Narcotics (also known as Opioids)

ADVERSE REACTIONS - What are the possible side effects of narcotics?

Central Nervous System: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, depression or other mood changes.

Nervous System: Weakness, headache, agitation, tremor, uncoordinated muscle movements, seizure, paresthesia, alterations of mood (nervousness, apprehension, depression, floating feelings), dreams, transient hallucination and disorientation, visual disturbances, insomnia, nightmares or unusual dreams, increased intracranial pressure.

Special Senses: Blurred or double vision, nystagmus, diplopia, miosis, ringing or buzzing in the ears.

Gastrointestinal System: Dry mouth, biliary tract spasm, laryngospasm, anorexia, loss of appetite, diarrhea, cramps, taste alterations, nausea and vomiting (more frequent in ambulatory than in recumbent patients). The antiemetic phenothiazines are useful in suppressing these effects; however, some phenothiazine derivatives seem to be antianalgesic and to increase the amount of narcotic required to produce pain relief, while other phenothiazines reduce the amount of narcotic required to produce a given level of analgesia. Prolonged administration of NARCOTICS may produce constipation. Opiate agonist- induced increase in intra-luminal pressure may endanger surgical anastomosis.

Cardiovascular System: Abnormally fast or slow heartbeat, circulatory depression, peripheral circulatory collapse and cardiac arrest have occurred with the use of narcotics. Orthostatic hypotension and fainting may occur in patients receiving NARCOTICS. Flushing of the face, bradycardia, palpitations, faintness, and syncope. Serious cardiac arrhythmia (ventricular tachycardia, ventricular fibrillation, torsade de pointes) and continuous abnormal cardiograms (prolonged QT), as well as cardiac arrest and sudden death have been reported with the use of narcotics.

Body as a Whole: Edema, antidiuretic effect, chills, muscle tremor, muscle rigidity.

Hematologic- Reversible thrombocytopenia has been described in a narcotics addict with chronic hepatitis.

Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported. Urine retention or hesitance, reduced libido and/or potency. Narcotics may cause impotence due to decrease testosterone levels.

Respiratory Depression: NARCOTICS produces dose-related respiratory depression by acting directly on brain stem respiratory centers. NARCOTICS also affects centers that control respiratory rhythm, and may produce irregular and periodic breathing. If significant respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride. The usual adult dose of 0.4 to 0.8 mg given intramuscularly or intravenously, promptly reverses the effects of morphine-like opioid agonists such as NARCOTICS. In patients who are physically dependent, small doses of naloxone may be sufficient not only to antagonize respiratory depression, but also to precipitate withdrawal phenomena. The dose of naloxone should therefore be adjusted accordingly in such patients Since the duration of action of NARCOTICS may exceed that of the antagonist, the patient should be kept under continued surveillance; repeated doses of the antagonist may be required to maintain adequate respiration. Apply other supportive measures when indicated.

Skin/Dermatological: Itching, pruritus, urticaria and other skin rashes, edema, and, rarely, hemorrhagic urticaria, yellowing of the skin or whites of the eyes.

Drug Abuse and Dependence: Most narcotics are Schedule II drugs. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, NARCOTICS should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when NARCOTICS are used for a short time for the treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, usually assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia. is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients, but it can be observed after 28 days of continued usage. Opioid analgesics may cause psychological and physical dependence (see WARNINGS). Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug, or these symptoms may be precipitated through the administration of drugs with antagonistic activity, e.g., naloxone or mixed agonist/antagonist analgesics (pentazocine, etc.). Physical dependence usually does not occur, to a clinically significant degree, until several weeks of continued opioid usage. Tolerance, in which increasingly larger doses are required to produce the same degree of analgesia, is initially manifested by a shortened duration of analgesic effect and, subsequently, by decreases in the intensity of analgesia. In patients with chronic pain, as well as in opioid-tolerant cancer patients, the administration of narcotics should be guided by the degree of tolerance manifested. Physical dependence, per se, is not ordinarily a concern when one is dealing with opioid-tolerant patients whose pain and suffering is associated with an irreversible illness.

