ZOFRAN INJECTION 2 MG/ML

GLAXOSMITHKLINE MANUFACTURING S.P.A - ITALYDELPHARM BOUCHERVILLE CANADA INC. (CANADA)🇸🇬 Health Sciences Authority

Approval Date: Oct 16, 1990
Approval ID: a38caccbc8c5ccc6
Company: GLAXOSMITHKLINE MANUFACTURING S.P.A - ITALYDELPHARM BOUCHERVILLE CANADA INC. (CANADA)
Type: Therapeutic

Approval Details

Approval Id: a38caccbc8c5ccc6
Drug Name: ZOFRAN INJECTION 2 MG/ML
Product Name: ZOFRAN INJECTION 2 MG/ML
Approval Number: SIN05135P
Approval Date: 1990-10-16
Registrant: SANDOZ SINGAPORE PTE. LTD.
Licence Holder: SANDOZ SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION
Dosage: DOSAGE REGIMEN AND ADMINISTRATION Dosing Regimen CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV and RINV) The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge. CINV and RINV in Adults The recommended intravenous (IV) or intramuscular (IM) dose of ZOFRAN is 8 mg administered immediately before treatment. For highly emetogenic chemotherapy, a maximum initial ondansetron dose of 16 mg IV infused over 15 minutes may be used. A single IV dose greater than 16 mg should not be given due to dose-dependent increase of QT prolongation risk (see sections WARNINGS AND PRECAUTIONS, ADVERSE DRUG REACTIONS, CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The efficacy of ZOFRAN in highly emetogenic chemotherapy may be enhanced by the addition of a single IV dose of dexamethasone sodium phosphate 20 mg, administered prior to chemotherapy. IV doses greater than 8 mg and up to a maximum of 16 mg must be diluted in 50 mL to 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection before administration and infused over not less than 15 minutes (see section PHARMACEUTICAL INFORMATION - Instructions for Use and Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). ZOFRAN doses of 8 mg or less, do not need to be diluted and may be administered as a slow IM or IV injection in not less than 30 seconds. The initial dose of ZOFRAN may be followed by 2 additional IV or IM doses of 8 mg by 2 to 4 hours apart, or by a constant infusion of 1 mg/h for up to 24 hours. Oral treatment is recommended to protect against delayed or prolonged emesis after the first 24 hours. CINV in Children and Adolescents (aged 2 years and over) In children with a body surface area of 0.6 to 1.2 m2 ondansetron is administered as a single IV dose of 5 mg/m2 immediately before chemotherapy, followed by 4 mg orally 12 hours later. 4 mg orally twice daily can be continued for up to five days after a course of treatment. CINV and RINV in Elderly In patients 65 to 74 years of age, the initial IV dose of ZOFRAN 8 mg or 16 mg, infused over 15 minutes, may be followed by 2 doses of 8 mg infused over 15 minutes and given no less than 4 hours apart. All IV doses should be diluted in 50–100 mL of saline or other compatible infusion fluid and infused over 15 minutes. In patients 75 years of age or older, the initial IV dose of ZOFRAN should not exceed 8 mg infused over 15 minutes. The initial dose of 8 mg may be followed by 2 doses of 8 mg, infused over 15 minutes and given no less than 4 hours apart (see section CLINICAL PHARMACOLOGY - Special Patient Populations, Elderly – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). All IV doses should be diluted in 50–100 mL of saline or other compatible infusion fluid and infused over 15 minutes. POST-OPERATIVE NAUSEA AND VOMITING PONV in Adults For prevention of post-operative nausea and vomiting, the recommended dose of ZOFRAN injection is a single dose of 4 mg by IM or slow IV injection administered at the induction of anaesthesia. For treatment of established post-operative nausea and vomiting a single dose of 4 mg given by IM or slow IV injection is recommended. PONV in Children and Adolescents (aged 2 years and over) For prevention and treatment of PONV in paediatric patients having surgery performed under general anaesthesia, ZOFRAN may be administered by slow IV injection (not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum of 4 mg either prior to, at or after induction of anaesthesia, or after surgery. There is limited data on the use of ZOFRAN in the prevention and treatment of PONV in children under 2 years of age. PONV in Elderly There is limited experience in the use of ZOFRAN in the prevention and treatment of post-operative nausea and vomiting in the elderly, however ZOFRAN is well tolerated in patients over 65 years receiving chemotherapy. Special populations Renal Impairment No alteration of daily dosage or frequency of dosing, or route of administration are required. Hepatic Impairment Clearance of ondansetron is significantly reduced and serum half-life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg IV or oral should not be exceeded. Patients with Poor Sparteine/Debrisoquine Metabolism The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing is required.
Route Of Administration: INTRAVENOUS, INTRAMUSCULAR
Indication Info: INDICATIONS Adults ZOFRAN injection is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. ZOFRAN is also indicated for the prevention and treatment of post-operative nausea and vomiting. Paediatric Population Injection and oral formulations: ZOFRAN is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy. No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; IV injection is recommended for this purpose.
Contraindications: CONTRAINDICATIONS Based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphine is contraindicated (see section INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hypersensitivity to any components of the preparation (see sections WARNINGS AND PRECAUTIONS and ADVERSE DRUG REACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: A04AA01
Atc Item Name: ondansetron
Pharma Manufacturer Name: SANDOZ SINGAPORE PTE. LTD.
Company Detail Path: /organization/sandoz-singapore-pte-ltd

Active Ingredients

ONDANSETRON HYDROCHLORIDE DIHYDRATE EQV ONDANSETRON

2 mg/mL

ONDANSETRON HYDROCHLORIDE DIHYDRATE EQV ONDANSETRON

2 mg/mL

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 16, 1990

Approval ID

a38caccbc8c5ccc6

Type

Therapeutic

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