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KETEK is indicated for the treatment of community-acquired pneumonia (of mild to moderate severity) due to Streptococcus pneumoniae, (including multi-drug resistant S. pneumoniae [MDRSP1]), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae, for patients 18 years or older.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of KETEK and other antibacterial drugs, KETEK should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are isolates resistant to two or more of the following antibacterials: penicillin, 2 generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
DOSAGE AND ADMINISTRATION
The dosage of KETEK tablets is 800 mg (2 tablets of 400 mg) taken orally once daily for 7–10 days in patients 18 years or older. KETEK tablets can be administered with or without food.
Dosage In Patients With Renal And/Or Hepatic Impairment
In the presence of severe renal impairment (CLCR less than 30 mL/min), including patients who need dialysis, reduce the dosage of KETEK to 600 mg once daily. In patients undergoing hemodialysis, give KETEK after the dialysis session on dialysis days. [see CLINICAL PHARMACOLOGY]
In the presence of severe renal impairment (CLCR less than 30 mL/min), with coexisting hepatic impairment, reduce the dosage of KETEK to 400 mg once daily. Patients with mild or moderate renal impairment (CLCR of 30 mL/min or more) with or without coexisting hepatic impairment do not require a dosage adjustment. No dosage adjustments of KETEK are necessary in patients with hepatic impairment alone. [see CLINICAL PHARMACOLOGY]
Dosage Forms And Strengths
KETEK tablets are available in two strengths:
- Tablets: 400 mg supplied as light-orange, oval, film-coated tablets, imprinted “H3647” on one side and “400” on the other side.
- Tablets: 300 mg supplied as light-orange, oval, film-coated tablets, imprinted “38AV” on one side and blank on the other side.
Storage And Handling
KETEK® 400 mg tablets are supplied as light-orange, oval, film-coated tablets, imprinted “H3647” on one side and “400” on the other side.
Bottles of 60 (NDC 0088-2225-41)
KETEK® 300 mg tablets are supplied as light-orange, oval, film-coated tablets, imprinted “38AV” on one side and blank on the other side.
Bottles of 20 (NDC 0088-2223-20)
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Manufactured for: sanofi-aventis U.S. LLC,Bridgewater, NJ 08807, a Sanofi Company. Revised: December 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/19/2016
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