Sumavel Dosepro

Sumavel Dosepro Manufacturers

• Endo Pharmaceuticals
  

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  Sumavel Dosepro | West-ward Pharmaceuticals Corp.

  

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  Morphine sulfate injection is intended for intravenous administration.

  2.1 General Dosing Considerations

  Morphine sulfate injection is available in three concentrations for direct injection. Take care when prescribing and administering morphine sulfate injection to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and total dose in volume.

  Administration of morphine sulfate injection should be limited to use by those familiar with the management of respiratory depression. Morphine must be injected slowly; rapid intravenous administration may result in chest wall rigidity.

  Selection of patients for treatment with morphine sulfate injection should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  2.2 Individualization of Dosage

  Adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of morphine sulfate injection, give attention to the following:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate injection dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient’s pain; risk factors for abuse, addiction or diversion, including prior history of abuse, addiction or diversion

  The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  Continual reevaluation of the patient receiving morphine sulfate injection is important, with special attention to the management of pain and the relative incidence of side effects associated with therapy.

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between the physician, other members of the healthcare team, the patient, and the caregiver/family.

  2.3 Direct Intravenous Injection

  The usual starting dose in adults is 0.1 mg to 0.2 mg per kg every 4 hours as needed to manage pain. Administer the injection slowly.

  2.4 Dosing with Hepatic and Renal Impairment

  Morphine sulfate pharmacokinetics have been reported to be significantly altered in patients with cirrhosis and renal failure. Start these patients cautiously with lower doses of morphine sulfate injection and titrate slowly while carefully monitoring for side effects. [See Use in Specific Populations (8.7 and 8.8).]

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• Zogenix, Inc.
  

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  Sumavel Dosepro | Zogenix, Inc.

  

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  2.1 Dosing Information

  The maximum single recommended dose of Sumavel DosePro for the acute treatment of migraine or cluster headache is 6 mg given subcutaneously. For the treatment of migraine, if side effects are dose limiting, a lower dose (4 mg) may be used [see Clinical Studies (14.1)]. For the treatment of cluster headache, the efficacy of a lower dose has not been established.

  The maximum cumulative injected dose that may be given in 24 hours is 12 mg, with doses of Sumavel DosePro separated by at least 1 hour. Sumavel DosePro may be given at least 1 hour following a dose of another sumatriptan product. A second dose should only be considered if some response to a first dose was observed.

  2.2 Administration Using Sumavel® DosePro®

  Sumavel DosePro is available for use as 4 mg or 6 mg needle-free delivery systems. It is intended to be given subcutaneously only. Sumavel DosePro is designed for patient self-administration to sites on the abdomen or the thigh with an adequate subcutaneous thickness to accommodate penetration of sumatriptan injection into the subcutaneous space. Administration should not be made within 2 inches of the naval. Sumavel DosePro is not to be administered to other areas of the body, including the arm.  

  Instruct patients on the proper use of Sumavel DosePro and direct them to use proper injection sites. Patients should be instructed not to use Sumavel DosePro if the tip of the device is tilted or broken off upon removal from packaging [see Patient counseling Information (17)].

  Sumavel DosePro is for single use only. Discard after use.

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