Doctil Plus

Doctil® Plus 250 mg tablet: Each film-coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 250 mg and diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 62.5 mg.

Doctil® Plus 500 mg tablet: Each film-coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 500 mg and diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.

Doctil® Plus 70 ml PFS: Each 5 ml reconstituted suspension contains Cefuroxime Axetil USP equivalent to Cefuroxime 125 mg and diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 31.25 mg.

Cefuroxime Axetil is a second generation semi-synthetic cephalosporin and a beta-lactam antibiotic with bactericidal activity. It exerts its bactericidal effect by binding to an enzyme penicillin-binding proteins (PBPs) involved in bacterial cell wall synthesis. This binding results in inhibition of bacterial cell wall synthesis and subsequent cell death. Clavulanic acid is a β-Lactamase Inhibitor. It is a suicidal inhibitor of beta-lactamase enzymes from Streptomyces clavuligerus. It contains a beta-lactam ring and binds strongly to beta-lactamase at or near its active site, thereby hindering enzymatic activity.

Pharyngitis/tonsillitis, Acute bacterial otitis media, Acute bacterial maxillary sinusitis, Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis, Uncomplicated skin and skin-structure infections, Uncomplicated urinary tract infections, Uncomplicated gonorrhea, Early Lyme disease, Impetigo.

Route of administration: Orally

            •  Administer tablets with or without food

            •  Administer oral suspension with food

a. Common: Diarrhea, nausea/vomiting, dislike of taste.

b.  Rare: Headache and dizziness, Transient increases of hepatic enzyme levels.

Serious hypersensitivity (anaphylactic) reactions: In the event of a serious reaction, discontinue Doctil® Plus and institute appropriate therapy.

Clostridium difficile-associated diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD.

a) With medicine: Oral Contraceptives, effects on gut flora may lower estrogen reabsorption and reduce efficacy of oral contraceptives. Co-administration with probenecid increases systemic exposure to Doctil® Plus and is therefore not recommended, Drugs that reduce gastric acidity may lower the bioavailability of Doctil® Plus.

b) With food and others: No

Over-dosage of cephalosporins can cause cerebral irritation leading to convulsions or encephalopathy. Serum levels of Cefuroxime can be reduced by hemodialysis and peritoneal dialysis.

Doctil® Plus Tablet: Should be stored at a temperature not exceeding 25o C in a dry place. Protect from light and moisture.

Doctil® Plus 70 ml PFS: Should be stored at a temperature not exceeding 25o C in a dry place. Protect from light and moisture.  Once reconstituted suspension should be kept in a cool place preferably in refrigerator 2-8o C (but not frozen) and should be used by 7 days.

Doctil® Plus 250 mg tablet: Each box contains 2X10's tablets in Alu-Alu blister strips.

Doctil® Plus 500 mg tablet: Each box contains 2X10's tablets in Alu-Alu blister strips.

Doctil® Plus 70 ml powder for suspension: Bottle contains dry powder to make 70 ml suspension.