Tolrest: Mechanism of Action, Contraindications, Administration, Precautions, Adverse Reactions and Overdose

Sertraline hydrochloride is indicated to treat depression accompanied by anxiety and obsessive-compulsive disorder symptoms in adults and children.

It is also indicated for panic disorder, post-traumatic stress disorder, social phobia or social anxiety disorder, premenstrual tension syndrome, and premenstrual dysphoric disorder.

Mechanism of action

The Tourist acts on a substance found in the brain, called serotonin, increasing its availability and relieving depressive and anxious symptoms, typical of the disorders for which it is indicated.

Start acting in 7 days. The time needed to observe clinical improvement may vary depending on the patient’s characteristics and the type of disorder being treated.

Contraindications of Tolrest

It should not be used if you have a history of allergy to sertraline or other formula components, use antidepressants called monoamine oxidase inhibitors (MAOIs), or use pimozide.

Children should not use this medicine under six years of age.

Administration

It must be taken orally, in a single daily dose in the morning or at night, with or without food, preferably at the same time every day. The maximum recommended dose is 200 mg/day.

 

Follow the guidance of your doctor, always respecting the schedules, doses, and duration of treatment.

Do not interrupt the treatment without the knowledge of your doctor.

What should I do when I forget to use this medication?

If you forget to take Tolrest when prescribed by your doctor, take it as soon as you remember.

However, if you are already near the time of taking the next dose, skip the missed dose and take the following amount, usually following the recommended dose schedule. In this case, do not double the dose of medication to make up for the forgotten dose.

Omission of the dose may compromise the effectiveness of the treatment.

In case of doubt, seek guidance from the pharmacist or your doctor.

Precautions

Always tell your doctor about any medication you take when prescribed a new medication. The doctor needs to assess whether the drugs react with each other by altering their action; This is called a drug interaction.

The use of drugs that increase the availability of serotonin, such as Tourist, can lead to the occurrence of the so-called Serotonin Syndrome, characterized by alterations of the mental state and movements, among other manifestations.

Malignant Neuroleptic Syndrome can also occur, characterized by a muscular muscle contraction, fever, tachycardia, and tremor.

The risk of these syndromes is greater when Tolrest (sertraline) is used, along with other medications that increase serotonin availability.

In most cases, the monoamine oxidase enzyme inhibitors (MAOIs), examples of which are selegiline, moclobemide, linezolid, and methylene blue, some antipsychotic drugs, dopamine antagonists, and other drugs such as tryptophan, fenfluramine, fentanyl, and its analogs, tramadol, dextromethorphan, tapentadol, pethidine, methadone, pentazocine, and St. John’s wort.

Tell your doctor if you use any of these or any other medications.

If you take another antidepressant, you should not replace it with Tolrest without an adequate medical evaluation.

Variations in blood glucose levels can occur in some patients using Tourist. Diabetic patients should be carefully monitored for blood sugar levels. You should notify your doctor if you have diabetes.

There are reports of false-positive results on the urine test for the search for benzodiazepines (a type of controlled painkiller with black band inbox) in patients taking sertraline. This is due to the lack of specificity of the tests.

False-positive results can be expected several days after the end of sertraline treatment. Other confirmatory tests can distinguish sertraline in the urine.

Epidemiological studies show an increased risk of bone fractures in patients who use sertraline. The mechanism that leads to this risk is not fully known.

Sertraline can cause mydriasis (pupil dilation) and should be used with caution in patients with angle-closure glaucoma. This dilation may increase intraocular pressure and angle-closure glaucoma, especially in predisposed patients.

Sertraline users and their relatives about the possibility of aggravating the symptoms of depression and suicidal thoughts, especially at the beginning of therapy. Tell your doctor if you have any other health problems, whether or not you are being treated at the time.

Adverse reactions of Tourist

The adverse events associated with the treatment with Tolrest in patients participating in controlled clinical studies and post-marketing experiments are the following:

Widespread reactions (occurs in ≥ 1/10 of patients who use this medicine):

  • I am insomnia.
  • Drowsiness.
  • Dizziness
  • Headache.
  • Diarrhea.
  • Dry mouth.
  • Nausea (feeling unwell)
  • Disorders of ejaculation.
  • Fatigue (fatigue)

Common reactions (occurring between ≥ 1/100 and <1/10 of patients using this medicine):

  • Decreased or increased appetite.
  • Symptoms of depression.
  • Decrease in sexual desire
  • Agitation.
  • Anxiety.
  • Tingle.
  • Increase in muscle tension
  • Temblor.
  • Involuntary muscle contractions
  • Vision problems.
  • Palpitations
  • Blush.
  • Yawns
  • Vomiting
  • Abdominal pain.
  • Constipation.
  • Dyspepsia (poor digestion)
  • Exanthema.
  • Hyperhidrosis (excessive sweating).
  • Arthralgia (dolor articular).
  • Sexual dysfunction
  • Irregular menstruation.
  • Chest pain.
  • General discomfort.

