ntg
DESCRIPTION
NGTTRANSCRIPT
Inspection and Certifications received:
c-GMP – German Federal Health Agency (2010)
c-GMP – TGA (2009)
ISO 9001:2008 (2009)
c-GMP - UK MHRA (2008)
Indonesian GMP (CPOB) – BPOM (Nov 2002)
Successful Audits from Alliances:
UCB - Aug 2006 GSK - Mar 2004
Santen - Jan 2004 Novartis - Nov 2003
Actavis - Sep 2003
Congratulations for PT Ferron Par Pharmaceuticals!
The CVD Continuum
Chrysant SG, World J Cardiol 2010 March 26; 2(3): 43-49
Global CVD Mortality
http://www.who.int/cardiovascular_diseases/en/ ; http://www.world-heart-federation.org/cardiovascular-health/global-facts-map/
Ischemic Heart Disease Mortality
http://apps.who.int/iris/bitstream/10665/79059/1/WHO_DCO_WHD_2013.2_eng.pdf?ua=1
Indonesia: Mortality Rate 109-151 case per 100.000
RISKESDAS 2013
Thomas Münzel et al. Circulation. 2011;123:2132-2144
Acute Coronary Syndrome• Acute coronary syndrome (ACS) refers to a spectrum of
clinical presentations ranging from those for ST-segment elevation myocardial infarction (STEMI) to presentations found in non–ST-segment elevation myocardial infarction (NSTEMI) or in unstable angina.
• It is almost always associated with rupture of an atherosclerotic plaque and partial or complete thrombosis of the infarct-related artery.
http://emedicine.medscape.com/article/1910735-overview
Unstable Angina, NSTEMI, and STEMI differ with regard to duration, severity, and treatments
Overbaugh KJ. AJN t May 2009 t Vol. 109, No. 5
Mechanism of ActionNitroglycerine
FAST and POWERFUL…
Action of Nitrates on Circulation
The major effect is on the venous capacitance vessels, with additional coronary and peripheral arteriolar vasodilatory benefit
Opie LH & Horowitz JD. Nitrates and newer antianginals. In: Drugs for the Heart. 7 th ed. Saunders Elsevier. China
Nitrates Mechanism
Effects of nitrates in generating NO and stimulating guanylate cyclase to cause a vasodilation
Opie LH & Horowitz JD. Nitrates and newer antianginals. In: Drugs for the Heart. 7 th ed. Saunders Elsevier. China
Clinical Efficacy
FAST and POWERFUL…
Low-dose NTG significantly reduces cardiac filling pressures and improves microvascular perfusion in patients admitted for acute heart failure
Nitroglycerin in acute heart failure
Corstiaan A, et al. European Journal of Heart Failure (2009) 11, 386–390
IV Nitroglycerin is highly effective in preventing adverse ischemic events (reccurent or refractory angina) in patients with unstable angina secondary to restenosis
Perioperative hypertension
Varon J, Malik PE. Vascular Health and Risk Management 2008:4(3) 615–627
Perioperative nitroglycerin
ISDN was successful in treating hypertension in 63% of the events, whereas NTG had an 83% success. NTG has been found to be effective in controlling hypertension
Guidelines Nitroglycerin
FAST and POWERFUL…
ANGINA
2013 ESC guidelines on the management of stable coronary artery disease, European Heart Journal (2013) 34, 2949–3003
STEMI
2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, Circulation. 2013;127:e362-e425
2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, Circulation. 2013;127:e362-e425
2013 ACCF/AHA Guideline for the Management of Heart Failure, Circulation. 2013;128:e240-e327
HEARTFAILURE
2013 ACCF/AHA Guideline for the Management of Heart Failure, Circulation. 2013;128:e240-e327
Scottish Intercollegiate Guidelines Network (SIGN). Acute coronary syndromes. Edinburgh: SIGN; 2013. (SIGN publication no. 93). [February 2013]. Available from URL: http://www.sign.ac.uk
Product Profile
FAST and POWERFUL…
Farmakokinetik Nitroglycerin• Distribusi luas di dalam tubuh, VD: 200 L• Konsentrasi plasma terapetik 0,1-3 ng/ml (sd 5
ng/ml)• Nitroglycerin terikat 60% protein plasma, metabolit
1,3-glyceryl dinitrate 60%, 1,2-glyceryl dinitrate 30%• Onset 1-2 menit IV• Durasi 3-5 menit, • Waktu paruh 1-4 menit
