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host posted on March 25, 2011 23:41

.: KEMASAN & NO REG :.

  • Ranitidine 25 mg/mL injeksi (1 box berisi 10 ampul @ 2 mL), No. Reg. : GKL0608513443A1
  • Ranitidine 150 mg tablet (1 box berisi 10 strip @ 10 tablet), No. Reg : GKL0308509017A1

 

.: FARMAKOLOGI :.

Ranitidine adalah suatu histamin antagonis reseptor H2 yang menghambat kerja histamin secara kompetitif pada reseptor H2 dan mengurangi sekresi asam lambung. 
Pada pemberian i.m./i.v. kadar dalam serum yang diperlukan untuk menghambat 50% perangsangan sekresi asam lambung adalah 36–94 mg/mL. Kadar tersebut bertahan selama 6–8 jam. 
Ranitidine diabsorpsi 50% setelah pemberian oral. Konsentrasi puncak plasma dicapai 2–3 jam setelah pemberian dosis 150 mg. Absorpsi tidak dipengaruhi secara nyata oleh makanan dan antasida. Waktu paruh 2 ½–3 jam pada pemberian oral, Ranitidine diekskresi melalui urin.

 

.: INDIKASI :.

  • Pengobatan jangka pendek tukak usus 12 jari aktif, tukak lambung aktif, mengurangi gejala refluks esofagitis.
  • Terapi pemeliharaan setelah penyembuhan tukak usus 12 jari, tukak lambung.
  • Pengobatan keadaan hipersekresi patologis (misal : sindroma Zollinger Ellison dan mastositosis sistemik).
  • Ranitidine injeksi diindikasikan untuk pasien rawat inap di rumah sakit dengan keadaan hipersekresi patologis atau ulkus 12 jari yang sulit diatasi atau sebagai pengobatan alternatif jangka pendek pemberian oral pada pasien yang tidak bisa diberi Ranitidine oral.

 

.: KONTRA INDIKASI :.

Penderita yang hipersensitif terhadap Ranitidine.

 

.: DOSIS :.
Ranitidine injeksi


Injeksi i.m. : 50 mg (tanpa pengenceran) tiap 6 – 8 jam.
Injeksi i.v. : intermittent.


  • Intermittent bolus : 50 mg (2 mL) tiap 6 – 8 jam. Encerkan injeksi 50 mg dalam larutan NaCl 0,9% atau larutan injeksi i.v. lain yang cocok sampai diperoleh konsentrasi tidak lebih dari 2,5 mg/mL (total volume 20 mL). Kecepatan injeksi tidak lebih dari 4 mL/menit (dengan waktu 5 menit).
  • Intermittent infusion : 50 mg (2 mL) tiap 6 – 8 jam. Encerkan injeksi 50 mg dalam larutan dekstrosa 5% atau larutan i.v. lain yang cocok sampai didapat konsentrasi tidak lebih besar dari 0,5 mg/mL (total volume 100 mL).
  • Kecepatan infus tidak lebih dari 5 – 7 mL/menit (dengan waktu 15 – 20 menit).
  • Infus kontinyu : 150 mg Ranitidine diencerkan dalam 250 mL dekstrosa atau larutan i.v. lain yang cocok dan diinfuskan dengan kecepatan 6,25 mg/jam selama 24 jam. Untuk penderita sindrom Zollinger-Ellison atau hipersekretori lain, Ranitidine injeksi harus diencerkan dengan larutan dekstrosa 5% atau larutan i.v. lain yang cocok sehingga diperoleh konsentrasi tidak lebih dari 2,5 mg/mL. Kecepatan infus dimulai 1 mg/kg BB/jam dan harus disesuaikan dengan keadaan penderita.

