Moxgen-457

White coloured homogenous free flowing with raspberry flavour powder.
Each 5 mL (1 teaspoonful) of the reconstituted suspension contains: Amoxicillin (as trihydrate) USP equivalent to Amoxicillin 400 mg, Clavulanate Potassium USP equivalent to Clavulanic Acid 57 mg, Excipients q.s.

Pharmacotherapeutic group: Antibacterials for systemic use; beta-lactam antibacterials, penicillins; combinations of penicillins, incl. beta-lactamase inhibitors.
Pharmacology: Pharmacodynamics: Mechanism of Action: Co-Amoxiclav is a novel concept in antibiotic therapy. Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it can act on the pathogen. The Clavulanate anticipates this defense mechanism by blocking the β-lactamase enzymes, thus rendering the organisms sensitive to Amoxicillin's rapid bactericidal effect at concentrations readily attainable in the body. Clavulanate by itself has little Antibacterial activity; however, in association with Amoxicillin, it produces a novel antibiotic agent of broad spectrum with wide application in hospital and general practice.
Pharmacokinetics: Absorption: Amoxicillin and clavulanic acid are fully dissociated in aqueous solution at physiological pH. Both components are rapidly and well absorbed by the oral route of administration. Absorption of amoxicillin/clavulanic acid is optimised when taken at the start of a meal. Following oral administration, amoxicillin and clavulanic acid are approximately 70% bioavailable. The plasma profiles of both components are similar and the time to peak plasma concentration (Tmax) in each case is approximately one hour.
Distribution: About 25% of total plasma clavulanic acid and 18% of total plasma amoxicillin is bound to protein. The apparent volume of distribution is around 0.3-0.4 L/Kg for amoxicillin and around 0.2 L/Kg for clavulanic acid.
Biotransformation: Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to up to 10 to 25% of the initial dose. Clavulanic acid is extensively metabolized in man and eliminated in urine and faeces and as carbon dioxide in expired air.
Elimination: The major route of elimination for amoxicillin is via the kidney, whereas for clavulanic acid it is by both renal and nonrenal mechanisms.
Amoxicillin/clavulanic acid has a mean elimination half-life of approximately one hour and a mean total clearance of approximately 25 L/h in healthy subjects. Approximately 60 to 70% of the amoxicillin and approximately 40 to 65% of the clavulanic acid are excreted unchanged in urine during the first 6 hrs. after administration.

Co-amoxiclav is indicated for the short term treatment of common bacterial infections such as Upper Respiratory Tract Infections, including ENT (e.g., tonsillitis, sinusitis, otitis media), Lower Respiratory Tract Infections (e.g., acute and chronic bronchitis, lobar and bronchopneumonia), Genitourinary Tract Infections (e.g., cystitis, urethritis, pyelonephritis, female genital infections), Skin and Soft Tissue Infections, Bone and Joint Infections (e.g., osteomyelitis), and other infections (e.g., septic abortion, puerperal sepsis, intra-abdominal sepsis, septicaemia, peritonitis & post-surgical infections). Co-amoxiclav is indicated for prophylaxis against infections which may be associated with major surgical procedures such as gastrointestinal, pelvic, head and neck, cardiac, renal, joint replacement and biliary tract.

Children under 12 months: 25 mg/kg/day e.g., a 7.5 kg child would require 2 mL three times a day.
Children over 6 years (18-40 kg): 5 mL suspension three times a day. In severe infections, this may be increased up to 50 mg/kg/day in divided doses every eight hours.
Or as prescribed by the physician.

Signs and Symptoms of Overdose: Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, leading to renal failure in some cases, has been observed.
Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Amoxicillin has been reported to precipitate in bladder catheters, predominantly after intravenous administration of large doses. A regular check of patency should be maintained.
Treatment of Intoxication: Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.
Co-Amoxiclav may be removed from the circulation by haemodialysis.

A history of allergic reaction to β-lactams (e.g., penicillins or cephalosporins) is a contraindication. Co-Amoxiclav is contraindicated in patients with previous history of Co-Amoxiclav associated jaundice/hepatic dysfunction.

Drugs that delay peristalsis (e.g., opiates and diphenoxylate with atropine) may prolong and/or worsen the condition and should not be used. Fluids, electrolytes and protein replacement therapy should be provided when indicated.

Co-Amoxiclav should be used with care in patients with evidence of hepatic dysfunction. Co-Amoxiclav syrups contain aspartame and should be used with caution in patients with phenylketonuria.

Use in Pregnancy: There is limited experience of the use of Co-Amoxiclav in human pregnancy. As with all medicines, use should be avoided in pregnancy, especially during the first trimester, unless considered essential by the physician.
Use in Lactation: Amoxicillin is excreted in breast milk; there are no data on the excretion of Clavulanic Acid in human milk. Therefore, caution should be exercised when administering to a nursing woman.

Gastrointestinal Reactions: Gastritis, stomatitis, glossitis, black "hair" tongue, indigestions, nausea, vomiting, diarrhea, enterocolitis, pseudomembranous colitis and candidiasis have been reported.
Hypersensitivity Reactions: Skin rashes and urticaria have been reported. These are actions that may be controlled with antihistamines and if necessary, systemic corticosteroids. Rare cases of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and an occasional case of exfoliative dermatitis have been reported in patients on penicillin therapy. Cross sensitivity with other beta-lactam antibiotics (e.g., cephalosporins) may occur.
Hepatic Effects: As with some other Antibacterial agents, a few cases of transient hepatitis and cholestatic jaundice have been reported.
Haematologic Effects: Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported during therapy with penicillins.
Local Reactions: Phlebitis at the site of injection has also been reported.

Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol and estradiol has been noted. This effect may also occur with amoxicillin and therefore, with co-amoxiclav. Probenecid decreases the renal tubular secretion of amoxicillin but does not affect clavulanic acid excretion. Concurrent use with co-amoxiclav may result in increased and prolonged blood levels of amoxicillin but not for clavulanic acid. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both medicines as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia presenting these patients. No information is available about the concurrent use of co-amoxiclav and alcohol. However, the ingestion of alcohol whilst being treated with the beta-lactam antibiotics latamoxef, cefoperazone and cefamandole has precipitated a disulfiram-like (antabuse) reaction in some patients. Therefore, the ingestion of alcohol should be avoided during and for several days after treatment with co-amoxiclav.

Direction for Reconstitution: Slowly add 64 mL of water to make 70 mL of the suspension. Shake vigorously.
After reconstitution, keep the suspension in the refrigerator 2-8°C when not in use.
Use the reconstituted suspension within 7 days.

Store at temperatures not exceeding 30°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.

Rx