Clavoxel/Clavoxel-BID

Clavoxel: Each Film Coated Tablet contains: Amoxicillin (as trihydrate) 250 mg, Clavulanic Acid (as Clavulanate Potassium) 125 mg.
Each Film Coated Tablet contains: Amoxicillin (as trihydrate) 500 mg, Clavulanic Acid (as Clavulanate Potassium) 125 mg.
Each 5 mL (1 teaspoonful of the reconstituted suspension) contains: Amoxicillin (as trihydrate) 125 mg, Clavulanic Acid (as Clavulanate Potassium) 31.25 mg.
Each 5 mL (1 teaspoonful of the reconstituted suspension) contains: Amoxicillin (as trihydrate) 250 mg, Clavulanic Acid (as Clavulanate Potassium) 62.5 mg.
Clavoxel-BID: Each 5 mL (1 teaspoonful) contains: Amoxicillin (as trihydrate) 200 mg, Clavulanate Potassium 28.5 mg.
Each 5 mL (1 teaspoonful) contains: Amoxicillin (as trihydrate) 400 mg, 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 produce these enzymes. Clavulanic acid is a beta lactam structurally related to the penicillins, found in micro-organisms resistant to penicillins.
The formulation of amoxicillin with clavulanic acid protects amoxicillin from degradation by beta-lactamase 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 hour) as that of amoxicillin (1.3 hrs). Amoxicillin and clavulanic acid are both widely distributed to most tissues and body fluids including peritoneal fluid, blister fluid, urine, pleural fluid, middle ear fluid, intestinal mucosa, bone, gallbladder, lungs, female reproductive tissues and the bile. The penetration into CSF through non-inflamed meninges and into purulent bronchial secretions 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 excretion). Approximately 50-78% of amoxicillin and 25-40% of clavulanic acid are excreted unchanged in urine within the first 6 hours after administration.

Clavoxel: Co-amoxiclav is indicated for the treatment of the following infections caused by susceptible pathogens; lower respiratory tract infection, acute otitis media, sinusitis, urinary tract infections, skin and soft tissue infection.
Clavoxel-BID: Used for actinomycosis, anthrax, biliary-tract infections, bronchitis, endocarditis (particularly for prophylaxis), gastroenteritis, (including salmonella enteritis), gonorrhea, Lyme disease, mouth infections, otitis media, pneumonia, spleen disorders, typhoid & fever and urinary tract infections.

Clavoxel: The usual adult oral dosage of Amoxicillin and Clavulanic potassium is one tablet containing 250 mg of Amoxicillin and 125 mg of Clavulanic acid every 8 hours or as prescribed by physician.
Suspension: 7-12 years old: 10 mL (2 teaspoonfuls) of 125 mg/31.25 mg suspension three times a day or 5 mL (1 teaspoonful) of 250 mg/62.5 mg suspension three times a day or as prescribed by the physician.
2-6 years old: 5 mL (1 teaspoonful) of 125 mg/31.25 mg suspension three times a day or as prescribed by the physician.
Or under 20 kg bodyweight dose of 20-40 mg per kg daily in divided doses three times a day or as prescribed by the physician.
Clavoxel-BID 228.5 mg/5 mL powder for oral suspension: paratyphoid: 7-12 years: 10 mL (2 teaspoonfuls) of 228.5 mg suspension in every 12 hours or as prescribed by the physician.
2-6 years: 5 mL (1 teaspoonful) 228.5 mg suspension every 12 hours Or as prescribed by the physician. Under 20 kg bodyweight: dose of 20-40 mg per kg daily in divided doses every 12 hours.
9 months-1 year: 2.5 mL (1/2 teaspoonful) of 200 mg/28.5 mg suspension every 12 hours Or as prescribed by the physician.
Suspension 457 mg/5 mL powder for oral suspension: 2-6 years: 5 mL (1 teaspoonful) of 457 mg suspension every 12 hours.
Under 20 kg bodyweight: dose of 20-40 mg per kg daily in divided doses every 12 hours.
7-12 years: 10 mL (2 teaspoonfuls) of 457 mg suspension every 12 hours.

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

Changes in liver function tests have been observed in some patients receiving Co-amoxiclav. The clinical significance of this change 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 up to six weeks after treatment ceased.
Erythematous rashes have been associated with granular fever in patients receiving amoxicillin. Co-amoxiclav should be avoided if granular fever is suspected. Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
Clavoxel-BID: Therefore dosage should be used with caution in patients with severe renal impairment.

Nausea, vomiting, diarrhea, rashes, rarely antibiotics associated colitis.
Clavoxel-BID: Hepatitis and cholestatic jaundice have been reported with the combination amoxicillin with clavulanic acid, the clavulanic acid component has been implicated erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis and exfoliative dermatitis have been occasionally noted.

Direction for Reconstitution: Clavoxel: 125 mg/31.25 mg & 250 mg/62.5 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).
Clavoxel-BID: 457 mg per 5 mL powder for oral suspension: To make 70 mL reconstituted suspension mix with 58 mL cooled water and shake well until the powder are evenly suspended. After reconstitution, suspension is stable for 14 days under refrigeration (2-8°C).
228.5 mg per 5 mL powder for oral suspension: To make 70 mL reconstituted suspension first shake bottle to loosen powder. Then add 58 mL cooled water and shake well until the powder are evenly suspended or add water to 2/3 of fill line level on the label of the bottle shake well. After reconstitution, suspension is stable for 7 days under refrigeration (2-8°C).

Unreconstituted product should be stored at temperatures not exceeding or below 25°C.
Shake well before using.

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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