Universal reference book for medicines
Product name: ADEPRESS (ADEPRESS)

Active substance: paroxetine

Type: Antidepressant

Manufacturer: VEROPHARM (Russia)
Composition, form of production and packaging
The tablets covered with a
film (film) white or almost white color, round, biconcave.

1 tab.

paroxetine hydrochloride hemihydrate 22.2 mg,

which corresponds to the content of paroxetine 20 mg

Excipients: calcium hydrophosphate (calcium phosphate disubstituted) - 207.8 mg, corn starch - 134.8 mg, carboxymethyl starch sodium (primogel) - 11.4 mg, magnesium stearate - 3.8 mg.

Composition of the shell: Opadry II (hypromellose (hydroxypropylmethylcellulose), lactose monohydrate, macrogol (polyethylene glycol 3350, polyethylene glycol 4000), titanium dioxide) - 10 mg.

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Antidepressant.
It is a selective inhibitor of reuptake of serotonin (5-hydroxytryptamine, 5-HT) by neurons of the brain, which determines its antidepressant effect and effectiveness in the treatment of obsessive-compulsive (OCD) and panic disorder.
In the metabolism of paroxetine, the selective uptake of 5-HT neurons due to its action is not impaired.

Paroxetine has a low affinity for m-cholinergic receptors.

Having a selective effect, in contrast to tricyclic antidepressants, paroxetine showed low affinity for?
1 -,? 2 -,? -adrenoceptors, as well as to dopamine, 5HT 1 -like, 5HT 2 -like and histamine H 1 -receptors.
Paroxetine does not impair psychomotor functions and does not potentiate the inhibitory effect of ethanol on them.

According to the study of behavior and EEG in paroxetine, weak activating properties are revealed when it is administered at doses higher than those required to inhibit 5-HT capture.
In healthy volunteers, it does not cause a significant change in blood pressure, heart rate and EEG.
PHARMACOKINETICS

Suction

Paroxetine is well absorbed after ingestion and is metabolized by the "first pass" through the liver.

Distribution

The equilibrium state is reached after 7-14 days after the start of therapy, further pharmacokinetics with prolonged therapy does not change.
The clinical effects of paroxetine (side effect and efficacy) do not correlate with its concentration in the plasma.
Since paroxetine is subjected to the effect of "first passage" through the liver, its amount determined in the systemic circulation is less than that absorbed from the gastrointestinal tract.
With an increase in the dose of paroxetine or with multiple dosing, a partial absorption of the effect of "first passage" through the liver and a decrease in plasma clearance of paroxetine occur. As a result, an increase in the plasma paroxetine concentration and fluctuations in the pharmacokinetic parameters is possible, which can be observed only in those patients who, when taking the drug at low doses, achieve low levels of paroxetine in the plasma.
Paroxetine is extensively distributed in tissues, and pharmacokinetic calculations show that only 1% of it is present in the plasma, and at therapeutic concentrations 95% is associated with plasma proteins.

Metabolism

The main metabolites of paroxetine are polar and conjugated products of oxidation and methylation, which are rapidly excreted from the body, have weak pharmacological activity and do not affect its therapeutic effect.

Excretion

Excretion from the body of metabolites of paroxetine biphasic, first as a result of "first passage" through the liver, and then it is controlled by systemic elimination.
T1/2 of paroxetine varies, but usually is about 1 day.
The excretion of unchanged paroxetine in the urine is usually less than 2% of the dose, with metabolites accounting for about 64% of the dose.
The intestine excretes about 36% of the dose, probably through bile, in which unchanged paroxetine is less than 1% of the dose. Thus, paroxetine is excreted mainly in the form of metabolites.
Pharmacokinetics in special clinical cases

The concentration of paroxetine in the blood plasma increases when there is a violation of the liver and kidneys, as well as in the elderly, and the range of plasma concentrations almost coincides with the concentration range in healthy adult volunteers.

INDICATIONS

- depression of all types, including reactive, severe endogenous depression and depression, accompanied by anxiety;

- obsessive-compulsive disorder (ROC);

- panic disorder, incl.
with agoraphobia;
- social anxiety disorder / social phobia;

generalized anxiety disorder;

- Post-traumatic stress disorder.

DOSING MODE

Tablets should be taken 1 time / day, in the morning, while eating, without chewing, washing with water.

The dose is selected individually during the first 2-3 weeks after the start of therapy and is subsequently adjusted if necessary.
The effect in most cases develops gradually.
With depression, the recommended dose is 20 mg 1 time / day.
If necessary, the dose is gradually increased by 10 mg at intervals of 1 week before the therapeutic effect is achieved, the maximum daily dose should not exceed 50 mg / day.
In obsessive-compulsive disorders, the initial therapeutic dose is 20 mg / day, followed by a weekly increase of 10 mg to achieve a therapeutic response.
The recommended average therapeutic dose is 40 mg / day, if necessary, the dose may be increased to 60 mg / day.
In panic disorders, the initial dose is 10 mg / day (to reduce the possible risk of developing panic symptoms) followed by a weekly increase of 10 mg.
The average therapeutic dose is 40 mg / day. The maximum daily dose should not exceed 60 mg / day.
With socially-disturbing disorders / social phobias, the initial dose is 20 mg / day, in the absence of effect for at least 2 weeks, an increase in the dose to a maximum of 50 mg / day is possible.
The dose should be increased by 10 mg at intervals of at least a week in accordance with the clinical effect.
With post-traumatic stress disorder for most patients, the initial and therapeutic doses are 20 mg / day.
In some cases, a dose increase of up to 50 mg / day is recommended. The dose should be increased by 10 mg every week in accordance with the clinical effect.
In generalized anxiety disorders, the initial and therapeutic doses are 20 mg / day.

