Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
clindamycin hydrochloride, Quantity: 162.87 mg
Arrotex Pharmaceuticals Pty Ltd
clindamycin hydrochloride
Capsule, hard
Excipient Ingredients: maize starch; titanium dioxide; lactose monohydrate; Gelatin; iron oxide black; Shellac; magnesium stearate; purified talc
Oral
24 Capsules, 100 Capsules
(S4) Prescription Only Medicine
Clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin capsules are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate. Anaerobes Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and skin structure infections; septicaemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, non-gonococcal tubo-ovarian abscess, pelvic cellulitis and post-surgical vaginal cuff infection. Streptococci Serious respiratory tract infections; serious skin and skin structure infections, septicaemia. Staphylococci Serious respiratory tract infections; serious skin and skin structure infections; septicaemia; acute haematogenous osteomyelitis. Pneumococci Serious respiratory tract infections. Adjunctive Therapy In the surgical treatment of chronic bone and joint infections due to susceptible organisms. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. Bacteriological studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
Visual Identification: A hard gelatin capsule, size 1 white/white containing white crystalline powder, with marking "CLIN 150"; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-08-22
APO-CLINDAMYCIN CAPSULES 1 APO-CLINDAMYCIN CAPSULES _Contains the active ingredient Clindamycin hydrochloride _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 this medicine against the benefits they expect it will 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 THIS MEDICINE IS USED FOR Clindamycin is an antibiotic. It is used to treat infections in different parts of the body caused by bacteria. It works by killing or stopping the growth of the bacteria causing your infection. Clindamycin will not work against viral infections such as colds or flu. Clindamycin is recommended for patients who are allergic to penicillin or patients for whom penicillin is not suitable. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CLINDAMYCIN HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Clindamycin for another reason. This medicine is available only with a doctor's prescription. Clindamycin capsules are not recommended in children for formulation reasons. Clindamycin is not addictive. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing clindamycin or lincomycin • lactose or 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 AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. I Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – APO- CLINDAMYCIN CAPSULES (CLINDAMYCIN HYDROCHLORIDE) 1 NAME OF THE MEDICINE Clindamycin hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clindamycin hydrochloride is white or almost white, crystalline powder, very soluble in water, slightly soluble in ethanol (96 per cent). It is a semi- synthetic antibiotic produced by a 7(S)- chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The pKa value is 7.6. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM The capsules consist of a white cap and white body imprinted with ‘Clin 150’. Each capsule contains 150 mg of clindamycin hydrochloride as active ingredient. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin capsules are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate. ANAEROBES Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and skin structure infections; septicaemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, non-gonococcal tubo-ovarian abscess, pelvic cellulitis and post-surgical vaginal cuff infection. STREPTOCOCCI Serious respiratory tract infections; serious skin and skin structure infections, septicaemia. STAPHYLOCOCCI Serious respiratory tract infections; serious skin and skin structure infections; septicaemia; acute haematogenous osteomyelitis. PNEUMOCOCCI Serious respira Read the complete document