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Fimoxyclav – 250 mg+125 mg Tablet/pcs

৳ 25.08

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Generic Name: Amoxicillin + Clavulanic acid
Therapeutic class: Penicillins (Penicillins and Cephalosporins)
Manufacturer: Sanofi Bangladesh Ltd

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Indications

Co-amoxiclav is indicated for short-term treatment of bacterial infections at the following sites:

  • 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.
  • 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

Adults and children over 12 years:

Tablet:

  • The usual adult dose is one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours.
  • For more severe infections and infections of the respiratory tract, the dose should be one 1 gm Tablet every 12 hours or one 625 mg Tablet every 8 hours.

Suspension:

  • Children 6-12 years: 2 teaspoonful every 8 hours.
  • Children 1-6years: 1 teaspoonful every 8 hours.
  • Children below 1 year: 25 mg/kg/day in divided doses every 8 hours, for example a 7.5 kg child would require 2 ml suspension t.i.d, Treatment should not be extended beyond 14 days without review.

Forte suspension:

  • The usual recommended daily dosage: 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsilitis, lower respiratory infections, and skin and soft tissue infections)।
  • For serious infections: 45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections, e.g. otitis media and sinusitis, lower respiratory infections e.g. bronchopneumonia, and urinary tract infections).

Children of 2 to 12 years:
Mild to moderate infections:

  • 25/3.6 mg/kg/day (Suspension)
  • 2-6 years (13-21 kg) 2.5 ml suspension b.i.d
  • 7-12years (22-40kg) 5 ml suspension b.i.d

Serious infections:

  • 45/6.4 mg/kg/day (Forte Suspension)
  • 2-6 years (13-21 kg) 5 ml suspension b.i.d
  • 7-12 years (22-40 kg) 10 ml suspension b.i.d

IV Injection

Adults-

  • Usually, 1.2 gm every 8 hours
  • Increased in more serious infections to 1.2 gm every 6 hours
  • For surgical prophylaxis: The usual dose is 1.2 gm at induction, for high risk procedures (eg. colorectal surgery) up to 2-3 gm may be given every 8 hours.

Children-

  • 0 to 3 months: 30 mg/kg every 8 hours. (every 12 hours in the perinatal period and in premature infants.
  • 3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more serious infection to 30 mg/kg every 6 hours.

Side Effects

Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature. Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported, if gastrointestinal side effects occur with oral therapy, that may be reduced by taking Co-amoxiclav at the start of meals. Hepatitis and cholestatic jaundice have been reported rarely but are usually reversible. Urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative dermatitis have been reported. In common with other beta-lactam antibiotics, angioedema and anaphylaxis have been reported.

Pregnancy & Lactation

Animal studies with orally and parenterally administered Co-amoxiclav have shown no teratogenic effect. The drug has been used orally in human pregnancy in a limited number of cases with no untoward effect; however, the use of Co-amoxiclav in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.

Precautions & Warnings

Co-amoxiclav should be used with care in patients on anticoagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, dosage should be adjusted. During the administration of a high dose of Co-amoxiclav adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.

Use in Special Populations

The dose should be adjusted in case of patients with renal impairment

Adult:

  • Mild impairment (Creatinine clearance> 30ml/minute): No changein dosage.
  • Moderate impairment (Creatinine clearance 10-30 ml/minute): One 375 Tablet or one 625 Tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 12 hourly.
  • Severe impairment (Creatinine clearance <10 ml/minute): Not more than one 375 mg tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 24 hourly. Dialysis decreases serum concentrations of this preparation and an additional 0.6 gm IV dose may need to be given during dialysis and at the end of dialysis.

Children:

  • A similar reduction in dosage should be made for children.
  • Administration hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.

Overdose Effects

Problems of overdose with Co-amoxiclav are unlikely to occur, if encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Co-amoxiclav may be removed from the circulation by haemodialysis.

Reconstitution

IV injection: 1.2 gm IV injection can be reconstituted by dissolving the powder in 20 ml Water for Injection BP. This IV injection should not be reconstituted or mixed with: Dextrose solution, Sodium Bicarbonate solution for injection, Protein Hydrolysates or other Proteinaceous fluids, blood or plasma, Intravenous lipids. However, the reconstituted solution may be injected into the drip tubing of infusion fluids containing glucose, bicarbonate and dextran over a period of 3-4 minutes.

Storage Conditions

This should be stored below 25°C, protected from light and moisture. Once reconstituted suspension should be kept in the refrigerator (but not frozen) and should be usedby 7 days. Once reconstituted vial must be used within 20 minutes.

 

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