Country: United States
Language: English
Source: NLM (National Library of Medicine)
CILOSTAZOL (UNII: N7Z035406B) (CILOSTAZOL - UNII:N7Z035406B)
NCS HealthCare of KY, Inc dba Vangard Labs
CILOSTAZOL
CILOSTAZOL 100 mg
ORAL
PRESCRIPTION DRUG
Cilostazol tablets USP are indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance. Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class III-IV congestive heart failure. Cilostazol is contraindicated in patients with congestive heart failure of any severity. Cilostazol tablets are contraindicated in patients with hemostatic disorders or active pathologic bleeding, such as bleeding peptic ulcer and intracranial bleeding. Cilostazol inhibits platelet aggregation in a reversible manner. Cilostazol tablets are contraindicated in patients with known or suspected hypersensitivity to any of their components.
Cilostazol tablets USP are available as follows: 50 mg - white to off-white, pillow-shaped tablets, debossed with “TEVA” on one side and “7230” on the other, available in blisterpacks of 30. 100 mg - white to off-white, round tablets, debossed with “TEVA” on one side and “7231” on the other, available in blisterpacks of 30.
Abbreviated New Drug Application
CILOSTAZOL- CILOSTAZOL TABLET NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- CILOSTAZOL TABLETS USP RX ONLY REV. K 6/2012 CONTRAINDICATION Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class III-IV congestive heart failure. Cilostazol is contraindicated in patients with congestive heart failure of any severity. DESCRIPTION Cilostazol, USP is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). Cilostazol, USP is 6-[4-(1-cyclohexyl-1_H_-tetrazol-5-yl)butoxy]-3,4-dihydro- 2(1_H_)-quinolinone, CAS-73963-72-1. The structural formula is: C H N O M. W. 369.46 Cilostazol, USP occurs as white to off-white crystals or as a crystalline powder that is slightly soluble in methanol and ethanol, and is practically insoluble in water, 0.1 N HCl, and 0.1 N NaOH. Cilostazol tablets USP for oral administration are available in 50 mg pillow-shaped and 100 mg round, white to off-white debossed tablets. Each tablet, in addition to the active ingredient, contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, and starch. Meets USP Dissolution Test 3. CLINICAL PHARMACOLOGY MECHANISM OF ACTION The mechanism of the effects of cilostazol on the symptoms of intermittent claudication is not fully understood. Cilostazol and several of its metabolites are cyclic AMP (cAMP) phosphodiesterase III inhibitors (PDE III inhibitors), inhibiting phosphodiesterase activity and suppressing cAMP degradation 20 27 5 2 with a resultant increase in cAMP in platelets and blood vessels, leading to inhibition of platelet aggregation and vasodilation, respectively. Cilostazol reversibly inhibits platelet aggregation induced by a variety of stimuli, including thrombin, ADP, collagen, arachidonic acid, epinephrine, and shear stress. Effects on circulating plasma lipi Read the complete document