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Duloxetine Canon caps 30 mg N14 (Canonpharma)

Concomitant use of duloxetine (60 mg 2 times daily) did not have a significant effect on the pharmacokinetics of theophylline, which is metabolized by CYP1A2. Concomitant use of duloxetine with potential CYP1A2 inhibitors may result in increased duloxetine concentrations. The CYP1A2 inhibitor fluvoxamine (100 mg once daily) reduces the plasma clearance of duloxetine by approximately 77% and increases the AUC by 6-fold, 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 at a dose of 60 mg 2 times a day with a single dose of desipramine (CYP2D6 substrate), the AUC of desipramine increases 3-fold. Co-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 should be exercised when using duloxetine with drugs that are metabolized mainly by the CYP2D6 system and have a narrow therapeutic index. Concomitant use of duloxetine with potential CYP2D6 inhibitors may result in increased duloxetine concentrations. Paroxetine (20 mg once daily) reduces the clearance of duloxetine by approximately 37%. Caution should be used when using duloxetine with CYP2D6 inhibitors. Caution should be exercised when using duloxetine simultaneously with other drugs that affect the central nervous system (including benzodiazepines, antipsychotic drugs, phenobarbital, antihistamines with sedative effects, ethanol), especially with a similar mechanism of action. The simultaneous use of duloxetine with drugs that are highly bound to 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 disturbances with possible sharp fluctuations in vital signs and changes in mental status, including severe agitation with transition into delirium and coma) sometimes with fatal outcome. These reactions have also been observed in patients who were discontinued with a serotonin reuptake inhibitor shortly before being prescribed an MAO inhibitor. In some cases, patients experienced symptoms consistent with neuroleptic malignant syndrome. The effects of combined use of duloxetine and MAO inhibitors have not been evaluated in either 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 discontinuation. Based on the T1/2 duration of duloxetine, a break of at least 5 days should be taken 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 are a risk of bleeding. Cases of increased INR have been reported when used concomitantly with warfarin. In rare cases, the development of serotonin syndrome has been reported when using SSRIs (including paroxetine, fluoxetine) with serotonergic drugs. Caution should be exercised when duloxetine is used concomitantly with serotonergic antidepressants such as SSRIs, tricyclic antidepressants such as clomipramine and amitriptyline, St. John's wort, venlafaxine or triptans, tramadol, pethidine and tryptophan.

Use of the drug Duloxetine

For depression and diabetic neuropathy, it is prescribed orally at a dose of 60 mg 1 time per day daily, regardless of meals. Some patients may be advised to take a higher dose (up to a maximum of 120 mg/day in 2 divided doses). The possibility of prescribing doses exceeding 120 mg/day has not been studied. The initial dosage for patients with end-stage renal failure (creatinine clearance ≤30 ml/min) is 30 mg once daily. Patients with liver cirrhosis are prescribed a lower initial dose or with longer intervals between doses. No dose adjustment of duloxetine is required in elderly or elderly patients. The effect of duloxetine has not been studied in patients under 18 years of age.

Special instructions for the use of Duloxetine

Patients with a high risk of suicide during the treatment period should be under strict supervision, since before the onset of pronounced remission, the possibility of suicide attempts cannot be excluded. Duloxetine has not been studied in patients under 18 years of age and should not be used in this age group. As with other drugs that act on the central nervous system, duloxetine should be used with caution in patients with mania or a history of seizures. There have been reports of mydriasis in association with duloxetine, so duloxetine should be used with caution in patients with elevated intraocular pressure or at risk of developing acute narrow-angle glaucoma. Increased plasma concentrations of duloxetine have been reported in patients with severe renal impairment (creatinine clearance ≤30 mL/min) or severe hepatic impairment. It is recommended that such patients be given duloxetine at a lower initial dose. In some patients, taking duloxetine leads to an increase in blood pressure. In patients with hypertension (arterial hypertension) and/or other diseases of the cardiovascular system, it is recommended to monitor blood pressure. In clinical studies, an increase in the activity of liver enzymes in the blood was noted. In most patients receiving duloxetine, this increase was transient and disappeared after discontinuation of duloxetine treatment. Significant elevations in liver enzymes (more than 10 times normal) or liver damage with cholestasis, or significant increases in liver enzymes in combination with liver damage have occurred rarely and have been associated with alcohol abuse in some cases. Duloxetine did not have a mutagenic effect in experiments in vitro and in vivo . Adequate and controlled studies of the effects of duloxetine in pregnant women have not been conducted, therefore its use during pregnancy is not recommended. Duloxetine is excreted in breast milk. The approximate daily dose for an infant is 0.14% of the dose for a nursing woman (mg/kg). The safety of duloxetine in a nursing infant has not been established and breastfeeding while taking duloxetine is not recommended. During treatment with duloxetine, patients should refrain from potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Side effects of the drug Duloxetine

