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ONDANSETRON HYDROCHLORIDE DIHYDRATE is a brand name for Ondansetron, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults (18-64 years of age) Sandoz Ondansetron, Ondansetron Injection USP and Ondansetron Hydrochloride Dihydrate Injection are indicated for: the prevention of nausea and vomiting associated with emetogenic chemotherapy, including high dose cisplatin, and radiotherapy. the prevention and treatment of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Visually inspect IV solutions and discard if particulate matter or discolouration are observed. 4 Administration. Sandoz Ondansetron, Ondansetron Injection USP, and Ondansetron Hydrochloride Dihydrate Injection clearance is reduced in patients with moderate or severe hepatic impairme nt.
Their total daily dose should not exceed 8 mg, which may be given as a single intravenous or oral dose. See 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic. Sandoz Ondansetron, Ondansetron Injection USP, and Ondansetron Hydrochloride Dihydrate Injection have important cardiac side-effects dose-dependent QTc prolongation, coronary artery spasm, myocardial ischemia, and sequelae).
These effects are reported more often with intravenous administration, and are expected to be greater with a faster rate of infusion. 2 Pharmacodynamics, Electrocardiography. Though Sandoz Ondansetron, Ondansetron Injection USP, and Ondansetron Hydrochloride Dihydrate Injection efficacy and tolerance were similar for elderly compared to younger adults in chemotherapy clinical trials, exposure-response modelling predicted a greater effect on QTcF in patients ≥75 years of age compared to young adults.
3 Pharmacokinetics, Geriatrics. Dosing considerations that reduce cardiac risks: - Use the minimum effective dose. - Use oral formulations if possible (lower Cmax). Intravenous dosing considerations: o Infuse slowly, over a minimum of 15 minutes.
o Maximum IV dose is 16 mg (adults). o Consider ECG monitoring if treating elderly patients with an IV dose of 16 mg. SANDOZ ONDANSETRON ONDANSETRON INJECTION USP ONDANSETRON HYDROCHLORIDE DIHYDRATE INJECTION Page 6 of 59 There is an increased risk for slight QTcF interval prolongation above 10 ms (from baseline) for about 10 min.
4 Administration): - Elderly (age ≥65 years): all IV doses - Adults (age <65 years): IV doses >8 mg. g. at 4 and 8 hours). Cardiac side effects have been reported after subsequent dosing. The efficacy of Sandoz Ondansetron, Ondansetron Injection USP, and Ondansetron Hydrochloride Dihydrate Injection in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate 20 mg administered prior to chemotherapy.
The efficacy of twice daily dosage regimens for the treatment of post-chemotherapy emesis has been established only in adult patients receiving less emetogenic chemotherapy. The appropriateness of twice versus three times daily dosage regimens for other patient groups should be based on an assessment of the needs and responsiveness of the individual patient.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates o bserved in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Ondansetron has been administered to over 2500 patients worldwide in controlled clinical trials and has been well tolerated.
SANDOZ ONDANSETRON ONDANSETRON INJECTION USP ONDANSETRON HYDROCHLORIDE DIHYDRATE INJECTION Page 16 of 59 The most frequent adverse events reported in controlled clinical trials were headache (11%) and constipation (4%). Other adverse events include sensations of flushing or warmth (< 1%).
Cardiovascular:
There have been rare reports of tachycardia, angina (chest pain), bradycardia, hypotension, syncope and electrocardiographic alterations.
Central Nervous System:
There have been rare reports of seizures. 3%.
Dermatological:
Rash has occurred in approximately 1% of patients receiving ondansetron. g. blurred vision) have been reported during or shortly after intravenous administration of ondansetron, particularly at rates equal to or greater than 30 mg in 15 minutes.
Hepatic/ Biliary / Pancreatic There were transient increases of SGOT and SGPT of over twice the upper limit of normal in approximately 5% of patients. These increases did not appear to be related to dose or duration of therapy. There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics.
3 Pharmacokinetics, Geriatrics. Post-Operative Nausea and Vomiting Clinical experience in the use of ondansetron in the prevention and treatment of post-operative nausea and vomiting is limited; Sandoz Ondansetron, Ondansetron Injection USP and Ondansetron Hydrochloride Dihydrate Injection are not indicated for this use in the geriatric population.
SANDOZ ONDANSETRON ONDANSETRON INJECTION USP ONDANSETRON HYDROCHLORIDE DIHYDRATE INJECTION Page 5 of 59 2 CONTRAINDICATIONS Sandoz Ondansetron, Ondansetron Injection USP, and Ondansetron Hydrochloride Dihydrate Injection are contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.
1 Dosing Considerations Visually inspect IV solutions and discard if particulate matter or discolouration are observed. 4 Administration. Sandoz Ondansetron, Ondansetron Injection USP, and Ondansetron Hydrochloride Dihydrate Injection clearance is reduced in patients with moderate or severe hepatic impairme nt.
