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Lametic FC Tablet

Category
Supplements

Composition :
Lametic®  Film-coated tablet :
Each film-coated tablet contains Ondansetron hydrochloride dihydrate 10 mg equivalent to Ondansetron 8 mg.

Pharmacology :
Ondansetron is a 5HT3 reseptor antagonist which acts selectively and competitively in the control and prevention of nausea and vomiting induced by cytostatic drug and radiotherapy.

Indication :
Management of nausea and vomiting induced by chemotherapy and radiotherapy also surgery.

Dosage and Administration :
Prevention and treatment of postoperative nausea and vomiting :
a. 4 mg / i.m. as a single dose or slow injection i.v., or
b. 8 mg orally an hour before anaesthesia followed by 8 mg orally at 8 hours intervals.
c. 8 mg by mouth an hour before anaesthesia followed by 2 further doses of 8 mg at 8-hour intervals.
Prevent nausea and vomiting induced by chemotherapy :
a. Adults

  • Highly emetogenic chemotherapy, eg regimens containing cisplatin. Initially, ondansetron may be given as slow i.v. injection or 15-minutes infusion of 8 mg immediatelly before chemotherapy, followed by a continuous i.v. infusion of 1 mg/hour for up to 24 hours or by a further 2 doses of 8 mg, given by slow i.v. injection or 15-minutes infusion 4 hours apart. Either regimens is then followed by 8 mg orally 2 times daily for up to 5 days.
  • Less emetogenic chemotherapy, eg regimens containing cyclophosphamide, doxorubicin, carboplatin. Ondansetron may be given by as a slow i.v. injection or 15-minutes infusion of 8 mg, immediatelly before chemotherapy or 8 mg orally1-2 hours before chemotherapy, followed by 8 mg orally 2 times daily  for up to 5 days.
  • Nausea and vomiting due to radiotherapy. Tablet 8 mg, 3 times / day starting 1-2 hours before radiotherapy. Duration of treatment depends on the length of radiotherapy.

b. Children > 4 years

5 mg/m2 i.v. over 15 minutes immediatelly before chemotherapy, followed by oral therapy at doses of 4 mg every 12 hours for up to 5 days.

c. Elderly

Ondansetron was well tolerated in patients over 65 years and so no need to alter dosage, frequency or route of administration.

d. Patients with renal impairment

No need to alter daily dosage, frequency or route of administration.

e. Patients with hepatic impairment

The clearance of ondansetron was significantly reduced and serum half-life was significantly increased in patients with impaired liver function were moderate or severe. In some patients a the total daily dosage is not more than 8 mg.

Contraindications :
Hypersensitivity to ondansetron.

Precaution and Warnings :

  • Ondansetron should not be used during pregnancy, especially during 1st semester, unless the expected benefit to the patient is thought to outweigh any possible risk to the fetus.
  • It is recommended that mothers receiving ondansetron should not breastfeed their babies.


Side Effects :
Side effects that usually occur are headache, flushing or a warm sensation in the head and epigastrium. Side effects are rare and are usually temporary increase in the asymptomatic aminotransferase. Ondansetron can also increase the transit time of the colon and can cause constipation in some people. There are several reports of hypersensitivity reactions fast.

Overdosage :
There is no specific antidote.  Side effects were mild at doses of 84-145 mg i.v.

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