Luvox 100mg Abbott tablets treat depression, depression disorders (2 blisters x 15 tablets)

Dosage form Box of 2 blisters x 15 tablets
Specifications Fluvoxamine

Ingredient

Composition information	Content
Fluvoxamine	100mg

Uses

Indications

Luvox drug are indicated in the following cases:

The main . Ask your doctor for more information.

Pharmacological - Treatment Group: Antidepressants, Select Serotonin recovery (SSRI). The ability to attach to the receptors of alpha adrenergic, beta adrenergic, histaminergic, muscarinic, cholinergic or dopaminergic is negligible.

Fluvoxamine has a high affinity for Sigma - 1 receptor, where it acts as a fortunate owner at the dose of treatment.

pharmacokinetics

The detailed description below shows how the active ingredient of Luvox is metabolized in the body. Ask your doctor for more information.

absorption

Fluvoxamine is completely absorbed when taken. The peak concentration in plasma reaches 3-8 hours after drinking. Absolute bioavailability of an average of 53% due to the initial metabolism.

The pharmacokinetics of Fluvoxamine is not affected when used during meals.

Distribution

Fluvoxamine attached in vitro to protein - plasma is 80%. The distribution volume (VD) in humans is 25 liters/kg.

Metabolism

Fluvoxamine is strongly metabolized through the liver. Although In Vitro shows that CYP2D6 is the main isoenzyme involved in the metabolism of Fluvoxamine, the plasma concentrations of weak metabolic people through CYP2D6 catalysts are not higher than the concentrations of fluvoxamine in good metabolites.

The average selling time in plasma is about 13-15 hours after using the single dose of Fluvoxamine, and when used in a row, it lasts more than a part (17 - 22 hours). Plasma content in a stable state usually reaches within 10-14 days.

Fluvoxamine is strongly metabolized through the liver, mainly through methyl reduction and at least 9 metabolites, then excreted through the kidneys. The two main metabolites show insignificant pharmacological activity. Other metabolites may not have pharmacological activity.

Fluvoxamine is a substance with the potential of CYP1A2 and CYP2C19 inhibitors. A moderate inhibitor is detected for CYP2C9, CYP2D6 and CYP3A4. Fluvoxamine has linear pharmacokinetics with a single dose. The concentrations in a state of stability are higher than the computing concentrations from single dose data and this unbalanced increase is even more clear when the daily dose is higher.

Special subjects

The pharmacokinetics of Fluvoxamine are equivalent to the following subjects: healthy adults, elderly patients and patients with renal impairment. Metabolism of weakened fluvoxamine in patients with liver failure.

Fluvoxamine concentrations in plasma at a stable state are twice as higher than in children (6 - 11 years old) compared to teenagers (12 - 17 years old). The concentrations of adult's plasma are equivalent to adults.

Before taking Luvox 100mg Abbott tablets treat depression, depression disorders (2 blisters x 15 tablets)

How to use

Take Luvox tablets with water, do not chew pills.

Dosage

always use Luvox as the doctor prescribed. If you need more information, ask your doctor or pharmacist.

Do not use fluvoxamine to treat typical depression in adolescents under 18 years of age.

Depression

The recommended starting dose is 50 or 100mg, should be used as a single dose in the evening. The doctor may consider increasing the dose gradually until the dose is effective. The effective dose is usually 100mg per day. This dose should be adjusted by the doctor, depending on how you respond to treatment. Daily dose should not be higher than 300mg.

If the doctor prescribes you a daily dose of more daily 150mg, do not take all at all times. The doctor will tell you how to divide those doses (2 or 3 times) during the day.

According to the World Health Organization's instructions, you should continue using antidepressants for at least 6 months after recovering. Moreover, a 100mg fixed daily dose is recommended to prevent relapse.

Rapid impulsive disorder

Adults:

The starting dose is recommended by 50mg/day for the first 3-4 days of treatment. The dose is usually usually from 100mg to 300mg per day. The doctor may consider increasing the dose gradually until the dose is effective, up to 300mg per day.

Dosage up to 150mg can be used as single dose, preferably taken in the evening. If the doctor prescribes you a daily dosage of more than 150mg not used immediately at a time. The doctor will notify you how to divide the dose (2 or 3 doses) during the day.

If you respond well to the drug, the treatment may be continued and your daily dose can be adjusted according to your personal needs. If there is no progress within 10 weeks, the doctor may consider treatment with Luvox. Although no system studies have to show that Fluvoxamine treatment can be continued safely, OCD is a chronic condition and your doctor may want you to continue treating for more than 10 weeks. Dosage should be carefully adjusted, according to your personal needs, to make sure you do not use more drugs than you need. Your treatment needs should be re -evaluated by the doctor. Doctors may recommend participating in psychotherapy to add to the use of drugs for OCD.

