Cilosinamin tablets

Cilosinamin

  • Active Ingredient: Cilostazol
  • 100 mg, 50 mg
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What is Cilosinamin?

The active ingredient of Cilosinamin brand is cilostazol. Cilostazol is a vasodilator that works by relaxing the muscles in your blood vessels to help them dilate (widen). Cilostazol dilates arteries that supply blood to your legs. Cilostazol also improves circulation by keeping platelets in the blood from sticking together and clotting. Cilostazol USP occurs as white to off-white 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 are available for oral administration containing 50 mg or and 100 mg Cilostazol USP. Each tablet, in addition to the active ingredient, contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Each tablet meets the requirements of Test 3 for Dissolution in the USP monograph for Cilostazol Tablets USP.

Used for

Cilosinamin is used to treat diseases such as: Intermittent Claudication.

Side Effect

Possible side effects of Cilosinamin include: redness of the face, neck, arms and occasionally, upper chest; bloody or black tarry stools; bruises or red spots on the skin; Dizziness or lightheadedness when getting up suddenly from a lying or sitting position; unusual bleeding or bruising; bleeding tendency; fainting; Abnormal bleeding.

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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 studies in pregnant women.

In a rat developmental toxicity study, oral administration of 1000 mg Cilosinamin/kg/day was associated with decreased fetal weights, and increased incidences of cardiovascular, renal, and skeletal anomalies (ventricular septal, aortic arch and subclavian artery abnormalities, renal pelvic dilation, 14 th rib, and retarded ossification). At this dose, systemic exposure to unbound Cilosinamin in nonpregnant rats was about 5 times the exposure in humans given the MRHD. Increased incidences of ventricular septal defect and retarded ossification were also noted at 150 mg/kg/day (5 times the MRHD on a systemic exposure basis). In a rabbit developmental toxicity study, an increased incidence of retardation of ossification of the sternum was seen at doses as low as 150 mg/kg/day. In nonpregnant rabbits given 150 mg/kg/day, exposure to unbound Cilosinamin was considerably lower than that seen in humans given the MRHD, and exposure to 3,4-dehydroCilosinamin was barely detectable.

When Cilosinamin was administered to rats during late pregnancy and lactation, an increased incidence of stillborn and decreased birth weights of offspring was seen at doses of 150 mg/kg/day (5 times the MRHD on a systemic exposure basis).

Cilosinamin affects both vascular beds and cardiovascular function. It produces heterogeneous dilation of vascular beds, with greater dilation in femoral beds than in vertebral, carotid or superior mesenteric arteries. Renal arteries were not responsive to the effects of Cilosinamin.

In dogs or cynomolgus monkeys, Cilosinamin increased heart rate, myocardial contractile force, and coronary blood flow as well as ventricular automaticity, as would be expected for a PDE III inhibitor. Left ventricular contractility was increased at doses required to inhibit platelet aggregation. A-V conduction was accelerated. In humans, heart rate increased in a dose-proportional manner by a mean of 5.1 and 7.4 beats per minute in patients treated with 50 and 100 mg twice daily, respectively.

Cilosinamin did not inhibit the metabolism of R-and S-warfarin after a single 25-mg dose of warfarin.

12.2 Pharmacodynamics

Cilosinamin's 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 arteriosclerosis over a range of doses from 50 mg every day to 100 mg three times a day. Cilosinamin significantly inhibited platelet aggregation in a dose-dependent manner. The effects were observed as early as 3 hours post-dose and lasted up to 12 hours following a single dose. Following chronic administration and withdrawal of Cilosinamin, the effects on platelet aggregation began to subside 48 hours after withdrawal and returned to baseline by 96 hours with no rebound effect. A Cilosinamin dosage of 100 mg twice daily consistently inhibited platelet aggregation induced with arachidonic acid, collagen and adenosine diphosphate (ADP). Bleeding time was not affected by Cilosinamin administration.

Effects on circulating plasma lipids have been examined in patients taking Cilosinamin. After 12 weeks, as compared to placebo, Cilosinamin 100 mg twice daily produced a reduction in triglycerides of 29.3 mg/dL (15%) and an increase in HDL- cholesterol of 4.0 mg/dL (≅10%).

Short-term (less than or equal to 4 days) coadministration of aspirin with Cilosinamin increased the inhibition of ADP- induced ex vivo platelet aggregation by 22% to 37% when compared to either aspirin or Cilosinamin alone. Short-term (less than or equal to 4 days) coadministration of aspirin with Cilosinamin increased the inhibition of arachidonic acid-induced ex vivo platelet aggregation by 20% compared to Cilosinamin alone and by 48% compared to aspirin alone. However, short-term coadministration of aspirin with Cilosinamin had no clinically significant impact on PT, aPTT, or bleeding time compared to aspirin alone. Effects of long-term coadministration in the general population are unknown.

