Morphine Extended Release Capsules

Name: Morphine Extended Release Capsules

Morphine Extended Release Capsules - Clinical Pharmacology

12.1 Mechanism of Action

Hydrocodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.

The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

12.2 Pharmacodynamics

CNS Depressant/Alcohol Interaction

Additive pharmacodynamic effects may be expected when Morphine Sulfate Extended-Release Capsules are used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.

Effects on the Central Nervous System

Morphine produces respiratory depression by direct action on brainstem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brainstem respiratory centers to both increases in carbon dioxide tension and to electrical stimulation.

Morphine causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.

Effects on the Gastrointestinal Tract and Other Smooth Muscle

Morphine causes a reduction in motility and is associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.

Morphine may also cause spasm of the sphincter of the urinary bladder.

Effects on the Cardiovascular System

Morphine produces peripheral vasodilation which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.

Effects on the Endocrine System

Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see Adverse Reactions (6.2)]. They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon.

Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to hormonal changes that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions (6.2)].

Effects on the Immune System

Opioids have been shown to have a variety of effects on components of the immune system. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.

Concentration-Efficacy Relationships

The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. The minimum effective analgesic concentration of morphine for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome, and/or the development of analgesic tolerance [see Dosage and Administration (2.1, 2.2)].

Concentration–Adverse Reaction Relationships

There is a relationship between increasing morphine plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions [see Dosage and Administration (2.1, 2.2)].

12.3 Pharmacokinetics

Absorption

Morphine Sulfate Extended-Release Capsules consist of two components, an immediate-release component and an extended-release component.

The oral bioavailability of morphine is less than 40% and shows large inter-individual variability due to extensive pre-systemic metabolism.

Following single-dose oral administration of a 60 mg dose of Morphine Sulfate Extended-Release Capsules under fasting conditions, morphine concentrations of approximately 3 to 6 ng/mL were achieved within 30 minutes after dosing and maintained for the 24-hour dosing interval. The pharmacokinetics of Morphine Sulfate Extended-Release Capsules were shown to be dose-proportional over a single oral dose range of 30 to 120 mg in healthy volunteers and a multiple oral dose range of at least 30 to 180 mg in patients with chronic moderate to severe pain.

Food Effect: When a 60 mg dose of Morphine Sulfate Extended-Release Capsules was administered immediately following a high fat meal, peak morphine concentrations and AUC values were similar to those observed when the dose of Morphine Sulfate Extended-Release Capsules was administered in a fasting state, although achievement of initial concentrations was delayed by approximately 1 hour under fed conditions. Therefore, Morphine Sulfate Extended-Release Capsules can be administered without regard to food. When the contents of Morphine Sulfate Extended-Release Capsules were administered by sprinkling on applesauce, the rate and extent of morphine absorption were found to be bioequivalent to the same dose when administered as an intact capsule.

Steady State: Steady-state plasma concentrations of morphine are achieved 2 to 3 days after initiation of once-daily administration of Morphine Sulfate Extended-Release Capsules.

Morphine Sulfate Extended-Release 60 mg capsules (once-daily) and 10 mg morphine oral solution (6 times daily) were equally bioavailable.

Graph 1

Mean Steady-State Plasma Morphine Concentrations Following Once-Daily Administration of Morphine Sulfate Extended-Release Capsules or 6-Times Daily Administration of Morphine Solution

Graph 1 Mean Steady-State Plasma Morphine Concentrations Following Once-Daily Administration of Morphine Sulfate Extended-Release Capsules or 6-Times Daily Administration of Morphine Solution

A once-daily dose of Morphine Sulfate Extended-Release Capsules provided similar Cmax, Cmin, and AUC values and peak-trough fluctuations (% FL, Cmax-Cmin/Cav) compared to 6-times daily administration of the same total daily dose of morphine oral solution (Table 2).

Table 2 Pharmacokinetic Data Mean ± SD
 Parameter Morphine Sulfate Extended-Release Capsules Once-Daily Morphine Oral Solution
6-Times Daily
 AUC (ng/mL.h)  273.25 ± 81.24  279.11 ± 63.00
 Cmax (ng/mL)  18.65 ± 7.13  19.96 ± 4.82
 Cmin (ng/mL)  6.98 ± 2.44  6.61 ±2.15
 % FL  106.38 ± 78.14  116.22 ± 26.67

Distribution

Once absorbed, morphine is distributed to skeletal muscle, kidneys, liver, intestinal tract, lungs, spleen and brain. Although the primary site of action is the CNS, only small quantities cross the blood-brain barrier. Morphine also crosses the placental membranes and has been found in breast milk [see Use in Specific Populations (8.1, 8.3)]. The volume of distribution of morphine is approximately 1 to 6 L/kg, and morphine is 20 to 35% reversibly bound to plasma proteins.

