Antidepressants can cause excess sweating and overheating – how to cope

Feeling the heat? Your medication might be to blame (Picture: Getty/Metro.co.uk)

Yes, it is extremely hot right now.

But if you’ve noticed that you’re sweating more than you ever have before, there might be another reason: your antidepressants.

Many antidepressants increase your likelihood of excessive sweating, known as hyperhidrosis.

It’s not clear why mental health medication can trigger a major case of sweaty upper lip syndrome, but the good news is that if you are experiencing this, you’re certainly not alone – and there are ways to reduce the struggles.

Let’s get into it.

Why do antidepressants make you sweat more?

‘The majority of antidepressants increase the risk of hyperhidrosis,’ explains Dr Kandi Ejiofor. ‘Some American studies cite that excess sweating can affect up to 15% of people take antidepressants.

‘Specifically, Tricyclic Acid and SSRI (selective serotonin reuptake inhibitors) antidepressants are responsible for this.

‘The way in which antidepressants cause excessive sweating is still relatively unknown – it is thought to be linked to the effects of serotonin, the happy hormone, in trying to maintain the internal core temperature of the body.

‘Your body sweats to try and cool down the body but overstimulation of this process can lead to overheating and excess sweating.’

What risks do antidepressants pose in hot weather?

In the current heatwave, some people who are taking antidepressants will notice not only more sweating than usual, but also simply feeling the heat more.

This can then lead to dehydration, heat stroke, heat rash, and other heat related issues, so it’s essential that you’re really on top of all the regular hot-weather-related care, such as drinking plenty of water, taking time out of the sun, and avoiding overexertion.

Dr Stephanie Ooi, GP at MyHealthcare Clinic, notes that the hot weather could also disguise the symptoms of serotonin syndrome, a rare, but potentially serious set of side effects that are linked to SSRIs

‘Serotonin syndrome occurs when the levels of serotonin in your brain are too high,’ says Dr Stephanie. ‘This can occur if you take an SSRI in combination with something else that also raises serotonin levels, such as another antidepressant or St John’s Wort.’

Symptoms of serotonin syndrome can include:

• confusion
• agitation
• muscle twitching
• sweating
• shivering
• diarrhoea

That is unlikely, by the way. The main risks you’ll face in the UK heatwave when taking antidepressants are the minor, but annoying ones: feeling super sweaty, hot, and uncomfortable.

This poses a greater risk though: that you might get so fed up of being covered in sweat that you stop taking your medication in an attempt to lower your temperature.

This is not a good idea.

‘Sweating secondary to antidepressant medication is usually not a cause for concern on its own but the symptoms can be so bothersome that it causes people to stop taking their medication, which of course could be problematic,’ says Dr Kandi.

Your GP might be able to help tackle the sweaty effects of your meds (Picture: Getty Images/iStockphoto)

What should you do if your antidepressants are causing excess sweating?

First things first: keep taking your meds. Don’t do a sudden stop out of desperation to cool down.

Instead, it’s worth talking to your GP if hyperhidrosis is negatively affecting your life.

‘They may consider prescribing you another medication to counteract the effects of the medication you are on,’ suggests Dr Kandi.

Along with this, there are many things you can do on your own to reduce any hot weather induced discomfort.

Measure your temperature

Dr Kandi recommends investing in a thermometer, so you can regularly measure your temperature and thus know when there’s a problem.

‘If your core temperature is consistently raised above the baseline, it is worthwhile discussing with your doctor to review you and manage your symptoms appropriately,’ she notes.

Drink plenty of fluids

Make sure you’re sipping water throughout the day, carrying a bottle with you wherever you go.

This is key to avoid dehydration, especially if you’re losing a lot of fluid from excess sweating.

Take it easy

Now might not be a great time to rush around doing loads of things at once, or to do super intense workouts. Give yourself plenty of rest and prioritise keeping cool.

Wear the right clothes

‘Wear loose clothing in breathable materials such as cotton or linen,’ Dr Stephanie suggests. ‘Avoid tight clothing or synthetic materials.’

More: Health

Avoid other triggers for increased sweating

Drinking alcohol and eating spicy food can make your sweating worse.

Get a good antiperspirant

Speak to your pharmacist about one that will work best for excess sweating.

You can also buy armpit or sweat shields if you’re worried about protecting your clothing.