Children and teenagers:

recommended starting dose for children over 8 years old and adolescents is 25mg/day, should drink in the evening before going to bed.

Increase the dose gradually 25mg for every 4-7 days until the treatment is reached. The treatment dose is usually usually from 50mg to 200mg per day, the maximum dose in children does not exceed 200mg/day. If the daily dose is greater than 50mg/day, it should be divided into 2 doses to drink. If 2 doses are not equal, the larger dose should be used in the evening before going to bed.

Symptoms of cessation encountered when stopping Fluvoxamine:

It is necessary to avoid sudden stop treatment, when stopping using Fluvoxamine dose should be slowly reduced for at least 1 or 2 weeks to reduce the risk of cessation reactions (see warning and caution, especially when taking drugs and unwanted effects). If the symptoms of non -tolerated drugs occur after a decrease in the dose or stop treatment, then it may be considered for the dose first. Then, the doctor may continue to reduce the dose but decrease slowly.

liver or kidney failure

If you are suffering from liver or kidney failure, you will start with low doses of Luvox and your doctor must monitor you carefully.

What to do when overdose?

Symptoms

If you take more luvox than you are indicated, you may experience symptoms including stomach - intestines (nausea, vomiting and diarrhea), drowsiness (feeling of drowsiness), dizziness, cardiovascular phenomena such as fast heartbeat (fast heartbeat than normal), heart beating (slow heartbeat than normal) and lower blood pressure (low blood pressure). Liver dysfunction, convulsions (epilepsy types) and coma have also been reported.

Fluvoxamine has a large safety space when overdose. Since being circulated on the market, it is very rare to report death as a result of overdose. The highest dose of fluvoxamine is known to be taken by a patient of 12 grams. This patient has completely recovered. Sometimes, more serious complications have been recorded in the case of intentionally using Fluvoxamine overdose in combination with other drugs.

Treatment

There is no specific antidote to Fluvoxamine. In the case of an overdose, the stomach must be as soon as possible after drinking and must be started to treat symptoms.

Using activated carbon repeatedly in combination with penetrating laxative (if necessary) is also recommended. The diuretics or separation are not sure to bring results.

What to do when forgetting the dose? If you need more information, ask your doctor or pharmacist for advice.

Side Effects

Like other drugs, Luvox may have side effects. If you notice any side effects that are not described in this user manual, or if any unwanted effect becomes serious, notify your doctor or pharmacist.

Side effects recorded in clinical studies at the frequency listed below, are often related to depression and are not necessarily related to treatment.

Frequency estimates: Very common (1/10), common (1/100 to 1/10000 to

Unwanted effects according to the agency system

Common

Uncommon

rare

is very rare

Unknown frequency

Endocrine disorders

Anorexia

Mental disorders

Perfect, stress, anxiety , insomnia, shiver, drowsiness, headache, dizziness

seizures

heart disorders

Brushing the chest drum/tachycardia

abdominal pain, constipation , diarrhea, dry mouth, indigestion, nausea, vomiting

Increase sweating

Skin hypersensitivity reactions (including vascular nerve edema, rash, itching)

Sensitive reaction to light

Flowing in the nipple

Demonstrate, difficult in

The mechanism leading to this risk is not known.

Symptoms of cessation encountered when stopping Fluvoxamine treatment

Stop using fluvoxamine (especially sudden) often leads to symptoms of cessation. Therefore, when there is no need for treatment with fluvoxamine, stop slowly by gradually reducing the dose should be conducted (see the dose and usage and caution items when taking the drug).

Warnings

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

Contraindicated

Do not use Luvox if you have allergies (sensitive) with active ingredients or any excipients.

Do not use Luvox tablets in combination with tizanidine, monoamine oxidase inhibitors (Maois) or with ramelteon (see drug interactive section).

The doctor will inform you the time to start taking the drug, it should be known that if you are using Maoi: you can only start treating with Luvox 2 weeks after stopping using MAII inhibitors that cannot be reversed or on the next day after stopping the reverse MAOI inhibitor (for example, Moclobemide, Linezolid).

Also, you must stop using Luvox at least 1 week before starting treatment with any MAOI inhibitors.

