Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Mercaptopurine
Aspen Pharmacare Australia Pty Ltd
Medicine Registered
PURI-NETHOL ® _mercaptopurine 50mg tablets_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PURI-NETHOL. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking PURI- NETHOL against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PURI-NETHOL IS USED FOR PURI-NETHOL contains mercaptopurine as the active ingredient. It belongs to a group of medicines called cytotoxics. PURI-NETHOL is used solely or in combination with other medicines to treat acute leukaemia, a cancer of certain blood cells. It works by interfering with the growth of cancer cells. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PURI- NETHOL HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. This medicine is only available with a doctor's prescription. There is no evidence that it is addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE PURI-NETHOL IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO: • mercaptopurine • any of the tablet ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin. DO NOT TAKE PURI-NETHOL IF YOU ARE PLANNING TO BECOME PREGNANT OR FATHER A CHILD UNLESS YOU AND YOUR DOCTOR HAVE DISCUSSED THE RISKS AND BENEFITS INVOLVED. As with all cytotoxic drugs, PURI - NETHOL may harm eggs and sperm. Reliable contraceptive methods must be taken to avoid pregnancy whilst you or your partner is taking this medicine. DO NOT TAKE PURI-NETHOL IF YOU ARE PREGNANT UNLESS YOU AND YOUR DOCTOR HAVE DISCUSSED THE RISKS AND BEN Read the complete document
PURI-NETHOL TABLETS – Product Information Page 1 of 7 PRODUCT INFORMATION PURI-NETHOL ® TABLETS NAME OF THE MEDICINE: PURI-NETHOL tablets contain 50 mg mercaptopurine. The chemical name (CAS) of mercaptopurine is 6_H_-Purine-6-thione, 1,7-dihydro-, monohydrate, it has a relative molecular mass of 170.2, its molecular formula is C 5 H 4 N 4 S ⋅H 2 O, CAS No.: 6112-76-1 (monohydrate) and the chemical structure is: N H N N N SH H 2 O DESCRIPTION: Mercaptopurine is odourless or practically odourless, yellow crystalline powder, with a solubility of 0.26 mg/mL in water at 37 °C. Each PURI-NETHOL tablet also contains lactose, starch-maize, starch-hydrolysed maize, magnesium stearate and stearic acid. PHARMACOLOGY: Mercaptopurine is an analogue of adenine, one of the bases required for nucleic acid biosynthesis, and of the purine base hypoxanthine. Hence PURI-NETHOL acts as an antimetabolite and interferes with the synthesis of nucleic acids in proliferating cells. Its metabolites are also pharmacologically active. PHARMACOKINETICS: Absorption of an oral dose of PURI-NETHOL is incomplete and variable averaging about 50% of the administered dose. The half-life of mercaptopurine in the circulation is of the order of 90 minutes. It is extensively metabolised and excreted via the kidneys and the active metabolites have a longer half-life than the parent drug. Mercaptopurine has pKa’s of 7.7 and 11. INDICATIONS: Treatment of acute leukaemia. It is of value in remission induction and is particularly indicated for maintenance therapy in acute lymphoblastic leukaemia and acute myelogenous leukaemia. PURI-NETHOL is also used in the treatment of chronic granulocytic leukaemia. PURI-NETHOL TABLETS – Product Information Page 2 of Read the complete document