Latran solution for intravenous and intramuscular administration 2 mg/ml 4 ml ampoules 5 pcs. in Moscow
INSTRUCTIONS for using LATRANUM
APPROVED:
Pharmacological State Committee of the Ministry of Health of the Russian Federation on March 23, 2000 in return
instructions approved on April 11, July 6, 1995, March 28, 1996, 29
July 1998
Latran (ondansetron) - 9-methyl-3-(2-methyl-1H-imidazol-1-ylmethyl)-1,2,3,9-tetrahydrocarbazole-4
(H)-one hydrochloride dihydrate - white or off-white
crystalline powder. In medical practice it is used in the form of an injection solution and tablets.
Pharmacological properties
Latran is an antiemetic from the group of serotonin antagonists. Pharmacodynamics.
Selectively blocks 5-HT3 receptors of the central and peripheral nervous system, incl. in the neural centers that regulate the implementation of gag reflexes. The drug has anxiolytic activity and does not cause sedation, impaired coordination of movements or decreased activity and performance. Eliminates somatic and psychopathological symptoms of mild to moderate alcohol withdrawal syndrome.
Indications for use
Nausea and vomiting caused by X-ray or chemotherapy
antitumor drugs or exposure to ionizing radiation.
Prevention and treatment of vomiting in the postoperative period. Symptomatic
treatment of alcohol withdrawal syndrome (especially mild and moderate
degree of severity).
Directions for use and doses
Latran solution 0.2% for injection is administered intravenously, Latran tablets are taken orally. For adults, Latran solution 0.2% is first administered once intravenously at a dose of 0.008–0.016 g over 15 minutes immediately before chemotherapy. After 2 hours, start taking Latran tablets orally in a single dose of 0.008 g every 8 hours, but not more than 5 days. For children over 4 years of age, Latran solution 0.2% is administered once intravenously for 15 minutes immediately before chemotherapy at a dose determined at the rate of 0.005 g of the drug per 1 m2 of the child’s body surface, after which Latran tablets are taken orally at 0.004 g every 8 h, but not more than 5 days. When exposed to ionizing radiation, the drug is taken orally in a single dose of 0.008 g (2 tablets) 1 hour before or immediately after radiation exposure. For the symptomatic treatment of alcohol withdrawal syndrome, a dose of 0.008 g is administered intravenously in the form of a 0.2% solution in 400 ml of hemodez, chlosol or saline. If necessary, re-administration of the drug Latran is possible.
Contraindications
Hypersensitivity, pregnancy, breastfeeding period.
Side effect
From the side of the central nervous system:
headache; rarely - transient visual disturbances and dizziness (with rapid intravenous administration), involuntary movements.
From the cardiovascular system:
chest pain, arrhythmias, bradycardia, arterial hypotension.
From the digestive system:
constipation, diarrhea, transient increase in serum transaminases.
Allergic reactions:
rarely - bronchospasm, angioedema, urticaria; in some cases - anaphylactic reactions.
Other:
urinary retention, feeling of warmth and rush of blood to the head and epigastric region.
special instructions
When used in patients with moderate and severe liver dysfunction, it is not recommended to exceed a dose of 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 when used simultaneously with drugs that are inducers or inhibitors of this enzyme system, Cl and T1/2 of ondansetron change.
Release form
Solution 0.2% for injection in ampoules of 2 ml or 4 ml, 5 ampoules per box; tablets of 0.004 g, film-coated, 10 pcs. in blister packs, 1 pack in a box, or in jars of 60 or 100 pcs., or in jars of 0.5 kg.
Storage conditions
Ampoules with solution - in a place protected from light. Tablets - in a dry place, protected from light. List B.
Best before date
3 years.
Dispensed by prescription.
Manufacturer - State Enterprise SPC "Pharmzashchita", 141400, Khimki, Moscow region, Vashutinskoe highway, 11
LATRAN solution for intravenous and intramuscular administration 2 mg/ml ampoule 4 ml No. 5
Intravenously, intramuscularly, orally. Cytostatic therapy: the choice of dosage regimen is determined by the emetogenicity of antitumor therapy. For adults, the daily dose is usually 8–32 mg, the following regimens are recommended: For moderate emetogenic chemotherapy or radiotherapy, 8 mg IV in a slow stream or IM immediately before starting therapy; 8 mg orally (2 tablets) 1–2 hours before the start of therapy, then another 8 mg (2 tablets) 12 hours after the start of therapy. For highly emetogenic chemotherapy, 8 mg IV infusion slowly immediately before the start of chemotherapy, and then 2 more IV injections of 8 mg at intervals of 2–4 hours; continuous 24-hour infusion of 24 mg at a rate of 1 mg/h; 16–32 mg, diluted in 50–100 ml of an appropriate infusion solution, as a 15-minute infusion immediately before the start of chemotherapy. The effectiveness of Latran® can be increased by a single intravenous administration of a glucocorticoid (for example, 20 mg of dexamethasone) before starting chemotherapy. To prevent delayed vomiting that occurs after the first 24 hours from the start of chemotherapy, it is recommended to continue taking the drug orally in tablet form, 8 mg 2 times a day for 5 days. For children over 2 years of age, the drug is prescribed at a dose of 5 mg/m2 IV immediately before the start of chemotherapy, followed by oral administration at a dose of 4 mg after 12 hours; after completion of chemotherapy, it is recommended to continue treatment at a dose of 4 mg orally 2 times a day for 5 days. Prevention of postoperative nausea and vomiting: adults are given a single dose of 8 mg intravenously in a slow stream at the beginning of anesthesia, or 16 mg is prescribed orally 1 hour before the start of anesthesia. To relieve nausea and vomiting, it is recommended to administer 8 mg of the drug intramuscularly or slowly intravenously. Latran® can be administered intramuscularly into the same area of the body in a dose not exceeding 8 mg. For children, to prevent postoperative nausea and vomiting, Latran® is used exclusively parenterally in a single dose of 0.1 mg/kg (maximum 4 mg) as a slow IV injection before or after anesthesia. For the treatment of developed postoperative nausea and vomiting in children, slow intravenous administration of a single dose of 0.1 mg/kg (maximum up to 4 mg) is recommended. In Russia there is not enough experience in using the drug to prevent and treat postoperative nausea and vomiting in children under 2 years of age. When exposed to ionizing radiation, Latran® is taken orally in a single dose of 8 mg (2 tablets) 1 hour before or immediately after radiation exposure. For the symptomatic treatment of alcohol withdrawal syndrome, the drug is administered intravenously at a dose of 8 mg (in the form of a solution of 2 mg/ml, 4 ml) in 400 ml of hemodez, chlorsol or saline solution. If necessary, the drug can be re-administered. Elderly patients do not need to change the dosage. Patients with kidney damage do not need to change the usual daily dose or frequency of administration of the drug. If there is liver damage, the dose should be reduced to 8 mg per day. The following solutions can be used to dilute the injection solution: 0.9% sodium chloride solution; 5% glucose solution; Ringer's solution; 0.3% potassium chloride solution and 0.9% sodium chloride solution; 0.3% potassium chloride solution and 5% glucose solution.
