Finished product reference

Pethidine Hydrochloride

Injection · Parenteral · 50 mg/1mL · 1 mL

List code
1354
Boxed warning

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MEPERIDINE HYDROCHLORIDE INJECTION WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MEPERIDINE HYDROCHLORIDE INJECTION See full prescribing information for complete boxed warning. Meperidine Hydrochloride Injection exposes users to risks of addiction, abuse, and misuse, which can also lead to overdose and death.

What it is and how it works

Mechanism of Action Meperidine hydrochloride is an opioid agonist 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.

Indications

Meperidine Hydrochloride Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. Meperidine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Meperidine Hydrochloride Injection is indicated for preoperative medication, support of anesthesia, for obstetrical analgesia, and for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Dosage and administration (summary)

Meperidine Hydrochloride should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Reserve titration to higher doses of Meperidine Hydrochloride Injection for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.

Contraindications

Meperidine Hydrochloride Injection is contraindicated in patients with: Significant respiratory depression Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment Concomitant use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days Known or suspected gastrointestinal obstruction, including paralytic ileus Hypersensitivity to meperidine (e.g., anaphylaxis) Significant respiratory depression.

Warnings and precautions

Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. Serotonin Syndrome with Concomitant Use of Serotonergic Drug s: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue Meperidine Hydrochloride Injection if serotonin syndrome is suspected.

Pregnancy

Pregnancy Risk Summary Prolonged use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome . Available data with Meperidine Hydrochloride Injection are insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes.

Storage and supply

For Parenteral Use Meperidine Hydrochloride Injection, USP is clear and colorless and is available in the following packages: 25 mg/mL 1 mL Single Dose vials packaged in 25s ( NDC 0641-6052-25) 50 mg/mL 1 mL Single Dose vials packaged in 25s ( NDC 0641-6053-25) 100 mg/mL 1 mL Single Dose vials packaged in 25s ( NDC 0641-6054-25) Store at 20 ° to 25…

Source: Meperidine Hydrochloride (Meperidine Hydrochloride) — US FDA prescribing information, 2024-04-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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