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RX ITEM-Factive 320Mg Tab 7 By Vansen Pharma

NDC 44001-0321-07 UPC/GTIN No.3-44001-32107-9 Mfg.Part No.132107BRAND: FACTIVE NDC: 44001-0321-07,44001032107 UPC: 3-44001-32107-9,344001321079 Vansen Pharma IncOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Factive 320Mg Tab 7 By Vansen Pharma

$0.00

item No.:RX257459 NDC No.44001032107 UPC No.:344001321079 NDC No. 44001-0321-07 UPC/GTIN No. 3-44001-32107-9 MPN 132107 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No. Rx257459 Factive 320mg Tab 7 by Vansen Pharma Item No. 3257459 NDC No. 44001032107 UPC No. 344001321079 Other Name Factive, GEMIFLO

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FACTIVE- gemifloxacin mesylate tablet
Merus Labs International Inc.

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

Fluoroquinolones, including FACTIVE � , have been associated with with disabling and potentially irreversible serious adverse reactions that have occurred together (See WARNINGS) including:

Tendinitis and tendon rupture
Peripheral neuropathy
Central nervous system effects


Discontinue FACTIVE immediately and avoid the use of fluoroquinolones, including FACTIVE, in patients who experience any of these serious adverse reactions (See WARNINGS ).

Fluoroquinolones, including FACTIVE, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid FACTIVE in patients with known history of myasthenia gravis (See WARNINGS ).
Because fluoroquinolones, including FACTIVE, have been associated with serious adverse reactions (See WARNINGS), reserve FACTIVE for use in patients who have no alternative treatment options for acute bacterial exacerbation of chronic bronchitis (See INDICATIONS AND USAGE).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of FACTIVE and other antibacterial drugs, FACTIVE should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

DESCRIPTION

FACTIVE (gemifloxacin mesylate) is a synthetic broad-spectrum antibacterial agent for oral administration. Gemifloxacin, a compound related to the fluoroquinolone class of antibiotics, is available as the mesylate salt in the sesquihydrate form. Chemically, gemifloxacin is (R,S)-7-[(4Z)-3-(aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid.

The mesylate salt is a white to light brown solid with a molecular weight of 485.49. Gemifloxacin is considered freely soluble at neutral pH (350 ?g/mL at 37�C, pH 7.0). Its empirical formula is C18 H20 FN5 O4 �CH4 O3 S and its chemical structure is:

Gemifloxacin Mesylate
(click image for full-size original)
Each white to off-white, oval, film-coated FACTIVE tablet has breaklines and GE 320 debossed on both faces and contains gemifloxacin mesylate equivalent to 320 mg gemifloxacin. The inactive ingredients are crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide.

CLINICAL PHARMACOLOGY

Pharmacokinetics
The pharmacokinetics of gemifloxacin are approximately linear over the dose range from 40 mg to 640 mg. There was minimal accumulation of gemifloxacin following multiple oral doses up to 640 mg a day for 7 days (mean accumulation <20%). Following repeat oral administration of 320 mg gemifloxacin once daily, steady-state is achieved by the third day of dosing.

Absorption and Bioavailability
Gemifloxacin, given as an oral tablet, is rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations of gemifloxacin were observed between 0.5 and 2 hours following oral tablet administration and the absolute bioavailability of the 320 mg tablet averaged approximately 71% (95% CI 60%-84%). Following repeat oral doses of 320 mg to healthy subjects, the mean � SD maximal gemifloxacin plasma concentrations (Cmax) and systemic drug exposure (AUC (0-24)) were 1.61 � 0.51 ?g/mL (range 0.70-2.62 ?g/mL) and 9.93 � 3.07 ?g�hr/mL (range 4.71-20.1 ?g�hr/mL), respectively. In patients with respiratory and urinary tract infections (n=1423), similar estimates of systemic drug exposure were determined using a population pharmacokinetics analysis (geometric mean AUC (0-24), 8.36 ?g�hr/mL; range 3.2 � 47.7 ?g�hr/mL).

The pharmacokinetics of gemifloxacin were not significantly altered when a 320 mg dose was administered with a high-fat meal. Therefore FACTIVE tablets may be administered without regard to meals.

NDC 44001-0321-07 UPC/GTIN No.3-44001-32107-9 Mfg.Part No.132107
RX ITEM-Factive 320Mg Tab 7 By Vansen Ph
NDC 44001-0321-07 UPC/GTIN No.3-44001-32107-9 Mfg.Part No.132107

BRAND: FACTIVE NDC: 44001-0321-07,44001032107 UPC: 3-44001-32107-9,344001321079 Vansen Pharma Inc
Factive 320Mg Tab 7 By Vansen Pharma
BRAND: FACTIVE NDC: 44001-0321-07,44001032107 UPC: 3-44001-32107-9,344001321079 Vansen Pharma Inc

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
GEMIFLOXACIN MESYLATE ORA
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.