Description

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Indications:

depressive form of peripheral diabetic neuropathygeneralized anxiety disorder chronic pain syndrome of the musculoskeletal system (including caused by fibromyalgia, chronic pain syndrome in the lower back and osteoarthritis of the knee joint)

Contraindications:

Hypersensitivity to the drug; Simultaneous use with monoamine oxidase inhibitors (IMAO) (see section “Special instructions”); Uncompensated angle-closure glaucoma; Children under 18 years of age; Sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption; Liver diseases accompanied by hepatic insufficiency; Simultaneous administration of powerful inhibitors of the CYP1A2 isoenzyme (fluvoxamine, ciprofloxacin, enoxacin); Severe CRF (creatinine clearance less than 30 ml/min); Uncontrolled arterial hypertension.

With caution:

Mania and bipolar disorder (including in the anamnesis), seizures (including in the anamnesis), intraocular hypertension or the risk of developing an acute attack of angle-closure glaucoma, suicidal thoughts and attempts in the anamnesis, increased risk of hyponatremia (elderly patients, cirrhosis of the liver, dehydration, taking diuretics), impaired liver function and renal failure (CC 30-60 ml / min).

Pregnancy and lactation:

Due to insufficient experience with the use of duloxetine during pregnancy, the drug should be prescribed during pregnancy only if the potential benefit to the patient significantly exceeds the potential risk to the fetus. Patients should be warned that in case of pregnancy onset or planning during treatment with duloxetine, they need to inform their doctor about this.

Epidemiological data suggest that the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy, especially in late pregnancy, may increase the risk of persistent pulmonary hypertension of newborns. Despite the lack of studies on the relationship between persistent pulmonary hypertension of newborns and the use of SSRIs, a potential risk cannot be excluded, given the mechanism of action of duloxetine (inhibition of serotonin reuptake).

As with the appointment of other serotonergic drugs, the “withdrawal” syndrome can be observed in newborns in the case of the use of duloxetine by the mother in late pregnancy.

The “withdrawal” syndrome includes the following symptoms: low blood pressure, tremor, syndrome of increased neuro-reflex excitability, difficulty feeding, respiratory distress syndrome, convulsions. Most of the symptoms were observed during childbirth or in the first few days after delivery.

Due to the fact that duloxetine penetrates into breast milk (the concentration in the fetus is approximately 0.14% of the concentration in the mother at the rate of mg / kg of body weight), breast-feeding during duloxetine therapy is not recommended.