FIELD: medicine; pharmaceutics.
SUBSTANCE: group of inventions relates to a pharmaceutical composition containing an opioid antagonist, methods of using it and devices containing such a composition. Disclosed composition for treating opioid overdose or suspected opioid overdose is intended for intranasal administration. Composition contains in an aqueous solution with volume of 100 to 250 mcl: 1 to 10 mg of nalmefene hydrochloride or a hydrate thereof; from 2 to 2.0 mg of an isotonic agent and from 0.05 to 2.5 % wt/volume of an absorption enhancer, which is dodecyl maltoside or tetradecyl maltoside. Pre-filled devices (single-dose or double-dose) are proposed, containing said composition and intended for nasal delivery by actuation of the corresponding device applied to the patient's nostril. Methods of using the composition include treating an opioid overdose or symptom thereof in a patient, including, treatment of opioid overdose or its symptom within 15 minutes after its onset in patient and/or treatment for at least 3 hours in patient, as well as a method for inducing complete or partial elimination of narcotic depression or respiratory depression caused by opioids in a patient by nasal administration of said composition to the patient, in particular, using the above devices.
EFFECT: use of the above absorption enhancers enables using the formulation containing nalmefene as a first-aid (emergency) drug for opioid overdose.
36 cl, 5 dwg, 5 tbl, 11 ex
