Colistimethate Injection (Coly-Mycin M)
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Colistimethate Injection (Coly-Mycin M)

Coly-Mycin® M Parenteral
(colistimethate) for Injection, USP

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M (colistimethate injection) and other antibacterial drugs, Coly-Mycin M (colistimethate injection) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

FOR INTRAMUSCULAR AND INTRAVENOUS USE

DRUG DESCRIPTION

Coly-Mycin® M Parenteral (Colistimethate for Injection, USP) is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration.

Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity).

Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The empirical formula is C58H105N16Na5O28S5 and the structural formula is represented below:

Coly-Mycin® M Parenteral 
  (Colistimethate) Structural Formula Illustration

What are the possible side effects of colistimethate (Coly Mycin M)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • fever;
  • urinating less than usual or not at all;
  • muscle weakness; or
  • trouble breathing.

Less serious side effects may include:

  • mild numbness or tingling in your hands or feet;
  • dizziness, spinning feeling;
  • itching, mild skin...

Read All Potential Side Effects and See Pictures of Coly-Mycin M »

What are the precautions when taking colistimethate injection (Coly-Mycin M)?

Before using colistimethate, tell your doctor or pharmacist if you are allergic to it; or to polymyxin B or colistin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diseases of the nerves/muscles (such as myasthenia gravis), kidney disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery or any procedure requiring anesthesia or medications that block nerve or muscle activity, tell...

Read All Potential Precautions of Coly-Mycin M »

Last reviewed on RxList: 7/27/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Coly-Mycin M (colistimethate injection) Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Coly-Mycin M (colistimethate injection) Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.

Coly-Mycin M (colistimethate injection) Parenteral may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M (colistimethate injection) and other antibacterial drugs, Coly-Mycin M (colistimethate injection) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

Important: Coly-Mycin M Parenteral is supplied in vials containing colistimethate sodium equivalent to 150 mg colistin base activity per vial.

Reconstitution: The 150 mg vial should be reconstituted with 2.0 mL Sterile Water for Injection, USP. The reconstituted solution provides colistimethate sodium at a concentration equivalent to 75 mg/mL colistin base activity.

During reconstitution swirl gently to avoid frothing.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions are observed, the product should not be used.

Dosage

Adults and pediatric patients—Intravenous or Intramuscular Administration: Coly-Mycin M (colistimethate injection) Parenteral should be given in 2 to 4 divided doses at dose levels of 2.5 to 5 mg/kg per day for patients with normal renal function, depending on the severity of the infection.

In obese individuals, dosage should be based on ideal body weight.

The daily dose should be reduced in the presence of renal impairment. Modifications of dosage in the presence of renal impairment are presented in Table 1.

TABLE 1. Suggested Modification of Dosage Schedules of Coly-Mycin M Parenteral for Adults with Impaired Renal Function

Renal Function Degree of Impairment
Normal Mild Moderate Considerable
Plasma creatinine, mg/100 mL 0.7–1.2 1.3–1.5 1.6–2.5 2.6–4.0
Urea clearance,% of normal 80–100 40–70 25–40 10–25
Dosage
Unit dose of Coly-Mycin M, mg 100–150 75–115 66–150 100–150
Frequency, times/day 4 to 2 2 2 or 1 every 36 hr
Total daily dose, mg 300 150–230 133–150 100
Approximate daily dose, mg/kg/day 5.0 2.5–3.8 2.5 1.5
Note: The suggested unit dose is 2.5–5 mg/kg; however, the time INTERVAL between injections should be increased in the presence of impaired renal function.

INTRAVENOUS ADMINISTRATION

  1. Direct Intermittent Administration—Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours.
  2. Continuous Infusion—Slowly inject one-half of the total daily dose over 3 to 5 minutes. Add the remaining half of the total daily dose of Coly-Mycin M Parenteral to one of the following:
    • 0.9% NaCI
      5% dextrose in 0.9% NaCI
      5% dextrose in water
      5% dextrose in 0.45% NaCI
      5% dextrose in 0.225% NaCI
      lactated Ringer's solution
      10% invert sugar solution

There are not sufficient data to recommend usage of Coly-Mycin M (colistimethate injection) Parenteral with other drugs or other than the above listed infusion solutions.

Administer the second half of the total daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the presence of impaired renal function, reduce the infusion rate depending on the degree of renal impairment.

The choice of intravenous solution and the volume to be employed are dictated by the requirements of fluid and electrolyte management.

Any infusion solution containing colistimethate sodium should be freshly prepared and used for no longer than 24 hours.

