Nufotin hard capsules 20mg Danapha treat depression (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Fluoxetin

Ingredient

Composition information	Content
Fluoxetin	20mg

Uses

indications

Nufotin 20mg drug is indicated in the following cases:

Adults

Depression;

Rapid - obsessive impulse disorders;

Invisible food;

Panic syndrome.

Children over 8 years old

Moderatic depression is severe if not responded to psychological therapy after 4 -6 rounds of treatment. Should use the drug simultaneously with psychotherapy.

Pharmacological

Fluoxetin is an antidepressant that has a selective inhibitory effect to recover serotonin. In the synap of serotonergic nerve cells, increasing serotonin levels to the post -synap, thereby improving depression symptoms in depression patients.

The main metabolites of fluoxetin, norfluoxetin, have the same effect as fluoxetin, so the effect increases very strong serotonin levels.

Although fluoxetin has the effect of rapidly increasing the serotonin level at the Synap Serotonergic slot of nerve cells, the effectiveness of improving clinical symptoms of depression slowly, usually for 3 -5 weeks, so severe depression can not be relieved right after taking this medication.

In the treatment dose, fluoxetin only has a selective inhibitory effect on Serotonin recovery channel, so the risk of side effects is often seen when using old 3-ring antidepressants such as cholinergic resistance (dry mouth, blurred vision, ive, constipation), acidgic blockers (vertical posture hypotension) or antihistamine (drowsiness) rarely treated with fluoxetin.

pharmacokinetics

absorption:

Fluoxetin absorbs well in the gastrointestinal tract when taken, reaching the maximum concentration after 6-8 hours. Oral bioavailability is about 95 %, food does not affect the absorption process.

Distribution:

Fluoxetin is widely distributed throughout the body and highly linked to plasma proteins.

Metabolism:

The drug is strongly metabolized in the liver by the enzyme CYP2D6 to norfluoxetin is still active.

Era:

both fluoxetin and norfluoxetin are very slowly eliminated through the urine. Fluoxetin waste time after using the only dose is about 2-3 days, but after using the dose repeated, the speed of excretion decreases, the selling time increases to about 4-5 days.

Before taking Nufotin hard capsules 20mg Danapha treat depression (3 blisters x 10 tablets)

How to use

Take oral use. Can be used by a single dose or divided, orally during or between meals. When stopping treatment, the drug still exists in the body for a few weeks, so be careful when starting and stopping Fluoxetin treatment.

Dosage

adults

Treatment of depression: The starting dose is usually 20 mg/day, taken once in the morning. The dose may increase to up to 60 mg/day. The maintenance dose is changed according to the clinical response of each person, so it should be maintained at the lowest dose effectively.

Normally, after a few weeks to achieve adequate treatment effect, therefore, do not increase the dose regularly. Should be treated for at least 6 months.

Treatment of forced-pulse pulse disorders:

The starting dose of 20 mg/day. The dose over 20 mg must be divided into 2 times, morning and afternoon. In some cases, if after 2 weeks do not respond to a dose of 20 mg/day, the dose may gradually increase to a maximum of 60 mg/day. If the condition does not improve after 10 weeks of taking the drug, it is advisable to reconsider the treatment with fluoxetin ..

Treatment of insatiable diet: 60 mg/day, can be taken once in the morning or divided into several times a day.

Treatment of panic syndrome:

The dose starts 10 mg/day, taken once in the morning. After a week of treatment may increase the dose to 20 mg/day. The increase in the dose may be considered after a few weeks of treatment but not effective. The maximum dose of 60 mg/day. However, patients need to be periodically evaluated to determine the need to continue treatment with fluoxetin.

Children over 8 years old

Treatment of depression is severe to severe:

The treatment should be started and monitored by experienced doctor. Need to adjust the dose carefully on each patient to ensure the lowest doses are effective. After 1-2 weeks, it may increase to 20 mg/day. For patients with good response, it is necessary to consider continuing treatment after 6 months.

With mild weight, lower plasma drug concentrations, treatment effects can be achieved at a lower dose.

Elderly

Should be cautious when increasing the dose. The daily dose should not exceed 40 mg/day. Maximum recommendations of 60 mg/day.

Hepatic failure

Needs to reduce the dose, for example, dose of 20 mg every 2 days.

