MEDOLAPRAM
(Escitalopram)




COMPOSITION

Film coated tablet contains

Active ingredient : escitalopram (as escitalopram oxalate) 10 mg or 20 mg.

Excipients: microcrystalline cellulose, silica colloidal anhydrous, croscarmellose sodium, talc, magnesium stearate.

Film coating composition of Opadry Ò White YS-1-7003: hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80.

THERAPEUTIC INDICATIONS

- major depressive disorder;

- panic disorders with or without agoraphobia;

- social anxiety disorder (social phobia);

- generalized anxiety disorder;

- obsessive compulsive disorder.

CONTRAINDICATIONS

- hypersensitivity to the active substance or to any other drug component;

- coadministration of monoamine oxidase (МАО) inhibitors;

- children and adolescents younger 18 years old.

ADVERSE EFFECTS

Side effects appear more often in the first or second week of the treatment and then they usually become less intensive and appear rarely in case of the treatment continuation.

Digestive system: most frequently - nausea, loss of appetite, diarrhea, constipations; rarely - taste disorders; possibly - vomiting, dry mouth, change of laboratory indices of liver function.

Central nervous system and peripheral nervous system: most frequently - insomnia or drowsiness, dizziness, weakness; possibly - blurred vision, convulsive attacks, tremor, motor disturbances, serotonin syndrome, hallucinations, mania, confused mental state, agitation, anxiety, depersonalization, panic attacks, increased irritability.

Metabolism: most frequently - excessive sweating, hyperthermia; possibly - hyponatremia.

Reproductive system: most frequently - decreased interest, impotence, ejaculation disturbance, anorgasmia (in women).

Cardiovascular system: it is possible an orthostatic hypotension.

Endocrine system: possibly - insufficient secretion of antidiuretic hormone (ADH), galactorrhea.

Allergic reactions: possibly - anaphylactic reactions, angioneurotic edema.

Dermatological reactions: possibly - skin rash, itch, ecchymosis, purpura.

Others: most frequently - sinusitis; possibly - arthralgia, myalgia, urine retention.

In case of abrupt withdrawal of the drug after the continuous administration the following withdrawal reactions are possible: dizziness, headache and vomiting. The severity of these reactions is insignificant and the duration is limited.

DOSAGE AND ADMINISTRATION

Medolapram is administrated peroraly one time per day without regard to food.

Major depressive disorder

Usually the drug is prescribed in dose of 10 mg one time per day. Depending on the individual reaction of a patient the drug dose can be increased up to the maximum 20 mg per day dose. An antidepressant effect usually appears 2-4 weeks after the treatment beginning. After the disappearance of the depression symptoms at least during 6 months more it is necessary to continue the therapy for the preservation of the obtained effect.

Panic disorders with or without agoraphobia

During the first week of the treatment it is recommended to administer 5 mg dose per day that subsequently should be increased up to 10 mg per day. Depending on the individual reaction of a patient the drug dose can be increased up to the maximum 20 mg per day dose. The maximum therapeutic effect is attained approximately 3 months after the treatment beginning. The therapy continues during some months.

Social anxiety disorder (social phobia)

Usually the drug is prescribed in dose of 10 mg one time per day. The symptoms weakening are usually observed 2-4 weeks after the treatment beginning. Depending on the individual reaction of a patient the drug dose can be subsequently decreased to 5 mg per day or the drug dose can be increased up to the maximum 20 mg per day dose. Considering that the social anxiety disorder is a chronic disease, the minimum recommended duration of a therapeutic course is 12 weeks. To prevent the disease relapses the drug can be prescribed during 6 months or longer depending on the individual reaction of a patient.

Generalised anxiety disorder

The recommended initial dose is 10 mg one time per day. Depending on the individual reaction of a patient the drug dose can be increased up to the maximum 20 mg per day dose. It is allowed the continuous drug administration (6 months and longer) in dose of 20 mg per day.

Obsessive compulsive disorder

Usually the drug is prescribed in dose of 10 mg one time per day. Depending on the individual reaction of a patient the drug dose can be subsequently increased up to the maximum 20 mg per day dose. Considering that the obsessive compulsive disorder is a chronic disease, the treatment course should be continuous enough to ensure the complete symptom resolution; and the treatment should last at least during 6 months. To prevent the disease relapses it is recommended the treatment duration not less than 1 year.

