Prescribing InformationFluvoxamine

Prescribing Information
Fluvoxamine Tablets BP
OCIVOX 50/100
Composition:
Each tablet contains fluvoxamine maleate B.P. 50/100 mg

PHARMACOLOGICAL CLASSIFICATIONS:Psychoanaleptics (antidepressants)

PHARMACOLOGICAL ACTION:
The mechanism of action of fluvoxamine is presumably linked to its serotonin re-uptake inhibition in brain neurons.

Pharmacokinetics:
Fluvoxamine is variably absorbed after oral administration. Bioavailability is about 50%. Fluvoxamine is extensively metabolised in the liver. The metabolites are pharmacologically inactive and are renally excreted. The elimination half-life is 15 to 20 hours. Steady state plasma levels are reached within 2 weeks of treatment with a constant dose.

INDICATIONS:
Fluvoxamine Tablet is indicated for the treatment of major depressive disorders and for short-term treatment of severe, disabling obsessive-compulsive disorders, where the obsessions or compulsions significantly interfere with social or occupational functioning, cause severe distress or are time-consuming.

CONTRA INDICATIONS:
Hypersensitivity to fluvoxamine or any of the ingredients of Fluvoxamine Tablet MAO inhibitors: Fluvoxamine Tablet should not be used in combination with MAO inhibitors or within 2 weeks of terminating treatment with MAO inhibitors. MAO inhibitors should not be introduced within 2 weeks of cessation of therapy with Fluvoxamine Tablet.
Children under the age of 18 years.
Pregnancy and lactation.
Safety in liver impairment, moderate to severe renal impairment and epilepsy have not been established.

WARNINGS:
Patients with major depressive disorder, both adults and children, may experience worsening of their depression and or the emergence of suicidal ideation and behaviour, whether or not they taking antidepressant medicines. This risk may persist until significant remission occurs. A causal role, however, for antidepressant medicines in inducing such behaviour has not been established. Patients being treated with Fluvoxamine Tablet should, nevertheless, be observed closely for clinical worsening and suicidality, especially at the beginning of a course of therapy, or at any time of dose changes, either increases or decreases.

Because of the possibility of co-morbidity between major depressive disorder and other psychiatric and non-psychiatric disorders, the same precautions observed when treating patients with major depressive disorder should be observed when treating patients with other psychiatric and non-psychiatric disorders.
The following symptoms have been reported in patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric: anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness, impulsivity, akathisia, hypomania, and mania). Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, consideration should be given to changing the therapeutic regimen, including possibly discontinuing Fluvoxamine Tablet, in patients for whom such symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.
If the decision is made to discontinue treatment, Fluvoxamine Tablet should be tapered

Fluvoxamine Tablet should be used with caution in:
Patients with a history of seizures – There is an increased risk of seizures. Fluvoxamine Tablet should be discontinued in any patient who develops a seizure. Fluvoxamine Tablet should be used with caution in:
Patients with controlled epilepsy and should be avoided in those with unstable epilepsy.
Mania or history of mania – Reactivation of hypomania or mania may occur.
Concomitant use of Fluvoxamine Tablet and alcohol is not advised.

INTERACTION:
Tricyclic antidepressants – increased plasma concentrations of the tricyclic antidepressant has been reported.
Monoamine oxidase inhibitors (MAOI) – Concurrent use is contra-indicated. (See
CONTRA INDICATIONS). Other serotonergic medicines or medicines with serotonergic activity, including tryptophan – Increased risk of developing the serotonin syndrome.

Lithium – The combination has resulted in seizures and the serotonin syndrome.

Warfarin – Concurrent use may result in an increase in warfarin plasma levels. Monitoring is required.

Fluvoxamine Tablet is a potent inhibitor of cytochrome P450 1A2 (CYP1A2) and has also been shown to inhibit CYP3A4 and CYP2C9 and to weakly inhibit CYP2D6. Fluvoxamine Tablet can therefore cause an increase in the plasma levels of co-administered medicines that are metabolised by these enzymes such as: some benzodiazepines (e.g. alprazolam, bromazepam and diazepam), propranolol, theophyline, carbamazepine, clozapine, phenytoin and methadone. It is advisable to lower the dose of these medicines when Fluvoxamine Tablet is administered concurrently.

PREGNANCY AND LACTATION:
Safety and efficacy in pregnancy and lactation have not been established. Fluvoxamine Tablet is excreted into the breast milk.



