Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DOXYCYCLINE HYDROCHLORIDE/HYCLATE
PFIZER (MALAYSIA) SDN. BHD.
DOXYCYCLINE HYDROCHLORIDE/HYCLATE
100Tablet Tablets
PFIZER PHARMACEUTICALS LIMITED
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ VIBRAMYCIN ® TABLET Doxycycline Hydrochloride (100 mg) 1 WHAT IS IN THIS LEAFLET 1. What VIBRAMYCIN is used for 2. How VIBRAMYCIN works 3. Before you use VIBRAMYCIN 4. How to use VIBRAMYCIN 5. While you are using it 6. Side effects 7. Storage and Disposal of VIBRAMYCIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT VIBRAMYCIN IS USED FOR VIBRAMYCIN is an antibiotic. It is used to treat many bacterial infections such as: - Fever associated with louse or tick bites (typhus fever) - Chest, lung or nasal infections e.g. pneumonia - Sexually transmitted diseases e.g. gonorrhoea, syphilis, chlamydia - Urinary tract infections (the passage through which urine passes) e.g. urethritis It is also used for the prevention and treatment of malaria (when chloroquine is not effective), leptospirosis (a bacteria carried by animals and found in soil and water), and cholera. It is used with other medicines to treat acne and intestinal parasites. It is also used to prevent scrub typhus and traveler's diarrhea. HOW VIBRAMYCIN WORKS VIBRAMYCIN kills or prevents bacteria from growing. BEFORE YOU USE VIBRAMYCIN - _When you must not use it_ Do not use VIBRAMYCIN if you are allergic to doxycycline or any of its other ingredients or any other tetracycline. _Pregnancy and lactation_ Do not take VIBRAMYCIN if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take VIBRAMYCIN if you are breast-feeding. Doxycycline is present in the milk of breastfeeding women. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it_ Tell your doctor if - you are in the last half of pregnancy or the medicine has been prescribed for a child under the age of 8 years as it may cause permanent discolouration of teeth (yellow-gray- brown). - you have diarrhoea or usually get diarrhoea when you take antibiotics. If you develop severe diarrhoea during or after Baca dokumen lengkap
Pfizer Confidential 1 VIBRAMYCIN Doxycycline Hydrochloride 1. NAME OF THE MEDICINAL PRODUCT VIBRAMYCIN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline and is available as doxycycline hyclate (hydrochloride hemiethanolate hemihydrate). The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. 3. PHARMACEUTICAL FORM Doxycycline is available as: Film-coated tablets containing 100 mg of doxycycline as the hyclate salt. DESCRIPTION Doxycycline film-coated tablets are a smooth, well formed, round biconvex, white film-coated tablet, 8.1 mm in diameter, debossed with “PT” and “097” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TREATMENT: Doxycycline is indicated for treatment of the following infections: Rocky Mountain spotted fever, typhus fever and the typhus group; Q fever, rickettsial pox and tick fevers caused by _Rickettsiae_; Respiratory infections caused by _Mycoplasma pneumoniae_; Psittacosis caused by _Chlamydia psittaci_; Lymphogranuloma venereum, caused by _Chlamydia trachomatis_; Uncomplicated urethral, endocervical or rectal infections in adults caused by _ Chlamydia _ _trachomatis_; Trachoma caused by _ Chlamydia trachomatis _ although the infectious agent is not always eliminated, as judged by immunofluorescence; Pfizer Confidential 2 Inclusion conjunctivitis caused by _Chlamydia trachomatis _may be treated with oral doxycycline alone or with a combination of topical agents; Granuloma inguinale (donovanosis) caused by _Calymmatobacterium granulomatis_; Early (Stage 1) Lyme disease caused by _Borrelia burgdorferi_; Louse-borne relapsing fever caused by _Borrelia recurrentis_; Tick-borne relapsing fever caused by _Borrelia duttonii_; Non-gonococcal urethritis (NGU) caused b Baca dokumen lengkap