ASCRS Practice Parameters

ASCRS Practice Parameters strongly recommend topical nitroglycerin (NTG) as an option for chronic anal fissure (CAF)1

This is a table of prescription therapies for CAF            Topical NTG is graded 1A (strong recommendation based on high-quality evidence)            Use of topical NTG reduces pain during the therapy period            The most common side effect is headache            Topical calcium channel blockers are graded 1B (strong recommendation based on moderate-quality evidence)            The most common side effect is headache            Botulinum toxin injections are graded 1C (strong recommendation based on low-quality evidence)            The most common side effects are temporary gas and stool incontinence            No head-to-head trials of RECTIV vs other prescription therapies for CAF have been conducted.

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

ASCRS, American Society of Colon and Rectal Surgeons.

Reference: 1. Stewart DB, Gaertner W, Glasgow S, Migaly J, Feingold D, Steele SR; on behalf of the Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. Clinical practice guideline for the management of anal fissures. Dis Colon Rectum. 2017;60(1):7-14.

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