Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
efavirenz, Quantity: 600 mg
Merck Sharp & Dohme (Australia) Pty Ltd
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; sodium lauryl sulfate; hyprolose; lactose monohydrate; magnesium stearate; Carnauba Wax; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400
Oral
STORCRIN is indicated for use in combination with other antiviral agents for the treatment of HIV-1 infection in adults and children. (See Clinical Trials; Use in Children)
Visual Identification: YELLOW, MODIFIED CAPSULAR-SHAPED TABLETS DEBOSSED WITH "225" ON ONE SIDE AND BLANK ON THE OTHER.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2002-08-29
STOCRIN ® S T O C R I N ® 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 USING STOCRIN? STOCRIN contains the active ingredient Efavirenz. STOCRIN is used to help treat HIV (Human Immunodeficiency Virus) infection. It is used in combination with other appropriate medicines used to treat the HIV virus. For more information, see Section 1. Why am I using STOCRIN? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE STOCRIN? Do not use if you have ever had an allergic reaction to STOCRIN or any of the ingredients listed at the end of the CMI. 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 use STOCRIN? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with STOCRIN 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 USE STOCRIN? Your doctor will tell you how many tablets you need to take each day. • For adults and children weighing greater than or equal to 40 kg, the normal dose is 600 mg once a day. It is important that you are started and continue on this dose. • For children and teenagers 3 to 17 years old, the dose depends on body weight. Your child's doctor will decide the dose. More instructions can be found in Section 4. How do I use STOCRIN? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING STOCRIN? THINGS YOU SHOULD DO • Report any changes in your condition to your doctor immediately to ensure any infections which occur due to your low immunity are treated promptly. • Continue to use safe sexual practices. THINGS YOU SHOULD NOT DO • Do not stop taking STOCRIN or change the dose without first checking with your doctor. Do not let yourself run out of medicine over weekends or on h Read the complete document
AUSTRALIAN PRODUCT INFORMATION STOCRIN ® (efavirenz) Tablets 1 NAME OF THE MEDICINE Efavirenz 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Efavirenz is a white to slightly pink crystalline powder. STOCRIN is available as tablets for oral administration. Each STOCRIN tablet contains 50, 200, 300 or 600 mg of efavirenz. List of excipients with known effect: contains sugars (as lactose). FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM STOCRIN 50mg tablets are yellow, round shaped tablets with "113" on one side and plain on the other. STOCRIN 200mg tablets are yellow, round shaped tablets with "223" on one side and plain on the other. STOCRIN 300mg tablets are white, capsular film-coated tablets with "224" in purple ink on both sides. STOCRIN 600mg tablets are yellow, capsular film-coated tablets with "225" in purple ink on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS STOCRIN is indicated for use in combination with other antiviral agents for the treatment of HIV-1 infection in adults and children (See section 5.1 Pharmacodynamic properties Use in Children). 4.2 DOSE AND METHOD OF ADMINISTRATION STOCRIN should be taken in the fasted state, preferably at bedtime. Food increases the bioavailability of STOCRIN and this may be associated with a higher frequency of side effects. In order to improve the tolerability of nervous system side effects, bedtime dosing is recommended during the first two to four weeks of therapy and in patients who continue to experience these symptoms (see section 4.8 Adverse effects (undesirable effects)). Concomitant Antiretroviral Therapy: STOCRIN must be given in combination with other antiretroviral medications (see section 4.5 Interactions with other medicines and other forms of interactions). Adults: The recommended dosage of STOCRIN in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs) is 600 mg orally, once daily. Adolescents and Children (17 years and under): The recommend Read the complete document