Lomir2.5 mg

Lomir is indicated for the treatment of hypertension (high blood pressure). It may be used alone or in combination with other antihypertensive agents, most commonly a thiazide diuretic, when a single agent does not adequately control blood pressure.

• Established/FDA-approved use: Management of essential hypertension, as monotherapy or as part of combination antihypertensive therapy.
• Combination therapy: Lomir has been studied and used together with thiazide-type diuretics for an additive antihypertensive effect in patients not controlled on a single agent.

Lomir is not approved for the treatment of acute hypertensive emergencies or angina.

Each capsule/tablet contains Isradipine as the active ingredient, in strengths typically of 2.5 mg, 5 mg, or 10 mg (immediate-release capsules and controlled-release tablets), along with pharmaceutically acceptable excipients.

Lomir is a dihydropyridine calcium channel blocker used primarily to lower blood pressure in patients with hypertension. It works by relaxing and widening blood vessels, which reduces the resistance the heart must pump against.

Lomir is available in immediate-release capsule form and as a controlled-release tablet formulation, allowing for flexible dosing schedules depending on the clinical situation.

Lomir belongs to the dihydropyridine class of calcium channel blockers (calcium antagonists), a subclass of antihypertensive/vasodilator agents.

Isradipine is a dihydropyridine calcium channel blocker. It inhibits the transmembrane influx of calcium ions into vascular smooth muscle and, to a much lesser extent, cardiac muscle, by blocking L-type (slow) calcium channels.

This action produces relaxation of vascular smooth muscle, resulting in peripheral vasodilation and a reduction in systemic vascular resistance, which lowers arterial blood pressure. Isradipine has relatively selective action on vascular smooth muscle compared to cardiac muscle, so it has minimal direct negative effect on cardiac contractility or conduction at usual clinical doses, although reflex sympathetic activation can occur.

Pharmacokinetics: Isradipine is well absorbed orally, undergoes extensive first-pass hepatic metabolism (mainly via CYP3A4) with low absolute bioavailability, and is eliminated primarily as inactive metabolites in urine and feces. Its elimination half-life is approximately 8 hours.

Lomir capsules/tablets should be swallowed whole with water, taken at the same time(s) each day. Controlled-release tablets must not be crushed or chewed. Lomir may be taken with or without food, but should be taken consistently the same way each day.

• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, protease inhibitors): may significantly increase Lomir blood levels, increasing the risk of hypotension and other adverse effects; concurrent use should be avoided or done with caution and monitoring.
• CYP3A4 inducers (e.g., rifampin): may substantially reduce Lomir plasma levels and reduce its antihypertensive effect.
• Grapefruit juice: can increase Lomir plasma concentrations; patients should avoid grapefruit juice while taking Lomir.
• Other antihypertensive agents and diuretics: concurrent use with other blood pressure-lowering drugs (including beta-blockers) can produce additive hypotensive effects; dose adjustment and monitoring may be needed.
• NSAIDs: may reduce the antihypertensive effect of Lomir due to fluid retention and prostaglandin inhibition.

Common side effects of Lomir are generally related to its vasodilatory action and are often dose-dependent:

• Peripheral edema (swelling of the ankles/feet)
• Headache
• Dizziness or lightheadedness
• Flushing
• Palpitations and reflex tachycardia
• Fatigue

Less commonly, Lomir may cause symptomatic hypotension, and rarely, worsening of angina symptoms may occur at the start of therapy or with dose increases (see Precautions and Warnings). Patients should report persistent or severe side effects to their physician.

Pregnancy: Safety of Lomir in human pregnancy has not been well established. Lomir should be used during pregnancy only if clearly needed and if the potential benefit to the mother justifies the potential risk to the fetus. A physician should always be consulted before use in pregnancy.

Lactation: It is not known whether Lomir is excreted in human breast milk. Caution should be exercised, and a physician should be consulted before using Lomir while breastfeeding.

• Hypotension: Lomir can cause symptomatic hypotension, particularly at the start of treatment or with dose increases, and especially when combined with other antihypertensive agents. Blood pressure should be monitored closely.
• Peripheral edema: Dose-related peripheral edema may occur; monitor and manage as clinically indicated.
• Reflex tachycardia: Vasodilation may trigger a reflex increase in heart rate in some patients.
• Worsening angina/heart failure: Rarely, patients may experience increased frequency, duration, or severity of angina, or myocardial infarction, on starting Lomir or during dose titration, particularly in patients with obstructive coronary artery disease. Lomir should be used with caution in patients with heart failure, particularly those with underlying ischemic heart disease.
• Hepatic impairment: Since Lomir is extensively metabolized by the liver, patients with hepatic impairment require careful dose titration and monitoring.
• Abrupt discontinuation: Should be avoided; consult a physician before stopping treatment.

Overdose with Lomir may result in excessive peripheral vasodilation leading to marked and prolonged systemic hypotension, reflex tachycardia or bradycardia, and, in severe cases, shock.

If an overdose of Lomir is suspected, seek immediate medical attention or contact emergency services / a poison control center right away. Treatment is generally supportive, with monitoring of cardiovascular status; management should only be carried out under medical supervision.

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

• Pediatric patients: Safety and efficacy of Lomir in children have not been established; use in this population is generally not recommended.
• Elderly patients: Older patients may show a greater blood pressure response to Lomir; a lower starting dose and careful monitoring are advised.
• Hepatic impairment: Requires dose reduction and careful monitoring due to extensive hepatic metabolism of Lomir (see Precautions and Warnings).
• Renal impairment: No specific dose adjustment generally required, though blood pressure should be monitored.

Lomir is typically used as a long-term, ongoing therapy for chronic management of hypertension. Duration of treatment should be determined by the prescribing physician based on blood pressure control and response, and treatment should not be stopped or altered without medical advice.

Calcium Channel Blocker (Dihydropyridine class); Antihypertensive Agent

Isradipine blocks the influx of calcium ions through L-type calcium channels in vascular smooth muscle cells, causing relaxation of arterial smooth muscle and vasodilation, which reduces peripheral vascular resistance and lowers blood pressure.

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Safety and efficacy of Lomir have not been established in pediatric patients. Lomir is generally not recommended for use in children, and its use should be avoided in this population unless specifically directed by a specialist physician.