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Generic Name

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Meperidine hydrochloride, 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 oral solution is a pleasant-tasting, nonalcoholic, banana-flavored solution containing 50 mg
of DEMEROL, brand of meperidine hydrochloride, per 5 mL teaspoon (25 drops contain 13 mg
of DEMEROL). The tablets contain 50 mg or 100 mg of the analgesic.

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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 (5.2)], 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.

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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
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
Other adverse reactions include:
Nervous System: Euphoria, dysphoria, weakness, headache, agitation, tremor, uncoordinated
muscle movements (e.g. muscle twitches, myoclonus), severe convulsions, transient
hallucinations and disorientation, visual disturbances.
Gastrointestinal: Dry mouth, constipation, biliary tract spasm.
Cardiovascular: Flushing of the face, tachycardia, bradycardia, palpitation, hypotension , syncope.
Genitourinary: Urinary retention.
Allergic: Pruritus, urticaria, other skin rashes, wheal and flare over the vein with intravenous
injection. Hypersensitivity reactions including anaphylaxis.

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DEMEROL is contraindicated in patients with hypersensitivity to meperidine.
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. 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.)

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