Molteni Farmaceutici


Medicell Pharma
Concise Prescribing Info
Morphine sulfate pentahydrate
Symptomatic relief of severe chronic pain.
Dosage/Direction for Use
Adult Initially 5-15 mL every 4-6 hr.
Hypersensitivity. Diarrhoea caused by poisoning. Acute resp insufficiency or depression, obstructive airways disease. Concurrent administration w/ MAOIs or w/in 2 wk of discontinuation. Evalute risk-benefit use in acute abdomen; asthma attacks, & acute & severe bronchial obstruction; cardiac arrhythmias; history of convulsions; acute alcohol intoxication; agitation in patients secondary to use of alcohol or hypnotics, emotional instability, suicidal ideation; head injury & conditions w/ increased intracranial pressure; acute liver disorders (hepatitis, hepatic porphyria); paralytic ileus; coma; pheochromocytoma (endogenous histamine release may be induced, thereby stimulating catecholamine release). Pregnancy & lactation.
Special Precautions
Obstructive resp disorders, reduced resp reserve (eg, kyphoscoliosis, emphysema or severe adiposis), anoxia, hypercapnia, resp insufficiency (patients may become comatose), pulmonary disorders; cor pulmonale; impaired conciousness, shock, CNS depression; known opioid dependency; post-surgery w/in the 1st 24 hr; hypovolemia; chronic kidney or liver diseases, pancreatits, myxoedema, adrenocortical insufficiency, hypothyroidism, pheochromocytoma, prostatic hypertrophy w/ residual urine (risk of bladder rupture secondary to urinary retention); fulminant ulcerative colitis; obstructive bile or urinary tract diseases or spasms of bile ducts & urinary tract secondary to stone formation; post-surgery affecting biliary system; epilepsy or increased propensity to seizures. Immediately discontinue when paralytic ileus is suspected or occurs during use. Obstructive bowel disorder, biliary colic, operations on the biliary tract, acute pancreatitis or prostatic hyperplasia. May be treated w/ appropriate laxatives if constipation occurs. Inflammatory bowel disease. May obscure the diagnosis or clinical course of patients w/ acute abdominal conditions & complications following abdominal surgery. Severe hypotension may occur; careful dosing is needed in the elderly, patients w/ heart insufficiency & w/ impaired liver or kidney function, respectively. Risk of physical &/or psychological dependence or tolerance. Monitor for reversible adrenal insufficiency. Monitor plasma cortisol conc in patients w/ pre-existing adrenocortical insufficiency (eg, Morbus Addison) & substitute corticoids if needed. Monitor for acute chest syndrome in patients w/ sickle cell disease. Risk of decreased sex hormones & increased prolactin w/ long-term use. Hyperalgesia. Concomitant use of sedative medicines eg, benzodiazepines; closely follow patients for signs & symptoms of resp depression & sedation. Concomitant use w/ rifampicin & P2Y12 inhibitor (eg, clopidogrel, prasugrel, ticagrelor). Interference w/ diagnostic determination of CSF pressure, plasma conc of amylase & lipase, SGPT, SGOT, serum bilirubin & alkaline phosphatase. May cause allergic reactions due to methyl & propyl parahydroxybenzoate. Not to be given to patients suffering from alcoholism; those w/ rare hereditary conditions of fructose/galactose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency. Diabetics. May have an impact on the capability to react to such an extent that the ability to drive or use machines is impaired. Renal & hepatic impairment. Only give to males w/ procreative potential & to females w/ childbearing potential if effective contraceptive measures are guaranteed. Elderly.
Adverse Reactions
Mood changes (mostly euphoria, but also dysphoria). Dizziness, headache; changes in activity (mostly sedation, but also enhanced activity or agitation), insomnia, cognitive & sensory function alterations (eg, thinking disturbances, altered apprehensiveness/hallucinations, confusion); miosis; nausea, vomiting (especially at the beginning of therapy), constipation, anorexia, dyspepsia & taste alterations; sweating, hypersensitivity reactions (eg, urticaria, pruritus).
Drug Interactions
Additive CNS depressant effect w/ sedatives eg, benzodiazepines or related drugs. Potential death due to increased CNS depressing effect (especially depressive effect on respiration) w/ tranquilisers, anaesth, hypnotics, TCAs, antipsychotics, sedating H1 antihistamines (eg, hydroxyzine), alcohol. Resp depression may be augmented, risk of hypotension may be increased & sedative effects may be enhanced by phenothiazines. Delayed & decreased exposure of oral P2Y12 inhibitor antiplatelet therapy (eg, clopidogrel, prasugrel, ticagrelor). Enhanced anticholinergic side effects & risk of severe constipation &/or urinary retention may be increased w/ antihistamines, antiemetics, antimuscarinics. Possible life-threatening effects on the CNS, respiration or circulation can occur w/ MAOIs (if used w/in 14 days prior to initiation of & concomitantly administered w/ morphine). Inhibited metabolism by cimetidine. Enhanced effect of muscle relaxants. Reduced plasma conc & decreased analgesic effect w/ rifampicin. Antagonised analgesic, CNS & resp depressant effects & w/drawal symptoms may be precipitated by levallorphan/naloxone. Additive CNS & resp depressant & hypotensive effects w/ methadone & opioid agonist analgesics. May have additive central resp depressant effects w/ neuromuscular blocking agents.
MIMS Class
Oramorph syr 2mg/mL
(w/ 5-mL measuring pipette) 100 mL x 1's
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