Prex-3

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Indication: Cefixime is indicated in the following infectious diseases-Respiratory Tract Infections, Pneumonia, Sinusitis, Pharyngitis and Tonsillitis, Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis (AECB), Otitis Media, Typhoid, Urinary Tract Infections, Uncomplicated gonorrhea (cervical/urethral), Switch therapy (injectable to oral).

Composition:

Cefixime USP Prex-3 200 Capsule: Each capsule contains Cefixime Trihydrate USP 224 mg equivalent to 200 mg Cefixime.

Prex-3 400 Capsule: Each capsule contains Cefixime Trihydrate USP 448 mg equivalent to 400 mg Cefixime.

Prex-3 Powder for Suspension: After reconstitution each 5 ml suspension contains Cefixime Trihydrate USP 112 mg equivalent to 100 mg Cefixime.

Therapeutic Class: Third generation Cephalosporin.

Generic Name: Cefixime Trihydrate USP

Trade Name:

Clear
SKU: N/A Category: Tag:

Description

 Pharmacology: Cefixime binds to 1 or more of the penicillin-binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death.

 Dose & Administration:

Prex-3 Capsule: 200 mg – 400 mg, as a single dose or in 2 divided doses daily for 7-14 days, according to the severity of infection.

Prex-3 Powder for Suspension: Child dose: 8 mg/kg daily as a single dose or in two divided doses for 7-14 days according to the severity of infection or for children of age 1/2-1 year: 3.75 ml or 75 mg; 1-4 years: 5 ml or 100 mg; 5-10 years: 10 ml or 200 mg; 11-12 years: 15 ml or 300 mg; above 12 years: adult dose.

Geriatric Use: Clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. A pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters. These differences were small and do not indicate a need for dosage adjustment of the drug in the elderly.

Contraindication: Hypersensitivity to cephalosporin antibiotics.

Warnings and Precaution: Hypersensitivity to cephalosporin and penicillin antibiotics. Markedly impaired renal function.

Side-Effects:

a) Common: Cefixime is generally well tolerated. Diarrhoea, stool changes, nausea, vomiting, abdominal pain, dyspepsia, headache and dizziness,

b) Rare: The majority of side-effects observed in clinical trials were mild and self-limiting in nature

Use in Pregnancy and Lactation:

Pregnancy: Pregnancy category B. No data are available. Not to be used during pregnancy unless considered essential by the physician

Lactation: Not to be used for nursing mothers unless considered essential by the physician.

Use in children & adolescents: Safety and effectiveness of Cefixime in children aged less than six months old have not been established. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving Capsules.

Drug Interaction:

a) With Medicine: Contraindicated with Carbamazepine, Warfarin and Anticoagulants,

b) With Food and others: Preferably on an empty stomach, rate of absorption is decreased with food but extent of absorption remains the same: not really problematic.

Overdose: Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 gm of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Storage: For Capsule, store below 30°C and for Suspension, store below 25°C temperature, in a dry place and keep away from light.

Medicines keep out of reach of children

Packing:

Prex-3 200 Capsule: 2×7’s capsules in Alu-Alu blister pack.

Prex-3 400 Capsule: 1×7’s capsules in Alu-Alu blister pack,

Prex-3 50 ml PFS: Amber glass bottle containing powder to prepare 50 ml suspension.

Prex-3 30 ml PFS: Amber glass bottle containing powder to prepare 30 ml suspension.

Additional information

Weight

200 mg, 30 ml, 400 mg, 50 ml

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