Coly Mycin M

Colistimethate is injected into a muscle, or into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Colistimethate is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

After mixing colistimethate for injection into a vein (IV infusion), you must use the medicine right away. Do not store for later use.

After mixing colistimethate for injection into a muscle, you may store the mixture in a refrigerator. Do not freeze. Use within 7 days.

Colistimethate must be given slowly. Your IV infusion may take 3 to 5 minutes to complete. In some cases, colistimethate is given over a period of up to 23 hours. Follow your doctor's dosing instructions very carefully.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Colistimethate will not treat a viral infection such as the flu or a common cold.

If you need surgery, tell the surgeon ahead of time that you are using colistimethate. You may need to stop using the medicine for a short time.

Store unmixed colistimethate powder at cool room temperature, away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include confusion, dizziness, loss of balance or coordination, severe numbness or tingling, rapid eye movement, slurred speech, weak or shallow breathing, or loss of consciousness.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Coly Mycin M is part of the drug class:

• Polymyxins

Colistimethate is an antibiotic that fights bacteria in the body.

Colistimethate is used to treat infections caused by bacteria.

Colistimethate may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Colistimethate is injected into a muscle, or into a vein through an IV. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Colistimethate is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

After mixing colistimethate for injection into a vein (IV infusion), you must use the medicine right away. Do not store for later use.

After mixing colistimethate for injection into a muscle, you may store the mixture in a refrigerator or at cool room temperature. Do not freeze. Use within 7 days.

Colistimethate must be given slowly. Your IV infusion may take 3 to 5 minutes to complete. In some cases, colistimethate is given over a period of up to 23 hours. Follow your doctor's dosing instructions very carefully.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Colistimethate will not treat a viral infection such as the flu or a common cold.

If you need surgery, tell the surgeon ahead of time that you are using colistimethate. You may need to stop using the medicine for a short time.

Store unmixed colistimethate powder at cool room temperature, away from moisture and heat.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of colistimethate can be fatal.

Overdose symptoms may include confusion, dizziness, loss of balance or coordination, severe numbness or tingling, rapid eye movement, problems with speech, weak or shallow breathing, or loss of consciousness.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• any injected or IV antibiotics--amikacin, gentamicin, neomycin, polymyxin, streptomycin, tobramycin.

This list is not complete. Other drugs may interact with colistimethate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Antibacterial; prodrug of colistin134 140 141 142 (a polymyxin antibiotic structurally and pharmacologically related to polymyxin B).134

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Blood in the urine
• bluish lips or skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in the frequency or amount of urine
• cough
• decrease in amount of urine
• difficulty with breathing or swallowing
• dizziness
• drowsiness
• fast heartbeat
• fever
• hives, itching, skin rash
• increased thirst
• loss of appetite
• nausea or vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• slurred speech
• swelling of the feet or lower legs
• tightness in the chest
• tingling of the arms, legs, and tongue
• troubled breathing
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

• Dizziness
• mood or mental changes
• shakiness and unsteady walk
• uncontrolled eye movements
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• redness of the skin
• sensation of spinning
• stomach cramps or pain
• swelling, tenderness, or pain at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat bacterial infections.

Applies to colistimethate: compounding powder, injectable powder for injection

Nervous system

Nervous system side effects have included tingling of the tongue and extremities, slurred speech, dizziness, vertigo, paresthesia, confusion, psychosis, and seizures. Neuromuscular blockade may occur with overdoses.[Ref]

Respiratory

Respiratory side effects have included respiratory distress and apnea. Inhalation treatment has been associated with cough and bronchospasm. At least one case of fatal acute respiratory distress syndrome with nebulized colistimethate (the active ingredient contained in Coly Mycin M) has been reported.[Ref]

Dermatologic

Dermatologic side effects have included generalized itching, urticaria, and rash.[Ref]

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal upset, nausea, and vomiting.[Ref]

Hypersensitivity

Hypersensitivity side effects have included rash, drug fever, and eosinophilia.[Ref]

Local

Local side effects have included pain at the injection site.[Ref]

Musculoskeletal

Musculoskeletal side effects have included muscular weakness.[Ref]

Other

Other side effects have included fever.[Ref]

Renal

Renal side effects have included increases in blood urea nitrogen and serum creatinine, nephrotoxicity, decreased urine output, acute tubular necrosis, and hematuria.[Ref]

Some side effects of Coly Mycin M may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.