Ramos 2.5 mcg

INDICATIONS

Ramosetron Hydrochloride is indicated for Diarrhea-predominant irritable bowel syndrome.

PHARMACOLOGY

Ramosetron Hydrochloride is a serotonin 5-HT3 receptor antagonist. Serotonin is a member of neurotransmitter which is greatly related to gastrointestinal motility, secretion and sensation. Stress may stimulate the serotonin release and activate the 5-HT3 receptors on enteric nerve, which induces the acceleration of intestinal transit resulting in diarrhea. In addition, the increase in intracolonic pressure also induces serotonin release, and it will bind to 5-HT3 receptor at the terminal of afferent neuron, causing intestinal nociceptive transmission to central nervous system. Ramosetron Hydrochloride improves abnormal defecation associated with the acceleration of intestinal transit by inhibiting 5-HT3 receptor selectively. It also improves visceral hypersensitivity by suppressing the transmission of intestinal nociception. Ramosetron Hydrochloride improves diarrhea by exerting an opposing effect on serotonin 5-HT3 receptors on the efferent nerves. It also improves abdominal pain by exerting an opposing effect on serotonin 5-HT3 receptors on the afferent nerves. Carcinostatics drugs such as cisplatin cause enterochromaffin cells in the gastrointestinal tract to release serotonin. The released serotonin binds to 5-HT3 receptors present in the afferent vagal nerve-endings in the gastrointestinal mucosa, and the stimulation that is evoked induces emesis via the vomiting center. Ramosetron Hydrochloride is considered to exert its antiemetic action by blocking 5-HT3 receptors.

DOSAGE & ADMINISTRATION

Male patients with diarrhea-predominant irritable bowel syndrome: The usual dose for male adults is 5 mcg of Ramosetron Hydrochloride, administered once daily orally. The dose may be adjusted according to the patients' clinical condition. The daily dose should not exceed 10 mcg. Female patients with diarrhea-predominant irritable bowel syndrome: The usual dose for female adults is 2.5 mcg of Ramosetron Hydrochloride, administered once daily orally. The dose may be increased for patients who do not adequately respond to the initial dose. The daily dose should not exceed 5 mcg.

INTERACTION

Ramosetron Hydrochloride may interact with anti-depressants (fluvoxamine), diuretics (bumetanide), anti-psychotics, tricyclic anti-depressants, anti-cholinergic, opioid narcotics, and phenothiazine drugs.

SIDE EFFECTS

The most commonly reported adverse reactions include constipation and hardened stool. The other important adverse effects are facial pallor, cold sweat, dizziness on standing up, sudden abdominal pain, bloody stool, fever.

PREGNANCY & LACTATION

Ramosetron Hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Ramosetron Hydrochloride is administered to nursing mothers.

PRECAUTIONS & WARNINGS

Should be used with caution in patients with constipation due to the increased risk of worsening of the patient's condition. Appropriate corrective measures, dose adjustments, or replacement with a suitable alternative may be necessary in some cases.Should be used with caution in patients with liver diseases due to the increased risk of adverse effects. Regular monitoring of liver function tests is necessary for such patients. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.Should be used with caution in patients with kidney diseases due to the increased risk of adverse effects. Regular monitoring of kidney function tests is necessary for such patients. Appropriate dose adjustments or replacement with a suitable alternative maybe required in some cases based on the clinical condition.

USE IN SPECIAL POPULATIONS

Safety of Ramosetron Hydrochloride in newborns, infants and children has not been established.

THERAPEUTIC CLASS

Drugs for Irritable Bowel Syndrome

STORAGE CONDITIONS

Do not store above 30°C temperature. Keep away from light and wet place. Keep out of reach of children.