DEMEROL™ Dosage and Administration

(Meperidine Hydrochloride Injection, USP)

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

•
DEMEROL Injection 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 of time consistent with individual patient treatment goals [see Warnings and Precautions (5)]. Because the risk of overdose increases as opioid doses increase, reserve ‎titration to higher doses of DEMEROL 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.‎
•
Many acute pain conditions (e.g., the pain that occurs with a number of surgical ‎procedures or acute musculoskeletal injuries) require no more than a few days of ‎an opioid analgesic. Clinical guidelines on opioid prescribing for some acute ‎pain conditions are available.‎
•
There is variability in the opioid analgesic dose and duration needed to ‎adequately manage pain due both to the cause of pain and to individual patient ‎factors. ‎Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].
•
Respiratory depression can occur at any time during opioid therapy, especially ‎when initiating and following dosage increases with DEMEROL Injection.‎ Consider this risk when selecting an initial dose and when making dose ‎adjustments [see Warnings and Precautions (5)].
•
Inspect DEMEROL Injection for particulate matter and discoloration prior to administration. Do not use if color is darker than pale yellow, if it is discolored in any other way, or if it contains a ‎precipitate.‎

2.2 For Management of Pain

Initial Dosage

Dosage should be adjusted according to the severity of the pain and the response of the patient. While subcutaneous administration is suitable for occasional use, intramuscular administration is preferred when repeated doses are required. If intravenous administration is required, dosage should be decreased and the injection made very slowly, preferably utilizing a diluted solution.

Adults:  Initiate treatment in a dosing range of 50 mg to 150 mg intramuscularly or subcutaneously every 3 to 4 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia. Elderly patients should usually be given meperidine at the lower end of the dose range and observed closely.

Children:  Initiate treatment in a dosing range of 0.5 mg/lb to 0.8 mg/lb intramuscularly or subcutaneously up to the adult dose, every 3 to 4 hours as necessary, and at the lowest dose necessary to achieve adequate analgesia.

Titration and Maintenance of Therapy

Titrate the dose based upon the individual patient’s response to their initial dose of DEMEROL Injection. Individually titrate DEMEROL Injection to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving DEMEROL Injection to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and other adverse reactions, as well as to reassess for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1, 5.15)]. Frequent communication is important among the prescriber, other members of the health and care 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 Injection dosage. If after increasing the dosage, unacceptable opioid-related adverse reactions are observed (including an increase in pain after a dosage increase), consider reducing the dosage [see Warnings and Precautions ‎‎(5)]. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation of DEMEROL Injection

When a patient who has been taking DEMEROL Injection regularly and may be physically-dependent no longer requires therapy with DEMEROL Injection, 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 Injection in a physically-dependent patient [see Warnings and Precautions (5.15), Drug Abuse and Dependence (9.3)].

2.3 For Preoperative Medication

Adults: The usual dosage is 50 mg to 100 mg intramuscularly or subcutaneously, 30 to 90 minutes before the beginning of anesthesia. Elderly patients should usually be given meperidine at the lower end of the dose range and observed closely.

Children: The usual dosage is 0.5 mg/lb to 1 mg/lb intramuscularly or subcutaneously up to the adult dose, 30 to 90 minutes before the beginning of anesthesia.

2.4 For Support of Anesthesia

Repeated slow intravenous Injections of fractional doses (e.g., 10 mg/mL) or continuous intravenous infusion of a more dilute solution (e.g., 1 mg/mL) should be used. The dose should be titrated to the needs of the patient and will depend on the premedication and type of anesthesia being employed, the characteristics of the particular patient, and the nature and duration of the operative procedure. Elderly patients should usually be given meperidine at the lower end of the dose range and observed closely.

2.5 For Obstetrical Analgesia

The usual dosage is 50 mg to 100 mg intramuscularly or subcutaneously when pain becomes regular, and may be repeated at 1- to 3-hour intervals.

