Sertraline Hydrochloride Tablets for Treatment of Depression

• Transport Package: Box
• Specification: 50mg*14tab/box
• Trademark: FUL
• Origin: China
• Model NO.: FC117
• Production Capacity: 10000PCS/ Month

Product Description

Item Name:Sertraline hydrochloride tablets
Molecular formula: C₁₇H₁₇NCl₂·HCl

Item Description

Item nanme: Sertraline hydrochloride tablets
Item character: This product is white

Indication:
Sertraline is used to treat depression related symptoms, including depression with anxiety, with or without a history of mania. After the curative effect is satisfied, continuing to take sertraline can effectively prevent the recurrence and recurrence of depression.
Sertraline is also used to treat obsessive-compulsive disorder. After the curative effect is satisfied, continuing to take sertraline can effectively prevent the recurrence of the initial symptoms of obsessive-compulsive disorder.

Item specifications:  50mg*14tab/box

Usage and dosage: Shequlin tablets are given orally once a day, either early or late. It can be taken at the same time as food or taken separately.
Adult dose:
Initial treatment: Take 1 tablet of sertraline (50mg) daily.
Dose adjustment: for patients who take one tablet (50mg) daily with poor efficacy and good drug tolerance, the elimination half-life of sertraline is 24 hours, and the time interval for adjusting dose should not be shorter than 1 week. The maximum dose was 4 tablets (200mg / day).
The effect can be seen within seven days. It takes longer to be effective at all, especially in the treatment of obsessive-compulsive disorder.
Maintenance treatment: long term medication should adjust dose according to curative effect and maintain the lowest effective treatment dose.
Dose of children (children and adolescents):
Obsessive compulsive disorder - in children (6-12 years old), the initial dose of this product should be 25 mg, once a day; In adolescents (13-17 years old), the initial dose of this product should be 50 mg once a day.
Although the dose-effectiveness relationship has not been established for the treatment of obsessive-compulsive disorder, clinical trials have shown that patients can be administered within 25-200 mg/ day and can effectively treat children with obsessive-compulsive disorder (6-17 years old). If the efficacy of this product is not good at 25 or 50 mg/ day, the increased dose (up to 200 mg/ day) may benefit the patient. Children with obsessive-compulsive disorder usually weigh less than adults, and should be considered before administration to avoid overdose. The half-life of sertraline was 24 hours, and the interval of dose adjustment should not be shorter than 1 week.

Adverse reactions
Although it is not certain that all events were caused by sertraline, we still reported all adverse events collected during clinical trials and post market reports.
Clinical trial data
In the multi dose controlled clinical study of sertraline and placebo for depression, the common adverse reactions were as follows compared with placebo:
Gastrointestinal tract: diarrhea / lean stool, dry mouth, dyspepsia and nausea.
Metabolism and nutrition: Anorexia
Nervous system: vertigo, drowsiness and tremor.
Spirit: Insomnia
Reproductive system and breast: sexual dysfunction (mainly male ejaculation delay).
Skin and subcutaneous tissue: sweating
The adverse effects observed in the double-blind, placebo-controlled trial in patients with obsessive-compulsive disorder were similar to those observed in clinical trials in patients with depression.
Post IPO information:
After sertraline was listed, spontaneous reports of adverse events in patients taking sertraline have been received. It includes:
Blood and lymphoid system: neutropenia and thrombocytopenia.
Heart: palpitation and tachycardia.
Ear and lost: Tinnitus
Endocrine: hyperprolactinemia, hypothyroidism and ADH dyssecretion syndrome.
Ophthalmology: pupil enlargement and visual abnormality.
Gastrointestinal tract: abdominal pain, constipation, pancreatitis and vomiting.
Body and drug delivery: weakness, chest pain, peripheral edema, fatigue, fever and discomfort.
Hepatobiliary system: severe liver disease (including hepatitis, jaundice and liver failure) and asymptomatic serum transaminase (SGOT and SGPT).
Immune system: allergic reaction, allergy and anaphylaxis.
Examination: abnormal clinical test results, changes of 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 spasm.
Nervous system: coma, convulsion, headache, hypoesthesia, migraine, dyskinesia (including extrapyramidal side effects such as hyperactivity, increased muscle tension, molars and gait abnormalities), muscle involuntary contraction, sensory abnormality and fainting. There are also symptoms and signs related to serotonin syndrome, such as anxiety, confusion of consciousness, sweating, diarrhea, fever, hypertension, myotonia and tachycardia caused by the simultaneous use of serotonin.
Spirit: aggressive response, agitation, anxiety, depression, euphoria, hallucinations, female hyposexual desire, male sexual desire decline, nightmare and mental illness.
Kidney and urinary system: * urinary incontinence and urinary retention.
Reproductive system and breast: overflow milk, excessive breast development in men, irregular menstruation and abnormal erection of penis.
Breathing, chest and mediastinum: bronchospasm and yawn.
Skin and subcutaneous tissue: alopecia, vascular edema, facial edema, periocular edema, skin photosensitive response, pruritus, purpura, rash (rare desquamate dermatitis, such as polymorphous erythema: Stevens Johnson syndrome, epidermal necrosis dissolution) and urticaria.
Blood vessels: abnormal bleeding (such as nose, gastrointestinal bleeding or hematuria), hot tide and high blood pressure.
Trauma, poisoning and postoperative / surgical / operative complications: fractures (incidence unknown (not judged based on all current data)
Others: symptoms of sertraline after withdrawal were reported including anxiety, anxiety, dizziness, headache, nausea and sensory abnormalities.

