Duloxetine

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Dosage and Administration

Adverse reactions

Frequency: very often (1/10 m more), often (more than 1/100 and less than 1/10), infrequently (1/1000 and less than 1/100), rarely (1/10000 and less than 1/1000), very rarely (less than 1/10000), the frequency is unknown (cannot be estimated from the available data).
On the part of the nervous system: very often - headache, drowsiness; often - dizziness, tremor, lethargy, paresthesia, insomnia, unusual dreams, anxiety, agitation; infrequently - dyskinesia, poor quality of sleep, nervousness, myoclonus, impaired concentration, sleep disturbance, apathy, disorientation, bruxism; rarely - mania, aggressiveness, anger; frequency is unknown - serotonin syndrome, convulsions, akathisia, psychomotor anxiety, extrapyramidal syndrome, suicidal attempts, suicidal thoughts, hallucinations.
On the part of the digestive system: very often - nausea, dryness of the oral mucosa; often - diarrhea, constipation, vomiting, dyspepsia, flatulence, abdominal pain; infrequently - gastroenteritis, stomatitis, gastritis, belching, taste disturbance, hepatitis, acute liver failure, increased activity of "liver" transaminases (ALT, AST, alkaline phosphatase); rarely - an unpleasant smell when breathing, unchanged blood in the feces; frequency is unknown - gastrointestinal bleeding, jaundice, liver failure.
On the part of the genitourinary system: often - erectile dysfunction, decreased libido, changes in the ability to experience feelings of orgasm; infrequently - urinary retention, intermittent urination, dysuria, nocturia, polyuria, decreased urine flow, impaired sexual function, impaired ejaculation, incl. delayed ejaculation, gynecological bleeding; rarely, menopause symptoms; frequency unknown - change in the smell of urine.
From the side of the cardiovascular system: often - the heartbeat, "tides" of blood infrequently - tachycardia, syncope and orthostatic hypotension (which were reported only at the beginning of treatment), increased blood pressure, cooling of the extremities; rarely - supraventricular arrhythmia, mainly atrial fibrillation; frequency is unknown - hypertensive crisis.
On the part of the senses: often - blurred visual perception, tinnitus; infrequently - blurred vision, mydriasis, vertigo, pain in the ears; rarely glaucoma.
On the part of the respiratory system: often - yawning; infrequently - nose bleeding, feeling of squeezing of a throat.
On the part of the skin: often - a rash, excessive sweating, night sweats, infrequently - photosensitivity, increased tendency to subcutaneous hemorrhage, contact dermatitis, urticaria, cold sweat; frequency is unknown - angioedema, Stevens-Johnson syndrome.
On the part of the musculoskeletal system: often - muscle spasm, musculoskeletal pain, muscle stiffness; infrequently - muscle twitching; rarely - trismus.
On the part of the endocrine system: rarely - hypothyroidism.
On the part of the metabolism: often - loss of appetite; infrequently, hyperglycemia (reported mainly in patients with diabetes mellitus); rarely - dehydration, syndrome of inadequate secretion of antidiuretic hormone, hyponatremia.
Infections: infrequently - laryngitis.
Others: often - fatigue, weight loss; infrequently - weight gain, malaise, gait disturbance, loss of sensitivity, feeling cold, feeling warm, thirst, chills, raising CPK; rarely, hypercholesterolemia; frequency unknown - chest pain.
Allergic reactions: infrequently - hypersensitivity reactions; rarely anaphylactoid reactions.
With abrupt cancellation - the syndrome of "cancellation", the most frequent symptoms of which were dizziness, sensory disturbances (including paresthesia), sleep disorders (including insomnia, intense dreams), agitation or anxiety, nausea and / or vomiting , tremor, headache, irritability, diarrhea, hyperhidrosis, vertigo.

Contraindications

Hypersensitivity, liver disease, accompanied by liver failure, simultaneous use of non-selective irreversible MAO inhibitors, potent inhibitors of CYP1A2 (fluvoxamine, ciprofloxacin, enoxacin), severe CRF (CC less than 30 ml / min), unsuperfluid periodypodipation, etc. no application experience).
For LF containing sucrose (optional): congenital fructose intolerance, glucose-galactose malabsorption, sucrose-isomaltase deficiency.
Carefully. Mania and bipolar disorder (including history), convulsions (including history), intraocular hypertension or the risk of developing an acute attack of angle-closure glaucoma, suicidal thoughts and attempts at anamnesis, increased risk of hyponatremia (elderly patients, cirrhosis liver, dehydration, diuretic), pregnancy.

