Morphine Sulfate Injection

Pronunciation

Dosage Form: injection, solution

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MORPHINE SULFATE
INJECTION, USP

Warning: May be habit forming.

CII

Rx only

Morphine Sulfate Injection Description

Morphine is the principal alkaloid of opium. The sulfate is prepared by neutralizing the alkaloid with sulfuric acid.

Morphine sulfate is a white crystalline, odorless powder which is soluble in water. Morphine sulfate is a narcotic analgesic supplied in Carpuject® sterile cartridge unit with Luer Lock for parenteral use. Each mL contains 2 mg, 4 mg, 8 mg, 10 mg, or 15 mg morphine sulfate, 8 mg sodium biphosphate, 1 mg sodium metabisulfite, 1 mg sodium formaldehyde sulfoxylate, and 5 mg phenol. Sodium chloride is added to adjust isotonicity. The pH is adjusted between 2.5 and 6.5 with sodium hydroxide or hydrochloric acid. The product is sterile.

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Morphine sulfate (C17H19NO3)2 • H2SO4 • 5H2O (758.83), contains on the anhydrous basis, not less than 98 percent of (C17H19NO3)2 • H2SO4 (668.77). Morphine sulfate is 7,-8-Didehydro-4, 5α-epoxy-17-methylmorphinan-3, 6α-diol sulfate (2:1)(salt) pentahydrate, and has the following structural formula:

Morphine Sulfate Injection - Clinical Pharmacology

Morphine is a narcotic analgesic; its principal therapeutic effect is relief of pain. The precise mechanism of action of morphine and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics produce drowsiness, changes in mood, and mental clouding; although neither sensory modalities nor motor activity are blocked at therapeutic doses. There is no intrinsic limit to the analgesic effect. Clinically, however, dosage limitations are imposed by the adverse effects, primarily respiratory depression, nausea, and vomiting, which can result from high doses.

Morphine has diverse additional actions. It depresses the respiratory center, stimulates the vomiting center, depresses the cough reflex, constricts the pupils, increases the tone of the gastrointestinal and genitourinary tracts, and produces mild vasodilatation. Morphine is detoxified in the liver by means of conjugation with glucuronic acid. Small amounts of the free drug and larger amounts of conjugated morphine are present in the urine, and these account for most of the administered drug. Ninety percent of the total excretion occurs within the first 24 hours.

INDICATION AND USAGE

Morphine is indicated for the relief of severe pain.

CONTRAINDICATION

Morphine is contraindicated in patients who are hypersensitive to it.

Warnings

Respiratory Depression: Morphine produces dose-related respiratory depression by acting directly on brain stem respiratory centers. Morphine also affects centers that control respiratory rhythm, and may produce irregular and periodic breathing. If significant respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride. (See OVERDOSAGE.)

Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure. Furthermore, narcotics can produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Precautions

Special Risk Patients: Morphine should be used with caution in elderly or debilitated patients and those with impaired renal or hepatic function, hypothyroidism, Addison’s disease, prostatic hypertrophy, or urethral stricture. In asthma and pulmonary emphysema, the indiscriminate use of morphine may, due to its drying action upon the mucosa of the respiratory tract, precipitate severe respiratory insufficiency resulting from increased viscosity of the bronchial secretions and suppression of the cough reflex. As with any narcotic analgesic agent, the usual precautions should be observed and the possibility of respiratory depression should be kept in mind.

Ambulatory Patients: Since narcotics may impair the mental and/or physical abilities, patients should be warned not to drive cars, or operate machinery, or unnecessarily expose themselves to hazards.

Drug Interactions: Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, tranquilizers, sedative-hypnotics, monoamine oxidase inhibitors (MAOI), tricyclic antidepressants or other CNS depressants (including alcohol) concomitantly with morphine may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

Pregnancy Category C: Morphine has been shown to be teratogenic in hamsters when given in doses several hundred times the human dose.

There are no adequate and well-controlled studies in pregnant women. Morphine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: Dependence has been reported in newborns whose mothers received opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life.

Labor and Delivery: As with all narcotics, administration of morphine to the mother during labor or shortly before delivery may result in some degree of respiratory depression in the newborn. Morphine prolongs labor. Naloxone may be used in the neonate to reverse morphine-induced respiratory depression.

Nursing Mothers: It is not known whether this drug is excreted in human milk; many are. Because of the potential for serious adverse reactions in nursing infants from morphine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Adverse Reactions

Central Nervous System: Sedation, drowsiness, mental clouding, dizziness, lethargy, impairment of mental and physical performance, anxiety, convulsion, fear, miosis, dysphoria, psychic dependence, mood changes, and respiratory depression.

Gastrointestinal System: Nausea, vomiting, increased pressure in the biliary tract, constipation.

Cardiovascular System: Orthostatic hypotension, fainting, tachycardia, circulatory depression, peripheral circulatory collapse, and cardiac arrest have occurred after rapid intravenous injection.

Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported.

Other: Flushing, sweating, pruritus, allergic reactions, suppressed cough reflex.

Drug Abuse and Dependence

Morphine is a controlled substance in Narcotic Class II.

Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, morphine should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when morphine is used for a short time for the treatment of pain. Physical dependence assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Withdrawal symptoms in patients dependent on morphine include yawning, sweating, lacrimation, rhinorrhea, restlessness, sleeplessness, dilated pupils, gooseflesh, irritability, tremor, nausea, vomiting, and diarrhea.

