Vasocil100 mg

Vasocil is FDA-approved for the reduction of symptoms of intermittent claudication, a condition caused by peripheral arterial disease (PAD) in which reduced blood flow to the legs causes pain, cramping, or fatigue in the calf, thigh, or buttock muscles during walking or exercise.

• Established/FDA-approved use: Improvement of walking distance (both pain-free and maximum walking distance) in patients with intermittent claudication.
• Guideline-supported adjunct use: Some vascular guidelines support Vasocil as an option to reduce restenosis after peripheral endovascular procedures (e.g., after angioplasty or stenting), used in addition to standard antiplatelet therapy, though this is not a primary FDA-labeled indication.
• Off-label use (limited evidence): Vasocil is sometimes used off-label as an adjunct antiplatelet agent after certain neurovascular or coronary stenting procedures in specific patient groups; this use should only be under specialist supervision.

Vasocil does not cure peripheral arterial disease and does not replace lifestyle measures such as smoking cessation, supervised exercise programs, and control of cardiovascular risk factors.

Each tablet of Cilostazol typically contains 50 mg or 100 mg of Cilostazol as the active pharmaceutical ingredient, along with pharmaceutically acceptable excipients such as fillers, binders, and disintegrants used in standard tablet formulation.

Vasocil is an orally administered antiplatelet and vasodilating agent belonging to the phosphodiesterase III (PDE3) inhibitor class. It is used specifically to reduce the symptoms of intermittent claudication associated with peripheral arterial disease. Vasocil and its active metabolites work by inhibiting platelet aggregation and producing direct arterial vasodilation, which together help improve blood flow and walking capacity in affected patients.

Vasocil is supplied as oral tablets and is intended for long-term, regular use under medical supervision; symptomatic improvement is usually gradual, occurring over several weeks.

Vasocil belongs to the therapeutic class of antiplatelet agents / peripheral vasodilators, and pharmacologically to the phosphodiesterase III (PDE3) inhibitor class.

Cilostazol and its major active metabolites (particularly the dehydro metabolite) selectively inhibit phosphodiesterase III (PDE3), an enzyme that breaks down cyclic adenosine monophosphate (cAMP) within platelets and vascular smooth muscle cells.

• Antiplatelet effect: Increased intracellular cAMP in platelets inhibits platelet aggregation induced by various stimuli (e.g., ADP, collagen, thrombin, shear stress, epinephrine).
• Vasodilatory effect: Increased cAMP in vascular smooth muscle produces direct arterial vasodilation, most notably in the femoral vascular bed, increasing blood flow to the limbs.
• Lipid effects: Cilostazol has also been shown to modestly reduce triglycerides and increase HDL cholesterol.

Cilostazol is extensively metabolized in the liver primarily via CYP3A4 and CYP2C19 enzymes and is highly protein bound (95-98%). Its active metabolites contribute significantly to its overall pharmacologic effect. Elimination is mainly renal, as metabolites, with a plasma half-life of approximately 11-13 hours.

Vasocil tablets should be taken orally, at least 30 minutes before or 2 hours after breakfast and dinner, as food (especially high-fat meals) can increase absorption of the drug. Tablets should be swallowed whole with water and taken at the same times each day to maintain consistent blood levels. Do not stop taking Vasocil abruptly without consulting a physician, even if symptoms have not yet improved, unless advised to do so.

Vasocil is metabolized mainly by CYP3A4 and CYP2C19; drugs that inhibit these enzymes can significantly increase Vasocil blood levels and the risk of adverse effects, requiring dose reduction to 50 mg twice daily.

Always inform the treating physician about all other medications, herbal products, and supplements being used before starting Vasocil.