DOSAGE AND DIRECTIONS FOR USE
Major depressive episodes 100 mg as a single dose in the evening.
The dose may be increased as needed and tolerated in increments of 50 mg a day up to a maximum of 300 mg a day. The effective daily dose usually varies between 100 mg to 200 mg a day.

Obsessive-compulsive disorder 50 mg as a single dose in the evening for 3 to 4 days.
The dose may be increased as needed and tolerated in increments of 50 mg a day up to a maximum of 300 mg a day. The effective daily dose usually varies between 100 mg to 200 mg a day with a maximum of 300 mg a day.

If the total daily dose is greater than 150 mg then it should be given in 2 to 3 divided doses. If patients being treated for obsessive-compulsive disorder have not improved within 10 weeks of therapy. Fluvoxamine Tablet therapy should be reconsidered. The patient should be maintained at the lowest effective dose and the need for treatment reassessed periodically.

Side-effects:
Central nervous system
Commonly occurring side-effects: Somnolence, agitation, tremor, headache, insomnia, drowsiness, dizziness, nervousness, dyskinesia, anxiety
Gastrointestinal:
Most frequently occurring side-effects:
Nausea, vomiting
Commonly occurring side-effects:
Constipation, anorexia, dry mouth, dyspepsia, diarrhea
Kidney/Genitourinary:
Commonly occurring side-effects:
Decreased libido, abnormal (delayed) ejaculation
Musculoskeletal:
Commonly occurring side-effect:
Asthenia
Ocular:
Commonly occurring side-effect:
Vision disturbances
Skin:
Commonly occurring side-effects:
Sweating, rash
Other:
Commonly occurring side-effects:
Mass gain

Special Precautions:
Patients with mild hepatic/renal impairment should start on a low dose of Fluvoxamine Tablet and liver/renal function should be regularly monitored. Fluvoxamine Tablet may increase liver enzymes. It is recommended that treatment should be withdrawn in these patients.
Fluvoxamine Tablet may cause sedation. Patients are advised not to drive or operate machinery if they are affected.
Extrapyramidal effects and exacerbation of Parkinson’s disease have been reported with the use of selective serotonin re-uptake inhibitors. Fluvoxamine Tablet should be avoided in such patients. If therapy with Fluvoxamine Tablet is to be discontinued, it is recommended that the dose is decreased gradually in order to prevent the possibility of a withdrawal syndrome.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
There is no specific antidote to Fluvoxamine Tablet.
The stomach should be emptied as soon as possible in the event of overdosage.
Treatment is symptomatic and supportive.

PRESENTATION
Blister strips of 10 x 10 tablets

ผลลัพธ์ (อังกฤษ) 2:

