NITROSTAT- nitroglycerin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

NITROGLYCERIN

Composition:

NITROGLYCERIN 0.4 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. 4.1 PDE-5-Inhibitors and sGC-Stimulators Do not use NITROSTAT in patients who are taking PDE-5 Inhibitors, such as avanafil, sildenafil, tadalafil, vardenafil hydrochloride. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see DRUG INTERACTIONS (7.1)]. Do not use NITROSTAT in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. Concomitant use can cause hypotension. 4.2 Severe Anemia NITROSTAT is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). 4.3 Increased Intracranial Pressure NITROSTAT 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). 4.4 Hypersensitivity NITRO

Product summary:

NITROSTAT is supplied as white, round, flat-faced tablets in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles containing 100 tablets each, with color-coded labels, and in color-coded Patient Convenience Packages of 4 bottles of 25 tablets each. Store at Controlled Room Temperature 20°–25°C (68°–77°F) [see USP]. Nitroglycerin should be kept in the original glass container and must be tightly capped after each use to prevent loss of tablet potency.

Authorization status:

New Drug Application

Patient Information leaflet

NITROSTAT- NITROGLYCERIN TABLET
General Injectables & Vaccines, Inc
----------
NITROSTAT®
(NITROGLYCERIN SUBLINGUAL TABLETS,
USP)
Read this information carefully before you start NITROSTAT®
(NYE-troe-stat) and each time you refill
your prescription. There may be new information. This information does
not replace talking with your
doctor. If you have any questions about NITROSTAT, ask your doctor.
Your doctor will know
if NITROSTAT is right for you.
What is NITROSTAT?
NITROSTAT is a type of medicine known as an organic nitrate and is a
vasodilating agent. It is used to
treat a type of chest pain called angina.
What is Angina?
Angina is a pain or discomfort that keeps coming back when part of
your heart does not get enough
blood. Angina feels like a pressing or squeezing pain, usually in your
chest under the breastbone.
Sometimes you can feel it in your shoulders, arms, neck, jaws, or
back. NITROSTAT can relieve this
pain.
Who should not use NITROSTAT?
Do not use NITROSTAT if you are allergic to organic nitrates (like the
active ingredient
in NITROSTAT).
You should not take NITROSTAT if you have the following conditions:
•
very recent heart attack
•
severe anemia
•
increased pressure in the head
Do not take NITROSTAT with drugs for erectile dysfunction, like
VIAGRA® (sildenafil citrate),
CIALIS®(tadalafil), or LEVITRA® (vardenafil hydrochloride), as this
may lead to extreme lowering of
your blood pressure.
Do not take NITROSTAT if you take medicines called guanylate cyclase
stimulators which include
riociguat, a medicine that treats pulmonary arterial hypertension and
chronic-thromboembolic pulmonary
hypertension.
What should I tell my doctor before taking NITROSTAT?
Before using NITROSTAT, tell your doctor if:
•
You are taking any medicines that are used to treat angina, heart
failure, or an irregular heartbeat.
•
You are taking any medicines that reduce blood pressure.
•
You are taking any diuretics (water pills).
•
You are taking medicines that can cause dry mouth such as tricyclic
antidepress

Summary of Product characteristics

NITROSTAT- NITROGLYCERIN TABLET
GENERAL INJECTABLES & VACCINES, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
NITROSTAT®
(NITROGLYCERIN SUBLINGUAL TABLETS, USP)
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NITROSTAT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NITROSTAT
NITROSTAT (NITROGLYCERIN) SUBLINGUAL TABLET
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
NITROSTAT is a nitrate vasodilator indicated for relief of an attack
or prophylaxis of angina pectoris due to
coronary artery disease. (1) (1)
DOSAGE AND ADMINISTRATION
At the onset of an attack, administer one tablet under the tongue or
buccal pouch. One additional
tablet may be administered every 5 minutes as needed. No more than 3
total tablets are
recommended within a 15 minute period. (2)
If chest pain persists after three tablets, seek prompt medical
attention. (2)
May be used prophylactically 5 to 10 minutes prior to engaging in
activities that might precipitate an
acute attack. (2)
DOSAGE FORMS AND STRENGTHS
Sublingual tablets, 0.3 mg; 0.4 mg; 0.6 mg (3) (3)
CONTRAINDICATIONS
Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil,
sildenafil, tadalafil, or vardenafil,
or soluble guanylate cyclase (sGC) stimulators. (4.1, 7.1)
Severe anemia (4.2)
Increased intracranial pressure (4.3)
Hypersensitivity to NITROSTAT or to other nitrates or nitrites or any
excipient (4.4)
Circulatory failure and shock (4.5)
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, dizziness and
paresthesia. (6) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PFIZER, INC. AT
1-800-438-1985 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
DRUG INTERACTIONS
Ergotamine: increased bioavailability of ergotamine. Avoid concomitant
use. (7.2) (7)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING. (7)
REVISED: 2/2018