Renal failure

It is necessary to consider adjusting the dose for patients with renal insufficiency due to the risk of accumulation of fluoxetin and its metabolites.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

Symptoms

Overdose of solitary fluoxetin often has a light stage.

Symptoms of overdose include: nausea, vomiting, agitation, tremor, eyeball, drowsiness, convulsions, cardiovascular dysfunction from asymptomatic arrhythmia (including ventricular arrhythmia and atrial -vented node rhythm) or extension of QT to cardiac arrest, coordinated dysfunction and signs of changing CNS status from stimulation to coma.

Death of exclusive fluoxetin overdose is very rare

Management

Mainly treat symptoms and support monitoring of heart disease and survival signs.

There is no specific antidote. Activated carbit and sorbitol can be used, mandatory measures of blood, mandatory diuretic or blood change may not be effective.

Overdose treatment should consider the patient's use of many other drugs. It takes more time to closely monitor patients who have used too many 3 -round antidepressants with fluoxetin.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using nucotin 20mg you may experience unwanted effects (ADR).

Very common, ADR> 1/10

Mental disorders: Insomnia;

Neurological disorders: headache; digestive disorders: diarrhea, nausea; general disorder: fatigue.

Common, 1/10 1/100

Metabolic disorders: Anorexia;

Mental disorders: restlessness, anxiety, agitation, sex reduction, sleep disorders, nightmares;

neurological disorders: Concentration, dizziness, taste disorder, sleep, sleep, tremor;

visual disorders: blurred vision;

Cardiovascular disorders: Heart beat fast, extend QT;

Respiratory, chest and mediastinum disorders: yawning;

digestive disorders: vomiting, dry mouth, indigestion;

Skin and subcutaneous tissue disorders: rash, urticaria, itching, increased sweat;

musculoskeletal and connective tissue disorders: joint pain;

Magic and urinary disorders: urinate many times;

Genital disorders: vaginal bleeding, erectile dysfunction, ejaculation disorders;

General disorder: restlessness, fear, shiver;

Other: Losing weight.

Uncommon, 1/1000

Mental disorders: loss of personality, agitation, abnormal thinking, abnormal orgasm, grinding teeth, thinking and suicide behavior;

neurological disorders: increase mental activity, dysplasia, loss of transportation, balance disorders, muscle vibration, memory decrease.;

Reversible disorders: Delonged pupils;

Hearing disorders: tinnitus;

Pentecology: Hypertension decrease;

Respiratory, chest and mediastinum disorders: shortness of breath, nosebleeds;

Gastrointestinal disorders: difficulty swallowing, gastrointestinal bleeding;

Skin and subcutaneous tissue disorders: hair loss, prone to bruising, cold sweat;

Musculoskeletal and connective tissue disorders: muscle seizures;

Magic and urinary disorders: difficulty urinating;

Genital disorders: Sexual dysfunction;

Common disorders: discomfort, abnormalities;

Other: increasing transaminase, gamma-glutamyltransferase.

Rare, ADR

Blood disorders and lymphatic systems: thrombocytopenia, leukemia, neutropenia;

Immune disorders: Anaphylaxis, serum disease;

Endocrine disorders: The hormone ADH is not suitable;

Metabolic disorders: Hypotenia;

Mental disorders: manic, mild, illusion, agitation, battle, confusing pronunciation;

neurological disorders: convulsions, restless sitting, serotonin syndrome;

heart disorders: ventricular arrhythmia includes peaks;

Vascular disorders: vasculitis, vasodilation;

Respiratory disorders, chest and mediastinum: sore throat, lung disease;

Gastrointestinal disorders: esophageal pain;

Hepatitis disorders: hepatitis;

Skin and subcutaneous disorders: edema, bruising, light sensitivity, hemorrhage, Stevens - Johnson syndrome, Lyell syndrome;

muscle and bond tissue disorders: muscle pain;

Magic and urinary disorders: urinary retention, urination disorders;

Genital disorders: Milk secretion, penis pain, hyperlactin in the blood; general disorder: mucosal bleeding.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindications:

Nufotin medicine 20mg 3x10 Danapha is contraindicated in the following cases:

Hypersensitivity to fluoxetin or any ingredients of the drug;

Patients who are taking Mao inhibitors (using these two drugs must be at least 5 weeks apart);

Patients are taking Metoprolol to treat heart failure.

