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Dezocine (Systemic)


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Dezocine (Systemic)

US Brand Names

• Dalgan

Description

Dezocine (DEZ-oh-seen) belongs to the group of medicines known as narcotic analgesics (nar-KOT-ik an-al-JEE-zicks) . Narcotic analgesics act in the central nervous system (CNS) to relieve pain. Some of their side effects are also caused by actions in the CNS.

Dezocine is available only with your doctor's prescription. It is available in the following dosage form:

    Parenteral

    • Injection (U.S.)

Special Considerations

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to dezocine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy

Studies on birth defects with dezocine have not been done in pregnant women. Dezocine did not cause birth defects in animal studies. However, the birth weights of the newborn animals were lower than normal, probably because the pregnant animals ate less than usual.

Too much use of a narcotic during pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth. Also, narcotics may cause breathing problems in the newborn infant if taken just before delivery.

Breast-feeding

It is not known whether dezocine passes into the breast milk. However, it has not been reported to cause problems in nursing babies.

Children

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of dezocine in patients up to 18 years of age with use in other age groups.

Older adults

Elderly people are especially sensitive to the effects of narcotic analgesics such as dezocine. This may increase the chance of side effects, especially breathing problems, during treatment.

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 using dezocine, it is especially important that your health care professional know if you are taking any of the following:

    • Central nervous system (CNS) depressants, including other narcotics, or

    • Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])-The chance of side effects may be increased

    • Naltrexone (e.g., Trexan)-Dezocine may not be effective in people taking naltrexone

Other medical problems

The presence of other medical problems may affect the use of dezocine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Alcohol abuse, or history of, or

    • Drug dependence, especially narcotic abuse, or history of, or

    • Emotional problems-The chance of side effects may be increased; also, withdrawal symptoms may occur if a narcotic you are dependent on is replaced by dezocine

    • Brain disease or head injury or

    • Colitis or other intestinal disease or

    • Diarrhea or

    • Emphysema, asthma, or other chronic lung disease or

    • Enlarged prostate or problems with urination-Some of the side effects of narcotic analgesics can be dangerous if these conditions are present

    • Heart or blood vessel disease, severe, or

    • Gallbladder disease or gallstones or

    • Kidney disease or

    • Liver disease or

    • Underactive thyroid-The chance of side effects may be increased

Administration

Some narcotic analgesics given by injection may be used at home by patients who do not need to be in the hospital. If you are using dezocine at home, make sure you clearly understand and carefully follow your doctor's directions .

Take this medicine only as directed by your doctor . Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. This is especially important for elderly patients, who are more sensitive than younger adults to the effects of narcotic analgesics. If too much is taken, the medicine may become habit-forming (causing mental or physical dependence) or lead to medical problems because of an overdose.

Dosing

The dose of dezocine will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of dezocine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of milliliters (mL) of injection that you use for each dose depends on the strength of the medicine.

    • For parenteral dosage form (injection):

      o For pain:

        Adults-The usual dose is 10 milligrams (mg), injected into a muscle every three to six hours as needed. Some people may need only 5 mg and others may need 15 or 20 mg. The medicine may also be injected into a vein in a dose of 2.5 to 10 mg every two to four hours as needed. The total amount used in twenty-four hours should not be more than 120 mg. Elderly people, people who are very ill, and people with breathing problems may have to use lower doses than other adults.

        Children and teenagers up to 18 years of age-Use and dose must be determined by your doctor.

Missed dose

If your doctor has ordered you to use dezocine according to a regular schedule and you miss a dose, use it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses .

Storage

To store this medicine:

    • Keep out of the reach of children. Overdose is very dangerous in young children.

    • Store away from heat and direct light.

    • Keep the medicine from freezing.

    • Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions

Dezocine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicines including other narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine .

This medicine may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may help relieve these effects.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your doctor.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the health care professional in charge that you are taking this medicine. Serious side effects may occur if your health care professional gives you certain medicines without knowing that you are using dezocine.

If you think you or someone else may have taken an overdose, get emergency help at once . Taking an overdose of this medicine or taking alcohol or CNS depressants with it may lead to unconsciousness or death. Signs of overdose of narcotic analgesics include convulsions (seizures), confusion, severe nervousness or restlessness, severe dizziness, severe drowsiness, slow or troubled breathing, and severe weakness.

Side Effects

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.

Get emergency help immediately if any of the following symptoms of overdose occur :

Cold, clammy skin; confusion, nervousness, or restlessness (severe); convulsions (seizures); dizziness (severe); drowsiness (severe); low blood pressure; pinpoint pupils of eyes; slow heartbeat; slow or troubled breathing; weakness (severe).

Also, check with your doctor as soon as possible if any of the following side effects occur:

Rare

Chest pain; coughing occurring together with breathing problems; difficult, decreased, or frequent urination; difficult, slow, or shallow breathing; increase or decrease in blood pressure; irregular heartbeat; mental depression or other mood or mental changes; skin rash or itching; swelling of face, fingers, lower legs, or feet; weight gain.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Drowsiness; nausea or vomiting.

Less common or rare

Abdominal or stomach pain; anxiety or crying; blurred or double vision; confusion; constipation; diarrhea; dizziness or lightheadedness; flushing or redness of skin; slurred speech.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

Body aches; diarrhea; fast heartbeat; fever, runny nose, or sneezing; gooseflesh; increased sweating; increased yawning; loss of appetite; nausea or vomiting; nervousness, restlessness, or irritability; shivering or trembling; stomach cramps; trouble in sleeping; unusually large pupils of eyes; weakness.

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

August 29, 1994

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