Ondimax Md

Ondimax Md Tablet

Ondimax Md is a selective 5-HT3 receptor antagonist. While its mechanism of action has not been fully characterized, ondansetron is not a dopamine-receptor antagonist. Serotonin receptors of the 5-HT3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. It is not certain whether ondansetron's antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine.

Uses

Ondimax Md is used for: 

  • Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy
  • Prevention of nausea and vomiting associated with radiotherapy
  • Prevention of post operative nausea and vomiting

Ondimax Md is also used to associated treatment for these conditions: Chemotherapy-Induced Nausea and Vomiting (CINV), Cholestatic pruritus, Post Operative Nausea and Vomiting (PONV), Uremic Pruritus, Radiation therapy induced nausea and vomiting, Severe Hyperemesis gravidarum

Ondimax Md

Trade Name Ondimax Md
Generic Ondansetron
Ondansetron Other Names Ondansetron
Type Tablet
Formula C18H19N3O
Weight Average: 293.363
Monoisotopic: 293.152812245
Protein binding

The plasma protein binding associated with ondansetron was documented as approximately 73% .

Therapeutic Class Anti-emetic drugs
Manufacturer Universal Biogenics
Available Country India
Last Updated: June 23, 2021 at 9:00 am

Structure

Ondimax Md
Ondansetron Structure

Dosage

Ondimax Md dosage

Prevention of chemotherapy induced nausea & vomiting (CINV):

Adult- 

  • Tablet and oral solution: The recommended adult oral dosage of Ondimax Md is 24 mg given as three 8 mg tablets in highly emetogenic chemotherapy. In case of moderately emetogenic chemotherapy the oral dose is one 8 mg Ondimax Md tablet or 10 ml of Ondimax Md oral solution given twice daily.
  • Injection: The recommended i.v. dose of Ondimax Md is a single 32 mg dose or three 0.15 mg/kg doses. A single 32 mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of Ondimax Md.
  • Suppository: The recommended adult dose is one 16 mg suppository 1-2 hours before treatment. Ondimax Md should be continued for upto 5 days after a course of treatment.The recommended dose is one suppository daily.

Pediatric patients- 

  • Tablet and oral solution: for pediatric patients 4 through 11 years of age the dosage is one 4 mg Ondimax Md tablet or 5ml of Ondimax Md solution should be administered 3 times a day for 1 to 2 days after completion of chemotherapy.
  • Injection: the dosage in pediatric patients 4 to 18 years of age should three 0.15-mg/kg doses.
  • Suppository:Not recommended.

Radiotherapy induced nausea and vomiting:

Adult- 

  • Tablet and oral solution: the recommended oral dosage is one 8mg Ondimax Md tablet or 10ml of Ondimax Md oral solution given 3 times daily.

Post operative nausea & vomiting (PONV):

Adult- 

  • Tablet and oral solution: The recommended dosage is 16 mg given as two 8 mg Ondimax Md tablets or 20 ml of Ondimax Md oral solution 1hour before induction of anesthesia.
  • Injection: The recommended I.V. dosage of Ondimax Md for adults 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 experiences nausea and/or vomiting occurring shortly after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, I.V. dose of Ondimax Md 4 mg, administration of a second I.V. dose of 4 mg Ondimax Md postoperatively does not provide additional control of nausea and vomiting.
  • Suppository: The recommended adult dose is one 16 mg suppository 1-2 hours before treatment. Ondimax Md should be continued for upto 5 days after a course of treatment.The recommended dose is one suppository daily.

Pediatric patients- 

  • Injection: The recommended I.V. dosage of Ondimax Md for pediatric patients (2 to 12 years of age) is a single 0.1-mg/kg dose for pediatric patients weighing 40 kg or less, or a single 4 mg dose for pediatric patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes. Little information is available about dosage in pediatric patients younger than 2 years of age.
  • Suppository: Not recommended.

Prior to IV infusion, dilute in 50 ml dextrose 5% inj or normal saline.

Side Effects

The most common adverse effects include headache, constipation, diarrhea. In chemotherapy induced nausea and vomiting rash has occurred in approximately 1% of patients receiving Ondimax Md. Blurred vision, chest pain with or without ST segment depression, cardiac arrhythmias, hypotension and bradycardia have been rarely reported.

Precaution

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other 5-HT3 receptor antagonists. Ondimax Md is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondimax Md in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

Interaction

In patients treated with potent inducers of CYP3A4 (i.e Phenytoin, Carbamazepine or Rifampicin), the oral clearance of Ondimax Md was increased and Ondimax Md blood concentrations were decreased. Data from small studies indicate that Ondimax Md may reduce the analgesic effect of tramadol.

Food Interaction

  • Take with or without food. The absorption is unaffected by food.

Volume of Distribution

The volume of distribution of ondansetron has been recorded as being approximately 160L .

Half Life

The half-life of ondansetron after either an 8 mg oral dose or intravenous dose was approximately 3-4 hours and could be extended to 6-8 hours in the elderly .

Clearance

The clearance values determined for ondansetron in various patient age groups were recorded as approximately 0.38 L/h/kg in normal adult volunteers aged 19-40 yrs, 0.32 L/h/kg in normal adult volunteers aged 61-74 yrs, 0.26 L/h/kg in normal adult volunteers aged >=75 yrs .

Pregnancy & Breastfeeding use

In pregnancy: Pregnancy category B. Reproduction studies at daily oral dose up to 10 and 30 mg/kg/day have been performed in animals and have revealed no evidence of impaired fertility harm to the fetus due to Ondimax Md. There are, however, no adequate and well-controlled studies in pregnant women. So the drug should be used in pregnancy only if clearly needed.

In lactation: Ondimax Md excretes in milk of lactating animals. Caution should be exercised when Ondimax Md is administered to nursing mother.

Contraindication

Ondimax Md is contraindicated in patients with known hypersensitivity to the drug.

Special Warning

Pediatric use: Can be given in children 1 month of age and above. 

Geriatric use: No dosage adjustment is necessary in the elderly.Dosage adjustment for patients with impaired hepatic function:

  • Tablet and Oral Solution: The total daily dose of 8 mg should not be exceeded.
  • Injection: A single maximal dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
  • Suppository: Not recommended

Acute Overdose

There is no specific antidote for Ondimax Md overdose. In addition to the adverse events, hypotension (and faintness) occurred in a patient that took 48 mg of AVONA tablets. In all instances, the events resolved completely.

Storage Condition

Store in a cool and dry place, protected from light and moisture. For suppository- Store below 25º c.

Innovators Monograph

Ondimax Md contains Ondansetron see full prescribing information from innovator // generic/ondansetron/ondansetron-suppositories-prescribing-information" Monograph