Apo-Paroxetine (Apo-Paroxetine)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceParoxetineParoxetine
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    • Dosage form: & nbspfilm coated tablets
    Composition:

    Active Ingredients: paroxetine hydrochloride hemihydrate 22.30 mg in terms of paroxetine anhydrous 20.00 mg

    Inactive Ingredients: lactose anhydrous, carboxymethyl starch sodium, magnesium stearate, giprolose LF, hypromellose 2910 E5, macrogol 8000, titanium dioxide, D & C red No. 30 (helidone pink).

    Description:Oval, biconvex tablets covered with a pink film shell, with a risk and engraving "20" on one side and engraving "ARO" on the other side.
    Pharmacotherapeutic group:Antidepressant
    ATX: & nbsp

    N.06.A.B   Selective serotonin reuptake inhibitors

    N.06.A.B.05   Paroxetine

    Pharmacodynamics:Antidepressant, selectively inhibits the reuptake of serotonin (5-HT) in the central nervous system, enhances serotonergic transmission in the central nervous system. The effect manifests itself in 7-14 days. Reduces anxiety, depression.
    Pharmacokinetics:

    Absorption is high. Time to reach the equilibrium concentration with oral intake of 30 mg - 7-14 days; the time of onset of TCmax is 5.2 hours, Cmax is 61.7 ng / ml, and T1 / 2 is 21 hours. The connection with plasma proteins is 95%. With increasing dose and / or duration of treatment, non-linear dependence of pharmacological parameters on dose. Metabolism - in the liver with the formation of inactive metabolites. It is an inhibitor of the isoenzyme CYP2D6.

    It is excreted by the kidneys - 64% (unchanged - 2%); through the gastrointestinal tract - 36% (unchanged -1%).

    Indications:Depression of different etiology (including anxiety, reactive, recurrent, atypical and postpsychotic, depressive episodes of bipolar disorder, dysthymia, depression on the background of schizophrenia, organic diseases of the central nervous system and alcoholism).
    Contraindications:

    Hypersensitivity, taking MAO inhibitors and 2 weeks after their withdrawal, pregnancy, lactation.

    Children under 18 years.

    Carefully:Hepatic failure, chronic renal failure, elderly; closed-angle glaucoma, prostatic hyperplasia.
    Dosing and Administration:

    Inside, 1 time per day in the morning, the tablet is swallowed whole, washed down with water.

    With depression, 20 mg once a day; if necessary - a gradual increase in the dose of 10 mg / day, with an interval of at least 1 week, the maximum daily dose - 50 mg. The course of treatment is long. Efficacy is assessed after 6-8 weeks.

    In renal and / or hepatic insufficiency, in elderly and debilitated patients the initial daily dose is 10 mg, the maximum daily dose is 40 mg.

    Obsessive-compulsive disorder: the average therapeutic dose is 40 mg / day, if necessary - 60 mg / day.

    In panic disorder, the initial dose is -10 mg / day (to reduce the possible risk of exacerbation of panic symptoms), followed by a weekly increase of 10 mg. The average therapeutic dose is 40 mg / day. The maximum dose is -60 mg / day.

    Side effects:

    From the nervous system: insomnia, drowsiness, dizziness, paresthesia, tremor, nervousness, amnesia, agitation, asthenia, decreased ability to concentrate, anxiety.

    From the side of the musculoskeletal system: myalgia, myasthenia gravis, myoclonia, myopathic syndrome.

    From the sense organs: change in taste, impaired vision.

    From the genitourinary system: urinary retention, increased urination, impaired sexual function (including decreased potency, ejaculatory impairment), decreased libido.

    From the digestive system: a change in appetite (increase or decrease), nausea, dry mouth, constipation, or diarrhea.

    Other: rhinitis, increased sweating, skin rash.

    Overdose:

    Symptoms: nausea, vomiting, tremor, mydriasis, dry mouth, irritability, nystagmus, agitation, sweating, drowsiness, coma, sinus tachycardia, convulsions, bradycardia, increased blood pressure in the nodal rhythm. In severe overdose - "serotonin" syndrome, rarely - rhabdomyolysis.

    Treatment: gastric lavage, Activated carbon. If necessary, symptomatic therapy.

    Interaction:

    Incompatible with MAO inhibitors (the interval between administration is 14 days).

    With a simultaneous appointment with tryptophan can cause a "serotonin syndrome": agitation, anxiety, diarrhea.

    Increases the concentration of procyclidine.

    Increases bleeding time against indirect anticoagulants with unchanged prothrombin time.

    Inductors of microsomal oxidation in the liver (phenobarbital, phenytoin) reduce concentration and effectiveness; inhibitors of microsomal oxidation - increase.

    Antidepressants (nortriptyline, amitriptyline, imipramine, desipramine and fluoxetine), phenothiazine derivatives (thioridazine), antiarrhythmic drugs of 1C class (incl. propafenone) increase the risk of side effects.

    Special instructions:Joint reception of LS Li + is carried out under the control of their concentration in the blood.
    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Tablets, film-coated, 20 mg.

    Packaging:

    For hospital: 100 and 500 tablets in high-density polyethylene (PVD) bottles of white color, sealed with laminated paper, with a screwed polypropylene lid together and instructions for use in a cardboard box.

    From 30 to 400 bottles (the number of bottles depends on their size) is sealed in a polyethylene film (block), the blocks along with the appropriate number of instructions are placed in cardboard boxes.

    In case of packing by Russian enterprises:

    OOO "Production of Medicines", Russia:

    For 10 tablets in a contour mesh package made of a polyvinyl chloride film and aluminum foil. For 1, 3 or 10 contour mesh packages together with instructions for use, a cardboard pack.

    OOO Ozon, Russia:

    For 10 tablets in a contour mesh package made of a polyvinyl chloride film and aluminum foil. For 1, 3 or 10 contour mesh packages together with instructions for use, a cardboard pack.

    Storage conditions:In dry and protected from light and out of reach of children at a temperature of 15 ° C to 30 ° C.
    Shelf life:

    2 years.

    Do not use after the expiration date indicated on the label.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000792/08
    Date of registration:15.02.2008 / 14.01.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:Apothec Inc.Apothec Inc. Canada
    Manufacturer: & nbsp
    Representation: & nbspSAN PHARMACEUTICAL INDUSTRIES LTD. SAN PHARMACEUTICAL INDUSTRIES LTD. India
    Information update date: & nbsp09.09.2017
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