Klacid P125 & P250 125 mg/5 ml/250 mg Granules

KLACID P is indicated for the treatment of infections due to susceptible organisms, in the following conditions:

• Upper respiratory tract infections, e.g. pharyngitis and tonsillitis due to S. pyogenes.
• Lower respiratory tract infections, e.g. bronchitis.
• Mild to moderately severe acute otitis media due to S. pneumoniae, M. catarrhalis and H. influenzae.
• Mild to moderately severe skin and skin structure infections due to S. aureus.

The recommended daily dosage for KLACID P in children is given in the following table and is based on a 7.5 mg/kg twice daily regimen. (A maximum dose of 500 mg twice daily is recommended for the most severe infections). The usual duration of treatment is 5 - 10 days depending on the pathogen involved and the severity of the condition.

Reconstitution instructions: KLACID P125: 50 ml bottle: Add 29 ml of distilled water to reconstitute to 50 ml. Shake the bottle. KLACID P250: 50 ml bottle: Add 29 ml of distilled water to reconstitute to 50 ml. Shake the bottle. 100 ml bottle: Add 53 ml of distilled water to reconstitute to 100 ml. Shake the bottle.

KLACID P is contra-indicated in patients with known hypersensitivity to macrolide antibiotics.

Concomitant administration of KLACID P and any of the following drugs is contra-indicated: astemizole, cisapride, pimozide, terfenadine and ergotamine or dihydroergotamine. KLACID P is contra-indicated in patients receiving terfenadine therapy who have pre-existing cardiac abnormalities (arrhythmia, bradycardia, QT interval prolongation, ischaemic heart disease, congestive heart failure, etc.) or electrolyte disturbances.

Safety and efficacy in infants less than 6 months of age have not been established.

KLACID P is principally excreted by the liver. Caution should be exercised in administering this antibiotic to patients with impaired hepatic function. Caution should be exercised when administering KLACID P to patients with moderate to severe renal failure. There have been post-marketing reports of colchicine toxicity with concomitant use of KLACID and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients.

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-resistance between KLACID P and other macrolides, as well as lincomycin and clindamycin.

Data available to date indicate KLACID P 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 KLACID P and may be associated with elevations in serum levels of these 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, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral disopyramide, anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.

Results of clinical studies indicate that there is a modest but statistically significant (p < 0.05) increase in circulating theophylline and carbamazepine levels when either of these drugs was administered concomitantly with KLACID P. The use of KLACID P in patients receiving warfarin may result in a potentiation of the effects of warfarin. Prothrombin times should be monitored in these patients.

Safety in pregnancy and lactation has not been established. KLACID P is excreted into breast milk. If KLACID P is considered for patients of post-pubertal age, the physician should carefully weigh the benefits against the risk when pregnancy is either suspected or confirmed.

Not specified in the provided text.

The most commonly reported adverse events were diarrhoea, vomiting and abdominal pain. Adverse events are displayed in the following tables by System Organ Class and frequency, according to the following convention: Common (>1/100 to <1/10).

Post-Marketing Experience: The adverse reactions reported are consistent with those observed in clinical studies. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The ingestion of large amounts of KLACID P can be expected to produce gastrointestinal symptoms. One patient who had a history of bipolar disorder ingested eight grams of KLACID and showed altered mental status, paranoic behaviour, hypokalaemia and hypoxaemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed medicine and supportive measures. KLACID P serum levels are not expected to be appreciably affected by haemodialysis or dialysis.