What is Trental?
Vasonit is an oral drug used for treating symptoms of intermittent claudication caused by peripheral arterial disease (PAD).
Indications and Usage for Vasonit
Vasonit extended-release tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Vasonit extended-release tablets can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.
Oral sub-mucous fibrosis
Oral sub-mucous fibrosis is a common premalignant condition in the Indian subcontinent, caused by chewing areca nut and other irritants in various forms. The efficacy of Vasonit in oral sub mucous fibrosis, singly and as adjuvant therapy has been demonstrated in various studies.
Why is Trental prescribed to patients?
Vasonit is used for the treatment of intermittent claudication caused by peripheral arterial disease.
Mode of Action
Vasonit 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 Vasonit and the sequence of events leading to clinical improvement are still to be defined. Vasonit 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. Vasonit 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 Vasonit in patients with peripheral arterial disease.
Clinical trials were conducted using either extended-release Vasonit tablets for up to 60 weeks or immediate-release Vasonit capsules for up to 24 weeks. Dosage ranges in the tablet studies were 400 mg bid to tid and in the capsule studies, 200 mg to 400 mg tid. The table summarizes the incidence (in percent) of adverse reactions considered drug related, as well as the numbers of patients who received extended-release Vasonit tablets, immediate-release Vasonit capsules, or the corresponding placebos. The incidence of adverse reactions was higher in the capsule studies (where dose related increases were seen in digestive and nervous system side effects) than in the tablet studies. Studies with the capsule include domestic experience, whereas studies with the extended-release tablets were conducted outside the U.S.
The table indicates that in the tablet studies few patients discontinued because of adverse effects.
Extended-Release Tablets Commercially Available
Immediate-Release Capsules Used Only for Controlled Clinical Trials
Vasonit Extended-Release Tablets
Vasonit Extended- Release Tablets
Which drugs or supplements interact with Trental?
Vasonit reduces the breakdown of theophylline (Theo-Dur, Respbid, Slo-Bid, Theo-24, Theolair, Uniphyl, Slo-Phyllin) in the liver, increasing blood levels and side effects of theophylline. Combining Vasonit with warfarin (Coumadin) may increase the risk of bleeding. The mechanism for this interaction is unknown.
Is Trental safe to use during pregnancy or while breastfeeding?
Vasonit has not been adequately studied in pregnant women.
Vasonit is excreted in breast milk and may cause adverse effects in the infant.
What Other Drugs Interact with Vasonit?
If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.
Vasonit has no known severe interactions with other drugs.
Vasonit has no known serious interactions with other drugs.
Moderate interactions of Vasonit include:
Mild interactions of Vasonit include:
This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.
At the first sign of anaphylactic/anaphylactoid reaction, Vasonit must be discontinued.
Patients with chronic occlusive arterial disease of the limbs frequently show other manifestations of arteriosclerotic disease. Vasonit has 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 Vasonit causes 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 Vasonit 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).
Vasonit is a phosphodiesterase inhibitor with immune-modulating properties and ability to inhibit T helper 1 lymphocytes activity. In animal models, pharmacological treatment with Vasonit has resulted in reduced atherosclerosis and modification in plaque morphology . In humans, only few studies have focused specifically in modulating this particular immune response. Vasonit has been shown to increase interleukin 10 (IL-10), reduce IL-6, and inhibit C-reactive protein (CRP) expression and activity in peripheral blood cells and has been extensively used in patients with peripheral vascular disease . Fernandes et al. demonstrated a beneficial effect of Vasonit in the immunomodulation of the inflammatory activity in patients with CAD with a significant decrease in proinflammatory markers and increase in anti-inflammatory cytokines toward a more stable immune phenotype .
Other uses for this medicine
Vasonit also is used for leg ulcers, strokes, high-altitude sickness, eye and ear disorders, and sickle cell disease and to treat pain from diabetic neuropathy. Talk to your doctor about the possible risks of using this drug for your condition.