Product image of Isosorbidedinitraat-Vaselinecrème 1% Fna Fagron Nl (Isosorbide Dinitrate) supplied by GNH India

Isosorbidedinitraat-Vaselinecrème 1% Fna Fagron Nl

Active Ingredient:
Isosorbide Dinitrate
Origin:
EU

Isosorbidedinitraat-Vaselinecrème 1% Fna Fagron Nl (Isosorbide Dinitrate)

Isosorbide dinitrate, the active ingredient in Isosorbidedinitraat-Vaselinecrème 1% Fna Fagron Nl, is a nitrate vasodilator presented as a 1% w/w Vaseline cream for rectal use. It treats and prevents angina pectoris and relieves sphincter spasm in patients with anal fissure.

GNH India supplies Isosorbidedinitraat-Vaselinecrème 1% Fna Fagron Nl as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

Manufacturer / TM Owner

Fagron Nl B.V.

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Indications & Clinical Uses

Isosorbide dinitrate, a nitrate vasodilator, is used in cardiovascular and anorectal conditions.

  • Angina pectoris (prevention): provides prophylactic relief of chest pain episodes.
  • Angina pectoris (acute treatment): alleviates acute episodes of chest pain.
  • Anal fissure: relaxes the internal anal sphincter to facilitate healing and pain relief.

How It Works

  • Isosorbide dinitrate releases nitric oxide in vascular smooth muscle, activating guanylate cyclase and increasing cyclic GMP levels. Elevated cGMP leads to smooth‑muscle relaxation, vasodilation of coronary and peripheral vessels, and reduction of myocardial oxygen demand, while also relaxing the internal anal sphincter to ease fissure pain.

Side Effects

Common Side Effects

  • Headache: mild to moderate throbbing pain.
  • Flushing: warmth and redness of the skin.
  • Dizziness: sensation of light‑headedness.
  • Hypotension: transient drop in blood pressure.
  • Tachycardia: increased heart rate.
  • Nausea: mild gastrointestinal upset.

Serious or Rare Side Effects

  • Severe hypotension: marked blood pressure fall requiring medical attention.
  • Syncope: fainting episodes.
  • Myocardial infarction: rare but possible cardiac event.
  • Allergic reaction: rash, itching, or swelling.
  • Methemoglobinemia: rare blood disorder causing cyanosis.

Precautions & Warnings

Before using this product, consider the following safety measures.

  • Recent myocardial infarction: avoid use in patients with recent heart attack.
  • Concomitant nitrate therapy: risk of additive hypotension.
  • Phosphodiesterase‑5 inhibitors: contraindicated due to severe hypotension.
  • Hypotension monitoring: observe blood pressure after application.
  • Pregnancy and lactation: safety not established; use only if clearly needed.
  • Store at room temperature: keep in original container, protect from moisture and light.

Avoid Interactions

Isosorbide dinitrate may interact with several medicines; review patient medication lists.

Major Interactions (Avoid)

  • Phosphodiesterase‑5 inhibitors (e.g., sildenafil, tadalafil): can cause profound hypotension.
  • Other nitrates (e.g., nitroglycerin, isosorbide mononitrate): additive vasodilatory effect.
  • Guanylate cyclase stimulators: may amplify nitric‑oxide pathway.

Moderate Interactions (Monitor Closely)

  • Antihypertensives (ACE inhibitors, beta‑blockers): may enhance blood‑pressure lowering.
  • Alcohol: can increase hypotensive effect.
  • CYP3A4 inhibitors (e.g., erythromycin, ketoconazole): may raise nitrate levels.

Frequently Asked Questions

Isosorbidedinitraat-Vaselinecrème 1% contains isosorbide dinitrate and is prescribed to prevent and treat angina pectoris as well as to provide topical relief for anal fissures by relaxing the internal sphincter and promoting healing.

The active nitrate releases nitric oxide when applied to the rectal mucosa. Nitric oxide activates guanylate cyclase, raising cyclic GMP levels, which cause smooth‑muscle relaxation in coronary vessels and the anal sphincter, thereby reducing cardiac workload and easing fissure pain.

The appropriate dose and frequency are determined by the prescribing clinician based on the individual’s condition, severity, and response. The product is applied rectally as directed in the prescription.

Safety data for isosorbide dinitrate in pregnancy and lactation are limited. It should only be used if the potential benefit justifies any potential risk to the fetus or infant, and this decision must be made by a qualified healthcare professional.

Submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details, and any necessary import documentation.

Compared with oral nitrates, the rectal cream delivers the active ingredient locally, which can reduce systemic side effects such as severe hypotension while still providing effective vasodilation for angina and sphincter relaxation for fissure treatment.

Store the cream at room temperature, preferably below 25 °C. Keep it in the original packaging, protect it from moisture and direct light, and ensure the container is tightly closed to maintain stability.

The cream is applied rectally, typically using a measured amount as instructed by the prescriber. The patient should lie on their side or in a comfortable position to allow even distribution of the medication over the affected area.

Serious risks include severe hypotension, syncope, myocardial infarction, allergic reactions, and rare cases of methemoglobinemia. Patients should seek immediate medical attention if they experience fainting, chest pain, or signs of an allergic response.

Individuals with a recent myocardial infarction, those taking phosphodiesterase‑5 inhibitors, other nitrate preparations, or with known hypersensitivity to isosorbide dinitrate should avoid using this product unless specifically advised by a healthcare professional.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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