Nalbuphine Hydrochloride Solution for injection

What is this medicine?

NALBUPHINE (NAL byoo feen)is a pain reliever. It is used to treat moderate to severe pain. It is also used to prevent pain during surgery and childbirth.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• brain tumor

• breathing problems

• drug abuse or addiction

• head injury

• heart disease

• kidney disease

• liver disease

• an unusual or allergic reaction to nalbuphine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a vein, muscle, or under the skin. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

This medicine may interact with the following medications:

• alcohol

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for sleep

• narcotic medicines for pain

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have a new or different type of pain.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Call emergency for help if you have problems breathing.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• confusion

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• hallucination, loss of contact with reality

• seizures

• unusually slow heartbeat

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• dizziness

• dry mouth

• headache

• increased urination

• nausea, vomiting

• pain, redness, or irritation at site where injected

• sweating

• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.