Precautions when taking the drug

Depression is associated with an increase in the risk of suicide, self -causing risks and suicide (incidents related to suicide). This risk exists until it is significantly reduced. Because the improvement of the disease is not achieved in the first few weeks of treatment or longer, it is necessary to monitor patients carefully until the disease is really improved.

According to the general experience in clinical, the risk of suicide can increase in early stages of recovery.

Psychological conditions that are prescribed Fluvoxamine may be accompanied by an increased risk of suicide phenomena. In addition, these conditions can be stuck with the main depression. Therefore, it is necessary to be cautious when treating patients with other psychological disorders.

Patients with a history of commitments related to suicide and those who have an alarming level of suicide before the beginning of treatment will have a greater risk of suicide ideas and the plot of trying to commit suicide, so special monitoring of these patients during treatment.

Especially in the early stage of treatment and when changing the dosage, it is necessary to closely monitor patients, especially those at high risk when taking the drug.

Patients (and patient care) should be notified to monitor the deteriorating clinical signs, when committing suicide or any abnormal changes in behavior, immediately consult a doctor if these symptoms occur.

Children

Fluvoxamine should not be used in the treatment of diseases in children and adolescents under 18 unless there is an obsessive -up impulse disorder.

It is not recommended to use fluvoxamine in the treatment of depression for children because of lack of clinical experience in treatment.

In clinical studies, children and teenagers who have been treated with depression have shown signs of suicide acts that are still relevant (for example, ideas/or trying to commit suicide) as well as hostility, anger, and more anti -opposing behaviors that children and teenagers are used as placebo.

If based on clinical needs and to make treatment decisions with Fluvoxamine, it is necessary to monitor patients closely on any suicide signs.

Moreover, ineffective treatment when long -term use in children and teenagers using Fluvoxamine and its effects on growth, maturity, and development of attitudes and cognition.

Young people (18 to 24 years)

A general analysis of controlled clinical studies with antidepressants in adults with mental disorders shows the risk of increasing suicide acts when taking antidepressants compared to those who use placebo in a group of patients under the age of 25.

Older people

No need to adjust daily dose for elderly patients, but the doctor will be especially careful before prescribing this drug for you if you are in this age group. Moreover, if the dose increases are necessary, this must be done slowly more than other adults.

Lying restlessly

Using Fluvoxamine is accompanied by the development of uncomfortable restlessness or grief and is often accompanied by the ability to stand quietly. This reaction is common in the first weeks of treatment. If you have these symptoms, notify your doctor immediately. Increasing the dose can harm you if you experience these symptoms.

Hepatic failure and kidney failure

Patients with liver or kidney failure should start with low doses and consult a doctor more often to ensure safe use of drugs.

rarely treated Fluvoxamine is associated with liver enzymes, largely accompanied by clinical symptoms. In these cases, treatment must be stopped.

Nervous system disorders

Please inform your doctor if you have epilepsy. The doctor will decide if treatment with Luvox is good for you. Although in studies on Fluvoxamine animals does not cause seizures, the doctor will be careful before the Fluvoxamine prescription if you have convulsions disorders (such as epilepsy), it is necessary to avoid using fluvoxamine for patients with unstable epilepsy and for patients who need to carefully monitor with control seizures. If you experience convulsions or if you increase the frequency of seizures while using Luvox, ask your doctor immediately. In these cases, the doctor will be able to stop treatment.

In rare cases, there are reports on the development of "serotonin syndrome" or about the phenomena like malignant syndrome (signs and symptoms similar to malignant syndrome) when combined with Fluvoxamine treatment, especially when combined with serotonergic and/or other neuron drugs (see drug interactions).

These phenomena are indicated by a number of symptoms including high fever (high body temperature), stiffness (hard), muscle seizures (sudden shrinkage), unstable automatically accompanied by rapid fluctuations in life signs, mental changes, including confusion, stimulation, strong agitation to paranoia and stunning. Because these syndrome can lead to life -threatening conditions, Luvox should be stopped when these phenomena and doctors must start supporting and treating symptoms as soon as possible.

Metabolic and nutrition disorders

Like the preparations of this group (selective inhibitors with recovery of Serotonin SSRIs), have hypoglyc sodium hypoglycemia (reduced sodium levels) in rare cases. The condition can be recovered, due to the normal sodium level when stopping treatment with fluvoxamine. Most of these reports belong to the elderly patients.

The normal blood sugar level may be disturbed (for example, hyperglycemia, hypoglycemia, reducing glucose absorption), especially early stages of treatment. If you have (or have a history) diabetes, the dose should be adjusted for diabetes medications while using fluvoxamine.

