Nitrosol Topical Spray

Indications:

Nitrosol Sublingual Spray provides rapid relief for acute angina attacks and is used for the prevention of angina pectoris associated with coronary artery disease.

Description:

Nitrosol is an organic nitrate that functions as a potent vasodilator, affecting both arteries and veins. Each metered dose spray delivers 400 mcg of Nitrosol in the form of fine droplets administered under the tongue, with a total of 200 sprays per container.

Pharmacology:

Nitroglycerin, the active ingredient in Nitrosol, primarily relaxes vascular smooth muscle, resulting in vasodilation of both peripheral arteries and veins, with a stronger effect on veins. This relaxation leads to decreased venous return to the heart and reduced left ventricular end-diastolic pressure (pre-load). It also lowers systemic vascular resistance and arterial pressure (after-load) through arteriolar relaxation.

Dosage:

For immediate relief during an angina attack, administer 1 to 2 sprays under the tongue. Avoid exceeding 3 sprays within a 15-minute period. If chest pain persists, seek medical attention promptly. For prophylaxis, use the spray 5 to 10 minutes before engaging in activities that may trigger an attack.

Use as directed by a healthcare professional.

Administration:

Special Instructions:

• Always carry Nitrosol Sublingual Spray, and consider keeping an extra supply at home for easy access.
• This medication is for acute use only, not for routine administration.
• Avoid alcohol after using this spray.
• Do not combine with sildenafil, vardenafil, or tadalafil due to the risk of severe blood pressure drops.
• Store away from children.

How to Use Nitrosol Sublingual Spray:

1. Sit down if you experience angina.
2. Remove the plastic cap and hold the container upright without shaking.
3. Place the container as close to your mouth as possible, aiming under the tongue.
4. Press the top button slowly to spray.
5. Close your mouth and avoid swallowing immediately. Refrain from drinking water for 5-10 minutes post-application.
6. If needed, repeat the process for additional relief and replace the plastic cap.

Use as directed by a healthcare professional.

Interactions:

Consuming alcohol with Nitrosol can lead to severe hypotension. The medication may also increase the absorption of dihydroergotamine. Combined use with calcium channel blockers, phenothiazines, or tricyclic antidepressants may cause orthostatic hypotension.

Contraindications:

Do not use if you have a known hypersensitivity to nitrates or any component of the formulation, hypotension, hypovolemia, severe anemia, cerebral hemorrhage, brain trauma, mitral stenosis, angina from hypertrophic obstructive cardiomyopathy, or if you are taking phosphodiesterase inhibitors for erectile dysfunction.

Side Effects:

Possible side effects include headache, facial flushing, dizziness, nausea, vomiting, weakness, postural hypotension, and reflex tachycardia.

Pregnancy & Lactation:

Category C. Nitrosol should be used during pregnancy only if necessary, and it’s uncertain whether it is excreted in breast milk. Use with caution in nursing mothers.

Precautions & Warnings:

Monitor hemodynamics and clinical status closely during early stages of acute myocardial infarction. Use with caution in patients with severe renal or hepatic impairment, hypothyroidism, malnutrition, or hypothermia.

Use in Special Populations:

The safety and efficacy of Nitrosol in pediatric patients have not been established.

Overdose Effects:

Symptoms of overdose may include severe hypotension, persistent headache, dizziness, palpitations, visual disturbances, flushing, nausea, vomiting, syncope, methemoglobinemia, and possibly death due to circulatory collapse.

Treatment of Overdosage:

If overdose occurs, keep the patient lying down and warm. Administer oxygen and artificial ventilation if needed. For methemoglobinemia, administer methylene blue intravenously. Gastric lavage may be required if a large amount of spray was ingested recently.

Therapeutic Class:

Nitrates – Coronary Vasodilators

Storage Conditions:

Store in a cool, dry place away from light and heat. Keep out of reach of children.