Country: Australia
Language: English
Source: 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
(S4) Prescription Only Medicine
OTHER CONDITIONS: Protect from moisture. INDICATIONS: 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). Infections caused by the following Gram- negative microorganisms: Vibrio species (chlorea), Brucella sp. (Brucellosis; in conjuction 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 infuenzae, 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 tablet scored on one side for oral use, diameter 9.1mm; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2008-06-24
_Doxycycline AN tablets – Consumer Medicine Information _ _ _ _Doxycycline AN CMI v 3.0 _ _ _ _ _ _Page 1 _ DOXYCYCLINE AN TABLETS _Doxycycline hydrochloride 50 mg & 100 mg tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Doxycycline AN. 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 Doxycycline AN 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 DOXYCYCLINE AN IS USED FOR Doxycycline AN is an antibiotic used to • Treat certain infections • Control acne • Prevent malaria Doxycyline AN 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 Doxycycline AN for another purpose. Ask your doctor if you have any questions about why Doxycycline AN has been prescribed for you. This medicine is only available with a doctor’s prescription. There is no evidence that Doxycycline AN is addictive. BEFORE YOU TAKE DOXYCYCLINE AN _WHEN YOU MUST NOT TAKE _ _DOXYCYCLINE AN _ DO NOT TAKE DOXYCYCLINE AN 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 Read the complete document
_Doxycycline AN tablets Product Information _ _ _ _Amneal Pharma Australia Pty Ltd _ Doxycycline AN PI v4 Page 1 DOXYCYCLINE AN _ _ _(DOXYCYCLINE TABLETS) _ _ _ PRODUCT INFORMATION NAME OF THE MEDICINE The name of the medicine is doxycycline hyclate (hydrochloride) CHEMICAL NAME : hydrochloride hemiethanolate hemihydrate of (4S,4aR,5S,5aR,6R,12aS)-4-(dimethylamino)- 3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene- 2- carboxamide MOLECULAR FORMULA : C 22 H 25 ClN 2 0 8 MOLECULAR WEIGHT: 512.9 CAS NUMBER: [ _24390-14-5_ ] DESCRIPTION Doxycycline is a broad spectrum antibiotic synthetically derived from oxytetracycline. Chemical name: 6-deoxy-5-oxytetracycline. It is a light yellow crystalline powder which has a high lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. It will not degrade into an epianhydro form. Doxycycline AN 100 mg and Doxycycline AN 50 mg tablets also contain: microcrystalline cellulose, maize starch, colloidal anhydrous silica, magnesium stearate and Opadry white Y-1- 7000B. PHARMACOLOGY _Microbiology_ Doxycycline is primarily bacteriostatic and is thought to exert its anti-microbial effect by the inhibition of protein synthesis. It is active against a wide range of Gram-positive and Gram- negative organisms (see indications). _Doxycycline AN tablets Product Information _ _ _ _Amneal Pharma Australia Pty Ltd _ Doxycycline AN PI v4 Page 2 Disc Susceptibility Test: “Dilution or diffusion techniques – either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardized method (eg. Clinical and Laboratory Standards Institute [CLSI formely NCCLS]). Standardised susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. • A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usual Read the complete document