What is Sertraline?

Sertraline hydrochloride tablets, the indication is sertraline for the treatment of depression-related symptoms, including depression accompanied by anxiety, with or without a history of mania. After the effect is satisfactory, continuing to take sertraline can effectively prevent the recurrence and recurrence of depression. Sertraline is also used to treat OCD. After the effect is satisfactory, continuing to take sertraline can effectively prevent the recurrence of the initial symptoms of obsessive-compulsive disorder.

Sertraline hydrochloride tablets, the indication is sertraline for the treatment of depression-related symptoms, including depression accompanied by anxiety, with or without a history of mania. After the effect is satisfactory, continuing to take sertraline can effectively prevent the recurrence and recurrence of depression. Sertraline is also used to treat OCD. After the effect is satisfactory, continuing to take sertraline can effectively prevent the recurrence of the initial symptoms of obsessive-compulsive disorder.

Drug Name

Sertraline Hydrochloride Tablets

Drug type

Prescription drugs, medicines for medical workers' injuries

Use classification

Selective serotonin reuptake inhibitors

Sertraline hydrochloride warnings

Results of short-term clinical trials of suicidal tendency and antidepressants for depression (MDD) and other mental disorders show that antidepressants increase suicidal thoughts and implementation in children, adolescents and young people ([24 years) compared to placebo Risk of suicidal behavior (suicidal tendency). Anyone considering sertraline or other antidepressants for use in children, adolescents, or young people ([24 years) must weigh their risks with their clinical needs. Short-term clinical trials have not shown that the use of antidepressants in adults older than 24 years increases the risk of suicidal tendencies compared to placebo; while in adults aged 65 and older, suicide after using antidepressants The risk of inclination is reduced. Depression and certain mental disorders are themselves associated with an increased risk of suicide. It is necessary to closely observe the deterioration of clinical symptoms, suicidal tendency, and abnormal changes in behavior of patients of all ages after the start of antidepressant treatment.
Families and caregivers should be advised to observe closely and communicate with the doctor. Except for obsessive-compulsive disorder, sertraline has not been approved for use in pediatric patients (see [Cautions]-Warning, worsening of clinical symptoms and risk of suicide, and [pediatric use]).

Sertraline Hydrochloride Tablets Ingredients

The main ingredient of this product is sertraline hydrochloride, whose chemical name is: (1S-cis) -4- (3,4-dichlorophenyl) -1,2,3,4-tetrahydro-N-formyl -1-naphthyridine hydrochloride.
Chemical Structure:

Molecular formula: C ₁₇ H ₁₇ NCl ₂ · HCl
Molecular weight: 342.7

Properties of Sertraline Hydrochloride Tablets

This product is a white film-coated tablet with a white core.

Sertraline hydrochloride tablets indications

Sertraline is used to treat symptoms associated with depression, including depression accompanied by anxiety, with or without a history of mania. After the effect is satisfactory, continuing to take sertraline can effectively prevent the recurrence and recurrence of depression.
Sertraline is also used to treat OCD. After the effect is satisfactory, continuing to take sertraline can effectively prevent the recurrence of the initial symptoms of obsessive-compulsive disorder.

Sertraline Hydrochloride Tablets Specifications

50mg

Sertraline Hydrochloride Tablets Usage and Dosage

Sertraline tablets are administered orally once a day, either morning or evening. Can be taken with food or alone.
Adult dosage:
Initial treatment: Take sertraline 1 tablet (50mg) daily.
Dose adjustment: For patients who take 1 tablet (50mg) per day with poor curative effect and better tolerance to the drug, the dose can be increased. The elimination half-life of sertraline is 24 hours. week. The maximum dose is 4 tablets (200mg) / day.
The effect can be seen within seven days of taking the medicine. It takes longer to achieve full effect, especially for OCD treatment.
Maintenance treatment: For long-term medication, the dose should be adjusted according to the effect and the minimum effective therapeutic dose should be maintained.
Dose for children (children and adolescents):
Obsessive-compulsive disorder-in children (6-12 years), the starting dose of this product should be 25 mg once daily; in adolescents (13-17 years), the starting dose of this product should be 50 mg once daily .
Although a dose-effect relationship has not been established for the treatment of obsessive-compulsive disorder, clinical trials have shown that patients can be administered in the range of 25-200 mg / day, which is effective in treating children with obsessive-compulsive disorder (6-17 years old). If the efficacy of this product is not good at 25 or 50 mg / day, increasing the dose (up to 200 mg / day) may benefit the patient. Children with obsessive-compulsive disorder usually weigh less than adults, and this should be considered before administration to avoid overdose. Sertraline has a clearance half-life of 24 hours and the dose adjustment interval should not be shorter than 1 week.