Prioritise lowering stress and anxiety

You know the drill: you sweat, then you get self-conscious and panic about sweating, then you sweat more, and so the awful cycle continues.

Remind yourself that sweating is perfectly natural, and people will understand – it’s boiling right now, so we doubt anyone is judging you for perspiring.

In moments when your excess stress is bothering you, try to ground yourself and do breathing exercises to slow your heartrate and bring you back to a place of calm.

Do you have a story to share?

Get in touch by emailing [email protected].

MORE : What I wish I had known before I started taking antidepressants

MORE : ‘Urgent’ need for more evidence on safely stopping antidepressants, say experts

MORE : Postnatal depression rates doubled over lockdown – it hit me hard

8 Medicines that May be Making you Sweat | Wicked Sheets

More than 120 million people suffer from night sweats and hot flashes – that’s 3% of people worldwide, many of them caused by medicines and night sweats. Do you wake up to greasy bed head? Dehydration? Chapped lips? Do your pajamas go straight to the laundry and your sheets close behind? For many suffering from night sweats, medication may be the cause. Read below to see if your medicine is making you sweat.

1. Aspirin
2. Keytruda
3. Bupropin
4. Venaflaxine
5. Cortisone
6. Wellbutrin
7. Effexor
8. Zoloft
   

Night sweat inducing medicines come from many different types of medications, from those used to treat heart disease, to antibiotics used to cure bacterial and fungal infections.

Data from the National Center for Health Statistics shows that an excess of 1 in 10 adults in the U.S. are taking some form of antidepressant. Of those adults, twenty-two percent of them have reported sweating as a side effect.

Nearly all antidepressants, hormone regulators, and blood sugar stabilizers have night sweats and hot flashes as a side effect. These include tricyclic antidepressants, as well as selective serotonin reuptake inhibitors (SSRIs). Venlafaxine, also known as Effexor, and Bupropion, also known as Wellbutrin and Zyban, can induce night sweats, too.

Typical antihistamine ingredients like cortisone, prednisone, and prednisolone can be the cause of night sweats, as well as aspirin and other pain medications.

Cancer treatment drugs like Ketruda, a medicine that works to treat melanoma and lung cancer, also have reported similar side effects.

If you or someone you know has been suffering the discomforts of night sweats, share this information with them and see if medication is the culprit. Be sure to ask your physician (or a medical professional) if you are concerned that the dosage or side effects of the medications that you are taking are contributing to your night sweats.

2018 UPDATED MEDICINES! Read below!

Night sweats on Prozac are increasingly common. Classified as Selective Serotonin Reuptake Inhibitors (SSRI), these drugs can be used to treat depression, obsessive-compulsive disorder (OCD), bulimia nervosa, and panic disorders. Also known by the names Fluoxetine, Sarafem, and Prozac Weekly, the drug has the potential to cause night sweats and hot flashes when taken regularly as prescribed by a physician. SSRIs of this variety have the greatest chance of adverse side effects as it’s the most stimulating for the brain.

Pristiq, also known as Khedezla and the generic name Desvenlafaxine Succinate, are antidepressants that often elicit night sweats. Desvenlafaxine is used to treat depression. It may improve mood, feelings of well-being, and overall energy levels. Desvenlafaxine is known as a Serotonin-Norepinephrine Reuptake Inhibitor, an SNRI. It works by helping to restore the delicate balance of natural substances, serotonin and norepinephrine, in the brain. Night sweats and Pristiq are often linked, causing intense sweating while sleeping, leading to disrupted sleep.

Wellbutrin, known also as Aplenzin, Budeprion SR, Budeprion XL, Buproban, Forfivo XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL, Zyban, and by generic Bupropion Hydrochloride, is a smoking cessation aid and antidepressant that is also used to prevent depression brought on by Seasonal Affective Disorder, SAD. This medication works to restore neurotransmitters and neurotransmission within the brain. Night sweats and hot flashes as a result of Wellbutrin and its other names is common.

We will continue to update this list periodically as the information becomes available to us, but if you or someone you know is taking a medication that is causing night sweats, send us a note at [email protected] so that we can add it to the list.

official instructions for use, analogues, price, availability in pharmacies

Registration number :

Trade name : Zoloft ^® / Zoloft ^® 90 005

International (nonproprietary) name (INN) : Sertraline /Sertraline

Chemical name – cis-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthaleneamine

Dosage form : film-coated tablets.