If narcotics are abruptly discontinued, an abstinence syndrome may occur. Withdrawal symptoms, in patients dependent on morphine, begin shortly before the time of the next scheduled dose, reaching a peak at 36 to 72 hours after the last dose, and then slowly subside over a period of 7 to 10 days. Symptoms include yawning, sweating, lacrimation, rhinorrhea, restless sleep, dilated pupils, gooseflesh, irritability, tremor, nausea, vomiting, and diarrhea.

Treatment of the abstinence syndrome is primarily symptomatic and supportive, including maintenance of proper fluid and electrolyte balance. If withdrawal has inadvertently been precipitated in a patient who requires narcotics for pain management, the withdrawal syndrome can be terminated rapidly by the administration of an appropriate dose of a proof agonist opioid, such as morphine. The degree of physical dependence of a patient on narcotics can be intentionally reduced by a gradual reduction of dosage and symptomatic treatment of withdrawal symptomatology.

NOTE: Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect narcotics?

DRUG INTERACTIONS

Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, tranquilizers, sedative-hypnotics, tricyclic antidepressants or other CNS depressants (including alcohol) concomitantly with NARCOTICS may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Do not take narcotics if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result. The most serious interactions affecting narcotics are with those drugs that also cause sedation.

The following drugs may lead to dangerous sedation if taken with your narcotics:

antihistamines such as brompheniramine (Dimetane, Bromfed, others), diphenhydramine (Benadryl, Nytol, Compoz, others), chlorpheniramine (Chlor-Trimeton, Teldrin, others), and others;

tricyclic antidepressants, such as amitriptyline (Elavil) and doxepin (Sinequan), and serotonin reuptake inhibitors such as fluoxetine (Prozac), sertraline (Zoloft), and paroxetine (Paxil);

other commonly used antidepressants, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), and protriptyline (Vivactil);

anticholinergics such as belladonna (Donnatal), clidinium (Quarzan), dicyclomine (Bentyl, Antispas), hyoscyamine (Levsin, Anaspaz), ipratropium (Atrovent), propantheline (Pro-Banthine), and scopolamine (Transderm-Scop); phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Prolixin), thioridazine (Mellaril), and prochlorperazine (Compazine); and tranquilizers and sedatives such as phenobarbital (Solfoton, Luminal), amobarbital (Amytal), secobarbital (Seconal), alprazolam (Xanax), diazepam (Valium), lorazepam (Ativan), flurazepam (Prosom), and temazepam (Restoril).

Do not take meperidine (Demerol, Mepergan, etc.) if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. This particular interaction may result in death.

Do not take any of the drugs listed above without the approval of your doctor.

Drugs other than those listed here may also interact with narcotics. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

The concurrent administration of rifampin may possibly reduce the blood concentration of methadone. The mechanism by which rifampin may decrease blood concentrations of methadone is not fully understood although enhanced microsomal drug-metabolized enzymes may influence drug disposition.

Who should not take Narcotics?

WARNINGS

Respiratory Depression: NARCOTICS produces dose-related respiratory depression by acting directly on brain stem respiratory centers. NARCOTICS also affects centers that control respiratory rhythm, and may produce irregular and periodic breathing.

Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebra-spinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce effects which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Drug Abuse And Dependence: Most Narcotics are Schedule II drugs under the United States Controlled Substance Act (21 U.S.C. 801-886). Morphine is the most commonly cited prototype for narcotic substances that possess an addiction-forming or addiction-sustaining liability. A patient may be at risk for developing a dependence to narcotics if used improperly or for overly long periods of time. As with all potent opioids which are u-agonists, tolerance as well as psychological and physical dependence to narcotics may develop irrespective of the route of administration (oral, intravenous, intramuscular, intrathecal, or epidural). Individuals with a prior history of opioid or other substance abuse or dependence, being more apt to respond to euphorogenic and reinforcing properties of narcotics, would be considered to be at greater risk. Care must be taken to avert withdrawal symptoms when narcotics are discontinued abruptly or upon administration of a narcotic antagonist.

