Cephoral-PFS

Generic : Cefixime Trihydrate
Therapeutic : Cefixime Trihydrate

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Composition :

Cephoral 200 Capsule: Each capsule contains Cefixime 200 mg as Cefixime Trihydrate USP.

Cephoral 400 Capsule: Each capsule contains Cefixime 400 mg as Cefixime Trihydrate USP. Cephoral Powder for Suspension: After reconstitution, each 5 ml suspension contains 100 mg Cefixime as Cefixime Trihydrate USP.

Description :

Cefixime is a broad spectrum semi-synthetic cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic and stable to hydrolysis by many beta-lactamases. Cefixime kills bacteria by interfering in the synthesis of the bacterial cell wall.

Indications :

• Upper and Lower Respiratory Tract Infections
• Otitis Media
• Typhoid Fever
• Uncomplicated Gonorrhea
• Urinary Tract Infections

Dosage and Administration :

Adults and children over 10 years: 200-400 mg in 1-2 divided doses daily for 7 to 14 days. For treatment of Uncomplicated Gonorrhea, 400 mg as a single dose.

Children over 6 months:

8 mg/kg daily in 1-2 divided doses for 7 to 14 days

Side effects :

Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials are mild and self limiting in nature. Among them, diarrhoea, change in the color of stool, nausea, abdominal pain, dyspepsia, headache, dizziness, elevation of serum amylase may occur.

Use in  special group :

Pregnancy: The safety of Cefixime in the treatment of infection in pregnant women has not been established. This drug should be used during pregnancy only if the likely benefits of using Cefixime outweigh the potential risk to the fetus and/or the mother.

Lactation: It is not known whether Cefixime is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cefixime is administered to a nursing woman.

Children: Safety and effectiveness of Cefixime in children less than six months old have not been established.

Contraindications  :

Cefixime is contraindicated in patients with known allergy to the cephalosporin or penicillin antibiotics or to any ingredient in the formulation or component of the container.

Precautions :

Should  be  prescribed  with  cautions  in  individuals  with  a  history  of gastrointestinal  diseases,  particularly  colitis.  Dosage  adjustment  is  only necessary in severe renal failure.

Drug Interaction :

Cefixime should be administered with caution to patients receiving coumarin type anticoagulants such as warfarin potassium. Since Cefixime may enhance effects of the anticoagulants, prolonged prothrombin time with or without bleeding may occur.

Storage :

Store in a cool and dry place, away from light. Keep out of the reach of children.

Commercial Pack :

Cephoral 200 Capsule: Each box contains 2 x 7 capsules in Alu-Alu blister pack.

Cephoral 400 Capsule: Each box contains 1 x 7 capsules in Alu-Alu blister pack.

Cephoral Powder for Suspension: Each bottle contains dry powder for preparation of 50 ml suspension.

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