Coly-Mycin M Parenteral (Injection)

Colistimethate injection is used to treat bacterial infections in various parts of the body. It is an antibiotic that works by killing bacteria or stopping their growth. However, this medicine will not work for colds, flu, or other viral infections.

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

It is very important that your doctor closely monitors your or your child's progress during treatment to ensure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days, or if they worsen, consult your doctor.

Colistimethate injection may cause some people to feel dizzy or experience numbness and tingling in the hands, toes, and feet. Make sure you understand how this medicine affects you before driving, operating machinery, or doing anything else that could be dangerous if you are dizzy or have abnormal feelings in your hands and feet. If these symptoms are particularly bothersome, contact your doctor.

Serious lung or breathing problems may occur after you receive a shot of this medicine into one of your muscles. Call your doctor immediately if you or your child experience any changes in breathing after receiving this medicine.

Colistimethate injection may cause diarrhea, which can sometimes be severe. It may happen 2 months or more after you stop using this medicine. Do not take any medication to treat diarrhea without first consulting your doctor. Diarrhea medications may worsen the diarrhea or prolong it. If you have any questions about this, or if mild diarrhea persists or worsens, consult your doctor.

Contact your doctor immediately if you or your child experiences bloody urine, a decrease in the frequency or amount of urine, increased blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, difficulty breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be signs of a serious kidney problem.

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

In deciding to use a medicine, you and your doctor will need to think about the risks and benefits of the medicine. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

So far, studies have not shown any specific problems that would limit the use of colistimethate injection in children.

Geriatric

Studies have not found any specific problems related to the elderly that would limit the usefulness of colistimethate injection. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may need caution and possible dose adjustments for those receiving colistimethate injection.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In such cases, your doctor may adjust the dose or take other precautions. It is very important that your healthcare provider knows if you are taking any of the medicines listed below while receiving this medicine. The following interactions are chosen based on their potential importance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in certain situations. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both 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

Some medicines should not be taken around meal times or with certain foods due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Kidney disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

Incidence not known

• 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
• chest tightness
• 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
• severe abdominal or stomach cramps and pain
• slurred speech
• stomach tenderness
• swelling of the feet or lower legs
• tingling of the arms, legs, and tongue
• trouble breathing
• unusual tiredness or weakness
• watery and severe diarrhea, which may also be bloody

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

Symptoms of overdose

• Bluish lips or skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• confusion
• dizziness
• mood or mental changes
• not breathing
• 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also 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:

Incidence not known

• Feeling of constant movement of self or surroundings
• redness of the skin
• sensation of spinning
• 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.

In the U.S.

• Coly-Mycin M
• Coly-Mycin M Parenteral

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

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 one of your muscles.

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.