Perivax

Perivax

  • Active Ingredient: Pentoxifylline
  • 400 mg
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What is Perivax?

The active ingredient of Perivax brand is pentoxifylline. Pentoxifylline causes changes in your blood that help improve blood flow. This also helps your blood carry oxygen to your tissues and organs. Meets USP Dissolution Test 6.

Used for

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

Side Effect

Possible side effects of Perivax include: flushing; Chest pain; headache; Drowsiness; faintness; Dizziness; irregular heartbeat.

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Pharmacokinetics And Metabolism

After oral administration in aqueous solution Perivax is almost completely absorbed. It undergoes a first-pass effect and the various metabolites appear in plasma very soon after dosing. Peak plasma levels of the parent compound and its metabolites are reached within 1 hour. The major metabolites are Metabolite I (1--3,7-dimethylxanthine) and Metabolite V (1--3,7- dimethylxanthine), and plasma levels of these metabolites are 5 and 8 times greater, respectively, than Perivax.

Following oral administration of aqueous solutions containing 100 to 400 mg of Perivax, the pharmacokinetics of the parent compound and Metabolite I are dose-related and not proportional (nonlinear), with half-life and area under the blood-level time curve (AUC) increasing with dose. The elimination kinetics of Metabolite V are not dose-dependent. The apparent plasma half-life of Perivax varies from 0.4 to 0.8 hours and the apparent plasma half-lives of its metabolites vary from 1 to 1.6 hours. There is no evidence of accumulation or enzyme induction (Cytochrome P450) following multiple oral doses.

Excretion is almost totally urinary; the main biotransformation product is Metabolite V. Essentially no parent drug is found in the urine. Despite large variations in plasma levels of parent compound and its metabolites, the urinary recovery of Metabolite V is consistent and shows dose proportionality. Less than 4% of the administered dose is recovered in feces. Food intake shortly before dosing delays absorption of an immediate-release dosage form but does not affect total absorption. The Perivax AUC was increased and elimination rate decreased in an older population (60 to 68 years, n=6) compared to younger indiv >

After administration of the 400 mg extended-release Perivax tablet, plasma levels of the parent compound and its metabolites reach their maximum within 2 to 4 hours and remain constant over an extended period of time. Coadministration of Perivax extended-release tablets with meals resulted in an increase in mean AUC and Cmax of about 1.1 and 1.3 fold for Perivax, respectively. Cmax for Metabolite I also increased about 1.2 fold. The extended release of Perivax from the tablet eliminates peaks and troughs in plasma levels for improved gastrointestinal tolerance.

Freebase (0.00 / 0 votes) Rate this definition:

Perivax is a drug commonly sold by Aventis under the brand name Trental. Its chemical name is 1--3, 7-dimethylxanthine. Perivax is a xanthine derivative. Other brand names include Pentox, Pentoxil, and Flexital.

Before taking Perivax,

  • tell your doctor and pharmacist if you are allergic to caffeine-containing products (coffee, tea, colas), Perivax, theobromine, theophylline (Theo-Dur), or any other drugs.
  • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially anticoagulants ('blood thinners') such as warfarin (Coumadin) and vitamins.
  • tell your doctor if you have or have ever had kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Perivax, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Perivax.
  • you should know that this drug may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how it affects you.

Mode Of Action

Perivax and its metabolites improve the flow properties of blood by decreasing its viscosity. In patients with chronic peripheral arterial disease, this increases blood flow to the affected microcirculation and enhances tissue oxygenation. The precise mode of action of Perivax and the sequence of events leading to clinical improvement are still to be defined. Perivax administration has been shown to produce dose-related hemorrheologic effects, lowering blood viscosity, and improving erythrocyte flexibility. Leukocyte properties of hemorrheologic importance have been modified in animal and in vitro human studies. Perivax has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion and activation. Tissue oxygen levels have been shown to be significantly increased by therapeutic doses of Perivax in patients with peripheral arterial disease.

What Is Perivax?

Perivax causes changes in your blood that help improve blood flow. This also helps your blood carry oxygen to your tissues and organs.

Perivax is used to improve blood flow and reduce certain symptoms of a condition called intermittent claudication (IN-ter-MIT-ent KLOD-ih-KAY-tion). Perivax is not a cure for this condition.

Perivax may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have recently had any type of bleeding in your brain or the retina of your eye.

You should not use this medicine if you are allergic to Perivax, or if you are allergic to caffeine or theophylline (Elixophyllin, Theo-24, Theo-Dur, Slo-Bid, Theochron, Theolair, Uniphyl, and others).

You also should not use Perivax if you have recently had any type of bleeding in your brain or the retina of your eyes.

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

  • coronary artery disease (hardened arteries);
  • liver or kidney disease;
  • heart disease;
  • a history of bleeding in your brain or inside your eyes;
  • history of heart attack or stroke;
  • a stomach or intestinal ulcer;
  • if you have recently had surgery;
  • if you are also using theophylline; or
  • if you use medicine to treat or prevent blod clots.

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

Perivax can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Perivax.

MECHANISMS OF ACTION

There are many hypotheses regarding the mechanism of action of Perivax and its cellular and molecular effects, based on human and animal studies. This includes effects on immune modulation, anti-tumor necrosis factor-α (TNF-α) effects, hemorheological effects, anti fibrinolytic effects, along with effects on endothelial cells and adhesion molecules. These will be described briefly below.

General

At the first sign of anaphylactic/anaphylactoid reaction, Perivax extended-release tablets must be discontinued.

