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Astramorph (Morphine Sulfate Epidural) - Indications and Dosage

 
 



INDICATIONS AND USAGE:

Astramorph/PF is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain not responsive to non-narcotic analgesics. Astramorph/PF, administered epidurally or intrathecally, provides pain relief for extended periods without attendant loss of motor, sensory or sympathetic function.

DOSAGE AND ADMINISTRATION:

Astramorph/PF is intended for intravenous, epidural or intrathecal administration.

Intravenous Administration:

Dosage:

The initial dose of morphine sulfate should be 2 mg to 10 mg/70 kg of body weight. No information is available regarding the use of Astramorph/PF in patients under the age of 18.

Geriatric Use:

Administer with extreme caution (See PRECAUTIONS.)

Epidural Administration:

ASTRAMORPH/PF SHOULD BE ADMINISTERED EPIDURALLY BY OR UNDER THE DIRECTION OF A PHYSICIAN EXPERIENCED IN THE TECHNIQUE OF EPIDURAL ADMINISTRATION AND WHO IS THOROUGHLY FAMILIAR WITH THE LABELING. IT SHOULD BE ADMINISTERED ONLY IN SETTINGS WHERE ADEQUATE PATIENT MONITORING IS POSSIBLE. RESUSCITATIVE EQUIPMENT AND A SPECIFIC ANTAGONIST (NALOXONE INJECTION) SHOULD BE IMMEDIATELY AVAILABLE FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS WHICH MIGHT RESULT FROM INADVERTENT INTRATHECAL OR INTRAVASCULAR INJECTION. (NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL DOSAGE.) PATIENT MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS AFTER EACH DOSE, SINCE DELAYED RESPIRATORY DEPRESSION MAY OCCUR.

Proper placement of a needle or catheter in the epidural space should be verified before Astramorph/PF is injected. Acceptable techniques for verifying proper placement include: a) aspiration to check for absence of blood or cerebrospinal fluid, or b) administration of 5 mL (3 mL in obstetric patients) of 1.5% PRESERVATIVE-FREE Lidocaine and Epinephrine (1:200,000) Injection and then observe the patient for lack of tachycardia (this indicates that vascular injection has not been made) and lack of sudden onset of segmental anesthesia (this indicates that intrathecal injection has not been made).

Epidural Adult Dosage:

Initial injection of 5 mg in the lumbar region may provide satisfactory pain relief for up to 24 hours. If adequate pain relief is not achieved within one hour, careful administration of incremental doses of 1 to 2 mg at intervals sufficient to assess effectiveness may be given. No more than 10 mg/24 hr should be administered.

Thoracic administration has been shown to dramatically increase the incidence of early and late respiratory depression even at doses of 1 to 2 mg.

For continuous infusion an initial dose of 2 to 4 mg/24 hours is recommended. Further doses of 1 to 2 mg may be given if pain relief is not achieved initially.

Geriatric Use:

Administer with extreme caution. (See PRECAUTIONS.)

Epidural Pediatric Use:

No information on use in pediatric patients is available. (See PRECAUTIONS.)

Intrathecal Administration:

NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL DOSAGE.

ASTRAMORPH/PF SHOULD BE ADMINISTERED INTRATHECALLY BY OR UNDER THE DIRECTION OF A PHYSICIAN EXPERIENCED IN THE TECHNIQUE OF INTRATHECAL ADMINISTRATION AND WHO IS THOROUGHLY FAMILIAR WITH THE LABELING. IT SHOULD BE ADMINISTERED ONLY IN SETTINGS WHERE ADEQUATE PATIENT MONITORING IS POSSIBLE. RESUSCITATIVE EQUIPMENT AND A SPECIFIC ANTAGONIST (NALOXONE INJECTION) SHOULD BE IMMEDIATELY AVAILABLE FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS WHICH MIGHT RESULT FROM INADVERTENT INTRAVASCULAR INJECTION. PATIENT MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS AFTER EACH DOSE, SINCE DELAYED RESPIRATORY DEPRESSION MAY OCCUR. RESPIRATORY DEPRESSION (BOTH EARLY AND LATE ONSET) HAS OCCURRED MORE FREQUENTLY FOLLOWING INTRATHECAL ADMINISTRATION THAN EPIDURAL ADMINISTRATION.

Intrathecal Adult Dosage:

A single injection of 0.2 to 1 mg may provide satisfactory pain relief for up to 24 hours. (CAUTION: THIS IS ONLY 0.4 TO 2 ML OF THE 5 MG/10ML AMPULE/VIAL OR 0.2 TO 1 ML OF THE 10 MG/10 ML AMPULE/VIAL OF ASTRAMORPH/PF.) DO NOT INJECT INTRATHECALLY MORE THAN 2 ML OF THE 5 MG/10 ML AMPULE/VIAL OR 1 ML OF THE 10 MG/10ML AMPULE/VIAL. USE IN THE LUMBAR AREA ONLY IS RECOMMENDED. Repeated intrathecal injections of Astramorph/PF are not recommended. A constant intravenous infusion of naloxone, 0.6 mg/hr, for 24 hours after intrathecal injection may be used to reduce the incidence of potential side effects.

Geriatric Use:

Administer with extreme caution. (See PRECAUTIONS.)

Repeat Dosage :

If pain recurs, alternative routes of administration should be considered, since experience with repeated doses of morphine by the intrathecal route is limited.

Intrathecal Pediatric Use:

No information on use in pediatric patients is available. (See PRECAUTIONS.)

SAFETY AND HANDLING INSTRUCTIONS

Astramorph/PF is supplied in sealed ampules and vials. Accidental dermal exposure should be treated by the removal of any contaminated clothing and rinsing the affected area with water.

Each ampule/vial of Astramorph/PF contains a potent narcotic which has been associated with abuse and dependence among health care providers. Due to the limited indications for this product, the risk of overdosage and the risk of its diversion and abuse, it is recommended that special measures be taken to control this product within the hospital or clinic. Astramorph/PF should be subject to rigid accounting, rigorous control of wastage and restricted access.

Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. DO NOT USE IF COLOR IS DARKER THAN PALE YELLOW, IF IT IS DISCOLORED IN ANY OTHER WAY OR IF IT CONTAINS A PRECIPITATE.

HOW SUPPLIED

Preservative-free ASTRAMORPH/PF™ (Morphine Sulfate Injection, USP) is available in ampules and single dose vials for intravenous, epidural, or intrathecal administration:

0.5 mg/mL

NDC 0186-1159-03 2 mL (1 mg) Ampule,

Boxes of 10

NDC 0186-1150-02 10 mL (5 mg) Ampule,

Boxes of 5

NDC 0186-1152-12 10 mL (5 mg) Single Dose Vial, Boxes of 5 E-Z OFF vial closures

1 mg/mL

NDC 0186-1160-03 2 mL (2 mg) Ampule,

Boxes of 10

NDC 0186-1151-02 10 mL (10 mg) Ampule, Boxes of 5

NDC 0186-1153-12 10 mL (10 mg) Single Dose Vial, Boxes of 5 E-Z OFF vial closures

Storage:

PROTECT FROM LIGHT. Store in carton at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature] until ready to use. DO NOT FREEZE. Astramorph/PF contains no preservative or antioxidant. DISCARD ANY UNUSED PORTION. DO NOT HEAT-STERILIZE.

All trademarks are the property of the AstraZeneca group

© AstraZeneca 2002, 2004

AstraZeneca LP, Wilmington, DE 19850

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