Pronunciation:

sis-at-ra-KURE-ee-um BES-i-late

Brand Names:

• Nimbex

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Musculoskeletal Agent

Pharmacologic—

Cisatracurium

Uses of This Medicine:

Cisatracurium injection is used before and during surgery to provide muscle relaxation and make intubation easier.

This medicine must be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of cisatracurium injection in children 1 month to 12 years of age to provide intubation and in children 2 years of age and older to provide muscle relaxation during surgery. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cisatracurium injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

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.

Other medicines—

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amikacin
• Bacitracin
• Capreomycin
• Carbamazepine
• Colistimethate Sodium
• Desflurane
• Dibekacin
• Enflurane
• Fosphenytoin
• Framycetin
• Gentamicin
• Isepamicin
• Isoflurane
• Kanamycin
• Neomycin
• Netilmicin
• Nitrous Oxide
• Phenytoin
• Polymyxin B
• Procainamide
• St John's Wort
• Streptomycin
• Tobramycin

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:

• Benzyl alcohol—Some strengths of this medicine contain benzyl alcohol and should not be used in premature babies.

• Burn injury or
• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

• Carcinomatosis (cancer) or
• Electrolyte imbalance or
• Nerve or muscle disease (eg, myasthenia gravis, myasthenic syndrome) or
• Seizures, history of—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

This medicine may increase your or your child's risk for muscle weakness, leading to paralysis, or seizures. Talk to your doctor if you have concerns.

This medicine may cause a serious allergic reaction, called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may cause a condition called malignant hyperthermia (dangerous increase in body temperature). Check with your doctor right away if you or your child have a fast heartbeat, high fever, or rigid muscles.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

Rare

Blurred vision

chest pain or discomfort

confusion

cough

difficulty breathing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

lightheadedness, dizziness, or fainting

noisy breathing

slow or irregular heartbeat

sweating

tightness in the chest

unusual tiredness or weakness

Incidence not known

Difficulty swallowing

drowsiness

fast heartbeat

hives, itching, skin rash

muscular pain, tenderness, wasting, or weakness

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

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:

Rare

Feeling of warmth

redness of the face, neck, arms, and occasionally, upper chest

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.