Be cautious when using

children and teenagers under 18 years old

Acts related to suicide (suicide, suicide thoughts, and hatred (aggression, anger, opposition) are observed in children under 18 years of age treated with antidepressants.

Fluoxetin should only be used for children and teenagers under 18 years of age to treat depression from average to severe and should not be used for other indications. Based on clinical needs, if the treatment is still decided, it is necessary to closely monitor patients.

There is evidence of the limit of fluoxetin affecting growth, gender development, affection, awareness and behavioral development. Therefore, the delay in children's growth and development should be monitored during and after treatment with fluoxetin.

In children's tests, the mild manpower and manicular attacks are also often reported, so regular supervision. Fluoxetin should not be stopped when the patient entered the revolt stage.

suicide/suicide thought or worse condition

Depression is associated with an increase in the risk of suicide, self -hurt and suicide, the risk still exists until there is a significant improvement in the condition.

Because improvement may not occur in the first few weeks of treatment, patients should be closely monitored until improvement. The risk of suicide may increase in the early stages of the recovery process.

Patients with a history of suicide or suicide thought before starting treatment with fluoxetin should be carefully monitored during treatment.

It is necessary to have a close supervision of patients, especially those at high risk and drug therapy, especially in the early stages of treatment and after the dose changes.

Patients (and patient care) should be informed about the need to monitor any worse condition, thoughts or suicide behaviors and abnormal changes in behavior to immediately notify the doctor.

rash and allergic reactions: rash, anaphylactic reaction, vasodilation edema, urticaria and serious reactions related to skin, kidneys, liver or lungs have been reported. When rashes or allergic reactions appear but cannot identify any other causes, Fluoxetin should be stopped.

Epilepsy: Epilepsy is a potential risk to antidepressants. As with other antidepressants, fluoxetin should be used with caution in patients with a history of epilepsy. Treatment should be stopped when patients with epilepsy are worse or when there is an increase in epilepsy frequency. Avoid using fluoxetin in patients with unstable epilepsy disorders, so carefully monitor when using fluoxetin in patients with epilepsy has been controlled.

Heart: Be cautious when taking antidepressants in patients with a history of manic or mild mania. As with all antidepressants, it is recommended to stop using fluoxetin when the patient enters the revival stage.

Liver and kidney function: Fluoxetin metabolizes in the liver and eliminates through the kidneys. In patients with severe liver dysfunction, the dose should be reduced. When using Fluoxetin 20 mg/day for 2 months, the concentration of fluoxetin or norfluoxetin in plasma in patients with severe renal impairment must be dialysis (GFR

tamoxifen: Fluoxetin, a strong CYP2D6 inhibitor, can reduce endoxifen levels, one of the most important metabolites of Tamoxifen. Therefore, fluoxetin should be avoided while being treated with tamoxifen.

Cardiovascular effects: Cases that extend the QT and ventricular arrhythmia include the report that has been reported. Be cautious when using fluoxetin in patients with conditions such as congenital QT syndrome, family history with prolonged QT syndrome or other clinical conditions tend to be rhythmic (hypotension, blood magnesium, slow heart rate, acute myocardial infarction or left heart failure), or liver failure, or simultaneous use with drugs that cause extended QT and/or twisted. If the patient is treated with a stable heart disease, it is recommended to check the ECG before starting treatment with fluoxetin. If signs of arrhythmia occur during treatment, the drug should be discontinued and tested ECG.

Losing weight: can occur when using fluoxetin, but often corresponding to the original salary block of the body.

Diabetes: In diabetics, SSRIs can change blood sugar control. When using fluoxetin treatment, blood sugar decreases and when the drug is stopped, blood sugar increases. The dose should be adjusted for insulin and/or oral hypoglycemic drugs.

Sitting restlessly: The use of fluoxetin is associated with the development of restless sitting (uncomfortable, restlessness, need to move, unable to sit or stand still). This may occur in the first few weeks of treatment, so it should be limited to increasing the dose if this syndrome appears.

Symptoms of quitting smoking when stopping with SSRIs:

Symptoms of quitting smoking when stopping the drug are common, especially if the drug is sudden.

