COMPOSITION
Each film coated tablet contains
Ondansetron Hydrochloride USP eqv. to
Ondansetron 4mg
VOMICARE KID
Each dispersible tablet contains:
Ondansetron Hydrochloride USP eqv. to
Ondansetron 2mg
DESCRIPTION
It is the prototype of anew class of antiemetic drugs developed to
control cancer chemotherapy/radiotherapy induced vomiting and later found to be
highly effective in postoperative nausea and vomiting as well.
MECHNISM OF ACTION
Vomicare blocks the action of 5-HT through 5-HT3 receptors on
vagal afferents in the G.I.T. as well as in NTS and CTZ. Cytotoxic
drugs/radiation produces Nausea and vomiting by causing cellular damage. This
release mediators including 5-HT from intestinal mucosa which then causes
activation of vagal afferents in the gut. This sends the emetogenic impulses to
the NTS and CTZ causing Vomiting centre to induce vomit.
PHARMACOKINETICS
Vomicare is well absorbed from the gastrointestinal tract and undergoes
some first-pass metabolism. The absolute bioavailability is about 60%. It is
extensively distributed in the body; results in vitro suggest that about 70 to
75 % of the drug in plasma is protein bound. Bioavailability is slightly
enhance by food but is unaffected by antacids. It is cleared from the
systematic circulation by hepatic metabolism, and about 5% of the unchanged
drug excreted from the urine. The terminal elimination half life is about 3 hrs
in younger subjects; prolonged to 5 hrs in elderly. These differences are not
considered sufficient to warrant dose adjustments. However in patients with
severe hepatic impairment, to whom bioavailability may reach 100% and clearance
is markedly slowed, with elimination half-life of 15-32 hrs, dosage reduction
is advisable.
DOSAGE AND ADMINISTRATION
Vomicare is a highly selective 5-HT receptor antagonist with potent
antiemetic activity. It is use in the management of nausea and vomiting induced
by cytotoxic chemotherapy and radiotherapy, particularly when there is severe
or unresponsive to other therapy men.
Prevention of Nausea &
vomiting associated with highly emetogenic cancer therapy
The recommended adult oral dose of Vomicare is single 24mg (three 8mg
tablets) administered 30 mins before the start of single day highly emetogenic
chemotherapy, including ciplastin.
Geriatric Use: The recommended
dosage is same as for the general population.
Prevention of Nausea &
vomiting associated with moderate emetogenic cancer therapy:
The recommended adult oral dose is 8mg Vomicare tablet given twice a
day. The first dose should be administered 30 mins before the start of
emetogenic chemotherapy, with the subsequent dose 8hrs after the dose. One 8mg
of Vomicare should be administered twice a day (every 12hrs) for 1-2 days after
the completion of chemotherapy.
Paediatric use: For paediatric
patients 12 yrs of age and older, the dosage is the same as for adults. For
paediatric patients 4 to 11 yrs of age, the dosage is one 4mg Vomicare tablet
given three times a day. The first dose should be administered 30 mins before
the start of emetogenic chemotherapy, with the subsequent dose 4 and 8 hrs
after the first dose. One 4mg Vomicare tablets should be administered 3 times a
day (every 8 hrs)for 1- 2 days after the completion of chemotherapy.
Geriatric use: The recommended
dosage is same as for general population.
Prevention of Nausea &
vomiting associated with radiotherapy:
The recommended adult oral dose is 8mg vomicare tablet given three times
a day to be given 1-2 hours before the therapy.
Geriatric use: The recommended
dosage is same as for the general population.
Postoperative Nausea and
Vomiting:
The recommended dose is 16mg given as two 8mg Vomicare tablet or four
Vomicare tablet 1 hr before administration of anesthesia.
Dosage Adjustment for patients
with impaired renal function: The recommended dose is same for the general
population.
Dosage Adjustment for the
patients with hepatic function: In patients with severe hepatic impairment
clearance is reduced and apparent volume of distribution is increased with a
resultant increase in plasma half-life. In such patients, a total daily dose of
8mg should not be exceeded.
CONTRAINDIACTION:
Vomicare is contraindicated for patients known to have hypersensitivity
to Ondansetron Hydrochloride
SAFETY PROFILE
No dosage adjustment is required for Vomicare taking Phenytioin,
carbamazepine, Rifamicin as these drugs hasten the metabolism of other drugs.
Carcinogenesis, mutagenesis and
impairment of fertility:
Carcinogenic effects were not seen in 2 yrs studies in rats and mice
with dose up to 10 and 30 mg/kg/day, respectively. Ondansetron was not
mutagenic in standard tests for mutagenicty. Oral administration of Ondansetron
upto 15 mg/kg/day did not affect the fertility or general reproductive
performance of male and female rats.
Pregnancy: Teratogenicity:
Studies have been performed in pregnant rats and rabbits at daily oral
dose up to 15 and 30mg /kg/day, respectively and have revealed no evidence of
impaired fertility or harm to the fetus. There are however, no adequate and
well control tests carried out in pregnant women, the drug, should therefore be
used in pregnancy if clearly indicated.
Nursing Mothers:
Ondansetron is excreted in breast milk of rats. It is not known whether
Ondansetron is excreted in human milk, caution should be exercised when
ondansetron is administered to a nursing women.
Paediatric use:
Little information is available about dosage in pediatric patients 4 yrs
of age or younger.
Geriatric Use:
Of the total number of subjects enrolled in the cancer chemotherapy
induced and post operative nausea and vomiting clinical trials, no over all
differences in the safety and effectiveness were observed in young and
geriatric (over 65 yrs) subjects. Dose adjustment in not needed in patients
over the age of 65 yrs.
ADVERSE REACTION:
Flusing, rare case of hypersensitivity, angioedema, bronchospasm,
shortness of breath, hypotension, urticaria are some of the side effects
observed.