Nausea, sometimes vomiting is the most common side effects related to Fluvoxamine treatment. However, this effect often calms after the first two weeks of treatment. Please inform your doctor if these symptoms progress. Constantly treating without consulting the doctor.

Eye disorders

Disabilities have been reported to be related to SSRIs like Fluvoxamine. Therefore, it is necessary to be cautious when prescribing fluvoxamine for patients with increased pressure in the eye or patients at risk of acute angle increased angle.

Hematological disorders

Has encountered abnormal cases of skin bleeding such as bruises and rashes (the red spots appear larger or smaller/area/area due to bleeding under the skin and/or bruising) as well as other signs of bleeding (problems of hemorrhage) such as post -gastrointestinal bleeding or gynecological bleeding when using SSRIS (Serotonin recovery inhibitors, a special anti -depression). Especially if you are an elderly or if you are taking any drugs that affect platelet energy (for example, not typical sedatives and phenothiazine, many TCA (3 -round antidepressants), acetylsalicylic acid and NSAIDs (nonsteroidal anti -inflammatory drugs) or drugs that increase the risk of bleeding.

You also need to be cautious if you have a history of bleeding disorders or any conditions that lead to those risks, for example, thrombocytopenia (reducing the number of platelets) or coagulation disorders.Heart disorders

Combining Terfenadine, Astemizole or Cisapride with Fluvoxamine can lead to heart rate disturbance (extending the QT/Twisted segment). Do not take Luvox with these drugs.

Fluvoxamine may reduce the rate of heart rate is negligible (2 - 6 beats per minute).

Electricity of convulsions (ECT)

Clinical experience is limited to simultaneous use of Fluvoxamine and ECT, so be cautious.

C tracing reaction

There may be cessation reactions when you stop treating with Luvox, although evidence of preclinical and clinical values do not show that this drug may cause drug dependence, generally most of the reported symptoms when stopping Fluvoxamine include: dizziness, sensory disorders (including abnormalities (sense of ants and sadness on the skin) Sleeping and intense dreams), confusing, easily stimulated, confused, unstable emotions, headaches, nausea and/or vomiting, diarrhea, sweating, nervousness, shudder and anxiety (see unwanted effect).

In general, these symptoms are from mild to medium and pass; However, in some patients may be severe and prolonged. This usually happens within the first few days of stopping treatment. Therefore, it is necessary to reduce the dose of fluvoxamine from the stopping of Fluvoxamine treatment according to the needs of the patient (see the dosage and use).

Mental/Hung Cam

Fluvoxamine should be used cautiously in patients with a history of mental/manic. Fluvoxamine should be discontinued in any patient who enters the stage of neurological disorders.

The ability to drive and operate machinery

Fluvoxamine at a dose of up to 150mg shows no effect on mental skills related to driving and operating machinery in healthy volunteers. However, drowsiness has been recorded during Fluvoxamine treatment. Therefore, it is necessary to be cautious until determining the response of each individual for the drug.

Pregnancy and nursing mothers

Please notify your doctor or pharmacist before taking any medication during pregnancy or nursing.

Pregnancy

Epidemic data (research on population density) are used for SSRI (such as fluvoxamine) during pregnancy, especially during the last pregnancy may increase the risk of lung hypertension (lung disease) in newborn babies (PPHN). There is a risk of approximately 5 cases in 1,000 pregnant women. Overall 1 to 2 cases of PPHN in 1000 pregnant women. Fluvoxamine should be used caution during pregnancy unless the woman's clinical condition needs to be treated with Fluvoxamine.

Symptoms of cessation in newborn babies are reported very rare when Fluvoxamine is used at the end of pregnancy. Some babies have difficulty feeding and/or respiration, convulsions, unstable body temperature, glucose - blood, tremor, abnormal muscle tone, restlessness, fear, purple blue, irritant, coma, drowsiness, vomiting, difficulty sleeping and always crying after exposure with SSRIS (such as Fluvoxamine) and may need to extend the hospital.

Breastfeeding period

Fluvoxamine is excreted in small amounts of breast milk. Therefore, Luvox is not used for breastfeeding women.

Reproduction

Animal reproductive toxicity studies have shown that Fluvoxamine reduces fertility in men and women. The correctness of these findings for unknown people.

Fluvoxamine should not be used in pregnant patients unless the clinical condition of patients should be treated with fluvoxamine.

Medicinal interaction

Some drugs are not taken with Luvox while other drugs need to adjust the dose when coordinated. Please inform your doctor about any medication you are taking, including non -prescribing drugs.