Composition

Active ingredient: sertraline hydrochloride at a dose corresponding to 50 mg or 100 mg sertraline.
Excipients: calcium phosphate, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol, polysorbates, titanium dioxide (E171).

Description : white oblong tablets. On the surface of the tablet, “Pfizer” is squeezed out on one side, on the other side for a dosage of 50 mg “ZLT-50” (with a risk), for a dosage of 100 mg – “ZLT-100”.

Pharmacotherapeutic group:

antidepressant; ATX code N06AB06

Pharmacodynamic properties

Sertraline is an antidepressant, a powerful specific inhibitor of serotonin (5-HT) reuptake in neurons. It has very little effect on the reuptake of norepinephrine and dopamine. At therapeutic doses, sertraline blocks the uptake of serotonin in human platelets. It has no stimulant, sedative or anticholinergic effect. Due to selective inhibition of 5-HT uptake, sertraline does not enhance adrenergic activity. Sertraline has no affinity for muscarinic (cholinergic), serotonergic, dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine receptors. Sertraline does not cause drug dependence, does not cause an increase in body weight with long-term use.

Pharmacokinetic properties

Absorption – high (but at a slow rate). Bioavailability is increased by 25% during meals. Food increases the maximum concentration (Cmax) by 25% and shortens the time to reach the maximum concentration (Tcmax). In humans, when treated with sertraline at a dose of 50 to 200 mg once a day for 14 days, the plasma concentration of the drug reached a peak (Cmax) 4.5-8.4 hours after administration. Cmax and the area under the concentration-time curve (AUC) are proportional to the dose in the range of 50-200 mg of sertraline 1 time per day for 14 days, while a linear pharmacokinetic dependence is revealed. The pharmacokinetic profile in adolescents and the elderly does not differ significantly from that in patients aged 18 to 65 years. The mean half-life (T1 / 2) of sertraline in young and elderly men and women is 22-36 hours. According to the final T1 / 2, approximately two-fold accumulation of the drug is observed before equilibrium concentrations are reached after 1 week of treatment (dose once a day). Plasma protein binding is approximately 98%. The pharmacokinetics of sertraline in children with OCD (see below) has been shown to be similar to that in adults (although sertraline metabolism is somewhat more active in children). However, given the lower body weight in children (especially those aged 6-12 years), the drug is recommended to be used at a lower dose in order to avoid excessive plasma levels.
Sertraline undergoes active biotransformation during the first passage through the liver. The main metabolite found in plasma, N-desmethylsertraline, is significantly inferior (about 20 times) to sertraline in activity in vitro and is actually not active in models of depression in vivo. T1 / 2 N-desmethylsertraline varies within 62-104 hours. Sertraline and N-desmethylsertraline are actively biotransformed; the resulting metabolites are excreted in equal amounts with feces and urine. Unchanged sertraline is excreted in the urine in small amounts (<0.2%). In patients with cirrhosis of the liver, T1 / 2 of the drug and AUC increase compared to those in healthy people.

Indications for use

Depression of various etiologies (treatment and prevention), Obsessive-compulsive disorders (OCD) Panic disorders.
Post-traumatic stress disorder (PTSD). social phobia.

Contraindications

Known hypersensitivity to sertraline, children under 6 years of age, pregnancy and breastfeeding (see section Pregnancy and breastfeeding). The drug should not be administered to patients simultaneously receiving monoamine oxidase inhibitors (MAOIs) and pimozide. With caution: organic diseases of the brain (including mental retardation), epilepsy, liver and / or kidney failure, marked weight loss.
Pregnancy and breastfeeding: There are no controlled results from the use of sertraline in pregnant women, so it is worth prescribing the drug to them only if the expected benefit to the mother outweighs the potential risk to the fetus. Women of reproductive age who are to be prescribed sertraline should be advised to use effective contraception.
Sertraline is found in breast milk, and therefore, treatment with this drug during breastfeeding is not recommended. There is no reliable data on the safety of its use in this case. If treatment is still necessary, then it is better to stop breastfeeding. In the case of the use of sertraline during pregnancy and lactation, some newborns whose mothers took antidepressants from the group of selective serotonin reuptake inhibitors (SSRIs), including serotonin, may experience symptoms similar to the reaction to drug withdrawal.

