Demerol (Meperidine)

DEMEROL (meperidine hydrochloride, USP) Tablet and Oral Solution are opioid agonists. DEMEROL Tablets are available as 50 mg and 100 mg Tablets for oral administration. 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 meperidine hydrochloride.

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.

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.

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.

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)

SIDE EFFECTS

The following serious adverse reactions are described

• Addiction, Abuse, and Misuse
• Life-Threatening Respiratory Depression
• Neonatal Opioid Withdrawal Syndrome
• Interactions with Benzodiazepines or Other CNS Depressants
• Serotonin Syndrome
• Adrenal Insufficiency
• Severe Hypotension
• Gastrointestinal Adverse Reactions
• Seizures
• Withdrawal