Daptomycin (Intravenous Route)

Antibiotics are medicines used in the treatment of infections caused by bacteria. They work by killing bacteria or preventing their growth . Daptomycin will not work for colds, flu, or other virus infections.

Daptomycin is used to treat complicated skin infections. It is also used to treat infections in the bloodstream caused by a bacteria called Staphylococcus aureus.

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Powder for Solution

Before Using

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

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

Geriatric

Elderly people are especially sensitive to the effects of daptomycin. This may increase the chance of side effects during treatment .

Pregnancy

Breastfeeding

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.

Drug Interactions

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

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:

• Kidney diseasea€”Your doctor may need to lower your dose

• Liver diseasea€”Studies on this medicine have not been done in patients with severe liver disease.

• Muscle problemsa€”May be worsened by daptomycin.

Proper Use

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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

• For injection dosage form:
  
  
  
  • For complicated skin infections caused by bacteria:
    
    
    
    • Adultsa€”4 milligrams (mg) per kilogram (kg) (1.82 mg per pound) of body weight injected into a vein every 24 hours.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  
  
  
  • For bloodstream infections caused by bacteria:
    
    
    
    • Adultsa€”6 mg per kg (2.73 mg per pound) of body weight injected into a vein every 24 hours.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not take more than one dose each day.

Storage

Store in the refrigerator. Do not freeze .

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

If you have muscle pain or weakness while receiving this medicine, check with your 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 medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems .

Side Effects

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 immediately 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 getting up from a lying or sitting position suddenly


• Frequent urge 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


• Unusual bleeding or bruising


• Usual tiredness or weakness

Frequency not determined

• Abdominal or stomach cramps


• Abdominal tenderness


• Bloating


• Diarrhea, watery and severe, which may also be bloody


• Fever


• Increased thirst


• Pain


• Unusual weight loss


• Vomiting

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:

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

• Difficult or labored breathing


• Itching skin


• Limb pain


• Shortness of breath


• Skin rash


• Sleeplessness


• Tightness in chest


• Trouble sleeping


• 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 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.

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.