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Human

Roxim®

Capsule

200 mg

GENERIC NAMECefixime

MANUFACTURED BYEskayef Pharmaceuticals Ltd.

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Available Pack Sizes:7 Sizes

Purchase Option:Full Pack

Maximum Retail Price (MRP):

Quantity

৳ 288.00/ 8 x 2

(Unit: ৳ 40.00 / 1 Capsule)

16263

Composition

Roxim® 200 Capsule:Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 200 mg in HPMC capsule shell.

Roxim® 400 Capsule: Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 400 mg in HPMC capsule shell.

Roxim® Powder for Suspension (30 ml): After reconstitution each 5 ml contains Cefixime Trihydrate USP equivalent to Cefixime 100 mg.

Roxim® Powder for Suspension (50 ml): After reconstitution each 5 ml contains Cefixime Trihydrate USP equivalent to Cefixime 100 mg.

Roxim® DS Powder for Suspension (60 ml): After reconstitution each 5 ml contains Cefixime Trihydrate USP equivalent to Cefixime 200 mg.

Roxim® Powder for Paediatric Drops (15 ml): After reconstitution each ml contains Cefixime Trihydrate USP equivalent to Cefixime 25 mg.

Description

RoxIM®is a preparation of Cefixime, a third generation cephalosporin antibiotic for oral administration. Cefixime has marked in-vitro bactericidal activity against a wide variety of Gram-positive & Gram-negative organisms. Cefixime is also stable to hydrolysis by many beta-lactamases. Cefixime has a longer duration of action than the other cephalosporins that are active by mouth.

Indications

RoxIM® is indicated for the treatment of following acute infections, when caused by susceptible microorganisms.

Upper respiratory tract infections:

Otitis Media & other URTIs 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 infections:

e.g. Bronchitis.

Urinary tract infections:

e.g. Cystitis, Cystourethritis, Pyelonephritis.

Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, E. coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamases positive & negative), Moraxella catarrhalis (beta-lactamases positive & negative) & Enterobacter species. Cefixime is highly stable in the presence of beta-lactamase enzymes.

Most strains of Enterococci (Streptococcus faecalis, group D Streptococci) & Staphylococci (including coagulase positive & negative strains & methicillin resistant strains) are resistant to Cefixime. In addition, most strains of Pseudomonas, Clostridium, Bacteroids fragilis & Listeria monocytogenes are resistant to Cefixime.

Dosage & Administration

The usual treatment of Cefixime is 7 days. This may be continued for up to 14 days.

Adult & children over 10 years: 200-400 mg daily as a single dose or in 2 divided doses.

Children over 6 months.

Children 6 months-1 year.

: 75 mg daily.

Children 1-4 years.

Children 5-10 years.

: 8 mg/kg/day as a single dose or in 2 divided doses.

: 100 mg daily.

: 200 mg daily.

Contraindications

Patients with known hypersensitivity to cephalosporin antibiotics.

porphyria.

Side Effects

Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild & self-limiting in nature.

*Gastrointestinal disturbances:** Diarrhoea (If severe diarrhoea occurs, Cefixime should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting and flatulence have been reported. Central nervous system disturbances: Headache, dizziness.

*Others:** Hypersensitivity reactions, which usually subsided upon discontinuation of therapy; infrequent & reversible haematological changes, elevation of serum amylase.

Pregnancy & Lactation

Sufficient information is not available, so it is probably best to avoid using the drug during pregnancy & lactating period.

Precautions & Warnings

Cefixime should be prescribed with cautions in individuals with history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 mL/min).

Storage Conditions

Capsule: Do not store above 30°C temperature. Protect from moisture & light. Powder for Suspension: Do not store above 25°C temperature. Protect from moisture & light. Keep out of the reach of children.

For accurate dosing of the suspension, please check the direction for reconstitution and also the direction for administration of suspension on the opposite of this page.

Roxim® • 8 x 2

৳ 288.00