Sertraloft (sertraline) coated tablets 100 mg. №30

Description

Sertraloft (sertraline) coated tablets 100 mg. №30

Composition

active substance: sertraline;

1 tablet contains sertraline hydrochloride in terms of sertraline 25 mg or 50 mg or 100 mg;

excipients:

• dosage 25 mg – microcrystalline cellulose, corn starch, povidone, lactose monohydrate, magnesium stearate, silicon dioxide colloidal anhydrous, dry mixture “Opadry II yellow”, containing titanium dioxide (E 171), talc, polyethylene glycol, polyvinyl alcohol, yellow iron oxide (E 172), tartrazine (E 102) (in the form of aluminum varnish);
• dosage 50 mg – microcrystalline cellulose, povidone, lactose monohydrate, magnesium stearate, colloidal anhydrous silicon dioxide, indigo carmine (E 132), dry mixture “Opadry II white” containing titanium dioxide (E 171), talc, polyethylene glycol, polyvinyl alcohol;
• dosage 100 mg – microcrystalline cellulose, potato starch, povidone, celactose [a mixture of lactose monohydrate and powdered cellulose (75:25)], stearic acid, hypromellose, titanium dioxide (E 171), talc.

Medicinal form

Coated tablets.

The main physicochemical properties: tablets covered with a shell, with a biconvex surface, from light yellow to yellow (dosage 25 mg), blue (dosage 50 mg) or white (dosage 100 mg). The cross section shows two layers. Marbling and inclusions are allowed on the surface of the tablets (dosage 100 mg).

Pharmacotherapeutic group

Antidepressants. Selective serotonin reuptake inhibitors (SSRIs).
ATX code N06A B06.

Pharmacological properties

It is an antidepressant. It is a powerful selective (selective) inhibitor of serotonin reuptake (5-HT), while not exerting sedative, stimulating, anticholinergic, cardiotoxic effects.

Indications

Sertraloft tablets is shown:

• to treat, prevent recurrence of a major depressive episode;
• for the treatment of generalized anxiety disorder;
• for the treatment of social phobia;
• for the treatment of panic disorder with / without agoraphobia;
• for the treatment of obsessive-compulsive disorder;
• for the treatment of post-traumatic stress disorder.

Contraindications

Sertraloft tablets is not used:

• with intolerance to the components;
• with simultaneous treatment with pimozide, non-selective, irreversible MAOIs;
• children under six years old.

Application during pregnancy and lactation

Clinical data on use in pregnant women are limited. The drug is contraindicated in pregnant women, unless the need for its appointment has been proven (after considering all the risks and benefits). It is recommended to examine newborns whose mothers received the drug, especially in the third trimester (respiratory distress, hyperreflexia, apnea, cyanosis, seizures, temperature instability, difficulty in feeding, hypoglycemia, hypertension / hypotension, tremor, neurological symptoms, drowsiness may occur). The risk of developing persistent pulmonary hypertension in the newborn increases.
The active ingredient and its metabolite are excreted in milk in small quantities, therefore breastfeeding is not recommended.

Method of administration and dosage

Sertraloft tablets is used orally, regardless of food.
The required dose is taken once a day.
The standard starting dose for depression, OCD is 50 mg / day; with panic disorder, post-traumatic stress disorder, social anxiety disorder – 25 mg / day.
The dose can be increased, but not earlier than after a week of treatment, gradually increasing it by 50 mg with an interval of at least 1 week.
The maximum is 200 mg / day.
Dose adjustment is carried out no more than once a week.

Overdose

Symptoms: drowsiness, tremors, gastrointestinal disturbances, tachycardia, agitation, dizziness, coma, prolongation of the Q-T interval, ventricular tachycardia of the “pirouette” type.
Therapeutic measures: gastric lavage, prescription of sorbents, support of the respiratory system, adequate oxygenation, monitoring of vital functions, ECG monitoring, symptomatic treatment.

Side effects:

• Cardiovascular disorders: tachycardia / bradycardia, orthostatic hypotension, prolongation of the QT interval.
• Immune disorders: allergic reactions.
• Endocrine disorders: violation of the secretion of antidiuretic hormone, decrease / increase in body weight.
• Psychiatric disorders: anxiety, abnormal dreams, anxiety, decreased libido, anorgasmia, teeth grinding, nervousness, agitation, panic attacks, aggression, depersonalization, confusion, mania, suicidal behavior / thoughts, hallucinations.
• Digestive disorders: decreased / increased appetite, anorexia, constipation / diarrhea, dry mouth, vomiting, stomach bleeding, rectal bleeding, hepatitis.
• Neurological disorders: insomnia, dizziness, drowsiness, paresthesia, taste disturbance, loss of consciousness, tremor, sleep disturbance, dyskinesia, serotonin syndrome, convulsions, movement disorders, psychomotor anxiety, akathisia.
• Ophthalmic disorders: blurred vision, dilated pupil.
• Otolaryngological disorders: ringing in the ears.
• Respiratory disorders: nosebleeds, sinusitis, yawning.
• Dermatological disorders: increased sweating, rashes, edema, bruising, baldness, itching, urticaria.
• Musculoskeletal disorders: myalgia, arthralgia.
• Laboratory abnormalities: thrombocytopenia, hyponatremia.
• Urinary disorders: urinary retention, impotence, ejaculation disorders, menorrhagia, metrorrhagia, galactorrhea, priapism.
• General: pyrexia, fatigue.