Drugs Details

Drugs Info of Demerol HCl
Drugs Details
  • Drugs Type  : Multum
  • Date : 28th Feb 2015 03:18 am
  • Brand Name : Demerol HCl
  • Generic Name : meperidine (Pronunciation: me PER i deen)
Descriptions

Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C. It is readily soluble in water and has a neutral reaction and a slightly bitter taste. The solution is not decomposed by a short period of boiling.

The tablets contain 50 mg or 100 mg of DEMEROL brand of meperidine hydrochloride.

Inactive Ingredients: Calcium Sulfate, Dibasic Calcium Phosphate, Starch, Stearic Acid, Talc.

Chemically, DEMEROL is 4-Piperidinecarboxylic acid, 1-methyl-4-phenyl-, ethyl ester, hydrochloride and has the following structure:

 

Demerol® (meperidine hydrochloride, USP) Structural Formula Illustration

 

 

What are the possible side effects of meperidine (Demerol HCl)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • weak or shallow breathing, slow heartbeat;
  • severe drowsiness, feeling like you might pass out;
  • seizure (convulsions);
  • cold, clammy skin;
  • muscle movements you cannot control;
  • confusion, mood changes;
  • severe weakness or dizziness; or
  • agitation, hallucinations, fever, fast heart rate,...

Read All Potential Side Effects and See Pictures of Demerol »

What are the precautions when taking meperidine (Demerol)?

Before taking meperidine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., gallbladder disease, pancreatitis), adrenal gland problem (e.g., Addison's disease, pheochromocytoma), large blood loss (e.g., recent blood donation, stomach/intestinal bleeding), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), heart problems (e.g., irregular heartbeat, low blood pressure), kidney disease, liver disease, breathing problems (e.g., asthma,...

Read All Potential Precautions of Demerol »

 This monograph has been modified to include the generic and brand name in many instances.

Indications

DEMEROL is indicated for the relief of moderate to severe pain.

Dosage Administration

For Relief of Pain

Dosage should be adjusted according to the severity of the pain and the response of the patient. Meperidine is less effective orally than on parenteraladministration. The dose of DEMEROL should be proportionately reduced (usually by 25 to 50 percent) when administered concomitantly with phenothiazines and many other tranquilizers since they potentiate the action of DEMEROL.

Adults: The usual dosage is 50 mg to 150 mg orally, every 3 or 4 hours as necessary.

Pediatric Patients: The usual dosage is 1.1 mg/kg to 1.8 mg/kg orally, up to the adult dose, every 3 or 4 hours as necessary (see PRECAUTIONS,Pediatric use).

Safety And Handling

DEMEROL (meperidine HCl) tablets contain meperidine hydrochloride which is a controlled substance. Like morphine, meperidine is controlled under Schedule II of the Controlled Substances Act. Meperidine, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to flush DEMEROL tablets that are no longer needed.

DEMEROL has been targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substance Authority for information on how to prevent and detect abuse or diversion of this product.

How Supplied

For Oral Use

Tablets are white, round and convex. The 50 mg is a scored tablet and has a stylized “W” on one side and “D” over “35” on the other side. The 100 mg is not a scored tablet and has a stylized “W” on one side and “D” over “37” on the other side.

Tablets of 50 mg, HDPE plastic bottles of 100 (NDC 0024-0335-05) and100 mg, HDPE plastic bottles of 100 (NDC 0024-0337-05).

Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F) [SeeUSP Controlled Room Temperature].

Revised October 2011. Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The major hazards of meperidine, as with other narcotic analgesics, are respiratory depression and, to a lesser degree, circulatory depression; respiratory arrest, shock, and cardiac arrest have occurred.

The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not experiencing severe pain. In such individuals, lower doses are advisable. Some adverse reactions in ambulatory patients may be alleviated if the patient lies down.

Other adverse reactions include:

Nervous System: Mood changes (e.g. euphoria, dysphoria), weakness, headache, agitation, tremor, involuntary muscle movements (e.g. muscle twitches, myoclonus), severe convulsions, transient hallucinations and disorientation, confusion, delirium, visual disturbances.

