Clacee 250mg. 500mg Tablet

u2022 Lower respiratory tract infections, e.g . bronchitis, pneumonia

u2022 Upper respiratory tract infections, e.g . pharyngitis, sinusitis

u2022 Skin and soft tissue infections, e . g. folliculitis, cellulitis, erysipelas

u2022 Eradication of H.pylori, resulting in decreased recurrence of duodenal ulcer when used in combination with a proton-pump inhibitor to suppress acid secretion and another antibiotic . CLACEE has been used in treatment regimens which include CLACEE plus amoxycillin and omeprazole; CLACEE plus tinidazole and omeprazole; and CLACEE plus tetracycline and bismuth subsalicylate .

u2022 There is some evidence that disseminated and localised mycobacterial infections in HIV-positive adults, due to Mycobacterium avium or Mycobacterium intrace //u /are respond to CLACEE . Based on bacteriological results, CLACEE should be used in conjunction with other antimycobacterials. Localised infections due to Mycobacterium chelonae and Mycobacterium kansasii have responded to CLACEE to a lesser extent.

The recommended dosage of CLACEE is one 250 mg tablet twice daily . In more severe infections , the dosage can be increased to 500 mg tw i ce daily . In patients with renal impairment with creatinine clearance of less than 30 ml/min, the dosage of CLACEE should be reduced by one-half, i.e . 250 mg once daily, or 250 mg twice daily in more severe infections . Dosage should not be continued beyond 14 days in these patients.

Eradication of H. pylori: to decrease recurrence of duodenal ulcer in combination with a proton-pump inhibitor and another antibiotic: CLACEE 500 mg twice daily in combination with amoxycillin 1000 mg twice daily and omeprazole 20 mg daily for 7 - 10 days.

Dosage in HIV patients with mycobacterial infections: The recommended treatment for adults with disseminated or localised mycobacterium infections (M. avium , M. intrace/lulare , M. chelonae, M. kansasii) is 500 mg b . d.

CLACEE is contra-indicated in patients with known hypersensitivity to macrolide antibiotic drugs . Concomitant administration of CLACEE and any of the following drugs is contra- indicated: astemizole, cisapride, pimozide, terfenadine and ergotamine or dihydroergotamine (see INTERACTIONS).

CLACEE is principally excreted by the liver. Caution should be exercised in administering the antibiotic to patients with i mpaired hepatic function . Caution should also be exercised when administering CLACEE to patients with moderate to severe renal impairment. There have been post-marketing reports of colchicine toxicity with concomitant use of CLACEE and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients (see INTERACTIONS : Colchicine) . Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides, and may range in severity from mild to life-threatening. Attention should be paid to the possibility of cross-res i stance between CLACEE and other macrolide medicines, as well as lincomycin and clindamycin .

Data available to date indicate CLACEE is metabolised primarily by the hepatic cytochrome P450 3A (CYP3A) isozyme . This is an important mechanism determining many drug interactions. The metabolism of other drugs by this system may be inhibited by concomitant administration with CLACEE and may be associated with elevations in serum levels of these other drugs. The following drugs or drug classes are known or suspected to be metabolised by the same CYP3A isozyme : alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporine, disopyramide , ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin) , pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, l triazolam and vinblastine. Drugs interacting by similar mechanisms through other isoenzymes within the cytochrome P450 system include phenytoin, theophylline and valproate. Results of clinical studies indicate that there was a modest but statistically significant (p ::;; 0,05) increase of circulating theophylline or carbamazepine levels when either of these drugs was administered concomitantly with CLACEE. The use of CLACEE in patients receiving warfarin may result in potentiation of the effects of warfarin . Prothrombin times in these patients should be monitored.

Safety in pregnancy and lactation has not been established . The physician should not prescribe CLACEE to pregnant women without carefully weighing the benefits against risk, particularly during the first three months of pregnancy . CLACEE is excreted into human breast-milk.

Not provided in the text.

Summary of adverse drug events reported during clinical trials (BID dosing, all indications)* System organ class (MedDRA Term) Frequency * Adverse Events Infections and infestations Common Infection Nervous system disorders Common Dizziness Dysgeusia Headache Gastrointestinal disorders Common Abdominal pain Diarrhoea Dyspepsia Nausea Vomiting Skin and subcutaneous tissue disorders Common Pruritus General disorders and administration s i te conditions Common Asthenia Investigations Common Alanine aminotransferase increased Aspartate aminotransferase increased * Reported incidence of adverse events in cl i nical studies involving 3437 patients taking CLACEE Treatment of disseminated MAC infections in Al OS patients should continue as long as clinica l and microbiological benefit is demonstrated . A decrease in efficacy has been noted in patients on treatment exceeding 12 weeks . CLACEE should be used in conjunction with other antimycobacterial agents . Treatment of other non-tuberculous mycobacterial infections should continue at the discretion of the physician.

Reports indicate that the ingestion of large amounts of CLACEE can be expected to produce gastrointestinal symptoms. One patient who had a history of bipolar disorder ingested eight grams of CLACEE and showed altered mental status, paranoid behaviour, hypokalaemia and hypoxemia . Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures . CLACEE serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.