Expiration date: 08/2025
The composition and form of issue:
Solution for intravenous and intramuscular injection of 1 ml
ondansetron hydrochloride dihydrate (calculated as base) 2 mg
excipients: sodium chloride hydrochloric acid water for injections
in ampoules of 2 or 4 ml in a cardboard pack 1, 2 or 5 PCs.
Tablets, film-coated 1 tab.
ondansetron hydrochloride dihydrate (calculated as base) 4 mg
other ingredients: microcrystalline cellulose silicon dioxide colloidal (Aerosil) potato starch magnesium stearate
the shell: hydroxypropyl cellulose tween 80 (Polysorbate) tropeolin About castor oil
in a contour acheikova packing 10 PCs. in cardboard pack 1 pack, or in the banks dark glasses to 0.4 (4000) and 0.8 kg (8000 PCs).
Description pharmaceutical form:
Solution: colorless or nearly colorless transparent liquid.
Tablets: tablets, coated yellow.
Pharmacokinetics:
When the/m introduction Cmax in plasma achieved within 10 min after ingestion — after about 1.5 h the Distribution of ondansetron are equally in oral, in/m and/in the introduction. The absolute bioavailability is about 60%. The plasma protein binding is 70 to 76%. Metabolized in the liver. Urine in unaltered, less than 5% of the drug. After oral administration, and for parenteral administration, T1/2 is about 3 h, in elderly patients may reach 5 h, and in severe hepatic insufficiency — CH. 15-32 If the kidney damage (creatinine Cl <15 ml/min) T1/2 increasing to 4-5 h, but this increase has no clinical significance.
Description pharmacological action:
Selective receptor antagonist 5-HT3 (serotonin). Slow emergence of emetic effect through blockade of 5-HT3 receptors at the level of neurons, both Central and peripheral nervous system. Has anxiolytic activity, does not cause sedation, poor coordination of movement or reduction activity and health. Eliminates somatic and psychopathological symptoms in alcohol withdrawal syndrome.
Dosage:
INSTRUCTIONS for use of LATRAN (LATRANUM)
APPROVED:
Pharmacological state Committee of Ministry of health of the Russian Federation of 23 March 2000 in return
instructions, approved April 11, 6 Jul 1995 28 Mar 1996 29
July, 1998
Latran (ondansetron) — 9-methyl?3-(2-methyl?1H-imidazole?1-ylmethyl)?1,2,3,9-tetrahydrocarbazol?4
(N)-he hydrochloride dihydrate is a white or white with kremovatym
crystalline powder. In medical practice applied in the form solution for injection and tablets.
Pharmacological properties
Latran — antiemetic drug from the group of antagonists of serotonin. Pharmacodynamics. Selectively blocks 5-HT3 receptors Central and peripheral nervous system, including in neural centers that regulate the implementation of the gag reflex. The drug has anxiolytic activity, does not cause sedation, poor coordination of movement or reduction activity and health. Eliminates somatic and psychopathological symptoms in alcohol withdrawal syndrome mild and moderate severity.
Indications for use
Nausea and vomiting caused by rentgenology - or chemotherapy
anticancer drugs or ionizing radiation.
Prevention and treatment of vomiting in the postoperative period. Symptomatic
treatment of alcohol withdrawal syndrome (especially light and medium
severity).
Method of application and doses
Solution Latran 0.2% for injections administered in/in, tablets Latran is the inside. Adults solution Latran 0.2% of the initially administered once in/in the dose of 0,008–0,016 g for 15 min immediately before chemotherapy. After 2 hours begin to make tablets Latran orally in a dose of 0.008 g every 8 hours, but not more than 5 days. Children over 4 years of Latran solution of 0.2% administered once/in for 15 min immediately before chemotherapy at a dose determined at the rate of 0.005 g of the drug per 1 m2 of body surface of the child, then the pill Latran inside of 0.004 g every 8 hours, but not more than 5 days. When exposed to ionizing radiation the drug is taken orally at a dose of 0.008 g (2 table.) 1 hour before or immediately after radiation exposure. For the symptomatic treatment of alcohol withdrawal syndrome introduced in/drip in the dose of 0.008 g in the form of 0.2% solution in 400 ml gemodeza, glossolia or saline solution. If necessary, the re-introduction of the drug Latran.
Contraindications
Hypersensitivity, pregnancy, breastfeeding.
Side effects
CNS: headache, rarely — transient visual disturbances and dizziness (with the rapid on/in the introduction), involuntary movements.
From the side of cardiovascular system: chest pain, arrhythmia, bradycardia, hypotension.
From the digestive system: constipation, diarrhea, transient increase in transaminaz in the serum.
Allergic reactions: rare — bronchospasm, angioneurotic edema, urticaria in some cases — anaphylactic reactions.
Other: urinary retention, a feeling of warmth and rush of blood to the head and epigastric region.
Special instructions
When used in patients with mild and severe disorders of liver function is not recommended to exceed the dose 8 mg/day.
Interaction with other drugs
Due to the fact that ondansetron is metabolized in the liver by enzymes of the cytochrome P450 system, it is possible that concomitant use with drugs that are inducers or inhibitors of this enzyme system, change Cl and T1/2 of ondansetron.
Release form
A solution of 0.2% for injection in ampoules of 2 ml or 4 ml, 5 vials in a box of pills to 0,004 g, coated, 10 pieces in a contour acheikova packing, in carton 1 packing or in cans of 60 or 100 pieces, or in cans of 0.5 kg.
Storage conditions
Ampoules with a solution — in a dark place. Tablets in a dry, protected from light. List B.
Shelf life
3 years.
