"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
(Generic versions may still be available.)
Zagam (sparfloxacin) is indicated for the treatment of adults ( ≥ 18 years of age) with the following infections caused by susceptible strains of the designated microorganisms:
Community-acquired pneumonia caused by Chlamydia pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, or Streptococcus pneumoniae
Acute bacterial exacerbations of chronic bronchitis caused by Chlamydia pneumoniae, Enterobacter cloacae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Staphylococcus aureus, or Streptococcus pneumoniae
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to sparfloxacin. Therapy with sparfloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. Culture and susceptibility testing performed periodically during therapy will provide information on the continued susceptibility of the pathogen to the antimicrobial agent and also on the possible emergence of bacterial resistance.
DOSAGE AND ADMINISTRATION
Zagam (sparfloxacin) can be taken with or without food.
Antacids containing magnesium and aluminum or sucralfate or Videx®, (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution may be taken 4 hours after administration of Zagam (sparfloxacin).
The recommended daily dose of Zagam (sparfloxacin) in patients with normal renal function is two 200-mg tablets taken on the first day as a loading dose. Thereafter, one 200-mg tablet should be taken every 24 hours for a total of 10 days of therapy (11 tablets). The recommended daily dose of Zagam (sparfloxacin) in patients with renal impairment (creatinine clearance < 50 mL/min) is two 200-mg tablets taken on the first day as a loading dose. Thereafter, one 200-mg tablet should be taken every 48 hours for a total of 9 days of therapy (6 tablets).
|Strength||Size||NDC 62794-||Description / Markings|
|200 mg||Blister Pack of 11
|011-11||A white film-coated, round biconvex, tablet debossed with B over 11 on one side of the tablet and blank on the other side.|
|Bottle of 55||011-55|
Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP].
Keep out of the reach of children.
Distributed by: Bertek Pharmaceuticals Inc., Research Triangle Park, NC 27709-4149. Manufacturered by: Rhône-Poulenc Rorer Pharmaceuticals Inc., Collegeville, PA 19426. Rev. 02/03.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/7/2009
Additional Zagam Information
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