Elimination

Metabolism
The major pathways of morphine metabolism include glucuronidation to produce metabolites including morphine-3-glucuronide, M3G (about 50%) and morphine-6-glucuronide, M6G (about 5 to 15%) and sulfation in the liver to produce morphine-3-etheral sulfate. A small fraction (less than 5%) of morphine is demethylated. M6G has been shown to have analgesic activity but crosses the blood-brain barrier poorly, while M3G has no significant analgesic activity.

Excretion
Approximately 10% of a morphine dose is excreted unchanged in the urine. Elimination of morphine is primarily via hepatic metabolism to glucuronide metabolites M3G and M6G which are then renally excreted. A small amount of the glucuronide metabolites is excreted in the bile and there is some minor enterohepatic recycling. Seven to 10% of administered morphine is excreted in the feces. The mean adult plasma clearance of morphine is about 20 to 30 mL/minute/kg. The effective terminal half-life of morphine after IV administration is reported to be approximately 2 hours. The terminal elimination half-life of morphine following single dose of Morphine Sulfate Extended-Release Capsules administration is approximately 24 hrs.

 Specific Populations


Sex
An analysis of pharmacokinetic data from healthy subjects taking Morphine Sulfate Extended-Release Capsules indicated that morphine concentrations were similar in males and females.

Race/Ethnicity
Chinese subjects given intravenous morphine had a higher clearance when compared to Caucasian subjects (1852 +/- 116 mL/min compared to 1495 +/- 80 mL/min).

Hepatic Impairment
Morphine pharmacokinetics are altered in individuals with cirrhosis. Clearance was found to decrease with a corresponding increase in half-life. The M3G and M6G to morphine plasma AUC ratios also decreased in these subjects, indicating diminished metabolic activity. Adequate studies of the pharmacokinetics of morphine in patients with severe hepatic impairment have not been conducted. 

Renal Impairment
Morphine pharmacokinetics are altered in patients with renal failure. The AUC is increased and clearance is decreased and the metabolites, M3G and M6G, may accumulate to much higher plasma levels in patients with renal failure as compared to patients with normal renal function. Adequate studies of the pharmacokinetics of morphine in patients with severe renal impairment have not been conducted. 

Drug Interaction/Alcohol Interaction
In in vitro studies of the dissolution of Morphine Sulfate Extended-Release Capsules 30 mg mixed with 900 mL of buffer solutions containing ethanol (20% and 40%), the amount of morphine released increased in an alcohol concentration-dependent manner. While the relevance of in vitro lab tests regarding Morphine Sulfate Extended-Release Capsules to the clinical setting remains to be determined, this acceleration of release may correlate with in vivo rapid release of the total morphine dose, which could result in the absorption of a potentially fatal dose of morphine.

Clinical Studies

Morphine Sulfate Extended-Release Capsules were studied in a double-blind, placebo-controlled, fixed-dose, parallel group trial in 295 patients with moderate to severe pain due to osteoarthritis. These patients had either a prior sub-optimal response to acetaminophen, NSAID therapy, or previously received intermittent opioid analgesic therapy. Thirty-milligrams Morphine Sulfate Extended-Release Capsules administered once-daily, either in the morning or the evening, were more effective than placebo in reducing pain.

Table 3 Change from Baseline in WOMAC OA Index Pain VAS Subscale Score
 Overall  Placebo  Morphine Sulfate
Extended-Release
Capsules QAM

Morphine Sulfate
Extended-Release
Capsules QPM

 LS Mean  -36.23  -75.26a  -75.39a
 Std. Error  11.482  11.305  11.747
 a) P<0.05; REPEATED MEASURES ANALYSIS

This study was not designed to assess the effects of Morphine Sulfate Extended-Release Capsules on the course of the osteoarthritis.

