Promethazine Hydrochloride Solution for injection

What is this medicine?

PROMETHAZINE (proe METH a zeen) is an antihistamine. It is used to treat allergic reactions and to treat or prevent nausea and vomiting from illness or motion sickness. It is also used to make you sleep before surgery, and to help treat pain or nausea after surgery.

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:

• glaucoma
• high blood pressure or heart disease
• kidney disease
• liver disease
• lung or breathing disease, like asthma
• prostate trouble
• pain or difficulty passing urine
• seizures
• an unusual or allergic reaction to promethazine or phenothiazines, 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 muscle, or into a vein. 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. This medicine should not be given to infants and children younger than 2 years old.

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?

Do not take this medicine with any of the following medications:

• medicines called MAO Inhibitors like Nardil, Parnate, Marplan, Eldepryl
• other phenothiazines like trimethobenzamide

This medicine may also interact with the following medications:

• barbiturates like phenobarbital
• bromocriptine
• certain antidepressants
• certain antihistamines used in allergy or cold medicines
• epinephrine
• levodopa
• medicines for sleep
• medicines for mental problems and psychotic disturbances
• medicines for movement abnormalities as in Parkinson's disease, or for gastrointestinal problems
• muscle relaxants
• prescription pain medicines

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.

Your healthcare professional will discuss with you the risks and the benefits of using this medicine. This medicine has caused serious side effects in some patients after it was injected into a vein. Watch closely for any signs or symptoms of a local reaction like burning, pain, redness, swelling, and blistering and tell your healthcare professional immediately if any occur. These symptoms may occur when you receive the injection or may occur hours or even days after the injection.

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. To reduce the risk of dizzy or fainting spells, do not stand or sit up quickly, especially if you are an older patient. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

Keep out of the sun, or wear protective clothing outdoors and use a sunscreen. Do not use sun lamps or sun tanning beds or booths.

If you are diabetic, check your blood-sugar levels regularly.

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
• blurred vision
• burning, blistering, pain, redness, and/or swelling at the injection site
• irregular heartbeat, palpitations or chest pain
• muscle or facial twitches
• pain or difficulty passing urine
• seizures
• slowed or shallow breathing
• unusual bleeding or bruising
• yellowing of the eyes or skin

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

• headache
• nightmares, agitation, nervousness, excitability, not able to sleep (these are more likely in children)
• stuffy nose

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?

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.