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Cefixim
Cefixime Trihydrate USP
| NAME | STRENGTH | PACK SIZE | DOSAGE FORM |
|---|---|---|---|
| Cefixim 400 | 400 mg | 2X4 | Capsule |
| Cefixim 200 | 200 mg | 3X4 | Capsule |
| Cefixim 30 | 100 mg / 5 ml | 30 ml | Suspension |
| Cefixim 40 | 100 mg / 5 ml | 40ml | Suspension |
| Cefixim 50 | 100 mg / 5 ml | 50 ml | Suspension |
| Cefixim 50 DS | 200 mg / 5 ml | 50 ml | Suspension |
| Cefixim pediatric drops | 125 mg/ 5 ml | 21 ml | Paediatric drops |
| Cefixim 75 ml POS | 100 mg / 5 ml | 75 ml | Suspension |
Description
Cefixim (Cefixime Trihydrate) is a broad spectrum, third generation Cephalosporin antibiotic for oral use. Cefixime kills bacteria by interfering with the synthesis of bacterial cell wall. It is effective against most Enterobacteriaceae, Haemophilus influenzae and Neisseria Gonorrhoeae, β-hemolytic Streptococcus, Streptococcus pneumoniae. Cefixime is absorbed slowly and incompletely (60% of oral dose) from GIT, whether taken with food or not. About 65% of the drug in the circulation is bound to plasma protein. Cefixim is mainly excreted unchanged in bile and urine.
Composition
Cefixim Capsule: Each capsule contains Cefixime 200 mg as Cefixime Trihydrate USP. Cefixim 400 mg Capsule: Each capsule contains Cefixime 400 mg as Cefixime Trihydrate USP. Cefixim 21 ml pediatric drops: After reconstitution, each 5 ml suspension contains Cefixime 125 mg as Cefixime Trihydrate USP. Cefixim 30 ml Suspension: After reconstitution, each 5 ml suspension contains Cefixime 100 mg as Cefixime Trihydrate USP. Cefixim 40 ml Suspension: After reconstitution, each 5 ml suspension contains Cefixime 100 mg as Cefixime Trihydrate USP. Cefixim 50 ml Suspension: After reconstitution, each 5 ml suspension contains Cefixime 100 mg as Cefixime Trihydrate USP. Cefixim 75 ml Suspension: After reconstitution, each 5 ml suspension contains Cefixime 100 mg as Cefixime Trihydrate USP. Cefixim DS 50 ml Suspension: After reconstitution, each 5 ml suspension contains Cefixime 200 mg as Cefixime Trihydrate USP.
Indications And Uses
Cefixim is indicated in the treatment of infections caused by susceptible microorganism - Upper Respiratory Tract Infections (URTI): Otitis media and others where causative organisms are known or suspected to be resistant to other commonly used antibiotics or where treatment failure may carry significant risk. Lower Respiratory Tract infection (LRTI): Bronchitis, Pneumonia etc. Gastro-intestinal Tract Infection (GITI): Typhoid or enteric fever. Urinary Tract Infection (UTI): Cystitis, Cystourethritis and Pyelonephritis. It is also indicated in Skin & soft tissue infection, Bone & joint infection and also most suitable for switch therapy from parenteral therapy
Dosage And Administration
Cefixim the usual course of treatment is 7 days. This may be continued up to 14 days. Adults & Children over 10 years old: The recommended adult dosage is 200-400 mg daily according to the severity of the infection given either as a single dose or in two divided doses. Elderly: Elderly patients may be given the same dose as recommended for the adults. Renal functions should be assessed and dosage should be adjusted in severe renal impairment. Children: The recommended dosage for children is 8 mg/kg/day administered as single dose or in two divided doses. As a general guide the following daily doses are suggested: Children 6-12 months: Suspension 3.75 ml daily. Children 1-4 years: Suspension 5 ml daily. Children 5-10 years: Suspension 10 ml daily. Children weighing more than 50 kg or older than 10 years: Adult dose of Cefixime (200-400 mg daily) is recommended.
Side Effect
Cefixim is generally well tolerated. The majority of adverse reactions observed are mild and self-limiting in nature. Gastrointestinal disturbances: Diarrhoea and stool changes, nausea, abdominal pain, dyspepsia, vomiting and flatulence. CNS disturbances: Headache and dizziness. Hypersensitivity reaction: Rash, pruritus, urticaria, drug fever and arthralgia have been observed.
Precaution
It should be administered with caution in patients with markedly impaired renal function. Use suspension within 14 days of reconstitution.
Use In Pregnancy Lactation
Cefixim should not be used in pregnancy or nursing mother unless considered essential by the physicians. Dosage in Renal impairment: Cefixim may be administered in the presence of impaired renal function. In patient creatinine clearance less than 20 ml/min, it is recommended that a dose of 20 mg once daily should not be exceeded.
Storage
Store controlled temperature (15-25°C)
Contraindications
Cefixim is contraindicated in patients with known hypersensitivity to Cephalosporin group of drugs.
How Supplied
Cefixim Capsule: Each box contains 20 (2x10) capsules in alu-alu blister pack. Cefixim 400 Capsule: Each box contains 20 (2x10) capsules in alu-alu blister pack. Cefixim 21 ml pediatric drops: Each bottle contains powder for 21 ml oral suspension. Cefixim 30 ml Suspension: Each bottle contains powder for 30 ml oral suspension. Cefixim 40 ml Suspension: Each bottle contains powder for 40 ml oral suspension. Cefixim 50 ml Suspension: Each bottle contains powder for 50 ml oral suspension. Cefixim 75 ml Suspension: Each bottle contains powder for 75 ml oral suspension. Cefixim DS 50 ml Suspension: Each bottle contains powder for 50 ml DS oral suspension.