Gonitro

What is Gonitro used for?

Gonitro is a prescription medicine that is used to treat or prevent chest pain or pressure. Gonitro may be given to you for other reasons.

Description

Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C3H5N3O9). The compound has a molecular weight of 227.09. The chemical structure is:

GONITRO is a powder containing nitroglycerin. Each packet of GONITRO delivers 400 mcg of nitroglycerin when administered under the tongue. The sublingual powder is formulated with the following inactive ingredients: anhydrous dibasic calcium phosphate, isomalt, medium-chain triglycerides, peppermint oil, and oleoyl polyoxylglycerides.

Mechanism of Action

Nitroglycerin forms free radical nitric oxide (NO), which activates guanylate cyclase, resulting in an increase of guanosine 3′,5′-monophosphate (cyclic GMP) in smooth muscle and other tissues. This eventually leads to dephosphorylation of myosin light chains, which regulates the contractile state in smooth muscle and results in vasodilatation.

Before taking Gonitro, tell your doctor:

• If you are allergic to Gonitro; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Anemia, raised pressure in the head (like with bleeding in the brain or head injury), or recent heart attack.
• If you have heart problems.
• If you have low blood volume.
• If you are taking any of these drugs: Avanafil, riociguat, sildenafil, tadalafil, or vardenafil.
• If you are taking any of these drugs: Dihydroergotamine, ergonovine, ergotamine, or methylergonovine.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Gonitro with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Gonitro?

• Tell all of your health care providers that you take Gonitro. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Gonitro affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Check your blood pressure as you have been told.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Gonitro.
• Avoid drinking alcohol while taking Gonitro.
• If you are 65 or older, use Gonitro with care. You could have more side effects.
• Taking more of Gonitro or taking it more often than you have been told may cause it to not work as well. This is known as tolerance. Talk with your doctor if Gonitro stops working well. Do not take more than ordered.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Gonitro best taken?

Use Gonitro as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Sit down before use.
• Empty the packet contents under your tongue. Close your mouth and breathe normally through your nose. Let the powder dissolve before you swallow. Do not rinse your mouth or spit for 5 minutes after a dose.
• Your doctor will tell you how to take Gonitro. Be sure you know what your dose is, how often you can take a dose, and when you may need to get medical help. If your doctor does not tell you how to take Gonitro or if you are not sure how to take it, talk with your doctor.
• If using Gonitro to prevent chest pain, use it 5 to 10 minutes before activity that may lead to chest pain.

What do I do if I miss a dose?

• This medicine is taken on an as needed basis. Do not take more often than told by the doctor.

What are the side effects of Gonitro that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Fast, slow, or abnormal heartbeat.
• Flushing.
• Blurred eyesight.
• Dry mouth.
• Sweating a lot.
• Pale skin.
• Very upset stomach or throwing up.
• Restlessness.
• Feeling very tired or weak.

What are some other side effects of Gonitro?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness or headache.
• Mouth tingling.
• Burning.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Gonitro?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

Prinicpal Display PanelNDC 28595-705-12

• GONITRO®
  (nitroglycerin)
  sublingual powder
  400 mcg per packet
  12 single dose packets