HOW SUPPLIED

Coly-Mycin M Parenteral is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to slightly yellow Iyophilized cake and is available as one vial per carton (NDC 61570-414-51).

Store between 20°-25°C (68°-77°F). (See USP controlled room temperature.)

Store reconstituted solution in refrigerator 2°-8°C (36°-46°F) or between 20°-25°C (68°-77°F) and use within 7 days.

Prescribing Information as of October 2006. Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620 (A wholly owned subsidiary of King Pharmaceuticals, Inc.). Manufactured by: Parkedale Pharmaceuticals, Inc., Rochester, MI 48307.

Last reviewed on RxList: 7/27/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following adverse reactions have been reported:

Gastrointestinal: gastrointestinal upset

Nervous System: tingling of extremities and tongue, slurred speech, dizziness, vertigo and paresthesia

Integumentary: generalized itching, urticaria and rash

Body as a Whole: fever

Laboratory Deviations: increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance

Respiratory System:respiratory distress and apnea

Renal System: nephrotoxicity and decreased urine output

Read the Coly-Mycin M (colistimethate injection) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Certain other antibiotics (aminoglycosides and polymyxin) have also been reported to interfere with the nerve transmission at the neuromuscular junction. Based on this reported activity, they should not be given concomitantly with Coly-Mycin M (colistimethate injection) Parenteral except with the greatest caution.

Curariform muscle relaxants (e.g., tubocurarine) and other drugs, including ether, succinylcholine, gallamine, decamethonium and sodium citrate, potentiate the neuromuscular blocking effect and should be used with extreme caution in patients being treated with Coly-Mycin M (colistimethate injection) Parenteral.

Sodium cephalothin may enhance the nephrotoxicity of Coly-Mycin M (colistimethate injection) Parenteral. The concomitant use of sodium cephalothin and Coly-Mycin M (colistimethate injection) Parenteral should be avoided.

Last reviewed on RxList: 7/27/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Maximum daily dose should not exceed 5 mg/kg/day (2.3 mg/lb) with normal renal function.

Transient neurological disturbances may occur. These include circumoral paresthesia or numbness, tingling or formication of the extremities, generalized pruritus, vertigo, dizziness, and slurring of speech. For these reasons, patients should be warned not to drive vehicles or use hazardous machinery while on therapy. Reduction of dosage may alleviate symptoms. Therapy need not be discontinued, but such patients should be observed with particular care.

Nephrotoxicity can occur and is probably a dose-dependent effect of colistimethate sodium. These manifestations of nephrotoxicity are reversible following discontinuation of the antibiotic.

Overdosage can result in renal insufficiency, muscle weakness, and apnea (see OVERDOSE section). See PRECAUTIONS: DRUG INTERACTIONS subsection for use concomitantly with other antibiotics and curariform drugs.

Respiratory arrest has been reported following intramuscular administration of colistimethate sodium. Impaired renal function increases the possibility of apnea and neuromuscular blockade following administration of colistimethate sodium. Therefore, it is important to follow recommended dosing guidelines. See DOSAGE AND ADMINISTRATION section for use in renal impairment.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Coly-Mycin M (colistimethate injection) Parenteral, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

General

Since Coly-Mycin M (colistimethate injection) Parenteral is eliminated mainly by renal excretion, it should be used with caution when the possibility of impaired renal function exists. The decline in renal function with advanced age should be considered.

When actual renal impairment is present, Coly-Mycin M (colistimethate injection) Parenteral may be used, but the greatest caution should be exercised and the dosage should be reduced in proportion to the extent of the impairment. Administration of amounts of Coly-Mycin M (colistimethate injection) Parenteral in excess of renal excretory capacity will lead to high serum levels and can result in further impairment of renal function, initiating a cycle which, if not recognized, can lead to acute renal insufficiency, renal shutdown, and further concentration of the antibiotic to toxic levels in the body. At this point, interference of nerve transmission at neuromuscular junctions may occur and result in muscle weakness and apnea (see OVERDOSAGE section).

Signs indicating the development of impaired renal function include: diminishing urine output, rising BUN and serum creatinine and decreased creatinine clearance. Therapy with Coly-Mycin M (colistimethate injection) Parenteral should be discontinued immediately if signs of impaired renal function occur. However, if it is necessary to reinstate the drug, dosing should be adjusted accordingly after drug plasma levels have fallen (see DOSAGE AND ADMINISTRATION section).

Prescribing Coly-Mycin M (colistimethate injection) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal carcinogenicity studies and genetic toxicology studies have not been performed with colistimethate sodium. There were no adverse effects on fertility or reproduction in rats at doses of 9.3 mg/kg/day (0.30 times the maximum daily human dose when based on mg/m2).

