Sturgeon

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Sturgeon: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. Drug interactions
12. Analogs
13. Terms and conditions of storage
14. Terms of dispensing from pharmacies
15. Reviews
16. Price in pharmacies

Latin name: Osetron

ATX code: A04AA01

Active ingredient: Ondansetron (Ondansetron)

Manufacturer: Dr. Reddy's Laboratories Ltd. (India)

Description and photo update: 2018-24-10

Sturgeon is a drug with antiemetic action.

Release form and composition

Dosage forms of sturgeon release:

film-coated tablets: almost white or white, biconvex, round, embossed on one side "Rx", on the other side a smooth surface (4 or 10 pcs. in blisters, in a cardboard box 1 blister);
solution for intravenous (intravenous) and intramuscular (intramuscular) administration: colorless, transparent (in colorless glass ampoules of 2 or 4 ml, 2 or 5 ampoules in blisters, in a cardboard box of 1, 2 or 10 blisters).

Composition of 1 film-coated tablet Sturgeon:

active substance: ondansetron - 4 or 8 mg (ondansetron hydrochloride dihydrate - 5 or 9.976 mg);
additional components (4/8 mg): corn starch - 20/40 mg; microcrystalline cellulose (Ultra-102) - 85 / 170.024 mg; lactose - 13/26 mg; colloidal silicon dioxide - 1/2 mg; magnesium stearate - 1/2 mg;
shell (4/8 mg): talc - 0.25 / 0.5 mg; hypromellose (15 cps) - 2/4 mg; titanium dioxide - 0.5 / 1 mg; propylene glycol - 0.25 / 0.5 mg.

Composition of 1 ml of Sturgeon solution:

active substance: ondansetron - 2 mg (ondansetron hydrochloride dihydrate - 2.494 mg);
additional components: citric acid monohydrate - 0.5 mg; sodium chloride - 9 mg; sodium citrate - 0.25 mg; water for injection - up to 1 ml.

Pharmacological properties

Pharmacodynamics

Sturgeon is one of the centrally acting antiemetic drugs. Possesses anxiolytic activity. Plasma concentration of prolactin does not change.

The drugs used in cytostatic chemotherapy and radiotherapy can lead to an increase in serotonin levels, which causes the gag reflex.

Ondansetron, being a selective antagonist of serotonin 5HT ₃ -receptors, selectively blocks serotonin 5HT ₃ -receptors of neurons of the nervous system, endings of the vagus nerve in the centers of the central nervous system and the intestine, which regulate the implementation of gag reflexes.

The use of Sturgeon does not lead to impaired coordination of movements, decreased performance and the development of a sedative effect.

Pharmacokinetics

The time to reach C _max (maximum concentration of the substance) is 10/90 minutes (after i / m administration or oral administration, respectively).

Plasma protein binding - from 70 to 76%.

Metabolism occurs in the liver with the participation of microsomal enzymes (CYP2D6). The absence of the CYP2D6 enzyme (debrisoquine polymorphism) has no effect on the pharmacokinetics of ondansetron.

T _1/2 (half-life) for oral / parenteral administration is 3 hours. Less than 5% of the introduced substance is excreted in the urine unchanged.

With repeated administration of ondansetron, its pharmacokinetic parameters do not change.

In elderly patients, with oral / parenteral administration, T _1/2 can increase up to 5 hours.

With moderate renal failure (in patients with creatinine clearance of 15-60 ml / min), there is a decrease in systemic clearance and V _d (volume of distribution), as well as an increase in T _1/2 (has no clinical significance). In severe impairment of renal function in patients on chronic hemodialysis, the pharmacokinetics of the substance practically does not change.

In patients with severe hepatic impairment, the systemic clearance of ondansetron sharply decreases, and therefore T _1/2 increases to 15–20 hours (this indicator does not depend on the method of administration).

Indications for use

Sturgeon is prescribed to prevent / eliminate vomiting and nausea in the following cases:

carrying out cytotoxic radio- or chemotherapy;
postoperative period.

Contraindications

pregnancy and lactation;
age up to 2 years;
individual intolerance to any component of the drug.

Instructions for use of Sturgeon: method and dosage

Nausea and vomiting associated with cytostatic therapy

The scheme of application of Sturgeon is determined by the emetogenicity of anticancer therapy.

The average adult daily dose ranges from 8 to 32 mg.

Recommended dosage regimen:

moderately emetogenic chemotherapy or radiotherapy: by mouth - 8 mg 1–2 hours before the start of the main therapy with repeated administration of the same dose 12 hours later; i / m or i / v jet slowly - 8 mg immediately before starting therapy;
highly emetogenic chemotherapy: by mouth - 24 mg in combination with 12 mg of dexamethasone 1–2 hours before the start of the procedure; in order to prevent prolonged / late vomiting that develops after 24 hours, Sturgeon is shown to be taken 2 times a day, 8 mg for 5 days.

For parenteral administration, the following regimens are recommended:

IV stream slowly: 8 mg immediately before the start of the procedure, then with a break of 2-4 hours, 2 more injections of 8 mg are injected;
continuous 24-hour infusion at a rate of 1 mg / h: 24 mg;
15-minute infusion: 16–32 mg (the dose is diluted in an appropriate infusion solution of 50–100 ml) immediately before the start of the procedure.

An increase in the effectiveness of ondansetron can be achieved with a single intravenous injection before chemotherapy with glucocorticosteroids (in particular, dexamethasone at a dose of 20 mg).

