Ondansetron Hydrochloride

(BANM, USAN, rINNM)
Synonyms: GR-38032F; Hidrocloruro de ondansetrón; Ondansétron, chlorhydrate d’; Ondansetron hydrochlorid; Ondansetronhydroklorid; Ondansetroni hydrochloridum; Ondansetronihydrokloridi; Ondansetrono hidrochloridas; Ondanstroni Hydrochloridum; Ondánszetronhidroklorid; SN-307.
Cyrillic synonym: Ондансетрона Гидрохлорид.

💊 Chemical information

Chemical formula: C18H19N3O,HCl,2H2O = 365.9.
CAS — 99614-01-4; 103639-04-9.
ATC — A04AA01.
ATC Vet — QA04AA01.

Pharmacopoeias.

In Chin., Eur., and US.

Ph. Eur. 6.2

(Ondansetron Hydrochloride Dihydrate). A white or almost white powder. Sparingly soluble in water and in alcohol; slightly soluble in dichloromethane; soluble in methyl alcohol. Protect from light.

USP 31

(Ondansetron Hydrochloride). A white to off-white powder. Sparingly soluble in water and in alcohol; very slightly soluble in acetone, in chloroform, and in ethyl acetate; slightly soluble in dichloromethane and in isopropyl alcohol; soluble in methyl alcohol. Store in airtight containers at a temperature of 25°, excursions permitted between 15° and 30°. Protect from light.

Incompatibility.

Ondansetron hydrochloride and dexamethasone sodium phosphate were not compatible when high concentrations were combined in polypropylene syringes. 1 Lower concentrations (up to 640 micrograms/mL of ondansetron and 400 micrograms/mL of dexamethasone phosphate) were stable in 50 mL containers of infusion fluid for 30 days under refrigeration. Compatibility has been reported for 24 hours in plastic syringes at 4° or 23° with a variety of other drugs, 2 and with several antineoplastics (cytarabine, dacarbazine, doxorubicin, etoposide, or methotrexate) in PVC infusion bags for 48 hours at room temperature. 3 1. Hagan RL, et al. Stability of ondansetron hydrochloride and dexamethasone sodium phosphate in infusion bags and syringes for 32 days. Am J Health-Syst Pharm 1996; 53: 1431–5. 2. Stewart JT, et al. Stability of ondansetron hydrochloride and 12 medications in plastic syringes. Am J Health-Syst Pharm 1998; 55: 2630–4. 3. Stewart JT, et al. Stability of ondansetron hydrochloride and five antineoplastic medications. Am J Health-Syst Pharm 1996; 53: 1297–1300.

💊 Adverse Effects and Precautions

Ondansetron and other 5-HT 3 antagonists may cause headache, a sensation of flushing or warmth, hiccups, and constipation. A transient rise in liver enzymes has occasionally occurred.
1. White A, et al. Ondansetron in the treatment of schizophrenia. Lancet 1991; 337: 1173
2. Adler LE, et al. Improved P50 auditory gating with ondansetron in medicated schizophrenia patients. Am J Psychiatry 2005; 162: 386–8
3. Levkovitz Y, et al. The effect of ondansetron on memory in schizophrenic patients. Brain Res Bull 2005; 65: 291–5
4. Zoldan J, et al. Psychosis in advanced Parkinson’s disease: treatment with ondansetron, a 5-HT receptor antagonist. Neurology 1995; 45: 1305–8
5. Sirota P, et al. Use of the selective serotonin 3 receptor antagonist ondansetron in the treatment of neuroleptic-induced tardive dyskinesia. Am J Psychiatry 2000; 157: 287–9.
6. Toren P, et al. Ondansetron treatment in Tourette’s disorder: a 3week, randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2005; 66: 499–503
7. Hewlett WA, et al. Pilot trial of ondansetron in the treatment of 8 patients with obsessive-compulsive disorder. J Clin Psychiatry 2003; 64: 1025–30.