Sertraline hydrochloride tablets adverse reactions

Although it is not certain that all events were caused by sertraline, we still report all adverse events collected from clinical trials and post-market reports.
Clinical trial data < br In the multidose controlled clinical study of sertraline and placebo in the treatment of depression, compared with the placebo group, the common adverse reactions are:
Gastrointestinal tract: diarrhea / poor stools, dry mouth, indigestion and nausea.
Metabolism and nutrition: anorexia <br /> Sacral nervous system: dizziness, drowsiness, and tremor.
Spirit: Insomnia. Reproductive system and breast: sexual dysfunction (mainly delayed ejaculation in men).
Skin and subcutaneous tissue: Double-blind hyperhidrosis in obsessive-compulsive patients. Adverse reactions observed in placebo-controlled trials are similar to those observed in clinical trials in patients with depression.
Post-IPO Information:
Sertraline has received spontaneous reports of adverse events in patients taking sertraline after it was marketed. This includes:
Blood and lymphatic system: neutrophil deficiency and platelet deficiency.
Heart: palpitations and tachycardia.
Ear and labyrinth: tinnitus <br brEndocrine : hyperprolactinemia, hypothyroidism, and ADH secretion syndrome.
Ophthalmology: enlarged pupils and abnormal vision.
Gastrointestinal tract: abdominal pain, constipation, pancreatitis and vomiting.
Whole body and administration site: weakness, chest pain, peripheral edema, fatigue, fever and discomfort.
Hepatobiliary system: Severe liver disease (including hepatitis, jaundice, and liver failure) and asymptomatic elevated serum transaminase (SGOT and SGPT).
Immune system: allergic reactions, allergies and allergic reactions.
Examination: abnormal clinical test results, changes in platelet function, increased serum cholesterol, weight loss and weight gain.
Metabolism and nutrition: increased appetite and hyponatremia.
Musculoskeletal and connective tissue: joint pain and muscle spasms.
Nervous system: coma, convulsions, headaches, hypoesthesia, migraine, dyskinesias (including symptoms of extrapyramidal side reactions such as hyperactivity, increased muscle tone, molars and gait abnormalities), involuntary muscle contraction, paresthesia, and syncope. There are also symptoms and signs related to serotonin syndrome, such as anxiety, confusion, sweating, diarrhea, fever, high blood pressure, myotonia, and tachycardia caused by the simultaneous use of serotoninergic drugs.
Mental: Aggressive reactions, agitation, anxiety, depressive symptoms, euphoria, hallucinations, female libido, male libido, nightmares, and mental illness.
Kidney and urinary system: urinary incontinence and urinary retention.
Reproductive system and mammary glands: galactorrhea, male mammary overgrowth, irregular menstruation and abnormal penile erection.
Respiration, chest, and mediastinum: bronchospasm and yawning.
Skin and subcutaneous tissue: alopecia, angioedema, facial edema, puffiness around the eyes, skin photoreaction, itching, purpura, rash (rare peeling dermatitis, such as polymorphous erythema: Stevens-Johnson syndrome, epidermal necrolysis) And urticaria.
Blood vessels: abnormal bleeding (such as epistaxis, gastrointestinal bleeding, or hematuria), hot flashes, and hypertension.
Trauma, poisoning and postoperative / surgical / operational complications : fractures (incidence-unknown (cannot be judged based on all current data)
Others: Severe symptoms reported after sertraline discontinuation include anxiety, anxiety, dizziness, headache, nausea, and paresthesia.

Sertraline hydrochloride taboo

This product is contraindicated in people allergic to sertraline.
Sertraline is not allowed to be used in combination with monoamine oxidase inhibitors (MAOIs) (see [Drug Interactions] ).
Sertraline is contraindicated with pimozide (see Drug Interactions ).

Precautions for Sertraline Hydrochloride Tablets

caveat:
Deterioration of clinical symptoms and suicidal risk. Adults and children with depression, whether taking antidepressants or not, their depression may worsen, and suicidal ideation and suicidal behavior and abnormal changes in behavior may occur. This risk It will continue until there is a marked remission. Depression and certain mental disorders are known to be associated with the risk of suicide, and these mental disorders themselves are the strongest predictors of suicide. However, there have been long-standing concerns that antidepressants may play a role in inducing worsening depression symptoms, suicidal ideation, and behavior in the early stages of treatment in some patients. A meta-analysis of short-term placebo-controlled studies of antidepressants (including SSRIs and others) shows that in children, adolescents, and young people (18-24 years) with depression (MMD) and other mental disorders, compared with placebo, Antidepressants increase the risk of suicidal thoughts and suicidal behaviors (suicidal thoughts, behaviors); short-term clinical trials have not shown that in adults older than 24 years, the use of antidepressants compared with placebo Increasing the risk of suicidal thoughts and behaviors; among adults aged 65 and older, the risk of suicidal thoughts and behaviors is reduced after the use of antidepressants.
Placebo-controlled trials in children and adolescents with depression, obsessive-compulsive disorder (OCD), or other mental disorders (a total of 24 short-term clinical trials, 9 antidepressants, including 4,400 patients) and in patients with depression Placebo-controlled trials in adult patients with neurological or other mental disorders (a total of 295 short-term clinical trials (median duration of 2 months), 11 antidepressants, more than 77,000 patients], various drug-induced The risk of suicidal ideation and behavior is very different, but most drug studies show a trend of increasing suicidal risk in younger patients. The absolute risk of suicidal ideation and behavior is different in different indications. Absolute risk is highest. Although the absolute risk is different in each indication (compared to drugs and placebo), the risk is relatively stable across the age groups of different indications. Table 1 provides the risk difference (per 1,000 patients Differences in suicidal ideation and behavioral risk between Chinese medicine and placebo).