Prescribing Information
fluvoxamine Tablets BP
OCIVOX 50/100
Composition:
Each Tablet Contains mg fluvoxamine MALEATE BP 50/100. Pharmacological Classifications: Psychoanaleptics (antidepressants). Pharmacological ACTION: The mechanism of Action of fluvoxamine is presumably linked to ITS Re-uptake inhibition in Brain serotonin neurons. . Pharmacokinetics: After oral Administration fluvoxamine is variably absorbed. Bioavailability is about 50%. Fluvoxamine is extensively metabolised in the liver. The metabolites are pharmacologically inactive and are renally excreted. The elimination half-life is 15 to 20 hours. Steady State Plasma levels are reached Within 2 weeks of Treatment with a Constant dose. indications: fluvoxamine Tablet is indicated for The Treatment of Major depressive disorders and for Short-term Treatment of severe, disabling Obsessive-compulsive disorders, Where The obsessions or compulsions significantly. interfere with Social or Occupational functioning, Cause severe distress or are time-consuming. CONTRA indications: Hypersensitivity to fluvoxamine or any of The Ingredients of fluvoxamine Tablet MAO inhibitors: fluvoxamine Tablet should Not be Used in Combination with MAO inhibitors or Within 2 weeks of terminating. treatment with MAO inhibitors. Not MAO inhibitors should be introduced Within 2 weeks of cessation of Tablet Therapy with fluvoxamine. Children under 18 years of The Age. Pregnancy and Lactation. Safety in Liver impairment, Moderate to severe Renal impairment and Epilepsy Have Not been established. WARNINGS: Patients with major depressive disorder, both adults and children, may experience worsening of their depression and or the emergence of suicidal ideation and behaviour, whether or not they taking antidepressant medicines. This risk may persist until significant remission occurs. A causal role, however, for antidepressant medicines in inducing such behaviour has not been established. Patients being Treated with fluvoxamine Tablet should, nevertheless, be observed closely for Clinical worsening and suicidality, especially at The beginning of a course of Therapy, or at any time of dose Changes, either Increases or decreases. Because of The possibility of CO-morbidity. between Major depressive Disorder and Other Psychiatric and non-Psychiatric disorders, The Same Precautions observed When treating patients with Major depressive Disorder should be observed When treating patients with Other Psychiatric and non-Psychiatric disorders. The following symptoms Have been Reported in patients being Treated with. antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric: anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness, impulsivity, akathisia, hypomania, and mania). Although a causal link between the emergence of such symptoms and either the worsening of depression and / or the emergence of suicidal impulses has not been established, consideration should be given to changing the therapeutic regimen, including possibly discontinuing Fluvoxamine Tablet, in patients for whom such. symptoms are severe, abrupt in onset, or were Not Part of The Patient's presenting symptoms. If The decision is Made to discontinue Treatment, fluvoxamine Tablet should be Tapered. fluvoxamine Tablet should be Used with caution in:. Patients with a history of seizures - There is. an increased risk of seizures. Fluvoxamine Tablet should be discontinued in any patient who develops a seizure. Fluvoxamine Tablet should be Used with caution in:. Patients with controlled Epilepsy and should be avoided in those with unstable Epilepsy. Mania or history of Mania - reactivation of hypomania or Mania May occur. Concomitant Use of fluvoxamine Tablet and Alcohol is Not advised. INTERACTION: tricyclic antidepressants - tricyclic antidepressant The increased Plasma concentrations of has been Reported. Monoamine oxidase inhibitors (MAOI) - Concurrent Use is Contra-indicated. (See CONTRA indications). Other Medicines or Medicines with serotonergic serotonergic Activity, including Tryptophan - Increased risk of serotonin Developing The Syndrome. Lithium - The Combination has resulted in seizures and The serotonin Syndrome. Warfarin - Concurrent Use May Result in an increase in warfarin Plasma levels. Monitoring is Required. fluvoxamine is a potent inhibitor of cytochrome P450 Tablet 1A2 (CYP1A2) and has also been shown to inhibit CYP3A4 and CYP2C9 and to weakly inhibit CYP2D6. Fluvoxamine Tablet can therefore cause an increase in the plasma levels of co-administered medicines that are metabolised by these enzymes such as: some benzodiazepines (eg alprazolam, bromazepam and diazepam), propranolol, theophyline, carbamazepine, clozapine, phenytoin and methadone. It is advisable to Lower The dose of fluvoxamine these Medicines When Administered Concurrently Tablet is. PREGNANCY AND Lactation: Safety and efficacy in Pregnancy and Lactation Not Have been established. Fluvoxamine Tablet is excreted Into The Breast Milk. DOSAGE AND DIRECTIONS FOR USE Major depressive Episodes 100 mg As a single dose in The Evening. The dose May be increased As Needed and tolerated in Description of 50 mg a Day up to a Maximum of 300 mg. a day. The Effective Daily dose usually varies between 100 mg to 200 mg a Day. Obsessive-compulsive Disorder 50 mg As a single dose in The Evening for 3 to 4 days. The dose May be increased As Needed and tolerated in Description of 50 mg a Day. up to a maximum of 300 mg a day. The Effective Daily dose usually varies between 100 mg to 200 mg a Day with a Maximum of 300 mg a Day. If The total dose is greater than 150 mg Daily then IT should be Given in 2 to 3 divided doses. If patients being treated for obsessive-compulsive disorder have not improved within 10 weeks of therapy. Fluvoxamine Tablet therapy should be reconsidered. The Patient should be maintained at The Lowest Effective dose and The Need for Treatment reassessed Periodically. Side-Effects: Central Nervous System Commonly occurring Side-Effects: Somnolence, agitation, tremor, headache, Insomnia, drowsiness, dizziness, nervousness, dyskinesia, Anxiety. Gastrointestinal: Most Frequently occurring Side-Effects:. Nausea, vomiting Commonly occurring Side-Effects: Constipation, Anorexia, Dry Mouth, dyspepsia, diarrhea. Kidney / Genitourinary: Commonly occurring Side-Effects: Decreased libido, abnormal (Delayed) ejaculation. Musculoskeletal: Commonly occurring Side-Effect: Asthenia Ocular: Commonly occurring Side-Effect: Vision disturbances Skin: Commonly occurring Side-Effects: Sweating, Rash Other: Commonly occurring Side-Effects: Mass Gain Special Precautions: Patients with Mild hepatic / Renal impairment should start on a. low dose of Fluvoxamine Tablet and liver / renal function should be regularly monitored. Fluvoxamine Tablet may increase liver enzymes. It is recommended that Treatment should be withdrawn in these patients. fluvoxamine Tablet May Cause sedation. Patients are advised Not to Drive or operate MacHinery IF they are affected. Extrapyramidal Effects and exacerbation of Parkinson's disease The Have been Reported with Use of Selective Re-uptake inhibitors serotonin. Fluvoxamine Tablet should be avoided in such patients. IF Therapy with fluvoxamine Tablet is to be Discontinued, IT is recommended that The dose is Decreased gradually in Order to Prevent The possibility of a withdrawal Syndrome. KNOWN SYMPTOMS OF OVERDOSAGE AND particulars OF ITS TREATMENT:. There is no Specific Antidote to fluvoxamine Tablet. The stomach should be emptied As Soon As Possible in The event of Overdosage. Treatment is symptomatic and supportive. PRESENTATION Blister Strips of 10 x 10 tablets.

