Peringatan Keamanan

Short-term overdosage with somatrem may initially result in hypoglycaemia and then subsequently to hyperglycemia L1896, FDA Label. Moreover, this kind of short-term overdosage with somatrem is also likely to cause fluid retention L1896, FDA Label.

Long-term overdose with somatrem could leads to signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone L1896, FDA Label.

Some animal based oral LD50 values have been reported as: mouse = 300mg/kg, rabbit = 3200 mg/kg, rat = 980 mg/kg.

Somatrem

DB09098

biotech approved investigational withdrawn

Deskripsi

Despite the ability of almost all contemporary recombinant growth hormones to cause definite and demonstrable increases in growth rate in patients who are administered the drug, the use of these agents continues to be mired in persistent bioethical debate A32292. Such discussion revolves around whether patients' natural disposition of short stature should be considered a medical condition justifying medical treatment with such hormone therapy - especially when these hormone agents have been proven effective at increasing the height of children with or without growth hormone deficiency A32292.

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: Obat • Target • Gen • Enzim • (Panah → menunjukkan arah efek / relasi) • Transporter • Carrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) The mean terminal half-life after subcutaneous administration is 2.1 +/- 0.43 hours while the mean terminal half-life after intravenous administration is determined to be 19.5 +/- 3.1 minutes [L1896, FDA Label].
Volume Distribusi Animal studies with somatrem showed that growth hormone localizes to highly perfused organs, particularly the liver and kidney [L1896, FDA Label]. The volume of distribution at steady state for somatrem in health adult males is approximately 50 mL/kg body weight, approximating the serum volume [L1896, FDA Label].
Klirens (Clearance) The clearance of somatrem after intravenous administration in healthy adults and children is reported to be in the range of 116-174 mL/hr/kg [L1896, FDA Label].

Absorpsi

The absolute bioavailability of somatrem after subcutaneous administration in healthy adult males has been determined to be 81 +/- 20%. Additionally, as the subcutaneous terminal half-life is significantly longer than the intravenous terminal half-life, it appears as if the subcutaneous absorption of somatrem is slow and rate-limiting L1896, FDA Label.

Metabolisme

Both the liver and kidney have been shown to be important metabolizing organs for growth hormone L1896, FDA Label. Animal studies suggest that the kidney is the dominant organ of clearance. Growth hormone is filtered at the glomerulus and reabsorbed in the proximal tubules L1896, FDA Label. It is then cleaved within renal cells into its constituent amino acids, which return to the systemic circulation L1896, FDA Label.

Rute Eliminasi

Animal studies suggest that the kidney is the dominant organ of clearance L1896, FDA Label.

