Duloxetine 30mg N14 Capsules
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Description
Composition Duloxetine (in the form of hydrochloride) 30 mg Auxiliary substances: hypromellose E5 10.54 mg, hypromellose HP55 15.51 mg, starch 44.09 mg, mannitol 47.3 mg, sodium lauryl sulfate 5.22 mg, sucrose 17.46 mg, titanium dioxide 1.15 mg, cetyl alcohol 1.55 mg. The composition of the capsule shell: gelatin, titanium dioxide, blue patented dye V. Pharmacological action Antidepressant, an inhibitor of serotonin reuptake and norepinephrine (norepinephrine). Weakly inhibits dopamine uptake, does not have significant affinity for histamine, dopamine, cholinergic and adrenergic receptors. The mechanism of action of duloxetine is to suppress the reuptake of serotonin and norepinephrine (norepinephrine). Duloxetine has a central mechanism for the suppression of pain, which is primarily manifested by an increase in the pain sensitivity threshold in pain syndrome of neuropathic etiology.
Dosage and administration
The recommended initial dose is 60 mg 1 time / day. If necessary, you can increase the daily dose from 60 mg to a maximum dose of 120 mg / day in 2 divided doses. In patients with severe impaired renal function (CC less than 30 ml / min), the initial dose should be 30 mg 1 time / day. In patients with impaired liver function, reduce the initial dose of the drug or reduce the frequency of administration. Precautions During the period of treatment may worsen psoriasis. With pheochromocytoma, propranolol can be used only after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. Against the background of treatment with propranolol, IV administration of verapamil, diltiazem should be avoided. A few days before anesthesia, you must stop taking propranolol or pick up a remedy for anesthesia with minimal negative inotropic effects. Influence on the ability to drive vehicles and control mechanisms In patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient. Side Effects From the side of the central nervous system: often - dizziness (except vertigo), sleep disturbances (drowsiness or insomnia), headache (headache was observed less frequently than in patients receiving placebo). sometimes - tremor, weakness, blurred vision, lethargy, anxiety, yawning. very rarely - glaucoma, mydriasis, visual impairment, agitation, disorientation.On the part of the digestive system: often - dry mouth, nausea, constipation. sometimes - diarrhea, vomiting, loss of appetite, change in taste, impaired liver function indicators. very rarely - hepatitis, jaundice, increased activity of alkaline phosphatase, ALT, AST and bilirubin levels. belching, gastroenteritis, stomatitis. On the part of the musculoskeletal system: sometimes - muscle tension and / or twitching. very rarely - bruxism. Since the cardiovascular system: sometimes - heartbeat. very rarely - orthostatic hypotension, syncope (especially at the beginning of therapy), tachycardia, increased blood pressure, cooling of the extremities. On the part of the reproductive system: sometimes - anorgasmia, decreased libido, delayed and impaired ejaculation, erectile dysfunction. On the part of the urinary system: sometimes - difficulty urinating. very rarely - nocturia. Other: sometimes - weight loss, increased sweating, hot flashes, night sweats. very rarely - anaphylactic reactions, thirst, hyponatremia, chills, angioedema, rash, Stevens-Johnson syndrome, urticaria, feeling unwell, feeling hot and / or cold, weight gain, dehydration, photosensitization. When canceled, dizziness, nausea, and headache were often noted. In patients with the painful form of diabetic neuropathy, a slight increase in fasting blood glucose may be observed. Cautions Use with caution in exacerbation of manic / hypomania state, epileptic seizures, mydriasis, abnormal liver function or kidney, in patients with a tendency to suicidal attempts. When prescribing serotonin reuptake inhibitors in combination with MAO inhibitors, there have been cases of serious reactions, sometimes fatal (hyperthermia, rigidity, myoclonus, various disorders with possible drastic fluctuations in the vital functions of the body and changes in mental status, including pronounced agitation with going into delirium and to whom). Such reactions are also possible in cases where the serotonin reuptake inhibitor was canceled shortly before administration of MAO inhibitors (symptoms may develop, including those characteristic of a malignant neuroleptic syndrome). The effects of the combined use of duloxetine and MAO inhibitors have not been evaluated in humans or animals.The use of duloxetine simultaneously with MAO inhibitors or for up to 14 days after their cancellation is not recommended, since duloxetine is a serotonin reuptake inhibitor, and norepinephrine (norepinephrine). MAO inhibitors should not be prescribed for at least 5 days after discontinuation of duloxetine. Use with caution in patients with a history of manic episodes, as well as with epileptic seizures in history. Depressive states are accompanied by a high risk of suicidal behavior. As a consequence, patients with a diagnosis of depression taking duloxetine should inform the physician of any disturbing thoughts and feelings. With the use of the drug may develop mydriasis, caution should be exercised in the appointment of duloxetine in patients with elevated intraocular pressure or in individuals at risk of developing acute angle-closure glaucoma. In patients with arterial hypertension and / or other diseases of the cardiovascular system, it is recommended to monitor blood pressure. Influence on the ability to drive vehicles and control mechanisms Patients taking duloxetine should be careful when engaging in potentially hazardous activities (due to the possible occurrence of drowsiness). Use during pregnancy and breastfeeding Use of the drug during pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus, because Clinical experience with duloxetine during pregnancy is not enough. If necessary, the use of the drug during lactation should decide on the termination of breastfeeding (due to lack of experience with the application). Patients should be warned that in the event of the onset or planning of pregnancy during the period of use of duloxetine, they should be informed about this by their attending physician. Type: Medicinal product Amount in a package, pcs: 14 Expiration date: 24 months Active ingredient: Duloxetine (Duloxetine) Route of administration: Oral Vacation procedure: Prescription Release form: Prescription Storage conditions: In a dry place, In a dark place, Keep out of reach of children Maximum storage temperature, ° С: 25 Pharmacological group: N06AX21 Duloxetine Minimum age: 18 yearsActive ingredients
Duloxetine
Release form
Coated pills
Composition
Duloxetine (in the form of hydrochloride) 30 mg Auxiliary substances: hypromellose E5 10.54 mg, hypromellose HP55 15.51 mg, starch 44.09 mg, mannitol 47.3 mg, sodium lauryl sulfate 5.22 mg, sucrose 17.46 mg, titanium dioxide 1.15 mg, cetyl alcohol 1.55 mg. The composition of the capsule shell: gelatin, titanium dioxide, blue patent V.
