Dexyclav 500/DS/FDS

Dexyclav 500/DS/FDS

amoxicillin + clavulanic acid

Manufacturer:

Dexa Medica
Full Prescribing Info
Contents
Co-amoxiclav: Amoxycillin trihydrate & clavulanic acid.
Description
Each Forte caplet contains amoxycillin trihydrate equivalent to amoxycillin anhydrate 500 mg and potassium clavulanate equivalent to clavulanic acid 125 mg.
Each 5-mL dry syrup/Forte dry syrup contains amoxycillin trihydrate equivalent to amoxycillin anhydrate 125/250 mg and potassium clavulanate equivalent to clavulanic acid 31.25/62.5 mg.
Action
Pharmacology: Amoxycillin and clavulanic acid are bactericides. Clavulanic acid does not change the mechanism of action of amoxycillin. The combination of amoxycillin and clavulanic acid produces the synergistic effect of their bactericidal action. The spectrum of amoxycillin is thus widened to include organisms normally resistant by virtue of their ability to produce β-lactamase.
Indications/Uses
For infections caused by organisms eg, upper respiratory tract infections including sinusitis, tonsillitis and otitis media. Lower respiratory tract infections including acute and chronic bronchitis, pneumonia, emphysema, lung abscess.
Soft tissue and skin infections including abscess, cellulitis, wound infection.
Urogenital infections including cystitis, urethritis, septic abortion, pelvic infections, gonorrhoea.
Dosage/Direction for Use
Forte Caplet: Adults and Children >12 years: Mild to Moderate Infections: 250 mg 3 times a day.
Severe Infections: 1 forte caplet 3 times a day.
Children <12 years: 25-50 mg/kg body weight/day. Dosage depends on the severity of infection. Reduce dose accordingly. Dexyclav is well absorbed whether it is administered before or with meals.
For severe infections, dosage can be doubled.
Syrup: Children 7-12 years: 2 tsp; 2-7 years: 1 tsp; 9 months to 2 years: ½ tsp.
Forte Syrup: Children 7-12 years: 1 tsp. All doses to be taken thrice daily.
For severe infections, dosage can be doubled.
Use of Dexyclav should not exceed 14 days.
Preparation of Syrup: Shake the bottle well to loosen the powder, then add water. Shake well. Allow the suspension to stand for 5 min to ensure full dispersion. Once reconstituted, Dexyclav syrup must be stored in the refrigerator. Shake well before taking each dose. Dexyclav syrup should be consumed within 7 days after reconstitution.
Patients with Renal Impairment: Mild (creatinine clearance >30 mL/min): No change in dosage.
Moderate (creatinine clearance 10-30 mL/min): 1 caplet 250 or 500 mg every 12 hrs.
Severe (creatinine clearance <10 mL/min): Not more than 1 caplet 250 mg every 12 hrs.
Contraindications
Hypersensitivity to penicillin.
Use in children: Babies born of mothers hypersensitive to penicillin.
Special Precautions
Two Dexyclav caplets are not equivalent to 1 Dexyclav forte caplet (in the amount of clavulanic acid). Therefore, 2 Dexyclav caplets should not be substituted with 1 Dexyclav Forte caplet. Caution should be taken if Dexyclav is to be administered in patients with severe liver dysfunction.
Dosage should be adjusted in patients with moderate to severe renal impairment.
Use in pregnancy: Avoid administration of Dexyclav during the 1st trimester of pregnancy unless recommended by a doctor.
Side Effects
Diarrhoea, gastrointestinal tract disturbances, nausea, vomiting and candidiasis have been reported. Urticaria and erythematous rashes have been reported but their incidence are low.
Transient hepatitis and cholestatic jaundice have also been reported.
Drug Interactions
Probenecid: Concomitant administration of probenecid with amoxycillin/clavulanic acid will slow down the renal tubular secretion of amoxycillin. Thus, it will elevate and prolong amoxycillin concentration but the AUC, plasma half-life and peak plasma concentration of clavulanic acid will not be affected.
Aminoglycosides.
Storage
Store in a dry, cool place. Avoid direct light.
MIMS Class
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
Dry syrup 60 mL. Forte caplet (enteric-coated) 500 mg x 5 x 6's. Forte dry syrup 60 mL.
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