Clavokor Tablet

Manufacturer

Marketed in India by

Medicef

Koronis Pharmaceutical Pvt Ltd

Contents

Clavokor film-coated tab: amoxicillin 500 mg, clavulanic acid 125 mg.

Clavokor- DS film-coated tab: amoxicillin 875 mg, clavulanic acid 125 mg.
Clavokor dry syr: amoxicillin 200 mg, clavulanic acid 28.5 mg/5 mL.

Indication & Dosage

Oral
Otitis media
Adult: Based on amoxicillin dose, 250-500 mg every 8 hr or 500-750 mg every 12 hr.
Child: Based on amoxicillin dose: 125-250 mg every 8 hr. Children weighing <40 kg: 20-40 mg/kg/day in divided doses every 8 hr. Infants <3 mth: up to 30 mg/kg/day in divided doses every 12 hr.
Oral
Sinusitis
Adult: Based on amoxicillin dose, 250-500 mg every 8 hr or 500-750 mg every 12 hr.
Child: Based on amoxicillin dose: 125-250 mg every 8 hr. Children weighing <40 kg: 20-40 mg/kg/day in divided doses every 8 hr. Infants <3 mth: up to 30 mg/kg/day in divided doses every 12 hr.
Oral
Skin and soft tissue infections
Adult: Based on amoxicillin dose, 250-500 mg every 8 hr or 500-750 mg every 12 hr.
Child: Based on amoxicillin dose: 125-250 mg every 8 hr. Children weighing <40 kg: 20-40 mg/kg/day in divided doses every 8 hr. Infants <3 mth: up to 30 mg/kg/day in divided doses every 12 hr.
Oral
Upper and lower respiratory tract infections
Adult: Based on amoxicillin dose, 250-500 mg every 8 hr or 500-750 mg every 12 hr.
Child: Based on amoxicillin dose: 125-250 mg every 8 hr. Children weighing <40 kg: 20-40 mg/kg/day in divided doses every 8 hr. Infants <3 mth: up to 30 mg/kg/day in divided doses every 12 hr.

Oral
Susceptible infections
Adult: Based on amoxicillin dose, 250-500 mg every 8 hr or 500-750 mg every 12 hr.
Child: Based on amoxicillin dose: 125-250 mg every 8 hr. Children weighing <40 kg: 20-40 mg/kg/day in divided doses every 8 hr. Infants <3 mth: up to 30 mg/kg/day in divided doses every 12 hr.
Oral
Dental abscesses
Adult: Based on amoxicillin dose: 3 g as a single dose, followed by another dose 8 hr later.
Oral
Acute uncomplicated urinary tract infections
Adult: Based on amoxicillin dose: 3 g as a single dose, followed by another dose 10-12 hr later.
Oral
Severe or recurrent respiratory tract infections
Adult: Based on amoxicillin dose: 3 g bid.
Oral
Uncomplicated gonorrhoea
Adult: Based on amoxicillin dose: 3 g as a single dose with 1 g of oral probenecid.
Oral
Prophylaxis of endocarditis
Adult: Based on amoxicillin dose: 2 or 3 g as a single dose. To be taken 1 hr before the dental procedure.
Oral
H.pylori infection
Adult: Based on amoxicillin dose: 0.75-1 g bid or 500 mg tid. To be taken with metronidazole or claithromycin and a PPI or ranitidine bismuth citrate.
Parenteral
Susceptible infections
Adult: Based on amoxicillin dose: 500 mg every 8 hr. In severe infections, may increase to 1 g every 6 hr. Can be given via IM inj or slow IV inj over 3-4 minutes or IV infusion over 30-60 minutes.
Child: <10 yr: 50-100 mg/kg/day in divided doses.

Reconstitution: Powder for oral suspension: Reconstitute with appropriate amount of water as specified on the bottle. Shake vigorously until suspended.

Contraindications

Penicillin allergy.

Special Precautions

History of allergy especially to cephalosporins, infectious mononucleosis, severe renal impairment.

Adverse Drug Reactions

Nausea, vomiting, diarrhoea, indigestion, rash and urticaria, candida superinfection.
Potentially Fatal: Anaphylactic reaction with CV collapse esp with parenteral use.

Drug Interactions

Allopurinol may reduce renal tubular secretion of amoxicillin thus increasing the serum levels of amoxicillin. Concurrent use may reduce the efficacy of oral contraceptives.

Food Interaction

None on absorption. But incidence and severity of GI effects may be reduced.

Storage

Oral: Store below 25°C. Parenteral: Store below 25°C.

Mechanism of Action

Clavulanic acid has a high affinity for and binds to certain β-lactamases that generally inactivate amoxicillin by hydrolyzing its β-lactam ring. Combining clavulanate potassium with amoxicillin extends the antibacterial spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other penicillins and cephalosporins.
Distribution: Protein binding: About 25% (Clavulanic acid); about 18% (Amoxicillin). Amoxicillin distributes readily into most body tissues and fluids except the brain and spinal fluid.
Excretion: Half-life after oral admin: 1.3 hr (Amoxicillin); 1 hr (Clavulanic acid). About 50-70% of amoxicillin and 25-40% of clavulanic acid are excreted unchanged in urine during the 1st 6 hr after admin.



CIMS Class

Penicillins

ATC Classification

J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the treatment of systemic infections.

Presentation/Packing

Form

Packing (Max Retail Price)

Clavokor film-coated tab:

10’s (220.00 INR)

Clavokor- DS film-coated tab:


Clavokor dry syr: