Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
doxycycline hyclate, Quantity: 116.3 mg (Equivalent: doxycycline, Qty 100 mg)
Mayne Pharma International Pty Ltd
doxycycline hyclate (hydrochloride)
Capsule, modified release
Excipient Ingredients: microcrystalline cellulose; purified water; hypromellose phthalate; povidone; diethyl phthalate; magnesium stearate; wheat starch; hypromellose; lactose monohydrate; hyprolose; Gelatin; ethanol; Shellac; Pharmaceutical glaze; carbon black
Oral
7, 21
(S4) Prescription Only Medicine
Doxycycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. Doxycycline is active against a wide range of gram-positive and gram-negative organisms. NOTE: THE 50 mg CAPSULE IS NOT A PAEDIATRIC FORMULATION. MAYNE PHARMA Doxycycline Capsules are indicated in the treatment of infections caused by the following micro-organisms: Mycoplasma pneumoniae: primary atypical pneumonia. Rickettsiae: Queensland tick typhus, typhus fever and Q fever. Agents of psittacosis. Calymmatobacterium (Donovania) granulomitis: granuloma inguinale. Agents of lymphogranuloma venereum. Borreliae: relapsing fever. Chlamydia trachomatis. MAYNE PHARMA Doxycycline Capsules are 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 Capsules alone, or in combination with topical agents. MAYNE PHARMA Doxycycline is indicated in the treatment of infections caused by the following Gram-negative micro-organisms: Vibrio species: cholera. Brucella species: brucellosis (in conjunction with streptomycin). Yersinia pestis: plague. Francisella tularensis: tularemia. Bartonella bacilliformis: Bartonellosis. Bacteroides species. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: Treponema pallidum: syphilis. Treponema pertenue: yaws. Neisseria gonorrhoea: gonorrhoea (see Dosage and Administration). MAYNE PHARMA Doxycycline Capsules is not the drug of choice in the treatment of any type of Staphylococcal infection or infections caused by 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. Doxycycline should not be used in these infections unless the organism has been shown to be sensitive. For upper respiratory tract infections due to group A beta-haemolytic streptococci (including prophylaxis of rheumatic fever) penicillin is the usual drug of choice. Doxycycline is active against both pre-erythroycitic 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, for example chloroquine. In acute intestinal amoebiasis MAYNE PHARMA Doxycycline Capsules may be a useful adjunct to amoebicides. In severe acne MAYNE PHARMA Doxycycline Capsules may be a useful adjunctive therapy.
Visual Identification: Hard gelatin capsules, size 2, printed Doxy 100 in black and filled with yellow spheroidal pellets.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2004-09-14
MAYNE PHARMA DOXYCYCLINE CAPSULES 1 MAYNE PHARMA DOXYCYCLINE CAPSULES _doxycycline hyclate (hydrochloride) (dox-I-SYE-kleen) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Mayne Pharma Doxycycline 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 Mayne Pharma Doxycycline Capsules against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DOXYCYCLINE CAPSULES ARE USED FOR This medicine is an antibiotic used to: • treat certain types of infections • control acne • prevent some forms of malaria, sometimes in combination with another antimalarial medicine. 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. It also works against parasites that cause malaria. Tetracyclines will not work against viral infections 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. It is available only with a doctor's prescription. BEFORE YOU TAKE DOXYCYCLINE CAPSULES _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE DOXYCYCLINE CAPSULES IF YOU HAVE AN ALLERGY TO: • any medicine containing doxycycline • 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 troubled 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 PREPARATIONS CONTAINING VITAMIN A, ISOTRETINOIN OR E Lue koko asiakirja
v 5.0 1 AUSTRALIAN PRODUCT INFORMATON MAYNE PHARMA DOXYCYCLINE (DOXYCYCLINE HYCLATE (HYDROCHLORIDE)) CAPSULES 1. NAME OF THE MEDICINE Doxycycline hyclate (hydrochloride) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mayne Pharma Doxycycline Capsules contain either 50 mg or 100 mg of doxycycline (as doxycycline hyclate (hydrochloride)). Mayne Pharma Doxycycline Capsules also contain lactose and wheat starch. For the full list of excipients see Section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM Mayne Pharma Doxycycline Capsules contain modified release pellets of doxycycline hyclate (hydrochloride). The capsule contains pellets which are coated so as to retard but not prevent release in acid media. Mayne Pharma Doxycycline Capsules 50 mg are clear capsules marked doxy 50, containing yellow pellets. Mayne Pharma Doxycycline Capsules 100 mg are clear capsules marked doxy 100, containing yellow pellets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS NOTE: THE 50 mg CAPSULE IS NOT A PAEDIATRIC FORMULATION. Mayne Pharma Doxycycline Capsules are indicated in the treatment of infections caused by the following micro-organisms: _Mycoplasma pneumoniae_ : primary atypical pneumonia Rickettsiae: Queensland tick typhus, typhus fever and Q fever Agents of psittacosis _Calymmatobacterium (Donovania) granulomitis_ : granuloma inguinale Agents of lymphogranuloma venereum v 5.0 2 Borreliae: relapsing fever _Chlamydia trachomatis_ Mayne Pharma Doxycycline Capsules are 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 Capsules alone, or in combination with topical agents. Mayne Pharma Doxycycline Capsules are indicated in the treatment of infections caused by the following gram negative micro-organisms: _Vibrio_ species: cholera _Brucella_ species: brucellosis (in conjunction with streptomycin) _Yersinia pestis_ : plague _Francisella tularensis_ : tularemia _Bartonella bacilliformis_ : B Lue koko asiakirja