Ranitidine oral


  • 150 mg 2 kali sehari (pagi dan malam) atau 300 mg sekali sehari sesudah makan malam atau sebelum tidur, selama 4 – 8 minggu.
  • Tukak lambung aktif 150 mg 2 kali sehari (pagi dan malam) selama 2 minggu.
  • Terapi pemeliharaan pada penyembuhan tukak 12 jari dan tukak lambung Dewasa : 150 mg, malam hari sebelum tidur.
  • Keadaan hipersekresi patologis (Zollinger - Ellison, mastositosis sistemik) Dewasa : 150 mg, 2 kali sehari dengan lama pengobatan ditentukan oleh dokter berdasarkan gejala klinik yang ada. Dosis dapat ditingkatkan sesuai dengan kebutuhan masing-masing penderita. Dosis hingga 6 g sehari dapat diberikan pada penyakit yang berat.
  • Refluks gastroesofagitis Dewasa : 150 mg, 2 kali sehari.
  • Esofagitis erosif Dewasa : 150 mg, 4 kali sehari.
  • Pemeliharaan dan penyembuhan esofagitis erosif Dewasa : 150 mg, 2 kali sehari.
  • Dosis pada penderita gangguan fungsi ginjal Bila bersihan kreatinin < 50 mL / menit : 150 mg / 24 jam. Bila perlu dosis dapat ditingkatkan secara hati-hati setiap 12 jam atau kurang tergantung kondisi penderita.
  • Hemodialisis menurunkan kadar Ranitidine yang terdistribusi.

 

.: EFEK SAMPING :.

  • Sakit kepala
  • Susunan saraf pusat, jarang terjadi : malaise, pusing, mengantuk, insomnia, vertigo, agitasi, depresi, halusinasi.
  • Kardiovaskular, jarang dilaporkan : aritmia seperti takikardia, bradikardia, atrioventricular block, premature ventricular beats.
  • Gastrointestinal : konstipasi, diare, mual, muntah, nyeri perut. Jarang dilaporkan : pankreatitis.
  • Muskuloskeletal, jarang dilaporkan : artralgia dan mialgia.
  • Hematologik : leukopenia, granulositopenia, pansitopenia, trombositopenia (pada beberapa penderita). Kasus jarang terjadi seperti agranulositopenia, trombositopenia, anemia aplastik pernah dilaporkan.
  • Lain-lain, kasus hipersensitivitas yang jarang (contoh : bronkospasme, demam, eosinofilia), anafilaksis, edema angioneurotik, sedikit peningkatan kadar dalam kreatinin serum.

 

.: OVER DOSIS :.

Gejala-gejala overdosis antara lain, pernah dilaporkan : hipotensi, cara berjalan yang tidak normal.


Penanganan overdosis :


  • Induksi dengan cara dimuntahkan atau bilas lambung.
  • Untuk serangan : dengan cara pemberian diazepam injeksi i.v.
  • Untuk bradikardia : dengan cara pemberian atropin.
  • Untuk aritmia : dengan cara pemberian lidokain.

 

.: PERINGATAN DAN PERHATIAN :.

  • Umum : pada penderita yang memberikan respon simptomatik terhadap Ranitidine, tidak menghalangi timbulnya keganasan lambung.
  • Karena Ranitidine dieksresi terutama melalui ginjal, dosis Ranitidine harus disesuaikan pada penderita dengan gangguan fungsi ginjal.
  • Hati-hati pemberian pada gangguan fungsi hati karena Ranitidine di metabolisme di hati.
  • Hindarkan pemberian pada penderita dengan riwayat porfiria akut.
  • Hati-hati penggunaan pada wanita menyusui.
  • Khasiat dan keamanan penggunaan pada anak-anak belum terbukti.
  • Waktu penyembuhan dan efek samping pada usia lanjut tidak sama dengan penderita usia dewasa.
  • Pemberian pada wanita hamil hanya jika benar-benar sangat dibutuhkan.

 

.: INTERAKSI OBAT :.

  • Ranitidine tidak menghambat kerja dari sitokrom P450 dalam hati.
  • Pemberian bersama warfarin dapat meningkatkan atau menurunkan waktu protrombin.

 

.: LAIN-LAIN :.

Penyimpanan:


Ranitidine injeksi disimpan di tempat sejuk dan kering suhu 4–25oC, terlindung dari cahaya, harus dengan resep dokter. Ranitidine tablet disimpan di tempat kering, suhu 15–30oC, terlindung dari cahaya.

Posted in: Gastrointestinal , Antacid, antireflux agents & antiulcerants

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