Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
doxycycline hyclate, Quantity: 115 mg (Equivalent: doxycycline, Qty 100 mg)
Alphapharm Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; pregelatinised maize starch; titanium dioxide; lactose monohydrate; hypromellose; indigo carmine; sunset yellow FCF; quinoline yellow; macrogol 4000
Oral
21 tablets, 7 tablets
(S4) Prescription Only Medicine
Doxycycline is indicated in the treatment of 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; Calymmatobacterium (Donovania) granulomatis: granuloma inguinale; 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.); Doxycycline is indicated in the treatment of infections caused by the following Gram-negative microorganisms: Vibrio species: Cholera; Brucella species: Brucellosis (in conjunction with streptomycin); Yersinia pestis: plague; Francisella tularensis: tularaemia; Bartonella bacilliformis: Bartonellosis; Bacteroides species. Doxycycline is active against both pre-erythrocytic and asexual bloodstages of Plasmodium falciparum. The tetracyclines are only partially active against the pre-erythrocytic stages of Plasmodium vivax, and protection depends on drug suppression of the blood stages. Doxycycline has no activity against the relapsing forms (hypnozoites) of Plasmodium vivax. 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, eg. chloroquine. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: Treponema pallidum: syphilis; Treponema pertenue: yaws; Neisseria gonorrhoeae: gonorrhoea. Doxycycline may be a useful adjunct to amoebicides in the treatment of acute intestinal amoebiasis. In the treatment of severe acne, doxycycline may be a useful adjunctive therapy. Doxycycline is not the drug of choice in the following: Any type of staphylococcal infection or infections caused by Streptococcus pneumoniae, Haemophilus influenzae, Streptococcus pyogenes, Enterococcus faecalis, or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. Doxylin should not be used for these infections unless the organism has been shown to be sensitive. For upper respiratory infections due to group A B-haemolytic streptococci, (including prophylaxis of rheumatic fever), penicillin is the usual drug of choice.
Visual Identification: 8.5mm normal convex, yellow film coated tablet, debossed DE over 100 on one side, G on the reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius
Registered
1998-05-22
DOXYLIN _doxycycline hyclate (as hydrochloride)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about DOXYLIN. 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 DOXYLIN 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 DOXYLIN IS USED FOR DOXYLIN is an antibiotic used to: • treat certain infections caused by bacteria • control acne • prevent certain types of malaria This medicine belongs to a group of medicines called tetracyclines. It works by killing or stopping the growth of bacteria, which cause infections or make acne worse. DOXYLIN also works against parasites that cause malaria. It is sometimes used in combination with other anti-malarial medicines. Tetracyclines will not work against infections caused by viruses, such as colds or flu. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE DOXYLIN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE DOXYLIN IF YOU HAVE AN ALLERGY TO: • any medicine containing doxycycline • any medicines containing other tetracyclines • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE IF YOU ARE TAKING OTHER MEDICINES CONTAINING VITAMIN A, ISOTRETINOIN OR ETRETINATE. DOXYLIN SHOULD NOT BE TAKEN IF YOU ARE MORE THAN 18 WEEKS PREGNANT OR ARE BREASTFEEDING. Lees het volledige document
AUSTRALIAN PRODUCT INFORMATION DOXYLIN _doxycycline hyclate (as hydrochloride) film coated tablet _ 1 NAME OF THE MEDICINE Doxycycline hyclate (as hydrochloride) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains doxycycline hyclate hydrochloride equivalent to 50 mg or 100 mg of doxycycline. Excipients with known effect: lactose monohydrate and trace amounts of sulfites. For the full list of excipients, see section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM DOXYLIN 50 mg tablet: round, yellow film coated, marked “DE” over “50” on one side, “G” on the reverse. DOXYLIN 100 mg tablet: round, yellow film coated, marked “DE” over “100” on one side “G” on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NOTE: THE 50 MG TABLET IS NOT A PAEDIATRIC FORMULATION. Doxycycline is indicated in the treatment of 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 _Calymmatobacterium (Donovania) granulomatis_ : granuloma inguinale _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.) Doxycycline is indicated in the treatment of infections caused by the following Gram-negative microorganisms: _Vibrio_ species: cholera _Brucella_ species: Brucellosis (in conjunction with streptomycin) _Yersinia pestis_ : plague DOXYLIN – PRODUCT INFORMATION 2 _Francisella tularensis_ : tularaemia _Bartonella bacilliformis_ : Bartonellosis _Bacteroides_ species. Doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by _Plasmodium falcipa Lees het volledige document