Gastrointestinal: Dry mouth, constipation, biliary tract spasm.

Cardiovascular: Flushing of the face, tachycardia, bradycardia, palpitation,hypotension (see WARNINGS), syncope. Genitourinary: Urinary retention.

Allergic: Pruritus, urticaria, other skin rashes, wheal and flare over the veinwith intravenous injection. Hypersensitivity reactions, anaphylaxis.

Histamine release leading to hypotension and/or tachycardia, flushing, sweating, and pruritus.

Drug Abuse And Addiction

DEMEROL contains meperidine, a mu-agonist opioid with an abuse liability similar to morphine and is a Schedule II controlled substance. Meperidine, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.

Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common.

“Drug seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. DEMEROL, like other opioids, has been diverted for non-medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Abuse of DEMEROL poses a risk of overdose and death. This risk is increased with concurrent abuse of DEMEROL with alcohol and other substances. Due to the presence of talc as one of the excipients in tablets,parenteral abuse of crushed tablets can be expected to result in local tissuenecrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart disease. In addition, parenteral drug abuse is commonly associated with transmission of infectious diseases such ashepatitis and HIV.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Read the Demerol (meperidine) Side Effects Center for a complete guide to possible side effects

Learn More »
 
 
 

Interactions

Also see WARNINGS.

Acyclovir: Plasma concentrations of meperidine and its metabolite, normeperidine, may be increased by acyclovir, thus caution should be used with concomitant administration.

Cimetidine: Cimetidine reduced the clearance and volume of distribution of meperidine and also the formation of the metabolite, normeperidine, in healthy subjects and thus, caution should be used with concomitant administration.

CNS Depressants: Concomitant use of CNS depressants with usual doses of Demerol may result in respiratory depression, hypotension, profound sedation, coma or death (see PRECAUTIONS, Interactions with other CNS Depressants).

Phenytoin: The hepatic metabolism of meperidine may be enhanced by phenytoin. Concomitant administration resulted in reduced half-life and bioavailability with increased clearance of meperidine in healthy subjects, however, blood concentrations of normeperidine were increased, thus exercise caution when phenytoin is used concomitantly with meperidine.

Ritonavir: Plasma concentrations of the active metabolite normeperidine may be increased by ritonavir, thus concomitant administration should be avoided.

Opioid analgesics, including DEMEROL, may enhance the neuromuscularblocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Special Risk Patients

Meperidine should be given with caution and the initial dose should be reduced in certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal function, Sickle Cell Anemia,hypothyroidism, Addison's disease, Pheochromocytoma and prostatichypertrophy or urethral stricture. In patients with pheochromocytoma, meperidine has been reported to provoke hypertension.

Usage in Hepatically Impaired Patients

Accumulation of meperidine and/or its active metabolite, normeperidine, can occur in patients with hepatic impairment. Meperidine should therefore be used with caution in patients with hepatic impairment.

Usage in Renally Impaired Patients

Accumulation of meperidine and/or its active metabolite, normeperidine, can also occur in patients with renal impairment. Meperidine should therefore be used with caution in patients with renal impairment.

Read the Demerol Drug Interactions Center for a complete guide to possible interactions

Learn More »
 

This monograph has been modified to include the generic and brand name in many instances.

 
 

Warnings

Meperidine should not be used for treatment of chronic pain. Meperidine should only be used in the treatment of acute episodes of moderate to severe pain. Prolonged meperidine use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine.

DEMEROL is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.

DEMEROL can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing DEMEROL in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Misuse, Abuse, and Diversion of Opioids

Meperidine is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Meperidine can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing DEMEROL in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

DEMEROL has been reported as being abused by crushing, chewing, snorting, or injecting the dissolved product. These practices will result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose or death (see WARNINGS and Drug Abuse And Addiction).

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain.

Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Interactions with Alcohol and Drugs of Abuse

Meperidine may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of meperidine and its capacity to elevatecerebrospinal 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 adverse reactions which may obscure the clinical course of patients with head injuries. In such patients, meperidine must be used with extreme caution and only if its use is deemed essential.