Treatment of the abstinence syndrome is primarily symptomatic and supportive, including maintenance of proper fluid and electrolyte balance.

Overdosage

Signs and Symptoms: Overdosage with morphine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), pinpoint pupils, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur.

Treatment: Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Naloxone hydrochloride is a specific and effective antagonist for respiratory depression which may result from overdosage. The usual initial adult dose is 0.4 mg (1 mL) naloxone administered IV, lM, or SC. If the desired degree of counteraction and improvement in respiratory function is not obtained immediately following IV administration, it may be repeated intravenously at 2 to 3 minute intervals. Failure to obtain significant improvement after 2 or 3 doses suggests that the condition may be due partly or completely to other disease processes or non-opioid drugs. The usual initial pediatric dose is 0.01 mg/kg body weight given IV, IM, or SC. This dose may be repeated in accordance with the adult administration guideline. If necessary, naloxone can be diluted with Sterile Water for Injection, USP. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated.

Oral LD50 in the rat: 461 mg/kg, in the mouse: 670 mg/kg.

Toxic dose in humans by parenteral routes, doses in excess of 30 mg are likely to induce significant toxic effects in the nonaddicted adult who is not in pain. Morphine is not dialyzable.

Morphine Sulfate Injection Dosage and Administration

NOT FOR INTRATHECAL OR EPIDURAL USE.

Adults: The usual adult dose is 10 mg/70 kg of body weight subcutaneously or intramuscularly every four hours as necessary. More rapid action results from an intravenous dose of 4 mg to 10 mg, but the injection should be given very slowly.

Pediatric: The usual pediatric dose is 100 mcg/kg to 200 mcg/kg subcutaneously or intramuscularly up to a maximum of 15 mg per dose.

Prolonged administration is not recommended. May be habit forming.

Incompatibility: Morphine Sulfate Injection containing phenol as a preservative, is incompatible with soluble barbiturates, prochlorperazine, and promethazine. Parenteral products, such as Morphine Sulfate Injection, should be inspected for particulate matter and discoloration prior to administration.

How is Morphine Sulfate Injection Supplied

The injection is not to be used if its color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate.

Carpujects are packaged in a Slim-Pak® tamper detection package.

To prevent needle-stick injuries, needles should not be recapped, purposely bent, or broken by hand. Blunt Cannulas should not be recapped, purposely bent or broken by hand.

NDC

Container

Concentration

Fill

Quantity

0409-1264-31

Carpuject® with Luer Lock

15 mg/mL

1 mL

Box of 10

0409-1261-30

Carpuject with Luer Lock

10 mg/mL

1 mL

Box of 10

0409-1260-69

Carpuject with Luer Lock

8 mg/mL

1 mL

Box of 10

0409-1258-30

Carpuject with Luer Lock

4 mg/mL

1 mL

Box of 10

0409-1762-30

Carpuject with Luer Lock

2 mg/mL

1 mL

Box of 10

 

Store below 40°C (104°F). Protect from light and freezing.

Revised: November, 2007

 

 

Printed in USA                                                EN-1653

Hospira, Inc., Lake Forest, IL 60045 USA

RL-0113

RL-0116

RL-0118

RL-0119

RL-0827

MORPHINE SULFATE 
Morphine Sulfate Injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-1258
Route of Administration INTRAVENOUS DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 4 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC  
SODIUM METABISULFITE  
SODIUM FORMALDEHYDE SULFOXYLATE  
PHENOL  
Packaging
# Item Code Package Description
1 NDC:0409-1258-30 10 CARTRIDGE in 1 CARTON
1 1 mL in 1 CARTRIDGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/09/1997 09/01/2013
MORPHINE SULFATE 
Morphine Sulfate Injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-1260
Route of Administration INTRAVENOUS DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 8 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC  
SODIUM METABISULFITE  
SODIUM FORMALDEHYDE SULFOXYLATE  
PHENOL  
Packaging
# Item Code Package Description
1 NDC:0409-1260-69 10 CARTRIDGE in 1 CARTON
1 1 mL in 1 CARTRIDGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/09/1997 10/01/2013
MORPHINE SULFATE 
Morphine Sulfate Injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-1264
Route of Administration INTRAVENOUS DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 15 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC  
SODIUM METABISULFITE  
SODIUM FORMALDEHYDE SULFOXYLATE  
PHENOL  
Packaging
# Item Code Package Description
1 NDC:0409-1264-31 10 CARTRIDGE in 1 CARTON
1 1 mL in 1 CARTRIDGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/09/1997 06/01/2013
MORPHINE SULFATE 
Morphine Sulfate Injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-1762
Route of Administration INTRAVENOUS DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC  
SODIUM METABISULFITE  
SODIUM FORMALDEHYDE SULFOXYLATE  
PHENOL  
Packaging
# Item Code Package Description
1 NDC:0409-1762-30 10 CARTRIDGE in 1 CARTON
1 1 mL in 1 CARTRIDGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/01/1980 09/01/2013
MORPHINE SULFATE 
Morphine Sulfate Injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-1261
Route of Administration INTRAVENOUS DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC  
SODIUM METABISULFITE  
SODIUM FORMALDEHYDE SULFOXYLATE  
PHENOL  
Packaging
# Item Code Package Description
1 NDC:0409-1261-30 10 CARTRIDGE in 1 CARTON
1 1 mL in 1 CARTRIDGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/09/1997 03/01/2014
Labeler - Hospira, Inc. (141588017)
Revised: 01/2014
 
Hospira, Inc.
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