In eight randomized, placebo-controlled, double-blind clinical trials, aspirin was coadministered with Cilosinamin to 201 patients. The most frequent doses and mean durations of aspirin therapy were 75 to 81 mg daily for 137 days (107 patients) and 325 mg daily for 54 days (85 patients). There was no apparent increase in frequency of hemorrhagic adverse effects in patients taking Cilosinamin and aspirin compared to patients taking placebo and equivalent doses of aspirin.

Cilosinamin did not inhibit the pharmacologic effects (PT, aPTT, bleeding time, or platelet aggregation) of R- and S-warfarin after a single 25-mg dose of warfarin. The effect of concomitant multiple dosing of warfarin and Cilosinamin on the pharmacodynamics of both drugs is unknown.

13.2 Animal Toxicology and/or Pharmacology

Repeated oral administration of Cilosinamin 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 endocardial hemorrhage, hemosiderin deposition and fibrosis in the left ventricle, hemorrhage in the right atrial wall, hemorrhage and necrosis of the smooth muscle in the wall of the coronary artery, intimal thickening of the coronary artery, and coronary arteritis and periarteritis. At the lowest dose associated with cardiovascular lesions in the 52-week study, systemic exposure (AUC) to unbound Cilosinamin was less than that seen in humans at the maximum recommended human dose (MRHD) of 100 mg twice daily. Similar lesions have been reported in dogs following the administration of other positive inotropic agents (including PDE III inhibitors) and/or vasodilating agents. No cardiovascular lesions were seen in rats following 5 or 13 weeks of administration of Cilosinamin at doses up to 1500 mg/kg/day. At this dose, systemic exposures (AUCs) to unbound Cilosinamin were only about 1.5 and 5 times (male and female rats, respectively) the exposure seen in humans at the MRHD. Cardiovascular lesions were also not seen in rats following 52 weeks of administration of Cilosinamin at doses up to 150 mg/kg/day. At this dose, systemic exposures (AUCs) to unbound Cilosinamin were about 0.5 and 5 times (male and female rats, respectively) the exposure in humans at the MRHD. In female rats, Cilosinamin AUCs were similar at 150 and 1500 mg/kg/day. Cardiovascular lesions were also not observed in monkeys after oral administration of Cilosinamin for 13 weeks at doses up to 1800 mg/kg/day. While this dose of Cilosinamin produced pharmacologic effects in monkeys, plasma Cilosinamin levels were less than those seen in humans given the MRHD, and those seen in dogs given doses associated with cardiovascular lesions.

What should I discuss with my healthcare provider before taking Cilosinamin (Pletal)?

Do not take Cilosinamin if you have congestive heart failure. Cilosinamin can make this condition worse.

To make sure Cilosinamin is safe for you, tell your doctor if you have:

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Cilosinamin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Cilosinamin Pictures

By Lynn Marks | Medically Reviewed by Robert Jasmer, MD

Latest Update: 2016-01-18 Copyright © 2014 Everyday Health Media, LLC

Cilosinamin Warnings

Cilosinamin contains a black-box warning because similar medications have caused an increased risk of death in people with congestive heart failure.

Tell your doctor if you have or have ever had any type of heart failure before taking this drug.

Also, tell your doctor if you have or have ever had:

  • Bleeding problems or a disorder that causes an inability to form blood clots
  • Any active bleeding (especially a peptic ulcer or brain bleeding)
  • Low blood platelet levels
  • Liver disease
  • Kidney disease
  • Allergies to medications, foods, or other substances

Tell your doctor or dentist you're taking this medication before any type of surgical procedure, and let your healthcare provider know if you've had a recent surgery before starting on Cilosinamin.

In rare instances, this drug can lower your body's ability to fight infection. Avoid contact with people who have colds or infections.

Cilosinamin should be used with extreme caution in children. Safety and effectiveness in kids hasn't been confirmed.

Older adults may be more sensitive to the side effects of Cilosinamin.

This medicine controls symptoms of intermittent claudication, but it doesn't cure the condition.

Continue to take Cilosinamin even if you feel well. Don't stop taking the drug without first talking to your doctor.

You might notice improvements within two to four weeks of starting on Cilosinamin, but it can take up to 12 weeks for you to experience the full benefits of the medicine.

Be sure to keep all doctor and laboratory appointments while taking Cilosinamin.

CONTRAINDICATIONS

PLETAL is contraindicated in patients with:

  • Heart failure of any severity: Cilosinamin 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 Cilosinamin or any components of PLETAL (e.g., anaphylaxis, angioedema)

Where can I get more information?

Your pharmacist can provide more information about Cilosinamin.

