Zoloft (sertraline) coated tablets 50 mg. №28

Description

Zoloft (sertraline) coated tablets 50 mg. №28

Composition

active substance: sertraline;

one film-coated tablet contains sertraline hydrochloride in an amount equivalent to 50 mg sertraline;

Excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, Opadry white (hydroxypropylmethylcellulose, titanium dioxide (E 171)), polyethylene glycol, Opolylopropyl, Opolyadryl glycol, Opolysyl hydroxide, polysorbate, polysorbate

Dosage form

Film-coated tablets.

Main physicochemical properties: white, film-coated, capsule-shaped, Pfizer-coated tablets on one side and ZLT 50 on the other. The tablets have a functional dash between “ZLT” and “50”.

Pharmacotherapeutic group

Antidepressants. Selective serotonin reuptake inhibitors. ATX code N06A B06.

Pharmacological properties

Zoloft (sertraline) is a potent and specific inhibitor of neuronal serotonin uptake (5-HT) in vitro, which potentiates the effects of 5-HT in animals. Sertraline has only a very weak effect on the renal neuronal uptake of norepinephrine and dopamine. At clinical doses, sertraline blocks the uptake of serotonin into human platelets. The drug does not show stimulating, sedative, anticholinergic or cardiotoxic effects in animal experiments. In controlled studies in healthy volunteers, sertraline was not sedative and did not affect psychomotor function. According to its inherent selective inhibition of 5-HT uptake, sertraline does not increase catecholaminergic activity. The drug has no affinity for muscarinic (cholinergic), serotonergic, dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine receptors. Prolonged use of sertraline in animals has been associated with a decrease in the number of norepinephrine receptors in the brain, which is observed with the use of other effective in clinical practice antidepressants and anti-obsessive drugs.

Indication

Zoloft (sertraline) is indicated for the treatment of the following disorders:

• major depressive episodes. Prevention of recurrence of major depressive episodes;
• panic disorders with or without agoraphobia.
  Obsessive-compulsive disorder (OCD) in adults and children 6-17 years;
• social anxiety disorder;
• post-traumatic stress disorder (PTSD).

Contraindication

Hypersensitivity to the active substance or to any of the excipients.

Concomitant use of sertraline with monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of developing serotonin syndrome with symptoms such as agitation, tremor and hyperthermia. Sertraline therapy should not be initiated for at least 14 days after discontinuation of an irreversible MAO inhibitor. Sertraline should be discontinued at least 7 days before initiating therapy with an irreversible MAO inhibitor.

Concomitant use of sertraline and pimozide is contraindicated.

Method of application and dosage

Zoloft (sertraline) should be taken once a day (morning or evening).
Zoloft (sertraline) tablets can be taken with or without food.

Beginning of treatment

• depression and OCD
  Sertraline treatment should be initiated at a dose of 50 mg / day;
• panic disorders, PTSD and social anxiety disorder
  Treatment should be started at a dose of 25 mg / day. After 1 week, the dose should be increased to 50 mg once daily. This dosage regimen has been shown to reduce the incidence of panic side effects at the initial stage of treatment.

Maintenance dose
Dosage during long-term therapy should be kept at the lowest effective level, followed by adjustment depending on the therapeutic response.

• depression
  Long-term therapy can also be used to prevent the recurrence of major depressive episodes. In most cases, the recommended dose to prevent recurrence of major depressive episodes is the same as the dose used to treat this depressive episode. Patients with depression should be treated for sufficient time, at least 6 months, to ensure complete absence of symptoms;
• panic disorders and OCD
  Patients with panic disorders and OCD should be evaluated regularly during long-term treatment, as these disorders have not been shown to be effective in preventing relapse.

Application for children

Children and adolescents with obsessive-compulsive disorder:

• adolescents aged 13–17 years: the initial dose is 50 mg once daily;
• children aged 6-12 years: the initial dose is 25 mg once a day. After 1 week, the dose can be increased to 50 mg once a day.

If necessary, in case of insufficient effect, it is possible to further increase the dose by increasing by 50 mg 1 time over a period of several weeks. The maximum dose is 200 mg / day. However, if the dose is increased above 50 mg, the lower body weight of children compared to adults should be taken into account. The dose should not be changed more than once a week.

The effectiveness of the drug in children with major depressive disorder has not been demonstrated.

Overdose:

• toxicity
  Sertraline has a safety range that depends on the patient population and / or concomitant medications. Fatalities with sertraline overdose have been reported with single use and in combination with other drugs and / or alcohol. Therefore, each case of overdose requires intensive care;
• symptoms
  Symptoms of overdose include serotonin-mediated side effects such as drowsiness, gastrointestinal disorders (eg, nausea and vomiting), tachycardia, tremor, agitation, and dizziness. The development of coma was reported less frequently.

Side effects:

• infections and invasions: upper respiratory tract infections, pharyngitis, rhinitis;
• metabolic and nutritional disorders: decreased appetite, increased appetite;
• mental disorders: insomnia, anxiety, depression *, agitation, decreased libido, nervousness, depersonalization, night terrors, bruxism;
• from the nervous system: dizziness, headache, drowsiness, tremor, movement disorders (including extrapyramidal symptoms such as hyperkinesia, hypertension, dystonia, jaw spasms or gait disturbances), paresthesia, hypertension, attention deficit, dysgeusia;
• on the part of the visual organs: visual impairment;
• from the organs of hearing and balance: ringing in the ears;
• from the heart: a feeling of palpitations;
• from vessels: tides;
• from the respiratory system, chest and mediastinum: yawning;
• from the gastrointestinal tract: nausea, diarrhea, dry mouth, dyspepsia, constipation, abdominal pain, vomiting, flatulence;
• from the skin and subcutaneous tissue: hyperhidrosis, rash;
• from the musculoskeletal system and connective tissue: back pain, arthralgia, myalgia.