During clinical trials, side effects such as constipation, nausea, dry mouth, dizziness, fatigue, insomnia and headache (≥10%) were observed. Less commonly (with a frequency of ≤10%, but ≥1%) - tachycardia, dyspepsia, vomiting, loss of appetite, drowsiness, tremor, lethargy, sweating, feeling hot, yawning. From the reproductive system, disorders of ejaculation and erection were noted (with a frequency of ≤10%, but ≥1%), decreased libido and anorgasmia. Rarely (≤1%, but ≥0.1%) - gastroenteritis, stomatitis, increased blood pressure, weight gain, muscle tension, taste and vision disturbances, agitation, urinary retention. Treatment with duloxetine in placebo-controlled clinical trials was associated with nonsignificant increases in ALT, AST, and CK levels compared with placebo. In clinical trials of duloxetine for the treatment of diabetic neuropathy, the mean duration of diabetes mellitus was approximately 11 years, the mean initial fasting serum glucose concentration was up to 163 mg/dL, and the mean initial glycosylated hemoglobin concentration was 7.80%. In these studies, there was a nonsignificant increase in initial fasting blood glucose concentrations at 12 weeks in patients treated with duloxetine compared with placebo, followed by a usual regimen of 52 weeks. There were no changes in glycosylated hemoglobin, patient body weight, lipid concentrations (C, LDL, HDL, TG) or any side effects associated with diabetes. According to post-marketing studies, the following side effects were noted: on the part of the visual organ: very rarely (≤0.01%) - glaucoma; from the hepatobiliary system: very rarely (≤0.01%) - hepatitis, jaundice; from the immune system: very rarely (≤0.01%) - anaphylactic reactions; from laboratory parameters: very rarely (≤0.01%) - increased activity of ALT, AST, alkaline phosphatase, bilirubin level in the blood; from the metabolic side: very rarely (≤0.01%) - hyponatremia; from the skin: rarely (0.01–0.1%) - rash; very rarely (≤0.01%) - angioedema, Stevens-Johnson syndrome, urticaria; from the cardiovascular system: very rarely (≤0.01%) - orthostatic hypotension and syncope (especially at the beginning of treatment).

Pharmacological properties of the drug Duloxetine

Serotonin and norepinephrine reuptake inhibitor. It slightly inhibits dopamine uptake and has no significant affinity for histamine and dopamine, cholinergic and adrenergic receptors. The mechanism of the therapeutic effect of duloxetine in depression is due to the inhibition of the reuptake of serotonin and norepinephrine and, as a result, an increase in serotonergic and noradrenergic neurotransmission in the central nervous system. Duloxetine also normalizes pain threshold in some experimental models of neuropathic and inflammatory pain and reduces pain severity in a model of chronic pain. The analgesic effect of duloxetine is probably due to a slowdown in the transmission of nociceptive impulses to the central nervous system. Duloxetine is well absorbed after oral administration. The maximum concentration in blood plasma is achieved 6 hours after administration. Simultaneous food intake slows down absorption, the period of reaching maximum concentration in the blood increases from 6 to 10 hours, and absorption decreases (by approximately 11%). Duloxetine is highly bound to plasma proteins (more than 90%). Duloxetine is extensively metabolized in the body, metabolites are excreted primarily in the urine. Isoenzymes CYP 2D6 and CYP 1A2 catalyze the formation of two main metabolites of duloxetine (glucuronide combined with 4-hydroxyduloxetine, sulfate combined with 5-hydroxy, methoxy-duloxetine). The resulting metabolites do not have pharmacological activity. The half-life of duloxetine is 12 hours. The average clearance of duloxetine from blood plasma is 101 l/h. In patients with end-stage renal failure who are constantly on dialysis, there is a doubling of duloxetine plasma concentrations and an increase in AUC compared to healthy individuals. Therefore, in patients with chronic renal failure, duloxetine is prescribed at a lower initial dose.