Colistin inhalation solution powder 80mg (1000000IU), 28pcs

Composition

Solvent:  sodium chloride solution 0.9% – 3 ml

Pharmacological action

A cyclic polypeptide antibiotic. Sodium colistimethate is produced by Bacillus polymyxa, a subspecies of colistinus. Colistimethate is a colistin methanesulfonate. Sodium colistimethate has a bactericidal effect on gram-negative microorganisms that are at the stage of division and dormancy, by changing the structure and function of the outer and cytoplasmic membranes. The drug is active against Pseudomonas aeruginosa, Haemophilus influenzae, Acinetobacter spp., Citrobacter spp., Enterobacter spp., Klebsiella spp., Salmonella spp., Shigella spp. It is not active against Burkholderia cepacia and Staphylococcus aureus. Caution is required when determining the sensitivity or resistance of pathogens when using sodium colistimethate by inhalation.

Indications

Treatment of respiratory tract infections caused by Pseudomonas aeruginosa in cystic fibrosis.

Use during pregnancy and lactation

Due to the risk of developing nephrotoxic and neurotoxic reactions in the fetus, Colistin should be used during pregnancy under the supervision of a doctor with caution and only for vital indications.

If it is necessary to use Colistin during lactation, breastfeeding should be discontinued.

Contraindications

• Children under 6 years of age;
• hypersensitivity to the components of the drug.

The drug should be used with caution in cases of bronchial asthma, impaired renal function, hemoptysis, and pregnancy.

Side effects

Allergic reactions:  angioedema.

From the central nervous system and peripheral nervous system:  dizziness, paresthesia.

Respiratory system disorders:  bronchospasm (>10%), increased cough, increased sputum production, mucositis (inflammation of the airway mucosa), pharyngitis, shortness of breath.

From the digestive system:  nausea, heartburn.

From the urinary system:  acute renal failure.

Interaction

When using Colistin concomitantly with inhaled anesthetic agents (ether, halothane), muscle relaxants or curare-like drugs (tubocurarin, succinylcholine) or aminoglycosides, you should carefully monitor the possibility of developing neurotoxic reactions.

Concomitant use of Colistin with potentially nephrotoxic drugs (aminoglycosides, cephalosporins, cyclosporin) may increase nephrotoxicity.

Pharmaceutical interaction

The prepared Colistin solution should not be mixed with other medications.

How to take, course of use and dosage

The drug is used by inhalation.

For adults and children over 6 years of age, the daily dose of the drug is from 2 million mg. UNITS up to 6 million. ED depending on the severity of the disease. As a rule, they assign 1 million rubles each. UNITS 2 times/day with an interval of 12 hours.

The duration of rehabilitation therapy for primary colonization / infection caused by Pseudomonas aeruginosa is from 3 weeks to 3 months. There are no time limits on the duration of therapy for chronic infection caused by Pseudomonas aeruginosa.

In patients with impaired renal function, the dose of the drug should not be reduced.

Overdose

Symptoms:  from the central nervous system and peripheral nervous system – dizziness, paresthesia, diplopia (due to paresis of the eye muscles), ptosis, general weakness, speech disorders, areflexia, visual disturbances, dysphagia, convulsions and coma; neuromuscular blockade can cause death due to respiratory paralysis; from the urinary system-damage to the epithelial cells of the renal tubules and necrosis of the tubules.

Treatment:  conducting symptomatic therapy, it is advisable to conduct peritoneal dialysis( or hemodialysis); mechanical ventilation. Calcium gluconate and neostigmine do not stop neuromuscular blockage.

Special instructions

Inhaled medications, including Colistin, may cause acute bronchoconstriction in sensitive patients. Therefore, the use of the first dose of Colistin for inhalation should be carried out under the supervision of experienced medical personnel, while inhalation should be preceded by the use of a bronchodilator if it is included in the patient’s treatment regimen.

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

The first use of Colistin should be carried out under the supervision of medical personnel who have experience working with patients suffering from cystic fibrosis.

Patients with impaired renal function should be carefully monitored for the possibility of developing side effects from the nervous system and regularly monitor renal function.

Take a break between inhaling dornase alpha and inhaling Colistin.

When treated with Colistin, in rare cases, resistant strains of Pseudomonas aeruginosa may appear. After discontinuation and / or modification of therapy, it is possible to restore the effectiveness of the drug.

During treatment with the drug, the patient should refrain from drinking alcohol.

Influence on the ability to drive motor vehicles and manage mechanisms

During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Rules for using the drug

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

2. A solvent ampoule is opened using a file or ampoule opening device.

3. The contents of the ampoule are completely poured into a bottle with powder. The powder dissolves with a light shake. Strong agitation should be avoided due to excessive foam formation.

4. The solution is poured into a nebulizer and used by inhalation according to the nebulizer manufacturer’s instructions.

5. The patient performs the Colistin inhalation procedure in a sitting or standing position, in a normal calm state, taking as deep breaths as possible through the mouthpiece of the nebulizer. To facilitate inhalation through the mouth, you can use a nose clip.

6. After each use, the inhaler should be rinsed and disinfected following the manufacturer’s instructions.

In patients receiving other types of inhalation therapy, inhaled Colistin should be administered immediately after the use of a bronchodilator, as well as after physiotherapy procedures on the chest.

Active ingredient

Sodium Colistimethate

Conditions of release from pharmacies

By prescription

Dosage form

powder for inhalation