ผลลัพธ์ (อังกฤษ) 3:

Prescribing Information
Fluvoxamine Tablets BP
OCIVOX 50 / 100

Composition Each tablet contains fluvoxamine maleate, B.P. 50 / 100 mg

PHARMACOLOGICAL CLASSIFICATIONS: Psychoanaleptics (antidepressants)

PHARMACOLOGICAL ACTION:
The mechanism of. Action of fluvoxamine is presumably linked to its serotonin re-uptake inhibition in brain neurons.

Pharmacokinetics:
.Fluvoxamine is variably absorbed after oral administration. Bioavailability is about 50%. Fluvoxamine is extensively metabolised. In the liver. The metabolites are pharmacologically inactive and are renally excreted. The elimination half - life is 15 to 20, hours. Steady state plasma levels are reached within 2 weeks of treatment with a constant dose.

INDICATIONS:
.Fluvoxamine Tablet is indicated for the treatment of major depressive disorders and for short-term treatment, of severe. Disabling obsessive-compulsive disorders where the, obsessions or compulsions significantly interfere with social or occupational. Functioning cause severe, distress or are time-consuming.

CONTRA INDICATIONS:
.Hypersensitivity to fluvoxamine or any of the ingredients of Fluvoxamine Tablet MAO inhibitors: Fluvoxamine Tablet should. Not be used in combination with MAO inhibitors or within 2 weeks of terminating treatment with MAO inhibitors. MAO inhibitors. Should not be introduced within 2 weeks of cessation of therapy with Fluvoxamine Tablet.
Children under the age of 18 years.
Pregnancy. And lactation.
.Safety in liver impairment moderate to, severe renal impairment and epilepsy have not been established.


, WARNINGS Patients With major, depressive disorder both adults and children may experience, worsening of their depression and or the emergence. Of suicidal ideation, and behaviour whether or not they taking antidepressant medicines. This risk may persist until significant. Remission occurs.A, causal role however for antidepressant, medicines in inducing such behaviour has not been established. Patients being. Treated with Fluvoxamine, Tablet should nevertheless be observed, closely for clinical worsening, and suicidality especially. At the beginning of a course of therapy or at, any time of dose changes either increases, or decreases.

.Because of the possibility of co-morbidity between major depressive disorder and other psychiatric and non-psychiatric. Disorders the same, precautions observed when treating patients with major depressive disorder should be observed when treating. Patients with other psychiatric and non-psychiatric disorders.
.The following symptoms have been reported in patients being treated with antidepressants for major depressive disorder. As well as for, other indications both psychiatric and non-psychiatric: anxiety agitation panic attacks,,,,,, irritability insomnia Hostility (aggressiveness impulsivity akathisia,,,, hypomania and mania).Although a causal link between the emergence of such symptoms and either the worsening of depression and / or the emergence. Of suicidal impulses has not, been established consideration should be given to changing the, therapeutic regimen including. Possibly discontinuing Fluvoxamine Tablet in patients, for whom such symptoms are severe abrupt in onset,,Or were not part of the patient 's presenting symptoms.
If the decision is made to discontinue treatment Fluvoxamine Tablet,, Should be tapered

Fluvoxamine Tablet should be used with caution in:
Patients with a history of seizures - There is an. Increased risk of seizures. Fluvoxamine Tablet should be discontinued in any patient who develops a seizure.Fluvoxamine Tablet should be used with caution in:
Patients with controlled epilepsy and should be avoided in those with. Unstable epilepsy.
Mania or history of mania - Reactivation of hypomania or mania may occur.
Concomitant use of Fluvoxamine. Tablet and alcohol is not advised.

