Trade Name: NITROLINGUAL

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Espero Pharmaceuticals, Inc.

Presentation: SPRAY, HUMAN PRESCRIPTION DRUG

Strength: 400 ug/1

Storage and handling

NITROGLYCERIN Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
  • Nitrolingual Pumpspray is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease ().
  • No data
  • At the onset of an attack, administer onto or under the tongue.u00a0Repeat every 5 minutes as needed ().n
  • Do up to three metered sprays within a 15-minute period. If chest pain persists, advise prompt medical attention (). n
  • May be used prophylactically 5u00a0to 10u00a0minutes prior to engaging in activities thatu00a0might precipitate an acute attack ().
  • Lingual spray, 400 mcg per spray available in either 60 or 200 metered sprays per container.
  • Lingual spray, 400 mcg per spray, available in 60 or 200 metered sprays per container ().
  • No data
  • Use of u00a0phosphodiesterase type 5 (PDE-5) Inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). (, )
  • Severe anemia. ()
  • Increasedu00a0 intracranial pressure. ()
  • Hypersensitivity to Nitrolingual Pumpspray or to other nitrates or nitrites or any excipient. ()
  • Tolerance:
  • Hypotension:
  • Most common adverse reactions occurring at a frequency greater than 2 % are headache, dizzinesss and paresthesiau00a0().
  • No data
  • Antihypertensives: possible additive hypotensive effects. ()
  • Ergotamine: increased bioavailability of ergotamine. Avoidu00a0concomitant use ()
  • No data
  • No data
  • Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (CHNO). The compound has a molecular weight of 227.09. The chemical structure is:
  • CHu2013ONOn
  • |
  • CHu2013ONOn
  • |
  • CHu2013ONOn
  • Nitrolingual Pumpspray (nitroglycerin lingual sprayu00a0400 mcg) is a metered dose spray containing nitroglycerin. This product delivers nitroglycerin (400 mcg per spray, 60 or 200 metered sprays) in the form of spray droplets onto or under the tongue. Inactive ingredients: medium-chain triglycerides, dehydrated alcohol, medium-chain partial glycerides, peppermint oil, sodium lactate, lactic acid.
  • No data
  • Animal carcinogenesis studies with sublingual nitroglycerin have not been performed.
  • Rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years developed dose-related fibrotic and neoplastic changes in liver, including carcinomas, and interstitial cell tumors in testes. At high dose, the incidences of hepatocellular carcinomas in both sexes were 52 % vs. 0 % in controls, and incidences of testicular tumors were 52 % vs. 8 % in controls. Lifetime dietary administration of up to 1058 mg/kg/day of nitroglycerin was not tumorigenic in mice.
  • Nitroglycerin was weakly mutagenic in Ames tests performed in two different laboratories. There was no evidence of mutagenicity in an dominant lethal assay with male rats treated with doses up to about 363 mg/kg/day, p.o., or in cytogenic tests in rat and dog tissues and for chromosomal aberration in Chinese hamster ovary cells.
  • In a three-generation reproduction study, rats received dietary nitroglycerin at doses up to about 434 mg/kg/day for six months prior to mating of the F generation with treatment continuing through successive F and F generations. The high dose was associated with decreased feed intake and body weight gain in both sexes at all matings. No specific effect on the fertility of the F generation was seen. Infertility noted in subsequent generations, however, was attributed to increased interstitial cell tissue and aspermatogenesis in the high- dose males. In this three-generation study there was no clear evidence of teratogenicity.
  • In a randomized, double-blind single-dose, 5-period cross-over study in 51 patients with exertional angina pectoris significant dose-related increases in exercise tolerance, time to onset of angina and ST-segment depression were seen following doses of 0.2, 0.4, 0.8 and 1.6 mg of nitroglycerin delivered by metered pumpspray as compared to placebo.
  • The drug showed a profile of mild to moderate adverse events.
  • 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 sprayu00a0which will deliver 60 or 200 metered sprays containing 400 mcg of nitroglycerin per spray after priming.
  • Nitrolingual Pumpspray is available as:
  • Store at 20u00b0C - 25u00b0C (68u00b0F - 77u00b0F); excursions permitted to 15 - 30u00b0C (59 - 86u00b0F) [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.
  • Advise the patient to read the FDA-approved patient labeling (Instructions for Use)
  • The following trademarks are either registered trademarks or trademarks of Pohl-Boskamp in the United States and/or other countries: Pohl-Boskamp word mark; Pohl-Boskamp logo; Nitrolingual word mark; Nitrolingual Pumpspray shapes, Nitrolingual Pumpspray colors.
  • U.S. Patent No. 7,872,049
  • Manufactured forEsperou00a0Pharmaceuticals, Inc.u00a0Jacksonville, FL 32250by G. Pohl-Boskamp GmbH & Co. KG,25551 Hohenlockstedt, Germany.
  • Instructions for Usen- Nitrolingualu00ae Pumpspray n- (n- nu012b-tru014d-lingu00b4gwal)n- (nitroglycerinn- )n- lingualn- spray
  • Read this Instructions for Use before you start using Nitrolingual Pumpspray and each time you get your prescription refilled. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
  • Important information:
  • Nitrolingual Pumpspray parts:
  • Figure A
  • How n- should In- usen- Nitrolingual Pumpsprayn- ?
  • Priming Nitrolingual Pumpsprayn- :
  • Before you use Nitrolingual Pumpspray for the first time, you must prime it. To prime your Nitrolingual Pumpspray, follow the steps below:
  • Step 1.
  • Figure B
  • Step 2.
  • Figure C
  • Giving a dose of Nitroln- in- ngual Pumpsprayn- :
  • Step n- 3.
  • Step 4.
  • Step n- 5.
  • Figure D
  • Step n- 6.
  • Step n- 7.
  • Step n- 8.
  • Check the level of the fluid in your Nitrolingual Pumpspray container regularly.
  • How should I store Nitrolingual Pumpspray?
  • Keep Nitrolingual Pumpspray and all medicines out of the reach of children
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration. u00a0
  • Manufactured for Esperou00a0Pharmaceuticals, Inc. Jacksonville, FL 32250
  • by G. Pohl-Boskamp GmbH & Co. KG, 25551 Hohenlockstedt, Germany.
  • Revised: 07/2018
  • The following trademarks are either registered trademarks or trademarks of Pohl-Boskamp in the United States and / or other countries: Pohl-Boskamp word mark; Pohl-Boskamp logo; Nitrolingual word mark; Nitrolingual Pumpspray shapes, Nitrolingual Pumpspray colors.
  • PRINCIPAL DISPLAY PANEL
  • PRINCIPAL DISPLAY PANEL

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Nitroglycerin (NITROLINGUAL) which is also known as NITROLINGUAL and Manufactured by Espero Pharmaceuticals, Inc.. It is available in strength of 400 ug/1.

Nitroglycerin (NITROLINGUAL) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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