Trombonot tablets

Trombonot

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

The active ingredient of Trombonot 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

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

Side Effect

Possible side effects of Trombonot include: nausea, heartburn, or indigestion (severe or continuing); skin rash; stomach pain; difficulty with swallowing; diarrhea; confusion; vomiting of blood or material that looks like coffee grounds; red skin lesions, often with a purple center.

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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 Trombonot. Reduce Trombonot dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP3A4 .

Inhibitors of CYP2C19

Coadministration with CYP2C19 inhibitors (e.g., omeprazole) increases systemic exposure of Trombonot active metabolites. Reduce Trombonot dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP2C19 .

Pregnancy and Trombonot

It's not known whether Trombonot is safe to take during pregnancy.

Talk to your doctor before taking this medicine if you're pregnant or plan to become pregnant.

It's also not known whether the medication passes into breast milk or could harm a breastfeeding baby.

Don't breastfeed while taking Trombonot without first talking to your doctor.

2.1 Recommended Dosage

The recommended dosage of Trombonot Tablets 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 Trombonot tablets.

Why is this medication prescribed?

Trombonot is used to reduce the symptoms of intermittent claudication (pain in the legs that worsens when walking and improves when resting that is caused by narrowing of the blood vessels that supply blood to the legs). Trombonot is in a class of medications called platelet-aggregation inhibitors (antiplatelet medications). It works by improving blood flow to the legs.

OVERDOSE

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, hypotension, tachycardia, and possibly cardiac arrhythmias. The patient should be carefully observed and given supportive treatment. Since Trombonot is highly protein-bound, it is unlikely that it can be efficiently removed by hemodialysis or peritoneal dialysis. The oral LD50 of Trombonot is greater than 5 g per kg in mice and rats and greater than 2 g per kg in dogs.

Summary

Trombonot (Pletal) is a drug prescribed to improve walking speed and distance in individuals with intermittent claudication. Side effects, drug interactions, warnings and precautions, and pregnancy safety should be reviewed prior to taking this medication.

Pharmacodynamics

Trombonot'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. Trombonot 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 Trombonot, the effects on platelet aggregation began to subside 48 hours after withdrawal and returned to baseline by 96 hours with no rebound effect. A Trombonot 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 Trombonot administration.

Effects on circulating plasma lipids have been examined in patients taking PLETAL. After 12 weeks, as compared to placebo, PLETAL 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%).

Left Ventricular Outflow Tract Obstruction

Left ventricular outflow tract obstruction has been reported in patients with sigmoid shaped interventricular septum. Monitor patients for the development of a new systolic murmur or cardiac symptoms after starting Trombonot.

Trombonot dosing information

Usual Adult Dose for Intermittent Claudication:

100 mg orally twice a day at least 30 minutes before or 2 hours after breakfast and dinner

Comments:-Patients may respond as early as 2 to 4 weeks after initiation of therapy, but treatment for up to 12 weeks may be required before a beneficial effect is experienced.-If symptoms remain unimproved after 3 months, discontinue this drug.

Use: Reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance.

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 were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be excluded. Pharmacokinetic studies have not disclosed any age-related effects on the absorption, distribution, metabolism, and elimination of Trombonot and its metabolites.

What Is Trombonot and How Does It Work?

Trombonot is available under the following different brand names: Pletal.

Dosages of Trombonot:

Dosage Forms and Strengths

Dosage Considerations – Should be Given as Follows:

  • 100 mg orally every 12 hours 30 minutes before or 2 hours after meals

  • CYP2C19 or CYP3A4 inhibitors: Reduce dosage to 50 mg orally every 12 hours

Thrombotic Complications of Coronary Angioplasty (Off-label)

  • 100 mg every 12 hours 30 minutes before or 2 hours after meals

  • CrCl less than 25 mL/min: Use caution

  • Moderate to severe: Use caution

  • Safety and efficacy not established


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