Their total daily dose should not exceed 8 mg, which may be given as a single intravenous or oral dose. See 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic. Sandoz Ondansetron, Ondansetron Injection USP, and Ondansetron Hydrochloride Dihydrate Injection have important cardiac side-effects dose-dependent QTc prolongation, coronary artery spasm, myocardial ischemia, and sequelae).
These effects are reported more often with intravenous administration, and are expected to be greater with a faster rate of infusion. 2 Pharmacodynamics, Electrocardiography. Though Sandoz Ondansetron, Ondansetron Injection USP, and Ondansetron Hydrochloride Dihydrate Injection efficacy and tolerance were similar for elderly compared to younger adults in chemotherapy clinical trials, exposure-response modelling predicted a greater effect on QTcF in patients ≥75 years of age compared to young adults.
Sandoz Ondansetron, Ondansetron Injection USP, and Ondansetron Hydrochloride Dihydrate Injection are contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 Dosing Considerations. 4 Administration), infused over 15 minutes, given 30 minutes before chemotherapy: o usually 8 mg. o maximum 16 mg. - Post-chemotherapy: o 4 hours and 8 hours after the initial dose: 8 mg IV, infused over 15 minutes.
o After the first 24 hours: 8 mg orally every 8 hours, for up to 5 days. 1 Dosing Considerations. Use in Adults: SANDOZ ONDANSETRON ONDANSETRON INJECTION USP ONDANSETRON HYDROCHLORIDE DIHYDRATE INJECTION Page 7 of 59 - Initial dose: o 8 mg orally, given 1-2 hours before chemotherapy.
4 Administration), infused over 15 minutes, given 30 minutes before chemotherapy. - After chemotherapy: doses of 8 mg orally, twice daily, for up to 5 days. Use in Children 4-12 years of age - Initial dose: 3 to 5 mg/m2 IV, infused over 15 minutes, at least 30 minutes before chemotherapy.
- After chemotherapy: 4 mg orally, every 8 hours. Use in Children <4 years of age Sandoz Ondansetron, Ondansetron Injection USP, and Ondansetron Hydrochloride Dihydrate Injection are not indicated for this use in this pediatric population.
3 Pharmacokinetics, Geriatrics. Elderly (65-74 years of age): - Initial IV dose: 8 mg or 16* mg, diluted, infused over 15 minutes. - May be followed by two IV doses of 8 mg, diluted, infused over 15 minutes, at least 4 hours apart. * When the initial dose is 16 mg, there is a predicted increase of the risk for a slight QTcF interval prolongation above 10 ms (from baseline) for about 10 min.
ECG monitoring may be considered. Elderly (>=75 years of age): - Initial IV dose: maximum 8 mg, diluted, infused over 15 minutes. - May be followed by two IV doses** of 8 mg, diluted, infused over 15 minutes, at least 4 hours apart. ** For the third dose, there is a predicted increase of the risk for a slight QTcF interval prolongation above 10 ms (from baseline) for about 10 min.
ECG monitoring may be considered. 1 Dosing Considerations. Use in Adults: SANDOZ ONDANSETRON ONDANSETRON INJECTION USP ONDANSETRON HYDROCHLORIDE DIHYDRATE INJECTION Page 8 of 59 - Initial dose: 8 mg orally, given 1 to 2 hours before radiotherapy.
- After radiotherapy: 8 mg orally, given every 8 hours, for up to 5 days after a course of treatment. Use in Children (<18 years of age): Sandoz Ondansetron, Ondansetron Injection USP, and Ondansetron Hydrochloride Dihydrate Injection are not indicated for this use in the pediatric population.
Use in Elderly […]
The etiology of the liver failure is unclear.
Hypersensitivity:
Rare cases of immediate hypersensitivity reactions sometimes severe, including anaphylaxis, bronchospasm, urticaria and angioedema have been reported.
Local Reactions:
Pain, redness and burning at the site of injection have been reported.
Metabolic:
There have been rare reports of hypokalaemia.
Other:
There have been reports of abdominal pain, weakness and xerostomia. 5 Post-Market Adverse Reactions Over 250 million patient treatment days of ondansetron have been supplied since the launch of the product worldwide. The following events have been spontaneously reported during post- approval use of ondansetron, although the link to ondansetron cannot always be clearly established.
The adverse event profiles in children and adolescents were comparable to that seen in ad ults. , laryngeal oedema, stridor, laryngospasm and cardiopulmonary arrest) have also been reported. 01%) of myocardial infarction, myocardial ischemia, angina, chest pain with or without ST segment depression, arrhythmias (including ventricular or supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), electrocardiographic alterations (including second degree heart block), palpitations and syncope.