Side effect

Digestive system: dyspeptic disorders (flatulence, nausea, vomiting, diarrhea, constipation), abdominal pain, pancreatitis, dry mouth.
Cardiovascular system: palpitations, tachycardia, arterial hypertension.
Musculoskeletal system: arthralgia, muscle cramps.
Central and peripheral nervous system: extrapyramidal disorders (dyskinesias, akathisias, teeth grinding, gait disturbance), involuntary muscle contractions, paresthesias, syncope, drowsiness, headache, migraine, dizziness, tremor, insomnia, anxiety, agitation, hypomania, mania, hallucinations, euphoria, nightmares, psychosis, decreased libido, suicide, coma.
Respiratory system: bronchospasm, yawning.
Urinary system: enuresis, incontinence or urinary retention.
Reproductive system and mammary gland: sexual dysfunction (delayed ejaculation, reduced potency), galactorrhea, gynecomastia, menstrual disorders, priapism.
Organs of vision : blurred vision, mydriasis.
Endocrine system: hyperprolactinemia, hypothyroidism, syndrome of inappropriate ADH secretion.
Hepatobiliary system: hepatitis, jaundice, liver failure.
Allergic reactions: urticaria, pruritus, anaphylactoid reaction.
Other: weakness, reddening of the skin or flushing of the face, ringing in the ears, alopecia, angioedema, swelling of the face, periorbital edema, photosensitivity reaction, purpura, increased sweating, decreased appetite (rarely increased), up to anorexia, decrease or increase in body weight, bleeding (including nasal, gastrointestinal or hematuria), peripheral edema, occasionally Steven-Johnson syndrome and epidermal necrolysis.
Laboratory data: rarely, with prolonged use, an asymptomatic increase in serum transaminase activity occurs. Cancellation of the drug in this case leads to the normalization of enzyme activity. Perhaps the development of leukopenia and thrombocytopenia, as well as an increase in the level of cholesterol in the blood serum. With the termination of treatment with sertraline, rare cases of withdrawal syndrome have been described. Paresthesias, hypesthesias, symptoms of depression, hallucinations, aggressive reactions, psychomotor agitation, anxiety, or symptoms of psychosis that cannot be distinguished from the symptoms of the underlying disease may appear.

Overdose

Sertraline overdose did not cause severe symptoms even when the drug was administered in high doses. However, with simultaneous administration with other drugs or alcohol, severe poisoning can occur, up to coma and death. Overdose can cause serotonin syndrome with nausea, vomiting, drowsiness, tachycardia, agitation, dizziness, psychomotor agitation, diarrhea, increased sweating, myoclonus and hyperreflexia. Treatment: There are no specific antidotes. Intensive maintenance therapy and constant monitoring of vital body functions are required. Inducing vomiting is not recommended. The introduction of activated charcoal may be more effective than gastric lavage. The airway must be maintained. Sertraline has a large volume of distribution, and therefore increased diuresis, dialysis, hemoperfusion, or blood transfusion may be ineffective.

Interaction with other drugs

Pimozide – With the combined use of sertraline and pimozide, an increase in the levels of pimozide was noted when it was administered once at a low dose (2 mg). The increase in pimozide levels was not associated with any ECG changes. Since the mechanism of this interaction is not known, and pimozide has a narrow therapeutic index, the simultaneous use of pimozide and sertraline is contraindicated.
Monoamine oxidase inhibitors (MAOIs). Severe complications have been noted with the simultaneous use of sertraline and MAOIs (including selectively acting (selegiline) MAOIs and with a reversible type of action (moclobemide, as well as linezolid). Serotonin syndrome may develop (hyperthermia, rigidity, myoclonus, lability of the autonomic nervous system (rapid fluctuations in parameters respiratory and cardiovascular system), changes in mental status, including increased irritability, marked agitation, confusion, which in some cases can turn into a delirious state or coma). Similar complications, sometimes fatal, occur when MAOIs are prescribed during treatment with antidepressants, inhibiting neuronal uptake of monoamines or immediately after their withdrawal.0029 Central nervous system depressants and ethanol.

