Dosage and Administration
for RECTIV1

  • Apply 1 inch of ointment* intra-anally every 12 hours for up to 3 weeks
    • A finger covering such as plastic wrap, a disposable surgical glove or finger cot should be placed on the finger to apply the ointment
    • The tube is gently squeezed until a line of ointment the length of the measuring line is expressed onto the covered finger
    • The ointment is gently inserted into the anal canal using the covered finger no further than to the first finger joint and the ointment is applied around the side 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
  • Treatment may be continued for up to 3 weeks
  • RECTIV ointment is not for oral, ophthalmic, or intravaginal use
  • Hands should be washed after application of the ointment

*375 mg of ointment is equivalent to 1.5 mg of nitroglycerin.

Reference: 1. RECTIV [package insert]. Bridgewater, NJ: Aptalis Pharma US, Inc.; July 2013.

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® 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® 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