INTERACTION:
.Tricyclic antidepressants - increased plasma concentrations of the tricyclic antidepressant has been reported.
Monoamine. Oxidase inhibitors (MAOI) - Concurrent use is contra-indicated. (See
CONTRA INDICATIONS). Other serotonergic medicines. Or medicines with, serotonergic activity including tryptophan - Increased risk of developing the serotonin syndrome.

.Lithium - The combination has resulted in seizures and the serotonin syndrome.

Warfarin - Concurrent use may result in. An increase in warfarin plasma levels. Monitoring is required.

Fluvoxamine Tablet is a potent inhibitor of cytochrome P450. 1A2 (CYP1A2) and has also been shown to inhibit CYP3A4 and CYP2C9 and to weakly inhibit CYP2D6.Fluvoxamine Tablet can therefore cause an increase in the plasma levels of co-administered medicines that are metabolised. By these enzymes such as: some benzodiazepines (e.g. Alprazolam bromazepam and, diazepam), propranolol theophyline carbamazepine,,,, Clozapine phenytoin and, methadone. It is advisable to lower the dose of these medicines when Fluvoxamine Tablet is administered. Concurrently.

.PREGNANCY AND LACTATION:
Safety and efficacy in pregnancy and lactation have not been established. Fluvoxamine Tablet is. Excreted into the breast milk.



DOSAGE AND DIRECTIONS FOR USE
Major depressive episodes 100 mg as a single dose in the. Evening.
The dose may be increased as needed and tolerated in increments of 50 mg a day up to a maximum of 300 mg a day.The effective daily dose usually varies between 100 mg to 200 mg a day.

Obsessive-compulsive disorder 50 mg as a single. Dose in the evening for 3 to 4 days.
The dose may be increased as needed and tolerated in increments of 50 mg a day up to. A maximum of 300 mg a day. The effective daily dose usually varies between 100 mg to 200 mg a day with a maximum of 300 mg. A day.

.If the total daily dose is greater than 150 mg then it should be given in 2 to 3 divided doses. If patients being treated. For obsessive-compulsive disorder have not improved within 10 weeks of therapy. Fluvoxamine Tablet therapy should be, reconsidered. The patient should be maintained at the lowest effective dose and the need for treatment reassessed periodically.

Side-effects:
.Central nervous system
Commonly occurring side-effects: Somnolence agitation tremor,,,,,,, drowsiness insomnia headache ,,, dizziness nervousness dyskinesia anxiety

Gastrointestinal Most frequently occurring side-effects Nausea vomiting

, Commonly. Occurring side-effects:
Constipation anorexia dry,,,, mouth dyspepsia diarrhea
Kidney / Genitourinary:
Commonly occurring. Side-effects:
Decreased, libidoAbnormal (delayed) ejaculation

Musculoskeletal Commonly occurring side-effect:


Asthenia Ocular Commonly occurring side-effect:
Vision. Disturbances

Skin Commonly occurring side-effects:


, Sweating rash Other Commonly occurring side-effects Mass gain


Special. Precautions:
.Patients with mild hepatic / renal impairment should start on a low dose of Fluvoxamine Tablet and liver / renal function should. Be regularly monitored. Fluvoxamine Tablet may increase liver enzymes. It is recommended that treatment should be withdrawn. In these patients.
Fluvoxamine Tablet may cause sedation. Patients are advised not to drive or operate machinery if they. Are affected.
.Extrapyramidal effects and exacerbation of Parkinson 's disease have been reported with the use of selective serotonin re-uptake. Inhibitors. Fluvoxamine Tablet should be avoided in such patients. If therapy with Fluvoxamine Tablet is to, be discontinued. It is recommended that the dose is decreased gradually in order to prevent the possibility of a withdrawal syndrome.

.KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
There is no specific antidote to Fluvoxamine Tablet.
The. Stomach should be emptied as soon as possible in the event of overdosage.
Treatment is symptomatic and supportive.


, PRESENTATION Blister Strips of 10 x 10 tablets
.