ZOFRAN TABLET 8 MG

ASPEN BAD OLDESLOE GMBH (GERMANY)🇸🇬 Health Sciences Authority

Approval Date: Oct 16, 1990
Approval ID: 49d7010f24b625e4
Company: ASPEN BAD OLDESLOE GMBH (GERMANY)
Type: Therapeutic

Approval Details

Approval Id: 49d7010f24b625e4
Drug Name: ZOFRAN TABLET 8 MG
Product Name: ZOFRAN TABLET 8 MG
Approval Number: SIN05133P
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: TABLET, FILM COATED
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. Adults EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY The recommended oral dose is 8 mg taken 1 to 2 hours before chemotherapy or radiation treatment, followed by 8 mg orally every 12 hours later for a maximum of 5 days. To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ZOFRAN should be continued for up to 5 days after a course of treatment. The recommended oral dose is 8 mg to be taken twice daily. HIGHLY EMETOGENIC CHEMOTHERAPY e.g. high-dose cisplatin ZOFRAN can be given by oral, intravenous (IV), or intramuscular (IM) administration. ZOFRAN has been shown to be equally effective in the following dose schedules over the first 24 hours of chemotherapy: <ul> <li>A single dose of 8 mg by slow intravenous injection immediately before chemotherapy.</li> <li>A dose of 8 mg by slow intravenous injection immediately before chemotherapy, followed by two further intravenous dose of 8 mg two to four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours. Doses of greater than 8 mg up to 16 mg of ZOFRAN may only be given by IV infusion diluted in 50–100 ml of saline or other compatible infusion fluid and infused over not less than 15 minutes immediately before chemotherapy. A single dose greater than 16 mg should not be given due to dose-dependent increase of QT-prolongation risk (see Warnings and Precautions, Adverse Reactions, Pharmacodynamic Effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> </ul> The efficacy of ZOFRAN 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. To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ZOFRAN should be continued for up to 5 days after a course of treatment. The recommended oral dose is 8 mg to be taken twice daily. 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 i.v. 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 5 days after a course of treatment. CINV and RINV in Elderly No alteration of oral dose, or frequency of administration is required. POST-OPERATIVE NAUSEA AND VOMITING (PONV) PONV in Adults For prevention of post-operative nausea and vomiting, the recommended oral dose is 16 mg given 1 hour prior to anesthesia. For treatment of established post-operative nausea and vomiting, ZOFRAN administration by injection is recommended. PONV in Children and Adolescents (aged 2 years and over) No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; slow IV injection (not less than 30 seconds) is recommended for this purpose. 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. Methods of administration The tablets should be swallowed whole with liquid.
Route Of Administration: ORAL
Indication Info: INDICATIONS Adults ZOFRAN oral formulations are indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. ZOFRAN is also indicated for the prevention of post-operative nausea and vomiting. Paediatric Population 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 component 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.

Active Ingredients

ONDANSETRON HCl DIHYDRATE EQV ONDANSETRON

8 mg

ONDANSETRON HCl DIHYDRATE EQV ONDANSETRON

8 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 16, 1990

Approval ID

49d7010f24b625e4

Type

Therapeutic

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