Zoloft – composition, action, dosage, contraindications. Side effects of the drug Zoloft.

Proven content

Zoloft is an antidepressant drug belonging to the group of serotonin reuptake inhibitors. In the opinion of patients and pharmacists, it is one of the most popular and most frequently used antidepressants. Read what composition and action of Zoloft and what are its side effects.

Zoloft – composition

Zoloft contains the active substance sertraline. Sertraline belongs to a group of medicines called Selective Serotonin Reuptake Inhibitors. These medicines are used to treat depression and / or anxiety disorders.

The composition of the drug Zoloft is as follows:

1. Zoloft 50 mg film-coated tablets: each film-coated tablet contains 50 mg of sertraline as sertraline hydrochloride,
2. Zoloft 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of sertraline as sertraline hydrochloride.

Coated tablet core:

1. calcium hydrogen phosphate dihydrate (E341),
2. microcrystalline cellulose (E460),
3. hydroksypropyloceluloza (E463),
4. sodium carboxymethyl starch (type A),
5. magnesium stearate (E572).

Film-coated tablet coating:

1. titanium dioxide (E171)
2. hypromeloza 2910, 3 mPas (E464),
3. hypromeloza 2910, 6 mPas (E464),
4. macrogol 400 (E1521),
5. polisorbat 80 (E433).

Opadry Clear:

1. hypromeloza 2910, 6 mPas (E464),
2. macrogol 400 (E1521),
3. macrogol 8000 (E1521).

Zoloft – indications

Zoloft can be used to treat:

1. depression and stopping depression coming back (in adults)
2. social anxiety disorder (in adults),
3. post-traumatic anxiety disorder (PTSD) (in adults)
4. panic disorder (in adults)
5. obsessive compulsive disorder (OCD) (in adults and children and adolescents aged 6-17 years).

Depression is a disorder with symptoms such as feeling sad, unable to sleep well or to enjoy life.

Obsessive Compulsive Disorder and Panic disorder are anxiety disorders with constant anxiety about persistent ideas (obsessions) that make you carry out repetitive rituals (compulsions).

Post-traumatic anxiety disorder is a condition that can occur after a very traumatic experience and has symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is a disorder related to anxiety. It is characterized by increased anxiety or stress in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in front of other people, or fear of potentially embarrassing behavior).

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Zoloft – action

Sertraline is a potent and specific inhibitor of serotonin (5HT) uptake in nerve cells, which in animals increases the effect of 5HT. It has only a very weak effect on the reuptake of norepinephrine and dopamine. In At therapeutic doses, sertraline blocks the uptake of serotonin in human platelets.

The medicinal product has not been shown to have a stimulating, sedative, cholinolytic or cardiotoxic effect in animal studies. In controlled studies in healthy volunteers, sertraline did not sedate or alter psychomotor performance.

As a selective 5HT uptake inhibitor, sertraline has no effect on catecholaminergic transmission. Sertraline has no affinity for muscarinic (cholinergic), serotonin, dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine receptors.

Long-term administration of sertraline to animals reduced the number and sensitivity of brain noradrenergic receptors. A similar effect was seen with other antidepressants and drugs used in the treatment of OCD.

See: Anti-anxiety drugs – types, action, natural preparations. How are anxiety disorders treated?

Zoloft – dosage

The dose of Zoloft depends on the disease it is used for and the stage of treatment.

Beginning of treatment

1. Depression and OCD: Sertraline treatment should be started at a dose of 50 mg daily.
2. Panic disorder, PTSD and social anxiety disorder: Treatment should be started with a dose of 25 mg per day. After one week, the dose should be increased to 50 mg once daily. This dosing regimen reduces the incidence of adverse reactions that are characteristic of the initial treatment phase of panic disorder.

Increasing the dose

1. Depression, OCD, panic disorder, social anxiety disorder and PTSD: Patients not responding to the 50 mg dose may need to be increased. Adjustments in dosage should be made at intervals of at least one week, in steps of 50 mg, up to a maximum dose of 200 mg per day. Adjustments to the dosage should not be made more frequently than once per week given the 24 hour elimination half-life of sertraline.