Respiratory Conditions

Meperidine should be used with extreme caution in patients having an acuteasthmatic attack, patients with chronic obstructive pulmonary disease or cor pulmonale, patients having a substantially decreased respiratory reserve, and patients with preexisting respiratory depression, hypoxia, orhypercapnia. In such patients, even usual therapeutic doses of narcotics may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea.

Hypotensive Effect

The administration of meperidine may result in severe hypotension in thepostoperative patient or any individual whose ability to maintain blood pressure has been compromised by a depleted blood volume or the administration of drugs such as the phenothiazines or certain anesthetics.

Usage in Ambulatory Patients

Meperidine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient should be cautioned accordingly.

Meperidine, like other narcotics, may produce orthostatic hypotension in ambulatory patients.

Usage in Pregnancy

Meperidine should not be used in pregnant women prior to the labor period, unless in the judgment of the physician the potential benefits outweigh the possible risks, because safe use in pregnancy prior to labor has not been established relative to possible adverse effects on fetal development.

Labor and Delivery

Meperidine crosses the placental barrier and can produce depression ofrespiration and psychophysiologic functions in the newborn. Resuscitationmay be required (see OVERDOSAGE). Therefore meperidine is not recommended during labor.

Nursing Mothers

Meperidine appears in the milk of nursing mothers receiving the drug. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the potential benefits of the drug to the nursing woman.

Precautions

General

Opioid analgesics can have a narrow therapeutic index in certain patient populations, particularly when combined with CNS depressant drugs. The use of these products should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.

Use of DEMEROL may be associated with increased potential risks and should be used with caution in the following conditions: sickle cell anemia, pheochromocytoma, acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary, or renal function; and toxic psychosis (seePRECAUTIONS, Special Risk Patients).

The administration of meperidine may obscure the diagnosis or clinical course in patients with acute abdominal conditions. All opioids may induce or aggravate seizures in some clinical settings.

Interactions with Other CNS Depressants

DEMEROL should be used with caution and consideration should be given to starting with a reduced dosage in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers, and alcohol. Drug-drug interactions may result in respiratory depression, hypotension, profound sedation,coma, or death if these drugs are taken in combination with the usual doses of DEMEROL.

Interactions with Mixed Agonist/Antagonist Opioid Analgesics

Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol, and buprenorphine) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonistanalgesic such as meperidine. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of meperidine and/or may precipitate withdrawal symptoms in these patients due to competitive blocking of receptors.

Supraventricular Tachycardias

Meperidine should be used with caution in patients with atrial flutter and other supraventricular tachycardias because of a possible vagolytic action which may produce a significant increase in the ventricular response rate.

Convulsions

Meperidine may aggravate preexisting convulsions in patients with convulsive disorders. If dosage is escalated substantially above recommended levels because of tolerance development, convulsions may occur in individuals without a history of convulsive disorders.

Acute Abdominal Conditions

The administration of meperidine or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Tolerance and Physical Dependence

Meperidine has the potential to produce tolerance and drug dependence. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning,perspiration, chills, myalgia, mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

In general, opioids used regularly should not be abruptly discontinued.

Use in Drug and Alcohol Addiction

DEMEROL is an opioid with no approved use in the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia. DEMEROL should be used with caution in patients with alcoholism and other drug dependencies due to the increased frequency of narcotic tolerance, dependence, and the risk of addiction observed in these patient populations. Abuse of DEMEROL in combination with other CNS depressant drugs can result in serious risk to the patient.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies to assess the carcinogenic or mutagenic potential of meperidine have not been conducted. Studies to determine the effect of meperidine on fertility have not been conducted.

Pregnancy: Teratogenic Effects

Pregnancy Category C: Animal reproduction studies have not been conducted with meperidine. It is also not known whether DEMEROL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DEMEROL should be given to a pregnant woman only if clearly needed.

Labor and Delivery

See WARNINGS.

Nursing Mothers

See WARNINGS.

Pediatric Use

The safety and effectiveness of meperidine in pediatric patients has not been established. Literature reports indicate that meperidine has a slower elimination rate in neonates and young infants compared to older children and adults. Neonates and young infants may also be more susceptible to the effects, especially the respiratory depressant effects. If meperidine use is contemplated in neonates or young infants, any potential benefits of the drug need to be weighed against the relative risk of the patient.