Rarely and predominantly with intravenous ondansetron, transient ECG changes including QTc interval prolongation, Torsade de Pointes, ventricular fibrillation, coronary artery spasm, cardiac arrest, and sudden death have been reported (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Eye Disorder:
There have been very rare cases of transient blindness following ondansetron treatment, generally within the recommended dosing range and predominantly during intravenous administration. The majority of blindness cases reported resolved within 20 minutes.
Although most patients had received chemotherapeutic agents, including cisplatin a few cases of transient blindness occurred following ondansetron administration for the treatment of postoperative nausea or vomiting and in the absence of cisplatin treatment.
Some cases of transient blindness were reported as cortical in origin.
Hepatic/Biliary/Pancreatic:
Occasional asymptomatic increases in liver function tests have been reported. 1%) have been reported predominantly during or upon completion of IV infusion of ondansetron. g. ), movement disorders and dyskinesia have been reported without definitive evidence of persistent clinical sequelae.
Serotonin syndrome and neuroleptic malignant syndrome -like events have been reported with 5-HT3 receptor antagonist antiemetics, including ondansetron, when given in combination with other serotonergic and/or neuroleptic drugs (see 7 WARNINGS AND PRECAUTIONS, Neurologic).
Respiratory, Thoracic and Mediastinal Disorders:
There have also been rare reports of hiccups.
Skin and Subcutaneous Tissue Disorders:
Very rare reports have been received for bullous skin and mucosal reactions, including fatal cases. These reports include toxic skin eruptions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and have occurred in patients taking other medications that can be associated with bullous skin and mucosal reactions.
SANDOZ ONDANSETRON ONDANSETRON INJECTION USP ONDANSETRON HYDROCHLORIDE DIHYDRATE INJECTION Page 18 of 59
3 Pharmacokinetics, Geriatrics. Dosing considerations that reduce cardiac risks: - Use the minimum effective dose. - Use oral formulations if possible (lower Cmax). Intravenous dosing considerations: o Infuse slowly, over a minimum of 15 minutes.
o Maximum IV dose is 16 mg (adults). o Consider ECG monitoring if treating elderly patients with an IV dose of 16 mg. SANDOZ ONDANSETRON ONDANSETRON INJECTION USP ONDANSETRON HYDROCHLORIDE DIHYDRATE INJECTION Page 6 of 59 There is an increased risk for slight QTcF interval prolongation above 10 ms (from baseline) for about 10 min.
4 Administration): - Elderly (age ≥65 years): all IV doses - Adults (age <65 years): IV doses >8 mg. g. at 4 and 8 hours). Cardiac side effects have been reported after subsequent dosing. The efficacy of Sandoz Ondansetron, Ondansetron Injection USP, and Ondansetron Hydrochloride Dihydrate Injection in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate 20 mg administered prior to chemotherapy.
The efficacy of twice daily dosage regimens for the treatment of post-chemotherapy emesis has been established only in adult patients receiving less emetogenic chemotherapy. The appropriateness of twice versus three times daily dosage regimens for other patient groups should be based on an assessment of the needs and responsiveness of the individual patient.
1 Dosing Considerations. 4 Administration), infused over 15 minutes, given 30 minutes before chemotherapy: o usually 8 mg. o maximum 16 mg. - Post-chemotherapy: o 4 hours and 8 hours after the initial dose: 8 mg IV, infused over 15 minutes.
o After the first 24 hours: 8 mg orally every 8 hours, for up to 5 days. 1 Dosing Considerations. Use in Adults: SANDOZ ONDANSETRON ONDANSETRON INJECTION USP ONDANSETRON HYDROCHLORIDE DIHYDRATE INJECTION Page 7 of 59 - Initial dose: o 8 mg orally, given 1-2 hours before chemotherapy.
4 Administration), infused over 15 minutes, given 30 minutes before chemotherapy. - After chemotherapy: doses of 8 mg orally, twice daily, for up to 5 days. Use in Children 4-12 years of age - Initial dose: 3 to 5 mg/m2 IV, infused over 15 minutes, at least 30 minutes before chemotherapy.
- After chemotherapy: 4 mg orally, every 8 hours. Use in Children <4 years of age Sandoz Ondansetron, Ondansetron Injection USP, and Ondansetron Hydrochloride Dihydrate Injection are not indicated for this use in this pediatric population.
3 Pharmacokinetics, Geriatrics. Elderly (65-74 years of age): - Initial IV dose: 8 mg or 16* mg, diluted, infused over 15 minutes. - May be followed by two IV doses of 8 mg, diluted, infused over 15 minutes, at least 4 hours apart. * When the initial dose is 16 mg, there is a predicted increase of the risk for a slight QTcF interval prolongation above 10 ms (from […]
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