Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
nevirapine, Quantity: 400 mg
Boehringer Ingelheim Pty Ltd
Nevirapine
Tablet, modified release
Excipient Ingredients: lactose monohydrate; hypromellose; iron oxide yellow; magnesium stearate
Oral
30 extended-release tablets, 10 extended-release tablets
(S4) Prescription Only Medicine
Viramune (nevirapine) oral suspension in combination with antiretroviral agents is indicated for the treatment of HIV-1 infection in adults and children over the age of 2 months. Viramune XR (nevirapine) extended-release tablets in combination with antiretroviral agents is indicated for the treatment of HIV-1 infection in adults and children over the age of three years. Extended-release tablets are not suitable for the 14 day lead-in period for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used. Resistant virus emerges rapidly when Viramune is administered as monotherapy or in dual combination therapy with an antiretroviral agent. Therefore, Viramune should always be administered in combination with at least two additional antiretroviral agents.
Visual Identification: Yellow, oval, biconvex tablets debossed with V04 on one side and the BI tower logo on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2012-01-04
VIRAMUNE ® XR V I R A M U N E X R C M I 0 1 3 5 - 0 7 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I TAKING VIRAMUNE XR? Viramune XR contains the active ingredient nevirapine. Viramune XR is used in the treatment of the infection caused by the Human Immunodeficiency Virus (HIV-1). For more information, see Section 1. Why am I taking Viramune XR? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE VIRAMUNE XR? Do not take Viramune XR if you have ever had an allergic reaction to nevirapine or any of the ingredients listed at the end of the CMI. Do not take Viramune XR if you have rare inherited conditions of galactose intolerance, severe liver dysfunction or if you previously experienced serious liver or skin reactions while taking Viramune or Viramune XR. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I take Viramune XR? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Viramune XR and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE VIRAMUNE XR? Adults 16 years and older: • FIRST 14 DAYS: Take one nevirapine tablet or 20 mL Viramune oral suspension once daily • AFTER THE FIRST 14 DAYS: Take one Viramune XR tablet once daily. Children (aged 3 years or older) and adolescents to 15 years: • Your child's doctor will determine the dose of Viramune XR based on your child's age and body weight, or body surface area. • FIRST 14 DAYS: Viramune oral suspension is given once daily. • AFTER THE FIRST 14 DAYS: Your child may be switched to Viramune XR tablet, given once daily. More instructions can be found in Section 4. How do I take Viramune XR? in the full CMI. 5. WHAT SHOULD I KNOW W Read the complete document
VIRAMUNE PI0097-16 1 AUSTRALIAN PRODUCT INFORMATION – VIRAMUNE ® ORAL LIQUID, VIRAMUNE ® XR (NEVIRAPINE) EXTENDED-RELEASE TABLETS 1 NAME OF THE MEDICINE nevirapine (VIRAMUNE XR extended-release tablets) nevirapine hemihydrate (VIRAMUNE oral suspension) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION VIRAMUNE is available as extended-release VIRAMUNE XR tablets or as a suspension for oral administration. Each VIRAMUNE XR extended-release tablet contains 400 mg of nevirapine. Each 5 mL of the VIRAMUNE oral suspension contains 50 mg of nevirapine (as nevirapine hemihydrate). Excipients with known effect: Each VIRAMUNE XR extended-release 400 mg tablet contains 400 mg of lactose monohydrate. Each mL of VIRAMUNE oral suspension contains 150 mg sucrose, 162 mg sorbitol, 1.8 mg of methyl hydroxybenzoate and 0.24 mg of propyl hydroxybenzoate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 400 mg extended-release tablets Yellow, oval, biconvex tablets. The tablets are debossed with “V04” on one side and the BI tower logo on the other side. Oral Suspension White to off-white suspension containing nevirapine 10 mg/1mL (as nevirapine hemihydrate). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VIRAMUNE (nevirapine) oral suspension in combination with antiretroviral agents is indicated for the treatment of HIV-1 infection in adults and children over the age of 2 months. VIRAMUNE XR (nevirapine) extended-release tablets in combination with antiretroviral agents is indicated for the treatment of HIV-1 infection in adults and children over the age of three years. Extended-release tablets are not suitable for the 14 day lead-in period for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used. Resistant virus emerges rapidly when VIRAMUNE is administered as monotherapy or in dual combination therapy with an antiretroviral agent. Therefore, VIRAMUNE should always be administered in combination with at least Read the complete document