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.
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.
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.
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.