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

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Description

Uses

Meperidine is used to help relieve moderate to severe pain. It may also be used before and during surgery or other procedures. Meperidine belongs to a class of drugs known as opioid analgesics and is similar to morphine. It works in the brain to change how your body feels and responds to pain.

Meperidine should not be used to treat long-term or ongoing pain. It should only be used to treat sudden episodes of moderate to severe pain. See also Precautions section.

How to use Demerol Vial

This medication is given by injection into a vein, into a muscle, or under the skin as directed by your doctor.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

When meperidine is injected into a vein, it is given very slowly to prevent serious side effects. If this medication is given into a muscle or under the skin, it is important to change the injection site each time to lessen injury under the skin. You should be lying down when the injection is given to prevent side effects such as dizziness.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed because your risk of side effects may increase. Properly stop the medication when so directed.

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.

If you have nausea, ask your doctor or pharmacist for ways to decrease it (such as lying down with as little head movement as possible).

Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxietytrouble sleeping, thoughts of suicide), watering eyesrunny nose, nausea, diarrheasweating, muscle aches, or sudden changes in behavior.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Use this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your pain does not get better or if it gets worse.

INDICATIONS

DEMEROL Tablets and Oral Solution are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations Of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS], reserve DEMEROL Tablets or Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

  • Have not been tolerated, or are not expected to be tolerated,
  • Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

DEMEROL Tablets or Oral Solution should not be used for treatment of chronic pain. Prolonged DEMEROL Tablet or Oral Solution use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine.

DOSAGE AND ADMINISTRATION

Important Dosage And Administration Instructions

Ensure accuracy when prescribing, dispensing, and administrating DEMEROL Oral Solution to avoid dosing errors due to confusion between mg and mL, and with other Meperidine Hydrochloride Oral Solutions of different concentrations, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume.

Do not use household teaspoons or tablespoons to measure DEMEROL Oral Solution, as using a tablespoon instead of a teaspoon could lead to overdosage.

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].

Dilute each dose of DEMEROL oral solution in one-half glass of water because the undiluted solution may exert a slight topical anesthetic effect on mucous membranes.

Initiate the dosing regimen for each patient individually; taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS].

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with DEMEROL Tablets or Oral Solution and adjust the dosage accordingly [see WARNINGS AND PRECAUTIONS].

Initial Dosage

Adults

Initiate treatment with DEMEROL Tablets or Oral Solution in a dosing range of 50 mg to 150 mg orally, every 3 or 4 hours as needed for pain.

Pediatric Patients

Initiate treatment with DEMEROL Tablets or Oral Solution in a dosing range of 1.1 mg/kg to 1.8 mg/kg orally, up to the adult dose, every 3 or 4 hours as necessary.

Dosage Modification With Concomitant Use With Phenothiazines

The dose of DEMEROL Tablets or Oral Solution should be reduced by 25 to 50% when administered concomitantly with phenothiazines and other tranquilizers.

Titration And Maintenance Of Therapy

Individually titrate DEMEROL Tablets and Oral Solution to a dose that provides adequate analgesia and minimizes adverse reactions. If adequate pain management cannot be achieved with a total daily dosage of 600 mg or less, discontinue treatment with DEMEROL Tablets or Oral Solution by tapering the dose and select an alternate analgesic.

Continually reevaluate patients receiving DEMEROL Tablets or Oral Solution to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS AND PRECAUTIONS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the DEMEROL Tablets or Oral Solution dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation Of DEMEROL Tablets Or Oral Solution

When a patient who has been taking DEMEROL Tablets or Oral Solution regularly and may be physically dependent no longer requires therapy with DEMEROL Tablets or Oral Solution, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue DEMEROL Tablets or Oral Solution in a physically-dependent patient. [see WARNINGS AND PRECAUTIONSDrug Abuse And Dependence].

HOW SUPPLIED

Dosage Forms And Strengths

Tablets
  • 50 mg scored tablet (white, round and convex with a stylized “W” on one side and “D” over “35” on the other side)
  • 100 mg scored tablet (white, round and convex with a stylized “W” on one side and “D” over “37” on the other side)
Oral Solution
  • Nonalcoholic, banana-flavored 50mg per 5mL (10 mg/mL), bottles of 16 fl. oz.

Storage And Handling

DEMEROL (meperidine hydrochloride) Tablets 50 mg, are white, round, convex scored tablets debossed with “W” on one side and “D” over “35” on the other, and are supplied as: HDPE plastic bottles of 100 (NDC Number 30698-335-01)

DEMEROL (meperidine hydrochloride) Tablets 100 mg, are white, round, convex scored Tablets debossed with “W” on one side and “D” over “37” on the other, and are supplied as: HDPE plastic bottles of 100 (NDC Number 30698-337-01)

DEMEROL (meperidine hydrochloride) Oral Solution, 50mg per 5mL (10 mg/mL) is nonalcoholic, banana-flavored syrup, and is supplied in 16 fl. oz. bottles (NDC Number 30698-33216).

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

Side Effects

Nauseavomitingconstipationsweatinglightheadednessdizziness, drowsiness, or pain/redness at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

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

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: interrupted breathing during sleep (sleep apnea), mental/mood changes (such as agitation, confusion, hallucinations), stomach/abdominal pain, difficulty urinating, slow/irregular/fast heartbeat, shaking (tremors), vision changes, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).

Get medical help right away if you have any very serious side effects, including: faintingseizure, severe drowsiness/difficulty waking up.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrheatwitching muscles, unexplained fever, unusual agitation/restlessness.

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: rashitching/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.

Demerol 100 mg/mL injection solutionicon
Demerol 100 Mg/ML Injection Solution

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Demerol 50 mg/mL injection solutionicon
Demerol 50 Mg/ML Injection Solution

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