Unusual reaction (occurs between ≥ 1 / 1,000 and <1/100 of patients who use this medicine):

  • Hypersensitivity (allergic reaction).
  • Hypothyroidism (decreased production of thyroid hormone).
  • Hallucinations
  • Aggression.
  • Euphoria.
  • Confusion.
  • Bruxism (teeth grinding).
  • Coma.
  • Convulsions
  • Syncope (fainting)
  • Extrapyramidal disorders (secondary tremors, slow movements).
  • Hyperkinesia (excessive muscular activity).
  • Acatisia (difficulty staying in the same place or need to move the legs).
  • Headache.
  • Hypoesthesia (decreased sensitivity).
  • Mydriasis (dilation of the pupil).
  • Periorbital edema (swelling around the eyes).
  • Tachycardia (increased heart rate).
  • Hemorrhage.
  • Hypertension (high blood pressure)
  • Bronchospasm (contraction of the bronchi and bronchioles).
  • Epistaxis (nosebleeds).
  • Gastrointestinal bleeding.
  • Urticaria.
  • Tiny purple spots on the skin or mucous membranes.
  • Itching (itching)
  • Alopecia (hair loss)
  • Muscle spasms.
  • Swelling in the extremities of the body.
  • Fever.
  • Asthenia (weakness).
  • Increase in ALT or TGP (liver enzyme).
  • Increase in AST or TGO.
  • Edema facial.
  • Decrease or increase in weight.
  • Abnormal laboratory tests.

Rare reactions (occurring between ≥1 / 10,000 and <1 / 1,000 of patients using this medicine):

  • The leukopenia (decreased white cell count in the blood).
  • Thrombocytopenia (low platelets).
  • Anaphylactoid reactions (allergic reactions).
  • The inappropriate secretion of antidiuretic hormone (which decreases urine production).
  • Hyperprolactinemia (increased concentration of prolactin hormone in the blood).
  • Diabetes mellitus.
  • Hyponatremia (low levels of sodium in the blood).
  • Hypoglycemia.
  • Hyperglycemia
  • Psychotic disorder (hallucinations and delusions).
  • Nightmares.
  • Dystonia (involuntary movement).
  • Vasoconstricción cerebral.
  • Pancreatitis (inflammation of the pancreas).
  • Liver injury
  • Epidermal necrolysis.
  • Exfoliative eruption (red spots with peeling skin).
  • Photosensitivity reaction (sensitivity of the skin exaggerated to light).
  • Hematuria (blood in the urine).
  • Enuresis.
  • Priapism (spontaneous penile erection without persistent and painful stimulation).
  • Gynecomastia (breast enlargement in men).

Tell your doctor or pharmacist about the appearance of undesirable reactions through the use of the medication.

A unique population of Tourist

Pregnancy and lactation

Pregnant women should not use it without medical advice.

It should not be used during lactation without medical advice.

Children

Doctors must monitor pediatric patients for long-term treatment.

Ability to drive vehicles or operate machines

During treatment, the patient should not drive vehicles or operate machines, as their ability and attention may be impaired.

Composition of Tolrest

Each 50 mg or 100 mg coated tablet contains:

  • Sertraline hydrochloride
  • Excipients: croscarmellose sodium, starch, lactose monohydrate, silicon dioxide, magnesium stearate, hypromellose, macrogol, titanium dioxide, yellow dye FDC # 6, and aluminum lacquer.

Overdose

Find a doctor immediately. Overdose symptoms include drowsiness, dizziness, vomiting, increased heartbeat, tremor, and agitation.

Coma may occur, but it is not frequent. Deaths due to sertraline overdose occurred mainly in combination with other medications and alcohol. There are no specific antidotes, and the induction of vomiting is not recommended.

If large amounts of this medication are used, seek prompt medical attention and take the medication container or package insert.

Care and storage of Tourist

  • The presentation of 50 and 100 mg tablets should be kept at room temperature (between 15 and 30 ° C), protected from light and moisture.
  • You must verify the batch number and dates of manufacture and validity.
  • Do not use the medication with the expiration date expired.

Presentation of the Tourist

The Tourist is a coated tablet, orange, oval, and with a fold on one side.

The sale is only made under medical prescription and with prescription withholding.