No suicides occurred in children's clinical trials. Suicides have occurred in adult clinical trials, but the number has not been sufficient to draw conclusions about the effects of drugs on suicide.
It is unknown whether the risk of suicidal ideation and behavior will continue during long-term medication (such as a few months later). However, the evidence from clinical trials of placebo-controlled maintenance therapy in adult patients with depression shows that the use of antidepressants can delay the relapse of depression.
Regardless of the indication being treated, all patients receiving antidepressant medication should be properly monitored and closely monitored for worsening clinical symptoms, suicidal tendency, and abnormal behavior changes, especially within the first few months of the drug's initial treatment, and increasing Or reduce the dose.
Adults and children with depression, other psychotic or non-psychiatric disorders can be treated with antidepressants in the following symptoms: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsiveness, meditation Impossible (psychomotor restlessness) and mild mania and mania. Although a causal relationship between the appearance of these symptoms and the exacerbation of depression and / or the generation of suicidal impulses has not been established, it is noted that the appearance of these symptoms may be a precursor to suicidal tendencies.
When the patient's depressive symptoms continue to worsen, suicidal tendency appears, or symptoms that may be aggravated or depressive of suicidal symptoms, careful consideration should be given to adjusting the treatment plan including the possible discontinuation of drug treatment. This is especially true if these symptoms are severe, sudden, or not compatible with the patient's current symptoms.
If it is decided to discontinue treatment, the dose should be reduced as soon as possible, but be aware that sudden withdrawal may cause certain symptoms (see description of risks in stopping sertraline treatment).
When using antidepressants to treat children with depression or other psychotic or non-psychiatric disorders, family members and caregivers should be reminded of the need to monitor the patient for agitation, irritability, abnormal behavior changes, other Symptoms and suicidal tendencies are reported to health professionals as soon as they occur. Family members and caregivers should perform the above-mentioned inspections on patients daily. When using sertraline, the prescription should start with the lowest dose and cooperate with good patient management to reduce the risk of overdose.
Screening for patients with bipolar disorder:
Depression episodes may be an early manifestation of bidirectional affective disorder. It is generally accepted (though not clear from controlled trials) that treating such episodes with antidepressants alone may increase the likelihood of mixed / manic episodes in patients at risk for bipolar disorder. It is not clear whether the above-mentioned symptoms imply that such a change may occur. However, before starting treatment with antidepressants, patients with depressive symptoms should be adequately screened to determine whether they are at risk for bipolar disorder; the screening should include a family history of suicide, bipolar disorder, and Detailed mental history including family history of depression. It should be noted that sertraline is not approved for the treatment of depression in bipolar disorder.
Potential interactions with monoamine oxidase inhibitors (MAOIs):
Severe adverse reactions, sometimes even fatal adverse reactions, have been reported in combination of Zoloft (sertraline hydrochloride, a selective serotonin reuptake inhibitor) and monoamine oxidase inhibitor (MAOI). MAOI includes selective monoamine oxidase inhibitors, selegiline; reversible monoamine oxidase inhibitors, moclobemide; monoamine oxidase inhibitor drugs, such as linezolid (an antibiotic that is a reversible non-selective MAOI) and methylene blue . These adverse reactions include high fever, tonicity, muscle spasms and instability of vital signs, changes in mental state (including extreme agitation, which gradually progresses to delirium and coma). These reactions have also been reported in patients who recently discontinued SSRI therapy and started MAOI therapy. Some patients behave like malignant syndrome with neuroleptic drugs. In addition, limited animal experimental data on the combination of SSRIs and MAOIs suggest that these drugs may have synergistic effects in increasing hypertension and inducing excitatory behavior. Therefore, sertraline cannot be administered to patients treated with MAOI or to patients who have stopped MAOI for 14 days. Similarly, sertraline should be discontinued for at least 14 days before starting treatment with MAOI.
Serotonin Syndrome or NMS-Like Reaction:
It has been reported that SNRIs and SSRIs are used separately, including sertraline, especially with serotoninergic drugs (including triptans and fentanyl), drugs that impair serotonin metabolism (including MAOIs), When combined with tranquillizers or other dopamine antagonists, potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS) -like reactions can occur.
Serotonin syndrome may include changes in mental state (eg, agitation, hallucinations, coma), autonomic nervous system disorders (eg, tachycardia, blood pressure changes, hyperthermia), neuromuscular system disorders (eg, hyperreflexia, movements Disorders) and / or gastrointestinal symptoms (for example, nausea, vomiting, diarrhea). The most severe serotonin syndrome is similar to the malignant syndrome of neuroleptics, including high fever, muscle rigidity, autonomic instability that may be accompanied by rapid fluctuations in vital signs, and changes in mental state. Monitor serotonin syndrome or malignant syndrome-like signs and symptoms.
