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Embeda

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Embeda

Embeda

INDICATIONS

EMBEDA is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

EMBEDA is not for use:

  • As an as-needed (prn) analgesic
  • For pain that is mild or not expected to persist for an extended period of time
  • For acute pain
  • For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.

EMBEDA 100 mg/4 mg capsules are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid-tolerant are those taking at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.

DOSAGE AND ADMINISTRATION

Initial Dosing

Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with EMBEDA [see WARNINGS AND PRECAUTIONS].

Consider the following factors when selecting an initial dose of EMBEDA:

  • Total daily dose, potency, and any prior opioid the patient has been taking previously;
  • Reliability of the relative potency estimate used to calculate the equivalent dose of morphine needed (Note: potency estimates may vary with the route of administration);
  • Patient's degree of opioid experience and opioid tolerance;
  • General condition and medical status of the patient;
  • Concurrent medication;
  • Type and severity of the patient's pain.

EMBEDA is administered at a frequency of either once daily (every 24 hours) or twice daily (every 12 hours).

Use of EMBEDA as the First Opioid Analgesic

Initiate EMBEDA therapy with the 20 mg/0.8 mg capsule.

Conversion from Other Oral Morphine Formulations to EMBEDA

Patients receiving other oral morphine formulations may be converted to EMBEDA by administering one-half of the patient's total daily oral morphine dose as EMBEDA twice daily or by administering the total daily oral morphine dose as EMBEDA once daily. There are no data to support the efficacy or safety of prescribing EMBEDA more frequently than every 12 hours.

Conversion from Parenteral Morphine, or Other Opioids to EMBEDA

While there are useful tables of oral and parenteral equivalents, there is substantial inter -patient variation in the relative potency of different opioid drugs and formulations. As such, it is safer to underestimate a patient's 24-hour oral morphine requirement and provide rescue medication (e.g., immediate-release morphine) than to overestimate and manage an adverse reaction. Consider the following general points:

Parenteral to Oral Morphine Ratio: Between 2 mg and 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of oral morphine that is three times the daily parenteral morphine requirement is sufficient.

Other Oral or Parenteral Opioids to Oral Morphine Sulfate: Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.

The first dose of EMBEDA may be taken with the last dose of any immediate-release opioid medication due to the extended-release characteristics of the EMBEDA formulation.

Titration and Maintenance of Therapy

Individually titrate EMBEDA to a dose that provides adequate analgesia and minimizes adverse reactions at a frequency of either once or twice daily. Continually reevaluate patients receiving EMBEDA to assess the maintenance of pain control and the relative incidence of adverse reactions. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

If the level of pain increases, attempt to identify the source of increased pain, while adjusting the EMBEDA dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 24 to 36 hours, EMBEDA dosage adjustments may be done every 1 to 2 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication with a small dose of an immediate-release medication. In patients experiencing inadequate analgesia with once daily dosing of EMBEDA, consider a twice daily regimen.

If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation of EMBEDA

When a patient no longer requires therapy with EMBEDA, use a gradual downward titration, of the dose every 2 to 4 days, to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue EMBEDA.

Administration of EMBEDA

Instruct patients to swallow EMBEDA capsules intact. The pellets in the capsules are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of morphine [see WARNINGS AND PRECAUTIONS]. Consuming EMBEDA capsules that have been altered by crushing, chewing, or dissolving the pellets can release sufficient naltrexone to precipitate withdrawal in opioid-dependent individuals [see WARNINGS AND PRECAUTIONS].

Alternatively, the contents of the EMBEDA capsules (pellets) may be sprinkled over applesauce and then swallowed. This method is appropriate only for patients able to reliably swallow the applesauce without chewing. Other foods have not been tested and should not be substituted for applesauce. Instruct the patient to:

  • Sprinkle the pellets onto a small amount of applesauce and consume immediately without chewing.
  • Rinse the mouth to ensure all pellets have been swallowed.
  • Discard any unused portion of the EMBEDA capsules after the contents have been sprinkled on applesauce.

Do not administer EMBEDA pellets through a nasogastric or gastric tubes.

