MORPHINE SULFATE EXTENDED-RELEASE (Page 6 of 6)

Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

There has been no systematic evaluation of morphine sulfate extended-release tablets as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using extended-release morphine, it is ordinarily advisable to begin treatment using an immediate-release formulation (see Special Instructions for Morphine Sulfate Extended-Release 100 mg and 200 mg Tablets).

Considerations in the Adjustment of Dosing Regimens

Whatever the approach, if signs of excessive opioid effects are observed early in a dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, “breakthrough” pain occurs late in the dosing interval, the dosing interval may be shortened. Alternatively, a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments can be made to obtain an appropriate balance between pain relief, opioid side effects, and the convenience of the dosing schedule.

In adjusting dosing requirements, it is recommended that the dosing interval never be extended beyond 12 hours because the administration of very large single doses may lead to acute overdose. (Morphine sulfate extended-release tablets are an extended-release formulation; it does not release morphine continuously over the dosing interval.)

For patients with low daily morphine requirements, the 15 mg tablet should be used.

Special Instructions for Morphine Sulfate Extended-Release 100 mg and 200 mg Tablets (For use in opioid-tolerant patients only.)

Morphine sulfate extended-release 100 mg and 200 mg tablets are for use only in opioid-tolerant patients requiring daily morphine equivalent dosages of 200 mg or more for the 100 mg tablet and 400 mg or more for the 200 mg tablet. It is recommended that these strengths be reserved for patients that have already been titrated to a stable analgesic regimen using lower strengths of morphine sulfate extended-release tablets or other opioids.

Supplemental Analgesia

Most patients given around-the-clock therapy with extended-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (including incident pain).

Continuation of Therapy

The intent of the titration period is to establish a patient-specific daily dose that will provide adequate analgesia with acceptable side effects and minimal rescue doses (2 or less) for as long as pain relief is necessary. Should pain recur, the dose can be increased to re-establish pain control as outlined above. During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g. every 6 to 12 months) as appropriate.

Cessation of Therapy

When the patient no longer requires therapy with morphine sulfate extended-release tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

Conversion from Morphine Sulfate Extended-Release Tablets to Parenteral Opioids

When converting a patient from morphine sulfate extended-release tablets to parenteral opioids, it is best to assume that the parenteral to oral potency is high. NOTE THAT THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE CONSERVATIVELY. For example, to estimate the required 24-hour dose of morphine for IM use, one could employ a conversion of 1 mg of morphine IM for every 6 mg of morphine as morphine sulfate extended-release tablets. The IM 24-hour dose would have to be divided by six and administered on a q4h regimen. This approach is recommended because it is least likely to cause overdose.

SAFETY AND HANDLING

Morphine sulfate extended-release tablets contain morphine sulfate which is a controlled substance under Schedule II of the Controlled Substances Act. Morphine, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to flush any unneeded morphine sulfate extended-release tablets down the toilet.

Morphine sulfate extended-release tablets may be targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE, AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED, OR CRUSHED. TAKING BROKEN, CHEWED, DISSOLVED, OR CRUSHED MORPHINE SULFATE EXTENDED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.

Morphine sulfate extended-release 100 mg and 200 mg tablets are for use only in opioid-tolerant patients requiring daily morphine equivalent dosages of 200 mg or more for the 100 mg tablet and 400 mg or more for the 200 mg tablet. These strengths are potentially fatal if accidentally ingested and patients and their families should be instructed to take special care to avoid accidental or intentional ingestion by individuals other than those for whom the medication was originally prescribed.

HOW SUPPLIED

Each Morphine Sulfate Extended-Release Tablet 15 mg is available as a round, blue convex tablet, one side debossed Imprint Code and the other side debossed “15”.

Bottles of 28 — NDC 42549-614-28

Bottles of 56 — NDC 42549-614-56

Each Morphine Sulfate Extended-Release Tablet 30 mg is available as a round, purple convex tablet, one side debossed Imprint Code and the other side debossed “30”.

Bottles of 28 — NDC 42549-572-28

Bottles of 56 — NDC 42549-572-56

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container.

For information about this product that was written for healthcare professionals, visit www.Mallinckrodt.com or call 1-800-778-7898.

CAUTION

DEA Order Form Required.

Imprint Code is a trademark of Mallinckrodt Inc.

Mallinckrodt Inc.

Hazelwood, MO 63042 USA

Printed in U.S.A.

Rev 09/2010 r1

Mallinckrodt

COVIDIEN™

PACKAGE LABEL — MORPHINE SULFATE ER C-II — 15 mg TABLETS

CII — Rx Only

Morphine Sulf ER C-II 15 mg Image
(click image for full-size original)

PACKAGE LABEL — MORPHINE SULFATE ER C-II — 30 mg TABLETS

C-II — Rx Only

Morphine Sulf ER C-II 30 mg Image
(click image for full-size original)

Relabeling and Repackaging by :

STAT Rx USA LLC

Gainesville, GA 30501

MORPHINE SULFATE EXTENDED-RELEASE morphine sulfate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42549-614(NDC:0406-8315)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 15 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (15000 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL
POLYDEXTROSE
SILICON DIOXIDE
TITANIUM DIOXIDE
TRIACETIN
FD&C BLUE NO. 2
Product Characteristics
Color blue Score no score
Shape ROUND Size 7mm
Flavor Imprint Code M;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42549-614-28 28 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
2 NDC:42549-614-56 56 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
3 NDC:42549-614-60 60 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076412 10/21/2010
MORPHINE SULFATE EXTENDED-RELEASE morphine sulfate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42549-572(NDC:0406-8330)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 30 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (15000 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL
POLYDEXTROSE
SILICON DIOXIDE
TITANIUM DIOXIDE
TRIACETIN
FD&C BLUE NO. 2
D&C RED NO. 7
Product Characteristics
Color purple Score no score
Shape ROUND Size 7mm
Flavor Imprint Code M;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42549-572-28 28 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
2 NDC:42549-572-56 56 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
3 NDC:42549-572-60 60 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076412 10/21/2010
Labeler — STAT Rx USA LLC (786036330)
Registrant — PSS World Medical Inc. (101822682)
Establishment
Name Address ID/FEI Operations
STAT Rx USA LLC 786036330 relabel, repack

Revised: 04/2012 STAT Rx USA LLC

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