Pronunciation:

hye-drox-oh-koe-BAL-a-min

Brand Names:

• Cyanokit

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Cyanide Antidote

Pharmacologic—

Vitamin B (class)

Uses of This Medicine:

Hydroxocobalamin injection is an emergency treatment (antidote) used in patients with known or suspected cyanide poisoning. Cyanide poisoning is a life-threatening condition that requires immediate medical attention. It is more likely to occur if you breathe smoke from closed-space household and industrial fires, or you have swallowed or breathe cyanide (a chemical poison), or your skin is exposed to cyanide. Signs and symptoms include chest tightness, confusion, dilated or enlarged pupils, nausea or vomiting, rapid or shallow breathing, trouble breathing, or seizures.

This medicine is to be given only by or under the direct supervision of a 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 have not been performed on the relationship of age to the effects of hydroxocobalamin injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydroxocobalamin injection in the elderly.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Allergy to cyanocobalamin or hydroxocobalamin—Use with caution.

• Hypertension (high blood pressure) or
• Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A doctor or an emergency care provider will give you this medicine. This medicine is given through a needle placed in one of your veins for 15 minutes.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly. Blood tests will also be needed to check for unwanted effects.

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

This medicine may cause high or low blood pressure. Tell your doctor right away if you have fast, slow, pounding, or uneven heartbeats while receiving this medicine.

This medicine may cause skin redness and make your skin more sensitive to sunlight. This effect may last for up to 2 weeks after you have received this medicine. Avoid being in the sun while your skin is red. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

This medicine may cause an acne-like rash that appears 7 to 28 days after treatment. This rash will disappear within a few weeks.

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:

More common

Blurred vision

dizziness

headache

nervousness

pounding in the ears

redness of the skin

slow or fast heartbeat

Incidence not known

Bloating or swelling of the face, arms, hands, lower legs, or feet

cough

difficult or labored breathing

difficulty with swallowing

feeling of warmth

hives or welts, itching, or skin rash

large, hive-like swelling on the , eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

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

rapid weight gain

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

sudden sweating

tightness in the chest

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

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:

More common

Blemishes on the skin

dry, red, hot, or irritated skin

nausea

pimples

red colored urine

Incidence not known

Acid or sour stomach

being forgetful

belching

diarrhea

heartburn

indigestion

redness or swelling of the eyes

restlessness

stomach discomfort, upset, or pain

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.