Interaksi Obat

278 Data
Cortisone acetate The serum concentration of the active metabolites of Cortisone acetate can be reduced when Cortisone acetate is used in combination with Somatrem resulting in a loss in efficacy.
Macimorelin The therapeutic efficacy of Macimorelin can be decreased when used in combination with Somatrem.
Antipyrine The metabolism of Antipyrine can be increased when combined with Somatrem.
Fluvoxamine The metabolism of Fluvoxamine can be increased when combined with Somatrem.
Bortezomib The metabolism of Bortezomib can be increased when combined with Somatrem.
Betaxolol The metabolism of Betaxolol can be increased when combined with Somatrem.
Caffeine The metabolism of Caffeine can be increased when combined with Somatrem.
Anagrelide The metabolism of Anagrelide can be increased when combined with Somatrem.
Carmustine The metabolism of Carmustine can be increased when combined with Somatrem.
Ropinirole The metabolism of Ropinirole can be increased when combined with Somatrem.
Theophylline The metabolism of Theophylline can be increased when combined with Somatrem.
Lidocaine The metabolism of Lidocaine can be increased when combined with Somatrem.
Conjugated estrogens The metabolism of Conjugated estrogens can be increased when combined with Somatrem.
Ropivacaine The metabolism of Ropivacaine can be increased when combined with Somatrem.
Penciclovir The metabolism of Penciclovir can be increased when combined with Somatrem.
Zolmitriptan The metabolism of Zolmitriptan can be increased when combined with Somatrem.
Acetaminophen The metabolism of Acetaminophen can be increased when combined with Somatrem.
Amitriptyline The metabolism of Amitriptyline can be increased when combined with Somatrem.
Olanzapine The metabolism of Olanzapine can be increased when combined with Somatrem.
Chlorzoxazone The metabolism of Chlorzoxazone can be increased when combined with Somatrem.
Clozapine The metabolism of Clozapine can be increased when combined with Somatrem.
Grepafloxacin The metabolism of Grepafloxacin can be increased when combined with Somatrem.
Mirtazapine The metabolism of Mirtazapine can be increased when combined with Somatrem.
Mexiletine The metabolism of Mexiletine can be increased when combined with Somatrem.
Tacrine The metabolism of Tacrine can be increased when combined with Somatrem.
Triamterene The metabolism of Triamterene can be increased when combined with Somatrem.
Sorafenib The metabolism of Sorafenib can be increased when combined with Somatrem.
Promazine The metabolism of Promazine can be increased when combined with Somatrem.
Zolpidem The metabolism of Zolpidem can be increased when combined with Somatrem.
Entecavir The metabolism of Entecavir can be increased when combined with Somatrem.
Imipramine The metabolism of Imipramine can be increased when combined with Somatrem.
Nabumetone The metabolism of Nabumetone can be increased when combined with Somatrem.
Fluoxetine The metabolism of Fluoxetine can be increased when combined with Somatrem.
Chlorpromazine The metabolism of Chlorpromazine can be increased when combined with Somatrem.
Flutamide The metabolism of Flutamide can be increased when combined with Somatrem.
Haloperidol The metabolism of Haloperidol can be increased when combined with Somatrem.
Albendazole The metabolism of Albendazole can be increased when combined with Somatrem.
Erlotinib The metabolism of Erlotinib can be increased when combined with Somatrem.
Mephenytoin The metabolism of Mephenytoin can be increased when combined with Somatrem.
Rofecoxib The metabolism of Rofecoxib can be increased when combined with Somatrem.
Fluorouracil The metabolism of Fluorouracil can be increased when combined with Somatrem.
Cinnarizine The metabolism of Cinnarizine can be increased when combined with Somatrem.
Propranolol The metabolism of Propranolol can be increased when combined with Somatrem.
Fenfluramine The metabolism of Fenfluramine can be increased when combined with Somatrem.
Clonidine The metabolism of Clonidine can be increased when combined with Somatrem.
Diclofenac The metabolism of Diclofenac can be increased when combined with Somatrem.
Imatinib The metabolism of Imatinib can be increased when combined with Somatrem.
Efavirenz The metabolism of Efavirenz can be increased when combined with Somatrem.
Guanabenz The metabolism of Guanabenz can be increased when combined with Somatrem.
Pemetrexed The metabolism of Pemetrexed can be increased when combined with Somatrem.
Estrone The metabolism of Estrone can be increased when combined with Somatrem.
Verapamil The metabolism of Verapamil can be increased when combined with Somatrem.
Tamoxifen The metabolism of Tamoxifen can be increased when combined with Somatrem.
Warfarin The metabolism of Warfarin can be increased when combined with Somatrem.
Tizanidine The metabolism of Tizanidine can be increased when combined with Somatrem.
Paroxetine The metabolism of Paroxetine can be increased when combined with Somatrem.
Thiabendazole The metabolism of Thiabendazole can be increased when combined with Somatrem.
Riluzole The metabolism of Riluzole can be increased when combined with Somatrem.
Zileuton The metabolism of Zileuton can be increased when combined with Somatrem.
Clopidogrel The metabolism of Clopidogrel can be increased when combined with Somatrem.
Etoposide The metabolism of Etoposide can be increased when combined with Somatrem.
Estradiol The metabolism of Estradiol can be increased when combined with Somatrem.
Mefenamic acid The metabolism of Mefenamic acid can be increased when combined with Somatrem.
Acyclovir The metabolism of Acyclovir can be increased when combined with Somatrem.
Naproxen The metabolism of Naproxen can be increased when combined with Somatrem.
Pentoxifylline The metabolism of Pentoxifylline can be increased when combined with Somatrem.
Trifluoperazine The metabolism of Trifluoperazine can be increased when combined with Somatrem.
Perphenazine The metabolism of Perphenazine can be increased when combined with Somatrem.
Dacarbazine The metabolism of Dacarbazine can be increased when combined with Somatrem.
Terbinafine The metabolism of Terbinafine can be increased when combined with Somatrem.
Ranitidine The metabolism of Ranitidine can be increased when combined with Somatrem.
Ethanol The metabolism of Ethanol can be increased when combined with Somatrem.
Ondansetron The metabolism of Ondansetron can be increased when combined with Somatrem.
Cyclobenzaprine The metabolism of Cyclobenzaprine can be increased when combined with Somatrem.
Maprotiline The metabolism of Maprotiline can be increased when combined with Somatrem.
Alosetron The metabolism of Alosetron can be increased when combined with Somatrem.
Azelastine The metabolism of Azelastine can be increased when combined with Somatrem.
Ethinylestradiol The metabolism of Ethinylestradiol can be increased when combined with Somatrem.
Lomefloxacin The metabolism of Lomefloxacin can be increased when combined with Somatrem.
Ramelteon The metabolism of Ramelteon can be increased when combined with Somatrem.
Azathioprine The metabolism of Azathioprine can be increased when combined with Somatrem.
Frovatriptan The metabolism of Frovatriptan can be increased when combined with Somatrem.
Levobupivacaine The metabolism of Levobupivacaine can be increased when combined with Somatrem.
Cinacalcet The metabolism of Cinacalcet can be increased when combined with Somatrem.
Selegiline The metabolism of Selegiline can be increased when combined with Somatrem.
Tocainide The metabolism of Tocainide can be increased when combined with Somatrem.
Praziquantel The metabolism of Praziquantel can be increased when combined with Somatrem.
Melatonin The metabolism of Melatonin can be increased when combined with Somatrem.
Primaquine The metabolism of Primaquine can be increased when combined with Somatrem.
Hesperetin The metabolism of Hesperetin can be increased when combined with Somatrem.
Leflunomide The metabolism of Leflunomide can be increased when combined with Somatrem.
Pimozide The metabolism of Pimozide can be increased when combined with Somatrem.
Nifedipine The metabolism of Nifedipine can be increased when combined with Somatrem.
Carvedilol The metabolism of Carvedilol can be increased when combined with Somatrem.
Doxepin The metabolism of Doxepin can be increased when combined with Somatrem.
Cilostazol The metabolism of Cilostazol can be increased when combined with Somatrem.
Propafenone The metabolism of Propafenone can be increased when combined with Somatrem.
Domperidone The metabolism of Domperidone can be increased when combined with Somatrem.
Dexfenfluramine The metabolism of Dexfenfluramine can be increased when combined with Somatrem.
Flecainide The metabolism of Flecainide can be increased when combined with Somatrem.

Target Protein

Growth hormone receptor GHR
Insulin-like growth factor 1 receptor IGF1R

Referensi & Sumber

Artikel (PubMed)
  • PMID: 15127004
    Allen DB, Fost N: hGH for short stature: ethical issues raised by expanded access. J Pediatr. 2004 May;144(5):648-52. doi: 10.1016/j.jpeds.2004.02.028.

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