The package insert of the medicine Serenata

the package insert of the medicine Serenade. Therapeutic class of the anti-Depressants. Active principlesHydrochloride Sertraline.

what For?

Serenade (hydrochloride of sertraline) is indicated in the treatment of symptoms of depression, including depression accompanied by anxiety symptoms, in patients with or without history of mania.

After a satisfactory response, continuation of treatment with Serenade (hydrochloride of sertraline) is effective both in the prevention of relapse of symptoms of the initial episode of depression, as well as in the recurrence of other depressive episodes.

Serenade (hydrochloride of sertraline) is also indicated for the treatment of the following conditions:

    the

  • Obsessive Compulsive disorder (OCD). After the initial response, sertraline maintains the efficacy, safety and tolerability in long-term treatment, as has been shown in clinical studies up to 2 years duration;
  • the

  • Obsessive Compulsive disorder (OCD) in pediatric patients;
  • the

  • panic Disorder, with or without agoraphobia;
  • the

  • Stress Disorder Post-Traumatic stress disorder (PTSD);
  • the

  • Symptoms of the Syndrome Pre-Menstrual Tension (STPM) and/or premenstrual Dysphoric Disorder (PMDD);
  • the

  • Social Phobia (Anxiety Disorder Social).

After a satisfactory response, continuation of treatment with Serenade (hydrochloride of sertraline) is effective in the prevention of relapses of the initial episode of social phobia.

oral – Use adult and children above 6 years (only for the treatment of obsessive compulsive disorder (ocd)

Contraindications

When should I not use?

The medicine is contraindicated to patients with known hypersensitivity to sertraline or to other components of the formulation.

The concomitant use of sertraline in patients using monoamine oxidase inhibitors (MAOIS) is contraindicated (see Precautions and Warnings).

The concomitant use of sertraline in patients using pimozide is contraindicated (see Drug Interactions).

Dosage

How to use?

Serenade (hydrochloride of sertraline) should be administered orally as a single dose daily in the morning or evening, with or without food, at the same time every day.

The maximum recommended dose of the Serenade (hydrochloride of sertraline is 200 mg/day.

Each film-coated tablet Serenade (hydrochloride of sertraline) 50 mg contains hydrochloride sertraline equivalent to 50 mg of sertraline base.

the Initial Treatment

    the

  • Depression and OCD

The treatment with Serenade (hydrochloride of sertraline) should be done with a dose of 50 mg/day.

    the

  • Panic Disorder, Stress Disorder, Post-Traumatic stress disorder (PTSD) and Social Phobia

treatment should be started at 25 mg/day, increasing to 50 mg/day after one week.

This dosing regimen has been shown to reduce the frequency of side effects emerging at the beginning of treatment, are characteristic of panic disorder.

    the

  • Syndrome of Pre-Menstrual Tension (STPM) and/or premenstrual Dysphoric Disorder (PMDD)

treatment should be initiated with 50 mg/day, being able to adopt the continuous treatment (during the entire menstrual cycle or only during the luteal phase of the cycle, according to medical advice.

Titration

    the

  • Depression, OCD, Panic Disorder, Stress Disorder, Post-Traumatic stress disorder and Social Phobia

patients who do not respond to a dose of 50 mg, may benefit from a dose increase.

The changes in the doses should be performed with a minimal interval of 1 week, up to the maximum recommended dose of sertraline, which is 200 mg/day.

Changes in the doses should not be made more than 1 time per week due to the half-life of elimination of sertraline of 24 hours.

The beginning of the therapeutic effects can occur within 7 days.

However, longer periods are usually necessary, especially in the treatment of OCD.

    the

  • Syndrome of Pre-Menstrual Tension (STPM) and premenstrual Dysphoric Disorder (PMDD)

since the relationship between dose and effect has not yet been established for the treatment of the symptoms of the Syndrome Pre-Menstrual Tension and/or premenstrual Dysphoric Disorder, the patients who participated in clinical studies were treated with doses ranging from 50-150 mg/day, with increases of dose to each new menstrual cycle.

The patients that are not getting results with the dose of 50 mg/day may be benefited with the increase of dose (increments of 50 mg each menstrual cycle up to a maximum of 150 mg/day when administered daily throughout the menstrual cycle, or up to a maximum of 100 mg/day when administered only during the luteal phase of the cycle.

If the dose of 100 mg/day is established for the luteal phase, titers equivalent to 50 mg/day, for 3 days, should be used at the beginning of the treatment of each luteal phase of the cycle.

