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ondansetron orally disintegrating tablets, USP | Ondansetron

04:56 EDT 27th August 2014 | BioPortfolio

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IMAGE ondansetronod-str.jpg
Table 1. Pharmacokinetics in Normal Volunteers: Single 8 mg Ondansetron Hydrochloride Tablet Dose
Age-group
(years)
Mean Weight
(kg)
   n    
Peak Plasma
Concentration
(ng/mL)
Time of Peak
Plasma
Concentration
(h)
Mean Elimination
Half-life
(h)
Systemic
Plasma Clearance
L/h/kg
Absolute
Bioavaila-bility
18-40 M
69
6
26.2
2
3.1
0.403
0.483
F
62.7
5
42.7
1.7
3.5
0.354
0.663
 61-74 M
77.5
6
24.1
2.1
4.1
0.384
0.585
 F
60.2
6
52.4
1.9
4.9
0.255
0.643
≥75 M
78
5
37
2.2
4.5
0.277
0.619
F
67.6
6
46.1
2.1
6.2
0.249
0.747
Table 2. Pharmacokinetics in Normal Volunteers: Single 24 mg Ondansetron Hydrochloride Tablet Dose
Age-group
(years)
Mean Weight
(kg)
   n   
Peak Plasma
Concentration
(ng/mL)
Time of Peak
Plasma Concentration
(h)
Mean Elimination
Half-life
(h)
18-43 M
84.1
8
125.8
1.9
4.7
F
71.8
8
194.4
1.6
5.8
Table 3. Emetic Episodes: Treatment Response
* The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. An 8 mg ondansetron hydrochloride tablet was administered twice a day for 2 days after completion of chemotherapy.
Median undefined since at least 50% of the patients were withdrawn or had more than 2 emetic episodes.
Median undefined since at least 50% of patients did not have any emetic episodes.
 
Ondansetron
8 mg b.i.d.
Ondansetron
Hydrochloride Tablets*
Placebo
p Value
   Number of patients
33
34
   Treatment response
      0 Emetic episodes
20 (61%)
2 (6%)
<0.001
      1 to 2 Emetic episodes
6 (18%)
8 (24%)
   More than 2 emetic episodes/withdrawn
7 (21%)
24 (71%)
<0.001
   Median number of emetic episodes
0
Undefined
   Median time to first emetic episode (h)
Undefined
6.5
Table 4. Emetic Episodes: Treatment Response
* The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. An 8 mg ondansetron hydrochloride tablet was administered twice a day for 2 days after completion of chemotherapy.
The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. An 8 mg ondansetron hydrochloride tablet was administered 3 times a day for 2 days after completion of chemotherapy.
Median undefined since at least 50% of patients did not have any emetic episodes.
§ Visual analog scale assessment: 0 = no nausea, 100 = nausea as bad as it can be.
 
Ondansetron
8 mg b.i.d.
Ondansetron
Hydrochloride
Tablets*
8 mg t.i.d.
Ondansetron
Hydrochloride
Tablets
   Number of patients
165
171
   Treatment response
      0 Emetic episodes
101 (61%)
99 (58%)
      1 to 2 Emetic episodes
16 (10%)
17 (10%)
      More than 2 emetic episodes/withdrawn
48 (29%)
55 (32%)
   Median number of emetic episodes
0
0
   Median time to first emetic episode (h)
Undefined
Undefined
   Median nausea scores (0 to 100)§
6
6

 

