Rx Item-Nitroglycerin Ling 400Mcg Spr Spray 4.9Gm By Perrigo Pharma

Clinical Information
Gen. Code and Des.
44359 nitroglycerin TRANSLING SPRAY 400MCG/SPR
GCN and Des.
92257 nitroglycerin TRANSLING SPRAY 400MCG/SPR
Strength
400MCG
Dose Form
SPRAY, NON-AEROSOL (GRAM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
24120800 NITRATES AND NITRITES
Active Ingredients
683 nitroglycerin 55630
Inactive Ingredients
2464 alcohol 64175
7989 peppermint


NITROLINGUAL PUMPSPRAY- nitroglycerin spray, metered
Arbor Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended dosage
Instruct the patient to administer one or two metered sprays (400 mcg of nitroglycerin per spray) at the onset of an attack onto or under the tongue. A spray may be repeated approximately every five minutes as needed. No more than three metered sprays are recommended within a 15-minute period. If the chest pain persists after a total of three sprays, advise prompt medical attention. Nitrolingual Pumpspray may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.

2.2 Priming


The pump must be primed prior to the first use. Each metered spray of Nitrolingual Pumpspray delivers 48 mg of solution containing 400 mcg of nitroglycerin after an initial priming of five sprays. It will remain adequately primed for 6 weeks. If the product is not used within 6 weeks it can be adequately re-primed with one spray. If the product is not used within 3 months it can be adequately re-primed with up to five sprays. There are 60 or 200 metered sprays per bottle. The total number of available doses is dependent, however, on the number of sprays per use (1 or 2 sprays), and the frequency of priming.

2.3 Administration
Instruct patients that during administration, the patient should rest, ideally in the sitting position. Hold the container vertically with the valve head uppermost and the spray orifice as close to the mouth as possible. Spray the dose preferably onto or under the tongue by pressing the grooved-button firmly and the mouth closed immediately after each dose. THE SPRAY SHOULD NOT BE INHALED. The medication should not be expectorated or the mouth rinsed for 5 to 10 minutes following administration. Instruct patients to familiarize themselves with the position of the spray orifice, which can be identified by the finger rest on top of the valve, in order to facilitate orientation for administration at night [see Patient Information (17)].

The amount of liquid remaining in the container should be checked periodically. The transparent container can be used for continuous monitoring of the consumption. With the container upright and level, check to be sure the end of the center tube extends below the level of the liquid. Once fluid falls below the level of the center tube, remaining sprays will not deliver intended dose.

3 DOSAGE FORMS AND STRENGTHS

Lingual spray, 400 mcg per spray available in either 60 or 200 metered sprays per container.

Nitroglycerin Ling 400Mcg Spr Spray 4.9G
Item No.:RX245712 NDC No.45802021001 45802-210-01 4580221001 UPC No.:345802210012 NDC No. 45802-0210-01 UPC/GTIN No. 3-45802-21001-2 345802210012 345802-210012 MPN 21001

RX ITEM-Nitroglycerin Ling 400Mcg Spr Sp
Item No.:RX245712 NDC No.45802021001 45802-210-01 4580221001 UPC No.:345802210012 NDC No. 45802-0210-01 UPC/GTIN No. 3-45802-21001-2 345802210012 345802-210012 MPN 21001

NITROGLYCERIN TRANSLING S
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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