Dear Doctor,
RECTIV® (nitroglycerin) Ointment 0.4% is FDA approved and manufactured under strict quality
standards
RECTIV is the first and only FDA-approved medication for moderate to severe pain associated with
chronic anal fissure. It offers a uniform, standardized formulation that has been tested in clinical trials.
RECTIV:
• Meets standards enforced by the FDA for identity, strength, quality, and purity
Has undergone extensive stability testing to establish appropriate expiration dating
• Is manufactured under Current Good Manufacturing Practices in an FDA-inspected facility
o
The safety and efficacy of RECTIV have been demonstrated in clinical trial data that were reviewed by
a team of FDA physicians, statisticians, chemists, pharmacologists, and other scientists to establish
approved labeling (US Prescribing Information).
Prescribe RECTIV as you would any other FDA-approved medication
RECTIV is available at most pharmacies, including chain pharmacies. Patients can fill their RECTIV
prescription at the local pharmacy they are familiar with, where they fill their other prescriptions and
where their medication history is on file.
Additionally, with RECTIV, patients receive FDA-approved full US Prescribing Information, which
provides Important Safety Information and clear instructions on how to use the medication. Aptalis
also provides ongoing adverse event monitoring for RECTIV.
Ensure your RECTIV Rx is not substituted with compounded nitroglycerin
Write “Dispense as Written” on the prescription.
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Important Safety Information
• RECTIV is contraindicated in patients:
o Taking
phosphodiesterase type 5 (PDE5) inhibitors (eg, sildenafil, vardenafil, and tadalafil),
which can potentiate the hypotensive effect of organic nitrates
o With severe anemia
o With increased intracranial pressure
o With known hypersensitivity to nitroglycerin, other nitrates and nitrites, or any components of the
ointment
• Patients with cardiovascular disorders should be closely monitored while using RECTIV
o Venous and arterial dilation as a consequence of nitroglycerin treatment can result in
hypotension
• Exercise caution in patients with any of the following conditions: blood volume depletion, existing
hypotension, cardiomyopathies, congestive heart failure, acute myocardial infarction, or poor
cardiac function for other reasons
• The adverse reactions of RECTIV are likely to be more pronounced in the elderly
• Nitroglycerin produces dose-related headaches, which may be severe
• The following drug interactions may occur in patients taking RECTIV:
o PDE5 inhibitors: potentiation of hypotensive effects of organic nitrates; concomitant use is
contraindicated
o Antihypertensives: possible additive hypotensive effects
o Aspirin: increased nitroglycerin levels
o Tissue-type plasminogen activator (t-PA): decreased thrombolytic effect
o Heparin: anticoagulant effect of heparin may be reduced. Monitor activated partial
thromboplastin time (APTT)
o Ergotamine: increased bioavailability of ergotamine
o Alcohol: additive vasodilatory effects to nitroglycerin. Consumption of alcohol should be avoided
• The most common adverse reactions (≥2%) are headache and dizziness
• RECTIV ointment is for intra-anal use, and not for oral, ophthalmic, or intravaginal use
Click here to access the full US Prescribing Information for RECTIV.
For more information, please visit www.rectiv.com.
Cordially,
Dr. Salvatore Volpe, MD, FAAP FACP, CHCQM
Chief Medical Officer
Physicians’ Desk Reference®
Aptalis Pharma US, Inc.
100 Somerset Corporate Boulevard, Suite 2000
Bridgewater, NJ 08807 USA
Tel: (908) 927-9600
Fax: (908) 927-9648
www.aptalispharma.com
RE138-1012
RECTIV is a registered trademark of Aptalis Pharma US, Inc.
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The above message is sponsored by
Aptalis Pharma US, Inc., who is solely
responsible for its content.