Ondansetron 4mg Tablet, 30ct Bottle

Description

What is Ondansetron and how is it used?

Ondansetron (ondansetron hydrochloridc) Injection is an antiemetic (anti nausea and vomiting) used to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy). Ondansetron is available in generic form.

What are side effects of Ondansetron?

Common side effects of Ondansetron include:

• headache,
• fever,
• cold feeling,
• lightheadedness,
• dizziness,
• drowsiness,
• tiredness,
• diarrhea,
• constipation,
• itching,
• numbness,
• tingling, or
• injection site reactions (redness, pain, burning).

Tell your doctor if you have serious side effects of Ondansetron including:

• stomach pain,
• muscle stiffness or spasm, or
• vision changes (e.g., temporary loss of vision, blurred vision, uncontrollable eye movements).

INDICATIONS

Prevention Of Nausea And Vomiting Associated With Initial And Repeat Courses Of Emetogenic Cancer Chemotherapy

ONDANSETRON is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin [see Clinical Studies].

ONDANSETRON is approved for patients aged 6 months and older.

Prevention Of Postoperative Nausea And/Or Vomiting

Ondansetron is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Ondansetron and experience nausea and/or vomiting postoperatively, Ondansetron may be given to prevent further episodes

ONDANSETRON is approved for patients aged 1 month and older.

DOSAGE AND ADMINISTRATION

Prevention Of Nausea And Vomiting Associated With Initial And Repeat Courses Of Emetogenic Chemotherapy

Ondansetron should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

Adults

The recommended adult intravenous dosage of ONDANSETRON is three 0.15-mg/kg doses up to a maximum of 16 mg per dose. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ONDANSETRON.

Pediatrics

For pediatric patients aged 6 months through 18 years, the intravenous dosage of ONDANSETRON is three 0.15-mg/kg doses up to a maximum of 16 mg per dose The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ONDANSETRON. The drug should be infused intravenously over 15 minutes.

Prevention Of Postoperative Nausea And Vomiting

Ondansetron should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

Adults

The recommended adult intravenous dosage of ONDANSETRON is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg

ondansetron postoperatively does not provide additional control of nausea and vomiting.

Pediatrics

For pediatric patients aged 1 month through 12 years, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ONDANSETRON.

Stability And Handling

After dilution, do not use beyond 24 hours. Although Ondansetron is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

Ondansetron is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

Precaution

Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

Dosage Adjustment For Patients With Impaired Hepatic Function

In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients.

Storage: Store vials between 2° and 30°C (36° and 86°F). Protect from light.