Coly-Mycin M Parenteral

In the U.S.

• Coly-Mycin M
• Coly-Mycin M Parenteral

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

Colistimethate injection is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines called antibiotics that works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is to be given only by or under the direct supervision of your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of colistimethate injection in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of colistimethate injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving colistimethate injection.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alcuronium
• Amikacin
• Atracurium
• Capreomycin
• Cholera Vaccine, Live
• Cisatracurium
• Doxacurium
• Fazadinium
• Gallamine
• Gentamicin
• Hexafluorenium
• Kanamycin
• Metocurine
• Mivacurium
• Neomycin
• Pancuronium
• Paromomycin
• Pipecuronium
• Rapacuronium
• Rocuronium
• Streptomycin
• Tobramycin
• Tubocurarine
• Vecuronium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or
• Lung disease, severe—May make these conditions worse.

• Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

This section provides information on the proper use of a number of products that contain colistimethate. It may not be specific to Coly-Mycin M Parenteral. Please read with care.

A nurse or other trained health professional will give you or your child this medicine. This medicine may be given through a needle placed into one of your veins or as a shot into your muscle.

Sometimes this medicine will be used in a nebulizer (a breathing machine). The patient will breathe it into the lungs to treat an infection. When used this way, the medicine should be mixed right before you put it in the nebulizer for a breathing treatment. You must throw away any leftover liquid medicine that is not used. Do not use pre-mixed liquid medicine that has been stored for any length of time for your breathing treatment. If you bought pre-mixed liquid medicine at the pharmacy, throw it away. Ask your pharmacist or doctor for instructions on how to mix your medicine for the breathing treatment. If you have any questions, talk to your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Urine tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Colistimethate injection may cause some people to become dizzy or to have numbness and tingling sensations in the hands, toes, and feet. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or do not have normal feelings in your hands and feet. If these symptoms are especially bothersome, check with your doctor.

Serious lung or breathing problems may occur after you get a shot of this medicine into one of your muscles. Call your doctor right away if you or your child have any change in your breathing after you receive this medicine.

Colistimethate injection may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues, or gets worse, check with your doctor.

Check with your doctor right away if you or your child have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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.