The combined use of sertraline and substances that depress the central nervous system requires close attention, and the use of alcoholic beverages and preparations containing alcohol during treatment with sertraline is prohibited. There was no potentiation of the effect of ethanol, carbamazepine, haloperidol or phenytoin on cognitive and psychomotor function in healthy people; however, co-administration of sertraline and alcohol is not recommended.
Indirect anticoagulants (earfarin) – when they are co-administered with sertraline, there is a slight, but statistically significant increase in prothrombin time – in these cases, it is recommended to control prothrombin time at the beginning of treatment with sertraline and after its withdrawal.

Special instructions

Sertraline should not be co-administered with an MAOI or for 14 days after stopping MAOI treatment. Similarly, after the abolition of sertraline, MAOIs are not prescribed for 14 days.
Serotonin syndrome and neuroleptic malignant syndrome

When using selective serotonin reuptake inhibitors (SSRIs), cases of serotonin syndrome (SS) and neuroleptic malignant syndrome (NMS) have been described, the risk of which increases when SSRIs are combined with other serotonergic drugs (including triptans), as well as drugs that affect serotonin metabolism (including monoamine oxidase inhibitors), antipsychotics and other dopamine receptor antagonists. Manifestations of SS may include changes in mental status (in particular, agitation, hallucinations, coma), autonomic lability (tachycardia, fluctuations in blood pressure, hyperthermia), changes in neuromuscular transmission (hyperreflexia, impaired coordination of movements) and / or disorders of the gastrointestinal tract. intestinal tract (nausea, vomiting and diarrhea). Some manifestations of SS, including hyperthermia, muscle rigidity, autonomic lability with the possibility of rapid fluctuations in vital signs, and changes in mental status, may resemble the symptoms that develop in NMS. It is necessary to monitor patients for the development of clinical manifestations of SS and NMS.
Other serotonergic agents – Caution should be exercised when sertraline is co-administered with other drugs that enhance serotonergic neurotransmission, such as tryptophan, fenfluramine, or 5-HT agonists. Such co-administration, if possible, should be excluded, given the likelihood of pharmacodynamic interaction.
Switching from other selective serotonin reuptake inhibitors (SSRIs), antidepressants or anti-obsessional drugs. The experience of clinical studies, the purpose of which was to determine the optimal time required for the transfer of patients from other antidepressant and anti-obsessional drugs to sertraline, is limited. Care must be taken when switching, especially from long-acting drugs such as fluoxetine. The necessary interval between the abolition of one selective serotonin reuptake inhibitor and the start of another similar drug has not been established. It should be noted that there is no sufficient experience with sertraline in patients undergoing electroconvulsive therapy.
The possible success or risk of such combined treatment has not been studied. There is no experience with the use of sertraline in patients with convulsive syndrome, so its use in patients with unstable epilepsy should be avoided, and patients with controlled epilepsy should be carefully monitored during treatment. If convulsions occur, the drug should be discontinued. Patients suffering from depression are at risk for suicidal attempts. This danger persists until remission develops. Therefore, from the beginning of treatment until the achievement of the optimal clinical effect, patients should be under constant medical supervision.
Mania/hypomania activation. During clinical trials prior to the introduction of sertraline to the market, hypomania and mania were observed in approximately 0.4% of patients receiving sertraline. Cases of activation of mania/hypomania are also described in a small proportion of patients with manic-depressive psychosis treated with other antidepressant or anti-obsessional drugs.
Use in liver failure. Sertraline is actively biotransformed in the liver. According to a pharmacokinetic study, with repeated administration of sertraline in patients with stable cirrhosis of the lung, an increase in the half-life of the drug and an almost threefold increase in AUC (area under the concentration/time curve) and maximum concentration of the drug were observed compared with those in healthy people. There were no significant differences in plasma protein binding between the two groups. Sertraline should be used with caution in patients with liver disease. When prescribing the drug to a patient with impaired liver function, it is necessary to discuss the advisability of reducing the dose or increasing the interval between taking the drug.
Use in renal failure

Sertraline undergoes active biotransformation, therefore, unchanged in the urine, it is excreted in small quantities. In patients with mild to moderate renal insufficiency (creatinine clearance 30-60 ml / min) and patients with moderate or severe renal insufficiency (creatinine clearance 10-29 ml / min), pharmacokinetic parameters (AUC0-24 and Cmax) of sertraline with repeated its intake did not differ significantly from the control group. In all groups, the half-life of the drug was the same, as well as there were no differences in plasma protein binding. The results of this study suggest that, as expected given the negligible renal excretion of sertraline, no dosage adjustment is required based on the severity of renal impairment.
Pathological bleeding/hemorrhage

