| SEROD
Tegaserod
Composition:
Each tablet contains Tegaserod Maleate INN equivalent
to Tegaserod 6 mg.
Pharmacology:
Tegaserod is a selective and partial agonist
for the serotonin type-4 (5-HT4)
receptors. By mimicking the action of endogenous serotonin at
the 5-HT4 receptor site,
tegaserod increases contractility and stimulates the peristaltic
reflex in the upper and lower gastrointestinal (GI) tract.
Following oral administration, tegaserod undergoes
hydrolysis in the gut, producing the major acid glucuronidated
metabolite. Tegaserod and acid metabolite are then absorbed
and undergo glucuronidation metabolism in the liver. The half-life
is reported to be 11 hours. Administration with food reduces
the AUC by ≈ 50%, primarily because of a reduction in
the extent, rather than the rate, of absorption.
Indications:
Tegaserod is indicated for the treatment of constipation
predominant irritable bowel syndrome whose main symptoms are
constipation and abdominal pain and/or discomfort.
Dosage & Administration:
One tablet twice daily orally before meal for
a maximum of 12 weeks. Treatment should be discontinued if there
has been no response after 4 weeks.
Contraindications:
Tegaserod is not recommended in patients with
severe renal or hepatic impairment. It is also contraindicated
in patients with hypersensitivity to tegaserod or any excipient
of this formulation.
Side-effects:
Generally well tolerated but some patients may
experience diarrhoea which is transient and resolves during
continued treatment without any need for dose modification.
Less frequent side effects are headache, abdominal pain, nausea,
flatulence, dizziness, back pain etc.
Use in pregnancy:
In view of limited experience in humans, use
of tegaserod during pregnancy is not recommended.
Use in nursing mother:
It is not known whether tegaserod is excreted
in human milk. Therefore, tegaserod should not be prescribed
to women who are breast-feeding.
Use in children:
The safety and effectiveness of tegaserod in
children have not been established and use in this age group
is not recommended.
Drug Interaction:
During clinical studies with tegaserod, no drug-drug
interaction was reported.
Packing:
Box containing 3×10’s tablets in blister pack. |