Instructions For Use

Morphine Sulfate (mor' feen sul' fate)
Extended-Release Capsules, USP (Once Daily) CII

  • If you cannot swallow Morphine Sulfate Extended-Release Capsules, tell your healthcare provider. There may be another way to take Morphine Sulfate Extended-Release Capsules that may be right for you. If your healthcare provider tells you that you can take Morphine Sulfate Extended-Release Capsules using this other way, follow these steps:

Morphine Sulfate Extended-Release Capsules can be opened and the pellets inside the capsule can be sprinkled over applesauce, as follows:

           Open the Morphine Sulfate Extended-Release Capsule and sprinkle the pellets over approximately one tablespoon of applesauce (See Figure 1).
 Figure 1     
     Swallow all of the applesauce and pellets right away. Do not save any of the applesauce and pellets for another dose (See Figure 2).
 Figure 2     
    Rinse your mouth to make sure you have swallowed all of the pellets. Do not chew the pellets (See Figure 3).
 Figure 3     
    Flush the empty capsule down the toilet right away (See Figure 4).
 Figure 4     

You should not receive Morphine Sulfate Extended-Release Capsules through a nasogastric tube or gastric tube (stomach tube).

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Actavis Elizabeth LLC
Elizabeth, NJ 07207 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

40-9072
(MG 41-1185/1216)

PRINCIPAL DISPLAY PANEL
NDC 0228-3090-11
Rx Only
(Once Daily)
Morphine Sulfate
Extended-Release
Capsules, USP
30 mg
100 capsules

 

PRINCIPAL DISPLAY PANEL
NDC 0228-3116-11
Rx Only
(Once Daily)
Morphine Sulfate
Extended-Release
Capsules, USP
45 mg
100 capsules

 

PRINCIPAL DISPLAY PANEL
NDC 0228-3091-11
Rx Only
(Once Daily)
Morphine Sulfate
Extended-Release
Capsules, USP
60 mg
100 capsules

 

PRINCIPAL DISPLAY PANEL
NDC 0228-3117-11
Rx Only
(Once Daily)
Morphine Sulfate
Extended-Release
Capsules, USP
75 mg
100 capsules

 

PRINCIPAL DISPLAY PANEL
NDC 0228-3092-11
Rx Only
(Once Daily)
Morphine Sulfate
Extended-Release
Capsules, USP
90 mg
100 capsules

 

PRINCIPAL DISPLAY PANEL
NDC 0228-3093-11
Rx Only
(Once Daily)
Morphine Sulfate
Extended-Release
Capsules, USP
120 mg
100 capsules

 