Maintenance

The dose of the Serenade (hydrochloride of sertraline) during the therapy of prolonged maintenance should be maintained with the lowest effective dose, with subsequent adjustment depending on therapeutic response.

Use in Children

Treatment of OCD: the safety and efficacy of the use of sertraline has been established for pediatric patients (with ages ranging between 6 and 17 years old) only for the treatment of OCD.

The administration of sertraline in pediatric patients with ages ranging between 13 and 17 years should begin with 50 mg/day.

The treatment of pediatric patients with ages ranging between 6 and 12 years should begin with 25 mg/day and increase to 50 mg/day after one week.

In the case of the absence of a clinical response, the dose can subsequently be increased in increments of 50 mg/day, up to 200 mg/day, if necessary.

In a clinical study with patients with ages ranging between 6 and 17 years with depression or OCD, sertraline showed a pharmacokinetic profile similar to that observed in adults.

However, the smaller body weight of a child, when compared to that of an adult, should be considered when thinking about increase dose of 50 mg.

Titration in Children and Adolescents: since the half-life of elimination of sertraline is approximately 24 hours, the dosage changes should not occur at intervals smaller than a week.

Use in the Elderly

The same dosage indicated for younger patients can be used in elderly patients.

More than 700 elderly patients (age over 65 years of age) participated in clinical studies that have demonstrated the efficacy of sertraline in this population of patients.

The pattern and incidence of adverse reactions in the elderly were similar to those observed in younger patients.

Use in Liver Failure

The use of sertraline in patients with liver disease must be done with care.

A lower dose or less frequent should be considered for patients with hepatic insufficiency (see Warnings).

Use in Renal Insufficiency

sertraline is extensively metabolized.

The excretion of drug unchanged in the urine is a route of elimination little significant.

according To the low renal excretion of sertraline, dose of sertraline do not need to be adjusted based on the degree of renal failure (see Warnings).

Side Effects

What are the evils that can cause me?

The adverse reactions more common that can occur with the use of this medicine are: nausea, diarrhea, loose stool, loss of appetite, malaise, digestive, tremor, dizziness, insomnia, sleepiness, sweating, dry mouth, and delayed ejaculation.

Warnings and Precautions

what should I know before using?

The safety and effectiveness of the use of sertraline has been established for pediatric patients (6 to 17 years old) only for the treatment of Obsessive Compulsive disorder.

Serenata in pregnancy and lactation:

This medicine should not be used by pregnant women without medical or dental surgeon.

If the patient is of childbearing age must use appropriate methods of contraception to not get pregnant during the treatment with Serenade (hydrochloride of sertraline).

The patient should not use Serenata (hydrochloride of sertraline) during breastfeeding without medical advice, and should tell your doctor or dentist if you are breast-feeding or will begin breast feeding during the use of this medicine.

During treatment, the patient should not drive vehicles or operate machinery, as your skill and attention may be harmed.

Drug Interactions

During the treatment with Serenade (hydrochloride of sertraline), it should not be used the drugs MAOIS (monoamine oxidase inhibitors), depressants of the central nervous system, alcohol, other drugs with similar action to the Serenade (hydrochloride of sertraline) drugs serotonergic) and pimozide.

If during the treatment with Serenade (hydrochloride of sertraline) the patient is also using lithium, phenytoin, sumatriptana, warfarin, cimetidine, diazepam or tolbutamide, these treatments should be properly tracked and monitored by the doctor.

Overdose

what to do if someone use a larger amount than is recommended?

According to the available evidence, the hydrochloride sertraline has a wide margin of safety in the superdose.

have Been reported superdose with hydrochloride sertraline alone in doses of up to 13.5 g.

have Also been reported deaths involving superdose with cloridclick of sertraline, primarily in combination with other drugs and/or alcohol.

Therefore, any superdose should be treated strictly.

The symptoms of superdose include: adverse effects mediated by serotonin, such as drowsiness, gastrointestinal disorders (nausea and vomiting), tachycardia, tremor, agitation and dizziness. The coma has been reported with less frequency.

there are No specific antidotes to sertraline.

If necessary, establish and maintain assisted, ensure ventilation and oxygenation adequate, if necessary.

the activated Charcoal, can be used with an agent cathartic, may be as or more effective than lavage, and should be considered in the treatment of the superdose.

The induction of emesis is not recommended.

Monitoring of cardiac and vital signs monitoring are recommended along with the control of symptoms and general measures of support.

Due to the large volume of distribution of sertraline, forced diuresis, dialysis, hemoperfusão and blood transfusion probably does not bring benefits.