Colistin, for inhalation 80 mg (1000000 units) 28 pcs

The antibiotic is polypeptide cyclic. Colistimethate sodium is formed by Bacillus polymyxa, subspecies colistinus. Colistimethate is a methanesulfonate of colistin.

Sodium colistimethate has a bactericidal effect on Gram-negative microorganisms in the stage of division and resting by changing the structure and function of the outer and cytoplasmic membrane.

The drug is active against Pseudomonas aeruginosa, Haemophilus influenzae, Acinetobacter spp., Citrobacter spp., Enterobacter spp., Klebsiella spp., Salmonella spp., Shigella spp.

Not active against Burkholderia cepacia and Staphylococcus aureus. Caution is required when determining the sensitivity or resistance of pathogens when using colistimethate sodium by inhalation.

Indications

Active ingredient

Composition

Solvent: 0.9% sodium chloride solution – 3 ml.

How to take, the dosage

The drug is used by inhalation.

In adults and children over 6 years of age the daily dose of the drug is from 2 million IU to 6 million IU, depending on the severity of the disease. As a rule, 1 million IU twice a day with an interval of 12 hours is prescribed.

The duration of sanation therapy in primary colonization/infection caused by Pseudomonas aeruginosa is from 3 weeks to 3 months. There is no time limit for the duration of therapy for chronic infection caused by Pseudomonas aeruginosa.

In patients with impaired renal function the drug dose does not need to be reduced.

Interaction

In concomitant use of Colistin with potentially nephrotoxic drugs (aminoglycosides, cephalosporins, cyclosporine) nephrotoxicity may be increased.

Pharmaceutical interactions

Prepared Colistin solution should not be mixed with other drugs.

Special Instructions

Inhaled medications, including Colistin, may cause acute bronchoconstriction in sensitive patients. Therefore, the first dose of Colistin for inhalation should be administered under the supervision of experienced medical personnel, and inhalation should be preceded by the use of a bronchodilator if it is part of the patient’s therapy.

Before and after inhalation of Colistin, a 1-second PEF should be measured. If a patient who is not receiving bronchodilators shows signs of drug-induced bronchial obstruction, the test should be repeated with the addition of a bronchodilator the next time Colistin is used.

The first use of Colistin should be under the supervision of medical personnel experienced in working with patients with cystic fibrosis.

In patients with impaired renal function, the possibility of nerve side effects should be closely monitored and renal function monitored regularly.

Between inhalation of dornase alfa and inhalation of Colistin, a break should be taken.

In rare cases, resistant strains of Pseudomonas aeruginosa may emerge during treatment with Colistin. After withdrawal and/or modification of the therapy, the drug efficacy may be restored.

The patient should refrain from drinking alcohol during treatment with the drug.

Impact on driving and operating machinery

At the time of treatment the patient should refrain from driving and engaging in potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

The rules of use of the drug

1. The bottle with the powder is opened by removing the aluminum cap with control of the first opening and opening the rubber stopper.

2. The solvent ampoule is opened using a saw or ampoule opener.

3. The contents of the ampoule are poured completely into the vial with the powder. The powder dissolves with gentle shaking. Vigorous shaking should be avoided due to excessive foaming.

Pour the solution into a nebulizer and administer by inhalation according to the nebulizer manufacturer’s instructions.

5. The patient performs the Colistin inhalation procedure while sitting or standing in a normal, relaxed position, taking as deep breaths as possible through the nebulizer mouthpiece. The use of a nasal clip makes it easier to breathe in through the mouth.

6. The nebulizer should be rinsed and disinfected after each use, following the manufacturer’s instructions.

In patients receiving other types of inhalation therapy, inhalation use of Colistin should be done immediately after bronchodilator use and after chest physiotherapy procedures.

Contraindications

With caution, use the drug in bronchial asthma, renal disorders, hemoptysis, pregnancy.

Side effects

Allergic reactions: angioedema.

CNS and peripheral nervous system disorders: dizziness, paresthesias.

Respiratory system: bronchospasm (>10%), increased coughing, increased sputum formation, mucositis (inflammation of the mucous membrane of the airways), pharyngitis, shortness of breath.

Digestive system disorders: nausea, heartburn.

Urinary system disorders: acute renal failure.

Overdose

Symptoms: CNS and peripheral nervous system – dizziness, paresthesias, diplopia (due to paresis of the eye muscles), ptosis, general weakness, speech disorders, areflexia, vision disorders, dysphagia, seizures and coma; neuromuscular block may cause death due to paralysis of respiration; urinary system – renal tubule epithelial cell damage and tubule necrosis.

Treatment: carrying out symptomatic therapy, peritoneal dialysis (or hemodialysis) is advisable; artificial ventilation. Calcium gluconate and neostigmine do not stop neuromuscular blockade.

Pregnancy use

Due to the risk of nephro- and neurotoxic reactions in the fetus, Colistin should be used during pregnancy under medical supervision with caution and only for vital signs.

Breastfeeding should be discontinued if it is necessary to use Colistin during lactation.