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RECTIV® (nitroglycerin) Ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure.
DOSAGE AND ADMINISTRATION
Apply 1 inch of ointment (375 mg of ointment equivalent to 1.5 mg of nitroglycerin) intra-anally every 12 hours for up to 3 weeks. A finger covering, such as plastic-wrap, disposable surgical glove or a finger cot, should be placed on the finger to apply the ointment. To obtain a 1.5 mg dose of nitroglycerin, the covered finger is laid alongside the 1 inch dosing line on the carton.
Refer to carton for accurate dosage guide.
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 three weeks.
RECTIV ointment is not for oral, ophthalmic, or intravaginal use. Hands should be washed after application of the ointment.
Dosage Forms And Strengths
Ointment, 0.4% w/w (4 mg /1 g) in 30 g tubes.
Storage And Handling
RECTIV (nitroglycerin) Ointment 0.4% is available in 30 g (NDC 58914-301-80) aluminum tubes with polyethylene screw caps.
Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
Keep the tube tightly closed. Use within 8 weeks of first opening.
Manufactured by: PHARBIL Waltrop GmbH, Im Wirrigen 25,45731 Waltrop, Germany. Manufactured for: Aptalis Pharma US, Inc., 100 Somerset Corporate Boulevard, Bridgewater, NJ 08807. Revised: July 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/13/2016
Additional Rectiv Information
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