Pabal - Instructions For Use, Price Of The Drug, Analogues, Reviews

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Pabal - Instructions For Use, Price Of The Drug, Analogues, Reviews
Pabal - Instructions For Use, Price Of The Drug, Analogues, Reviews

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Pabal

Pabal: 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. In case of impaired renal function
  11. 11. For violations of liver function
  12. 12. Drug interactions
  13. 13. Analogs
  14. 14. Terms and conditions of storage
  15. 15. Terms of dispensing from pharmacies
  16. 16. Reviews
  17. 17. Price in pharmacies

Latin name: Pabal

ATX code: H01BB03

Active ingredient: Carbetocin (Carbetocin)

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

Description and photo update: 2019-29-10

Solution for intravenous and intramuscular administration Pabal
Solution for intravenous and intramuscular administration Pabal

Pabal - oxytocin drug, uterotonic, labor stimulant.

Release form and composition

Dosage form - solution for intravenous (i / v) and intramuscular (i / m) administration: colorless, transparent (in a cardboard box 1 cell package with 5 ampoules of colorless glass containing 1 ml of solution, and instructions for use of Pabal).

1 ampoule with solution contains:

  • active substance: carbetocin - 100 μg [oxytocin activity is approximately 50 international units (IU) of oxytocin per ml);
  • auxiliary components: sodium chloride - 9000 mcg; glacial acetic acid - up to pH 3.8; water for injection - up to 1 ml.

Pharmacological properties

Pharmacodynamics

Carbetocin (1-deamino-1-monocarb- [2-0-methyltyrosine] -oxytocin) is a long-acting oxytocin agonist. It, like oxytocin, selectively binds in the smooth muscles of the uterus with hormone receptors, stimulates rhythmic contractions of the uterus, increases the tone of the uterine muscles and the frequency of existing contractions.

After childbirth, carbetocin increases the speed and strength of spontaneous uterine contractions. The introduction of Pabal promotes an increase in uterine contractions and, after 2 minutes, causes a sharp contraction.

To maintain an adequate contraction of the uterus, preventing the appearance of profuse bleeding and uterine atony, it is sufficient to administer 0.1 mg of carbetocin, which is comparable to the use of oxytocin, which acts for several hours.

Pharmacokinetics

  • absorption and distribution: after the introduction of carbetocin, its maximum concentration in blood plasma is reached within 15 minutes and is 1035 ± 218 pg per ml within 1 hour. The substance penetrates into breast milk, while its maximum concentration is almost 56 times less than in blood plasma after 2 hours;
  • metabolism: the drug, like oxytocin, is hydrolyzed by proteinases;
  • Excretion: The excretion of the substance is biphasic with linear pharmacokinetics in the dose range from 0.4 to 0.8 mg. The half-life of carbetocin is approximately 40 minutes. The renal clearance of the drug in unchanged form is low. Through the kidneys, less than 1% of the administered dose of the substance is excreted unchanged.

Indications for use

Pabal is prescribed to prevent uterine atony in the following cases:

  • operative delivery by cesarean section (after removing the child);
  • the presence of a high probability of postpartum hemorrhage in women in labor with natural delivery.

Contraindications

Absolute:

  • impaired renal or liver function;
  • epilepsy;
  • violations of conduction, rhythm and other serious pathologies of the cardiovascular system;
  • induction of labor;
  • pregnancy and labor (before the baby is born);
  • individual intolerance to the components of the drug.

Relative (Pabal is appointed under medical supervision):

  • any conditions against which a rapid increase in the volume of extracellular fluid can lead to the development of complications associated with overhydration;
  • migraine;
  • bronchial asthma;
  • cardiovascular pathology;
  • preeclampsia, eclampsia, preeclampsia of the second half of pregnancy, severe (requires constant monitoring of blood pressure).

Since carbetocin has a certain antidiuretic effect, it is important to take into account the likelihood of hyponatremia during its use, especially in patients who are injected with large volumes of solution by intravenous infusion. In order to prevent seizures and coma, it is recommended to pay attention to the first manifestations of hyponatremia (headache, apathy, drowsiness).

Pabal, instructions for use: method and dosage

The Pabal solution is administered intravenously or intramuscularly, once, only after the birth of the child. Re-administration of the drug is not recommended.

Do not mix the drug with other solutions in the same syringe.

If insoluble particles or discoloration are found, the solution cannot be used. Unused drug must be destroyed.

Recommended dosage:

  • operative delivery by caesarean section: 1 dose of Pabal is administered immediately after the baby is removed, before the placenta is separated (preferably);
  • vaginal delivery: 1 dose of Pabal is injected into the upper thigh immediately after the release of the placenta.