Drug interactions

The simultaneous use of duloxetine (60 mg 2 times a day) had no significant effect on the pharmacokinetics of theophylline, metabolized by CYP1A2.
Simultaneous administration of duloxetine with potential inhibitors of CYP1A2 may lead to an increase in duloxetine concentration. The CYP1A2 inhibitor fluvoxamine (100 mg 1 time per day) reduces the plasma clearance of duloxetine by about 77% and increases AUC 6 times, so duloxetine should not be used in combination with potential CYP1A2 inhibitors, such as fluvoxamine.
Duloxetine is a moderate inhibitor of CYP2D6. When taking duloxetine in a dose of 60 mg 2 times a day along with a single dose of desipramine (CYP2D6 substrate), the AUC of desipramine increases 3 times. Simultaneous administration of duloxetine (40 mg 2 times a day) increases the AUC of tolterodine (2 mg 2 times a day) by 71%, but does not affect the pharmacokinetics of the 5-hydroxyl metabolite. Caution must be exercised when using duloxetine with drugs that are metabolized mainly by the CYP2D6 system and have a narrow therapeutic index.
The simultaneous use of duloxetine with potential inhibitors of CYP2D6 can lead to an increase in duloxetine concentrations.
Paroxetine (20 mg 1 time per day) reduces the clearance of duloxetine by approximately 37%. When using duloxetine with CYP2D6 inhibitors, caution should be exercised.
Caution should be exercised when using duloxetine simultaneously with other drugs that affect the central nervous system (including benzodiazepines, antipsychotic drugs, phenobarbital, antihistamine drugs with sedative effect, ethanol), especially with a similar mechanism of action.
The simultaneous use of duloxetine with drugs, highly associated with plasma proteins, can lead to an increase in the concentration of free fractions of both drugs.
In patients receiving a serotonin reuptake inhibitor in combination with non-selective irreversible MAO inhibitors, there have been cases of severe adverse reactions (hyperthermia, muscle rigidity, myoclonus, peripheral abnormalities with possible sharp fluctuations in vital signs and changes in mental status, including pronounced stimulation with transition delirium and to whom) is sometimes fatal. These reactions were also observed in patients who, shortly before prescribing an MAO inhibitor, a serotonin reuptake inhibitor was canceled. In some cases, patients had symptoms characteristic of neuroleptic malignant syndrome. The effects of the combined use of duloxetine and MAO inhibitors have not been evaluated in humans or animals.Therefore, given the fact that duloxetine is an inhibitor of both serotonin and norepinephrine, it is not recommended to take duloxetine in combination with non-selective irreversible MAO inhibitors or for at least 14 days after their withdrawal. Based on the duration of T1 / 2 duloxetine, you should take a break of at least 5 days after stopping duloxetine before taking MAO inhibitors. With respect to selective reversible MAO inhibitors, such as moclobemide, the risk of developing serotonin syndrome is low, however, simultaneous use of the drug with selective reversible MAO inhibitors is not recommended.
Anticoagulants and antiplatelet drugs - the risk of bleeding. Cases have been reported of an increase in the INR when used simultaneously with warfarin.
In rare cases, the development of serotonin syndrome has been reported with the use of SSRIs (including paroxetine, fluoxetine) with serotonergic drugs. Care must be taken when simultaneously using Duloxetine with serotonergic antidepressants such as SSRIs, tricyclic antidepressants such as clomipramine and amitriptyline, venous finum or triptocylone, tramadol, petidine and tryptophanom.

Special instructions

Overdosage

• Brand name: Duloxetine
• Active ingredient: Duloxetine
• Dosage form: Capsules enteric solid gelatin number 1, the body and the lid is blue; The contents of the capsules are spherical microgranules from almost white to yellowish white.
• Manufacturer: Canonpharma
• Country of Origin: Russia