Caution is advised when prescribing selective serotonin reuptake inhibitors in combination with drugs that have an established ability to alter platelet function, as well as in patients with a history of hemorrhagic diseases.
Hyponatremia

Transient hyponatremia may occur during treatment with sertraline. This often develops in elderly patients, as well as when taking diuretics or a number of other drugs. A similar side effect is associated with the syndrome of inappropriate secretion of antidiuretic hormone. With the development of symptomatic hyponatremia, sertraline should be discontinued and adequate therapy aimed at correcting the level of sodium in the blood should be prescribed. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, weakness, and unsteadiness, which can lead to falls. In more severe cases, hallucinations, fainting, convulsions, coma, respiratory arrest, and death may occur.
Influence on the ability to drive vehicles and control mechanisms:

Appointment, sertraline, as a rule, is not accompanied by a violation of psychomotor functions. However, its use simultaneously with other drugs can lead to impaired attention and coordination of movements. Therefore, during treatment with sertraline, it is not recommended to drive vehicles, special equipment or engage in activities associated with an increased risk.

Form

Opaque polypropylene and aluminum foil blisters of 14 film-coated tablets of 50 and 100 mg; 1 or 2 blisters in a cardboard box along with instructions for use.

Expiration date :
5 years. Do not use after the expiry date stated on the package.

Storage conditions

List B.
At a temperature not exceeding 30 ° C, out of the reach of children.

Terms of dispensing from pharmacies

Prescription.

Manufacturer

Pfizer Inc., USA, manufactured by Haupt Pharma Latina S.r.l., Italy Legal address: S.S. 156 Km 47, 600 04100, Borgo San Michele, Latina, Italy.
Claims of consumers and complaints about the quality of the drug should be sent to the address of the representative office of Pfizer H. Si. Pi. Corporation»:
109147 Moscow, Taganskaya street, 17-23

Zoloft®, tablets, 100 mg their cancellation.

Blood levels of tricyclic antidepressants should be monitored to assess the need for dose adjustment.

With the simultaneous use of sertraline and tolbutamide, it is necessary to control the concentration of blood glucose (see section “Drug Interactions”).

Serotonin syndrome

Serotonin syndrome (SS) and neuroleptic malignant syndrome (NMS) have been reported with SSRIs. The risk of these complications increases with the simultaneous use of SSRIs with other serotonergic drugs (including amphetamines, triptans and fentanyl and their analogues, tramadol, dexomethorphan, tapentadol, meperedine, methadone, pentazocine), as well as drugs that affect the metabolism of serotonin (in including MAO inhibitors), antipsychotics and other dopamine receptor antagonists. Manifestations of SS may include changes in mental status (in particular, agitation, hallucinations, coma), autonomic lability (tachycardia, fluctuations in blood pressure, hyperthermia), changes in neuromuscular transmission (hyperreflexia, impaired coordination of movements) and / or disorders of the gastrointestinal tract (nausea, vomiting and diarrhea). Some manifestations of SS, incl. hyperthermia, muscle rigidity, autonomic lability with possible rapid fluctuations in vital signs, and changes in mental status may resemble symptoms that develop in NMS. Patients should be observed for the development of clinical manifestations of SS and NMS.

QT interval prolongation _c or torsade de pointes (TdP) ventricular tachysystolic arrhythmia

Cases of QT interval prolongation have been reported during post-marketing use of sertraline _c on the ECG and the development of ventricular tachysystolic arrhythmia pirouette type (TdP). Most of the cases were observed in patients with risk factors for the development of such conditions. Therefore, caution should be exercised when using sertraline in patients with risk factors for QT prolongation _c on the ECG or the development of ventricular tachysystolic arrhythmia of the “pirouette” type (TdP) (see the section “Drug Interactions”).

Switching from other SSRIs, antidepressants or anti-obsessional drugs

The necessary interval between stopping one SSRI and starting another similar drug has not been established. Caution should be exercised when switching to sertraline from other SSRIs, antidepressants, or anti-obsessional drugs, especially from long-acting drugs such as fluoxetine.

There is no need for a “washout period” when replacing one serotonin reuptake inhibitor with another. However, caution is required when changing the course of treatment.

