GNH USA

Europe — EMA

Isodur Xl

GNH USA supplies Isodur XL (Isosorbide 5‑mononitrate), a nitrate vasodilator for prophylaxis of chronic stable angina pectoris.

Isosorbide 5 Mononitrate

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What is Isosorbide 5 Mononitrate?

Isosorbide 5‑mononitrate, the active ingredient in Isodur XL, is a nitrate vasodilator presented as an extended‑release tablet for oral use. It reduces myocardial oxygen demand and is indicated for the prophylaxis of chronic stable angina pectoris in adult patients.

GNH USA supplies Isodur XL as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing consistent quality and regulatory compliance for global distribution. The company adheres to EU GMP standards and offers reliable logistics for timely delivery.

What is Isosorbide 5 Mononitrate used for?

Isosorbide 5‑mononitrate is an anti‑anginal nitrate used in the management of coronary artery disease.

- Chronic stable angina pectoris: provides prophylactic relief of angina attacks by decreasing myocardial oxygen demand. - Exercise‑induced angina: reduces the frequency of chest pain during physical activity. - Variant (Prinzmetal) angina: helps prevent vasospasm‑related chest discomfort.

What are the side effects of Isosorbide 5 Mononitrate?

Isodur XL may cause a range of adverse reactions.

Common Side Effects: - Headache: throbbing pain often occurring shortly after dosing. - Dizziness or light‑headedness: related to blood pressure reduction. - Flushing: warmth and redness of the skin. - Nausea or upset stomach. - Palpitations: awareness of heartbeat. - Hypotension: mild drop in blood pressure.

Serious or Rare Side Effects: - Severe hypotension: marked blood pressure fall requiring medical attention. - Syncope: sudden loss of consciousness. - Tachycardia: rapid heart rate. - Allergic reaction: rash, itching, swelling, or difficulty breathing. - Methemoglobinemia: rare blood disorder causing cyanosis.

What precautions apply to Isosorbide 5 Mononitrate?

When prescribing or dispensing Isodur XL, consider the following precautions.

- Concomitant nitrate therapy: avoid use with other nitrates to prevent excessive hypotension. - Phosphodiesterase‑5 inhibitors: do not combine with sildenafil, tadalafil, or similar agents. - Hypotensive patients: monitor blood pressure closely, especially at therapy initiation. - Renal or hepatic impairment: dose may need adjustment; assess organ function. - Elderly patients: start with the lowest effective dose and titrate slowly. - Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

What does Isosorbide 5 Mononitrate interact with?

Isodur XL can interact with several drug classes.

Major Interactions (Avoid): - Other nitrates (e.g., nitroglycerin, isosorbide dinitrate): risk of profound hypotension. - Phosphodiesterase‑5 inhibitors (sildenafil, tadalafil): additive vasodilatory effect. - Guanylate cyclase stimulators: may amplify nitric‑oxide pathway.

Moderate Interactions (Monitor Closely): - Antihypertensives (ACE inhibitors, beta‑blockers, calcium channel blockers): monitor blood pressure. - Diuretics: increased risk of volume depletion and hypotension. - Alcohol: may enhance vasodilatory effects. - Smoking: induces metabolism, potentially reducing efficacy.

Frequently asked questions

What is Isodur XL used for?+
Isodur XL contains isosorbide 5‑mononitrate and is prescribed for the prophylaxis of chronic stable angina pectoris. It helps prevent angina attacks by lowering the heart’s oxygen demand, making it useful for patients with documented coronary artery disease who experience chest pain during physical exertion.
How does Isosorbide 5‑mononitrate work?+
The molecule releases nitric oxide after oral absorption. Nitric oxide activates guanylate cyclase in vascular smooth muscle, increasing cyclic GMP levels. Elevated cyclic GMP causes relaxation of arteries and veins, reducing preload and afterload, which in turn decreases myocardial oxygen consumption and alleviates angina.
What is the usual dose of Isodur XL?+
Dosing of Isodur XL is individualized. The prescribing clinician determines the appropriate strength and frequency based on the patient’s clinical condition, response, and tolerance. Patients should follow the exact regimen written on their prescription and not adjust the dose without medical advice.
Is Isodur XL safe during pregnancy or breastfeeding?+
Safety data for isosorbide 5‑mononitrate in pregnancy and lactation are limited. It should only be used if the potential benefit justifies any possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.
How do I order Isodur XL from GNH USA?+
To request Isodur XL, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.
How does Isodur XL compare with other anti‑anginal drugs?+
Isodur XL belongs to the nitrate class, offering once‑daily extended‑release dosing, which can improve adherence compared with short‑acting nitrates like nitroglycerin that require multiple daily doses. Unlike beta‑blockers, nitrates primarily act by vasodilation rather than heart‑rate reduction, making them suitable for patients who cannot tolerate beta‑blockade.
How should Isodur XL be stored and handled?+
Store the tablets at temperatures below 25 °C in their original blister pack, protecting them from moisture and direct sunlight. Do not expose the product to excessive heat or humidity, and keep it out of reach of children. No special refrigeration is required for this oral extended‑release formulation.
How is Isodur XL administered?+
Isodur XL is taken orally as a whole extended‑release tablet. Swallow the tablet whole with a glass of water; do not crush, chew, or split it, as this can destroy the controlled‑release mechanism and increase the risk of side effects.
What are the most serious risks to watch for while taking Isodur XL?+
The most serious adverse events include severe hypotension, syncope (fainting), and rare allergic reactions such as rash, swelling, or breathing difficulty. Patients should seek immediate medical attention if they experience sudden dizziness, fainting, or signs of an allergic response.
Who should not use Isodur XL?+
Isodur XL is contraindicated in patients who are currently taking other nitrate medications, have severe hypotension (systolic blood pressure below 90 mmHg), or have known hypersensitivity to isosorbide derivatives. Caution is also advised for individuals with recent phosphodiesterase‑5 inhibitor use.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Isosorbide 5 Mononitrate
Route
Oral Use
Manufacturer
Galen Limited
Origin
EU

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