Each film-coated tablet contains
Active ingredients
| Cefixim | 200 mg |
(*) Bioequivalence of Generic Drugs
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BOSTOKEN 200
202309-0293 • 5429 Views • Al/Al blister. Box of 02 blisters x 10 film-coated tablets with leaflet.
COMPOSITION
Cefixime is an orally active cephalosporin antibiotic which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms.
BOSTOKEN 200 is indicated for the treatment of the following acute infections when caused by susceptible micro-organisms:
- Upper Respiratory Tract Infections (URTI): e.g. otitis media; and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk.
- Lower Respiratory Tract Infection: e.g. bronchitis.
- Urinary Tract Infections: e.g. cystitis, cystourethritis, uncomplicated pyelonephritis.
Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Kliebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobacter species. Cefixime is highly stable in the presence of beta-lactamase enzymes.
Cefixime is resistant to most enterococci (Streptococcus faecalis, group D Streptococcus) and staphylococci (including coagulase-negative strains and methicillin-resistant strains), and most strains of Pseudomonas, Bacteriodes fragilis, Listeria monocytogenes, and Clostridia.
DOSAGE AND ADMINISTRATION
Dosage
The usual duration of treatment with cefixime is 7 days, but may be extended to 14 days if necessary.
Adults and children over 10 years of age or weighing more than 50 kg
The recommended dose is 200-400 mg/day, depending on the severity of the infection, administered as a single dose or in two divided doses.
Elderly
The dosage is the same as for adults. Renal function should be assessed and dosage adjusted for patients with severe renal impairment.
Children under 10 years of age
BOSTOKEN 200 is not recommended for children under 10 years of age. Safety and efficacy in children under 6 months have not been established.
Renal impairment
BOSTOKEN 200 can be used in patients with impaired renal function.
- Patients with creatinine clearance (Clcr) ≥ 20 mL/min: No dosage adjustment is necessary.
- Patients with Clcr < 20 mL/min: Do not exceed 200 mg once daily.
- Patients on peritoneal dialysis or hemodialysis: Do not exceed 200 mg once daily.
Administration
Oral use. The absorption of cefixime is not affected by food.
CONTRAINDICATIONS
Patients with hypersensitivity to cephalosporin antibiotics or any component of the drug.
USE IN PREGNANCY AND LACTATION
Pregnancy
Reproduction studies performed in mice and rats at doses up to 400 times the human dose revealed no evidence of harm to the fetus due to cefixime.
In rabbits, no teratogenic effects were observed at doses up to 4 times the human dose, but a higher incidence of miscarriage and maternal death was noted, likely due to the sensitivity of rabbits to the gastrointestinal microbiome disruption caused by antibiotics.
There are no adequate and well-controlled studies in pregnant women. BOSTOKEN 200 should not be used during pregnancy unless the potential benefits outweigh the risks and it has been carefully considered by a physician.
Lactation
It is not known whether cefixime is excreted in human milk. Therefore, BOSTOKEN 200 should not be used in breastfeeding women unless deemed necessary by a physician.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Patients experiencing adverse effects such as encephalopathy (including seizures, confusion, cognitive impairment, and motor disturbances) should not drive or operate machinery.
Al/Al blister. Box of 02 blisters x 10 film-coated tablets with leaflet.
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