PLETAL Tablet (2017)
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1. Indications and Usage
PLETAL is indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance.
2. Dosage and Administration
2.1 Recommended dosage The recommended dosage of PLETAL 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 ...
3. Dosage Forms and Strengths
PLETAL is available as 50 mg triangular and 100 mg round, white debossed tablets.
4. Contraindications
PLETAL 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 ...
5. Warnings and Precautions
5.1 Tachycardia Cilostazol may induce tachycardia, palpitation, tachyarrhythmia or hypotension. The increase in heart rate associated with cilostazol is approximately 5 to 7 bpm. Patients with a history ...
6. Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the labeling: Patients with Heart Failure <em>[see Boxed Warning]</em> Tachycardia <em>[see Warnings and Precautions ...
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 ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of PLETAL. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible ...
7. Drug Interactions
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 ...
8.1. Pregnancy
Teratogenic Effects Pregnancy Category C. PLETAL has been shown to be teratogenic in rats at doses that are greater than 5-times the human MRHD on a body surface area basis. There are no adequate and well-controlled ...
8.3. Nursing Mothers
Transfer of cilostazol into milk has been reported in rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from PLETAL, discontinue ...
8.4. Pediatric Use
Safety and effectiveness of PLETAL in pediatric patients have not been established.
8.5. Geriatric Use
Of the total number of subjects (n=2,274) in clinical studies of PLETAL, 56 percent were 65 years old and over, while 16 percent were 75 years old and over. No overall differences in safety or effectiveness ...
8.6. Hepatic Impairment
No dose adjustment is required in patients with mild hepatic impairment. Patients with moderate or severe hepatic impairment have not been studied in clinical trials and dosing recommendations cannot be ...
8.7. Renal Impairment
No dose adjustment is required in patients with renal impairment. Patients on dialysis have not been studied, but, it is unlikely that cilostazol can be removed efficiently by dialysis because of its high ...
10. Overdosage
Information on acute overdosage with PLETAL in humans is limited. The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: severe headache, diarrhea, ...
11. Description
PLETAL (cilostazol) is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The empirical formula of cilostazol is C<sub>20</sub>H<sub>27</sub>N ...
12.1. Mechanism of Action
PLETAL and several of its metabolites inhibit phosphodiesterase III activity and suppress cAMP degradation with a resultant increase in cAMP in platelets and blood vessels, leading to inhibition of platelet ...
12.2. Pharmacodynamics
Cilostazols effects on platelet aggregation were evaluated in both healthy subjects and in patients with stable symptoms of cerebral thrombosis, cerebral embolism, transient ischemic attack, or cerebral ...
12.3. Pharmacokinetics
PLETAL is absorbed after oral administration. A high fat meal increases absorption, with an approximately 90% increase in C<sub>max</sub> and a 25% increase in AUC. Absolute bioavailability is not known. ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Dietary administration of cilostazol to male and female rats and mice for up to 104 weeks, at doses up to 500 mg/kg/day in rats and 1000 mg/kg/day in mice, revealed no evidence of carcinogenic potential. ...
13.2. Animal Toxicology and/or Pharmacology
Repeated oral administration of cilostazol to dogs (30 or more mg/kg/day for 52 weeks, 150 or more mg/kg/day for 13 weeks, and 450 mg/kg/day for 2 weeks), produced cardiovascular lesions that included ...
14. Clinical Studies
The ability of PLETAL to improve walking distance in patients with stable intermittent claudication was studied in eight, randomized, placebo-controlled, double-blind trials of 12 to 24 weeks' duration ...
16.1. How Supplied
PLETAL is supplied as 50 mg and 100 mg tablets. The 50 mg tablets are white, triangular, debossed with PLETAL 50, and provided in bottles of 60 tablets (NDC 59148-003-16). The 100 mg tablets are white, ...
16.2. Storage and Handling
Store PLETAL tablets at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information) Advise the patient: to take PLETAL at least one-half hour before or two hours after food. to discuss with their doctor ...