Sullivan

Sullivan

amoxicillin + clavulanic acid

Manufacturer:

Medhaus

Distributor:

Medhaus
Full Prescribing Info
Contents
Co-amoxiclav: Amoxicillin and clavulanic acid.
Description
Each Film-coated tablet contains: Amoxicillin (as trihydrate) 500 mg, Clavulanic Acid (as Clavulanate Potassium) 125 mg.
Each 5 mL contains (1 teaspoonful) of reconstituted product contains: Amoxicillin (as trihydrate) 125 mg, Clavulanic Acid (as Clavulanate Potassium) 31.25 mg.
Amoxicillin (as trihydrate) 250 mg, Clavulanic Acid as Clavulanate Potassium) 62.5 mg.
Amoxicillin (as trihydrate) 400 mg, Clavulanic Acid as Clavulanate Potassium) 57 mg.
Action
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-lactamase 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 microorganisms 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 are approximately 90% and 75% respectively. Clavulanic acid has about the same plasma elimination half-life (1 hr) as that of amoxicillin (1.5 hrs). Amoxicillin and clavulanic acid are widely distributed to most tissues and body fluids including peritoneal fluid, blister fluid, pleural fluid, middle ear fluid, intestinal mucosa, bone, gallbladder, lungs, female reproductive tissues and bile. The secretions is low. Amoxicillin and clavulanic acid readily cross the placenta and are distributed into breast milk into 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 the dose of clavulanic acid are metabolized. Amoxicillin and clavulanic acid are eliminated primarilly unchanged through the renal route (glomerular filtration and tubular secretion). Approximately 50-70% of amoxicillin and 25-40% of clavulanic acid are excreted unchanged in urine within the first 6 hours after administration.
Indications/Uses
Amoxicillin and Clavulanic Acid is used for actinomycosis, anthrax, biliary tract infections, bronchitis, endocarditis (particularly prophylaxis), gastroenteritis (including salmonella enteritis), gonorrhea, lyme disease mouth infections, otitis media, pneumonia, spleen disorders, pneumococcal infections prophylaxis, typhoid & paratyphoid fever and urinary tract infections.
Dosage/Direction for Use
Adult and children over 12 years old: Severe infection: One 625 mg tablet three times a day or as prescribed by the physician.
Children: 7-12 years old: 10 mL (1 tablespoonful) 156.25 mg suspension three times a day or 5 mL (1 teaspoonful) 312.5 mg suspension three times a day or as prescribed by the physician.
2-6 years old: 5 mL (1 teaspoonful ) 156.25 mg suspension three times a day or as prescribed by the physician.
2.5 mL (½ teaspoon) 312.5 mg suspension three times a day or as prescribed by the physician.
9 months-1 year old: 2.5 mL (½ teaspoon) 156.25 mg suspension three times a day or as prescribed by the physician.
400 mg/57 mg powder for suspension: 7-12 years: 400 mg/57 mg every 12 hours or as prescribed by the physician.
2-6 years: 200 mg/28.5 mg every 12 hours or as prescribed by the physician.
9 months-1 year: 100 mg/14.25 mg every 12 hours or as prescribed by the physician.
Under 20 kg bodyweight dose of 20-40 mg per kg daily in divided dose every 12 hours.
Contraindications
A history of allergic reactions to beta-lactam antibiotics, penicillin hypersensitivity, history of Amoxicillin and Clavulanic Acid associated jaundice or hepatic dysfunction.
Special Precautions
Changes in the liver function test have been observed in some patients receiving Amoxicillin and Clavulanic Acid. Therefore dosage should be reduced for patients with severe renal impairment. The clinical significance of the change is uncertain but Amoxicillin and Clavulanic Acid 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. Amoxicillin and Clavulanic Acid should be avoided if glandular fever is suspended. Prolonged use may also occasionally result in overgrowth on non-susceptible organisms.
Adverse Reactions
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, exfoliative dermatitis, nausea, vomiting, diarrhea, rashes and antibiotic associated colitis have been occasionally noted.
Caution For Usage
Direction For Reconstitution: Co-Amoxiclav 125 mg/31.25 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 are evenly suspended. After reconstitution, suspension is stable for 7 days under refrigeration (2-8°C).
To make 30 mL reconstituted suspension, mix thoroughly the contents with 25 mL cooled water and shake well until the powder are evenly suspended. After reconstitution, suspension is stable for 7 days under refrigeration (2-8°C).
Co-Amoxiclav 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 are evenly suspended. After reconstitution, suspension is stable for 7 days under refrigeration (2-8°C).
To make 30 mL reconstituted suspension, mix thoroughly the contents with 25 mL cooled water and shake well until the powder are evenly suspended. After reconstitution, suspension is stable for 7 days under refrigeration (2-8°C).
Co-Amoxiclav 400 mg/57 mg per 5 mL powder for suspension: To make 70 mL reconstituted suspension first shake bottle to loosen powder. Add 58 mL cooled water and shake well until the powder is evenly suspended or add water to 2/3 of fill line level on the label of the bottle. After reconstitution, suspension is stable for 7 days under refrigeration (2-8°C).
Storage
Unreconstituted product should be stored at temperatures below 25°C.
Shake well before using.
400 mg/57 mg per 5 mL powder for suspension: Store at temperatures not exceeding 30°C.
Shake well before use.
MIMS Class
Penicillins
ATC Classification
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Presentation/Packing
625 mg tab 100's. 125 mg/31.25 mg/5 mL powd for oral susp 60 mL. 250 mg/62.5 mg/5 mL powd for oral susp 60 mL. 400 mg/57 mg/5 mL powd for oral susp 70 mL.
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