Attention should be paid to avoiding the combination of levoblotox with other drugs that can enhance serotonin nerve conduction, because levoxopine may have pharmacodynamic interactions with these drugs, such as: tryptophan, fenfluramine, fentanyl , 5-HT agonist or St. John's wort (St. John's wort).
Sertraline is not allowed to be used in combination with MAOIs to treat depression (see [Contraindications] and [Cautions]]-Warning, potential interactions with monoamine oxidase inhibitors (MAOIs).
If there is a reasonable clinical need, sertraline and serotonin receptor agonist (triptan) should be used in combination. It is recommended to closely monitor the patient's condition, especially at the beginning of treatment and increasing the dose (see [Drug Interactions]).
The combined use of sertraline and serotonin precursors (eg tryptophan) is not recommended. When sertraline is combined with any serotonergic or anti-dopaminergic drugs, including tranquilizers, if any of the above events occur, the drug must be discontinued immediately and symptomatic supportive treatment should be started.
Diabetes / poor glycemic control. New cases of diabetes have been reported in patients treated with SSRIs, including zolopirox. Poor glycemic control has also been reported in patients with / without a history of diabetes, including hyperglycemia and hypoglycemia. Therefore, patients should be monitored for signs and symptoms of blood glucose fluctuations. Glucose should be closely monitored in patients with diabetes, as it may require adjustments to the dosage of insulin and / or oral hypoglycemic agents.
Laboratory tests have reported false positive results for benzodiazepines in patients undergoing sertraline urine immunoassay screening experiments. This is due to the lack of specificity of this screening experiment. False positive results may occur within days after sertraline is discontinued. Confirmatory tests such as gas chromatography / mass spectrometry can distinguish benzodiazepines from sertraline.
Angle-closure glaucoma SSRIs, including sertraline, may affect pupil size and cause pupil dilation. This mydriasis may cause atrial angle stenosis, leading to increased intraocular pressure and angle-closure glaucoma, especially for patients with this tendency before medication. Therefore, sertraline should be used with caution in patients with angle-closure glaucoma or a history of glaucoma.
General considerations Causes mania / hypomania In pre-market trials, approximately 0.4% of patients treated with sertraline developed hypomania or mania.
2. Weight loss Some patients may experience significant weight loss when using this product. However, on average, in the clinically controlled trials, only a slight 1 or 2 pounds of body weight loss occurred with sertraline compared to placebo. Rare patients discontinued due to weight loss.
3 Seizures-This product has not been evaluated in patients with epilepsy. These patients were excluded from the premarketing clinical trials. In the treatment of about 3000 patients with depression, no epileptic author was found. However, of the approximately 1,800 (220 patients [18 years of age) OCD patients receiving sertraline, 4 (approximately 0.2%) developed seizures, of which 3 were adolescents and 2 had In epilepsy, one patient had a family history of epilepsy, and all four patients did not receive anticonvulsant medications.
Therefore, sertraline should be used with caution in patients with epilepsy.
4 Sertraline is discontinued after sertraline and other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors) are marketed, with spontaneous reports of adverse events when discontinued, especially when abrupt discontinuation , Including the following symptoms: emotional irritability, irritability, agitation, dizziness, sensory disturbances [such as paresthesia (such as electric shock-like sensations)], anxiety, blurred consciousness, headache, lethargy, emotional instability, insomnia, and hypomania. Although these events are generally self-limiting, severe withdrawal symptoms have been reported.
These symptoms should be monitored when this product is discontinued. If possible, a gradual reduction is recommended rather than a sudden withdrawal. In case of intolerable symptoms after reduction or discontinuation, consider resuming the previous dose. The doctor can then continue to reduce the dose, but should use a slower rate (see Dosage and Administration).
5. Abnormal bleeding SSRIs (including sertraline) and SNRIs may increase the risk of bleeding events. The combination of aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anticoagulants may increase the risk. Case reports and epidemiological trials (case-control and cohort design) have shown that gastrointestinal bleeding can occur after taking medications that affect serotonin reuptake. Bleeding events associated with the use of SSRIs and SNRIs include petechiae, hematomas, epistaxis, petechiae, and life-threatening bleeding.
Patients should be warned of the risk of bleeding with sertraline in combination with NSAIDs, aspirin, or other drugs that affect blood coagulation.
6. Weak uric acid excretion-Serum uric acid decrease (approximately 7% decrease) after application of this product. The clinical significance of this weak uric acid excretion is unknown.