Supportive care

1. During long-term maintenance treatment, the dosage should be kept as low as to achieve a therapeutic effect, and then adjusted as necessary.
2. Depression – Long-term treatment may also be necessary to prevent major depressive episodes from coming back. In most cases, the recommended dose will be the same that is used for the current episode. People with depression should receive treatment for a sufficient period of time, at least 6 months, to ensure that their symptoms have resolved.
3. Panic disorder and OCD – In panic disorder and OCD, the need for continued treatment should be reassessed regularly as the ability to prevent relapse has not been proven in these disorders.

Use in the elderly

Elderly patients should be used with caution as they may be at increased risk of hyponatraemia.

Use in people with liver failure

Sertraline should be used with caution in people with hepatic insufficiency. Lower doses of the medicinal product should be used or the frequency of administration should be reduced. Since no adequate clinical data are available, sertraline should not be used in patients with severe hepatic insufficiency.

Use in people with renal insufficiency

No dose adjustment is required in people with renal insufficiency.

Use in children and adolescents with OCD

1. Age 13-17 years: initially 50 mg once daily,
2. Age 6-12 years: 25 mg once daily initially.

After one week, the dose may be increased to 50 mg once daily.

When no effect is expected with a dose of 50 mg daily, subsequent doses may be higher in the following weeks, depending on the needs. The maximum dose is 200 mg daily. However, when increasing the daily dose above 50 mg, the lower body weight in children should be taken into account compared to adults. The dosage should not be changed more than once a week.

The efficacy of the medicinal product in cases of major depression in children has not been demonstrated.

Read: Experts: Untreated ADHD increases the risk of depression in a child

Zoloft – contraindications

Zoloft should not be used if a person:

1. is allergic to sertraline or any of the other ingredients of this medicine
2. uses monoamine oxidase inhibitors (MAO inhibitors, e.g. selegiline, moclobemide), or drugs similar to MAO inhibitors (e.g. linezolid). When stopping treatment with sertraline, you must wait at least one week before starting treatment with a MAOI. After stopping treatment with a MAOI, you must wait at least 2 weeks before you can start treatment with sertraline.
3. are taking pimozide (a medicine for mental disorders such as psychosis).

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Zoloft – warnings and precautions

Talk to your doctor or pharmacist before taking Zoloft. Medicines are not always suitable for everyone.

Tell your doctor before taking Zoloft, if you suffer from or have suffered in the past from any of the following:

1. Epilepsy (an attack) or a history of seizures: if you have an (epileptic) fit, contact your doctor immediately.
2. History of manic depressive disorder (bipolar) or schizophrenia: contact your doctor immediately if you have a manic episode.
3. You have or have had thoughts of harming or killing yourself in the past
4. Low sodium levels in the blood: as this can occur with Zoloft. You should also tell your doctor if you are taking medicines to treat high blood pressure, as these can also change the amount of sodium in your blood.
5. Older people: you may be more at risk of having low sodium levels in your blood (see above),
6. Liver disease: your doctor may decide to reduce the dose of Zoloft
7. Diabetes mellitus: Zoloft may change blood glucose levels and therefore the dosage of your diabetes medicines may need to be changed.
8. You have a history of blood clotting disorders (tendency to bruise) or if you are pregnant, or have ever used medicines that prevent blood clotting (e.g. acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding.
9. Children or adolescents under 18 years of age: Zoloft should only be used in children and adolescents aged 6 to 17 years to treat obsessive compulsive disorder (OCD). People treated for this disease should be closely monitored by a doctor,
10. Electroconvulsive therapy used,
11. Eye problems such as certain types of glaucoma (increased pressure in the eye)
12. An electrocardiogram disturbance known as a long QT interval
13. Heart disease, low potassium or magnesium levels, prolonged QT interval in any of your relatives, slow heart rate and concomitant use of drugs that prolong QT interval,
14. Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome: The development of potentially life-threatening syndromes such as Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) has been observed in SSRI users, including those taking sertraline. The risk of SS or NMS increases when other serotonergic drugs (including other serotonergic antidepressants, amphetamines, triptans) are used simultaneously with medicinal products that impair serotonin metabolism (including MAO inhibitors, e.g. methylene blue), antipsychotics and other dopamine antagonists, and with opioids,
15. Akathisia / psychomotor restlessness: The use of sertraline has been associated with the development of akathisia, characterized by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. The disorder most commonly occurs during the first few weeks of treatment. In individuals who develop these symptoms, increasing the doses of this medicinal product may be detrimental.
16. Driving and using machines: Psychotropic drugs such as sertraline may have an influence on the ability to drive or use machines. Wait until you know how Zoloft affects your ability to perform these activities before you do the above activities.