HOW SUPPLIED

Dosage Forms And Strengths

EMBEDA contains creamy white to light tan spheroidal pellets, have an outer opaque capsule with colors as identified below and are available in six dosage strengths:

Each 20 mg/0.8 mg capsule contains 20 mg of morphine sulfate and 0.8 mg of naltrexone hydrochlor ide in a two-toned yellow opaque capsule with “EMBEDA” printed in grey ink on the darker-toned cap and a single grey band around ¾ of the circumference. The lighter-toned body has “20” reverse-printed in a grey circle.

Each 30 mg/1.2 mg capsule contains 30 mg of morphine sulfate and 1.2 mg of naltrexone hydrochloride in a two-toned blue violet opaque capsule with “EMBEDA” printed in grey ink on the darker-toned cap and a single grey band around ¾ of the circumference. The lighter-toned body has “30” reverse-printed in a grey circle.

Each 50 mg/2 mg capsule contains 50 mg of morphine sulfate and 2 mg of naltrexone hydrochloride in a two-toned blue opaque capsule with “EMBEDA” printed in grey ink on the darker-toned cap and a single grey band around ¾ of the circumference. The lighter-toned body has “50” reverse-printed in a grey circle.

Each 60 mg/2.4 mg capsule contains 60 mg of morphine sulfate and 2.4 mg of naltrexone hydrochloride in a two-toned pink opaque capsule with “EMBEDA” printed in grey ink on the darker-toned cap and a single grey band around ¾ of the circumference. The lighter-toned body has “60” reverse-printed in a grey circle.

Each 80 mg/3.2 mg capsule contains 80 mg of morphine sulfate and 3.2 mg of naltrexone hydrochloride in a two-toned light peach opaque elongated capsule with “EMBEDA” printed in grey ink on the darker-toned cap and a single grey band around ¾ of the circumference. The lighter-toned body has “80” reverse-printed in a grey circle.

Each 100 mg/4 mg capsule contains 100 mg of morphine sulfate and 4 mg of naltrexone hydrochloride in a two-toned green opaque capsule with “EMBEDA” printed in grey ink on the darker-toned cap and a single grey band around ¾ of the circumference. The lighter-toned body has “100” reverse-printed in a grey circle.

Storage And Handling

  EMBEDA 20 mg/0.8 mg EMBEDA 30 mg/1.2 mg EMBEDA 50 mg/2 mg EMBEDA 60 mg/2.4 mg EMBEDA 80 mg/3.2 mg EMBEDA 100 mg/4 mg
Morphine sulfate 20 mg 30 mg 50 mg 60 mg 80 mg 100 mg
Sequestered naltrexone hydrochloride 0.8 mg 1.2 mg 2 mg 2.4 mg 3.2 mg 4 mg
Capsule Description For all strengths, the darker-toned cap has “EMBEDA” printed in grey ink and a single grey band around ¾ of the circumference. Two-toned, yellow opaque hard gelatin capsule. The lighter-toned body has “20” reverse-printed in a grey circle. Two-toned, blue violet opaque hard gelatin capsule. The lighter-toned body has “30” reverse-printed in a grey circle. Two-toned, blue opaque hard gelatin capsule. The lighter-toned body has “50” reverse-printed in a grey circle. Two-toned, pink opaque hard gelatin capsule. The lighter-toned body has “60” reverse-printed in a grey circle. Two-toned, light peach opaque elongated hard gelatin capsule. The lighter-toned body has “80” reverse-printed in a grey circle. Two-toned, green opaque hard gelatin capsule. The lighter-toned body has “100” reverse-printed in a grey circle.
Bottle Size 75 cc 75 cc 75 cc 75 cc 75 cc 75 cc
NDC # 60793-430-20 60793-431-20 60793-433-20 60793-434-20 60793-435-20 60793-437-20

Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F).

Dispense in a sealed, tamper-evident, childproof, light-resistant container.

This product's label may have been updated. For current full prescribing information please visit www.pfizer.com. Distributed by: Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. Revised: 07/2013.

Last reviewed on RxList: 11/18/2013
This monograph has been modified to include the generic and brand name in many instances.

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