2.6 Dosage Modifications with Concomitant Phenothiazines

The dose of DEMEROL Injection 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 Injection.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

•
DEMEROL Injection 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 of time consistent with individual patient treatment goals [see Warnings and Precautions (5)]. Because the risk of overdose increases as opioid doses increase, reserve ‎titration to higher doses of DEMEROL 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.‎
•
Many acute pain conditions (e.g., the pain that occurs with a number of surgical ‎procedures or acute musculoskeletal injuries) require no more than a few days of ‎an opioid analgesic. Clinical guidelines on opioid prescribing for some acute ‎pain conditions are available.‎
•
There is variability in the opioid analgesic dose and duration needed to ‎adequately manage pain due both to the cause of pain and to individual patient ‎factors. ‎Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].
•
Respiratory depression can occur at any time during opioid therapy, especially ‎when initiating and following dosage increases with DEMEROL Injection.‎ Consider this risk when selecting an initial dose and when making dose ‎adjustments [see Warnings and Precautions (5)].
•
Inspect DEMEROL Injection for particulate matter and discoloration prior to administration. Do not use if color is darker than pale yellow, if it is discolored in any other way, or if it contains a ‎precipitate.‎

2.2 For Management of Pain

Initial Dosage

Dosage should be adjusted according to the severity of the pain and the response of the patient. While subcutaneous administration is suitable for occasional use, intramuscular administration is preferred when repeated doses are required. If intravenous administration is required, dosage should be decreased and the injection made very slowly, preferably utilizing a diluted solution.

Adults:  Initiate treatment in a dosing range of 50 mg to 150 mg intramuscularly or subcutaneously every 3 to 4 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia. Elderly patients should usually be given meperidine at the lower end of the dose range and observed closely.

Children:  Initiate treatment in a dosing range of 0.5 mg/lb to 0.8 mg/lb intramuscularly or subcutaneously up to the adult dose, every 3 to 4 hours as necessary, and at the lowest dose necessary to achieve adequate analgesia.

Titration and Maintenance of Therapy

Titrate the dose based upon the individual patient’s response to their initial dose of DEMEROL Injection. Individually titrate DEMEROL Injection to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving DEMEROL Injection to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and other adverse reactions, as well as to reassess for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1, 5.15)]. Frequent communication is important among the prescriber, other members of the health and care 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 Injection dosage. If after increasing the dosage, unacceptable opioid-related adverse reactions are observed (including an increase in pain after a dosage increase), consider reducing the dosage [see Warnings and Precautions ‎‎(5)]. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation of DEMEROL Injection

When a patient who has been taking DEMEROL Injection regularly and may be physically-dependent no longer requires therapy with DEMEROL Injection, 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 Injection in a physically-dependent patient [see Warnings and Precautions (5.15), Drug Abuse and Dependence (9.3)].

2.3 For Preoperative Medication

Adults: The usual dosage is 50 mg to 100 mg intramuscularly or subcutaneously, 30 to 90 minutes before the beginning of anesthesia. Elderly patients should usually be given meperidine at the lower end of the dose range and observed closely.

Children: The usual dosage is 0.5 mg/lb to 1 mg/lb intramuscularly or subcutaneously up to the adult dose, 30 to 90 minutes before the beginning of anesthesia.

2.4 For Support of Anesthesia

Repeated slow intravenous Injections of fractional doses (e.g., 10 mg/mL) or continuous intravenous infusion of a more dilute solution (e.g., 1 mg/mL) should be used. The dose should be titrated to the needs of the patient and will depend on the premedication and type of anesthesia being employed, the characteristics of the particular patient, and the nature and duration of the operative procedure. Elderly patients should usually be given meperidine at the lower end of the dose range and observed closely.

2.5 For Obstetrical Analgesia

The usual dosage is 50 mg to 100 mg intramuscularly or subcutaneously when pain becomes regular, and may be repeated at 1- to 3-hour intervals.

2.6 Dosage Modifications with Concomitant Phenothiazines

The dose of DEMEROL Injection 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 Injection.
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