Other serotonergic drugs, eg tryptophan, fenfluramine and 5HT agonists paraty, St. John’s wort) follows be carried out with caution and, if possible, avoided, given the potential pharmacodynamic interaction.

Suicidal behavior

Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide. This risk persists until a stable remission. Given that improvement in the patient’s condition may not occur in the first few weeks of therapy or longer, patients should be carefully monitored until such improvement occurs. It is also common to increase the risk of suicide in the early stages of recovery.

Other conditions for which sertraline may be prescribed may also be associated with an increased risk of suicidal events. In addition, these disorders may accompany major depressive disorder. In this regard, the same precautions should be taken as in the treatment of major depressive disorder.

Patients with a history of suicidal tendencies or patients prone to suicidal ideation before therapy have a higher risk of suicidal thoughts or suicide attempts. Such patients should also be under close medical supervision during therapy.

All patients, especially at risk, receiving sertraline therapy should be closely monitored for the development or worsening of symptoms of suicidal behavior. Patients, their relatives and caregivers should be advised to monitor for the onset or worsening of depression, the appearance of suicidal thoughts or behavior, and for any changes in behavior, especially at the beginning of therapy and with any change in the dose of the drug. The risk of suicide attempts should also be kept in mind, especially in patients with depression. In this regard, in order to reduce the risk of overdose, it is necessary to take the minimum dose of the drug that provides a sufficient therapeutic effect.

Patients with depression and other psychiatric disorders are at risk of suicidal behavior. By themselves, these diseases are strong predisposing factors for such behavior. In children, adolescents and young adults (aged 18-24 years) with depression or other psychiatric disorders, antidepressants (SSRIs and others) have been found to increase the risk of suicidal thoughts and suicidal behavior compared to placebo. Therefore, when using sertraline or any other antidepressant in children, adolescents and young adults (under 24 years of age), the risk of suicide should be weighed against the benefits of their use. In addition, there was no increase in the risk of suicidal behavior in adults older than 24 years, and in patients aged 65 years and older, there was a decrease in such risk.

Sexual dysfunction

Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see section “Side Effects”). There have been reports of prolonged sexual dysfunction, the symptoms of which persisted despite discontinuation of SSRIs.

Use in children and adolescents under 18 years of age

Sertraline should not be used in children and adolescents under 18 years of age, except in patients with OCD aged 6-17 years. Suicidal tendencies (suicide attempts or suicidal thoughts) and hostility (predominantly aggressiveness, oppositional behavior and anger) were more frequently observed in patients receiving antidepressant therapy than in patients receiving placebo. If, based on a clinical assessment of the patient, a decision was made to conduct therapy, the patient’s condition should be carefully monitored for symptoms of suicidal behavior. In addition, it should be borne in mind that data on the effect of the drug on growth, puberty and the cognitive and behavioral development of the child are limited. In long-term therapy of pediatric patients, clinicians should monitor for developmental abnormalities.

Withdrawal syndrome

Discontinuation of the drug often causes withdrawal symptoms, especially in case of abrupt withdrawal of the drug. Withdrawal symptoms were observed in 23% of patients who stopped taking sertraline and in 12% of patients who continued taking the drug. The risk of developing these symptoms depends on several factors, including the duration of therapy and dosage, as well as the rate of dose reduction. The most common reactions are dizziness, sensory disturbances (including paresthesia), sleep disturbances (including insomnia and deep sleep), agitation or anxiety, nausea and/or vomiting, tremor and headache. Usually these symptoms are mild to moderate; however, in some cases they can be severe. Usually these symptoms occur within the first few days of discontinuation of therapy, but there are very rare reports of the development of such symptoms in patients who inadvertently missed a dose. Usually these manifestations do not worsen and disappear within 2 weeks, except in some cases when they can last longer (2-3 months or more). In this regard, it is recommended to cancel the drug gradually, reducing the dose over several weeks or months, depending on the patient’s condition.

Akathisia/psychomotor agitation

The use of sertraline may be associated with the development of akathisia, characterized by a subjective sensation of discomfort or restlessness and a need to move, accompanied by an inability to sit or stand still. Most often, these symptoms are observed in the first weeks of treatment. Increasing the dose in these patients may be harmful.

