Cebralat tablets

Cebralat

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

The active ingredient of Cebralat 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

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

Side Effect

Possible side effects of Cebralat include: fainting; hives; red, irritated eyes; inability to speak; red skin lesions, often with a purple center.

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12.3 Pharmacokinetics

Cebralat is absorbed after oral administration. A high fat meal increases absorption, with an approximately 90% increase in Cmax and a 25% increase in AUC. Absolute bioavailability is not known. Cebralat is extensively metabolized by hepatic cytochrome P-450 enzymes, mainly 3A4, and, to a lesser extent, 2C19, with metabolites largely excreted in urine. Two metabolites are active, with one metabolite appearing to account for at least 50% of the pharmacologic (PDE III inhibition) activity after administration of Cebralat.

Pharmacokinetics are approximately dose proportional. Cebralat and its active metabolites have apparent elimination half-lives of about 11 to 13 hours. Cebralat and its active metabolites accumulate about 2-fold with chronic administration and reach steady state blood levels within a few days. The pharmacokinetics of Cebralat and its two major active metabolites were similar in healthy subjects and patients with intermittent claudication due to peripheral arterial disease (PAD). Figure 1 shows the mean plasma concentration-time profile at steady state after multiple dosing of Cebralat 100 mg twice daily.

El Cebralat puede provocar efectos secundarios. AvГ­sele a su mГ©dico si alguno de estos sГ­ntomas es intenso o no desaparece:

  • dolor de cabeza
  • diarrea
  • mareos
  • acidez estomacal
  • nГЎuseas
  • dolor de estГіmago
  • dolor muscular

8.4 Pediatric Use

Safety and effectiveness of Cebralat in pediatric patients have not been established.

Advertencia:

Medicamentos similares al Cebralat provocaron un mayor riesgo de muerte en pacientes con insuficiencia cardГ­aca congestiva (afecciГіn en la que el corazГіn no puede bombear una cantidad suficiente de sangre a las demГЎs partes del cuerpo). DГ­gale a su mГ©dico si tiene o ha tenido insuficiencia cardГ­aca congestiva. Probablemente su mГ©dico le diga que no tome Cebralat.

Consulte a su mГ©dico sobre los riesgos de tomar Cebralat.

IMPORTANT WARNING:

Medications similar to Cebralat caused an increased risk of death in patients with congestive heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body). Tell your doctor if you have or have ever had congestive heart failure. Your doctor will probably tell you not to take Cebralat.

Talk to your doctor about the risks of taking Cebralat.

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Serious Side Effects of Cebralat

Tell your doctor right away if you experience any of the following serious side effects:

  • Fast or irregular heartbeat
  • Unusual bruising or bleeding
  • Sudden, severe headache or vomiting
  • Vision changes
  • Unusual weight gain
  • Swelling of the hands, arms, feet, ankles, or lower legs
  • Dark, tarry, or bloody stools
  • Vomit that looks like coffee grounds
  • Signs of infection, which may include fever, sore throat, rash, or chills

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

Cebralat and Alcohol

Alcohol may worsen certain side effects of Cebralat.

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

What is the most important information I should know about Cebralat?

Do not take Cebralat if you have congestive heart failure.

Rated Cebralat for Intermittent Claudication Report

I was experiencing both acute lumbar and upper leg pain. The legs started first and would many times wake me about an hour after going to sleep. My Dr. just gave me Valium. Had to have back surgery and a year later had a device implanted for lumbar pain but leg pain continued. After checking internet I suggested Cebralat to my Dr. After just a few days all pain I endured for years was GONE! Now I can go walking and enjoy life again!

Erythromycin and other macrolide antibiotics

Erythromycin is a moderately strong inhibitor of CYP3A4. Coadministration of erythromycin 500 mg every 8h with a single dose of Cebralat 100 mg increased Cebralat Cmax by 47% and AUC by 73%. Inhibition of Cebralat metabolism by erythromycin increased the AUC of 4´-trans-hydroxyCebralat by 141% .

Diltiazem 180 mg decreased the clearance of Cebralat by

30%. Cebralat Cmax increased

30% and AUC increased

Grapefruit juice increased the Cmax of Cebralat by

50%, but had no effect on AUC.

How should I take Cebralat (Pletal)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Cebralat is usually taken twice a day on an empty stomach, at least 30 minutes before or 2 hours after breakfast or dinner.

Take the medicine at the same time each day.

It may take up to 12 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Store at room temperature away from moisture and heat.

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 Cebralat. Reduce Cebralat 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 Cebralat active metabolites. Reduce Cebralat dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP2C19 .

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 Cebralat and its metabolites.

13.2 Animal Toxicology and/or Pharmacology

Repeated oral administration of Cebralat 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 Cebralat 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 Cebralat at doses up to 1500 mg/kg/day. At this dose, systemic exposures (AUCs) to unbound Cebralat 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 Cebralat at doses up to 150 mg/kg/day. At this dose, systemic exposures (AUCs) to unbound Cebralat were about 0.5 and 5 times (male and female rats, respectively) the exposure in humans at the MRHD. In female rats, Cebralat AUCs were similar at 150 and 1500 mg/kg/day. Cardiovascular lesions were also not observed in monkeys after oral administration of Cebralat for 13 weeks at doses up to 1800 mg/kg/day. While this dose of Cebralat produced pharmacologic effects in monkeys, plasma Cebralat levels were less than those seen in humans given the MRHD, and those seen in dogs given doses associated with cardiovascular lesions.

ВїPara cuГЎles condiciones o enfermedades se prescribe este medicamento?

El Cebralat se usa para reducir los sГ­ntomas de la claudicaciГіn intermitente (dolor en las piernas que empeora al caminar y mejora al estar en reposo, provocado por el estrechamiento de los vasos sanguГ­neos que irrigan sangre a las piernas). El Cebralat pertenece a una clase de medicamentos llamados inhibidores de la agregaciГіn plaquetaria (medicamentos antiplaquetarios). ActГєa mejorando el flujo de sangre a las piernas.

Before taking Cebralat,

  • tell your doctor and pharmacist if you are allergic to Cebralat, any other medications, or any of the ingredients in Cebralat. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (''blood thinners'') such as warfarin (Coumadin); aspirin; antifungal medications such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); antiplatelet medications such as clopidogrel (Plavix), prasugrel (Effient), and ticlopidine (Ticlid); clarithromycin (Biaxin); diltiazem (Cardizem, Dilacor, Tiazac, others); erythromycin (E-mycin, Ery-Tab, others); fluoxetine (Prozac); fluvoxamine (Luvox); nefazadone; omeprazole (Prilosec); and sertraline (Zoloft). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have bleeding ulcers (sores in the lining of the stomach or small intestine that are bleeding), bleeding in the brain, bleeding from any other part of your body, a low number of platelets in your blood, or any other condition that causes severe bleeding. Your doctor will probably tell you not to take Cebralat.
  • tell your doctor if you have or have ever had heart, kidney, or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Cebralat, call your doctor.

What are the side effects of Cebralat?

The most common adverse effects of Cebralat are:

Other important side effects which have also been reported with Cebralat include a reduction in numbers of white blood cells and platelets. Severe skin reactions also have been reported.

Cebralat inhibits the enzyme phosphodiesterase III. Other drugs that inhibit this enzyme have caused death in individuals with heart failure. Therefore, individuals with heart failure should not use Cebralat.

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