OSETRON

Active material: Ondansetron
When ATH: A04AA01
CCF: Antiemetic drugs of the central action, blocking serotonin receptors
When CSF: 11.06.01
Manufacturer: DR. REDDY`S LABORATORIES LTD. (India)

Pharmaceutical form, composition and packaging

Solution for in / and the / m clear, colorless.

	1 ml	1 amp.
Ondansetron hydrochloride dihydrate	2.494 mg	4.988 mg,
that corresponds to the content of ondansetron	2 mg	4 mg

[Ring] citric acid monohydrate, sodium citrate, sodium chloride, water d / and.

2 мл – ампулы (2) – блистеры (1) – пачки картонные.
2 мл – ампулы (5) – блистеры (2) – пачки картонные.
2 мл – ампулы (5) – блистеры (10) – пачки картонные.

Solution for in / and the / m clear, colorless.

	1 ml	1 amp.
Ondansetron hydrochloride dihydrate	2.494 mg	9.976 mg,
that corresponds to the content of ondansetron	2 mg	8 mg

[Ring] citric acid monohydrate, sodium citrate, sodium chloride, water d / and.

4 мл – ампулы (2) – блистеры (1) – пачки картонные.
4 мл – ампулы (5) – блистеры (2) – пачки картонные.
4 мл – ампулы (5) – блистеры (10) – пачки картонные.

Pills, Film-coated white or nearly white, round, lenticular, с тиснением “Rx” на одной стороне и гладкой поверхностью на другой стороне.

	1 tab.
Ondansetron hydrochloride dihydrate	5 mg,
that corresponds to the content of ondansetron	4 mg

[Ring] corn starch, microcrystalline cellulose (Ultra-102), lactose, colloidal silicon dioxide, magnesium stearate.

4 PC. – стрипы (1) – пачки картонные.
10 PC. – стрипы (1) – пачки картонные.

Pills, Film-coated white or nearly white, round, lenticular, с тиснением “Rx” на одной стороне и гладкой поверхностью на другой стороне.

	1 tab.
Ondansetron hydrochloride dihydrate	9.976 mg,
that corresponds to the content of ondansetron	8 mg

[Ring] corn starch, microcrystalline cellulose (Ultra-102), lactose, colloidal silicon dioxide, magnesium stearate.

4 PC. – стрипы (1) – пачки картонные.
10 PC. – стрипы (1) – пачки картонные.

DESCRIPTION OF ACTIVE SUBSTANCES

Pharmacological action

Antiemetic. Effectively prevents and eliminates nausea and vomiting, occurring on a background of cancer chemotherapy or radiotherapy, and postoperatively. The mechanism of action is due to the ability to selectively block ondansetron serotonin 5-HT₃-receptors. It is believed, that of nausea and vomiting during the anticancer therapy plays an important role stimulation of afferent vagal fibers serotonin, released from the enterochromaffin cells of the gastrointestinal mucosa. Blocking the 5-HT₃-receptors, ondansetron prevents the occurrence of the gag reflex. Besides, Ondansetron inhibits the central units of the gag reflex, blocking the 5-HT₃-receptors bottom of the IV ventricle (The last area).

Pharmacokinetics

After oral administration, ondansetron is well absorbed from the gastrointestinal tract. Подвергается эффекту “первого прохождения” через печень. High protein binding (70-76%). Biotransformed in the liver, mainly by hydroxylation. Average T_1/2

in adult patients about 4 no. If abnormal liver function observed increase in T_1/2.

Testimony

Prevention of nausea and vomiting during chemotherapy antitumor- or radiotherapy; prevention and treatment of nausea and vomiting in the postoperative period.

Dosage regimen

Individual, depending on indications and treatment regimens.

Side effect

CNS: headache; редко – транзиторные нарушения зрения и головокружение (With the rapid on / in a), involuntary movements.

Cardio-vascular system: редко – боли в груди, Arrhythmia, bradycardia, hypotension.

From the digestive system: constipation, diarrhea, stomach ache, transient increase in serum transaminases.

Allergic reactions: редко – бронхоспазм, angioedema, hives; in some cases, anaphylactic reaction.

Other: a feeling of warmth and a rush of blood to the head, and the epigastrium.

Contraindications

I trimester of pregnancy, Hypersensitivity to ondansetron.

Pregnancy and lactation

Ondansetron is contraindicated for use in the I trimester of pregnancy. If necessary, use during lactation should stop breastfeeding.

Cautions

When applied in patients with moderate and severe hepatic impairment is not recommended to exceed the dose 8 mg / day.

With careful use of ondansetron in surgical interventions on the abdominal cavity, tk. its use may mask a progressive ileus.

Drug Interactions

Because, that ondansetron is metabolized by the liver enzyme cytochrome P450, perhaps, that while the use of drugs, are inducers or inhibitors of this enzyme system, change clearance and half-life of ondansetron.