Trade Name: GONITRO

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: POWDER, HUMAN PRESCRIPTION DRUG

Strength: 400 ug/1

Storage and handling

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

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

nitroglycerin (GONITRO) 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.

  • No data
  • GONITRO is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
  • GONITROu00a0is 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 one or two packets (400 mcg each) under the tongue.u00a0One additionalu00a0packet may be administered every 5 minutes as needed.u00a0No more than three total packets (1200 mcg) are recommended within a 15 minute period. ()n
  • If chest pain persists after three packets, advise prompt medical attention. ()n
  • May be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. ()
  • GONITROu00a0(nitroglycerin) sublingual powder, in packets containing 400 mcg of nitroglycerin.
  • Sublingual powder, 400 mcg per packet. ()
  • No data
  • Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulators. (, )n
  • Severe anemia. ()n
  • Increasedu00a0intracranial pressure. ()n
  • Hypersensitivity to GONITRO or to other nitrates or nitrites or any excipient. ()n
  • Circulatory failure and shock. ()
  • No data
  • Tolerance: Excessive use may lead to tolerance. ()u00a0n
  • Hypotension: Severe hypotension may occur. ()
  • Most common adverse reactions occurring at a frequency greater than 2% are headache, dizzinesss and paresthesia. ()
  • No data
  • Antihypertensives: possible additive hypotensive effects. ()n
  • 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:
  • GONITRO is a powder containing nitroglycerin. Each packet of GONITROu00a0delivers 400 mcg of nitroglycerin whenu00a0administered under the tongue. The sublingual powder is formulated with the following inactive ingredients: anhydrous dibasic calcium phosphate, isomalt,u00a0medium-chain triglycerides, peppermint oil, and oleoyl polyoxylglycerides.
  • 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 52u00a0% vs. 0u00a0% in controls, and incidences of testicular tumors were 52u00a0% vs. 8u00a0% 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 200-1600 mcg of sublingual nitroglycerin as compared to placebo.
  • The drug showed a profile of mild to moderate adverse events.
  • Each box of GONITRO (nitroglycerin)u00a0sublingual powder, contains 12, 36 or 96u00a0packets.
  • Each packet contains 400 mcg of nitroglycerin.
  • GONITRO is available as:u2022 Box of 12u00a0packetsu00a0NDC 70007-400-12u2022 Box of 36u00a0packetsu00a0NDC 70007-400-36u2022 Box of 96u00a0packetsu00a0NDC 70007-400-96
  • Storeu00a0at 20u00b0C - 25u00b0Cu00a0(68u00b0F - 77u00b0F); excursions permitted between 5u00b0Cu00a0u2013 40u00b0C (41u00b0F u2013 104u00b0F).
  • Rx Only.
  • Advise the patient to read the FDA-approved Instructions for Use.
  • Manufactured forEspero Pharmaceuticals, Inc.Jacksonville, FL 32250(800) 235-6520by G. Pohl-Boskamp GmbH & Co. KG25551 Hohenlockstedt, Germany.
  • U.S. Patent No. 9,101,592
  • Instructions for Usen- GONITRO (GO-NYE-troh)n- (nitroglycerin) n- sublingual powder
  • Read these Instructions for Use before you start takingu00a0GONITROu00a0and each time you get a refill. 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:
  • Takingn- a dose of n- GONITROn- Step 1.n- Arrayn- Step 2.n- Step 3.n- Arrayn- Arrayn- Arrayn- Arrayn- Step 4. n- Step 5.n- Step 6. n- Arrayn- Step n- 7n- . n- Arrayn- Array
  • How should I store n- GONITRO
  • Store GONITROat room temperature between 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).u00a0
  • Keep n- GONITROn- Arrayn- and all medicines out of the reach of children
  • These Instructions for Use have been approved by the U.S. Food and Drug Administration.
  • Manufactured forEspero Pharmaceuticals, Inc.Jacksonville, FL 32250(800) 235-6520by G. Pohl-Boskamp GmbH & Co. KG25551 Hohenlockstedt, Germany.
  • Issued: 06/2016
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