Pregnancy - Teratogenic Effects

Pregnancy Category C: Colistimethate sodium given intramuscularly during organogenesis to rabbits at 4.15 and 9.3 mg/kg resulted in talipes varus in 2.6% and 2.9% of fetuses, respectively. These doses are 0.25 and 0.55 times the maximum daily human dose based on mg/m2. In addition, increased resorption occurred at 9.3 mg/kg. Colistimethate sodium was not teratogenic in rats at 4.15 or 9.3 mg/kg. These doses are 0.13 and 0.30 times the maximum daily human dose based on mg/m2. There are no adequate and well-controlled studies in pregnant women. Since colistimethate sodium is transferred across the placental barrier in humans, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether colistimethate sodium is excreted in human breast milk. However, colistin sulphate is excreted in human breast milk. Therefore, caution should be exercised when colistimethate sodium is administered to nursing women.

Geriatric Use

Clinical studies of colistemethate sodium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Pediatric Use

In clinical studies, colistimethate sodium was administered to the pediatric population (neonates, infants, children and adolescents). Although adverse reactions appear to be similar in the adult and pediatric populations, subjective symptoms of toxicity may not be reported by pediatric patients. Close clinical monitoring of pediatric patients is recommended.

Last reviewed on RxList: 7/27/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Overdosage with colistimethate sodium can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may lead to apnea, respiratory arrest and death. Overdosage with the drug can also cause acute renal failure, manifested as decreased urine output and increases in serum concentrations of BUN and creatinine.

As in any case of overdose, colistimethate sodium therapy should be discontinued and general supportive measures should be utilized.

It is unknown whether colistimethate sodium can be removed by hemodialysis or peritoneal dialysis in overdose cases.

CONTRAINDICATIONS

The use of Coly-Mycin M (colistimethate injection) Parenteral is contraindicated for patients with a history of sensitivity to the drug or any of its components.

Last reviewed on RxList: 7/27/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Typical serum and urine levels following a single 150 mg dose of Coly-Mycin M (colistimethate injection) Parenteral IM or IV in normal adult subjects are shown in Figure 1.

Figure 1

Typical serum and urine levels following a single 150 mg dose - Illustration

Higher serum levels were obtained at 10 minutes following IV administration. Serum concentration declined with a half-life of 2–3 hours following either intravenous or intramuscular administration in adults and in the pediatric population, including premature infants.

Average urine levels ranged from about 270 mcg/mL at 2 hours to about 15 mcg/mL at 8 hours after intravenous administration and from 200 to about 25 mcg/mL during a similar period following intramuscular administration.

Microbiology

Colistimethate sodium is a surface active agent which penetrates into and disrupts the bacterial cell membrane. It has been shown to have bactericidal activity against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS section:

Aerobic gram-negative microorganisms

Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.

Susceptibility Tests

Colistimethate sodium is no longer listed as an antimicrobial for routine testing and reporting by clinical microbiology laboratories.

Last reviewed on RxList: 7/27/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients should be counseled that antibacterial drugs including Coly-Mycin M (colistimethate injection) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Coly-Mycin M (colistimethate injection) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectivenss of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Coly-Mycin M (colistimethate injection) or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Last reviewed on RxList: 7/27/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients should be counseled that antibacterial drugs including Coly-Mycin M (colistimethate injection) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Coly-Mycin M (colistimethate injection) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectivenss of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Coly-Mycin M (colistimethate injection) or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Last reviewed on RxList: 7/27/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Coly-Mycin M Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

COLISTIMETHATE - INJECTION

(koe-LIS-ti-METH-ate)

COMMON BRAND NAME(S): Coly-Mycin M

USES: Colistimethate is an antibiotic used to treat certain bacterial infections. It works by stopping the growth of bacteria.

OTHER USES: This section contains uses of this drug that are not listed in the approved US professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

In patients with cystic fibrosis, inhaled colistimethate may be used to treat serious bacterial lung infections (Pseudomonas aeruginosa). See also the Storage section for information about important safety concerns when this medication is inhaled.

HOW TO USE: Colistimethate for injection is usually given into a vein or a muscle as directed by your doctor. The dosage is based on your medical condition and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

If you are inhaling this medication, learn how to prepare the solution and use the nebulizer machine properly. See also the Storage section. If you have any questions, ask your health care professional.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, use this drug at evenly spaced intervals.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition does not improve or if it worsens.

