Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
doxycycline hyclate, Quantity: 115.4 mg (Equivalent: doxycycline, Qty 100 mg)
Arrotex Pharmaceuticals Pty Ltd
doxycycline hyclate (hydrochloride)
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; maize starch; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; indigo carmine; macrogol 4000
Oral
7 tablets, 21 tablets
(S4) Prescription Only Medicine
Infections caused by the following organisms; Mycoplasma pneumoniae (primary atypical pneumonia); Rickettsiae (Queensland tick typhus, epidemic typhus fever, Q fever, murine endemic typhus fever, Australo-Pacific endemic scrub typhus); Chlamydia psittaci (psittacosis); Chlamydia trachomatis (lymphogranuloma venereum, trachoma, inclusion conjunctivitis). (Doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis may be treated with oral doxycycline alone, or in combination with topical agents). Borreliae (relapsing fever). Calymmatobacterium (Donovania) granulomatis (granuloma inguinale). Infection caused by the following Gram-negative microorganisms: Vibrio species (chlorea), Brucella sp. (Brucellosis; in conjunction with streptomycin), Haemophilus ducreyi (chancroid), Yersinia pestis (plague), Francisella turarenis (tularaemia), Bartonella bacilliformis (Bartonellosis), Bacteroides sp. When penicillin is contraindicated, Doxy-100 is an alternative drug in the treatment of infections due to : Treponema pallidum (syphilis); Treponema pertenue (yaws); Neisseria gonorrhoea (see Dosage and Administration). Doxy-100 is not the drug of choice in the treatment of any type of staphylococcal infection or infections due to Streptococcus pneumoniae, Haemophilus influenzae, Streptococcus pyogenes, Streptococcus faecalis or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. Doxy-100 should not be used in these infections unless the organism has been shown to be sensitive. For upper respiratory infections due to group A beta-haemolytic streptococci (including prophylaxis of rheumatic fever), penicillin is the usual drug of choice. In acute intestinal amoebiasis, doxycycline may be a useful adjunct to amoebicides. In severe acne, doxycycline may be useful adjunctive therapy. Doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by Plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by Plasmodium vivax. Doxycycline is only able to suppress malaria caused by P. vivax. As there are relatively few locations where P. vivax does not co-exist to some extent with P. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example, chloroquine.
Visual Identification: White, film-coated, biconvex tablets with a breakline on one face, for oral use, diameter 9.1mm.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2008-06-24
_DOXSIG tablets – Consumer Medicine Information _ _ _ _DOXSIG CMI July 2019 _ _ _ _ _ _Page 1 _ DOXSIG TABLETS _doxycycline hyclate (hydrochloride) _ _ 50 mg & 100 mg tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DOXSIG. 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 benefits and risks. Your doctor has weighed the risks of you taking DOXSIG against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT DOXSIG IS USED FOR DOXSIG is an antibiotic used to • Treat certain infections • Control acne • Prevent malaria DOXSIG tablets belong to a class of medicines called tetracyclines. These medicines work by killing or stopping the growth of bacteria which cause infections or make acne worse. They also work against parasites which cause malaria. Tetracyclines will not work against viral infections such as colds or the ‘flu’. Your doctor, however, may prescribe DOXSIG for another purpose. Ask your doctor if you have any questions about why DOXSIG has been prescribed for you. This medicine is only available with a doctor’s prescription. There is no evidence that DOXSIG is addictive. BEFORE YOU TAKE DOXSIG _WHEN YOU MUST NOT TAKE _ _DOXSIG _ DO NOT TAKE DOXSIG IF: 1. You have ever had an ALLERGIC REACTION to • Medicines containing doxycycline, or doxycycline hydrochloride • Medicines containing other tetracyclines • Any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction to tetracyclines may include: rash, itching or hives of the skin, swelling of the face, lops and tongue or other parts of the body, shortness of breath, wheezing or troubled breathing 2. You are TAKING PREPARATIONS CONTAINING VITAMIN A, ISOTRETINOIN OR ETRETINATE Ask your doctor or Lugege kogu dokumenti
1 AUSTRALIAN PRODUCT INFORMATION – DOXSIG (DOXYCYCLINE HYCLATE (HYDROCHLORIDE)) TABLETS 1 NAME OF THE MEDICINE Doxycycline hyclate (hydrochloride) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Doxycycline is a broad spectrum antibiotic synthetically derived from oxytetracycline. DOXSIG tablets contain doxycycline 5 0 m g o r 100mg as doxycycline hyclate ( hydrochloride). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM DOXSIG 50 mg tablets: White film-coated circular biconvex tablet having a diameter of 6.3 mm. DOXSIG 100 mg tablets: White film-coated, biconvex tablet, with a breakline on one face. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Infections caused by the following microorganisms: Mycoplasma pneumoniae (primary atypical pneumonia); Rickettsiae (Queensland tick typhus, epidemic typhus fever, Q fever, murine endemic typhus fever, Australo-Pacific endemic scrub typhus): Chlamydia psittaci (psittacosis); Chlamydia trachomatis (lymphogranuloma venereum, trachoma, inclusion conjunctivitis). (Doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis may be treated with oral doxycycline alone, or in combination with topical agents.) Borreliae (relapsing fever); Calymmatobacterium (Donovania) granulomatis (granuloma inguinale). Infections caused by the following Gram-negative microorganisms: Vibrio sp. (cholera); Brucella sp. (Brucellosis; in conjunction with streptomycin); Haemophilus ducreyi (chancroid); Yersinia pestis (plague); Francisella tularensis (tularaemia); Bartonella bacilliformis (Bartonellosis); Bacteroides sp. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: Treponema pallidum (syphilis); Treponema perenue (yaws); Neisseria gonorrhoea (see section 4.2 DOSE AND METHOD OF ADMINISTRATION). Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infection Lugege kogu dokumenti