STATEX Oral Drops, Suppositories, Oral Syrup, Tablets (2019)
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Περιεχόμενα
Name of the medicinal product
STATEX Morphine sulfate. Oral Drops: 50 mg/mL Suppositories: 5, 10, 20 and 30 mg Oral Syrup: 1 and 5 mg/mL Tablets: 5, 10, 25 and 50 mg
Summary product information
Route of Administration Dosage Form/Strength Nonmedicinal Ingredients Oral Oral drop 50 mg/mL Citric acid anhydrous, dextrose monohydrate, glycerine, sodium benzoate, sodium cyclamate, propylene glycol, ...
Indications and clinical use
Adults STATEX is indicated for the symptomatic relief of severe chronic pain. STATEX is not indicated as an as-needed (prn) analgesic. Geriatrics (>65 years of age) In general, dose selection for an elderly ...
Contraindications
Patients who are hypersensitive to the active substance morphine sulfate or other opioid analgesics or to any ingredient in the formulation. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND ...
Warnings and precautions
General Patients should be instructed not to give STATEX (morphine sulfate) to anyone other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, ...
Adverse reactions
Adverse Drug Reaction Overview Adverse effects of STATEX (morphine sulfate) drops, suppositories, syrup and tablets are similar to those of other opioid analgesics, and represent an extension of pharmacological ...
Drug interactions
Overview <u>Interaction with Benzodiazepines and Other Central Nervous System (CNS) Depressants:</u> Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants ...
Dosage and administration
STATEX should only be used in patients for whom alternative treatment options are ineffective or not tolerated (e.g., non-opioid analgesics). STATEX tablets must be swallowed whole. Cutting, breaking, ...
Overdosage
For management of a suspected drug overdose, contact your regional Poison Control Centre. <u>Symptoms:</u> Serious morphine overdosage is characterized by respiratory depression (reduced respiratory rate ...
Action and clinical pharmacology
Mechanism of Action Morphine sulfate is an opioid analgesic that acts as an agonist, interacting with stereo specific receptor sites in the brain and other tissues. Pharmacodynamics <u>Central Nervous ...
Storage and stability
Store all preparations between 15-30°C in a well closed light resistant container.
Special handling instructions
Not applicable.
Dosage forms, composition and packaging
Composition <u>Statex Oral Drop 50 mg/ mL:</u> Each 1mL of clear unflavored and colorless liquid contains 50 mg of morphine sulfate. The non-medicinal ingredients are citric acid anhydrous, dextrose monohydrate, ...
Pharmaceutical information
Drug Substance Proper name: morphine sulfate Chemical name: morphinan-3, 6-diol,7,8-didehydro-4,5-epoxy-17-methyl-(5α , 6 α )- sulfate(2:1) (salt), pentahydrate Molecular formula: (C<sub>17</sub>H<sub> ...
Detailed pharmacology
Morphine alters both the perception of pain and the emotional response to pain. The spectrum of actions of morphine due to its receptor affinity also include decreased gastrointestinal motility, respiratory ...
Marketing authorization holder
Paladin Labs Inc., 100 Alexis Nihon Blvd., Suite 600, St-Laurent, Quebec, H4M 2P2
Submission control number
229677
Date of approval
December 4, 1985
Date of revision
August 2, 2019
References
British National Formulary, 7th ed., British Medical Association and The Pharmaceutical Society of Great Britain, London, England, 1984, pp. 163-167. Compendium of Pharmaceuticals and Specialties. 19th ...
Serious warnings and precautions box
Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the risks of overdose and death with immediate release opioid formulations, ...
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