Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalized anxiety disorder.
active substance: duloxetine;
1 capsule contains duloxetine hydrochloride equivalent to duloxetine 30 mg or 60 mg;
Diuxet Excipients: spherical sugar, hypromellose 603, sucrose, talc, triethyl citrate, hypromellose acetate succinate (AS-LF), ammonium hydroxide solution 25%, Opadry White 02A28361: hypromellose, titanium dioxide (E 171), talc;
composition of gelatin capsule №3 for 30 mg: titanium dioxide (E 171), indigo carmine (E 132), gelatin;
composition of gelatin capsule №1 for 60 mg: titanium dioxide (E 171), indigo carmine (E 132), iron oxide yellow (E 172), gelatin.
Diuxet Dosage form
Capsules are enteric.
Basic physical and chemical properties:
30 mg: hard gelatin capsules with an opaque white body and an opaque dark blue cap, containing white or almost white pellets;
60 mg: hard gelatin capsules with an opaque green body and an opaque dark blue cap, containing white or almost white pellets.
Antidepressants. ATX code N06A X21.
Duloxetine is a serotonin and norepinephrine reuptake inhibitor. It slightly inhibits dopamine uptake, has no significant affinity for histamine and dopamine, cholinergic and adrenergic receptors. The mechanism of action of duloxetine in the treatment of depression is due to inhibition of serotonin and norepinephrine reuptake and, as a consequence, increased serotonergic and noradrenergic neurotransmission in the central nervous system. Duloxetine also has an analgesic effect, which is probably the result of slowing the transmission of pain impulses in the central nervous system.
When taken orally, duloxetine is well absorbed. The maximum concentration is reached in 6 hours after taking the drug. Eating delays the absorption time, the time to reach the maximum concentration increases from 6 to 10 hours, while absorption decreases (approximately 11%).
Distribution. Duloxetine is effectively bound to serum proteins (> 90%).
Metabolism. Duloxetine is metabolized by the isoenzymes CYP2D6 and CYP1A2. The metabolites formed are not pharmacologically active.
Breeding. The half-life of duloxetine is 12 hours. The mean plasma clearance of duloxetine is 101 l / h.
Renal failure. Patients with end-stage renal disease who were constantly on dialysis had a doubling of duloxetine concentration and area under the concentration-time curve (AUC) compared to healthy volunteers. Therefore, patients with chronic renal failure should use a lower starting dose.
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalized anxiety disorder.
Hypersensitivity to duloxetine or to any of the excipients.
Concomitant use with non-selective irreversible monoamine oxidase inhibitors (MAOIs) or for at least 14 days after discontinuation of MAOIs. Due to the half-life of duloxetine, MAO inhibitors should not be prescribed for at least 5 days after discontinuation of duloxetine.
Concomitant use with fluvoxamine, ciprofloxacin or enoxacin (strong CYP1A2 inhibitors) due to increased plasma concentrations of duloxetine.
Unstable hypertension, which can provoke a hypertensive crisis.
Terminal stage of renal failure (creatinine clearance <30 ml / min).
Liver disease that can cause liver failure.