RECTIV- nitroglycerin ointment

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)

متاح من:

Allergan, Inc.

INN (الاسم الدولي):

NITROGLYCERIN

تركيب:

NITROGLYCERIN 4 mg in 1 g

طريقة التعاطي:

RECTAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

RECTIV® (nitroglycerin) Ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure. Administration of RECTIV is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), such as sildenafil, vardenafil, and tadalafil, as these are shown to potentiate the hypotensive effects of organic nitrates [see 7.1 DRUG INTERACTIONS]. RECTIV is contraindicated in patients with severe anemia. RECTIV is contraindicated in patients with increased intracranial pressure. RECTIV is contraindicated in patients who have shown hypersensitivity to it or to other nitrates or nitrites. Skin reactions consistent with hypersensitivity have been observed with organic nitrates. Pregnancy Category C Animal reproduction and teratogenicity studies have not been conducted with RECTIV. Nitroglycerin was not teratogenic when administered by topical or dietary route. There are no adequate and well-controlled

ملخص المنتج:

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.

الوضع إذن:

New Drug Application

خصائص المنتج

RECTIV- NITROGLYCERIN OINTMENT
ALLERGAN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RECTIV (NITROGLYCERIN)
OINTMENT 0.4% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR RECTIV.
RECTIV (NITROGLYCERIN) OINTMENT 0.4%, FOR INTRA-ANAL USE
INITIAL U.S. APPROVAL: 1955
INDICATIONS AND USAGE
RECTIV is a nitrate vasodilator indicated for the treatment of
moderate to severe pain associated with
chronic anal fissure (1).
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 (2).
RECTIV ointment is not for oral, ophthalmic, or intravaginal use (2)
DOSAGE FORMS AND STRENGTHS
Ointment 0.4% w/w (4 mg nitroglycerin/1 g ointment) (3)
CONTRAINDICATIONS
Use of PDE5 inhibitors (e.g. sildenafil, vardenafil and tadalafil) as
these are shown to potentiate the
hypotensive effects of organic nitrates. (4.1).
Severe anemia (4.2)
Increased intracranial pressure (4.3)
Known hypersensitivity to nitroglycerin, other nitrates and nitrites,
or any components of the ointment.
(4.4)
WARNINGS AND PRECAUTIONS
Cardiovascular Disorders: Venous and arterial dilatation as a
consequence of nitroglycerin treatment
can result in hypotension. Exercise caution when treating 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
(5.1).
Headache: Nitroglycerin produces dose-related headaches which may be
severe (5.2)
ADVERSE REACTIONS
Most common adverse reactions are headache and dizziness. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALLERGAN AT
1-800-678-1605- OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
PDE5 inhibitors: potentiation of hypotensive effects of organic
nitrates; concomitant use is
contraindicated. (4.1, 7.1)
Antihypertensives: possible additive hypotensive effects. (7.2)
Asp