Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
tacrolimus monohydrate
Pharmacor Pty Ltd
tacrolimus monohydrate
________________________________________________________________________________________________ Pharmacor Tacrolimus CMI v0316 1 PHARMACOR TACROLIMUS _TACROLIMUS _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET _ _ _ _ This leaflet answers some common questions about PHARMACOR TACROLIMUS Capsules. 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 taking PHARMACOR TACROLIMUS against the benefits this medicine is expected to have for you. If you have any concerns about using PHARMACOR TACROLIMUS ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again._ _ _ _ WHAT PHARMACOR TACROLIMUS IS USED FOR You have been given a new transplanted liver or kidney, lung or heart from another person because your own was no longer healthy. Your body recognises that this new organ is different from your organs and will try to reject it by attacking it in the same way that it would attack germs that enter your body. This could make you become ill again. PHARMACOR TACROLIMUS stops this attack; it is very important to take PHARMACOR TACROLIMUS given to you by your doctor regularly so that your new liver, kidney, lung or heart will not be attacked or rejected. If you have been taking other medicines for this purpose, but are still feeling unwell, your doctor may change your treatment and begin giving you PHARMACOR TACROLIMUS. PHARMACOR TACROLIMUS contains the active ingredient tacrolimus, which is an immunosuppressive agent. Your doctor may have prescribed PHARMACOR TACROLIMUS for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU USE PHARMACOR TACROLIMUS WHEN YOU MUST NOT USE IT Do not use PHARMACOR TACROLIMUS if you have an allergy to tacrolimus, other macrolides (these are antibiotics of the erythromycin family – trade names are Eryc, EES, Klacid, Zithromax, Rul Read the complete document
Product Information – 0316 Page 1 of 17 AUSTR 209266;209267;209268;209270;209272;209274 PHARMACOR PTY LIMITED PHARMACOR TACROLIMUS (TACROLIMUS CAPSULES 0.5 MG, 1 MG, 5 MG) PRODUCT INFORMATION NAME OF THE MEDICINE Tacrolimus _[3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-_ _ 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a_-hexadecahydro-5,19-dihydroxy-3- [ 2- (4- hydroxy- 3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18- tetramethyl-8- (2-propenyl)-15,19-epoxy-3H-pyrido [ 2,1-c] [1,4] oxaazacyclotricosine- 1,7,20,21(4H,23H)- tetrone, monohydrate. Molecular Formula: C 44 H 69 NO 12 .H 2 O Molecular Weight: 822.03. CAS 104987-11-3 DESCRIPTION Tacrolimus appears as white to off white powder, soluble in acetone, chloroform and ethyl acetate, insoluble in water. Tacrolimus is obtained by fermentation as a single enantiomer but exists in tautomeric equilibration in aqueous solution. Pharmacor Tacrolimus capsules also contain hypromellose, croscarmellose sodium, lactose anhydrous and magnesium stearate. The capsule shell contains gelatin, water, sodium lauryl sulfate, titanium dioxide and colorants (ferric oxide yellow E172 for 0.5 mg capsules, and ferric oxide red E172 for 5 mg capsules). The capsules have a trace of printing ink (that used in the 0.5 mg and 1 mg capsules contains shellac and ferric oxide red E172; that used in the 5 mg capsule contain shellac, potassium hydroxide, titanium dioxide). PHARMACOLOGY Product Information – 0316 Page 2 of 17 AUSTR 209266;209267;209268;209270;209272;209274 Tacrolimus is a macrolide lactone with potent _in vitro _and _in vivo _immunosuppressive activity. Studies suggest that tacrolimus inhibits the formation of cytotoxic lymphocytes which are regarded as being primarily responsible for graft rejection. Tacrolimus suppresses T-cell activation and T-helper-cell-dependent B-cell proliferation, as well as the formation of lymphokines such as interleukins-2 and -3 and gamma-interferon and the expression of the interleukin-2 receptor. Read the complete document