Nitrofix SR Tablets (lsosorbide - 5- Mononitrate )

• Composition :
  Each tablet contains Sustained Release Isosorbide -5- mononitrate 30/60mg.
• Indications :
  Isosorbide mononitrate tablets are indicated in prophylaxis of angina pectoris, CHD post MI, therapy of pulmonary hypertension.
• Pharmacodynamics :
  The principal pharmacological action is relaxation of vascular smooth muscle and consequent dilation of peripheral arteries and veins.
• Dosage and administration :
  The recommended starting dose of Isosorbide -5- mononitrate is 30mg (given as single 30mg or half of 60mg tablet) or 60 mg once daily.
• Contraindications :
  Isosorbide mononitrate is contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.
• Precautions and warnings :
  Amplification of the vasodilator effects of isosorbide mononitrate by sildenafil can result in severe hypotension. Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide mononitrate. Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Should be used in pregnancy only if clearly needed. It is not known whether isosorbide mononitrate is excreted in human milk. Hence, caution should be exercised when administered to nursing women. Safety and effectiveness in pediatric patients have not been established.
• Drug interactions :
  Concomitant use is contraindicated with phosphodiesterase inhibitors, riociguat and should be monitored while using with vasodilators and calcium channel blockers. Drugs for erectile dysfunction such as sildenafil, concomitant use can cause severe hypotension.
• Adverse reactions :
  The most frequent reported adverse events include: headache, dizziness, abdominal pain, cough, nausea and fatigue
• Therapy Area :
  Anti-Anginals