Rectiv (nitroglycerin) Ointment - formerly Cellegesic

                            Rectiv

Generic Name: nitroglycerin
Date of Approval: June 21, 2011
Company: ProStrakan Group plc

Treatment for: Anal Fissures

The U.S. Food and Drug Administration (FDA) has approved Rectiv (nitroglycerin) Ointment 0.4 % for the treatment of moderate to severe pain associated with chronic anal fissures.

Rectiv Medication Guide

Read this Medication Guide before you start receiving Rectiv and before each treatment. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is Rectiv?

Rectiv Ointment contains 0.4% nitroglycerin in an ointment base. It is used for treatment of moderate to severe pain associated with chronic anal fissures.

Before using Rectiv

Before using Rectiv, you should be aware of some precautions associated with the use of Rectiv.

Rectiv is not recommended for use in children or in adolescents under 18 years of age.

You should not use Rectiv if you suffer from:

• severe anemia (low blood count)
• glaucoma (increased eye pressure)
• hypotension (low blood pressure)
• increased intracranial pressure (high pressure inside your head)

Also you should not use Rectiv if you are pregnant or breastfeeding or if you are allergic to nitroglycerin or any of the other ingredients in Rectiv.

Important information about Rectiv

You should not use Rectiv if you are taking Viagra (sildenafil), Cialis (tadalafil) or Levitra (vardenafil).

Advise your doctor if you are already taking any medication for chest pain or the treatment of any other heart condition. If you are taking oral nitrate products (such as nitroglycerin, isosorbide mononitrate or isosorbide dintrate) or using nitroglycerin patches, you should not use Rectiv unless advised to do so by your doctor.

Your doctor may need to adjust the dose of Rectiv and advise you on arrangements for a daily 'nitrate-free period' that suits both medications.

Rectiv may cause dizziness, light headedness, blurred vision, headaches or tiredness in some patients, especially when you first start to use it. Be careful driving a car or operating machinery until you know how Rectiv affects you.

Be careful when drinking alcohol while you are using Rectiv as your blood pressure may drop, making you feel dizzy and faint. It is advisable to reduce or stop alcohol consumption during treatment with Rectiv.

How do I use Rectiv?

Because Rectiv contains nitroglycerin it must be used strictly as directed.

Use Rectiv as directed and measure amount according to the instructions on the product packaging or as recommended by your doctor.

The ointment should be inserted into the anal canal with your finger. An applicator is not recommended since it is difficult to judge the amount being squeezed into the anal passage. Do not exceed the recommended dosage. Wash your hands after use.

You should ensure that you have a period of 12 hours each day where you do not use Rectiv. This is necessary to avoid tolerance (to maintain the full effect of the medication).

If the tube is difficult to squeeze - soften the ointment by warming the tube between your hands or in a glass of lukewarm water.

Rectiv side effects

Headache is a common side effect experienced with Rectiv. These are usually mild and occur after the first few applications only, due to intolerance to the Rectiv. The headache may be relieved with a painkiller such as acetaminophen.

After applying Rectiv, you may also experience fainting effect or dizziness, particularly if you are elderly. Changing position slowly from lying or sitting to standing up may help you to avoid this problem.

If you experience any of these side effects, do not use any more ointment for at least eight hours, then continue treatment by reducing the amount of ointment by half. If the side effects persist, stop the treatment and see your doctor. If anal bleeding increases, stop treatment and tell your doctor.

What happens if I overdose?

Overdosage may occur if you use too much ointment or if you are sensitive to the effects of Rectiv. Some signs of overdosage are headache, fainting or dizziness. If any of these symptoms persist, stop using Rectiv and consult your doctor.

How should I store Rectiv?

Close the tube tightly, immediately after each use. Store the Rectiv in a cool place (below 77 degrees F, 25 degrees C) away from light.