Lupin Pharmaceuticals, Inc.

Products

Physicians - Dosing

Adults:
Tablets: The recommended dose of Suprax® is one 400-mg tablet daily. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended. Oral suspension: Once Suprax® is reconstituted, the recommended dose of the suspension is 400 mg/day. For the treatment of uncomplicated gonococcal infections, a single oral dose of 400 mg is recommended.

Children:

The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in 2 divided doses, as 4 mg/kg every 12 hours.

PEDIATRIC DOSAGE CHART

Patient Weight (kg)

Patient Weight
(lb)

Dose
(mg/day)

SUPRAX®
100mg / 5ml
(tsp/day)

SUPRAX®
200mg / 5ml
(tsp/day)

6.25

13.75

12.5

27.5

100

18.75

41.25

150

1˝

25.0

55.0

200

31.25

68.75

250

2˝

1ź

37.5

82.5

300

1˝

Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose.

	Efficacy and safety in infants aged less than 6 months have not been established.

	Otitis media should be treated with the suspension. Clinical studies of otitis media were
	conducted with the suspension, and the suspension results in higher peak blood levels than the tablet when administered at the same dose. Therefore, the tablet should not be substituted for the suspension in the treatment of otitis media.

Renal Impairment

Suprax® may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Patients whose clearance is between 21 and 60 mL/min or patients who are on renal hemodialysis may be given 75% of the standard dosage at the standard dosing interval (i.e. 300 mg daily). Patients whose clearance is < 20 mL/min, or patients who are on continuous ambulatory peritoneal dialysis may be given half the standard dosage at the standard dosing interval (i.e. 200 mg daily). Neither hemodialysis nor peritoneal dialysis remove significant amounts of drug from the body.

HOW SUPPLIED

Suprax® (cefixime) for Oral Suspension is an off-white to pale yellow colored powder. Suprax® is supplied as follows:

Suprax® 100mg/5ml

NDC 68180-202-03 - 50 mL Bottle

NDC 68180-202-01 - 100 mL Bottle

Suprax® 200mg/5ml

NDC 27437-206-03 - 50 mL Bottle

NDC 27437-206-02 - 75 mL Bottle

After reconstituted as directed, each 5mL of reconstituted suspension contains 100 mg cefixime as the trihydrate.

After reconstituted as directed, each 5mL of reconstituted suspension contains 200 mg cefixime as the trihydrate.

Suprax® (cefixime) Tablets are white to off-white, film-coated, capsule-shaped tablets supplied as follows:

Suprax® 400-mg Tablets

NDC 27437-201-08 50-tablet Bottle

Please view Package insert for more information about side effects and safe use of Suprax®