, or 150 mg (one whole 150 mg tablet) taken once daily. Patients changing between lamivudine oral solution and lamivudine tablets should follow the dosing recommendations that are specific for the formulation (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). </li> </ul> <ul> <li>Children less than three months of age The limited data available are insufficient to propose specific dosage recommendations (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). </li> </ul> <ul> <li>Renal impairment Lamivudine plasma concentrations (AUC) are increased in patients with moderate to severe renal impairment due to decreased clearance (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The dosage should therefore be reduced for patients with a creatinine clearance of < 30 mL/minute as shown in the table below. <img src="/TGIF/Epivir-Table1_220223.png" alt="Epivir Dosage Table 1" /> There are no data available on the use of lamivudine in children with renal impairment. A reduction in the dose and/or increase in the dosing interval should be considered in children aged at least three months and weighing less than 25 kg with a creatinine clearance of less than 50 mL/min. <img src="/TGIF/Epivir-Table2_220223.png" alt="Epivir Dosage Table 2" /> </li> </ul> <ul> <li>Hepatic impairment No dose adjustment is necessary in patients with moderate or severe hepatic impairment unless accompanied by renal impairment (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). </li> </ul> <ul> <li>Elderly No specific data are available, however special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters. </li> </ul>
Route Of Administration: ORAL
Indication Info: Indications EPIVIR, in combination with other antiretroviral agents, is indicated for the treatment of HIV - infected adults and children.
Contraindications: Contraindications The use of EPIVIR is contraindicated in patients with known hypersensitivity to lamivudine or to any ingredient of the preparation.
Atc Code: J05AF05
Atc Item Name: lamivudine
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD
Company Detail Path: /organization/glaxosmithkline-pte-ltd

Active Ingredients

LAMIVUDINE

10 mg/ml

LAMIVUDINE

10 mg/ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jan 11, 1997

Approval ID

3f992c641c8cc6df

Type

Therapeutic

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