Bleeding:

There was a report on blood abnormalities such as bruising and SSRIs. Other hemorrhage manifestations such as gynecological bleeding, gastrointestinal bleeding also occur. Blood.

Delivering pupils: has been reported related to fluoxetin. Be cautious when prescribing fluoxetin in patients with internal hypertension or those at risk of acute narrow angle increased angle.

Electric shock therapy (ECT): There is a prolonged epilepsy report in patients with electric shock therapy using fluoxetin. Should be used carefully.

Serotonin syndrome or symptoms such as malignant neuropular syndrome:

has been reported related to the use of fluoxetin, especially when used with other serotonergic drugs (such as l-tryptophan) and/or neurological drugs. Stop using fluoxetin and symptomatic treatment.

imao:

Some cases of serious reactions, sometimes death when sharing SSRIs with imao, symptoms that occur similar to serotonin syndrome: high fever, muscle stiffness, neurological disorders, mental changes. Stop using Imao at least 2 weeks before starting using fluoxetin. Stop using Fluoxetin at least 5 weeks before starting to use imao. For patients with fat diarrhea. Patients allergic to wheat should not be used.

The ability to drive and operate machinery

The drug can cause drowsiness, reduce the ability to consider, judge, think or mobilize, so be careful when driving, operating machinery or jobs that need to be alert.

Pregnancy

Some epidemiological studies show the risk of increasing cardiovascular deformities related to the use of fluoxetin in the first 3 months of pregnancy (2/100 defect ratio compared to the rate of 1/100 in the population in general).

Epidemiological data also shows that the use of SSRIs during pregnancy, especially the late period of pregnancy, is associated with an increase in the risk of persistent lung hypertension in infants (5/1000 pregnancy compared to 1 - 2/1000 cases of pregnancy in the general population).

Therefore, Fluoxetin should not be used for pregnant women unless the mother's clinical condition is really necessary and the condition can affect the fetus. Do not stop the drug suddenly.

Although fluoxetin can be used during pregnancy, it is necessary to be cautious, especially in the late period of pregnancy and just before labor because it can cause side effects in infants such as discomfort, tremor, hypotension, persistent crying, difficulty sucking, difficulty sleeping.

Lactation period

fluoxetin and its metabolites, norfluoxetin distributed into breast milk, has reported on unwanted effects affecting breastfed babies. If it is necessary to use fluoxetin, you should consider stopping breastfeeding, if you continue breastfeeding, the lowest dose should be effective. intensity and frequency of continuing treatment.

Drug interaction

should not be used simultaneously fluoxetin with monoamine oxydase such as furazolidon, processbazin and Selegilin because it can be confused, agitated, gastrointestinal symptoms, high fever, severe seizures or hypertension.

Fluoxetin strongly inhibits the CYP2D6 liver enzymes. Simultaneous treatment with metabolites thanks to this enzyme and narrow treatment index (e.g. Flecainid, Encainid, Vinblastin, Carbamazepin and 3 -round antidepressants) must start or adjust these drugs at low doses. This also applies if fluoxetin was used within 1 week.

Using fluoxetin with serotonin release stimulants can cause serotonin syndrome such as agitation, hallucinations, coma, body temperature, nausea, vomiting, diarrhea.

The concentration of 3 -round antidepressants, Maprotilin or Trazodon in plasma can be doubled when used simultaneously with fluoxetin. Some doctors recommend reducing about 50% of these drugs when used simultaneously with fluoxetin.

Simultaneous use of fluoxetin with diazepam can extend Diazepam's disposal time in some patients, but physiological and mental response may not be affected.

Electrical shock treatment: Prolonged seizures when treated with fluoxetin.

Simultaneous use with nervous effects may increase the risk of side effects.

Periodic drugs with plasma proteins such as anticoagulants, digitalis or digitoxin when used simultaneously with fluoxetin can be pushed out of the protein bonding position, increasing the concentration of free plasma drugs and increasing side effects.

Phenytoin concentration may be increased when used simultaneously with fluoxetin leading to poisoning, so closely monitoring phenytoin concentrations in plasma.

using fluoxetin simultaneously with lithium may increase or decrease the level of lithium in the blood, there have been cases of lithium poisoning occurred. Therefore, lithium concentration should be monitored.

Storage

In a dry place, avoid light, the temperature does not exceed 30 ° C.

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