Geriatric Use

Clinical studies of DEMEROL during product development did not include sufficient numbers of subjects aged 65 and over to evaluate age-related differences in safety or efficacy. Literature reports indicate that geriatric patients have a slower elimination rate compared to young patients and they may be more susceptible to the effects of meperidine. Reducing the total daily dose of meperidine is recommended in elderly patients and the potential benefits of the drug should be weighed against the relative risk to a geriatric patient.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Symptoms

Serious overdosage with meperidine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor orcoma, skeletal muscle flaccidity, hypothermia, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur.

Treatment

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including meperidine. Therefore, an appropriate dose of this antagonist should be administered as necessary, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation.

An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated.

In cases of overdosage with DEMEROL tablets, the stomach should be evacuated by emesis or gastric lavage.

NOTE: In an individual physically dependent on narcotics, the administration of the usual dose of a narcotic antagonist will precipitate an acute withdrawal syndrome. The severity of this syndrome will depend on the degree of physical dependence and the dose of antagonist administered. The use of narcotic antagonists in such individuals should be avoided if possible. If a narcotic antagonist must be used to treat serious respiratory depression in the physically dependent patient, the antagonist should be administered with extreme care and only one-fifth to one-tenth the usual initial dose administered.

ContrainDications

DEMEROL is contraindicated in patients with hypersensitivity to meperidine or to any of its ingredients.

Meperidine is contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitors or those who have recently received such agents. Therapeutic doses of meperidine have occasionally precipitated unpredictable, severe, and occasionally fatal reactions in patients who have received such agents within 14 days. The mechanism of these reactions is unclear, but may be related to a preexisting hyperphenylalaninemia. Some have been characterized by coma, severe respiratory depression, cyanosis, and hypotension, and have resembled the syndrome of acute narcotic overdose. Serotonin syndrome with agitation, hyperthermia, diarrhea,tachycardia, sweating, tremors and impaired consciousness may also occur. In other reactions the predominant manifestations have been hyperexcitability, convulsions, tachycardia, hyperpyrexia, and hypertension. Although it is not known that other narcotics are free of the risk of such reactions, virtually all of the reported reactions have occurred with meperidine. If a narcotic is needed in such patients, a sensitivity test should be performed in which repeated, small, incremental doses of morphine are administered over the course of several hours while the patient's condition and vital signs are under careful observation. (Intravenous hydrocortisone or prednisolone have been used to treat severe reactions, with the addition of intravenous chlorpromazine in those cases exhibiting hypertension and hyperpyrexia. The usefulness and safety of narcotic antagonists in the treatment of these reactions is unknown.)

DEMEROL is contraindicated in patients with severe respiratory insufficiency(see WARNINGS, Respiratory Conditions).

This monograph has been modified to include the generic and brand name in many instances.

 
 

Clinical Pharamacology

Meperidine hydrochloride is a narcotic analgesic with multiple actions qualitatively similar to those of morphine; the most prominent of these involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value are analgesia and sedation.

There is some evidence which suggests that meperidine may produce less smooth muscle spasm, constipation, and depression of the cough reflex than equianalgesic doses of morphine.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Information for Patients/Caregivers

If clinically advisable, patients receiving DEMEROL (meperidine hydrochloride) tablets or their caregivers should be given the following information by the physician, nurse, pharmacist, or caregiver:

  1. Patients should be aware that DEMEROL tablets contain meperidine, which is a morphine-like substance.
  2. Patients should be advised to report pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.
  3. Patients should be advised not to adjust the dose of DEMEROL without consulting the prescribing professional.
  4. Patients should be advised that DEMEROL may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
  5. Patients should not combine DEMEROL with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because dangerous additive effects may occur, resulting in serious injury or death.
  6. Women of childbearing potential who become, or are planning to becomepregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.
  7. Patients should be advised that DEMEROL is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
  8. Patients should be advised that if they have been receiving treatment with DEMEROL for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the DEMEROL dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.
  9. Patients should be instructed to keep DEMEROL in a secure place out of the reach of children. When DEMEROL is no longer needed, the unused tablets should be destroyed by flushing down the toilet.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

MEPERIDINE TABLET - ORAL

 

(meh-PAIR-id-een)

 

COMMON BRAND NAME(S): Demerol

 

USES: This medication is used to treat moderate to severe pain. Meperidine acts on certain centers in the brain to give you pain relief. This medication is a narcotic pain reliever similar to morphine.

