Cosmox/Cosmox 457

Cosmox: Each tablet contains: Amoxicillin trihydrate 500 mg, Potassium clavulanate 125 mg.
Cosmox 457: 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.

Pharmacology: 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 defence 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.

Cosmox: For infections due to β-lactamase-producing strains (where amoxicillin alone is not appropriate) including resp tract, GUT & abdominal infections, cellulitis, animal bites, severe dental infections w/ spreading cellulitis.
Cosmox 457: 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 Infection e.g., acute and chronic bronchitis, lobar and broncho-pneumonia, Genito-urinary Tract Infections e.g., Cystitis, urethritis, pyelonephritis, female genital infections, Skin and Soft Tissue Infections, Bone and Joint Infections e.g., Osteomyelitis, other Infections e.g., septic abortion, puerperal sepsis, intra-abdominal sepsis, septicaemia, peritonitis & postsurgical 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.

Cosmox: Adult and children ≥40 kg: 625 mg every 12 hours or 375 mg every 8 hours.
More severe & respiratory tract infections 625 mg every 8 hours.
Severely impaired patients w/ GFR 10-30 mL/min: 625 mg or 375 mg every 12 hours, depending on the severity of the infection;
<10 mL/min GFR 625 or 375 every 24 hours depending on severity of the infection.
Ped ≥40 kg Adult dose.
Cosmox 457: Children under 12 months 25 mg/kg/day e.g., a 7.5 kg child would require 2 mL three times a day.
Children 1-6 years (10-18 kg) 5 mL suspension 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.
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.

Co-Amoxiclav may be removed from the circulation by hemodialysis.

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, eg 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.
Cosmox: Provide fluids, electrolytes & protein replacement therapy when indicated. May delay peristalsis eg, opiates & diphenoxylate w/ atropine. Pregnancy (especially 1st trimester) & lactation.
Cosmox 457: 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 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, 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 (Antabuse) like reaction in some patients. Therefore the ingestion of alcohol should be avoided during and for several days after treatment with Co-Amoxiclav.

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.

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