7. Application in patients with concomitant diseases-This product has limited clinical application experience in patients with a systemic disease. Patients with diseases or conditions affecting metabolism or hemodynamics should be used with caution.
Pre-marketing clinical trials exclude patients with recent myocardial infarction or unstable heart disease. However, in a double-blind clinical trial, an electrocardiogram (ECG) evaluation was performed on 774 patients taking this product, which showed that the application of this product was not accompanied by significant ECG abnormalities.
A post-marketing placebo-controlled flexible dose (sertraline dose range of 50 to 200 mg / day, average dose 89 mg / day) trial randomized 372 patients who met the DSM-IV depression diagnostic criteria. The patient was recently hospitalized for myocardial infarction (MI) or unstable angina. Among other exclusion criteria, the trial excluded patients with uncontrolled hypertension, requiring cardiac surgery, having undergone coronary artery bypass graft (CABG) in the past 3 months, severe or symptomatic bradycardia, and non-arterial Atherosclerotic angina pectoris, clinically significant renal impairment (creatinine) 2.5 mg / dl, and clinically significant liver dysfunction. Patients started using this product during the acute recovery period (30 days after MI, or after hospitalization for unstable angina pectoris).
Compared to placebo at week 16, the differences were not significant at the following endpoints: left ventricular ejection fraction, all cardiovascular events (angina, chest pain, edema, palpitations, syncope, orthostatic dizziness, and congestive heart failure (CHF) , MI, tachycardia, bradycardia, and changes in blood pressure) and serious cardiovascular events (MI, CHF, stroke, or angina) that involve death or need hospitalization.
Patients with impaired liver function: Sertraline is fully metabolized in the liver. In patients with chronic mild hepatic impairment, sertraline clearance decreases, resulting in increased AUC and Cmax and extended clearance half-life. Sertraline has not been evaluated in patients with moderate to severe hepatic impairment. Sertraline should be used with caution in patients with liver disease. If patients with liver impairment take this product, the dosage or frequency of administration should be reduced (see Precautions and Dosage and Administration).
Patients with impaired renal function: Sertraline is fully metabolized, and only a small amount of this product is excreted from the urine as a prototype. A clinical trial comparing healthy volunteers and patients with mild to severe (requiring hemodialysis) renal impairment showed that kidney disease did not affect the pharmacokinetics and protein binding of sertraline. Based on this pharmacokinetic result, no dose adjustment is needed in patients with renal impairment (see Clinical Pharmacology).
8. Effects on Cognitive and Motor Function-In controlled trials, this product has no sedative effect and does not affect psychomotor function. Although laboratory data show that sertraline does not impair the complex psychomotor activity of normal subjects. However, drugs that act on the central nervous system may adversely affect some individuals. Patients should therefore be advised to exercise caution, such as driving a car or operating machinery, before learning how to use sertraline.
9. Hyponatremia may occur when treated with SSRIs (including sertraline) or SNRIs (serotonin and norepinephrine reuptake inhibitors). In many cases, hyponatremia is the result of the antidiuretic hormone hypersecretion syndrome (SIADH). Cases with serum sodium levels below 110 mmol / L have been reported. Elderly patients, patients taking diuretics, or patients with reduced blood volume for other reasons may have a greater risk of hyponatremia when using SSRIs and SNRIs (see [Geriatrics]). After symptomatic hyponatremia appears, consider discontinuing sertraline and take appropriate treatment measures.
Symptoms and signs of hyponatremia include: headache, difficulty concentrating, memory impairment, confusion, weakness, and impaired balance (which may cause falls). Symptoms and signs of more severe and / or acute hyponatremia include hallucinations, syncope, seizures, coma, apnea and death.
10 Platelet Function-Rarely reported changes in platelet function and / or abnormal laboratory results in patients taking this product. Although there have been several reports of abnormal bleeding or purpura after taking this product, it is not clear whether it is caused by this product.
11. Drug abuse and physical and psychological dependence: A randomized, double-blind, placebo-controlled trial comparing sertraline, alprazolam, and d-amphetamine-induced abuse trends. This product does not produce positive subjective effects suggesting possible abuse, such as euphoria and like taking drugs, and these symptoms can be seen in the other two drugs. Preclinical clinical experience of this product has not found any tendency to discontinue drug withdrawal syndrome and no drug-seeking behavior. No potential irritants or barbiturate-like (sedative) abuse were found in this animal test. However, as with all other CNS-active drugs, physicians should carefully assess the patient's history of drug abuse and follow up these patients closely to see if they show signs of misuse or abuse of sertraline (such as tolerance formation, increased doses) , Drug-seeking behavior).
12. Fracture epidemiological studies have shown increased fracture risk in patients treated with serotonin reuptake inhibitors (SRIs), including sertraline. However, the mechanism of action leading to fracture risk is unclear.