MORPHINE SULFATE 
morphine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0228-3090
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
DIETHYL PHTHALATE  
ETHYLCELLULOSES  
GELATIN  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
POLYETHYLENE GLYCOLS  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
FD&C BLUE NO. 1  
FERROSOFERRIC OXIDE  
BUTYL ALCOHOL  
ALCOHOL  
ISOPROPYL ALCOHOL  
POTASSIUM HYDROXIDE  
PROPYLENE GLYCOL  
WATER  
SHELLAC  
AMMONIA  
Product Characteristics
Color BLUE (Dark Blue) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 3090
Contains     
Packaging
# Item Code Package Description
1 NDC:0228-3090-03 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
2 NDC:0228-3090-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
3 NDC:0228-3090-11 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
4 NDC:0228-3090-50 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079040 02/04/2014
MORPHINE SULFATE 
morphine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0228-3116
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 45 mg
Inactive Ingredients
Ingredient Name Strength
DIETHYL PHTHALATE  
ETHYLCELLULOSES  
GELATIN  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
POLYETHYLENE GLYCOLS  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
FD&C BLUE NO. 1  
FD&C RED NO. 3  
FERROSOFERRIC OXIDE  
BUTYL ALCOHOL  
ALCOHOL  
ISOPROPYL ALCOHOL  
POTASSIUM HYDROXIDE  
PROPYLENE GLYCOL  
WATER  
SHELLAC  
AMMONIA  
Product Characteristics
Color PURPLE (Violet) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 3116
Contains     
Packaging
# Item Code Package Description
1 NDC:0228-3116-11 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079040 02/04/2014
MORPHINE SULFATE 
morphine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0228-3091
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 60 mg
Inactive Ingredients
Ingredient Name Strength
DIETHYL PHTHALATE  
ETHYLCELLULOSES  
GELATIN  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
POLYETHYLENE GLYCOLS  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
D&C YELLOW NO. 10  
FD&C GREEN NO. 3  
FERROSOFERRIC OXIDE  
BUTYL ALCOHOL  
ALCOHOL  
ISOPROPYL ALCOHOL  
POTASSIUM HYDROXIDE  
PROPYLENE GLYCOL  
WATER  
SHELLAC  
AMMONIA  
Product Characteristics
Color GREEN (Light Green) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 3091
Contains     
Packaging
# Item Code Package Description
1 NDC:0228-3091-03 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
2 NDC:0228-3091-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
3 NDC:0228-3091-11 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
4 NDC:0228-3091-50 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079040 02/04/2014
MORPHINE SULFATE 
morphine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0228-3117
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 75 mg
Inactive Ingredients
Ingredient Name Strength
DIETHYL PHTHALATE  
ETHYLCELLULOSES  
GELATIN  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
POLYETHYLENE GLYCOLS  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
FERROSOFERRIC OXIDE  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
BUTYL ALCOHOL  
ALCOHOL  
ISOPROPYL ALCOHOL  
POTASSIUM HYDROXIDE  
PROPYLENE GLYCOL  
WATER  
SHELLAC  
AMMONIA  
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code 3117
Contains     
Packaging
# Item Code Package Description
1 NDC:0228-3117-11 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079040 02/04/2014
MORPHINE SULFATE 
morphine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0228-3092
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 90 mg
Inactive Ingredients
Ingredient Name Strength
DIETHYL PHTHALATE  
ETHYLCELLULOSES  
GELATIN  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
POLYETHYLENE GLYCOLS  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
FERROSOFERRIC OXIDE  
FD&C BLUE NO. 1  
FERRIC OXIDE YELLOW  
BUTYL ALCOHOL  
ALCOHOL  
ISOPROPYL ALCOHOL  
POTASSIUM HYDROXIDE  
PROPYLENE GLYCOL  
WATER  
SHELLAC  
AMMONIA  
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 3092
Contains     
Packaging
# Item Code Package Description
1 NDC:0228-3092-03 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
2 NDC:0228-3092-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
3 NDC:0228-3092-11 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
4 NDC:0228-3092-50 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079040 02/04/2014
MORPHINE SULFATE 
morphine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0228-3093
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 120 mg
Inactive Ingredients
Ingredient Name Strength
DIETHYL PHTHALATE  
ETHYLCELLULOSES  
GELATIN  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
POLYETHYLENE GLYCOLS  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
FD&C BLUE NO. 1  
FERROSOFERRIC OXIDE  
BUTYL ALCOHOL  
ALCOHOL  
ISOPROPYL ALCOHOL  
POTASSIUM HYDROXIDE  
PROPYLENE GLYCOL  
WATER  
SHELLAC  
AMMONIA  
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code 3093
Contains     
Packaging
# Item Code Package Description
1 NDC:0228-3093-03 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
2 NDC:0228-3093-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
3 NDC:0228-3093-11 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
4 NDC:0228-3093-50 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079040 02/04/2014
Labeler - Actavis Pharma, Inc. (119723554)
Revised: 11/2016   Actavis Pharma, Inc.

How is this medicine (Morphine Extended-Release Capsules) best taken?

Use this medicine (morphine extended-release capsules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Take with food if it causes an upset stomach.
  • Do not inject or snort this medicine. Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.
  • To gain the most benefit, do not miss doses.
  • Take this medicine (morphine extended-release capsules) at the same time of day.
  • Swallow whole. Do not chew, break, crush, or melt before swallowing. Doing these things can cause very bad side effects and death.
  • Do not use for fast pain relief or on an as needed basis.
  • Do not use for pain relief after surgery if you have not been taking drugs like this medicine.
  • If you cannot swallow this medicine (morphine extended-release capsules) whole, you may sprinkle the contents on applesauce. If you do this, swallow the mixture right away without chewing.
  • Rinse mouth to make sure all contents have been swallowed.
  • Some brands of this medicine may be given down a certain type of feeding tube. Other brands must not be given down a feeding tube. Check with your pharmacist to see if you can give this medicine (morphine extended-release capsules) down a feeding tube.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some other side effects of Morphine Extended-Release Capsules?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling sleepy.
  • Dizziness.
  • Dry mouth.
  • Upset stomach or throwing up.
  • Hard stools (constipation).
  • Headache.
  • Anxiety.
  • Feeling tired or weak.
  • Belly pain.
  • Sweating a lot.
  • Loose stools (diarrhea).
  • Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Morphine Extended-Release Capsules?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
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