Ondacap

Ondacap

ondansetron

Manufacturer:

Caprifarmindo

Marketer:

Caprifarmindo
Full Prescribing Info
Contents
Ondansetron.
Description
Each mL contains: Ondansetron Hydrochloride Dihydrate equivalent to Ondansetron 2 mg.
Action
Pharmacology: Ondansetron is a selective 5-HT3 receptor antagonist and competitively prevent or treat nausea and vomiting associated with cytotoxic chemotherapy and radiotherapy.
Indications/Uses
ONDACAP injection is indicated for the management of nausea and vomiting induced by chemotherapy, radiotherapy, and operation.
Dosage/Direction for Use
Treatment of Postoperative Nausea and Vomiting: ONDACAP Injection 4 mg as single dose by i.m. or slow i.v. injection.
Prevention of Nausea and Vomiting Associated with Chemotherapy and Radiotherapy: Adult: Highly emetogenic chemotherapy, such as Cisplatin. Initially administer ONDACAP Injection 8 mg i.v. slowly or given as infusion for 15 minutes immediately before the start of chemotherapy, followed by continuous infusion of Ondansetron 1 mg/hour for less than 24 hours or 2 of ONDACAP Injection 8 mg administered by i.v. slowly or as infusion for 15 minutes with time interval 4 hours. Also could be followed by 8 mg orally twice daily for less than 5 days.
Moderately Emetogenic Chemotherapy, such as Cyclosphamide. ONDACAP Injection 8 mg administered i.v. slowly or as infusion for 15 minutes immediately before the start of chemotherapy, followed by 8 mg orally twice daily for less than 5 days.
Children older than 4 years: 5 mg/m2 by i.v. over 15 minutes immediately prior to chemotherapy, followed by 4 mg orally every 12 Hours for up to 5 days.
Geriatric: ONDACAP is well tolerated by patients > 65 years and no need alterations of daily dose, frequency or route of administration.
Patient with Impaired Renal Function: No need alterations of daily dose, frequency or route of administration.
Patient with Impaired Hepatic Function: Total daily dose of 8 mg should not be exceeded.
Overdosage
There is no specific antidote.
Contraindications
Hypersensitivity to Ondansentron.
Special Precautions
It should not be used during pregnancy, particularly in the 1st semester, unless the potential benefit outweighs the potential risk.
Lactating mothers were suggested not to breastfeed.
Adverse Reactions
Headache, a sensation of flushing or warmth in the head and epigastrum, sedation, constipation and diarrhea.
Storage
Store below 30°C, away from light.
MIMS Class
Antiemetics / Supportive Care Therapy
ATC Classification
A04AA01 - ondansetron ; Belongs to the class of serotonin (5HT3) antagonists. Used for the prevention of nausea and vomiting.
Presentation/Packing
Form
Ondacap inj 2 mg/mL
Packing/Price
2 mL x 5 × 1's (Rp132,000/boks);4 mL x 5 × 1's (Rp210,500/boks)
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