No combination of fluvoxamine with maoi inhibitors, including linezolid due to the risk of serotonin syndrome (see the control item).

The effect of fluvoxamine on oxidation of other drugs

Fluvoxamine can inhibit the metabolism of drugs metabolized by isenzyme Cytochrome P450 (CYPS). A powerful metabolite CYP1A2 and CYP2C19 has been shown in In vitro and in vivo studies. CYP2C9, CYP2D6 and CYP3Y4, CYP2C9, CYP2D6 are inhibited to a smaller range.

The drugs that are strongly metabolized through these enzymes may give higher or lower concentrations (for example, the case of drugs such as clopidogrel) in plasma of the active ingredient/metabolites, when they are used with fluvoxamine. The treatment of fluvoxamine along with these drugs should be started or adjusted to the lowest level compared to the highest in the healing dose sequence of these drugs. Plasma concentrations, effects or adverse effects of combined drugs should be strictly controlled and should reduce the dose/increase the dose of those drugs if necessary.

This is particularly related to drugs with narrow treatment index.

ramelteon

When using Fluvoxamine Maleate 100mg tablets to release immediately 2 times daily for 3 days then use a combination of 1 -dose Ramelteon 16mg with Fluvoxamine Maleate tablets instantly freeing the area under the AUC curve of Ramelteon to approximately 190 times and CMAX increases approximately 70 times compared to only Ramelteon.

Combining drugs with narrow treatment index

Use Fluvoxamine combination with drugs with narrow treatment index (such as tacrine, theophyline, methadone, mexiletine, phenytoin, carbamazepine and cyclosporine) should be carefully controlled when these drugs are separate or by the combination of CYP inhibited by Fluvoxamine.

Recommended the adjustment of these drugs if needed.

3 -round antidepressants and sedatives

Use Luvox to treat with 3 -round antidepressants (eg Clomipramine, Imipramine , Amitriptyline) and sedative drugs (eg clozapine, olazapine, quetiapine) can lead to increased content of these drugs in the body. Should consider reducing the dose of these drugs if luvox.

benzodiazepine

The concentration of nenzodiazepine in plasma (sedatives) that are specially metabolized (by oxidative metabolism) may increase when used with fluvoxamine. This is mainly true for Triazolam, Midazolam, Alprazolam and Diazepam, which should be reduced to the dose of these benzodiazepine when treated with Luvox.

Cases of increasing drug concentration in plasma

Ropinirol concentration in plasma may increase when combined with fluvoxamine, increasing the risk of overdose. For these reasons, the doctor needs to closely monitor and reduce the dose of Ropinirol (during both Fluvoxamine treatment and after stopping the drug).

Because of the propranolol concentration increased when combined with fluvoxamine, the doctor may reduce the dose of propranolol.

Warfarin concentration in plasma increases when fluvoxamine is used in combination. Prothrombin time (a laboratory value, especially to evaluate blood clotting) will be extended in these cases.

Cases of increasing side effects

There are some separate cases of heart disorders (toxicity on the heart) when combining fluvoxamine with thioridazine.

If you are drinking a lot of drinks containing caffeine (for example, black tea, coffee, coca), the concentration of caffeine in the blood will increase during Fluvoxamine treatment. Caffeine's undesirable effects such as tremor, fast heartbeat, nausea, restlessness and insomnia may occur. For these causes, you should reduce the amount of caffeine drinks when treated with Luvox. Terfenadine, Astemizole, Cisapride: (See the Warning and Care Special Special Use).

Complex Glucuro

Fluvoxamine does not affect the concentrations of digoxin in plasma.

Elimination through the kidneys

Fluvoxamine does not affect the concentration of Atenolol in plasma.

Pharmacological interaction

Fluvoxamine's serotonergic effect may increase when combined with serotonergic substances (including triptan, tramadol, SSRI, St. John ‘s wort) (see the whole" warning and caution when used ").

Use fluvoxamine in combination with lithium (the drug used in the treatment of severe patients) should be carefully done, because lithium (and may also be Tryptophan) that increases the serotonergic effect of fluvoxamine. It is necessary to limit this combination for severe patients, and drug resistance.

If you are taking anticoagulants (drugs that extend blood clots or blood thinning substances) you need to be carefully monitored by a doctor when using Luvox, because it may increase the risk of bleeding.

Do not drink alcohol while using luvox.

Storage

Do not store over 30 ° C. Keep the medicine in the original packaging, in a dry place and avoid light.

To be out of reach of children and vision of children.

Information on this guide is limited. For more information you can contact the doctor or pharmacist.

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