Taboo:
This product is forbidden for people who are allergic to sertraline.
Sertraline is prohibited from being used with monoamine oxidase inhibitors (MAOI s) (see [drug interactions].
Sertraline is not allowed to be used with pemoxite (see [drug interaction].

Matters needing attention:
Warning:
Deterioration of clinical symptoms and risk of suicide
Adult and child patients with depression, whether taking antidepressants or not, may have worse depression, and may have suicidal ideation, suicidal behavior and abnormal behavior changes. This risk will continue until the disease is significantly relieved. 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 deterioration of depressive symptoms, suicidal ideation and behavior in some patients in the early stage of treatment. Summary analysis of short-term placebo-controlled studies on antidepressants (including SSRIs and others) showed that antidepressants increased the risk of suicidal thoughts and behaviors (suicidal thoughts, behaviors) in children, adolescents and young people (18-24 years old) with depression (MDD) and other mental disorders compared with placebo; In short-term clinical trials, there was no evidence that antidepressant use increased the risk of suicidal ideation and behavior in adults over 24 years old compared with placebo; Among adults aged 65 and above, the risk of suicidal ideation and behavior decreased after using antidepressants.
Placebo controlled trials in children and adolescents with depression, obsessive-compulsive disorder (OCD) or other mental disorders (24 short-term clinical trials, 9 antidepressants, There were 295 short-term clinical trials (median duration was 2 months), 11 antidepressants and 77000 patients in adult patients with depression or other mental disorders, But most of the drug research shows that the risk of suicide in younger patients is increasing. In different indications, the absolute risk of suicidal ideation and behavior is different, and the absolute risk of depression is the highest. Although the absolute risk in each indication is different (drug vs placebo), the risk is relatively stable in the age group of different indications

Medication for pregnant and lactating women:
Only when the benefits of taking medicine in pregnant women are significantly greater than the potential risks to the fetus, can we take this product.
Pregnancy - non teratogenic effects - after exposure to sertraline and other SSRIs or SNRIs in the third trimester of pregnancy, neonatal complications may occur, which may require prolonged hospitalization, respiratory support and tube feeding. These findings are based on post market reports. These complications can occur immediately after delivery. The clinical manifestations reported included dyspnea, cyanosis, apnea, seizures, temperature instability, feeding difficulties, vomiting, hypoglycemia, hypotonia, myotonia, tendon hyperreflexia, tremor, nervousness, irritability and persistent crying. These characteristics may be consistent with the direct toxicity of SSRIs and SNRIs, or with withdrawal syndrome.
It should be noted that in some cases the clinical manifestations are consistent with serotonin syndrome (see warning).
Exposure to SSRIs in late pregnancy may increase the risk of persistent pulmonary hypertension (PPHN). In the overall population, 1-2 out of 1000 live births will have PPHN and can also have significant incidence rate and mortality. A retrospective case-control study included 377 women with PPHN at birth and 836 healthy women at birth. Compared with infants who were not exposed to antidepressants during pregnancy, infants exposed to SSRIs after the 20th week of pregnancy had a 6-fold increased risk of PPHN. At present, there is no conclusive evidence of PPHN risk after exposure to SSRIs during pregnancy; This is the first trial to study this potential risk. There are not enough cases of single SSRI in this trial, so it is not sure whether all SSRIs can cause a similar degree of PPHN risk. A study of 831324 infants born in Sweden from 1997 to 2005 found that the risk ratio of PPHN was 2.4 (95% CI 1.2-4.3) (CI: confidence interval) when mothers took SSRIs in early pregnancy; The risk ratio of PPHN was 3.6 (95% CI 1.2-8.3) according to the reports of mothers taking SSRIs in early pregnancy and prescription SSRI in late pregnancy.
When pregnant women take this product in the third trimester of pregnancy, doctors should seriously consider the potential risks and benefits of treatment. Doctors should note that in a prospective longitudinal trial of 201 women with a history of depression, they took antidepressants and were in a good mood at the beginning of pregnancy. Women who discontinued antidepressants during pregnancy were more likely to relapse than those who continued to take antidepressants.
Labor and childbirth - the effect of this product on human labor and childbirth is unknown.
Lactating women - it is not clear whether the product and its metabolites are secreted by breast milk; If it is secreted by breast milk, the amount of secretion is unknown. Because many drugs can be secreted by breast milk, lactating women should use this product with caution.