 

HOW TO USE: Take this medication by mouth, usually every 3 to 4 hours as needed or as directed by your doctor. You may take this drug with or without food. If you have nausea, you may take this drug with food, although this may cause your body to absorb less of the drug and get less benefit from it. Consult your doctor or pharmacist about other ways to decrease nausea (e.g., antihistamines, lying down for 1-2 hours with as little head movement as possible).

The dosage is based on your medical condition and response to therapy. Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

You may also take long-acting narcotic medications or use narcotic patches for ongoing pain if so directed by your doctor. In that case, this medication might be used for sudden (breakthrough) pain only as needed. Also follow your doctor's or pharmacist's instructions for safely using non-narcotic pain relievers (e.g., naproxen, ibuprofen). Ask your doctor if you have any questions.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, runny nose, watering eyes, trouble sleeping, severe abdominal/muscle pain, nausea, vomiting, rapid breathing, and fast heartbeat) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Though very unlikely, this medication can also be habit-forming and may result in abnormal drug-seeking behavior (addiction). To lessen the risk of becoming addicted, do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Inform your doctor if your pain persists or worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Nausea, vomiting, constipation, dry mouth, flushing, sweating, lightheadedness, dizziness, and drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: slow/irregular/fast heartbeat, mental/mood changes (e.g., confusion, hallucinations, nervousness), numbness, shakiness (tremors), severe stomach/abdominal pain, trouble urinating, change in the amount of urine.

Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, fainting, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Demerol (meperidine) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before taking meperidine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., gallbladder disease, pancreatitis), adrenal gland problem (e.g., Addison's disease, pheochromocytoma), large blood loss (e.g., recent blood donation, stomach/intestinal bleeding), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), heart problems (e.g., irregular heartbeat, low blood pressure), kidney disease, liver disease, breathing problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, emphysema), mental/mood disorders (e.g., depression, toxic psychosis), personal or family history of regular use/abuse of drugs/alcohol, sickle cell anemia, stomach/intestinal problems (e.g., diarrhea due to infection, paralytic ileus), a certain spinal problem (kyphoscoliosis), underactive thyroid (hypothyroidism), trouble urinating (e.g., due to enlarged prostate or narrowing of the urethra).

Meperidine is usually only used for a short time. Repeated or high doses may cause drug levels to build up in the body and cause serious side effects such as seizures and shaking. Caution is advised if this medication is used for conditions which require long-term or high-dosage treatment (e.g., sickle cell anemia, burns, cancer). Consult your doctor or pharmacist for details.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.

Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially drowsiness.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.

This drug passes into breast milk and is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: acyclovir, cimetidine, narcotic antagonists (such as naltrexone), certain other pain medications (e.g., narcotic agonist/antagonist such as butorphanol/nalbuphine), phenytoin, ritonavir.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Also report the use of drugs that might increase seizure risk when combined with meperidine such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and other narcotic pain relievers (such as codeine).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (e.g., amylase, lipase tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, slow heartbeat, seizure, loss of consciousness.

 

NOTES: Do not share this medication with others. It is against the law.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

 

MISSED DOSE: Not applicable.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Properly discard this product when it is expired or no longer needed. To discard this medication, the FDA recommends flushing down the toilet or pouring into a drain. However, consult your pharmacist or local waste disposal company.

 

Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Demerol HCl

Generic Name: meperidine (Pronunciation: me PER i deen)

  • What is meperidine (Demerol)?
  • What are the possible side effects of meperidine (Demerol)?
  • What is the most important information I should know about meperidine (Demerol)?
  • What should I discuss with my healthcare provider before taking meperidine (Demerol)?
  • How should I take meperidine (Demerol)?
  • What happens if I miss a dose (Demerol)?
  • What happens if I overdose (Demerol)?
  • What should I avoid while taking meperidine (Demerol)?
  • What other drugs will affect meperidine (Demerol)?
  • Where can I get more information?

