As a precaution, it is recommended that patients younger than 4 months receiving this drug be closely monitored [see Clinical Pharmacology No overall differences in safety or effectiveness were observed between subjects 65 years and older and younger subjects. A reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see Clinical Pharmacology There were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment is not needed in patients over the age of Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ondansetron. Rare cases of hypersensitivity reactions, sometimes severe e. A positive lymphocyte transformation test to ondansetron has been reported, which suggests immunologic sensitivity to ondansetron.
Hepatobiliary Liver enzyme abnormalities have been reported. Liver failure and death have been reported in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics.
Local Reactions Pain, redness, and burning at site of injection. Neurological Oculogyric crisis, appearing alone, as well as with other dystonic reactions. Transient dizziness during or shortly after intravenous infusion. Skin Urticaria , Stevens-Johnson syndrome , and toxic epidermal necrolysis.
Eye Disorders Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours.
Transient blurred vision, in some cases associated with abnormalities of accommodation , have also been reported. On the basis of limited available data, no dosage adjustment is recommended for patients on these drugs. Tramadol Although there are no data on pharmacokinetic drug interactions between ondansetron and tramadol, data from two small trials indicate that concomitant use of ondansetron may result in reduced analgesic activity of tramadol. In parenteral preparations, it is used to prepare isotonic solutions.
It is soluble in water 1 g in 2. H2O occurs as colorless or translucent crystals or as a white, crystalline, efflorescent powder that is odorless and has a strong, tart, acidic taste. The hydrated form may contain up to 8. One g is soluble in less than 1 mL of water and 1. The hydrous form is freely soluble in water 1 g in 1. Water for Injection is water that has been purified by distillation or reverse osmosis and contains no added substances. When the vial is stored upright after first use, clumps may occasionally form on the top of the vial.
Check the vial and the vial top carefully for particles. If particles are present, shake the vial to re-dissolve the particles. If any particles remain after the vial is shaken, do not use the liquid. Ondansetron injection should be clear and colorless. If you are using the premixed bags, after removing the bag from the outer wrapper, check for small leaks by squeezing the container firmly.
Transient blurred vision, in some cases associated with abnormalities of accommodation, have also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center. The background risk of major birth defects and miscarriage for the indicated population 4mg unknown. However, it has been demonstrated that ondansetron is present in the milk of rats. Hepatobiliary Liver enzyme abnormalities have been ondansetron. It is unknown whether hcl exposure in utero in the cases of cleft palate occurred during the time of palate formation the palate is formed between the 6th and 9th weeks of pregnancy or whether mothers of infants with cleft palate used other medications or had other risk factors for cleft palate in the offspring, ondansetron hcl 4mg injection. If a sterility-testing program is in place, a beyond-use date of up to 6 months may be used for this preparation. A reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see Clinical Pharmacology As a precaution, it is recommended that patients younger than 4 months receiving this drug be closely monitored. Elderly There is limited experience in the use of ondansetron in the prevention and treatment of PONV in the elderly, however ondansetron is well tolerated in patients over 65 years receiving chemotherapy. However, this effect may simply be due to the agent being used more frequently in people who injection with more severe illness. It works by blocking one of the body's natural substances serotonin that causes vomiting, ondansetron hcl 4mg injection. The comparative efficacy of these two different dosing regimens has not been investigated in clinical trials.
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