Cilostazol 50 mg/1
Cilostazol · TABLET · Chartwell RX, LLC
Cilostazol is a tablet containing cilostazol at 50 mg/1, taken oral. Manufactured by Chartwell RX, LLC.
Key Facts
- Brand Name
- Cilostazol
- Generic Name
- Cilostazol
- NDC Code (Product)
62135-983- Manufacturer
- Chartwell RX, LLC
- Strength
- 50 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077310
- Drug Class
- Phosphodiesterase 3 Inhibitor [EPC]
- Marketing Start
- 11/08/2005
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Aidapak Services, LLC
Labeling: Label Mixup: CILOSTAZOL, Tablet, 100 mg may be potentially mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003469, EXP: 6/20/2014.
Aidapak Services, LLC
Labeling:Label Mixup; CILOSTAZOL Tablet, 100 mg may be potentially mislabeled as DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071204, Pedigree: AD65475_1, EXP: 5/28/2014.
Aidapak Services, LLC
Labeling: Label Mixup: CILOSTAZOL, Tablet, 100 mg may have potentially been mislabeled as the following drug: TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg, NDC 00591042401, Pedigree: W002900, EXP: 6/10/2014.
Aidapak Services, LLC
Labeling:Label Mixup; CILOSTAZOL Tablet, 100 mg may be potentially mislabeled as DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071204, Pedigree: AD65475_1, EXP: 5/28/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. Cilostazol is a phosphodiesterase III inhibitor (PDE III inhibitor) indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage of cilostazol is 100 mg twice daily taken at least half an hour before or two hours after breakfast and dinner ( 2.1 ) Reduce the dose to 50 mg twice daily when coadministered with CYP3A4 inhibitors such as ketoconazole, itraconazole, erythromycin, and diltiazem, or CYP2C19 inhibitors such as ticlopidine, fluconazole, and omeprazole ( 2.2 ) 2.1 Recommended dosage The recommended dosage of cilostazol is 100 mg twice daily taken at least half an hour before or two hours after breakfast and dinner. Patients may respond as early as 2 to 4 weeks after the initiation of therapy, but treatment for up to 12 weeks may be needed before a beneficial effect is experienced. If symptoms are unimproved after 3 months, discontinue cilostazol. 2.2 Dose Reduction with CYP3A4 and CYP2C19 Inhibitors Reduce dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, erythromycin, and diltiazem) or inhibitors of CYP2C19 (e.g., ticlopidine, fluconazole, and omeprazole) [see Drug Interactions ( 7.1 )] .
Contraindications
4 CONTRAINDICATIONS Cilostazol is contraindicated in patients with: Heart failure of any severity: 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 heart failure. Hypersensitivity to cilostazol or any components of cilostazol tablets (e.g., anaphylaxis, angioedema) Heart failure of any severity ( 4 ) Hypersensitivity to cilostazol or any components of cilostazol tablets ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong and moderate CYP3A4 and CYP2C19 inhibitors: Increase exposure to cilostazol. Reduce cilostazol tablets dose ( 2.2 , 7.1 ) 7.1 Inhibitors of CYP3A4 or CYP2C19 Inhibitors of CYP3A4 Coadministration of strong (e.g., ketoconazole) and moderate (e.g., erythromycin, diltiazem and grapefruit juice) CYP3A4 inhibitors can increase exposure to cilostazol. Reduce cilostazol dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP3A4 [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )]. Inhibitors of CYP2C19 Coadministration with CYP2C19 inhibitors (e.g., omeprazole) increases systemic exposure of cilostazol active metabolites. Reduce cilostazol dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP2C19 [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Patients with Heart Failure [see Boxed Warning] Tachycardia [see Warnings and Precautions ( 5.1 )] Left Ventricular Outflow Tract Obstruction [see Warnings and Precautions ( 5.2 )] Hematologic Adverse Reactions [see Warnings and Precautions ( 5.3 )] Hemostatic Disorders or Active Pathologic Bleeding [see Warnings and Precautions ( 5.4 )] Most common adverse reactions greater than or equal to 2% and at least twice that for placebo in patients on 100 mg twice daily are headache, diarrhea, abnormal stools, and palpitation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions were assessed in eight placebo-controlled clinical trials involving patients exposed…
Frequently Asked Questions
What is Cilostazol used for?
Cilostazol contains Cilostazol. It is a tablet taken oral. Consult your doctor for specific uses.
Is Cilostazol a controlled substance?
Cilostazol is not classified as a controlled substance by the DEA.
What is the generic name for Cilostazol?
The generic name for Cilostazol is Cilostazol. There are 5 other brand versions of Cilostazol.
What is the NDC code for Cilostazol 50 mg/1?
The NDC (National Drug Code) for Cilostazol 50 mg/1 is 62135-983, listed by Chartwell RX, LLC.