What is meperidine (Demerol)?

 

Meperidine is an opioid pain medication. An opioid is sometimes called a narcotic.

Meperidine is used to treat moderate-to-severe pain.

Meperidine may also be used for purposes not listed in this medication guide.

Meperidine 50 mg-ROX

round, white, imprinted with 54 879

What are the possible side effects of meperidine (Demerol)?

 

Get emergency medical help if you have any of thesesigns of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • weak or shallow breathing, slow heartbeat;
  • severe drowsiness, feeling like you might pass out;
  • seizure (convulsions);
  • cold, clammy skin;
  • muscle movements you cannot control;
  • confusion, mood changes;
  • severe weakness or dizziness; or
  • agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

Less serious side effects may include:

  • constipation;
  • loss of appetite;
  • headache, dizziness, mild weakness;
  • dry mouth;
  • sweating;
  • itching;
  • urinating less than usual; or
  • loss of interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Demerol (meperidine) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about meperidine (Demerol)?

 

Meperidine may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

Do not drink alcohol while you are taking meperidine. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take meperidine in larger amounts, or for longer than recommended by your doctor, or you could have serious or life-threatening side effects. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how meperidine will affect you.

Do not stop using meperidine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using meperidine.

Side Effects Centers
  • Demerol

Patient Detailed How Take

What should I discuss with my healthcare provider before taking meperidine (Demerol)?

 

You should not use meperidine if you are allergic to it.

Do not use meperidine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

To make sure you can safely take meperidine, tell your doctor if you have any of these other conditions:

  • asthma, COPD, sleep apnea, or other breathing disorders;
  • liver or kidney disease;
  • underactive thyroid;
  • curvature of the spine;
  • a history of head injury or brain tumor;
  • epilepsy or other seizure disorder;
  • low blood pressure;
  • gallbladder disease;
  • sickle cell anemia;
  • pheochromocytoma (tumor of the adrenal gland), Addison's disease, or other adrenal gland disorders;
  • enlarged prostate, urination problems;
  • mental illness;
  • a history of drug or alcohol addiction; or
  • if you recently drank large amounts of alcohol.

Meperidine may be habit forming and should be used only by the person it was prescribed for. Never share meperidine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether meperidine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using meperidine.

Meperidine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using meperidine.

Older adults may be more sensitive to the effects of this medication.

How should I take meperidine (Demerol)?

 

Take exactly as prescribed. Never take meperidine in larger amounts or for longer than recommended by your doctor, or you could have serious or life-threatening side effects. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take this medicine with a full glass of water.

Take meperidine with food or milk if it causes stomach upset.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

Do not stop using meperidine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using meperidine.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Meperidine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet.

Side Effects Centers
  • Demerol

Patient Detailed Avoid Taking

What happens if I miss a dose (Demerol)?

 

Since meperidine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Demerol)?

 

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of meperidine can be fatal.

Overdose symptoms may include extreme drowsiness, muscle weakness, confusion, cold and clammy skin, pinpoint pupils, shallow breathing, slow heart rate, fainting, or coma.

What should I avoid while taking meperidine (Demerol)?

 

Do not drink alcohol while you are using meperidine. Dangerous side effects or death can occur when alcohol is combined with meperidine. Check your food and medicine labels to be sure these products do not contain alcohol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how meperidine will affect you.

What other drugs will affect meperidine (Demerol)?

 

Do not take meperidine with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Tell your doctor about all other medicines you use, especially:

  • phenytoin (Dilantin);
  • pentazocine (Talwin);
  • nalbuphine (Nubain);
  • butorphanol (Stadol); or
  • buprenorphine (Buprenex, Subutex).

This list is not complete and other drugs may interact with meperidine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your pharmacist can provide more information about meperidine.


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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 9.02. Revision date: 2/2/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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  • Demerol

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