Sertraline hydrochloride tablets for pregnant and lactating women

This product should only be taken if the benefits of taking the drug during pregnancy are significantly greater than the potential risk to the fetus.
Pregnancy-Non-teratogenic effects-After exposure to sertraline and other SSRIs or SNRIs in the third trimester, newborns may develop complications and therefore require extended hospitalization, respiratory support, and tube feeding. These findings are based on post-market reports. These complications can occur immediately after delivery. Reported clinical manifestations include dyspnea, cyanosis, apnea, seizures, unstable body temperature, difficulty feeding, vomiting, hypoglycemia, decreased muscle tone, increased muscle tone, hypertenoid reflexes, tremor, nervousness, irritability and Keep crying. These characteristics may be consistent with the direct toxicity of SSRIs and SNRIs, or may be consistent with the withdrawal syndrome.
It should be noted that in some cases the clinical manifestations are consistent with serotonin syndrome (see Warnings).
Infants exposed to SSRIs during late pregnancy may increase the risk of persistent pulmonary hypertension (PPHN) in the newborn. In the overall population, 1-2 PPHNs per 1,000 live births can be accompanied by significant neonatal morbidity and mortality. A retrospective case-control study involving 377 women with PPHN at birth and 836 women with health at birth. Compared to babies who were not exposed to antidepressants during pregnancy, babies exposed to SSRIs after the 20th week of pregnancy are about 6 times more likely to develop PPHN. There is no hard evidence for the risk of PPHN following pregnancy exposure to SSRIs; this is the first trial to study this potential risk. There are not enough cases of a single SSRI in this trial, so it is not possible to determine whether all SSRIs pose similar levels of PPHN risk. A study of 831,324 babies born in Sweden between 1997 and 2005 found that mothers taking SSRIs 'early pregnancy' reported a hazard ratio of 2.4 (95% CI 1.2-4.3) to PPHN in infants (CI: (Confidence Interval); Based on reports of mothers taking SSRIs in 'early pregnancy' and prescription SSRI in 'late pregnancy', the infant's risk of developing PPHN is 3.6 (95% CI 1.2-8.3).
When pregnant women take this product in the third trimester, doctors should carefully consider the potential risks and benefits of treatment. Physicians should be aware that in a prospective longitudinal trial of 201 women with a history of depression, they took antidepressants and were happy at the beginning of pregnancy. Women who discontinued antidepressants during pregnancy were more likely to relapse than women who continued to take antidepressants.
Labor and delivery-The effects of this product on human labor and delivery are unknown.
Lactating women-It is unclear whether this product and its metabolites are secreted by breast milk; if it is secreted by breast milk, its secretion amount is unknown. Because many drugs can be secreted through breast milk, lactating women should use this product with caution.

Sertraline hydrochloride tablets for children

Although sertraline is slightly metabolized by pediatric patients, in order to avoid excessive blood concentrations, it is recommended to use lower doses for pediatric patients, especially lighter children aged 6 to 12 years.

Sertraline hydrochloride tablets for the elderly

The clinical trial enrolled 663 elderly patients with depression aged 65 years or older in the United States, of which 180 were aged 75 years or older. There were no differences in the overall pattern of adverse reactions observed in clinical trials in elderly patients compared with adverse reactions reported by younger subjects. Moreover, based on other reported experiences, no differences in safety patterns between elderly and young subjects have been identified. As with other drugs, it does not exclude that some older patients have higher sensitivity. A clinical trial of this product versus placebo enrolled 947 elderly patients with depression. There were no differences in overall efficacy patterns observed in clinical trials in elderly patients compared with the efficacy reported by younger subjects.
Other adverse events in elderly patients: The overall adverse events in this product and placebo-controlled trials in 354 elderly patients were basically similar to those listed in this data sheet. Urinary tract infections were the only unlisted adverse event and reported a incidence of 2% in placebo-controlled trials, which was higher than in the placebo group.
Clinically significant hyponatremia can occur in elderly patients following SSRIs (including sertraline) and SNRIs. This adverse event may be more at risk for elderly patients (see [Cautions]-Hyponatremia).

