NARCOTICANALGESICS For Surgery andObstetrics (Systemic)

Some commonly used brand names are:

In the U.S.?

• Alfenta ¹
• Astramorph ⁶
• Astramorph PF ⁶
• Buprenex ²
• Demerol ⁵
• Duramorph ⁶
• Nubain ⁷
• Stadol ³
• Sublimaze ⁴
• Sufenta ⁹
• Ultiva ⁸

In Canada?

• Alfenta ¹
• Demerol ⁵
• Epimorph ⁶
• Nubain ⁷
• Stadol ³
• Sufenta ⁹
• Ultiva ⁸

Another commonly used name for meperidine is pethidine.

Category

• Analgesic
• Anesthesiaadjunct
• Anesthesia adjunct, opioid analgesic

Description

Narcoticanalgesics (nar-KOT-ik an-al-JEE-zicks) are given to relieve pain before and during surgery (includingdental surgery) or during labor and delivery. These medicines may also begiven before or together with an anesthetic (either a general anesthetic ora local anesthetic), even when the patient is not in pain, to help the anestheticwork better.

When a narcotic analgesic is used for surgery or obstetrics (labor anddelivery), it will be given by or under the immediate supervision of a medicaldoctor or dentist, or by a specially trained nurse, in the doctor's officeor in a hospital.

The following information applies only to these special uses of narcoticanalgesics. If you are taking or receiving a narcotic analgesic to relievepain after surgery, or for any other reason, ask your health care professionalfor additional information about the medicine and its use.

These medicines are available in the following dosage forms:

Parenteral
• Alfentanil
  • Injection (U.S. and Canada)
• Buprenorphine
  • Injection (U.S. and Canada)
• Butorphanol
  • Injection (U.S. and Canada)
• Fentanyl
  • Injection (U.S. and Canada)
• Meperidine
  • Injection (U.S. and Canada)
• Morphine
  • Injection (U.S. and Canada)
• Nalbuphine
  • Injection (U.S. and Canada)
• Remifentanil
  • Injection (U.S. and Canada)
• Sufentanil
  • Injection (U.S. and Canada)

Before Receiving This Medicine

In deciding to use a medicine, the risks of using the medicine must beweighed against the good it will do. This is a decision you and your doctorwill make. For narcotic analgesics, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to a narcotic analgesic. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Although studies on birth defects have not been donein pregnant women, these medicines have not been reported to cause birth defects.However, in animal studies, many narcotics have caused birth defects or otherunwanted effects when they were given for a long time in amounts that werelarge enough to cause harmful effects in the mother.

Use of a narcotic during labor and delivery sometimes causes drowsinessor breathing problems in the newborn baby. If this happens, your health careprofessional can give the baby another medicine that will overcome these effects.Narcotics are usually not used during the delivery of a premature baby.

Breast-feeding?Some narcotics have been shown to pass into thebreast milk. However, these medicines have not been reported to cause problemsin nursing babies.

Children?Children younger than 2 years of age may be especiallysensitive to the effects of narcotic analgesics. This may increase the chanceof side effects.

Older adults?Elderly people are especially sensitive to the effectsof narcotic analgesics. This may increase the chance of side effects.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, it may be necessary tochange the dose, or other precautions may be necessary. It is very importantthat you tell the person in charge if you are taking:

• Any other medicine, prescription or nonprescription (over-the-counter[OTC]), or
• ?Street? drugs, such as amphetamines (?uppers?),barbiturates (?downers?), cocaine (including ?crack?),marijuana, phencyclidine (PCP, ?angel dust?), and heroin or othernarcotics?Serious side effects may occur if anyone gives you an anestheticwithout knowing that you have taken another medicine

• Benzodiazepines or
• Central nervous system (CNS) depressants (medicine that causes drowsiness)?TheCNS depressant and other effects of either these medicines or the narcoticanalgesics may be increased

• Buprenorphine or similar medicines?The narcotic analgesicsmay not work if you are taking buprenorphine or other similar medicines

• Cimetidine or
• Erythromycin?Increased chance of side effects with some narcoticanalgesics

• Naltrexone?The narcotic analgesics will not work if you aretaking naltrexone

Other medical problems?The presence of other medicalproblems may affect the use of narcotic analgesics. Make sure you tell yourdoctor if you have any other medical problems,especially:

• Abdominal problems or
• Brain tumor or
• Head injury or
• Gallbladder disease or
• Heart disease or
• Kidney disease or
• Liver disease or
• Lung disease or
• Prostate disease or
• Thyroid disease or
• Urinary tract disease?Narcotic analgesics may make these conditionsor the symptoms of these conditions worse

Proper Use of This Medicine

Dosing?The dose of narcotic analgesic will be different for differentpatients. Your health care professional will decide on the right amount foryou, depending on:

• Your age;
• Your general physical condition;
• The reason you are receiving the narcotic analgesic; and
• Other medicines you are taking or will receive before or after thenarcotic analgesic is given.

Precautions After Receiving This Medicine

For patients going home within a few hours after surgery:

• Narcotic analgesics and other medicines that may be given with themduring surgery may cause some people to feel drowsy, tired, or weak for upto a few days after they have been given. Therefore, for at least 24 hours(or longer if necessary) after receiving this medicine, do not drive, use machines, or do anything else that could be dangerous ifyou are dizzy or are not alert.
• Unless otherwise directed by your medical doctor or dentist, do not drink alcoholic beverages or take other CNS depressants(medicines that slow down the nervous system, possibly causing drowsiness)for about 24 hours after you have received this medicine. To do somay add to the effects of the narcotic analgesic. Some examples of CNS depressantsare antihistamines or medicine for hay fever, other allergies, or colds; sedatives,tranquilizers, or sleeping medicine; prescription pain medicine or narcotics;barbiturates; medicine for seizures; and muscle relaxants.

Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Before you leave the hospitalor doctor's office, your health care professional will closely follow theeffects of this medicine. However, some effects may continue, or may not benoticed until later.

Check with your medical doctor or dentist assoon as possible if any of the following side effects occur:

More common

Dizziness, light-headedness, or feeling faint; drowsiness; nausea or vomiting; unusual tiredness or weakness

Less common or rare

Blurred or double vision or other vision problems; confusion; constipation; convulsions (seizures); difficult orpainful urination; mental depression; shortness of breath, trouble in breathing, tightness in the chest,or wheezing; skin rash, hives, or itching; unusual excitement

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketingfor a certain use, experience may show that it is also useful for other medicalproblems. Although not specifically included in product labeling, fentanylby injection is used in certain pediatric patients with the following medicalconditions:

• Pain, during surgery, neonatal

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.