Traktocil - Instructions For Use During Pregnancy, Price, Reviews

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

Tractocil

Traktocil: instructions for use and reviews

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

Latin name: Tractocile

ATX code: G02CX01

Active ingredient: atosiban (Atosiban)

Producer: Ferring, GmbH (Ferring, GmbH) (Germany)

Description and photo update: 2020-18-02

Prices in pharmacies: from 1866 rubles.

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Traktocil - blocker of oxytocin receptors; an agent that suppresses labor.

Release form and composition

Dosage form - a concentrate for the preparation of a solution for infusion: a transparent colorless solution (0.9 and 5 ml each in colorless glass vials with a volume of 2 and 5 ml, respectively, sealed with a bromobutyl stopper and hermetically sealed with a lid, instructions for use of Tractocil and 1 bottle in a cardboard box).

Composition of 1 ml of concentrate:

• active substance: atosiban (in the form of acetate) - 7.5 mg;
• auxiliary components: hydrochloric acid, mannitol, water for injection.

Pharmacological properties

Pharmacodynamics

Atosiban, the active substance of Traktocil, is a synthetic peptide that is a competitive antagonist of human oxytocin at the receptor level. The drug binds to oxytocin receptors, thereby reducing the frequency of uterine contractions and the tone of the myometrium. These reactions lead to a decrease in uterine contractility.

Atosiban also binds to vasopressin receptors and inhibits its effect, but does not affect the cardiovascular system.

In the recommended doses, the drug administered to women with preterm labor suppresses uterine contraction and provides it with functional rest.

The effect of Traktocil develops immediately after administration. Within 10 minutes, a significant decrease in the contractile activity of the myometrium is noted, due to this, a stable functional dormancy of the uterus is maintained over the next 12 hours (less than 4 contractions per hour).

Pharmacokinetics

Pharmacokinetic parameters of atosiban do not depend on the administered dose.

After intravenous (iv) administration of a dose of 300 mcg / min for 6-12 hours, the maximum plasma concentration (_Cmax) is observed within 1 hour and may be 298-533 ng / ml.

About 46-48% of atosiban binds to plasma proteins.

The drug crosses the placental barrier. After the introduction of Tractocil at a rate of 300 μg / min, the ratio of the concentration of atosiban in the fetus and in the mother's body is 0.12. The volume of distribution is on average 18.3 ± 6.8 liters.

Atosiban is metabolized to form metabolites, of which two have been identified. The main one is the M1 metabolite, which has the same pharmacological activity as atosiban. The ratio of the concentration of M1 and the concentration of atosiban in the blood plasma in the second hour of infusion is 1.4; after the end of the introduction - 2.8.

It is unlikely that atosiban inhibits cytochrome P ₄₅₀ isoforms.

As soon as the infusion of the drug is stopped, the plasma concentration of atosiban decreases rapidly. The initial half-life is 0.21 ± 0.01 hours, the final half-life is 1.7 ± 0.3 hours.

The average clearance is 41.8 ± 8.2 l / h.

In urine, the drug is determined in extremely small quantities. The concentration of M1 in urine is 50 times higher than the concentration of atosiban. The degree of excretion of the drug in the feces was not determined.

Indications for use

Tractocil is used in pregnant women with the threat of premature birth in the following cases:

• full gestation period 24–33 weeks;
• dilation of the cervix by 1–3 cm (or 0–3 cm for women who have not given birth before);
• normal fetal heart rate;
• regular (more than 4 times within 30 minutes) uterine contractions lasting at least 30 seconds;
• over 18 years of age.

Contraindications

Absolute:

• pregnancy is less than 24 or more than 33 complete weeks;
• death of the fetus in the womb;
• uterine bleeding requiring immediate delivery;
• suspicion of an intrauterine infection;
• intrauterine growth retardation;
• premature rupture of membranes during pregnancy more than 30 weeks;
• severe preeclampsia or eclampsia requiring urgent delivery;
• any pathology of the mother or fetus in which it is dangerous to maintain a pregnancy;
• placental abruption;
• presentation and abnormal attachment of the placenta;
• abnormal heart rate in the fetus;
• lactation period;
• hypersensitivity to any component of Traktocil.

Relative (due to the lack of clinical experience, the use of the drug requires caution):

• pregnancy at 24–27 weeks;
• multiple pregnancy.

In cases where there is a suspicion of premature rupture of the membranes, the benefits of prolonging labor must be weighed against the possible risk of developing chorioamnionitis.

Traktocil, instructions for use: method and dosage

Traktocil is intended for intravenous administration.

The use of the drug should be started as soon as the diagnosis of "preterm labor" is made. Therapy involves three administrations of the solution:

1. Within 1 minute, 1 vial containing 0.9 ml of the drug is injected without dilution (the dose of atosiban is 6.75 mg).
2. Immediately after the first injection, a three-hour infusion is given at a dose of 300 μg / min (the rate of administration is 24 ml / h, the dose of atosiban is 18 mg / h).
3. Then, a long-term (up to 45 h) infusion of Tractocil is carried out at a dose of 100 μg / min (atosiban dose is 6 mg / h) at a rate of 8 ml / h.

