Amoxicillin + Clavulanic acid
Therapeutic Group: Broad-spectrum penicillins
Pharmacology:
Amoxycillin & Clavulanic Acids an antibacterial combination consisting of the antibiotic Amoxicillin and therefore the beta-lactamase inhibitor Clavulanic Acid.
Amoxicillin features a broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms but it's vulnerable to degradation by beta-lactamases and thus the spectrum of activity doesn't include microorganisms, which produce these enzymes.
Clavulanic acid possesses the power to inactivate a good range of beta-lactamase enzymes commonly found in microorganisms immune to penicillins and cephalosporins. Thus Clavulanic acid together with Amoxicillin and Clavulanic acid protects Amoxicillin from degradation by beta-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a good range of microorganisms.
Indications:
Amoxycillin & Clavulanic Acid is indicated for short-term treatment of bacterial infections at the subsequent sites:
- Upper tract infections (including ENT); e.g., tonsillitis, sinusitis, otitis.
- Lower tract infections; e.g., acute and bronchitis, lobar, and bronchopneumonia.
- Genito-urinary tract infections; e.g., cystitis, urethritis, pyelonephritis.
- Skin and soft tissue infections.
- Bone and joint infections; e.g., osteomyelitis.
- Other infections; e.g., septic abortion, puerperal sepsis, intra-abdominal sepsis, etc.
Dosage & Administration :
Oral:
- Adults and youngsters over 12 years: One 375 mg tablet 3 times each day. In severe infection one 625 mg tablet 3 times each day or one 1 gm tablet twice each day.
- Children of 6-12 years: 2 teaspoonful Powder for Suspension every 8 hours.
- Children of 1 -6 years: 1 teaspoonful Powder for Suspension every 8 hours.
- Children below 1 year: 25 mg/kg/day in divided doses every 8 hours.
IV Injection:
- Adults and youngsters over 12 years: 1.2 g every 6-8 hours
- Children up to three months: 30 mg/kg every 8 hours (every 12 hours within the perinatal period and in premature infants)
- Child 3 months to 12 years: 30 mg/kg every 6-8 hours.
Interaction:
Prolongation of bleeding time and prothrombin time are reported in some patients receiving Co-amoxiclav. In common with other broad-spectrum antibiotics, Co-amoxiclav may reduce the efficacy of oral contraceptives and therefore the patient should be warned accordingly. Concomitant use of allopurinol during treatment with Amoxycillin can increase the likelihood of allergic skin reactions. There is not any data on the concomitant use of Co-amoxiclav and allopurinol.
Contraindications:
History of Penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g., cephalosporins. Also contraindicated for patients with a previous history of Amoxycillin & Clavulanic Acid or penicillin-associated cholestatic jaundice.
Side Effects:
Side effects, like Amoxicillin, are uncommon and mainly of light and transitory nature. Diarrhea, pseudomembranous colitis, indigestion, nausea, vomiting, and candidiasis are reported. If gastrointestinal side effects occur with oral therapy, which will be reduced by taking Amoxycillin & Clavulanic Acid at the beginning of meals. Hepatitis and cholestatic jaundice are reported rarely but are usually reversible. Urticarial and erythematous rashes sometimes occur.
Rarely erythema, Stevens-Johnson Syndrome, and exfoliative dermatitis are reported. In common with other beta-lactam antibiotics, angioedema and anaphylaxis are reported.
Pregnancy & Lactation:
Amoxicillin and Clavulanic acid are used orally in human pregnancy during a limited number of cases with no untoward effect; however, the use of Amoxycillin & Clavulanic Acid in pregnancy isn't recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin are often detected in breast milk.
Precautions & Warnings:
Amoxycillin & Clavulanic Acid should be used with care in patients on anticoagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, the dosage should be adjusted. During the administration of a high dose of Amoxycillin & Clavulanic Acid adequate fluid intake and urinary output should be maintained to attenuate the likelihood of crystalluria.
Overdose:
Problems of overdose with Co-amoxiclav are unlikely to occur if encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte balances could also be evident. Co-amoxiclav could also be far away from the circulation by hemodialysis.
Storage:
Should be stored at a temperature not exceeding 25° C or below. Protect from light and moisture. The once reconstituted suspension should be kept within the refrigerator (but not frozen) and will be employed for 7 days.