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Nitroglycerin (Nitrostat)

Trade Name : Nitrostat

Parke-Davis Div of Pfizer Inc

TABLET

Strength 0.3 mg/1

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Nitroglycerin (Nitrostat) which is also known as Nitrostat and Manufactured by Parke-Davis Div of Pfizer Inc. It is available in strength of 0.3 mg/1 per ml. Read more

Nitroglycerin (Nitrostat) 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.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • NITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
  • NITROSTAT is a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. ()
  • Administer one tablet under the tongue or in the buccal pouch at the first sign of an acute anginal attack. Allow tablet to dissolve without swallowing. One additional tablet may be administered every 5 minutes until relief is obtained. No more than three tablets are recommended within a 15-minute period. If the pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, seek prompt medical attention.
  • NITROSTAT may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.
  • For patients with xerostomia, a small sip of water prior to placing the tablet under the tongue may help maintain mucosal hydration and aid dissolution of the tablet.
  • Administer NITROSTAT at rest, preferably in the sitting position.
  • 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. ()
  • If chest pain persists after three tablets, seek prompt medical attention. ()
  • May be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. ()
  • NITROSTAT is supplied as white, round, flat-faced tablets in three strengths:
  • Sublingual tablets, 0.3 mg; 0.4 mg; 0.6 mg ()
  • No data
  • Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulators. (, )
  • Severe anemia ()
  • Increased intracranial pressure ()
  • Hypersensitivity to NITROSTAT or to other nitrates or nitrites or any excipient ()
  • Circulatory failure and shock ()
  • No data
  • Tolerance: Excessive use may lead to tolerance. ()
  • Hypotension: Severe hypotension may occur. ()
  • The following adverse reactions are discussed in more detail elsewhere in the label:
  • Vertigo, dizziness, weakness, palpitation, and other manifestations of postural hypotension may develop occasionally, particularly in erect, immobile patients. Marked sensitivity to the hypotensive effects of nitrates (manifested by nausea, vomiting, weakness, diaphoresis, pallor, and collapse) may occur at therapeutic doses. Syncope due to nitrate vasodilatation has been reported.
  • Flushing, drug rash, and exfoliative dermatitis have been reported in patients receiving nitrate therapy.
  • Most common adverse reactions occurring at a frequency greater than 2% are headache, dizziness and paresthesia. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or n
  • Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use. ()
  • No data
  • No data
  • NITROSTAT is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg , or 0.6 mg nitroglycerin; as well as lactose monohydrate, NF; glyceryl monostearate, NF; pregelatinized starch, NF; calcium stearate, NF powder; and silicon dioxide, colloidal, NF.
  • Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is:
  • Molecular weight: 227.09
  • No data
  • Animal carcinogenesis studies with sublingually administered nitroglycerin have not been performed.
  • Carcinogenicity potential of nitroglycerin was evaluated in rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years. Rats 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 males was 48% and in females was 33%, compared to 0% in untreated controls. 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 mutagenic in Ames tests performed in 2 different laboratories. Nevertheless, there was no evidence of mutagenicity in an in vivo dominant lethal assay with male rats treated with doses up to about 363 mg/kg/day, PO, or in ex vivo cytogenetic tests in rat and dog cells.
  • In a 3-generation reproduction study, rats received dietary nitroglycerin at doses up to about 434 mg/kg/day for 6 months prior to mating of the F0 generation, with treatment continuing through successive F1 and F2 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 F0 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 3-generation study, there was no clear evidence of teratogenicity.
  • 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 20u00b0u201325u00b0C (68u00b0u201377u00b0F) [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.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • This product's label may have been updated. For full prescribing information, please visit www.pfizer.com.
  • LAB-0180-9.0
  • Read this information carefully before you start (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 , ask your doctor. Your doctor will know if is right for you.
  • What is NITROSTAT?
  • NITROSTAT
  • 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. can relieve this pain.
  • Who should not use NITROSTAT?
  • Do not use if you are allergic to organic nitrates (like the active ingredient in ).
  • You should not take if you have the following conditions:
  • Do not take 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 pressuren
  • Do not take 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 , tell your doctor if:
  • How should I take NITROSTAT?
  • What should I avoid while taking NITROSTAT?
  • What are the possible side effects of NITROSTAT?
  • NITROSTAT
  • Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of . For a complete list, ask your doctor or pharmacist.
  • How do I store NITROSTAT?
  • NITROSTAT
  • Store tablets at room temperature (between 68u00b0 and 77u00b0F).
  • General advice about NITROSTAT
  • Sometimes doctors will prescribe a medicine for a condition that is not included in the patient information leaflets. Only use the way your doctor told you to. Do not give to other people, even if they have the same symptoms you have. It may harm them.
  • You can ask your pharmacist or doctor for information about , or you can visit the Pfizer website at or call 1-800-438-1985.
  • LAB-0422-3.0 Revised January 2018
  • ALWAYS DISPENSE WITHPATIENT PACKAGE INSERT
  • Pfizer
  • NDC 0071-0417-24
  • Nitrostat
  • 0.3 mg/tablet
  • 100 Sublingual Tabletsn n
  • ALWAYS DISPENSE WITHPATIENT PACKAGE INSERT
  • Pfizer NDC 0071-0417-24
  • Nitrostatn (Nitroglycerin SublingualTablets, USP)
  • 0.3 mg/tablet
  • tablets
  • 100 Sublingual Tablets Rx only
  • GTIN: 00300710417243
  • ALWAYS DISPENSE WITHPATIENT PACKAGE INSERT
  • Pfizer
  • NDC 0071-0418-13
  • Nitrostat
  • 0.4 mg / tablet
  • 25 Sublingual Tabletsn n
  • ALWAYS DISPENSE WITHPATIENT PACKAGE INSERT
  • Pfizer NDC 0071-0418-13
  • Nitrostatn (Nitroglycerin SublingualTablets, USP)
  • 0.4 mg / tablet
  • 4 Bottles u00d7 25 Sublingual Tablets Rx only
  • ALWAYS DISPENSE WITHPATIENT PACKAGE INSERT
  • Pfizer
  • NDC 0071-0419-24
  • Nitrostat
  • 0.6 mg/tablet
  • 100 Sublingual Tabletsn n
  • ALWAYS DISPENSE WITHPATIENT PACKAGE INSERT
  • Pfizer NDC 0071-0419-24
  • Nitrostatn (Nitroglycerin SublingualTablets, USP)
  • 0.6 mg/tablet
  • tablets
  • 100 Sublingual Tablets Rx only
  • GTIN: 00300710419247

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