Elderly patients (older than 65 years)

It is recommended to take one half of the usual recommended dose (i.e. a total of 5 mg per day) and lower maximum dose (10 mg per day).

Impaired kidney function

The dose adjustment is not required in case of mild and moderate impaired kidney function. The drug should be prescribed with caution to the patients with frank renal failure (CС is lower than 30 ml/min.).

Impaired liver function

The recommended initial dose during the first two weeks is 5 mg per day. Depending on the individual reaction of a patient the drug dose can be increased up to 10 mg per day.

Decreased activity of isoenzyme CYP2C19

For the patients with weak activity of isoenzyme CYP2C19 the recommended initial dose during the first two weeks is 5 mg per day. Depending on the individual reaction of a patient the drug dose can be increased up to 10 mg per day.

Treatment cessation

In case of the cessation of the treatment with Medolapram it is necessary to reduce gradually the dose during 1-2 weeks in order to avoid the appearance of the withdrawal syndrome.

SPECIAL INDICATIONS

Medolapram should be prescribed only 2 weeks after the withdrawal of irreversible inhibitors of МАО and 24 hours after the cessation of the therapy with reversible inhibitor of МАО. Nonselective inhibitors of МАО can be prescribed not earlier than 7 days after the withdrawal of escitalopram.

Some patients with panic disorder at the beginning of the treatment with escitalopram can have the increased anxiety that disappears usually during the following 2 weeks of the treatment. To lower the possibility of anxiety appearance it is recommended to use the low initial doses.

It is necessary to cancel the drug in case of epileptic seizures or their rate increase in case of pharmacologically uncontrolled epilepsy.

In case of maniacal state the administration of escitalopram should be canceled.

Medolapram can increase the glucose blood concentration in diabetes mellitus that can demand the adjustment of hypoglycemic drugs doses.

The clinical experience of escitalopram administration shows the possibly increase of risk of attempted suicide realization during the first weeks of the therapy, in connection with this it is very important to perform careful monitoring of the patients during this period.

Hyponatremia related to the decreased secretion of ADH against the background of escitalopram administration occurs rarely and usually disappears while its withdrawal.

When the serotonin syndrome is developed, the drug should be immediately cancelled and the symptomatic treatment should be prescribed.

It should be administered with caution in the patients with renal failure (CC less than 30 ml/min.), in the elderly patients, in case of liver cirrhosis, inclination to bleedings.

DRUG INTERACTIONS

When the drug is coadministrated with the МАО inhibitors, the risk of serotonin syndrome and serious adverse reactions is augmented.

The coadministration with serotonergic drugs (including with tramadol, sumatriptan and other triptans) can lead to the development of serotonin syndrome.

The coadministration with the drugs lowering the convulsion threshold increases the risk of developing seizures.

The administration of Medolapram simultaneously with the drugs containing the St. John's wort (Hypericum perforatum) can lead to the increase of side effect rate.

It strengthens the effect of tryptophan and lithium drugs; drugs influencing on the blood coagulation (it is necessary to control the indices of blood coagulation). It increases the plasma concentration of desipramine and metoprolol twofold.

The drugs metabolizing with the participation of system CYP2С19 (including omeprazole), аs well as the drugs that are strong inhibitors CYPЗА4 and CYP2D6 (including flecainide, propafenone, metoprolol, desipramine, clomipramine, nortriptyline, risperidone, thioridazine, haloperidol) increase the concentration of escitalopram.

The coadministration of escitalopram and alcohol is not recommended.

PREGNANCY AND LACTATION

The administration of Medolapram during pregnancy is possible only in the case if the expected benefit for mother exceeds the potential risk of complications for fetus.

In case of necessity to take the drug during lactation the breastfeeding should be stopped.

MANUFACTURED FORM AND PACKAGE

Film coated tablets. 14 tablets in a blister.

1, 2, 4 or 6 blisters with the enclosed leaflet in a carton box.

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