Presentation

Cefamax Capsule: Each capsule contains Ceftibuten Dihydrate INN equivalent to 400 mg of Ceftibuten.

Cefamax Suspension: After reconstitution each 5 ml suspension contains Ceftibuten Dihydrate INN equivalent to 90 mg of Ceftibuten

Description

Ceftibuten is a semisynthetic antibiotic of third generation cephalosporin for oral administration. It covers a wide variety of Gram-positive and Gram-negative bacteria. It is rapidly absorbed after oral administration. It is 65% bound to plasma proteins. Ceftibuten is excreted in the urine; approximately 56% of the administered dose of ceftibuten is recovered from urine and 39% from the feces within 24 hours.

Indications

Ceftibuten is indicated for the treatment of:

? Upper respiratory tract infections, including acute sinusitis; otitis media, pharyngitis, tonsillitis and scarlet fever.

? Lower respiratory tract infections including acute bronchitis, acute exacerbations of chronic bronchitis and acute pneumonia in patients appropriately considered for oral therapy ie, those with primary community-acquired infections.

? Urinary tract infections both complicated and uncomplicated infections.

? Enteritis and gastroenteritis caused by Salmonella, Shigella or E. coli.

Dosage & Administration

Adults (12 years of age and older): 400 mg once daily for 10 days.

Pediatric (<12 years of age): 9 mg/kg once daily for 10 days.

Maximum daily dose is 400 mg.

Suspension should be taken on an empty stomach (take 2 hr before or 1 hr after meals.);

Capsule may be taken with or without food.

Renal Impairment

Ceftibuten may be administered at normal doses in the presence of impaired renal function with creatinine clearance (Cr Cl) of 50 mL/min or greater. The recommendations for dosing in patients with varying degrees of renal insufficiency; Cr Cl > 50 mL/min: normal dosing schedule; Cr Cl 30-49 mL/min: 4.5 mg/kg or 200 mg once daily; Cr Cl 5-29 mL/min: 2.25 mg/kg or 100 mg once daily

Directions for mixing of Oral Suspension

First tap the bottle to loosen powder. Then add 45 ml water in two portions, shake well after adding each portion.

Final concentration of the suspension will be 90 mg per 5 mL.

After mixing, the suspension may be kept for 14 days and must be stored in the refrigerator. Keep tightly closed. Shake well before each use. Discard any unused portion after 14 days.

Side Effects

Common side effects may include Nausea, diarrhoea, and headache. Rarely, dyspepsia, gastritis, vomiting, abdominal pain & dizziness may occur.

Precautions

Special precaution should be taken before use in Penicillin-allergic patients; patients with impaired renal function, history of complicated GI disease, particularly chronic colitis.

Use in pregnancy & lactation: Pregnancy category B. There are no adequate and controlled studies in pregnant women or during labor and delivery. Because animal reproduction studies are not always predictive of human response, administration of Ceftibuten during such clinical situations should be weighed in terms of potential risk and benefit to both mother and fetus. Ceftibuten has not been detected in the milk of nursing mothers.

Use in children: Safety and efficacy of Ceftibuten in infants <6 months have not been established.

Use in Pregnancy & Lactation

Use in pregnancy & lactation: Pregnancy category B. There are no adequate and controlled studies in pregnant women or during labor and delivery. Because animal reproduction studies are not always predictive of human response, administration of Ceftibuten during such clinical situations should be weighed in terms of potential risk and benefit to both mother and fetus. Ceftibuten has not been detected in the milk of nursing mothers.

Use in children: Safety and efficacy of Ceftibuten in infants <6 months have not been established.

Drug Interaction

No significant drug interactions have been reported to date. Food taken concomitantly does not interfere with the efficacy of capsules. However, the rate and extent of absorption of suspension may be affected by concomitant food intake.

Storage

Capsule: Store the capsules between 2? and 25?C.

Suspension: Prior to reconstitution, the powder must be stored between 2? and 25?C. Once it is reconstituted, the oral suspension is stable for 14 days when stored in the refrigerator between 2? and 8?C.

Commercial Pack

Cefamax Capsule: Each box contains 2 blister strips of 4 Capsules.

Cefen powder for suspension: Each box contains a bottle containing powder for 60 ml suspension and a measuring cup.

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