Astramorph PF Side Effects

Generic Name: morphine

Please note - some side effects for Astramorph PF may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Astramorph PF - for the Consumer

Astramorph PF Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Astramorph PF Solution:

Agitation; anxiety; changes in vision; confusion; constipation; decreased sex drive; dizziness; drowsiness; dry mouth; exaggerated sense of well-being; fear; frequent urination; headache; incoordination; lack of energy; lightheadedness; loss of appetite; mental clouding; mood swings; nausea; pinpoint pupils; restless mood; sleeplessness; sweating; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased sexual ability; delirium; difficulty urinating; disorientation; fainting; fast or slow heartbeat; flushing of the face; hallucinations; itching; menstrual changes; mental or mood changes; pounding in the chest; seizures; slowed breathing; tremor; vomiting.

Astramorph PF Side Effects - for the Professional

Astramorph PF

The most serious adverse experience encountered during administration of Astramorph/PF is respiratory depression and/or respiratory arrest. This depression and/or respiratory arrest may be severe and could require intervention. Because of delay in maximum CNS effect with intravenously administered drug (30 min), rapid administration may result in overdosing. Single-dose neuraxial administration may result in acute or delayed respiratory depression for periods at least as long as 24 hours.

Tolerance and Myoclonus:

See WARNINGS for discussion of these and related hazards.

While low doses of intravenously administered morphine have little effect on cardiovascular stability, high doses are excitatory, resulting from sympathetic hyperactivity and increase in circulating catecholamines. Excitation of the central nervous system, resulting in convulsions , may accompany high doses of morphine given intravenously. Dysphoric reactions may occur after any size dose and toxic psychoses have been reported.

Pruritus:

Single-dose epidural or intrathecal administration is accompanied by a high incidence of pruritus that is dose-related but not confined to the site of administration. Pruritus, following continuous infusion of epidural or intrathecal morphine, is occasionally reported in the literature; these reactions are poorly understood as to their cause.

Urinary Retention:

Urinary retention, which may persist 10 to 20 hours following single epidural or intrathecal administration, is a frequent side effect and must be anticipated primarily in male patients, with a somewhat lower incidence in females. Also frequently reported in the literature is the occurrence of urinary retention during the first several days of hospitalization for the initiation of continuous intrathecal or epidural morphine therapy. Patients who develop urinary retention have responded to cholinomimetic treatment and/or judicious use of catheters.

Constipation:

Constipation is frequently encountered during continuous infusion of morphine; this can usually be managed by conventional therapy.

Headache:

Lumbar puncture-type headache is encountered in a significant minority of cases for several days following intrathecal catheter implantation; this, generally, responds to bed rest and/or other conventional therapy.

Other:

Other adverse experiences reported following morphine therapy include-- Dizziness, euphoria, anxiety, hypotension, confusion, reduced male potency, decreased libido in men and women, and menstrual irregularities including amenorrhea, depression of cough reflex, interference with thermal regulation and oliguria . Evidence of histamine release such as urticaria , wheals and/or local tissue irritation may occur. Nausea and vomiting are frequently seen in patients following morphine administration.

Pruritus, nausea/vomiting and urinary retention, if associated with continuous infusion therapy, may respond to intravenous administration of a low dose of naloxone (0.2 mg). The risks of using narcotic antagonists in patients chronically receiving narcotic therapy should be considered.

In general, side effects are amenable to reversal by narcotic antagonists.

NALOXONE INJECTION AND RESUSCITATIVE EQUIPMENT SHOULD BE IMMEDIATELY AVAILABLE FOR ADMINISTRATION IN CASE OF LIFE-THREATENING OR INTOLERABLE SIDE EFFECTS AND WHENEVER ASTRAMORPH/PF THERAPY IS BEING INITIATED.

Side Effects by Body System

Nervous system

Central nervous system side effects may be either depressant or excitatory. Excitatory symptoms are sometimes ignored as possible side effects of morphine. Severe adverse effects such as respiratory depression can be treated with the opiate antagonist, naloxone.

Patients receiving continuous infusion of morphine sulfate via indwelling intrathecal catheter should be monitored for new neurologic signs or symptoms. Further assessment or intervention should be based on the clinical condition of the individual patient.

Myoclonic spasms may occur in patients receiving high dose morphine, particularly in the setting of renal dysfunction. Hyperalgesia has also been reported with high doses.

Nervous system side effects have been frequently reported and include drowsiness and sedation. Inflammatory masses including granulomas (some of which have resulted in serous neurologic impairment including paralysis) have been reported to occur in patients receiving continuous infusion of opioid analgesics including morphine sulfate via indwelling intrathecal catheter. Delirium, seizures, tremors, dizziness, muscle twitches and confusion have also been reported.

Respiratory

Respiratory side effects including respiratory depression have been reported frequently. Bronchospasm has been reported in patients with underlying pulmonary disease.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, dyspepsia, constipation, dry mouth, increased gastroesophageal reflux, intestinal obstruction, and increased biliary pressure have been reported.

Morphine may cause constriction of the common bile duct and spasm of the sphincter of Oddi, thereby increasing intrabiliary pressure and worsening, rather than relieving, biliary colic.

In addition, morphine may cause intense but uncoordinated duodenal contraction and decreased gastric emptying.

Other

Withdrawal symptoms have been reported to have included agitation, restlessness, anxiety, piloerection, insomnia, convulsions, tremor, abdominal cramps, blurred vision, vomiting, and sweating.

Other side effects include a withdrawal symptoms after either abrupt cessation or fast tapering of morphine.

Cardiovascular

Cardiovascular side effects including hypotension related to a transient decrease in systemic arterial resistance has been reported, particularly in the setting of myocardial infarction.

Psychiatric

Psychiatric side effects have included fearfulness, agitation, paranoia, psychosis, hypervigilance, and hallucinations.

Genitourinary

Genitourinary side effects including acute urinary retention have been reported.

The risk of acute urinary retention is very high when morphine is administered by epidural or intrathecal injection. Clinicians should be attentive to the increased risk of urosepsis in this setting, particularly if instrumentation of the urinary tract is necessary.

Hematologic

Hematologic side effects including immune thrombocytopenia has been rarely reported.

Endocrine

Endocrine side effects such as menstrual irregularities including amenorrhea have been reported. Reduced male potency and decreased libido in both men and women have also been reported.

Musculoskeletal

Musculoskeletal side effects including opioid-induced involuntary muscle hyperactivity has been reported with chronic, high doses.

Dermatologic

Dermatologic side effects including sweating, flushing, pruritus have been reported frequently. A case of acute generalized exanthematous pustulosis has also been reported.

Ocular

Ocular side effects include keratoconjunctivitis and allergic conjunctivitis associated with lid urticaria. Visual disturbances and miosis have also been reported. A study has reported a temporary 26% decrease in pupil diameter following the administration of IV morphine.

Hypersensitivity

Hypersensitivity reactions including anaphylactoid reactions have been reported to occur very rarely.

General

Droperidol (2.5 mg intravenously) has been used successfully to reverse the pruritus associated with epidural morphine 2 or 4 mg dosages. A larger dose of droperidol (5 mg) unexplainably does not appear to reverse the pruritus.

General side effects including a sense of warmth have been frequently reported.

Hepatic

Hepatic side effects including increases in hepatic enzymes have been reported infrequently.

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