Rectiv Ointment

Name: Rectiv Ointment

Contraindications

PDE5 inhibitor use

Administration of RECTIV is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), such as sildenafil, vardenafil, and tadalafil, as these are shown to potentiate the hypotensive effects of organic nitrates [see 7.1 DRUG INTERACTIONS].

Severe anemia

RECTIV is contraindicated in patients with severe anemia.

Increased intracranial pressure

RECTIV is contraindicated in patients with increased intracranial pressure.

Hypersensitivity

RECTIV is contraindicated in patients who have shown hypersensitivity to it or to other nitrates or nitrites. Skin reactions consistent with hypersensitivity have been observed with organic nitrates.

Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common adverse reaction of RECTIV (nitroglycerin) Ointment 0.4% applied to the anal canal is headache.

Headache may be recurrent following each dose. Headaches are typically of short duration and can be treated with an analgesic, e.g. acetaminophen, and are reversible upon discontinuation of treatment.

In Study REC-C-001, a double-blind, placebo-controlled trial in patients with a painful chronic anal fissure, the most frequent (≥ 2%) adverse reactions reported were as follows (Table 1):

Table 1: Incidence of Adverse Reactions (≥ 2%) in Study REC-C-001
RECTIV
N = 123
Placebo
N = 124
System Organ Class
   Preferred term
Patients
n (%)
Events
n
Patients
n (%)
Events
n
Nervous system disorders
   Headache 79 (64) 938 51 (41) 225
   Dizziness 6 (5) 26 0 0

Hypotension

Transient episodes of light-headedness, occasionally related to blood pressure changes, also may occur. Hypotension (including orthostatic hypotension) occurs infrequently, but in some patients may be severe enough to warrant discontinuation of therapy.

Allergic Reactions

Flushing, allergic reactions and application site reactions (including drug rash and exfoliative dermatitis) have been reported rarely.

Methemoglobinemia

In rare cases, therapeutic doses of organic nitrates have caused methemoglobinemia (see 10 OVERDOSAGE).

Clinical Studies

Rectiv Ointment was evaluated in a 3-week double-blind, randomized, multi-center, placebo-controlled study. Patients with a painful chronic anal fissure for at least 6 weeks and moderate or severe pain prior to treatment (≥ 50 mm on the 100 mm visual analog scale, VAS) were randomized to receive 0.4% (1.5 mg) nitroglycerin or placebo ointment applied to the anal canal every 12 hours. Pain as assessed by the change in VAS from baseline to Days 14-18 was lower in patients receiving 0.4% ointment compared to placebo. The mean change from baseline was 44 mm for RECTIV and 37 mm for placebo. The difference in the mean change in pain between RECTIV and placebo was -7.0 mm (95% Confidence Interval: -13.6 to -0.4 mm).

How Supplied/Storage and Handling

RECTIV (nitroglycerin) Ointment 0.4% is available in 30 g (NDC 58914-301-80) aluminum tubes with polyethylene screw caps.

Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

Keep the tube tightly closed. Use within 8 weeks of first opening.

Patient Information

RECTIV® [REC-tiv]
(Nitroglycerin) Ointment 0.4%

IMPORTANT: For intra-anal use only

Read the Patient Information that comes with RECTIV before you start using the product and each time you get a refill because there may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. If you have any questions about RECTIV, ask your healthcare provider.


What is RECTIV?

RECTIV 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 assessed in people in this age group.


Who should not use RECTIV?

Do not use RECTIV 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 RECTIV 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 RECTIV.


What should I tell my healthcare provider before using RECTIV?

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 RECTIV will harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if the components of RECTIV will harm your child if you breast-feed.

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 healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Other medicines may affect how RECTIV works. RECTIV 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 RECTIV')
  • 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 RECTIV.


How should RECTIV be used?

Use RECTIV exactly as prescribed. See detailed Patient Instructions for Applying RECTIV 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 RECTIV you should talk to your doctor.


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 being treated with 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 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 RECTIV 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 RECTIV.
  • Dizziness, faintness on standing, or light-headedness

These are not all the possible side effects of RECTIV. 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 RECTIV?

  • Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
  • Keep the tube tightly closed.
  • Use within 8 weeks of first opening.

Keep RECTIV out of the reach of children.

Do not use RECTIV 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 RECTIV

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use RECTIV for a condition for which it is not prescribed. Do not give RECTIV 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 RECTIV. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about RECTIV that is written for health professionals.

For more information call 1-800-472-2634 or visit www.RECTIV.com.

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 RECTIV?

Active ingredient: nitroglycerin

Inactive ingredients: propylene glycol, lanolin, sorbitan sesquioleate, paraffin wax and white petrolatum.


Manufactured by:

PHARBIL Waltrop GmbH
Im Wirrigen 25
45731 Waltrop
Germany

Manufactured for:

Aptalis Pharma US, Inc.
100 Somerset Coporate Boulevard
Bridgewater, NJ 08807


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


U.S. Patent No. 7,189,761

Revised: July 2013

Principal display panel - ointment 0.4% - sample tube

RECTIV 
nitroglycerin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58914-301
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 4 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL  
LANOLIN  
SORBITAN SESQUIOLEATE  
PARAFFIN  
PETROLATUM  
Packaging
# Item Code Package Description
1 NDC:58914-301-80 1 TUBE in 1 CARTON
1 30 g in 1 TUBE
2 NDC:58914-301-85 1 TUBE in 1 CARTON
2 5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021359 06/21/2011
Labeler - Aptalis Pharma US, Inc. (033555307)
Establishment
Name Address ID/FEI Operations
Pharbil Waltrop GmbH 343740283 manufacture(58914-301), analysis(58914-301), pack(58914-301)
Revised: 07/2013   Aptalis Pharma US, Inc.
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