When
renal and / or liver failure, the recommended dose is 20 mg / day.
For
elderly patients daily dose should not exceed 40 mg.
To prevent relapse, supportive therapy should be provided.
After the disappearance of the symptoms of depression, this course can be 4-6 months, and with obsessional and panic disorders - more than 4-6 months.
Avoid abrupt discontinuation of the drug.

SIDE EFFECT

From the nervous system: often - drowsiness or insomnia, tremor, asthenia, dizziness, anxiety;
sometimes - confusion, hallucinations, extrapyramidal disorders, paresthesia, decreased ability to concentrate; in some cases - convulsions, mania, serotonin syndrome (agitation, hyperreflexia, diarrhea), panic disorders.
From the side of the organ of vision: in some cases - visual impairment, mydriasis.

From the osteomuscular system: in some cases - myasthenia gravis, myoclonia, arthralgia, myalgia.

From the urinary system: frequent urination;
in some cases, urinary retention.
On the part of the reproductive system: disorders of ejaculation, disorders of libido;
in some cases, hyperprolactinemia / galactorrhea, anorgasmia.
On the part of the digestive system: decreased appetite, nausea, vomiting, dry mouth;
sometimes - constipation or diarrhea; in some cases - hepatitis.
From the cardiovascular system: orthostatic hypotension.

Allergic reactions: in some cases -
rash, urticaria, ecchymatosis, itching, angioedema.
Other: increased sweating;
in isolated cases - hyponatremia, a violation of the secretion of antidiuretic hormone.
CONTRAINDICATIONS

- simultaneous administration of MAO inhibitors and a period of 14 days after their withdrawal;

- Unstable epilepsy;

- Pregnancy;

- the period of lactation (breastfeeding);

- Hypersensitivity to the components of the drug.

With caution , the drug should be prescribed for liver failure, renal insufficiency, closed-angle glaucoma, prostatic hyperplasia, mania, cardiac pathology, epilepsy, convulsive conditions, simultaneous appointment of electropulse therapy, simultaneous use of drugs that increase the risk of bleeding, the presence of risk factors for increased bleeding and diseases, increasing the risk of bleeding, as well as elderly patients.

PREGNANCY AND LACTATION

The drug is contraindicated for use in pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should prescribe the drug for kidney failure.
In renal failure, the recommended dose is 20 mg / day.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should prescribe the drug for liver failure.
In liver failure, the recommended dose is 20 mg / day.
APPLICATION FOR CHILDREN

Adepress use in children is not recommended, since its safety and efficacy in this group of patients are not established.

APPLICATION IN ELDERLY PATIENTS

Caution should be given to elderly patients.
In patients of advanced age, Adenpress may receive hyponatremia.
SPECIAL INSTRUCTIONS

To avoid the development of a malignant neuroleptic syndrome with caution, Adepress should be prescribed to patients taking antipsychotics.

Treatment Adepressom appoint 2 weeks after the abolition of MAO inhibitors.

In patients of advanced age, Adenpress may receive hyponatremia.

In some cases, a dose adjustment of simultaneously used insulin and / or oral hypoglycemic drugs is required.

With the development of seizures, treatment with Adepress is stopped.

At the first sign of mania, it is necessary to cancel Adepress therapy.

During the first few weeks of therapy, Adeptress should carefully monitor the patient's condition due to possible suicidal attempts.

During therapy, Adeptress should refrain from drinking alcohol because of the increased toxic effect.

Use in Pediatrics

Adepress use in children
is not recommended, as its safety and efficacy in this group of patients are not established.
Impact on the ability to drive vehicles and manage mechanisms

Despite the fact that paroxetine does not worsen cognitive and psychomotor functions, patients should abstain or observe extreme caution when driving a car and when engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

OVERDOSE

Symptoms: nausea, dilated pupils, fever, changes in blood pressure, headache, involuntary muscle contractions, agitation, anxiety, tachycardia.
In very rare cases, while taking with other psychotropic drugs and / or ethanol (alcohol), there may be changes in the ECG, coma.
Treatment: gastric lavage, reception of activated charcoal.
If necessary, conduct symptomatic therapy. There is no specific antidote.
DRUG INTERACTION

Simultaneous intake of food and antacids does not affect the absorption and pharmacokinetic parameters of Adepress.

Adepress should not be taken concomitantly with MAO inhibitors and within 14 days after their cancellation.

During therapy, Adeptress should refrain from taking alcohol because of the increased toxic effect of ethanol.

In connection with paroxetine inhibition of cytochrome P450, the effect of barbiturates, phenytoin, indirect anticoagulants, tricyclic antidepressants, phenothiazine antipsychotics and antiarrhythmics of class 1 C, metoprolol and an increased risk of side effects with the simultaneous administration of these drugs may be increased.

With concomitant administration with drugs that inhibit liver enzymes, a reduction in the Adapepress dose may be required.

Paroxetine increases bleeding time when taking warfarin with a constant prothrombin time.

With the simultaneous appointment of Adeptress with atypical antipsychotics, tricyclic antidepressants, phenothiazine series drugs, acetylsalicylic acid, NSAIDs, a disruption of the blood coagulation process is possible.

Simultaneous appointment of Adeptress with serotonergic drugs (tramadol, sumatriptan) may lead to an increase in the serotonergic effect.

Mutual enhancement of the action of tryptophan, lithium and paroxetine preparations was noted.

With the simultaneous administration of Adeptress with phenytoin and other anticonvulsants, a decrease in paroxetine concentration in the plasma and an increase in the incidence of side effects are possible.

Paroxetine much less suppresses the antihypertensive effects of guanethidine compared with antidepressants that inhibit the seizure of norepinephrine.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored in a dry place inaccessible to children at a temperature of no higher than 25 ° C.
Shelf life - 2 years.

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