Pharmacological effect
Antidepressant, serotonin reuptake inhibitor and norepinephrine (norepinephrine). Weakly inhibits dopamine uptake, does not have significant affinity for histamine, dopamine, cholinergic and adrenergic receptors. The mechanism of action of duloxetine is to suppress the reuptake of serotonin and norepinephrine (norepinephrine). Duloxetine has a central mechanism for the suppression of pain, which is primarily manifested by an increase in the pain sensitivity threshold in pain syndrome of neuropathic etiology.
Indications
Depression, painful form of diabetic neuropathy.
Contraindications
Uncompensated angle-closure glaucoma, simultaneous use with MAO inhibitors, hypersensitivity to duloxetine.
Use during pregnancy and lactation
Use of the drug during pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus, because Clinical experience with duloxetine during pregnancy is not enough. If necessary, the use of the drug during lactation should decide on the termination of breastfeeding (due to lack of experience with the application). Patients should be warned that in the event of the onset or planning of pregnancy during the period of use of duloxetine, they should be informed about this by their attending physician.
Dosage and administration
The recommended initial dose is 60 mg 1 time / day. If necessary, you can increase the daily dose from 60 mg to a maximum dose of 120 mg / day in 2 divided doses. In patients with severe impaired renal function (CC less than 30 ml / min), the initial dose should be 30 mg 1 time / day. In patients with impaired liver function, reduce the initial dose of the drug or reduce the frequency of administration.
Side effects
From the side of the central nervous system: often - dizziness (except vertigo), sleep disturbances (drowsiness or insomnia), headache (headache was observed less frequently than in patients receiving placebo). sometimes - tremor, weakness, blurred vision, lethargy, anxiety, yawning. very rarely - glaucoma, mydriasis, visual impairment, agitation, disorientation.On the part of the digestive system: often - dry mouth, nausea, constipation. sometimes - diarrhea, vomiting, loss of appetite, change in taste, impaired liver function indicators. very rarely - hepatitis, jaundice, increased activity of alkaline phosphatase, ALT, AST and bilirubin levels. belching, gastroenteritis, stomatitis. On the part of the musculoskeletal system: sometimes - muscle tension and / or twitching. very rarely - bruxism. Since the cardiovascular system: sometimes - heartbeat. very rarely - orthostatic hypotension, syncope (especially at the beginning of therapy), tachycardia, increased blood pressure, cooling of the extremities. On the part of the reproductive system: sometimes - anorgasmia, decreased libido, delayed and impaired ejaculation, erectile dysfunction. On the part of the urinary system: sometimes - difficulty urinating. very rarely - nocturia. Other: sometimes - weight loss, increased sweating, hot flashes, night sweats. very rarely - anaphylactic reactions, thirst, hyponatremia, chills, angioedema, rash, Stevens-Johnson syndrome, urticaria, feeling unwell, feeling hot and / or cold, weight gain, dehydration, photosensitization. When canceled, dizziness, nausea, and headache were often noted. In patients with the painful form of diabetic neuropathy, a slight increase in fasting blood glucose may be observed.
special instructions
From the side of the central nervous system: often - dizziness (except vertigo), sleep disturbances (drowsiness or insomnia), headache (headache was observed less frequently than in patients receiving placebo). sometimes - tremor, weakness, blurred vision, lethargy, anxiety, yawning. very rarely - glaucoma, mydriasis, visual impairment, agitation, disorientation. On the part of the digestive system: often - dry mouth, nausea, constipation. sometimes - diarrhea, vomiting, loss of appetite, change in taste, impaired liver function indicators. very rarely - hepatitis, jaundice, increased activity of alkaline phosphatase, ALT, AST and bilirubin levels. belching, gastroenteritis, stomatitis. On the part of the musculoskeletal system: sometimes - muscle tension and / or twitching. very rarely - bruxism. Since the cardiovascular system: sometimes - heartbeat. very rarely - orthostatic hypotension, syncope (especially at the beginning of therapy), tachycardia, increased blood pressure, cooling of the extremities.On the part of the reproductive system: sometimes - anorgasmia, decreased libido, delayed and impaired ejaculation, erectile dysfunction. On the part of the urinary system: sometimes - difficulty urinating. very rarely - nocturia. Other: sometimes - weight loss, increased sweating, hot flashes, night sweats. very rarely - anaphylactic reactions, thirst, hyponatremia, chills, angioedema, rash, Stevens-Johnson syndrome, urticaria, feeling unwell, feeling hot and / or cold, weight gain, dehydration, photosensitization. When canceled, dizziness, nausea, and headache were often noted. In patients with the painful form of diabetic neuropathy, a slight increase in fasting blood glucose may be observed.