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Zoloft – suicidal behavior

Depression is associated with an increased risk of suicidal thoughts, self harm and suicide. This risk persists until complete remission is achieved. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.

It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Other psychiatric conditions prescribed by sertraline may also be associated with an increased risk of suicidal behavior. Moreover, these disorders may coexist with major depressive disorders. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behavior with antidepressants compared to placebo in patients less than 25 years old.

Patients, especially those at high risk, should be closely monitored during treatment, especially at the beginning of therapy and after dose adjustments. Patients (and their caregivers) should be warned about the need to look for any clinical worsening of the disease, suicidal behavior or thoughts, and unusual changes in behavior, and if they occur, to seek medical attention immediately.

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Zoloft – children and teenagers

Sertraline should not be used in the treatment of children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder aged 6-17 years. In clinical trials, suicidal behavior (suicidal ideation and attempted suicide) and hostility (especially aggression, oppositional behavior and anger) were observed more frequently in children and adolescents treated with antidepressants than in the placebo group.

If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, there are only limited clinical data on the safety of long-term use in children and adolescents on growth, sexual maturation, and cognitive and behavioral development.

In the post-marketing period, a few cases of delayed growth and maturation have been reported. The clinical significance and the causal relationship have not been fully elucidated so far. The doctor must monitor the health of children and adolescents who have received long-term treatment in order to detect any abnormalities in growth and development.

See: How to help a child who is maturing and safely guide them through rebellion?

Zoloft – Withdrawal Symptoms

When stopping treatment, side effects (withdrawal symptoms) are common, especially if treatment is stopped suddenly. The risk of withdrawal symptoms depends on the length of treatment, dosage, and the rate at which the dose is reduced. Possible side effects include feeling anxious, trouble sleeping, dizziness and headaches, vomiting, nausea, agitation, muscle tremors, and numbness.

Generally, these symptoms are mild to moderate, however, in some patients they may be severe in intensity. They usually occur in the first days after stopping treatment. They generally resolve spontaneously within 2 weeks, but may persist in some patients (2-3 months or more).

When stopping treatment with sertraline it is recommended to reduce the dose gradually over a period of several weeks or months, and you should always discuss the best way of stopping treatment with your doctor.

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Zoloft – drug interactions

Tell your doctor about all the medicines you are taking or have recently taken, and about the medicines you plan to take. Some medicines can affect the way Zoloft works, or Zoloft itself may reduce the effectiveness of other medicines taken at the same time.

Taking Zoloft together with the following medicines can cause serious side effects:

1. medicines that are monoamine oxidase inhibitors (MAOIs), e.g. moclobemide (used to treat depression) and selegiline (used to treat Parkinson’s disease), the antibiotic linezolid and methylene blue (used to treat high levels of methaemoglobin in the blood). You should not use Zoloft together with these drugs,
2. medicines to treat mental disorders such as psychosis (pimozide). You should not use Zoloft together with pimozide.

Please inform your doctor if you are taking any of the following medications:

1. medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), excessive sleepiness and obesity,
2. herbal remedies containing St. John’s wort (Hypericum perforatum). The effect of St. John’s wort may last for 1-2 weeks,
3. preparations containing the amino acid tryptophan,
4. medicines used to treat severe or chronic pain (opioids e.g. tramadol, fentanyl),
5. drugs used in anesthesia (e.g. fentanyl, mivacurium and suxamethonium)
6. medicines to treat migraines (e.g. sumatriptan)
7. medicines to prevent blood clotting (warfarin),
8. medicines to treat pain / arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen, salicylic acid (aspirin))
9. sedatives (diazepam)
10. water tablets (diuretics),
11. medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine),
12. medicines to treat diabetes (tolbutamide),
13. drugs used to treat excessive gastric acid secretion, peptic ulcer disease and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole),
14. medicines to treat mania and depression (lithium),
15. other drugs to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine)
16. drugs for the treatment of schizophrenia and other mental disorders (such as perphenazine, levomepromazine and olanzapine),
17. medicines used to treat high blood pressure, chest pain or regulate the rate and rhythm of the heart (such as verapamil, diltiazem, flecainide, propafenone)
18. medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin)
19. medicines to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole)
20. medicines used to treat HIV / AIDS infection and hepatitis C (protease inhibitors such as ritonavir, telaprevir)
21. medicines used to prevent nausea and vomiting after chemotherapy (aprepitant).

