Cisatracurium Besylate Injection Multi-Dose: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• Cisatracurium Besylate Injection Single-Dose and

  Cisatracurium Besylate Injection Multi-Dose are used for providing muscle relaxation during surgery, or during other medical procedures. Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose are only used in conjunction with an anesthetic.

What it does:

Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose belong to a group of medicines called neuromuscular blockers. It works by blocking the effects of acetylcholine, a chemical involved in muscle contraction. This relaxes muscles in the body before surgery or insertion of a breathing tube.

When it should not be used:

Cisatracurium Besylate Injection Multi-Dose contains benzyl alcohol and should not be used in neonates (infants less that 1 month of age) or low birth weight infants or in patients allergic to benzyl alcohol. Cisatracurium Besylate Injection Single-Dose is benzyl alcohol free.

Before surgery, be sure to tell all consulting physicians if you:

• are allergic to cisatracurium besylate;
• are allergic to any other bis-benzylisoquinolinium agents;

• are allergic to benzyl alcohol.

What the medicinal ingredient is:

cisatracurium besylate

What the important nonmedicinal ingredients are:

Cisatracurium Besylate Injection Single-Dose 5 mL vials also contain benzenesulfonic acid and water for injection.

Cisatracurium Besylate Injection Multi-Dose 10 mL vials also contain benzenesulfonic acid, benzyl alcohol and water for injection.

What dosage forms it comes in:

Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose are available in single-dose vials of 5 mL and in multiple-dose vials of 10 mL.

WARNINGS AND PRECAUTIONS

BEFORE you use Cisatracurium Besylate Injection Single-Dose or Cisatracurium Besylate Injection Multi-Dose talk to your doctor or pharmacist if:

• You have difficulty with intubations
• You are susceptible to malignant hyperthermia
• You have kidney or liver problems

• You are pregnant, plan to become pregnant, or are breastfeeding

• You are taking any prescription or non-prescription medications or herbal medicines
• You are allergic to cisatracurium besylate, other medications or substances (e.g., benzyl alcohol)
• You have muscle weakness or partial paralysis on one side of the body or partial paralysis affecting the lower limbs (e.g., Lambert-Eaton syndrome, myasthenia gravis)
• You have an electrolyte disturbance or acid-base imbalance or tissue wasting, or are debilitated
• You have had a burn injury requiring medical treatment

Cisatracurium Besylate Injection Multi-Dose 10 mL contains benzyl alcohol, which could be lethal to neonates (infants less than 1 month of age) and low birth weight infants.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose include:

• succinylcholine
• inhalation anesthetics (e.g., isoflurane, enflurane)
• anticonvulsants (e.g., phenytoin, carbamazepine)
• antibiotics (e.g., aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin)
• anti-arrhythmics (e.g., procainamide and quinidine)
• lithium and magnesium salts
• local anesthetics

PROPER USE OF THIS MEDICATION

Usual dose:

Cisatracurium Besylate Injection Single-Dose or Cisatracurium Besylate Injection Multi-Dose is a medicine that is given by injection. Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose will be administered by an anesthetist or other trained professional during surgery or other medical procedures. The dosage will vary according to many factors such as body weight, age and the duration of the procedure. It will be given to you once you are anesthetised (lost all awareness) for your surgery or procedure.

Overdose:

Overdoses of Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose lead to prolonged relaxation of the body’s muscles. This can be readily treated; however, this situation is unlikely to occur because Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose are only administered by an anesthetist or other trained doctor who will closely monitor your progress.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose can cause uncommon side effects which include flushing, skin rashes, feeling agitated, increased cough, nausea, and vomiting.

After exposure to Cisatracurium Besylate Injection Single-Dose or Cisatracurium Besylate Injection Multi-Dose, you should contact your physician or anesthesia professional if you have any of the side effects listed in the table below.

This is not a complete list of side effects. For any unexpected effects while taking Cisatracurium Besylate Injection Single-Dose or Cisatracurium Besylate Injection Multi-Dose, contact your doctor or pharmacist.

HOW TO STORE IT

Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose should be stored under refrigeration (2 °C to 8 °C) and protected from light to preserve potency. PROTECT FROM FREEZING.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada, Postal Locator 0701E Ottawa, ON

    K1A 0K9

    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).

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.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at 1-877-821-7724.

Fresenius Kabi Canada Ltd.

45 Vogell Rd, Suite 200

Richmond Hill, ON L4B 3P6

Last revised: July 7, 2015