Cubicin

DRUG DESCRIPTION

CUBICIN contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-trireonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ?1-lactone. The chemical structure is:

CUBICIN® (daptomycin) Structural Formula Illustration

The empirical formula is C72H101N17O26; the molecular weight is 1620.67. CUBICIN is supplied in a single-use vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake containing approximately 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see DOSAGE AND ADMINISTRATION]. The only inactive ingredient is sodium hydroxide, which is used in minimal quantities for pH adjustment. Freshly reconstituted solutions of CUBICIN range in color from pale yellow to light brown.

What are the possible side effects of daptomycin (Cubicin)?

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:

  • unusual muscle pain, tenderness, or weakness;
  • numbness or tingling;
  • pain or burning when you urinate;
  • diarrhea that is watery or bloody;
  • pale skin, weakness, easy bruising or bleeding;
  • swelling; or
  • chest...

Read All Potential Side Effects and See Pictures of Cubicin »

What are the precautions when taking daptomycin injection (Cubicin)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe diarrhea (Clostridium difficile-associated diarrhea).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease or kidney dialysis, muscle problems (e.g., myopathy).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can...

Read All Potential Precautions of Cubicin »


Cubicin Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, diarrhea, headache, dizziness, trouble sleeping, anxiety, or pain/redness/swelling at the injection site may occur. If any of these effects persist or worsen, notify 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 immediately if any of these unlikely but serious side effects occur: muscle pain/cramps/weakness, numbness or tingling of hands or feet, unusual tiredness or weakness, change in amount of urine, chest pain, swelling, shakiness, sweating, increased thirst, blurred vision.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: unusual bleeding or bruising, irregular heartbeat, yellowing of the skin or eyes, dark urine, cough, difficult/painful breathing, new/unexplained fever.

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 immediately 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 oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/severe 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.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe diarrhea (Clostridium difficile-associated diarrhea).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease or kidney dialysis, muscle problems (e.g., myopathy).

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.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Cubicin Patient Information Including Side Effects

Brand Names: Cubicin

Generic Name: daptomycin (Pronunciation: DAP to my sin)

  • What is daptomycin (Cubicin)?
  • What are the possible side effects of daptomycin (Cubicin)?
  • What is the most important information I should know about daptomycin (Cubicin)?
  • What should I discuss with my healthcare provider before using daptomycin (Cubicin)?
  • How should I use daptomycin (Cubicin)?
  • What happens if I miss a dose (Cubicin)?
  • What happens if I overdose (Cubicin)?
  • What should I avoid while using daptomycin (Cubicin)?
  • What other drugs will affect daptomycin (Cubicin)?
  • Where can I get more information?

What is daptomycin (Cubicin)?

Daptomycin is an antibiotic that fights bacteria in the body.

Daptomycin is used to treat bacterial infections of the skin and underlying tissues.

Daptomycin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of daptomycin (Cubicin)?

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:

  • unusual muscle pain, tenderness, or weakness;
  • numbness or tingling;
  • pain or burning when you urinate;
  • diarrhea that is watery or bloody;
  • pale skin, weakness, easy bruising or bleeding;
  • swelling; or
  • chest pain.

Less serious side effects may include:

  • constipation, nausea, diarrhea, vomiting;
  • redness, discomfort, or irritation where the injection was given;
  • headache;
  • cough, sore throat;
  • back pain;
  • loss of appetite;
  • headache;
  • anxiety, confusion, sleep problems (insomnia); or
  • mild skin rash.

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.

What is the most important information I should know about daptomycin (Cubicin)?

Before using daptomycin, tell your doctor if you are taking a blood thinner or a cholesterol-lowering medication.

Daptomycin is given as an injection into a vein. You may be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Daptomycin will not treat a viral infection such as the common cold or flu.

Call your doctor at once if you have any numbness or tingling, or any unusual muscle pain, tenderness, or weakness.

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.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any scheduled appointments.

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