Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Octreotide
Sun Pharmaceuticals Industries Australia Pty Ltd
Medicine Registered
Octreotide SUN_CMI_20120203 Page 1 of 8 OCTREOTIDE SUN _Octreotide _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Octreotide SUN. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. Those updates may contain important information about the medicine and its use of which you should be aware. It does not contain all 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 using Octreotide SUN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT OCTREOTIDE SUN IS USED FOR Octreotide SUN has three uses: 1. Octreotide SUN is used to treat acromegaly. In people with acromegaly the body makes too much growth hormone, which controls the growth of tissues, organs and bones. This leads to enlargement of the bones, especially of the hands and feet. Other symptoms include headaches, increased sweating, tiredness, numbness of the hands and feet, pain and stiffness in the joints and loss of sexual function. By blocking the excess growth hormone, Octreotide SUN can relieve many of these symptoms. 2. Octreotide SUN is used to relieve symptoms of certain types of cancer such as carcinoid syndrome and VIPoma. By blocking hormones that are over-produc Read the complete document
Octreotide_PI Page 1 of 9 PRODUCT INFORMATION OCTREOTIDE SUN SOLUTION FOR INJECTION NAME OF THE MEDICINE Octreotide Chemical name: D-Phenylalanyl-L-cysteinyl-L-phenyalanyl-D-tryptophyl-L-Iysyl-L-threonyl-N-[2- hydroxy-1-(hydroxymethyl)propyl]-L-cysteinamide cyclic (27)–disulfide. DESCRIPTION Octreotide SUN is octreotide, a synthetic octapeptide analogue of somatostatin. where x = 1.4 to 2.5 CAS number: 79517-01-4. (octreotide acetate) MW: 1019.3 (free peptide) Each 1 mL ampoule contains 0.05 mg, 0.1 mg or 0.5 mg octreotide (present as acetate). The solution is clear and colourless. EXCIPIENTS: lactic acid, mannitol, sodium bicarbonate, water for injections. PHARMACOLOGY PHARMACODYNAMICS Octreotide is a synthetic octapeptide analogue of naturally occurring somatostatin with similar pharmacological effects, but with a considerably prolonged duration of action. It inhibits the secretion of serotonin and the gastro-entero-pancreatic peptides: gastrin, vasoactive intestinal peptide, insulin, glucagon, secretin, motilin, and pancreatic polypeptide, and of growth hormone (GH). Octreotide, like somatostatin, decreases splanchnic blood flow. In animals, octreotide is a more potent inhibitor of growth hormone, glucagon and insulin release than somatostatin with greater selectivity for GH-and glucagon-suppression. In healthy subjects octreotide, like somatostatin, has been shown to inhibit: • release of growth hormone (GH) stimulated by arginine, exercise and insulin-induced hypoglycaemia • postprandial release of insulin, glucagon, gastrin, other peptides of the GEP system, and arginine- stimulated release of insulin and glucagon • thyrotropin releasing hormone (TRH) stimulated release of thyroid stimulating hormone (TSH). Octreotide_PI Page 2 of 9 Read the complete document