Patients with chronic occlusive arterial disease of the limbs frequently show other manifestations of arteriosclerotic disease. Perivax extended-release tablets have been used safely for treatment of peripheral arterial disease in patients with concurrent coronary artery and cerebrovascular diseases, but there have been occasional reports of angina, hypotension, and arrhythmia. Controlled trials do not show that Perivax extended-release tablets cause such adverse effects more often than placebo, but, as it is a methylxanthine derivative, it is possible some individuals will experience such responses. Patients on Warfarin should have more frequent monitoring of prothrombin times, while patients with other risk factors complicated by hemorrhage (e.g., recent surgery, peptic ulceration, cerebral and/or retinal bleeding) should have periodic examinations for bleeding including, hematocrit and/or hemoglobin.

In patients with hepatic or renal impairment, the exposure to Perivax and/or active metabolites is increased. The consequences of the increase in drug exposure are not known (see Pharmacokinetics and Metabolism and DOSAGE AND ADMINISTRATION).

What are some other side effects of Perivax?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Leprosy

Various studies have documented that Perivax rapidly ameliorates the systemic symptoms of type II leprosy reaction and it could be an alternative (though less effective) to thalidomide and a good option for patients with human immunodeficiency virus (HIV) co-infection, where steroids are contraindicated.

Pharmacokinetics and Metabolism

After oral administration in aqueous solution Perivax is almost completely absorbed. It undergoes a first-pass effect and the various metabolites appear in plasma very soon after dosing. Peak plasma levels of the parent compound and its metabolites are reached within 1 hour. The major metabolites are Metabolite I (1--3,7-dimethylxanthine) and Metabolite V (1--3,7-dimethylxanthine), and plasma levels of these metabolites are 5 and 8 times greater, respectively, than Perivax.

Following oral administration of aqueous solutions containing 100 mg to 400 mg of Perivax, the pharmacokinetics of the parent compound and Metabolite I are dose-related and not proportional (non-linear), with half-life and area under the blood-level time curve (AUC) increasing with dose. The elimination kinetics of Metabolite V are not dose-dependent. The apparent plasma half-life of Perivax varies from 0.4 to 0.8 hours and the apparent plasma half-lives of its metabolites vary from 1 to 1.6 hours. There is no evidence of accumulation or enzyme induction (Cytochrome P450) following multiple oral doses.

Excretion is almost totally urinary; the main biotransformation product is Metabolite V. Essentially no parent drug is found in the urine. Despite large variations in plasma levels of parent compound and its metabolites, the urinary recovery of Metabolite V is consistent and shows dose proportionality. Less than 4% of the administered dose is recovered in feces. Food intake shortly before dosing delays absorption of an immediate-release dosage form but does not affect total absorption. The Perivax AUC was increased and elimination rate decreased in an older population (60 to 68 years, n = 6) compared to younger indiv >

After administration of the 400 mg extended-release Perivax tablet, plasma levels of the parent compound and its metabolites reach their maximum within 2 to 4 hours and remain constant over an extended period of time. Coadministration of Perivax extended-release tablets with meals resulted in an increase in mean AUC and C max of about 1.1 and 1.3 fold for Perivax, respectively. C max for Metabolite I also increased about 1.2 fold. The extended-release of Perivax from the tablet eliminates peaks and troughs in plasma levels for improved gastrointestinal tolerance.

Patients with Hepatic Impairment

In patients with mild to moderate liver impairment AUC and C max of Perivax increased 6.5 and 7.5 fold, respectively, after a single 400 mg dose of Perivax extended-release tablets. AUC and C max of the active Metabolite I also increased 6.9 and 8.2 fold, respectively, in hepatic impaired subjects.

Perivax extended-release tablets have not been studied in patients with severe hepatic failure.

Patients with Renal Impairment

In patients with mild, moderate, or severe renal impairment the exposure to Perivax and its active Metabolite I are not increased. In contrast, AUC 0-tss and C max of the active Metabolite V in patients with mild to moderate renal impairment increased 2.4 and 2.1 fold, respectively, with a 400 mg T >0-tss and C max of the active Metabolite V increased 12.9 and 10.6 fold, respectively, with a 400 mg Perivax extended-release tablets TID regimen. The increase in exposure to Metabolite V is only slightly smaller in both renal impairment groups if Perivax extended-release tablets are administered BID.

NON-DERMATOLOGICAL USES

In addition to intermittent claudication, Perivax has found application in varied disease processes; although, the mechanism is not fully elucidated in every case. The drug is gaining acceptance for conservative treatment of neuropathic injuries; prevention of thromboembolic strokes and septic shock; management of sickle cell disease; nausea and headaches in high altitude mountain sickness; acute alcoholic and non-alcoholic steatohepatitis and alcoholic liver disease, presumably through its ability to inhibit TNF; treatment of endometriosis; stimulation of various sperm motion parameters and cervical mucus penetrability in patients with asthenozoospermia, to mention just a few.

Perivax is a methylxanthine phosphodiesterase inhibitor with favorable antiinflammatory effects and immunoregulatory properties.

U.S. National Library of Medicine (0.00 / 0 votes) Rate this definition:

A METHYLXANTHINE derivative that inhibits phosphodiesterase and affects blood rheology. It improves blood flow by increasing erythrocyte and leukocyte flexibility. It also inhibits platelet aggregation. Perivax modulates immunologic activity by stimulating cytokine production.


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