Clovimax

Amoxicillin trihydrate, potassium clavulanate.

Each tablet contains: Amoxicillin (as trihydrate) 500 mg, Clavulanic Acid (as Clavulanate potassium) 125 mg.
Each 5 mL (1 teaspoonful) contains: 125/31.25 mg per 5 mL oral suspension: Amoxicillin (as trihydrate) 125 mg, Clavulanic Acid (as Clavulanate potassium) 31.25 mg.
312.5 mg per 5 mL powder for suspension: Amoxicillin (as trihydrate) 250 mg, Clavulanic Acid (as Clavulanate potassium) 62.5 mg.
457 mg per 5 mL powder for suspension: Amoxicillin (as trihydrate) 400 mg, Clavulanic Acid (as Clavulanate potassium) 57 mg.

Pharmacology: Pharmacodynamics: Mechanism of Action: Amoxicillin acts through inhibition of biosynthesis of the bacterial cell wall mucopeptide. It is bactericidal against susceptible organisms during the stage of active multiplication. Amoxicillin is active against many Gram-positive and Gram-negative pathogens. However, it is susceptible to degradation by beta-lactamases and therefore its spectrum does not include organisms, which produces these enzymes. Clavulanic acid is a beta-lactam structurally related to the penicillins, found in microorganisms resistant to penicillins.
The formulation of Amoxicillin with Clavulanic acid protects amoxicillin from degradation by beta-lactamases enzymes and effectively extends the antibiotic spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other beta-lactam antibiotics.
Pharmacokinetics: Amoxicillin and clavulanate potassium are both well absorbed after oral administration and are stable in the presence of gastric acid. Food does not affect the absorption and this combination product may be given without regard to meals. The oral bioavailability of amoxicillin and clavulanic acid is approximately 90% and 75% respectively.
Clavulanic acid has about the same plasma elimination half-life (1 hr) as that of amoxicillin (1.3 hrs). Amoxicillin and clavulanic acid are widely distributed to most tissues and body fluids including peritoneal fluid, blister, urine, pleural fluid, middle ear fluid, intestinal mucosa, bone, gallbladder, lungs, female reproductive tissues and bile. The penetration into CSF through non-inflamed meninges and into purulent bronchial secretion is low. Amoxicillin and clavulanic acid readily cross the placenta and are distributed into breast milk in low concentrations. Amoxicillin is bound to serum proteins to an extent of 17-20% while clavulanic acid is 20-30% bound to serum proteins. Approximately 10% of the dose of amoxicillin and less than 50% of dose of clavulanic acid are metabolized.
Amoxicillin and clavulanic acid are eliminated primarily unchanged through the renal route (glomerular filtration and tubular secretion). Approximately 50-78% of amoxicillin and 25-40% of clavulanic acid are excreted unchanged in the urine within the first six hours after administration.

For the treatment of urinary tract infection due to susceptible organisms, otitis media or sinusitis due to resistant microorganisms; H. influenza, S. pneumoniae, M. catarrhalis, lower respiratory tract and skin infections due to susceptible organisms; Polymicrobial infections, mixed aerobic and anaerobic such as diabetic foot, gynecologic infections, intra-abdominal infections.

Adult and Children over 12 years: Severe Infection: One 500 mg/125 mg tablet three times a day or as prescribed by the physician.
Children 7-12 years: 10 mL (2 teaspoonfuls) 125 mg/31.25 mg per 5 mL suspension three times a day or 5 mL (1 teaspoonful) 312.5 mg per 5 mL powder for suspension three times a day or as prescribed by the physician.
2-6 years: 5 mL (1 teaspoonful) 125 mg/31.25 mg per 5 mL suspension three times a day or as prescribed by the physician.
9 months-1 year: 2.5 mL (1/2 teaspoon) 125 mg/31.25 mg per 5 mL suspension three times a day or as prescribed by the physician.
457 mg per 5 mL powder for suspension: Children: The usual recommended daily dose is 25 mg/kg/day in divided doses every 8 hours. In more serious infections the dosage may be increased up to 45 mg/kg/day in divided doses every 8 hours.

A history of allergic reactions to beta-lactam antibiotics penicillin hypersensitivity, history of co-amoxiclav associated or penicillin-associated jaundice or hepatic dysfunction.

Changes in liver function test have been reported in some patients receiving Co-amoxiclav. The clinical significance of these changes is uncertain but Co-Amoxiclav should be used with caution in patients with evidence of hepatic dysfunction. Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent for up to six weeks after treatment ceased. Erythematous rashes have been associated with glandular fever in patients receiving Amoxicillin. Co-amoxiclav should be avoided if glandular fever is suspected. Prolonged use may also occur occasionally result in overgrowth of non-susceptible organisms.

Nausea, vomiting, diarrhea, rashes, rarely antibiotic associated colitis.

Direction for Reconstitution: Co-Amoxiclav 125 mg/31.25 mg per 5 mL & 312.5 mg per 5 mL Powder for Suspension: To make 60 mL reconstituted suspension, mix thoroughly the contents with 50 mL cooled water and shake well until the powder is evenly suspended. After reconstitution, suspension is stable for 7 days under refrigeration (2-8°C).

Unreconstituted products should be stored at temperatures below 25°C.

Penicillins

J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

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