PRECAUTIONS

General Precautions : Selection of patients for treatment with narcotics should be governed by the same principles that apply to the use of morphine or other potent opioid analgesics. Narcotic analgesics are drugs that have a narrow therapeutic index in the old, the sick, and the infirm, i.e., the very population in which their use is indicated. Physicians should individualize treatment with narcotics for every case, weighing the need for analgesia against the risks of serious or fatal reactions to the drug.

Special Risk Patients: NARCOTICS should be used with caution in elderly or debilitated patients and those with impaired renal or hepatic function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. As with any narcotic analgesic agent, the usual precautions should be observed and the possibility of respiratory depression should be kept in mind.

Cough Reflex: NARCOTICS suppresses the cough reflex; as with all narcotics, caution should be exercised when NARCOTICS is used postoperatively and in patients with pulmonary disease.

Usage in Ambulatory Patients: Narcotics may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly.

Drug Interactions: Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, tranquilizers, sedative-hypnotics, tricyclic antidepressants or other CNS depressants (including alcohol) concomitantly with NARCOTICS may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. The depressant effects of narcotics are potentiated by the presence of other CNS depressants such as alcohol, sedatives, antihistaminics, or psychotropic drugs. Use of neuroleptics in conjunction with oral narcotics may increase the risk of respiratory depression, hypotension and profound sedation, coma or death.

Parenteral Administration: The parenteral form of NARCOTICS may be given intravenously, but the injection should be given very slowly. Rapid intravenous injection of narcotic analgesics increases the possibility of side effects such as hypotension and respiratory depression.

Pregnancy: Pregnancy Category C. NARCOTICS has been shown to be teratogenic in hamsters when given in doses 600 times the human dose. There are no adequate and well-controlled studies in pregnant women. NARCOTICS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Teratogenic Effects - Category C: There are no well-controlled studies in women, but marketing experience does not include any evidence of adverse effects on the fetus following routine (short-term) clinical use of morphine sulfate products. Although there is no clearly defined risk, such experience cannot exclude the possibility of infrequent or subtle damage to the human fetus, or the possibility of fetal malformations

Nonteratogenic effects: Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexea, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7 to 1.0 mg/kg q.h. phenobarbital 2 mg/kg q.h. and paregoric 2 to 4 drops/kg q4h, have been used to treat withdrawal symptoms in infants. The duration ot therapy is 4 to 28 days, with the dosages decreased as tolerated.

Interaction with Mixed Agonist/Antagonist Opioid Analgesics: Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol, or buprenorphine) should NOT be administered to patients who have received or are receiving a course of therapy with a proof opioid agonist analgesic. In these patients, the mixed agonist/antagonist may alter the analgesic effect or may precipitate withdrawal symptoms.

Labor and Delivery: As with all narcotics, administration of NARCOTICS to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used. Narcotics are not recommended for use in women during and immediately prior to labor. Occasionally, opioid analgesics may prolong labor through actions which temporarily reduce the strength, duration and frequency of uterine contractions. Neonates, whose mothers received opioid analgesics during labor, should be observed closely for signs of respiratory depression. A specific narcotic antagonist, naloxone, should be available for reversal of narcotic-induced respiratory depression in the neonate.

Nursing Mothers: Narcotics should not be given to nursing mothers because some are excreted in maternal milk. Effects on the nursing infant are not known, but withdrawal symptoms can occur in breast-fed infants when maternal administration of narcotics is stopped. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from NARCOTICS, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in children have not been established.

Use in Patients with Increased Intracranial Pressure or with Head Injury: Narcotics should be used with extreme caution in patients with increased intracranial pressure or with head injury. The respiratory depressant effects of narcotics (increased pCO2) may result in elevation of cerebrospinal fluid pressure and may thus be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increased intracranial pressure. Narcotics produce effects which may obscure neurologic signs of further increases in pressure in patients with head injuries. Pupillary changes (miosis), associated with morphine, may conceal the existence, extent, and course of intracranial pathology.