For children from 2 years old, Sturgeon is prescribed intravenously at a dose of 5 mg / m ² immediately before the start of chemotherapy, after 12 hours, 4 mg is indicated orally; therapy is recommended to continue by taking the drug orally 2 times a day, 4 mg for 5 days.

Postoperative nausea and vomiting

For adults, in order to prevent postoperative vomiting and nausea, Sturgeon is injected at the beginning of anesthesia by intramuscular or intravenous jet (slowly) in a single dose of 4 mg, or 16 mg orally 1 hour before the start of general anesthesia. For children, the drug can be prescribed only parenterally in a single dose of 0.1 mg / kg (maximum 4 mg) in the form of a slow intravenous injection before / after anesthesia.

For the relief of vomiting and nausea that has arisen, adults are recommended intramuscular or slow intravenous administration of the drug at a dose of 4 mg. Children are prescribed a slow intravenous injection in a single dose of 0.1 mg / kg (maximum 4 mg).

It is impossible to inject more than 4 mg of ondansetron into the same area of the body.

For moderate / severe liver dysfunction, the maximum dose of Sturgeon is 8 mg.

The following solutions can be used to dilute the injection solution: 0.9% sodium chloride solution, Ringer's solution, 5% dextrose solution, 0.9% sodium chloride solution and 0.3% potassium chloride solution, 5% dextrose solution and 0.3% potassium chloride solution.

Side effects

digestive system: hiccups, dry mouth, diarrhea / constipation; sometimes - a transient asymptomatic increase in the serum activity of aminotransferases in the blood;
nervous system: dizziness, headache, seizures and spontaneous movement disorders;
cardiovascular system: chest pains occurring in some cases with ST segment depression, bradycardia, arrhythmias, decreased blood pressure;
local reactions (at the injection site): pain, hyperemia, burning;
allergic reactions: anaphylaxis, urticaria, laryngospasm, bronchospasm, angioedema;
others: hypokalemia, hypercreatinemia, fever, rush of blood to the skin of the face, short-term visual impairment.

Overdose

In case of a suspected overdose of Sturgeon, symptomatic therapy is indicated. The specific antidote is unknown. Ipecacuanha is not recommended (unlikely to be effective).

special instructions

In cases of a burdened history of allergic reactions to other selective blockers of 5HT ₃ receptors during the use of Sturgeon, there is an increased risk of their occurrence.

During therapy, it is possible to slow down the motility of the large intestine, therefore, if there are signs of intestinal obstruction, patients need regular monitoring.

The diluted infusion solution is stable for at least 24 hours under normal lighting or natural light (protection from light is not required during infusion). It should be prepared just before the introduction. If necessary, the ready-made solution for infusion can be stored for 24 hours, subject to the temperature regime from 2 to 8 ° C.

Application during pregnancy and lactation

According to the instructions, sturgeon is not prescribed to pregnant and lactating women (the safety of therapy in this group of patients has not been established).

Pediatric use

Sturgeon is not prescribed for patients under the age of 2 years.

Drug interactions

Combinations requiring caution:

barbiturates, papaverine, carbamazepine, phenylbutazone, carisoprodol, griseofulvin, glutethimide, dinitrogen oxide, phenytoin (possibly other hydantoins), rifampicin, tolbutamide and other inducers of cytochrome P ₄₅₀ isoenzymes (CYP2A) and CYP2A;
macrolide antibiotics, allopurinol, antidepressants (monoamine oxidase inhibitors), chloramphenicol, cimetidine, oral contraceptives with estrogen, diltiazem, disulfiram, valproic acid and its salts, erythromycin, fluoroquinolones, fluconiastinazol, isoconi nozolone, isoconizolone, quinine, verapamil and other inhibitors of P ₄₅₀ isoenzymes (CYP3A and CYP2D6).

Ondansetron at a concentration of 0.016-0.16 mg / ml is pharmaceutically compatible and can be injected intravenously via a Y-shaped injector simultaneously with the following drugs:

cisplatin: administration within 1–8 hours (concentration up to 0.48 mg / ml);
carboplatin: administration over 10-60 minutes (concentration 0.18-9.9 mg / ml);
5-fluorouracil: administration at a rate of 20 ml / h (concentration - up to 0.8 mg / ml, since the precipitation of ondansetron is possible at higher concentrations);
etoposide: administration over 30-60 minutes (concentration 0.14-0.25 mg / ml);
ceftazidime: IV bolus injection lasting 5 minutes (dose 250–2000 mg);
doxorubicin: IV bolus injection lasting 5 minutes (dose 10–100 mg);
cyclophosphamide: IV bolus injection lasting 5 minutes (dose 100-1000 mg);
dexamethasone: slow intravenous injection for 2-5 minutes (dose 20 mg; drugs can be administered through one dropper, while the concentration of dexamethasone in the solution may be 0.032-2.5 mg / ml, ondansetron - 0.008-0.1 mg / ml).

Analogs

Sturgeon analogues are: Ondansetron, Latran, Zofran, Domegan, Vero-Ondansetron, Emetron, Emeset and others.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Sturgeon

According to reviews, Sturgeon is a drug that has a rapid antiemetic effect. In most cases, it is highly effective. As disadvantages indicate its high cost, in some cases - pain at the injection site.

Sturgeon price in pharmacies

The approximate price for Sturgeon is:

solution for intravenous and intramuscular administration (10 ampoules, 4 ml each): 400 rubles;
tablets (10 tablets of 8 mg): 432 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!