At the second and third stages of the cycle, the concentrate is diluted with 0.9% sodium chloride solution, 5% glucose solution or Ringer's acetate solution. To do this, 10 ml is poured from the solvent bottle and 10 ml of Tractocil (2 bottles of 5 ml each) are added, thus, the concentration of the drug is 75 mg / 100 ml. The solution for infusion can be used within 24 hours after preparation. Do not enter the solution in case of color change or the presence of undissolved particles.

The total duration of the use of Tractocil should not exceed 48 hours, the maximum dose for the entire course is 330 mg.

If there is a need for a second course of treatment, the introduction of Tractocil begins from the first stage, proceeding further to the second and third. In total, three cycles are possible. If, after their end, the contractile activity of the uterus does not decrease, it is advisable to decide on the use of another drug.

Side effects

• from the digestive system: very often (> 1/10) - nausea; rarely (from> 1/1000 to <1/100) - vomiting;
• from the side of metabolism: often (from> 1/100 to <1/10) - hyperglycemia;
• from the central nervous system: often - headache, dizziness; rarely - insomnia;
• on the part of the cardiovascular system: often - arterial hypotension, tachycardia, hot flashes;
• local and skin reactions: rarely - hyperthermia at the injection site of Tractocil, skin rash, itching;
• others: very rarely (from> 1/10 000 to <1/1000) - uterine bleeding, uterine atony.

Overdose

Several cases of Tractocil overdose have been reported. There were no specific symptoms.

The antidote for atosiban has not been established. Treatment includes supportive and symptomatic therapy.

special instructions

If, after the introduction of Tractocil during pregnancy, there is no decrease in the contractile activity of the uterus, it is necessary to carefully monitor the uterine contractions and the heart rate in the fetus. It is also necessary to resolve the issue of introducing another drug.

Atosiban is thought to induce uterine relaxation and postpartum uterine bleeding, so postpartum bleeding should be carefully assessed.

Influence on the ability to drive vehicles and complex mechanisms

Given the indications for the use of the drug, it is forbidden to drive a car and perform potentially dangerous types of work during the treatment period.

Application during pregnancy and lactation

During pregnancy, Traktocil is prescribed to prevent premature birth.

During lactation, the administration of the drug is contraindicated.

Pediatric use

Traktocil is not intended for use in children.

With impaired renal function

There is no experience with the use of atosiban in pregnant women with renal impairment.

For violations of liver function

There is no experience with the use of atosiban in pregnant women with functional liver disorders.

Drug interactions

Atosiban does not affect the pharmacological properties of drugs that are metabolized by cytochrome P ₄₅₀.

There were no significant interactions with the simultaneous use of betamethasone.

Labetalol has no effect on the pharmacokinetics of Tractocil.

Interaction of atosiban with antibiotics is unlikely.

It is inappropriate to use Tractocil with ergot alkaloids, since they have opposite indications for use and antagonistic pharmacological action.

Analogs

Tractocil's analogs are Atosiban, Mirosiban.

Terms and conditions of storage

Store at a temperature of 2-8 ° C out of reach of children. Do not freeze.

Shelf life is 4 years. After dilution of the concentrate, the solution can be stored for 24 hours.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Tractocil

Atosiban is the only tocolytic that is specifically designed for use in the case of spontaneous uterine contractility. In many European countries, atosiban is the drug of choice for preventing premature birth.

In Russia, the drug containing atosiban was registered in 2012 under the name Traktocil. The assessment of its effectiveness was carried out in January 2013 on the basis of the Mother and Child hospitals. The drug was administered according to indications to 19 patients with the threat of premature birth. As a result, in 17 women, pregnancy ended with delivery on time. In 1 patient, therapy was not effective enough: the pregnancy was prolonged by 2 weeks, during which time the fetus gained 210 g in weight, the newborn is alive. In another 1 woman, therapy was ineffective: despite the administration of the drug, labor continued, premature birth occurred at 33 weeks, the child was alive.

Thus, doctors leave extremely positive reviews about Tractocil.

The price of Traktocil in pharmacies

The price of Traktocil in the form of a concentrate for preparing a solution for infusion is approximately 1,818 rubles. per bottle 0.9 ml and 6388 rubles. for a bottle of 5 ml.

Tractocil: prices in online pharmacies

Drug name Price Pharmacy

Traktocil 7.5 mg / ml solution for intravenous administration 0.9 ml 1 pc. 1866 RUB Buy

Traktocil 7.5 mg / ml concentrate for preparation of solution for infusion 5 ml 1 pc. RUB 6099 Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, 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!