Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalized anxiety disorder.
active substance: duloxetine;
1 capsule contains duloxetine hydrochloride – 33.7 mg or 67.4 mg, which is equivalent to duloxetine – 30 mg or 60 mg;
Diulok excipients: spherical sugar, hydroxypropylmethylcellulose, polyethylene glycol 6000, talc, sucrose, hydroxypropylmethylcellulose acetate succinate, triethylcitrate;
hard gelatin capsule № 3 (for 30 mg capsules):
the composition of the capsule shell: titanium dioxide (E 171), indigotine blue (E 132), gelatin;
hard gelatin capsule № 1 (for 60 mg capsules):
the composition of the capsule shell: titanium dioxide (E 171), indigotine blue (E 132), quinoline yellow (E 104), erythrosine (E 127), gelatin.
Diulok Dosage form
Intestinal soluble capsules.
Basic physical and chemical properties:
Capsules 30 mg: hard gelatin capsule № 3, blue body, white cap. The contents of the capsule are white or almost white pellets.
Capsules 60 mg: hard gelatin capsule № 1, blue body, ivory cap. The contents of the capsule are white or almost white pellets.
Antidepressants. ATX code N06A X21.
Duloxetine is a combined 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 efficiently 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 are constantly on dialysis have doubled duloxetine concentrations and exposure levels (AUC) compared to healthy subjects. Therefore, a lower starting dose should be used for patients with chronic renal failure.
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalized anxiety disorder.
Contraindication to the use of the drug is hypersensitivity to duloxetine or to any of the excipients of the drug.
Duloxetine should not be co-administered 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.
Dyulok® should not be prescribed to patients with unstable hypertension, as it may provoke a hypertensive crisis.
Dyulok® should not be prescribed to patients with end-stage renal disease (creatinine clearance up to 30 ml / min).
Dyulok® should not be used in patients with liver disease as it may cause liver failure.
Duloxetine is not recommended for use in children due to a lack of data on its safety and efficacy in this age group.
Duloc® should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (strong CYP1A2 inhibitors) due to increased plasma concentrations of duloxetine.