DAPTOMYCIN (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Cubicin

? Not commercially available in Canada.

Category

• Antibacterial, systemic

Description

Daptomycin (DAP-toe-mye-sin) belongsto the family of medicines called antibiotics. Antibiotics are medicines usedin the treatment of infections caused by bacteria. They work by killing bacteriaor preventing their growth. Daptomycin will not work for colds, flu, or othervirus infections.

Daptomycin is used to treat complicated skin infections.

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

Parenteral
• Injection (U.S.)

Before Receiving This Medicine

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

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to daptomycin. Also tell your doctor and pharmacist ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Daptomycin has not been studied in pregnant women.However, daptomycin has not been shown to cause birth defects or other problemsin animal studies.

Breast-feeding?It is not known whether daptomycin passes intobreast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast feeding. Mothers who are takingthis medicine and who wish to breast feed should discuss this with their doctor

Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of daptomycinin children with use in other age groups.

Older adults?Elderly people are especially sensitive to theeffects of daptomycin. This may increase the chance of side effects duringtreatment.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of daptomycin. Make sure you tell your doctorif you have any other medical problems, especially:

• Kidney disease?Your doctor may need to lower your dose

• Liver disease?Studies on this medicine have not been done inpatients with severe liver disease.

• Muscle problems?May be worsened by daptomycin.

Proper Use of This Medicine

Dosing?To help clear up your infection completely, daptomycin must be given for the full time of treatment, even if youbegin to feel better after a few days. Also, this medicine works best whenthere is a constant amount in the blood. To help keep the amount constant,daptomycin must be given on a regular schedule.

The dose of daptomycin will be different for different patients. Follow your doctor's orders or the directions on the label.The following information includes only the average doses of daptomycin. If your dose is different, do not change it unless yourdoctor tells you to do so.

• For injection dosage form:
  • For complicated skin infections caused by bacteria
    • Adults?4 mg per kg (1.82 mg per pound) injected into a veinevery 24 hours.
    • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not take morethan one dose each day.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator.
• Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Ifyou have muscle pain or weakness while receiving this medicine, check withyour doctor right away.

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

Do not take other medicines unless they have been discussed with your doctor.This especially includes nonprescription medicines, such as aspirin, and medicinesfor appetite control, asthma, colds, cough, hay fever, or sinus problems.

Side Effects of This Medicine

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

Check with your doctorimmediately if any of the following side effects occur:

Less common

Agitation; bladder pain; bloody or cloudy urine; blurred vision; coma; confusion; decreased urine output; depression; difficult, burning, or painful urination; dizziness; faintness, or lightheadedness when gettingup from a lying or sitting position suddenly; frequenturge to urinate; headache; hostility; irritability; itching in genital or other skin areas; lethargy; lower back or side pain; muscle twitching; nausea; nervousness; pale skin; pounding in the ears; rapid weight gain; scaling; seizures; slow or fast heartbeat; stupor; sweating; swelling of face, ankles, or hands; troubled breathing with exertion; usualtiredness or weakness; unusual bleeding or bruising

Frequency not determined

Abdominal or stomach cramps; abdominaltenderness; bloating; diarrhea,watery and severe, which may also be bloody; fever; increased thirst; pain; unusual weight loss; vomiting

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome.

More Common

bleeding, blistering, burning, coldness, discoloration of skin,feeling of pressure, hives, infection, inflammation, itching, lumps, numbness,pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling,ulceration, or warmth at site of injection; diarrhea,mild; difficulty having a bowel movement (stool)

Less common

Itching skin; limb pain; difficult or labored breathing; shortnessof breath; skin rash; sleeplessness; tightness in chest; troublesleeping; unable to sleep; wheezing

Rare

Acid or sour stomach; belching; difficulty in moving; heartburn; indigestion; muscle pain or stiffness; pain in joints

Other side effects may occur that usuallydo not need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. Also, your health care professionalmay be able to tell you about ways to prevent or reduce some of these sideeffects.

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.