CLAVOMED SUSP.
Back to Products156.25 mg / 5 ml
| Form | Powd. for susp. |
|---|---|
| Active Substance | Amoxicillin / Clavulanic acid |
| Presentation | Vial 80 ml |
| Treatment Category | Anti-infective agents |
About the Product
COMPOSITION
Each 5 mL of suspension contains:
amoxicillin/clavulanic acid 156.25 mg (125 mg/31.25 mg).
INDICATIONS FOR USE
·Respiratory tract and ENT infections (acute and chronic sinusitis, acute and chronic otitis media, tonsillopharyngitis, acute and chronic bronchitis, and pneumonia);
·Urinary tract infections (including cystitis, urethritis, and pyelonephritis);
·Bone and connective tissue infections, including chronic osteomyelitis;
·Skin and soft tissue infections, including cellulitis and wound infections;
·Biliary tract infections (cholecystitis and cholangitis);
·Sexually transmitted diseases (gonorrhea and chancroid);
·Odontogenic infections;
· Prevention of infections during surgical procedures.
DOSAGE AND ADMINISTRATION
For oral use.
For neonates and infants up to 3 months of age, the standard dose is 30 mg of amoxicillin per kg body weight per day, divided into 2 doses.
Standard doses for children older than 3 months are determined according to body weight.
| Patient Age and Body Weight | Suspension 156.25 mg/5 mL |
| Children 10–12 years, body weight 29–31 kg | 15 mL three times daily |
| Children 6–9 years, body weight 19–28 kg | 10 mL three times daily |
| Children 1–5 years, body weight 10–18 kg | 5 mL three times daily |
| Children 3 months–1 year, body weight 5–9 kg | 2.5 mL three times daily |
| Children 3 months–1 year, body weight 2–4 kg | 2.5 mL once or twice daily |
DOSAGE FORM
Рowder for oral suspension preparation, in an 80 mL bottle.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics and Pharmacokinetics
Clavomed is a combination of amoxicillin, a semi-synthetic penicillin with a broad spectrum of antibacterial activity, and clavulanic acid, an irreversible β-lactamase inhibitor.
Clavulanic acid forms a stable inactive complex with these enzymes and protects amoxicillin from loss of antibacterial activity caused by β-lactamase production by major pathogens, co-pathogens, and opportunistic microorganisms. Clavulanic acid itself possesses only weak antibacterial activity.
After oral administration, both components are rapidly absorbed from the gastrointestinal tract. Food intake does not affect absorption. Bioavailability is approximately 90%. Peak plasma concentration is reached within 45 minutes. The elimination half-life is 88 minutes for amoxicillin and 60 minutes for clavulanic acid. High concentrations are found in various organs and body fluids.
During the first 24 hours, 68% of the clavulanic acid dose is excreted in urine, 17% through exhaled air, and 8% in feces.
CONTRAINDICATIONS
·History of jaundice or hepatic dysfunction associated with the use of the drug;
·Hypersensitivity to β-lactam antibiotics (including penicillins and cephalosporins);
· Infectious mononucleosis.
ADVERSE REACTIONS
In most cases, adverse reactions are mild and transient.
DRUG INTERACTIONS
Concomitant use of Clavomed with probenecid is not recommended. Probenecid reduces the renal tubular secretion of amoxicillin, which may increase its blood concentration.
Concurrent administration of allopurinol and amoxicillin may increase the risk of allergic reactions.
Like other broad-spectrum antibiotics, Clavomed may reduce the effectiveness of oral contraceptives.
SPECIAL PRECAUTIONS
The drug should be used with caution in patients prone to allergic reactions.
When Clavomed is administered concomitantly with anticoagulants, appropriate monitoring is required, as an increase in prothrombin time may occur.
Caution should be exercised when using the drug in patients with impaired liver function.
During pregnancy, the drug may be prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus or child.
Experimental studies have not demonstrated any teratogenic effects of the drug.