Afacolist® (colistimetat) vial

Afacolist® (colistim sodium)

Powder for solution for intramuscular injection, intravenous injection, intravenous infusion and powder for solution for inhalation

1,000,000 IU and 2,000,000 IU

This medicine has been prescribed for your current condition. Therefore, do not use it for similar conditions or recommend its use to others.

General instructions:

Before using this medicine, consult your doctor in the following cases:

If you are allergic to this medicine or other medicines or any other substance such as food additives, preservatives, dyes, etc.

If you have kidney or liver disease

If you are taking medicinal products with neurotoxic or nephrotoxic effects such as aminoglycoside antibiotics including gentamicin, amikacin and tobramycin

If you have a history of myasthenia gravis and porphyria

If you are taking azithromycin and clarithromycin or fluoroquinolones such as ciprofloxacin in patients with myasthenia gravis

Use during pregnancy and lactation:

Clostimethate sodium should not be used during pregnancy and lactation except under the advice of a specialist.

Warnings:

During treatment, avoid driving dangerous vehicles and using dangerous machinery.

Colistimethate sodium should be administered with caution and at a reduced dose in renal patients due to the possibility of apnea and neuromuscular blockade, and renal function should be monitored at the beginning and during the course of treatment.
Colistimethate sodium reduces the presynaptic release of acetylcholine at the neuromuscular junction and is contraindicated in patients with myasthenia gravis.
Coadministration of colistimethate sodium with some antibiotics, such as aminoglycosides and polymyxins, should be done with caution due to interference with nerve signal transmission at the neuromuscular junction.
Cephalothin sodium may increase the nephrotoxicity of colistimethate sodium. Concomitant administration of cephalothin sodium and colistimethate should be avoided.
Respiratory arrest has been reported following intramuscular administration of colistimethate sodium.
Clostridium difficile-associated diarrhea should be considered in all patients who develop diarrhea after taking antibiotics.
Inhaled use of this drug may cause bronchospasm.
Due to the effects of colistimethate sodium on acetylcholine release, non-depolarizing muscle relaxants (atracurium, mivacurium, etc.) should be used with caution in patients receiving colistimethate sodium because their effects may be prolonged.

Dosage:

The dosage of the drug is determined by the attending physician for each patient. However, the usual dosage of the drug is as follows:

Injection method:

In adolescents and adults, a maintenance dose of 9 million units per day is given as an infusion, divided into 2 or 3 doses. In patients with severe disease, a loading dose of 9 million units should also be used. In some cases, loading and maintenance doses of up to 12 million units may be required in patients with normal renal function.

In children weighing less than 40 kg, 75,000 to 150,000 units per kilogram of body weight per day, divided into 3 doses per day.

For children weighing more than 40 kg, the same dosage recommendations as for adults should be considered.

Note:

Infusion dosage adjustment in patients with renal impairment should be made according to the physician’s instructions based on the creatinine clearance per minute.

Inhalation method:

Children 2 to 17 years of age and adults:

Inhalation of solution using a device: 1 to 2 million units 2 to 3 times a day, maximum 6 million units per day

How to prepare and dilute the drug:

Infusion solution: First, slowly add 2 ml of sterile water for injection or 0.9% sodium chloride solution to the contents of the vial, swirl the vial gently until foaming occurs and the powder is completely dissolved. Then, the resulting solution should be diluted in at least 50 cc of 0.9% sodium chloride solution for injection, 5% dextrose in 0.9% sodium chloride, 5% dextrose in 0.45% sodium chloride, 5% dextrose, lactated Ringer’s solution, and infused for 30 to 60 minutes.

Intravenous injection: First, slowly add 2 ml of sterile water for injection to the contents of the vial, swirl the vial gently until foaming occurs and the powder is completely dissolved. At least 5 minutes are required for injection.

Deep intramuscular injection: First, add 2 ml of sterile water for injection to the contents of the vial and gently swirl the vial to prevent foaming and ensure complete dissolution of the powder. The injection should be deep into the upper outer quadrant of the gluteal muscles.

Inhalation method: Colistimethate sodium 1 million units is intended for inhalation using a suitable nebulizer. Colistimethate sodium is very soluble in the preparation medium. The recommended technique for reconstitution is to add 3 ml of 0.9% isotonic sodium chloride solution to the vial containing Colistimethate sodium 1 million units with gentle shaking. Vigorous shaking should be avoided due to the possibility of foaming. The reconstituted solution should be clear and carefully transferred to the nebulizer medication reservoir. The solution is for single use only and any remaining solution should be discarded. The patient should sit upright and breathe normally. The nebulizer should be cleaned and disinfected according to the instructions for use of the respective nebulizer.

Note: The prepared solution in each case of use should be free of particles, clear and without discoloration.

Side effects:

Every medicine, along with the desired therapeutic effects, may also have some unwanted side effects. Inform your doctor if any of the following side effects occur.

Important side effects that require notification to the doctor if they occur:

Sudden allergic reactions such as swelling of the face, tongue, shortness of breath and skin rash.

When the drug is used by inhalation:

Joint pain, weakness and lethargy, asthma, balance disorders, chest discomfort, cough, bronchospasm, shortness of breath, fever, bleeding, headache, respiratory tract infection, nausea, respiratory disorders, change in taste in the mouth, sore throat, tinnitus, vomiting, anxiety when inhaling, decreased appetite, diarrhea, drowsiness, ear congestion, bloating, protein excretion in the urine, epilepsy, purulent sputum, thirst and weight change

When the drug is used by injection:

Dizziness, nephrotoxicity, anaphylactic shock, psychosis, speech disorders, visual impairment, paralysis of the respiratory muscles may lead to apnea and respiratory arrest and death, neurotoxicity, renal impairment, sensory disorders, tingling of the limbs and tongue, generalized itching, hives and skin rashes, fever, increased creatinine, increased blood urea nitrogen, decreased creatinine clearance, distress Respiratory, renal toxicity and decreased urine output

Storage conditions:

Store the dry product at a temperature below 25 ° C, away from light and moisture, and in the original medicine box until the medicine is used.

The prepared solution is stable for up to 24 hours at a temperature of 2 to 8 ° C.

Keep the medicine out of the reach of children.

Sale without a doctor’s prescription is prohibited.

Pharmaceutical forms and packaging:

Each vial contains 1 million international units of colistimethate sodium and is packaged in a box of 10 with an instruction sheet.

Product of Afashimi Pharmaceutical Company

Each vial contains 2 million international units of colistimethate sodium and is packaged in a box of 10 with an instruction sheet.

Afashimi Pharmaceutical Co. Product

Pdr.net

BNF 2020

Injectable Drugs Guide

Colistimethate Sodium emc

Coly-Mycin® M Parenteral NDA 50-108/S-026