Description
Indications of Rofixim 400
Upper and lower respiratory tract infections, Urinary tract infections, Gonococcal urethritis, Acute otitis media, Skin & soft tissue infection
Pharmaceutical Name of Rofixim 400
Radiant Pharmaceuticals Ltd.
Pharmacology
Cefixime is an oral semisynthetic cephalosporin antibiotic of the third generation. At easily attainable plasma concentrations, it is bactericidal against a wide range of gram positive and gram negative microorganisms. It kills bacteria by interfering with the formation of the bacterial cell wall. In the presence of Beta-lactamase enzyme, it is extremely stable. As a result of the presence of beta-lactamases, many organisms resistant to penicillins and certain cephalosporins may be sensitive to Cefixime. It is absorbed at a rate of 40% to 50% whether taken with or without meals.
Dosage & Administration of Rofixim 400
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.
Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.
Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
- ½-1 year: 75 mg daily.
- 1-4 years: 100 mg daily.
- 5-10 years: 200 mg daily.
- 11-12 years: 300 mg daily
- In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
Interaction of Rofixim 400
Elevated carbamazepine levels have been reported in postmarketing experience when Cefixime is administered concomitantly. ncreased prothrombin time, with or without clinical bleeding, has been reported when Cefixime is administered concomitantly with warfarin and anticoagulants.
Contraindications
Patients with known hypersensitivity cephalosporin group of drugs.
Side Effects of Rofixim 400
Common: Cefixime is generally well tolerated. The majority of adverse reactions in clinical trials were mild and self-limiting in nature. Gastro-intestinal disturbances: diarrhea (if severe diarrhea occurs,Rofixim@ should be discontinued), changes in the colour of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence have been reported; central nervous system disturbances: headache, dizziness.
Rare: Hypersensitivity reactions which usually subsided upon discontinuation of therapy; in frequents and reversible haemotological changes; elevation of serum amylase.
Pregnancy & Lactation
Use in Pregnancy: Cefixime should be used during pregnancy only if clearly needed.
Nursing Mothers: Consideration should be given to discontinuing nursing temporarily during treatment with Cefixime.
Precautions & Warnings
Rofixim@ should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance ml min•l).
Therapeutic Class
Antibacterial
Storage Conditions
Store at temperature of below 300C, protect from light & moisture.