Substance dependence.

Ondansetron is being studied in the management of alcohol dependence. However, in one study1 a significant reduction in alcohol consumption was found only in lighter drinkers after subgroup analysis. Another study2found a reduction in alcohol consumption by patients with earlyonset alcoholism (onset before age 25) who took ondansetron compared with placebo. No such effect was seen, however, in patients with late-onset alcoholism. Further study found that ondansetron also effectively ameliorated mood disturbances including symptoms of depression, anxiety, and hostility, in earlyonset alcoholics.3 Self-reported alcohol consumption also reduced in adolescents (between ages 14 and 20) with alcohol dependence who were given ondansetron in an open study.4
1. Sellers EM, et al. Clinical efficacy of the 5-HT antagonist ondansetron in alcohol abuse and dependence. Alcohol Clin Exp Res 1994; 18: 879–85
2. Johnson BA, et al. Ondansetron for reduction of drinking among biologically predisposed alcoholic patients. JAMA 2000; 284: 963–71
3. Johnson BA, et al. Ondansetron reduces mood disturbance among biologically predisposed, alcohol-dependent individuals. Alcohol Clin Exp Res 2003; 27: 1773–9
4. Dawes MA, et al. A prospective, open-label trial of ondansetron in adolescents with alcohol dependence. Addict Behav 2005; 30: 1077–85.

💊 Preparations

USP 31: Ondansetron Hydrochloride Oral Suspension; Ondansetron Injection; Ondansetron Oral Solution; Ondansetron Orally Disintegrating Ta b l e t s .

Proprietary Preparations

Arg.: Cetron; Dantenk; Dismolan; Emivox†; Espasevit; Finaber; Finoxi; Tiosalis; Zofran; Austral.: Ondaz; Onsetron; Zofran; Austria: Glaxosetron; Ondanoglax; Ondensan; Zofran; Belg.: Zofran; Braz.: Ansentron; Injectrax; Modifical; Nausedron; Ontrax; Vonau; Zofran; Canad.: Zofran; Chile: Amilene; Gardoton; Izofran; Odanex; Oncoemet; Trorix; Cz.: Danemet; Emeset; Emetron†; Novetron; Ondemet; Setron†; Setronon; Zofran; Denm.: Hexatron; Zofran; Fin.: Zofran; Fr.: Zophren; Ger.: Zofran; Gr.: Biosetron; Cruzafen; Dentron; Fedral; Odnatron; Onda; Ondameton; Ondaren; Ondaseprol; Setrodan; Vefron; Zetron; Zodatron; Zofron; Zophralen; Hong Kong: Zofran; Hung.: Antivom; Emetron; Ondagen; Zofran; India: Emeset; Periset; Vomiof; Indon.: Cedantron; Dantroxal; Entron; Frazon; Invomit; Narfoz; Ondavell; Onetic 4; Vomceran; Zantron; Zofran; Irl.: Emital; Zofran; Israel: Zofran; Ital.: Zofran; Malaysia: Osetron; Zofran; Mex.: Danac; Modifical; Precirux; Zofran; Neth.: Zofran; Norw.: Zofran; NZ: Onsetron; Zofran; Philipp.: Emodan; Zofran; Pol.: Atossa; Emetron; Setronon; Zofran; Port.: Nausiend; Otobrol; Zofran; Rus.: Emetron (Эметрон); Setronon (Сетронон); Zofran (Зофран); S.Afr.: Dantron; Nausetron; Zofran; Singapore: Zofran; Spain: Fixca†; Yatrox; Zofran; Swed.: Zofran; Switz.: Zofran; Thai.: Dantron; Emeset; Onsia; Vomitron†; Zetron; Zofran; Tu rk .: Zofer; Zofran; Zoltem; UK: Ondemet; Zofran; USA: Zofran; Venez.: Dismolan; Emeset; Tructum; Zofran.
Published February 03, 2019.