Hepatic impairment

If sertraline is required in patients with hepatic impairment, consideration should be given to reducing the dose or frequency of administration. Sertraline should not be taken in patients with severe hepatic impairment.

Impaired renal function

It was found that, as expected, given the insignificant renal excretion of sertraline, dose adjustment of its dose depending on the severity of renal failure was not required.

Electroconvulsive therapy

The possible success or risk of such combined treatment has not been studied (no clinical data).

Convulsions

There is no experience with the use of sertraline in patients with convulsive syndrome, therefore its use in patients with unstable epilepsy should be avoided, and patients with controlled epilepsy should be carefully monitored during treatment. If convulsions occur, the drug should be discontinued.

Activation of mania/hypomania

During clinical studies prior to the introduction of sertraline to the market, hypomania and mania were observed in approximately 0.4% of patients treated with sertraline. Cases of activation of mania/hypomania are also described in a small proportion of patients with manic-depressive psychosis treated with other antidepressant or anti-obsessional drugs. Sertraline should be used with caution in patients with a history of mania or hypomania. Careful supervision of a physician is necessary and sertraline should be discontinued if the patient shows any signs of a manic state.

Schizophrenia

Patients with schizophrenia may experience exacerbation of psychotic symptoms.

Pathological bleeding/bleeding

There have been reports of bleeding or bleeding (from ecchymosis and purpura to life-threatening bleeding/bleeding) during the use of SSRIs. Caution should be exercised when prescribing SSRIs in combination with drugs that have an established ability to influence platelet function (for example, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory drugs), as well as in patients with a history of hemorrhagic diseases.

In addition, when using sertraline with indirect anticoagulants, it is recommended to control prothrombin time at the beginning of sertraline treatment and after its withdrawal.

Hyponatremia

Transient hyponatremia occurs more often in older patients, in patients with dehydration or when taking diuretics. This side effect is associated with the syndrome of inappropriate ADH secretion. Cases of a decrease in the concentration of sodium in the blood plasma below 110 mmol / l have been reported. With the development of symptomatic hyponatremia, sertraline should be discontinued and adequate therapy aimed at correcting the concentration of sodium in the blood should be prescribed. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, weakness, and unsteadiness, which can lead to falls. In more severe cases, hallucinations, fainting, convulsions, coma, respiratory arrest and death may occur.

Because there is a clear relationship between depression and OCD, depression and panic disorder, depression and PTSD, depression and social phobia, the same precautions should be taken when treating patients with OCD, panic disorder, PTSD and social phobia as and in the treatment of depression.

Fractures

Epidemiological studies have shown that the use of serotonin reuptake inhibitors, including sertraline, increases the risk of fractures. The mechanism leading to increased risk is not fully understood.

Elderly patients

The profile of adverse reactions in elderly and young patients does not differ. In the elderly, the drug should be used with caution due to the increased risk of hyponatremia.

Diabetes mellitus/impaired blood glucose control

When using SSRIs, incl. Zoloft ^® , there have been cases of exacerbation of diabetes mellitus and / or impaired glucose control (hyperglycemia and hypoglycemia) in patients with or without diabetes mellitus. In this regard, it is necessary to control the level of glucose. Particular attention is required for patients with diabetes mellitus, because. they may require dose adjustment of oral hypoglycemic agents and/or insulin.

Angle-closure glaucoma

SSRIs, including sertraline, affect pupil size resulting in mydriasis. At the same time, there is a narrowing of the angle of the eye, which leads to an increase in intraocular pressure and the development of angle-closure glaucoma, especially in patients with a predisposition. The drug should be used with caution in patients with angle-closure glaucoma or a history of glaucoma.

Laboratory methods

False-positive urinary immunoassays for benzodiazepines have been reported in patients treated with sertraline. This is due to the low specificity of screening tests. Also, false-positive results may occur within a few days after discontinuation of sertraline therapy. Additional tests such as gas chromatography and mass spectrometry can help distinguish sertraline from benzodiazepines.

Grapefruit juice

Concomitant use of sertraline and grapefruit juice is not recommended.

Influence on the ability to drive vehicles and mechanisms

The use of sertraline, as a rule, is not accompanied by a violation of psychomotor functions. However, its use simultaneously with other drugs can lead to impaired attention and coordination of movements. Therefore, during treatment with sertraline, it is not recommended to drive vehicles, special equipment or engage in activities associated with an increased risk.