Indikasi NTG• Gagal jantung yang tidak responsif karena infark
miokard akut• Angina tidak stabil yang sulit disembuhkan dengan
beta blocker dan nitrat sublingual• Pembedahan
– Mengontrol hipertensi dengan cepat selama pembedahan jantung
– Menurunkan tekanan darah dan menjaga hipotensi yang terkontrol selama prosedur pembedahan
– Mengontrol iskemia miokard selama dan setelah pembedahan
DosisIndikasi Dosis Awal Dosis selanjutnya
Pembedahan 25 µg/menit (untuk mengontrol hipertensi )
Kenaikan dosis 25 µg/menit setiap 5 menit hingga tekanan darah stabil
Pengobatan iskemia miokard perioperatif
15-20 µg/menit Kenaikan dosis 10-15 µg/menit hingga efek yang diharapkan tercapai
Gagal jantung kongestif yang tidak responsif
20-25 µg/menit Dapat dikurangi menjadi 10 µg/menit atau ditingkatkan bertahap 20-25 µg/menit tiap 15-30 menit sampai efek yang diharapkan tercapai
Angina tidak stabil 10 µg/menit Kenaikan dosis 10 µg/menit dengan interval 30 menit sesuai dengan kebutuhan pasien
Cara Pemberian
• NTG harus diencerkan sebelum pemberian IV, Campuran pelarut yang
sesuai: 5% dextrose atau 0,9 % sodium chloride injection (NaCl)• Campuran disiapkan dengan cara mengganti volume nitroglycerin dengan
volume yang sama dari larutan pembawa (misal: 10 mg/50 cc ) • NTG: isotonis dan kompatibel dengan larutan infus yang umumnya
digunakan. Tidak ada inkompatibilitas• Kompatibel dengan botol infus gelas, polyethylene, pompa syringe, syringe
plastik atau gelas• Nitroglycerine tidak kompatibel dengan bahan PVC (dapat terjadi
kehilangan zat aktif dalam jumlah banyak <40%) & polyurethan• Hemodinamik dipantau selama pemberian
Konsentrasi Laju infus
100 µg/ml, 5x10 ml ampul NTG IV dalam 500 ml
Mikrotetes/menitml/jam
Tetes/menit
Dosis (µg/menit)
10 6 2
20 12 4
30 18 6
40 24 8
50 30 10
60 36 12
70 42 14
80 48 16
90 54 18
100 60 20
110 66 22
120 72 24
130 78 26
140 84 28
150 90 30
Peringatan dan Perhatian• Monitoring ketat denyut nadi dan tekanan darah• Pasien menderita hipotiroid, penyakit ginjal dan hati
yang berat, hipotermia dan malnutrisi• Pasien dengan tekanan desakan kapiler paru normal
atau rendah dapat menjadi sensitif khususnya terhadap efek hipotensi
• Masa kehamilan dan menyusui• Kemanan dan efikasi pada anak belum diketahui
Efek Samping• Sistem saraf: sakit kepala, pusing• Saluran cerna: mual, muntah dan nyeri abdomen• Jantung: hipotensi, takikardia, palpitasi, bradikardia
paradoksial• Lain-lain: diaforesis, ketakutan, kekelahan, rasa tidak
nyaman, retrosternal, kejang otot
Interaksi Obat• Obat penurun tekanan darah seperti: beta blocker,
antagonis kalsium, vasodilator• Alkohol meningkatkan efek nitroglycerin• Efek hipontensif disebabkan oleh obat-obat sbb:
sidenafil, tadalafil, vardenafil, neuroleptik dan antidepresan trisiklik
Overdosis
• OD ringan: hipotensi dan takikardia– Jika tekanan sistolik turun dibawah 90 mmHg dan
denyut jantung meningkat 10% dari nilai awalnya infus sebaiknya dihentikan
– Jika hipotensi menetap atau pada kasus yang berat, diatasi dengan mengangkat kaki dan atau memberikan obat yang meningkatkan tekanan darah atau menghentikan infus
• OD Berat: pemberian methoxamine atau phenylephrine IV
Summary
• FAST ACTING : Fast onset in 1 minutes• POWERFUL : Strong vasodilator• Recommended by Guidelines• Cost effective
Powerpoint Templates
Hypertensive emergency
Large elevations in SBP or DBP (>180 mmHg or >120 mmHg, respectively) associated with impending or progressive OD, such as major neurological changes, hypertensive encephalopathy, cerebral infarction, intracranial haemorrhage, acute LV failure, acute pulmonary oedema, aortic dissection, renal failure, or eclampsia.
Powerpoint Templates
NICAFERComposition:
Each ampoule (10 ml) contains nicardipine HCl
1 mg/ml
Indications:
• Emergency treatment of acute hypertensive crises during surgery
• Hypertensive emergencies
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