Side effects

Possible side effects of the drug Pabal [> 10% - very common; (> 1% and 0.1% and 0.01% and <0.1%) - rarely; <0.01%, including isolated messages - very rare]:

  • hematopoietic and lymphatic system: often - anemia;
  • nervous system: very often - tremor, headache; often - dizziness;
  • cardiovascular system: very often - facial hyperemia, increased blood pressure;
  • respiratory organs: often - shortness of breath, chest pain;
  • gastrointestinal tract: very often - abdominal pain, nausea; often - vomiting, metallic taste in the mouth;
  • skin: very often - itching;
  • musculoskeletal system: often - back pain;
  • general reactions: very often - a feeling of heat; often - pain at the injection site, chills.

Overdose

The main symptom of an overdose of carbetocin with the introduction of 0.8 mg per 1 ml of the drug may be tachycardia. With a single use of Pabal at the recommended dose of 0.1 mg per 1 ml, cases of overdose are very rare. In violation of the recommended dosage regimen, endometrial hypertonicity may develop, regardless of the absence or presence of hypersensitivity to carbetocin or postpartum hemorrhage. Severe overdose can cause overhydration and hyponatremia, especially with combined intravenous infusion of solutions in large volumes, carried out during childbirth.

If the recommended doses are exceeded, symptomatic and supportive treatment is necessary. A woman in labor who shows signs of overdose should be provided with adequate oxygenation. In cases of water intoxication, it is necessary to stimulate diuresis and correct electrolyte disturbances, to limit the flow of fluid into the body. It is also important to pay attention to the clinical symptoms of hyponatremia (in the form of headache, apathy and drowsiness) in order to prevent seizures and coma.

special instructions

The Pabal solution is administered intravenously or intramuscularly only in specialized obstetric departments, which are appropriately equipped and have experienced and qualified personnel. The use of carbetocin at any stage of labor before the birth of a child is unacceptable, since its stimulating effect on the uterus after a single administration at a dose of 0.1 mg per 1 ml continues for several hours, in contrast to the rapid decrease in the effect of oxytocin.

With incessant uterine bleeding against the background of the use of Pabal, it is necessary to exclude such reasons as a violation of blood coagulability and the presence of unseparated fragments of the placenta.

Pabal is entered once. In case of uterine atony or hypotension accompanied by profuse bleeding, it is recommended to consider the use of ergometrine and / or oxytocin. Since the drug has a certain antidiuretic effect, it is important to identify the first manifestations of hyponatremia in the form of headache, apathy and drowsiness in order to avoid the development of seizures and coma.

Influence on the ability to drive vehicles and complex mechanisms

Given the indications for the use of the drug Pabal, driving vehicles or complex mechanisms when using it is not possible.

Application during pregnancy and lactation

Pabal during pregnancy and childbirth is not assigned until the birth of the child.

A small amount of carbetocin can pass into breast milk and then be destroyed by the enzymes of the newborn.

With impaired renal function

For patients with impaired renal function, administration of Pabal is contraindicated.

For violations of liver function

Pabal is not prescribed to patients with impaired hepatic function.

Drug interactions

There were no drug interactions between carbetocin and drugs for spinal or epidural anesthesia, antispasmodics and analgesics. However, it is impossible to mix Pabal's solution with other agents in one syringe.

Since the drug belongs to analogs of oxytocin, interactions characteristic of it can be observed. After 3-4 hours after use for the prevention of vasoconstrictor agents in combination with caudal-conduction anesthesia, blood pressure may sharply increase.

The simultaneous use of carbetocin with ergot preparations (methylergometrine) can lead to an increase in the effect of the former and an increase in blood pressure.

In view of the possible intensification of the action of Pabal, its combined use with prostaglandins is not recommended. If it is necessary to use such a combination, the patient should be constantly monitored.

Drugs for inhalation anesthesia (for example, cyclopropane, halothane) can reduce the effect of the drug on the uterus and enhance its hypotensive effect.

The combined use of Pabal with oxytocin can cause arrhythmias.

Analogs

Pabal's analogs are Carbetocin, Mifeprex, Mifepristone, Mifegin, Oxytocin, Pencrofton, Prepidil, Enzaprost-F, etc.

Terms and conditions of storage

Store in a place protected from light and moisture, at a temperature of 2 to 8 ° C, do not freeze. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Pabal

According to reviews, Pabal is a safe and effective drug used to stimulate uterine contractions.

Among the disadvantages, the high cost of the drug is mainly noted.

Pabal price in pharmacies

The approximate price for Pabal (in a package of 5 ampoules of 1 ml of solution) ranges from 10,700 to 10,800 rubles.

Anna Kozlova
Anna Kozlova

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!

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