The most commonly reported adverse effects of Vasocil (100 mg twice daily) include:

• Headache (most common; approximately 34% of patients, often dose-related and may improve over time)
• Diarrhea (approximately 19%)
• Abnormal stools (approximately 15%)
• Dizziness (approximately 10%)
• Palpitations (approximately 10%)

Other less common effects can include nausea, dyspepsia, peripheral edema, rhinitis, pharyngitis, and infection. Rare but serious effects can include significant bleeding (see Contraindications for bleeding-related risk factors) and hypersensitivity reactions. Patients should seek prompt medical attention for chest pain, irregular heartbeat, unusual bleeding or bruising, or signs of an allergic reaction (rash, swelling, difficulty breathing) while taking Vasocil.

Pregnancy: Adequate and well-controlled studies of Vasocil in pregnant women are not available. In animal reproduction studies, Vasocil was associated with teratogenic and embryotoxic effects at maternal doses higher than those used clinically in humans. Vasocil should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; a physician should be consulted before use.

Lactation: It is not known whether Vasocil or its metabolites are excreted in human breast milk. Because many drugs are excreted in breast milk and the effects on a nursing infant are unknown, a decision should be made whether to discontinue breastfeeding or discontinue Vasocil, taking into account the importance of the drug to the mother; this decision should be made in consultation with a physician.

Vasocil carries an important boxed warning: it is contraindicated in patients with heart failure of any severity (see Contraindications). Additional precautions include:

• Use with caution in patients with a history of bleeding disorders, recent trauma, or recent surgery, given its antiplatelet effect.
• Caution is advised in patients on concurrent antiplatelet or anticoagulant therapy due to additive bleeding risk.
• Dose reduction is required with concomitant strong CYP3A4 or CYP2C19 inhibitors (see Interactions).
• Use with caution in patients with hepatic or renal impairment.
• Patients should be monitored for cardiovascular symptoms such as palpitations, chest pain, or irregular heartbeat, and should report these promptly.
• Vasocil should be discontinued if no symptomatic benefit is seen after 3 months of appropriate therapy.

Overdose with Vasocil may be expected to cause severe headache, diarrhea, hypotension, tachycardia, and possibly cardiac arrhythmias, based on its pharmacologic actions. There is no specific antidote for Vasocil overdose. In case of suspected overdose, seek immediate medical attention or contact emergency services / a poison control center. Treatment should consist of supportive and symptomatic care under medical supervision; because Vasocil is highly protein bound, hemodialysis is not expected to be effective in removing the drug.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Pediatric use: Safety and efficacy of Vasocil in pediatric patients have not been established; its use is not recommended in children.

Elderly: Clinical studies of Vasocil included patients aged 65 and older; while overall effectiveness was similar, elderly patients may be more sensitive to adverse effects such as dizziness and bleeding, and should be monitored closely. No specific dose adjustment based on age alone is established, but caution and individualized dosing are advised.

Hepatic/renal impairment: Use with caution; see Dosage and Administration.

Heart failure patients: Vasocil must not be used in any patient with heart failure of any severity (see Contraindications).

Treatment with Vasocil is generally long-term, as it is used for chronic management of intermittent claudication symptoms rather than short-term relief. Symptomatic benefit typically appears after 2-4 weeks, with maximal effect sometimes taking up to 12 weeks. If no improvement is seen after 3 months of consistent, correctly dosed therapy, a physician should reassess whether continued treatment with Vasocil is appropriate.

Cilostazol belongs to the phosphodiesterase III (PDE3) inhibitor class of drugs, functioning as an antiplatelet agent and peripheral vasodilator.

Cilostazol selectively inhibits phosphodiesterase III, increasing intracellular cyclic AMP levels in platelets and vascular smooth muscle. This produces inhibition of platelet aggregation and direct arterial vasodilation, which together improve peripheral blood flow and reduce the symptoms of intermittent claudication.

Category C

The safety and effectiveness of Vasocil in pediatric patients have not been established. Vasocil is not indicated or recommended for use in children or adolescents, as peripheral arterial disease with intermittent claudication is predominantly an adult condition and pediatric clinical data are lacking.