RECTIV can treat the pain of chronic anal fissure (CAF)

References: 1. RECTIV [package insert]. Bridgewater, NJ: Aptalis Pharma US, Inc.; July 2013. 2. Berry SM, Barish CF, Bhandari R, et al. Nitroglycerin 0.4% ointment vs placebo in the treatment of pain resulting from chronic anal fissure: a randomized, double-blind, placebo-controlled study. BMC Gastroenterology. 2013;13:106. 3. Data on file. Forest Laboratories, LLC.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Use of phosphodiesterase type 5 (PDE5) inhibitors (eg, sildenafil, vardenafil, and tadalafil), as these are shown to potentiate the hypotensive effects of organic nitrates.
  • Severe anemia
  • Increased intracranial pressure
  • Known hypersensitivity to nitroglycerin, other nitrates and nitrites, or any components of the ointment.

Warnings and Precautions

  • Cardiovascular Disorders: Venous and arterial dilatation 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. If patients with any of these conditions are treated with RECTIV, monitor cardiovascular status and clinical condition. The adverse reactions of RECTIV are likely to be more pronounced in the elderly.
  • Headache: RECTIV produces dose-related headaches, which may be severe. Tolerance to headaches occurs.

Drug Interactions

The following drug interactions may occur in patients taking RECTIV:
  • PDE5 inhibitors: potentiation of hypotensive effects of organic nitrates; concomitant use is contraindicated
  • Antihypertensives: possible additive hypotensive effects
  • Aspirin: increased nitroglycerin levels
  • Tissue-type Plasminogen Activator (t-PA): decreased thrombolytic effect
  • Heparin: anticoagulant effect of heparin may be reduced. Monitor activated partial thromboplastin time (APTT).
  • Ergotamine: increased bioavailability of ergotamine
  • Alcohol: additive vasodilatory effects to nitroglycerin. Consumption of alcohol should be avoided.

Adverse Reactions

  • The most common adverse reactions in RECTIV-treated patients (incidence ≥2% and greater than placebo) were headache (64% vs 41%) and dizziness (5% vs 0%).

Indications and Usage

  • RECTIV® (nitroglycerin) Ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure.

Please see full Prescribing Information.

The information provided in this site is intended for U.S. healthcare professionals only. The products described on this site may have different product labeling in countries outside of the United States. For additional information about RECTIV, call Allergan Medical Information toll-free at 1.800.678.1605.


Allergan

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

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

© 2017 Allergan. All rights reserved.REC52946_v307/17

IMPORTANT SAFETY INFORMATION

Contraindications

  • Use of phosphodiesterase type 5 (PDE5) inhibitors (eg, sildenafil, vardenafil, and tadalafil), as these are shown to potentiate the hypotensive effects of organic nitrates.
  • Severe anemia
  • Increased intracranial pressure
  • Known hypersensitivity to nitroglycerin, other nitrates and nitrites, or any components of the ointment.

Warnings and Precautions

  • Cardiovascular Disorders: Venous and arterial dilatation 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. If patients with any of these conditions are treated with RECTIV, monitor cardiovascular status and clinical condition. The adverse reactions of RECTIV are likely to be more pronounced in the elderly.
  • Headache: RECTIV produces dose-related headaches, which may be severe. Tolerance to headaches occurs.

Drug Interactions

The following drug interactions may occur in patients taking RECTIV:
  • PDE5 inhibitors: potentiation of hypotensive effects of organic nitrates; concomitant use is contraindicated
  • Antihypertensives: possible additive hypotensive effects
  • Aspirin: increased nitroglycerin levels
  • Tissue-type Plasminogen Activator (t-PA): decreased thrombolytic effect
  • Heparin: anticoagulant effect of heparin may be reduced. Monitor activated partial thromboplastin time (APTT).
  • Ergotamine: increased bioavailability of ergotamine
  • Alcohol: additive vasodilatory effects to nitroglycerin. Consumption of alcohol should be avoided.

Adverse Reactions

  • The most common adverse reactions in RECTIV-treated patients (incidence ≥2% and greater than placebo) were headache (64% vs 41%) and dizziness (5% vs 0%).

Indications and Usage

  • RECTIV® (nitroglycerin) Ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure.

Please see full Prescribing Information.

The information provided in this site is intended for U.S. healthcare professionals only. The products described on this site may have different product labeling in countries outside of the United States. For additional information about RECTIV, call Allergan Medical Information toll-free at 1.800.678.1605.


Allergan

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

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

© 2017 Allergan. All rights reserved.REC52946_v307/17