Table 5. Principal Adverse Events in U.S. Trials: Single Day Therapy With 24 mg Ondansetron Hydrochloride Tablets (Highly Emetogenic Chemotherapy)
Event
Ondansetron
24 mg q.d.
n = 300
Ondansetron
8 mg b.i.d.
n = 124
Ondansetron
32 mg q.d.
n = 117
   Headache
33 (11%)
16 (13%)
17 (15%)
   Diarrhea
13 (4%)
9 (7%)
3 (3%)
Table 6. Principal Adverse Events in U.S. Trials: 3 Days of Therapy With 8 mg Ondansetron Hydrochloride Tablets (Moderately Emetogenic Chemotherapy)
Event
Ondansetron
8 mg b.i.d.
n = 242
Ondansetron
8 mg t.i.d.
n = 415
Placebo
n = 262
   Headache
58 (24%)
113 (27%)
34 (13%)
   Malaise/fatigue
32 (13%)
37 (9%)
6 (2%)
   Constipation
22 (9%)
26 (6%)
1 (<1%)
   Diarrhea
15 (6%)
16 (4%)
10 (4%)
   Dizziness
13 (5%)
18 (4%)
12 (5%)
Table 7. Frequency of Adverse Events From Controlled Studies With Ondansetron Hydrochloride Tablets (Postoperative Nausea and Vomiting)
Adverse Event
Ondansetron 16 mg
(n = 550)
Placebo
(n = 531)
   Wound problem
152 (28%)
162 (31%)
   Drowsiness/sedation
112 (20%)
122 (23%)
   Headache
49 (9%)
27 (5%)
   Hypoxia
49 (9%)
35 (7%)
   Pyrexia
45 (8%)
34 (6%)
   Dizziness
36 (7%)
34 (6%)
   Gynecological disorder
36 (7%)
33 (6%)
   Anxiety/agitation
33 (6%)
29 (5%)
   Bradycardia
32 (6%)
30 (6%)
   Shiver(s)
28 (5%)
30 (6%)
   Urinary retention
28 (5%)
18 (3%)
   Hypotension
27 (5%)
32 (6%)
   Pruritus
27 (5%)
20 (4%)
IMAGE ondansetronod-fig1.jpgIMAGE ondansetronod-fig2.jpg

Manufacturer

Greenstone LLC

Active Ingredients

Source

Drugs and Medications [84 Associated Drugs and Medications listed on BioPortfolio]

Ondansetron [Aurobindo Pharma Limited]

Ondansetron Oral Solution, USP

Ondansetron hydrochloride [Aurobindo Pharma Limited]

Ondansetron Tablets, USP

Ondansetron [Aurobindo Pharma Limited]

Ondansetron Orally Disintegrating Tablets, USP

Ondansetron [NorthStar Rx LLC]

Ondansetron hydrochloride [WOCKHARDT USA LLC]

PRESCRIBING INFORMATION ONDANSETRON INJECTION USP

Clinical Trials [154 Associated Clinical Trials listed on BioPortfolio]

A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults

This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.

Ondansetron vs Ondansetron Plus Dexamethasone for Relieving Intrathecal Morphine Side Effects After C-section

Background: Common adverse side effects related to the use of neuraxial opioids in the obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor antagonists, ...

Efficacy of Ondansetron in LARS Treatment

Patients will be randomized (1:1 ratio) to receive either 4 weeks of Ondansetron followed by 4 weeks of placebo (O-P sequence) or 4 weeks of placebo followed by 4 weeks of Ondansetron (P-O...

Antiemetic Effect of the Addition of Ondansetron to the Morphine Solution in Patient-Controlled Analgesia (PCA)

PCA morphine always introduces nausea and vomiting during the postoperative period. Ondansetron can reduce PONV (postoperative nausea vomiting). We, the researchers at Khon Kaen Universit...

Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?

This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron...

PubMed Articles [15 Associated PubMed Articles listed on BioPortfolio]

Ondansetron for Treatment of Nausea and Vomiting of Pregnancy and the Risk of Specific Birth Defects.

To use data from two large studies of birth defects to describe time trends in ondansetron use for the treatment of first-trimester nausea and vomiting of pregnancy and to investigate associations, ei...

Ondansetron does not prevent physical dependence in patients taking opioid medications chronically for pain control.

In this study, we investigated the co-administration of ondansetron with morphine, and whether it could prevent the development of physical dependence in patients taking opioids for the treatment of c...

Prevention of Shivering during Spinal Anesthesia: Comparison between Tramadol, Ketamine and Ondansetron.

Shivering is an unpleasant experience after spinal anesthesia. We conducted this study to evaluate the efficacy of ondansetron, ketamine and tramadol for prevention of shivering.

Association of anti-emetic efficacy of Ondansetron with 18792A>G polymorphism in a drug target gene 5-HT3B in Pakistani population.

To evaluate the association of anti-emetic efficacy of ondansetron with 18792A>G polymorphism in the target gene of 5-hydroxytryptamine type 3 subtype B.

Sterile Basics of Compounding: Relationship Between Syringe Size and Dosing Accuracy.

The purpose of this study was to investigate the accuracy and reproducibility of a 2-mL volume injection using a 3-mL and 10-mL syringe with pharmacy student compounders. An exercise was designed to a...

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