Use in Hepatic or Renal Disease: The clearance of narcotics may be reduced in patients with hepatic dysfunction, while the clearance of its metabolites may be decreased in renal dysfunction. This will be manifested by both, a prolonged elimination half-life and the accumulation of levels of either the narcotic or its metabolites in excess of those produced in normals, with the potential for an increase of adverse effects These changes in the narcotic pharmacodynamics, in patients with hepatic or renal dysfunctions, should be considered when adjusting the dose and dosage intervals, taking also into account the slow-release character of some narcotics.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies of narcotics in animals to evaluate the drug's carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Use in the Elderly: The pharmacodynamic effects of narcotics in the aged are more variable than in the younger population. Patients will vary widely in the effective initial dose, rate of development of tolerance, and the frequency and magnitude of associated adverse effects as the dose is increased. Individualization of doses must receive careful attention in elderly patients

If you experience any of the following serious side effects, stop taking narcotics and seek emergency medical attention:

… Allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives)

… Slow, weak breathing

… Seizures

… Cold, clammy skin

… Severe weakness or dizziness

… Unconsciousness

Other, less serious side effects may be more likely to occur. Continue to take the narcotic and talk to your doctor if you experience

… Constipation

… Dry mouth, nausea, vomiting, or decreased appetite

… Dizziness, tiredness, or lightheadedness

… Muscle twitches

… Sweating

… Itching

… Decreased urination

… Decreased sex drive

Note: Narcotics are habit forming. They may cause addiction. They will cause physiological dependence. They may cause psychological dependence.

Risks: Narcotics can interfere with or exacerbate certain medical conditions. For these reasons, it is important that the prescribing physician be informed by the patient of any history of:

… alcohol abuse

… brain disease or head injury

… colitis

… drug dependency, particularly of narcotics

… emotional problems

… emphysema, asthma, or other chronic lung disease

… enlarged prostate

… gallstones or gallbladder disease

… heart disease

… kidney disease

… liver disease

… problems with urination

… seizures

… underactive thyroid

What happens if I miss a dose?

Do not take a double dose of the medication. Wait the prescribed amount of time before taking your next dose.

What can happen if I take more medicine than instructed?

You may overdose and die.

What are the signs of overdosing?

Symptoms of an overdose include tiredness, weakness, sedation, sleepiness, difficulty speaking, slow breathing, slow or troubled breathing, difficulty concentrating, dizziness, severe drowsiness, confusion, disorientation, loss of consciousness, coma, severe nervousness or restlessness, seizures, cold and clammy skin, small pupils, respiratory depression and death. Intentional or accidental overdose of narcotics can lead to unconsciousness, coma, or death. These symptoms are increased by alcohol or other central nervous system (CNS) depressants. Anyone who feels that he or she, or someone else, may have overdosed on a narcotic, or a combination of a narcotic and other central nervous system depressants, should seek emergency medical attention for that person at once.

What should I do if I am overdosing?

Seek emergency medical attention immediately. Call 911. Seek help. Have someone prevent you from going to sleep, until EMS (Emergency Medical Services) arrive, or have someone take you to the nearest emergency room. Failure to do any of the above, may result in death.

What should I avoid while taking narcotics?

Avoid alcohol at all cost, while taking any pain or nerve medication, or any other sedatives. Alcohol will greatly increase the drowsiness and dizziness caused by narcotics and could cause death. Also avoid sleeping pills, tranquilizers, sedatives, and antihistamines except under the supervision of your doctor. These medications will also cause dangerous sedation. Use caution when driving, operating machinery, or performing other hazardous activities. narcotics will impair your ability to safely perform these activities. If you experience drowsiness, avoid these activities. Be very careful about decision-making. Do not make any important decisions without the full approval or support of your family.

Where can I get more information?

Your pharmacist has additional information about narcotics written for health professionals that you may read.

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. Also keep in mind that every individual is different and therefore you should always seek the specific advice of your personal physician.