Pronunciation:

roe-kure-OH-nee-um

Brand Names:

• Zemuron

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Musculoskeletal Agent

Pharmacologic—

Neuromuscular Blocker, Non-Depolarizing

Uses of This Medicine:

Rocuronium injection is used with general anesthesia medicines for rapid sequence intubation and routine tracheal intubation. This medicine is also used to help relax the muscles during surgery or mechanical ventilation.

This medicine is to be given only by your doctor or other trained health professional.

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 rocuronium injection in children. However, use of this medicine in children for rapid sequence intubation is not recommended.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rocuronium injection in the elderly. However, elderly patients are more likely to have residual neuromuscular block or blood circulation problems, which may require caution in patients receiving this medicine.

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
• Dibekacin
• Epinephrine
• Fosphenytoin
• Framycetin
• Gentamicin
• Isepamicin
• Isoflurane
• Kanamycin
• Neomycin
• Netilmicin
• Phenytoin
• Polymyxin B
• Procainamide
• St John's Wort
• Streptomycin
• Tobramycin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Enflurane
• Magnesium
• Sevoflurane

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:

• Blood circulation problems or
• Eaton-Lambert syndrome (muscle problem) or
• Electrolyte imbalance or
• Heart or blood vessel disease or
• Heart rhythm problem (eg, QT prolongation) or
• Heart valve disease or
• Metabolic acidosis or alkalosis or
• Myasthenia gravis (muscle problem) or
• Pulmonary hypertension—Use with caution. May make these conditions worse.

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

• Malignant hyperthermia—Should be treated first before using this medicine.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check you or your child closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Myopathy may occur while using this medicine for a long period of time in intensive care unit (ICU). It may also occur if this medicine is used together with a steroid medicine. Tell your doctor right away if you or your child have extreme or ongoing muscle weakness while using this medicine.

Tell your doctor right away if you or your child have pale skin, pain, or redness at the injection site while using this medicine.

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

Cough

difficulty with breathing

dizziness

fainting

fast, slow, or irregular heartbeat

noisy breathing

swelling at the injection site

tightness in the chest

Incidence not known

Difficulty with swallowing

hives, itching, or skin rash

muscular pain, tenderness, wasting, or weakness

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

unusual tiredness or weakness

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.