MAXXCEFNIR 300

COMPOSITION: Each hard capsule contains:

Cefdinir…………300 mg

Excipients: Lactose monohydrate, Sodium starch glycolate, Magnesium stearate, Aerosil.

Pharmacotherapeutic group:

Cefdinir is a third-generation oral cephalosporin antibiotic

INDICATIONS

MAXXCEFNIR 300 is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

 - Community-Acquired Pneumonia caused by Haemophilus influenzae, Moraxella catarrhalis (including b-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only).

- Acute Exacerbations of Chronic Bronchitis caused by  Haemophilus influenzae, Moraxella catarrhalis (including b-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only).

- Acute Maxillary Sinusitis caused by Haemophilus influenzae, Moraxella catarrhalis (including b-lactamase producing strains) and Streptococcus pneumoniae (penicillin-susceptible strains only).

- Pharyngitis/Tonsillitis caused byStreptococcus pyogenes.

- Uncomplicated Skin and Skin Structure Infections caused byStaphylococcus aureus (including b-lactamase producing strains) and Streptococcus pyogenes.

- Acute Bacterial Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis (including b-lactamase producing strains), Streptococcus pneumoniae.

DOSAGE AND ADMINISTRATION

The dosage and duration of treatment for infections for individuals are prescribed by the doctor. The usual dosage is as follows:

• Duration of treatment is 5 to 10 days case-by-case. Once or twice daily.
• Adults and Adolescents (Age 13 years and Older): 300 mg x twice daily or 600 mg/once daily. The total daily dose for all infections is 600 mg.

Patients With Renal Insufficiency:

For adult patients with creatinine clearance < 30 ml/min, the dose of cefdinir should be 300 mg given once daily.

Method of Administration

The capsules should be swallowed whole.

You may take this medicine after meals and at least 2 hours before or after taking product containing antacids or iron supplements.

CONTRAINDICATIONS

• Patients with known allergy to the cephalosporin class of antibiotics or any ingredient of drug.
• Patients with known allergy to the penicillins.

PRECAUTIONS

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate alternative therapy should be administered.

Cefdinir should be prescribed with caution in individuals with a history of colitis.

Renal function should be monitored carefully if use of cefdinir at high dose and in long term treatment.

Pregnancy and Nursing mothers: There are no adequate studies in pregnant women and breastfeeding. This drug should therefore not be used in pregnancy or in nursing mothers unless clearly necessary.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

No studies on the effects on the ability to drive and use machines have been performed.

PRESENTATION: Blisters of 10 hard capsules, Box of 1 and 2 blisters.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

Manufactured  by: US PHARMA USA Co. Ltd.,        

Lot B1-10, D2 Street, Tay Bac Cu Chi Industrial Zone, Hochiminh city

For more information, please contact: Tel: 028 37908860 – 028 37908861, Fax: 028 37908856

Distributed by: AMPHARCO U.S.A PHARMACEUTICAL JOINT-STOCK COMPANY

Nhon Trach 3 Industrial Park, Hiep Phuoc Ward, Nhon Trach District, Dong Nai Province.

Tel: 02513 566 202    -     Fax: 02513 566 203