Patient information: uses, side effects, how to take - Nitroglycerin Rectal
What is nitroglycerin ointment?
Nitroglycerin ointment is a prescription medicine used to treat moderate to severe pain caused by chronic anal fissures. An anal fissure is a tear in the skin lining the anal canal.
Nitroglycerin ointment is not suitable for children and adolescents under the age of 18 years because it has not been assessed in people in this age group.
Who should not use nitroglycerin ointment?
Do not use nitroglycerin ointment if you:
- are taking a medicine for erectile dysfunction (male impotence), for example Viagra (sildenafil), Cialis (tadalafil) or Levitra (vardenafil).
- have been told by your doctor that you have severe anemia (low numbers of red blood cells in your blood)
- have increased intracranial pressure or high pressure within your skull e.g. following head trauma or bleeding in your brain
- are allergic to any of the ingredients in nitroglycerin ointment or if you have had allergic reactions to similar medicines in the past. See the end of this leaflet for a list of ingredients in nitroglycerin ointment.
What should I tell my healthcare provider before using nitroglycerin ointment?
Tell your healthcare provider about all your medical conditions, including if you:
- have low blood pressure
- have recently had a heart attack
- have heart or blood vessel disorders
- suffer from migraine or recurrent headaches
are pregnant or plan to become pregnant. It is not known if nitroglycerin ointment will harm your unborn baby.
- are breast-feeding or plan to breast-feed. It is not known if the components of nitroglycerin ointment will harm your child if you breast-feed.
Nitroglycerin ointment may lower your blood pressure. When getting up from a lying or sitting position, you should get up slowly, otherwise you might feel faint.
Tell your healthcare provider about all the medicines you take, including prescription and non- prescription medicines, vitamins and herbal supplements. Other medicines may affect how nitroglycerin ointment works. Nitroglycerin ointment may also affect how other medicines work.
Specifically, tell your doctor if you are taking any of the following:
- other nitroglycerin containing products
- a medicine for erectile dysfunction (male impotence), for example sildenafil, tadalafil or vardenafil (see the section above ‘Who should not use nitroglycerin ointment’)
- medicines used to treat high blood pressure
- are taking aspirin, ergotamine (used to treat migraine) or are receiving tissue-type plasminogen activator (used to help dissolve blood clots formed in blood vessels in the heart, lungs and brain)
- are to be given heparin. If so, close monitoring of your blood will be required as your dose of heparin may need to be altered. Please discuss with your doctor before stopping nitroglycerin ointment.
How should nitroglycerin ointment be used?
Use nitroglycerin ointment exactly as prescribed. See detailed Patient Instructions for Applying nitroglycerin ointment at the end of this Patient Information leaflet.
Treatment may be continued for up to 3 weeks. If your anal pain does not get better after using nitroglycerin ointment you should talk to your doctor.
What should I avoid while using nitroglycerin ointment?
Do not drive or operate machinery immediately after applying nitroglycerin ointment. If you feel dizzy or light-headed after applying the ointment do not drive or operate machinery until the dizziness has stopped.
Avoid consuming alcohol while you are being treated with nitroglycerin ointment as your blood pressure is more likely to be affected if you consume alcoholic beverages.
What are the possible side effects of nitroglycerin ointment?
Nitroglycerin ointment can cause serious side-effects: Stop using the ointment and seek medical attention immediately if you have an allergic reaction. You may have swelling of the face, lips, tongue or throat, or difficulty breathing.
Common side-effects of nitroglycerin ointment are:
- Headaches, which can be severe. You could take painkillers for this (such as acetaminophen). If the headaches are unpleasant, you may need to ask your doctor whether you should stop using nitroglycerin ointment.
- Dizziness, faintness on standing, or light-headedness
These are not all the possible side effects of nitroglycerin ointment. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.
How should I store nitroglycerin ointment?
- Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].
- Keep the tube tightly closed immediately after each use.
- Use within 8 weeks of first opening.
Keep nitroglycerin ointment out of the reach of children.
Do not use nitroglycerin ointment after the expiry date which is stated on the label and carton after ‘EXP.’ The expiry date refers to the last day of that month.
General information about nitroglycerin ointment
Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use nitroglycerin ointment for a condition for which it is not prescribed. Do not give nitroglycerin ointment to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about nitroglycerin ointment. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about nitroglycerin ointment that is written for health professionals.
For more information call 1-833-285-4151
Patient Instructions for Use When do I apply the ointment?
Apply the ointment every 12 hours exactly as your doctor has told you to.
How do I apply the ointment?
Cover your finger with plastic-wrap, a disposable surgical glove or a finger cot.
Lay the covered finger alongside the 1 inch dosing line marked on the side of the medicine box (see figure below) so that the tip of your finger is at one end of the dosing line. Starting at the tip of the finger, squeeze the ointment onto your finger for the same length marked on the box.
Refer to carton for accurate dosage guide.
Gently insert the finger with the ointment into the anal canal, up to the first finger joint. Carefully smear the ointment around the inner sides of the anal canal. If this cannot be achieved due to pain, application of the ointment should be made directly to the outside of the anus.
What do I do after I have applied the ointment?
Throw away the finger covering in the garbage, out of the reach of children and pets. Wash your hands.
What are the ingredients in nitroglycerin ointment?
Active ingredient: nitroglycerin
Inactive ingredients: propylene glycol, lanolin, sorbitan sesquioleate, paraffin wax and white petrolatum.
Manufactured by:
Encube Ethicals Pvt. Ltd.
Plot No. C-1, Madkaim Industrial Estate,
Madkaim, Post: Mardol, Ponda,
Goa - 403 404, India.
Distributed by:
Encube Ethicals, Inc.
200 Meredith Drive, Suite 202
Durham, NC 27713 USA
Revised: 10/2024