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Zoloft – pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The safety of sertraline has not yet been fully established in pregnant women. It should only be used during pregnancy if, according to the doctor’s assessment, the benefits of the medicine to the mother outweigh the possible risks to the developing baby.

Taking Zoloft towards the end of pregnancy may increase the risk of a serious vaginal bleeding shortly after birth, especially if you have a history of blood clotting disorders. If you are taking Zoloft, please inform your doctor or midwife so they can advise you.

These symptoms usually appear in the first 24 hours of life. If your baby has any of these symptoms you should contact your midwife or doctor immediately. Other complications may also occur in a newborn baby, usually within the first XNUMX hours after birth. Symptoms include:

1. difficulties with breathing,
2. a blueish skin, too hot or cold skin
3. Sine you,
4. vomiting or sucking problems
5. being very tired, having trouble falling asleep or crying all the time,
6. increased or decreased muscle tension,
7. tremors, muscle spasms or fits
8. increased reflexes, excitability,
9. low blood sugar.

If your baby has any of these symptoms when it is born, or if you are concerned about his condition, contact your doctor or midwife. There is evidence that sertraline is excreted in human milk. It can be used in breast-feeding women if, according to the doctor’s assessment, the benefits of the medicine outweigh any possible risks to the child.

Zoloft – side effects

Nausea is the most common side effect. The side effects depend on the dose and often disappear or lessen with continued treatment.

Tell your doctor immediately if you experience any of the following symptoms after taking this medicine, as these can be serious:

1. if you develop a severe skin rash that causes blistering (erythema multiforme; blisters may appear in the mouth and tongue). These could be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis. In these cases, your doctor will stop your treatment.
2. allergic reaction or allergy, with symptoms such as itchy skin rash, difficulty breathing, wheezing, swelling of the eyelids, face or lips
3. if the patient develops agitation, confusion, diarrhea, high temperature and blood pressure, sweating and increased heart rate. These are the symptoms of serotonin syndrome. In rare cases, this syndrome can occur when a person is taking certain medications at the same time as sertraline. The doctor may then stop the patient’s treatment,
4. if you develop yellow skin and eyes which may mean liver damage,
5. if you experience depressive symptoms with ideas of harming or killing yourself (suicidal thoughts)
6. if you start to feel restless after starting treatment with Zoloft and cannot sit or stand still in one place. If the patient begins to feel restlessness, he should tell the doctor.
7. if you experience an (epileptic) attack,
8. if you have manic episodes.

Very common side effects (may affect more than 1 in 10 people) are:

1. insomnia,
2. dizziness,
3. somnolence,
4. headaches,
5. diarrhea,
6. nausea,
7. dry mouth
8. ejaculation failure
9. tiredness.

Very common side effects (may affect up to 1 in 10 people) include:

1. bronchitis, sore throat, runny nose,
2. anorexia, increased appetite
3. anxiety, depression, agitation, decreased sexual interest, nervousness, feeling strange, nightmares, teeth grinding,
4. muscle twitching, disturbances in muscle movement (such as increased activity, increased muscle tone, difficulty walking and muscle stiffness, spasms and involuntary muscle movement), numbness and tingling, increased muscle tension
5. lack of concentration,
6. taste disturbance
7. blurred vision,
8. ringing in the ears
9. palpitations,
10. hot flushes,
11. yawning,
12. stomach upset, constipation, stomach pain, vomiting, gas
13. increased sweating, rash,
14. back pain, joint pain, muscle pain,
15. menstruation irregular, erectile dysfunction,
16. malaise, chest pain, weakness, fever,
17. weight gain.