NITROLINGUAL- nitroglycerin spray

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Allegis Pharmaceuticals, LLC

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Do not use Nitrolingual Pumpspray in patients who are taking PDE-5-Inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1) ]. Do not use Nitrolingual Pumpspray in patients who are taking soluble guanylate cyclase (sGC) stimulators, such as riociguat. Concomitant use can cause hypotension. Nitrolingual Pumpspray is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). Nitrolingual Pumpspray  may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e. g. cerebral hemorrhage or traumatic brain injury). Nitrolingual Pumpspray is contraindicated in patients who are allergic to nitroglycerin, other nitrates or nitrites or any excipient. Nitrolingual Pumpspray is contraindicated in patients with acute circulatory failure or shock. Risk summary Limited published data on the use of nitroglycerin are insufficient to determine a drug associated risk of major birth defects or miscarriage. In animal reproduction studies, there were no adverse developmental effects when nitroglycerin was administered intravenously to rabbits or intraperitoneally to rats during organogenesis at doses greater than 64-times the human dose [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively. Data Animal Data No embryotoxic or postnatal development effects were observed with transdermal application in pregnant rabbits and rats at doses up to 240 mg/kg/day for 13 days, at intraperitoneal doses in pregnant rats up to 20 mg/kg/day for 11 days, and at intravenous doses in pregnant rabbits up to 4 mg/kg/day for 13 days. Risk summary Sublingual nitroglycerin has not been studied in lactating women. It is not known if nitroglycerin is present in human milk or if nitroglycerin has effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for nitroglycerin and any potential adverse effects on the breastfed child from nitroglycerin or from the underlying maternal condition. Safety and effectiveness of nitroglycerin in pediatric patients have not been established. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly (greater than or equal to 65 years) and younger (less than 65 years) patients. In general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Περίληψη προϊόντος:

Each box of Nitrolingual Pumpspray contains one glass bottle coated with red transparent plastic which assists in containing the glass and medication should the bottle be shattered. Each bottle contains 4.9 g or 14.1 g (Net Contents) of nitroglycerin lingual spray which will deliver 60 or 200 metered sprays containing 400 mcg of nitroglycerin per spray after priming. Nitrolingual Pumpspray is available as: Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Note: Nitrolingual Pumpspray contains 20 % alcohol. Do not forcefully open or burn container after use. Do not spray toward flames. Rx Only.

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

NITROLINGUAL- NITROGLYCERIN SPRAY
ALLEGIS PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NITROLINGUAL®
PUMPSPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
NITROLINGUAL
PUMPSPRAY.
NITROLINGUAL® PUMPSPRAY(NITROGLYCERIN) LINGUALSPRAY
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Nitrolingual Pumpspray is a nitrate vasodilator indicated for acute
relief of an attack or prophylaxis of
angina pectoris due to coronary artery disease ( 1).
DOSAGE AND ADMINISTRATION
At the onset of an attack, administer onto or under the tongue. Repeat
every 5 minutes as needed (
2.1).
Do up to three metered sprays within a 15-minute period. If chest pain
persists, advise prompt medical
attention ( 2.1).
May be used prophylactically 5 to 10 minutes prior to engaging in
activities that might precipitate an
acute attack ( 2.1).
DOSAGE FORMS AND STRENGTHS
Lingual spray, 400 mcg per spray, available in 60 or 200 metered
sprays per container ( 3).
CONTRAINDICATIONS
Use of phosphodiesterase type 5 (PDE-5) Inhibitors, such as avanafil,
sildenafil, tadalafil, or vardenafil,
or soluble guanylate cyclase (sGC) stimulator (riociguat). ( 4.1, 7.1)
Severe anemia. ( 4.2)
Increased intracranial pressure. ( 4.3)
Hypersensitivity to Nitrolingual Pumpspray or to other nitrates or
nitrites or any excipient. ( 4.4)
WARNINGS AND PRECAUTIONS
Tolerance:Excessive use may lead to tolerance. ( 5.1)
Hypotension:Severe hypotension may occur. ( 5.2)
ADVERSE REACTIONS
Most common adverse reactions occurring at a frequency greater than 2
% are headache, dizzinesss and
paresthesia ( 6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALLEGIS
PHARMACEUTICALS, LLC AT 1-866-
633-9033 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Antihypertensives: possible additive hypotensive effects. ( 7.2)
Ergotamine: increased bioavailability of ergotamine. Avoid concomitant
use ( 7.3)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
L