Sertraline Hydrochloride Tablets Drug Interactions

Monoamine oxidase inhibitors (MAOIs): Sertraline is combined with monoamine oxidase inhibitors, including the selective monoamine oxidase inhibitor selegiline and the reversible monoamine oxidase inhibitor moclobemide, which has severe side effects and is sometimes fatal. Some cases have symptoms similar to serotonin syndrome, including: fever, rigidity, muscle cramps, autonomic dysfunction with rapid fluctuations in vital signs; changes in mental status include mental disorders, irritability, and extreme agitation until the development of delirium and coma. Therefore, sertraline should not be taken when taking a monoamine oxidase inhibitor or within 14 days after discontinuing the monoamine oxidase inhibitor; similarly, it takes 14 days or more after sertraline is discontinued to start treatment with a monoamine oxidase inhibitor.
Pimozide: In a single-dose low-dose pimozide (2mg) study with sertraline, it was confirmed that taking both drugs can increase the plasma concentration of pimozide. Elevated levels did not cause changes in EKG. The mechanism of this drug interaction is not clear. Sertraline and pimozide are not allowed to be co-administered due to the narrow therapeutic window of pimozide.
CNS inhibitors and alcohol: simultaneous administration of sertraline 200 mg daily does not increase the effects of ethanol, carbamazepine, haloperidol, or phenytoin on cognitive function and psychomotor activity in healthy subjects, but not Sertraline and alcohol are recommended.
Lithium: In a placebo-controlled trial of normal volunteers, the combination of sertraline and lithium did not significantly change the pharmacokinetic parameters of lithium, but the tremor increased compared to placebo, indicating that there is a drug between the two drugs The possibility of ergonomic interaction. Sertraline should be monitored when used in combination with other serotonergic drugs such as lithium.
Phenytoin: In placebo-controlled studies of healthy volunteers, long-term administration of sertraline at 200 mg daily did not significantly inhibit phenytoin metabolism. However, if it is required to be combined with sertraline, the serum concentration of phenytoin should be monitored when sertraline is started, and the dose of phenytoin should be adjusted appropriately. In addition, combination with phenytoin can cause sertraline blood concentration to decrease.
Sumatriptan: After sertraline was marketed, there have been individual reports of the combination of sertraline and sumatriptan in patients with frailty, hypertonic reflexes, ataxia, confusion, anxiety, and agitation. Patients should be closely monitored if sertraline is actually needed in combination with the drug in clinical practice.
Protein-bound drugs: Because sertraline binds to plasma proteins, attention should be paid to the possibility of interaction between sertraline and other plasma protein-bound drugs. However, in three formal studies of sertraline interacting with diazepam, tolbutamide, and warfarin, sertraline has not been shown to have a significant effect on the protein-binding rate of these drugs.
Warfarin: Sertraline 200mg / day combined with warfarin can cause a small but statistically significant increase in prothrombin time, and its clinical significance is not clear. Therefore, prothrombin time should be closely monitored when sertraline is combined with warfarin or discontinued.
Interactions with other drugs: Studies on the interactions between sertraline and other drugs have been performed. Sertraline 200 mg daily combined with diazepam or tolbutamide can cause some small but statistically significant changes in pharmacokinetic parameters. Combined with cimetidine can significantly reduce sertraline clearance. The clinical significance of these changes is unknown. Sertraline has no effect on the -adrenergic blockade of atenolol. There was no interaction between sertraline 200 mg daily and glipizide or digoxin.
Electroshock Therapy (ECT): There have been no clinical trials examining the advantages or risks of sertraline combined with electroshock therapy.
Cytochrome P450 (CYP) 2D6 Metabolic Drugs: Antidepressants have varying degrees of inhibition of the drug metabolism isoenzyme CYP 2D6. Its clinical significance depends on the degree of inhibition and the therapeutic index of the combined drug. CYP 2D6 substrates with a narrow therapeutic index include tricyclic antidepressants such as propafenone, flcainide, and class 1C antiarrhythmic drugs. Existing drug interaction studies show that long-term administration of sertraline at 50 mg daily can slightly increase the steady-state plasma concentration of desipramine (a marker of CYP 2D6 isoenzyme activity) (average 30- 40%).
Other cytochrome (CYP) enzyme metabolism drugs (CYP 3A3 / 4, CYP 2C9, CYP 2C19, CYP 1A2):
CYP 3A3 / 4: In vivo drug interaction tests show that long-term sertraline 200 mg administration will not inhibit CYP 3A3 / 4-mediated endogenous cortisol hydroxylation or metabolism of carbamazepine and terfenadine . In addition, long-term administration of sertraline at 50 mg daily did not inhibit CYP 3A3 / 4-mediated alprazolam drug metabolism. The data indicate that sertraline is not an inhibitor of CYP 3A3 / 4.
CYP 2C9: Sertraline 200 mg / day has no significant effect on the plasma concentrations of tolbutamide, phenytoin, and warfarin. This indicates that sertraline is not a clinically relevant inhibitor of CYP 2C9.
CYP 2C19: Long-term administration of sertraline 200 mg / day has no significant effect on the blood concentration of diazepam, indicating that sertraline is not an inhibitor of CYP 2C19.
CYP 1A 2: Sertraline has no significant inhibitory effect on CYP 1A2 in vitro.
Other serotoninergic drugs: Sertraline and drugs that enhance serotonin neurotransmission, such as tryptophan or fenfluramine, should be carefully considered to avoid possible pharmacodynamic interactions.

Sertraline hydrochloride tablets overdose

There is evidence that sertraline still has a large safety margin when overdose. Sertraline has been reported in excess of 13.5 grams alone. Deaths from sertraline overdose have been reported, but most often occur in combination with other drugs and / or alcohol. Therefore, any overdose should be actively treated.
Symptoms of overdose include adverse reactions due to serotonin such as drowsiness, gastrointestinal upsets (such as nausea and vomiting), tachycardia, tremor, agitation, and dizziness. Rarely reported coma. Sertraline has no specific antidote. Open and keep the airways open to ensure adequate oxygen and ventilation. Activated carbon can be used with laxatives, and may be as effective or even more effective as emetic or gastric lavage. At the same time as symptomatic treatment and supportive therapy, it is recommended to monitor the heart and vital signs. Because sertraline has a large distribution volume, forced diuresis, dialysis, hemoperfusion, and transfusion therapy have no significant meaning.

Sertraline Hydrochloride Clinical Trial

Depressive Disorders <br A study was performed in patients who participated in an 8-week sertraline 50-200mg / day open-label trial and treated effective depression patients. These patients (N = 295) were randomized to sertraline 50-200 mg / day or placebo, and a 44-week double-blind trial was continued. The relapse rate of patients in the sertraline group was significantly reduced compared to the placebo group. The average dose administered to patients who completed the study was 70 mg / day.
Obsessive-compulsive disorder < br In a long-term study, patients who participated in a 52-week single-blind trial of sertraline 50-200 mg / day and were treated effectively were eligible for DSM-III-R obsessive-compulsive disorder Diagnostic criteria. These patients (n = 224) were randomly assigned to sertraline or placebo to continue treatment for 28 weeks, and the proportion of patients who fell off due to relapse or poor efficacy was observed. During the 28 weeks of continued treatment, the proportion of patients who relapsed or fell off due to poor response was significantly lower in the sertraline group than in the placebo group. This feature is shown in both male and female patients.