FAQ
1.who are we?
We are based in Fujian, China, start from 2000,sell to North America(40.00%),Southeast Asia(25.00%),Western Europe(25.00%),Africa(10.00%).There are total about 50 people in our office.

2. how can we guarantee quality?
Always a pre-production sample before mass production;
Always final Inspection before shipment;

3.what can you buy from us?
Pharmaceutical production lines,Intermediates,APIs,Finished Drug Preparations & Vaccines.

4. why should you buy from us not from other suppliers?
We have our own manufacture factories and one professional sales team working for the clients all over the world.

5. what services can we provide?
Accepted Delivery Terms: FOB,CIF,EXW,DDP,Express Delivery;
Accepted Payment Currency:USD,EUR,CAD,AUD,GBP,CNY;
Accepted Payment Type: T/T,L/C,PayPal,Western Union;
Language Spoken:English,Chinese,Japanese

Our Ddvantage:
1. Quick delivery
2. Online payment
3. Quality assurance
4. Welcome big order
5. After-sales service 24 hours
6. Competitive advantage products
7. Our value information is "Quality is our culture"
8. Work with us to provide you with secure funds, your business is securely protected, our advantages

Our Service
a)  Free amples can be provided.
b) Guide customers through professional technology and teach them how to use our products after sale
c) Determine the lowest price of high-quality products
1. Skilled experience: Our company is a leading manufacturer of professional production in China pharmaceutical field for many years.
2. The highest quality: to ensure high quality, once any problems are found, the package will be re-shipped for you.
3. Safe transportation: by air express (FedEx, UPS, DHL, EMS). It is recommended that you choose the most professional freight forwarder.
4. Fast delivery: We have stock, so once payment is received, we can deliver quickly.
5. Quality service: We will provide you with enthusiastic after-sales service. If you have any questions, we will reply to youwithin 24 hours.
6. Competitive price: discounts will be obtained when making large orders.

Our Manufacture Factory
Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd is a comprehensive enterprise which integrates R & D, production and construction of pharmaceutical production equipments, development and transfer of biotechnology, and cooperative production and sales of drugs and vaccines. The self-developed pharmaceutical production equipment branded FUL has been put into operation in many well-known pharmaceutical enterprises such as SINOPHARM, CSPC and also cooperates with many well-known pharmaceutical enterprises in production and sales, including pharmaceutical intermediates, APIs and finished drug preparations.

Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd business radiates to all levels, including direct supply cooperation with government departments and industry representatives, as well as establishing supply cooperation relationship with retail industry. We supply high quality, safe and effective medicines and medical equipment to governments, hospitals, clinics and licensed pharmacies in different countries with timely and effective services at reasonable prices.

At present Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd has the SINOPHARM authorization to sell its intermediates and APIs,and has the authorizations of CSPC & HUABEI PHARM sell its finished drug preparations;then FUL is the only manufacture in China which can supply the complete service from pharmaceutical produciton lines,intermediates and APIs to finished drug preparations and vaccines.Then we are seeking the professional pharmaceutical enterprices to work together for further cooperations.




Factory View


Our Products


Our Business