Clacido® is indicated for the short-term treatment of bacterial infections at the following sites:

• Upper respiratory tract infections (including ENT), e.g., recurrent tonsillitis, sinusitis, otitis media
• Lower respiratory tract infections, e.g., acute exacerbation of chronic bronchitis, lobar and bronchopneumonia
• Genitourinary tract infections, e.g., cystitis, urethritis, pyelonephritis
• Skin and soft tissue infections
• Bone and joint infections, e.g., osteomyelitis
• Other infections, e.g., intra-abdominal sepsis, septic abortion, puerperal sepsis, septicaemia, peritonitis, post-surgical infections

Tablet

Adults
The usual adult dose is one Clacido® 625 mg tablet every 12 hours or one Clacido® 375 mg tablet every 8 hours. Formore severe infections and infections of the respiratory tract, the dose should be one Clacido® 1 gm tablet every 12hours or one Clacido® 625 mg tablet every 8 hours.

Suspension

Pediatric Patients

For neonates and infants younger than 12 weeks (under 3 months of age), the recommended dosage of Clacido® is 30 mg per kilogram of body weight per day, divided into two equal doses and administered every 12 hours. This dosing schedule helps ensure that the infant receives a consistent level of medication in the body while minimizing potential side effects. The dose should always be carefully measured using a proper dosing syringe or spoon, and given under medical supervision.

For children aged 12 weeks (3 months) and older, the dosing regimen varies depending on the severity of the infection and the formulation used.

In cases of moderate to severe infections, such as otitis media, sinusitis, or lower respiratory tract infections, there are two recommended regimens based on how frequently the medication is administered:

If dosing is done every 8 hours, the 125 mg/5 mL oral suspension should be used, with a total daily dose of 40 mg/kg/day, divided into three doses.

If dosing is done every 12 hours, the 400 mg/5 mL oral suspension is preferred, with a total daily dose of 45 mg/kg/day, divided into two doses.

For less severe infections, the dosage may be adjusted downward to reduce exposure while still effectively treating the condition:

When given every 12 hours, the recommended dose is 25 mg/kg/day, divided into two doses.
When given every 8 hours, the recommended dose is 20 mg/kg/day, divided into three doses.

Clacido® oral suspension may be taken with or without food, but administering it at the start of a meal is advised to improve absorption and minimize gastrointestinal discomfort. The treatment duration and exact dosage should always be determined by a healthcare professional based on the child’s specific medical condition, weight, and response to therapy.

Patients Weighing 40 kg or more: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.

The normal duration of treatment was 7 to 10 days. Clacido® may be taken without regard to meals; however, absorption of Clavulanate potassium is enhanced when Amoxicillin/Clavulanic acid is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin/Clavulanic acid should be taken at the start of the meal.

Injection

Adults and children over 12 years:
Usually 1.2 g eight hourly. In more serious infections, increase frequency to six-hourly intervals.

Children 3 months-12 years:
Usually 30 mg/kg eight hourly. In more serious infections, increase frequency to six-hourly intervals.

Children 0-3 months:
30 mg/kg eight hourly (every 12 hours in the perinatal period and in premature infants).

Adult dosage for surgical prophylaxis:
The usual dose is 1.2 g at the induction of anaesthesia , for high risk of infection, (e.g. colorectal surgery) may require three and up to four doses of 1.2 g intravenous in a 24-hour period.

Dosage in renal impairment

Adults

Children
Similar reductions in dosage should be made for children.

Dosage in hepatic impairment
Dose with caution; monitor hepatic function at regular intervals.

Clacido® should be used with care in patients on anti-coagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, dosage should be adjusted. During the administration of high dose of Clacido® adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.

• History of a serious hypersensitivity reaction to Clacido® or to other beta-lactams (e.g., penicillins or cephalosporins).

• History of cholestatic jaundice/hepatic dysfunction associated with Clacido®.

The most frequently reported adverse effects:

Diarrhea/loose stools (9%), Nausea (3%), Skin rashes and Urticaria (3%), Vomiting (1%) and Vaginitis (1%)

• Co-administration with probenecid is not recommended

• Concomitant use of Clacido® and oral anticoagulants may increase the prolongation of prothrombin time.

• Coadministration with allopurinol increases the risk of rash

• Clacido® may reduce efficacy of oral contraceptives

Pregnancy Category B. This drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. Caution should be exercised when amoxicillin/clavulanate potassium is administered to a nursing woman.

Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident.

Amoxicillin/Clavulanate potassium can be removed from the circulation by haemodialysis.

Clacido® Tablet: Should be stored at a temperature not exceeding 25 0 C in a dry place. Protect from light and moisture.

Clacido® Suspension: Should be stored at a temperature not exceeding 25 0 C in a dry place. Protect from light and moisture. Once reconstituted suspension should be kept in a cool place preferably in refrigerator 2-8 0 C (but not frozen) and should be used by 7 days.

Clacido® Injection: Should be stored at a temperature not exceeding 25 0 C in a dry place. Protect from light and moisture. Use within 20 minutes of reconstitution.

Medicine: Keep out of reach of children

Clacido® Tablet 375 mg: Each box contains 3 x 6’s film coated tablets in Alu-Alu blister pack.

Clacido® Tablet 625 mg: Each box contains 3 x 6’s film coated tablets in Alu-Alu blister pack.

Clacido® Tablet 1g: Each box contains 2 x 6’s film coated tablets in Alu-Alu blister pack.

Clacido® Powder for Suspension: Bottle containing dry powder to make 100 ml suspension.

Clacido® bid Powder for Suspension: Bottle containing dry powder to make 35 ml suspension.

Clacido®I.V. Injection1.2g: Each vial contains Amoxicillin Sodium BP 1060.20 mg equivalent to Amoxicillin 1000 mg and Clavulanate Potassium USP 238.14 mg equivalent to Clavulanic Acid 200 mg, one ampoule containing 20 ml of sterile water for injection. It also contains a complementary pouch comprising sterile disposable syringe (20 ml), butterfly needle, alcohol pad, first aid bandage and ampoule breaker.