About RECTIV

RECTIV ointment - for the treatment of moderate to severe pain associated with chronic anal fissure

RECTIV—for the treatment of moderate to severe pain associated with chronic anal fissure

RECTIV, a nitroglycerin ointment, is the only FDA-approved medicine for the treatment of moderate to severe pain from chronic anal fissure. In a clinical study, RECTIV was found to be effective in treating moderate to severe pain from chronic anal fissure.

One common side effect of RECTIV is headache. Here’s why: the nitroglycerin in RECTIV increases blood flow to the anal area. That same kind of increased blood flow also occurs in the head and brain, which can cause headaches.

RECTIV may cause dose-related headaches, which may be severe, but as you get used to RECTIV, they may become less severe. The good news is that this type of headache usually doesn’t last very long and can be treated with an over-the-counter medicine, such as Tylenol® (acetaminophen). If the headaches are unpleasant, you may need to ask your doctor whether you should stop using RECTIV.

There are additional side effects and risks associated with RECTIV. Please see Important Risk Information below.

How to use RECTIV

How to use RECTIV– A treatment for moderate to severe anal fissure pain
  • Apply the ointment every 12 hours exactly as your doctor has told you to
  • 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 so that the tip of your finger is at one end of the dosing line
    • Refer to carton for accurate dosage guide
  • Starting at the tip of the finger, squeeze the ointment onto your finger so it is the same length as what is marked on the box
  • 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, apply the ointment directly to the outside of the anus
  • When you are done, throw the finger covering into the garbage, out of the reach of children and pets. Remember to wash your hands

Follow your doctor’s instructions
about how often and how long to use RECTIV

FDA, U.S. Food and Drug Administration.

What is RECTIV®?

  • RECTIV (nitroglycerin) Ointment 0.4% 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.
  • RECTIV is not suitable for children and adolescents under the age of 18 years because it has not been studied in this age group.

IMPORTANT RISK INFORMATION

Who should not use RECTIV?

Do not use RECTIV if you:
  • Are taking a medicine for erectile dysfunction (male impotence), such as Viagra® (sildenafil), Cialis® (tadalafil), or Levitra® (vardenafil), or for pulmonary hypertension. If you have questions, consult your pharmacist or healthcare provider
  • Have been told by your doctor that you have severe anemia (low numbers of red blood cells)
  • Have increased intracranial pressure or high pressure within your skull (eg, following a head injury or bleeding in your brain)
  • Are allergic to any of the ingredients in RECTIV, or have had an allergic reaction to similar medications in the past

What should I tell my healthcare provider before using RECTIV?

Tell your healthcare provider about all of 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 RECTIV or the components of RECTIV will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if RECTIV or the components of RECTIV will harm your child if you breastfeed

RECTIV 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 doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Tell your doctor if you are taking other products that contain nitroglycerin, a medicine for erectile dysfunction, medicines used to treat high blood pressure, aspirin, ergotamine (used to treat migraine), tissue-type plasminogen activator (used to help dissolve blood clots in the heart, lungs, and brain), or are to be given heparin.

What should I avoid while using RECTIV?

  • Do not drive or operate machinery immediately after applying RECTIV. 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 using RECTIV as your blood pressure is more likely to be affected if you consume alcoholic beverages.

What are the possible side effects of RECTIV?

  • RECTIV can cause serious allergic reactions, including swelling of the face, lips, tongue, or throat, or difficulty breathing. If you have an allergic reaction, stop using RECTIV and seek immediate medical attention.
  • The most common side effects of RECTIV are:
    • Headaches, which can be severe. If you have a headache, you may take over-the-counter painkillers (such as acetaminophen), or ask your doctor whether you should stop taking RECTIV.
    • Dizziness, faintness on standing, or light-headedness

These are not all the possible side effects of RECTIV. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep RECTIV out of the reach of children.

Please also see the Patient Information within the full Prescribing Information.



Allergan® and its design are trademarks of Allergan, Inc.

RECTIV® is a registered trademark of Aptalis Pharma US, Inc., an Allergan affiliate.

All other trademarks are property of their respective owners.

© 2017 Allergan. All rights reserved.REC38876_v307/17

The product information provided in this site is intended only for residents of the United States. The products discussed on this site may have different product labeling outside of the United States.

The health information described in this site is provided for educational purposes only and is not intended to substitute discussions with a healthcare provider.

What is RECTIV®?

  • RECTIV (nitroglycerin) Ointment 0.4% 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.
  • RECTIV is not suitable for children and adolescents under the age of 18 years because it has not been studied in this age group.

IMPORTANT RISK INFORMATION

Who should not use RECTIV?

Do not use RECTIV if you:
  • Are taking a medicine for erectile dysfunction (male impotence), such as Viagra® (sildenafil), Cialis® (tadalafil), or Levitra® (vardenafil), or for pulmonary hypertension. If you have questions, consult your pharmacist or healthcare provider
  • Have been told by your doctor that you have severe anemia (low numbers of red blood cells)
  • Have increased intracranial pressure or high pressure within your skull (eg, following a head injury or bleeding in your brain)
  • Are allergic to any of the ingredients in RECTIV, or have had an allergic reaction to similar medications in the past

What should I tell my healthcare provider before using RECTIV?

Tell your healthcare provider about all of 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 RECTIV or the components of RECTIV will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if RECTIV or the components of RECTIV will harm your child if you breastfeed

RECTIV 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 doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Tell your doctor if you are taking other products that contain nitroglycerin, a medicine for erectile dysfunction, medicines used to treat high blood pressure, aspirin, ergotamine (used to treat migraine), tissue-type plasminogen activator (used to help dissolve blood clots in the heart, lungs, and brain), or are to be given heparin.

What should I avoid while using RECTIV?

  • Do not drive or operate machinery immediately after applying RECTIV. 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 using RECTIV as your blood pressure is more likely to be affected if you consume alcoholic beverages.

What are the possible side effects of RECTIV?

  • RECTIV can cause serious allergic reactions, including swelling of the face, lips, tongue, or throat, or difficulty breathing. If you have an allergic reaction, stop using RECTIV and seek immediate medical attention.
  • The most common side effects of RECTIV are:
    • Headaches, which can be severe. If you have a headache, you may take over-the-counter painkillers (such as acetaminophen), or ask your doctor whether you should stop taking RECTIV.
    • Dizziness, faintness on standing, or light-headedness

These are not all the possible side effects of RECTIV. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep RECTIV out of the reach of children.

Please also see the Patient Information within the full Prescribing Information.



Allergan® and its design are trademarks of Allergan, Inc.

RECTIV® is a registered trademark of Aptalis Pharma US, Inc., an Allergan affiliate.

All other trademarks are property of their respective owners.

© 2017 Allergan. All rights reserved.REC38876_v307/17

The product information provided in this site is intended only for residents of the United States. The products discussed on this site may have different product labeling outside of the United States.

The health information described in this site is provided for educational purposes only and is not intended to substitute discussions with a healthcare provider.