Disclaimer

Coly-Mycin M Consumer (continued)

SIDE EFFECTS: Stomach upset and itching may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling (especially of the arms/legs, around the mouth/tongue), strange feeling on the skin of the arms/legs, mental/mood changes (such as confusion, psychosis, seizures), difficulty walking, unsteadiness, slow/shallow/troubled breathing, dizziness/feeling of spinning, unexplained fever, slurred speech, muscle weakness, change in the amount of urine, red/pink urine.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in a new infection. Tell your doctor if you notice any symptoms of a new infection (such as white patches in your mouth, a change in vaginal discharge).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Coly-Mycin M (colistimethate injection) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using colistimethate, tell your doctor or pharmacist if you are allergic to it; or to polymyxin B or colistin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diseases of the nerves/muscles (such as myasthenia gravis), kidney disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery or any procedure requiring anesthesia or medications that block nerve or muscle activity, tell your doctor or dentist that you are using this medication.

This medication may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

Older adults may be more sensitive to the side effects of this drug, especially kidney problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Coly-Mycin M Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: extreme drowsiness, slow/shallow breathing, muscle weakness, inability to move.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as kidney tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss an injection, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

If you miss an inhaled dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: For colistimethate injection, consult the product instructions and your pharmacist for storage details.

If you are using colistimethate as an inhalation, store the unmixed vials at room temperature. Do not use premixed solution or prepare the solution ahead of time because this increases the risk of very serious breathing problems. Prepare the inhalation solution right before use. Discard any unused solution after 24 hours. Do not store for longer periods. Ask your health care professional for details.

Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised November 2011. Copyright(c) 2011 First Databank, Inc.

Coly-Mycin M Patient Information Including Side Effects

Brand Names: Coly Mycin M

Generic Name: colistimethate (Pronunciation: koe LIS ti METH ate)

What is colistimethate (Coly-Mycin M)?

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.

What are the possible side effects of colistimethate (Coly-Mycin M)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • fever;
  • urinating less than usual or not at all;
  • muscle weakness; or
  • trouble breathing.

Less serious side effects may include:

  • mild numbness or tingling in your hands or feet;
  • dizziness, spinning feeling;
  • itching, mild skin rash; or
  • upset stomach.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Coly-Mycin M (colistimethate injection) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about colistimethate (Coly-Mycin M)?

You should not use this medication if you are allergic to colistimethate.

Before using colistimethate, tell your doctor if you are allergic to any drugs, or if you have kidney disease. You may need a dose adjustment or special tests during treatment.

Colistimethate is given as an injection into a muscle or through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Keep using colistimethate for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Colistimethate will not treat a viral infection such as the common cold or flu.

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

Side Effects Centers

Coly-Mycin M Patient Information including How Should I Take

What should I discuss with my health care provider before taking colistimethate (Coly-Mycin M)?

You should not use this medication if you are allergic to colistimethate.

Before using colistimethate, tell your doctor if you are allergic to any drugs, or if you have kidney disease. You may need dose adjustments or special tests during treatment.

Your doctor will tell you if any of your medication doses need to be changed.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether colistimethate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take colistimethate (Coly-Mycin M)?

Colistimethate is given as an injection into a muscle or through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

The colistimethate injection is sometimes given every 12 hours. The medication can also be mixed with a liquid in an IV bag and given as a slow infusion over a 24-hour period.

Use each disposable needle and syringe only one time. Throw away used needles and syringes in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Use this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Keep using colistimethate for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Colistimethate will not treat a viral infection such as the common cold or flu.

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

If you store colistimethate at home, keep the medication at cool room temperature away from moisture and heat.

After colistimethate is mixed in an IV bag, it must be kept in a refrigerator and used within 7 days of mixing.

Side Effects Centers

Coly-Mycin M Patient Information including If I Miss a Dose

What happens if I miss a dose (Coly-Mycin M)?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Coly-Mycin M)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include confusion, dizziness, loss of balance or coordination, blurred vision, slurred speech, severe numbness or tingling, or trouble breathing.

What should I avoid while taking colistimethate (Coly-Mycin M)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

What other drugs will affect colistimethate (Coly-Mycin M)?

The following antibiotics can interact with colistimethate. Tell your doctor if you are using any of these:

  • amikacin (Amikin);
  • gentamicin (Garamycin);
  • kanamycin (Kantrex);
  • neomycin (Mycifradin, Neo-Fradin, Neo-Tab);
  • netilmicin (Netromycin);
  • polymyxin;
  • streptomycin; or
  • tobramycin (Nebcin, Tobi).

This list is not complete and there may be other drugs that can interact with colistimethate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about colistimethate.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.04. Revision date: 12/15/2010.

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