Buy Latran solution intravenously and intramuscularly 2 mg/ml 2 ml No. 5 in pharmacies
Instructions for use Latran Buy at the pharmacy Latran solution IV and IM 2mg/ml 2ml No. 5 Dosage forms injection solution 2mg/ml 2ml Synonyms Vero-Ondansetron Zofran Ondansetron Ondansetron-Altpharm Ondansetron-Lance Ondansetron-Teva Ondansetron- Ferein Ondansetron-Eskom Osetron Emeset Emetron Group Antiemetics International nonproprietary name Ondansetron Composition Active ingredient - ondansetron. Manufacturers Pharmzaschita SPC FMBA (Russia) Pharmacological action Antiemetic. By competitive type, it highly selectively blocks central (trigger zone chemoreceptors, vomiting center) and peripheral serotonin 5-HT3 receptors. Suppresses the gag reflex, eliminates and prevents vomiting mediated by the release of serotonin when using cytostatic anti-blastoma drugs (cisplatin, etc.), radiation therapy, in the postoperative period. With repeated administration, it slows down peristalsis and the passage of contents through the intestines. After intravenous administration of 0.15 mg/kg, the maximum concentration for age groups 19-40, 61-74, 75 and more years is 102, 106 and 170 ng/ml, half-life is 3.5, 4.7 and 5 ,5 hours. The maximum concentration with intramuscular administration is recorded after 10 minutes. Well absorbed from the gastrointestinal tract. The maximum concentration when taken orally is reached after 1.7 hours, the half-life is 3 hours. Binds to blood plasma proteins by 70-76% (corresponding to 10-500 ng/ml in vitro), partially penetrates into red blood cells. In women, the rate and duration of absorption from the gastrointestinal tract, absolute bioavailability and plasma parameters are higher, and the clearance and level of distribution are lower than in men. Side effects Constipation, diarrhea, dry mouth, hiccups, transient increases in aspartate aminotransferase and alanine aminotransferase, liver failure (possible death, especially against the background of hepatotoxic anti-blastoma therapy and antibiotics), headache, dizziness, visual impairment (blurredness, accommodation disorders), sensation warmth and flushing of the face, central nervous system depression, paresthesia, weakness, seizures, extrapyramidal symptoms, hypokalemia, tachycardia or bradycardia, hypotension, fainting, chest pain (anginal type), ECG abnormalities, including second degree blockade, fever, allergic reactions : urticaria, bronchospasm, angioedema, anaphylaxis, pain, redness and burning at the injection site; burning in the anus and rectum (suppositories). Indications for use Nausea and vomiting (prevention) during cytotoxic chemotherapy (initial and repeated courses, including the use of high doses of cisplatin), radiation therapy (irradiation of the entire surface of the body, partial single high-dose or daily irradiation of the abdominal area), in the postoperative period. Contraindications Hypersensitivity, insufficiency of liver function, abdominal surgery, pregnancy (especially the first 3 months), lactation, children's age: up to 2 years in the case of anesthesia, up to 4 years in chemotherapy, the entire age group in radiation therapy and for prescribing suppositories. Method of administration and dosage Adults 0.2% solution intravenously in a dose of 0.008-0.016 g once over 15 minutes immediately before chemotherapy; after 2 hours - orally in a single dose of 0.008 g and then every 8 hours, but not more than 5 days. For children over 4 years of age, a 0.2% solution at the rate of 0.005 g/sq.m of the child’s body surface once intravenously for 15 minutes immediately before chemotherapy, then 0.004 g orally every 8 hours, but not more than 5 days. When exposed to ionizing radiation - 0.008 g 1 hour before or immediately after radiation exposure. For alcohol withdrawal syndrome - intravenous drip of 0.2% solution at a dose of 0.008 g in 400 ml of hemodez, chlorsol or saline. If necessary, repeated administration is possible. Against the background of liver dysfunction, it is not recommended to exceed the dose of 8 mg/day. Overdose No data available. Interaction Compatible with infusion solutions of sodium and potassium chloride, dextrose, mannitol, Ringer, cisplatin, fluorouracil, carboplatin, etoposide, ceftazidime, cyclophosphamide, doxorubicin, dexamethasone. Special instructions It is not recommended to administer it in the same syringe with other drugs. Injection forms are diluted only with recommended solutions. Storage conditions List B. In a place protected from light, at room temperature. Dispensing order Dispensed by prescription
