Patient Medication Information: uses, side effects, how to take - Daptomycin for Injection Rf (Auro Pharma)

What is Daptomycin for Injection RF used for?

Daptomycin for Injection RF is used to treat bacterial infections:

of the skin and soft tissues (patients 1 year and older)
in the blood (patients 1 year and older)
certain heart valve infections (patients 18 years and older)

Antibacterial drugs like Daptomycin for Injection RF treat only infections caused by bacteria. They do not treat viral infections. Although you may feel better early in treatment, Daptomycin for Injection RF should be used exactly as directed. Misuse or overuse of Daptomycin for Injection RF could lead to growth of bacteria that will not be killed by Daptomycin for Injection RF (resistance). This means that Daptomycin for Injection RF may not work for you in the future.

How does Daptomycin for Injection RF work?

Daptomycin for Injection RF are antibiotics. They work by killing certain bacteria that cause your infection.

What are the ingredients in Daptomycin for Injection RF?

Medicinal ingredients: Daptomycin

Non-medicinal ingredients: Arginine Hydrochloride, Sodium hydroxide

Daptomycin for Injection RF comes in the following dosage forms:

Lyophilized powder for solution available as 500 mg/10 mL vial

Do not use Daptomycin for Injection RF if:

you are allergic to daptomycin.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Daptomycin for Injection RF. Talk about any health conditions or problems you may have, including if you:

have kidney or severe liver problems.
have high blood levels of creatine phosphokinase (CPK).
are pregnant, or planning on becoming pregnant.
are breastfeeding or plan to breastfeed. Breastfeeding should be stopped during treatment with Daptomycin for Injection.
are allergic to any antibiotics or other drugs.
are taking other medications (see The following may interact with Daptomycin for Injection RF).
have any questions about your treatment, both before and during treatment.

Other warnings you should know about:

Stop taking Daptomycin for Injection RF and contact your doctor right away if you:

have severe or lasting diarrhea (bloody or watery) with or without
fever.
stomach pain or tenderness.

You may have Clostridium difficile colitis (bowel inflammation).

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Daptomycin for Injection RF:

Drugs that lower cholesterol (HMG-CoA reductase inhibitors also known as “statins” such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin)
Tobramycin (another antibiotic)
Blood thinners (warfarin)

How to take Daptomycin for Injection RF:

Daptomycin for Injection RF will be given intravenously (injected into a vein) by a doctor or nurse in a hospital or clinical setting.

Usual dose:

Adults:

Serious skin infections: The usual adult dose is 4 mg for every kg of body weight. Your dose will be given either as an injection over a 2-minute period or by infusion over a 30-minute period every 24 hours for 7 to 14 days.

Bacterial infections in the blood, including certain heart valve infections: The usual adult dose is 6 mg for every kg of body weight. Your dose will be given either as an injection over a 2-minute period or by infusion over a 30-minute period every 24 hours for 10 to 56 days.

Children:

Your doctor will decide how much Daptomycin for Injection RF to give your child based on their age, weight and type of infection.

Serious skin infections:

Age Group	Dosage*
Duration of Therapy
12 to 17 years	5 mg/kg once every 24 hours infused over 30 minutes
Up to 14 days
7 to 11 years	7 mg/kg once every 24 hours infused over 30 minutes
2 to 6 years	9 mg/kg once every 24 hours infused over 60 minutes
1 to less than 2 years	10 mg/kg once every 24 hours infused over 60 minutes

Bacterial infections in the blood:

Age Group

Dosage

Duration of Therapy

12 to 17 years

7 mg/kg once every 24 hours infused over

30 minutes

Up to 42 days

7 to 11 years

9 mg/kg once every 24 hours infused over

30 minutes

1 to 6 years

12 mg/kg once every 24 hours infused over

60 minutes

Overdose:

If you think you have taken too much Daptomycin for Injection, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

What are possible side effects from using Daptomycin for Injection RF?

These are not all the possible side effects you may feel when taking Daptomycin for Injection. If you experience any side effects not listed here, contact your healthcare professional.

Common side effects may include:

headache or dizziness.
diarrhea or constipation.
nausea or vomiting.
rash or itching.
difficulty sleeping.

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional		Stop taking drug and get immediate medical help
Symptom / effect	Only if severe	In all cases
UNCOMMON A serious allergic reaction with symptoms such as: shortness of breath, difficulty swallowing. hives, itching, drug rash, blister-like sores. swelling of the mouth, throat, lips and limbs (angioedema).		X
Pain in the hands and feet with symptoms such as: burning, "pins and needles", numbness. muscle pain, weakness or tiredness (myopathy).		X
Irregular heartbeat		X
Kidney problems with symptoms such as: reduced kidney function, kidney failure. increased urination, bloody urine. lower back pain, pressure in the bladder. fatigue and nausea. Fever or rash		X
VERY RARE Respiratory problems with symptoms such as: fever, cough, shortness of breath or difficulty breathing (eosinophilic pneumonia). Inflammation of the lungs (organizing pneumonia)		X

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to
report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Daptomycin for Injection RF vials containing lyophilized powder should be stored at 15ºC to 30ºC.

Reconstituted solutions are to be used immediately or refrigerated (2ºC to 8ºC) and used within 72 hours, then discarded. Health Care professionals should refer to the Product Monograph for more details.

Keep out of reach and sight of children.

If you want more information about Daptomycin for Injection RF:

Talk to your healthcare professional
Find this document plus the full product monograph, prepared for health professionals and includes this Patient Medication Information by visiting the Health Canada website at (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drugproduct-database.html) the manufacturer’s website http://www.auropharma.ca, or by calling 1-855-648-6681.

Date of Revision: August 03, 2023.

Rx or OTC	Prescription (Rx)?
DIN	02540266
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Daptomycin 500 MG
Dosage form(s)	Powder For Solution
Route(s) of administration	Intravenous
Drug class (WHO ATC)	J Antiinfectives for systemic use J01 Antibacterials for systemic use J01X Other antibacterials J01XX Other antibacterials J01XX09 Daptomycin
Company	AURO PHARMA INC
Current status	Approved
Current status date	August 8, 2023

Daptomycin for Injection Rf (Auro Pharma): Uses, Side Effects and Dosage