Hepatotoxicity

In publications of the multiple, large prospective trials of Cilosinamin therapy, rates of serum ALT elevations during therapy were not provided. Furthermore, there were no reported instances of clinically apparent acute liver injury. Since its approval and wide scale use, there have been no published reports of hepatotoxicity attributed to Cilosinamin. Nevertheless, the current product label mentions that instances of serum enzyme elevations and hepatitis have been reported to the sponsor. The time of onset, clinical pattern and course of liver test abnormalities during Cilosinamin therapy have not been reported.

Likelihood score: E (unlikely cause of clinically apparent liver injury).

8.1 Pregnancy

Teratogenic Effects Pregnancy Category C.

Cilosinamin 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 studies in pregnant women.

In a rat developmental toxicity study, oral administration of 1000 mg Cilosinamin/kg/day was associated with decreased fetal weights, and increased incidences of cardiovascular, renal, and skeletal anomalies (ventricular septal, aortic arch and subclavian artery abnormalities, renal pelvic dilation, 14th rib, and retarded ossification). At this dose, systemic exposure to unbound Cilosinamin in nonpregnant rats was about 5 times the exposure in humans given the MRHD. Increased incidences of ventricular septal defect and retarded ossification were also noted at 150 mg/kg/day (5 times the MRHD on a systemic exposure basis). In a rabbit developmental toxicity study, an increased incidence of retardation of ossification of the sternum was seen at doses as low as 150 mg/kg/day. In nonpregnant rabbits given 150 mg/kg/day, exposure to unbound Cilosinamin was considerably lower than that seen in humans given the MRHD, and exposure to 3,4-dehydroCilosinamin was barely detectable.

When Cilosinamin was administered to rats during late pregnancy and lactation, an increased incidence of stillborn and decreased birth weights of offspring was seen at doses of 150 mg/kg/day (5 times the MRHD on a systemic exposure basis).

Cilosinamin side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

chest pain, pounding heartbeats or fluttering in your chest;

a light-headed feeling, like you might pass out;

fever, chills, body aches, flu symptoms;

bloody urine, painful urination;

shortness of breath, even with mild exertion; or

swelling of your ankles or feet.

Common side effects may include:

diarrhea, abnormal bowel movements;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Concomitant administration of quinidine with a single dose of Cilosinamin 100 mg did not alter Cilosinamin pharmacokinetics.

Cilosinamin and Alcohol

Alcohol may worsen certain side effects of Cilosinamin.

Talk to your doctor before consuming alcohol while taking this medication.

Less frequent clinical significant adverse reactions (less than 2%) that were experienced by patients treated with Cilosinamin 50 mg twice daily or 100 mg twice daily in the eight controlled clinical trials and that occurred at a frequency in the 100 mg twice daily group greater than in the placebo group are listed below.

Body as a whole: fever, generalized edema, malaise

Ca r diovascular: atrial fibrillation, heart failure, myocardial infarction, nodal arrhythmia, supraventricular tachycardia, ventricular extrasystoles, ventricular tachycardia

Dige s tive: anorexia, melena

Hematologic and L y mphati c : anemia

Metabolic and Nutritional: increased creatinine, hyperuricemia

Resp i ratory: epistaxis

Skin and Appendages: urticaria

Special Senses: conjunctivitis, retinal hemorrhage, tinnitus

U r ogenital: urinary frequency

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Cilosinamin. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system diso r der s : Aplastic anemia, granulocytopenia, pancytopenia, bleeding tendency

Ca r diac d i so r d e r s : Torsade de pointes and QTc prolongation in patients with cardiac disorders (e.g., complete atrioventricular block, heart failure; and bradyarrythmia), angina pectoris.

Gast r oin t e s t inal diso r de r s: Gastrointestinal hemorrhage, vomiting, flatulence, nausea

General diso r ders and administration site conditions: Pain, chest pain, hot flushes

Hepatobiliary diso r der s : Hepatic dysfunction/abnormal liver function tests, jaundice

Immune system diso r ders: Anaphylaxis, angioedema, and hypersensitivity

Investigations: Blood glucose increased, blood uric acid increased, increase in BUN (blood urea increased), blood pressure increase

Ner v ous system diso r der s : Intracranial hemorrhage, cerebral hemorrhage, cerebrovascular accident, extradural hematoma and subdural hematoma

Renal and urinary diso r der s : Hematuria

Respirator y , thoracic and mediastinal diso r ders: Pulmonary hemorrhage, interstitial pneumonia

Skin and subcutaneous tissue diso r ders: Hemorrhage subcutaneous, pruritus, skin eruptions including Stevens-Johnson syndrome, skin drug eruption (dermatitis medicamentosa), rash

V ascular diso r ders: Subacute stent thrombosis, hypertension.

Common Side Effects of Cilosinamin

Tell your doctor if any of the following side effects are severe or don't go away:

  • Diarrhea
  • Nausea
  • Stomach pain or gas
  • Heartburn or indigestion
  • Headache
  • Dizziness or lightheadedness
  • Increased frequency of coughing
  • Muscle pain


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