Sertraline Hydrochloride Tablets Pharmacology and Toxicology

Pharmacological effects < br Sertraline hydrochloride is a selective serotonin reuptake inhibitor. Its mechanism of action is related to the inhibition of serotonin reuptake by central neurons. Sertraline blocks serotonin uptake by human platelets at clinical doses. Studies suggest that sertraline is a potent and selective neuronal serotonin reuptake inhibitor with only a slight effect on norepinephrine and dopamine. In vitro studies show that sertraline has an effect on adrenergic receptors (1, 2, ), cholinergic receptors, GABA receptors, dopaminergic receptors, histamine receptors, serotoninergic receptors (5HT1A, 5HT1B, 5HT2) or benzodiazepine receptors have no significant affinity. Antagonism of these receptors is believed to be related to the sedative effects, anticholinergic effects and cardiotoxicity of other psychiatric medications. Long-term administration of sertraline in animals can down-regulate norepinephrine receptors in the brain, which is consistent with the clinical effect of other antidepressants. Sertraline has no inhibitory effect on monoamine oxidase.
Toxicological studies <br Genetic toxicity: bacterial mutation test, mouse lymphoma mutation test, in vivo mouse bone marrow and in vitro human lymphocyte genetics test results show that sertraline is uniform in the presence or absence of metabolic activation. No genotoxicity occurred.
Reproductive toxicity: At a dose of 80 mg / kg (in mg / m ² , 4 times the maximum recommended human dose of MRHD), a reduction in animal fertility was observed in one of two rat experiments. Reproductive toxicity studies were performed on rats and rabbits at doses of 80 mg / kg / day and 40 mg / kg / day, respectively (approximately 4 times the maximum recommended human dose in mg / m ² ). No teratogenic effects were found below. Delayed fetal ossification was observed in pregnant rats and rabbits given sertraline (dose 10 mg / kg and 40 mg / kg, respectively, equivalent to 0.5 and 4 times the MRHD in mg / m ² ) during organogenesis. . Sertraline was administered to female rats during late pregnancy and lactation at a dose of 20 mg / kg. The number of still-born pups and the first 4 days after birth increased, and the weight of the pups also decreased during the first 4 days after birth. The non-influential dose for rats was 10 mg / kg. The reduction in the survival rate of the young rats is caused by sertraline exposure in the uterus. But the clinical significance of these effects is unclear.
Carcinogenicity: Lifelong carcinogenicity studies were performed on CD-1 mice and Long-Evans rats at doses of 40 mg / kg / day (in mg / m ² , equivalent to approximately 1 and 2 times the MRHD, respectively) . At a dose of 10-40 mg / kg, male mice showed a dose-related increase in hepatic adenomas. No increase in hepatic adenomas or hepatocytes was observed in female mice or rats treated with the same administration. Increase in cancer. The spontaneous rate of hepatic adenoma in CD-1 mice fluctuates, and the significance of this result to humans is unclear. 40mg / kg female rats showed an increase in thyroid follicular adenoma without accompanying thyroid hyperplasia. Compared with the control group, the uterine adenoma of the rats in the 10-40 mg / kg administration group increased, but the correlation between the results and the drug was not clear.
Dependence: Animal studies have not shown the excitatory effect of this product or the potential for barbiturate-like (central inhibitor) abuse.

Sertraline Hydrochloride Tablets Pharmacokinetics

Sertraline is administered orally once a day to men at 50-200 mg. Sertraline exhibits pharmacokinetic characteristics that are directly proportional to the dosage. After 14 consecutive days of medication, the human blood drug concentration reaches the peak (Cmax) for 4.5-8.4 hours. There were no significant differences in pharmacokinetic parameters between adolescents and the elderly and adults between the ages of 18-65. Sertraline has an average half-life of 22-36 hours. Consistent with the terminal elimination half-life, the drug was administered once a day and reached a steady-state concentration after one week. During this process, twice the concentration was accumulated. Sertraline has a plasma protein binding rate of 98%. Animal experiment results show that sertraline has a large distribution volume.
Sertraline is mainly metabolized first by the liver. The main metabolite N-desmethylsertraline in plasma has a significantly lower pharmacological activity in vitro than sertraline, which is about 1/20 of sertraline. There is no evidence to suggest that The antidepressant model has pharmacological activity in vivo and its half-life is 62-104 hours. The final metabolites of sertraline and N-desmethylsertraline are excreted in equal amounts from feces and urine, and only a small amount (<0.2%) sertraline is excreted from the urine in its original form.
Food had no significant effect on the bioavailability of sertraline tablets.

Sertraline Hydrochloride Tablets Storage

Store tightly below 30 ° C.

Sertraline Hydrochloride Tablets Packaging

Aluminum plastic packaging, 14 pieces / box.

Sertraline Hydrochloride Tablets

60 months

Sertraline Hydrochloride Tablets

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