Fluoxetine hcl 10mg/20mg capsules,
List of Related Indications:
- Obscessive compulsive disorder
List Of Drugs:
- Fluoxetine ( ** ) @- selective serotonin reuptake inhibitors- (Mar 1990)
Indication Type Description:
Dosages/ Overdosage Etc
Interaction with Food
Pregnancy and lactation
Selective serotonin reuptake inhibitors include
- Fluoxetine, Fluvoxamine, Paroxetine, Sertraline
Interacting drugs - summary
Cimetidine + SSRIs paroxetidine
cimetidine increased steady-state paroxetine concn.
Cyproheptidine + Fluoxetine
Pharmacologic effects of flouoxetine may be decreased
Dextromethhorphan + Fluoxetine
Hallucinations occured during concurrent use
MAO inhibitors + SSRIs
Serious sometimes fatal reaction occurred
Phenobarbital + SSRIs Paroxetine
Phenobarbital decreased AUC and half-life of paroxetine
Phenytoin + SSRIs Paroxetine
Phenytoin reduced AUC and half life of paroxetine
SSRIs Paroxetine + Phenytoin
also paroxetine reduced AUC and half life of phenytoin
Smoking + SSRIs Fluvoxamine
smokers had 25% increase in metabolism of fluvoxamine
L-tryptophan + SSRIs Fluoxetine, Fluvoxamine, Paroxetine
Concurrent use with fluoxetine produce central toxicity symptoms
SSRIs + Alcohol
concurrent use not recommended in depressed patients
SSRIs Fluoxetine, fluvoxamine + Tricylic Antidepress
Plasma TCA levels increased
SSRIs , fluvoxamine, + Antihistamine- non sedat
Plasma level of astemazole,terfenadine increased
SSRIs , Fluvoaxamine, sertaline + Benzodizepine
clearance of benzodiazepine decreased
SSRIs Fluvoxamine + Betablockers
propranol plasma level increased
SSRIs Fluoxetine + Buspirone
Effects of buspirone decreased
SSRIs Fluvoxetine, Fuvoxamine + Carbamazepine
Serum carbamazepine level increased
SSRIs Fluvoxamine + Clozapine
Eevated serum clozapine level
SSRIs Fluvoxamine + Diltiazem
Bradycardia has occurred
SSRIs Paroxetine + Digoxin
Paroxetine decreased AUC of digoxin
SSRIs Fluvoxamine, Setraline, + Lithium
Serum levels increased by fluoxetine, setraline did not affect lithium levels
Lithium + SSRIs Fluvoxamine
Lithium enhance fluvoxamine effects
SSRIs Fluvoxamine + Methadone
Increased methadone level
SSRIs Paroxetine + Procyclidine
Paroxetine increased AUC level of procylidine
SSRIs Fluvoxamine + Theophylline
Clearance of theophylline decreased, reduce dosage
SSRIs Setraline + Tolbutamide
Decreased clearance of tolbutamide
SSRIs Fluoxamine + warfarin
Increased bleeding with unaltered PT
BODY AS A WHOLE -
Headache, Asthenia, Abdominal pain, Infection Viral/bact , Pain , Fever ,Chest pain , Influzenza/Flu synd,
Palpitations , Vasodilation
Insomnia, 13%Nervousness 15%, Anxiety,9%Dizziness 6%,Tremor 8%
Drowsiness 11% , Fatigue 4%
Nausea 21%, Vomiting 2% Diarrhea 12% Dyspepsia 6% Dry mouth 9%
Anorexia 8% Constipation 4% Flatulance 1%
Upper respiratory infectn 7% , Yawn 1%
Sweating 8% Rash 3% Pruritus 2%
Blurred vision 3% Taste perversion 2%
Menstruation painful 2%Urinary frequency 2%
Severe renal failure, lactation, hypersens, comcomittant MAOIs
Unstable epilepsy, liver failure, renal impairment, cardiac disease, diabetes, pregnancy. Anxiety nervousness and insomnia- occured in 2.6% of patients treated with an SSRI. These effects led to discontinuation of drug therapy im 1.1% to 5.3%.
Altered appetite and weight- significant weight loss especially in underweight depressed patients has occurred
Activation of mania/hypomania- ocured infrequently about 0.1% to 2.2% of patients taking SSRIs Seizures- have occured with fluoxetine, fluvoxamine.paroxetine and sertaline.
Usewith caution in patients with a history of seizures
Suicide- the possibility of a suicide attempt is inherent in depression and may persist until significantly remission occurs.
Write prescribtions for the smallest quantity of tablets or capsules to reduce the risk of overdose.
Concomittant ilness- clinical experiences is very limited. Use withcaution in patients withdiseases or conditions that could metabolism or hemodynamic response.
Electoconvulsive therapy- )ECT)- there are no clinical studies establishingthe benefit of the combined use of ECT and SSRI.
Hyponatremia- the majority of occurances have been
Diabetes- the dosage of insulin and sulfonylurea may need to be adjusted when fluoxetine is started or discontinued
Uricosuric acid- the clinical significance of weak uricosuric acid is unknown and there have been no reports of acute failure with sertaline.
Drug abuse and dependence- Before staring SSRI carefully evaluate patients for history of drug abuse and follow such patients closely,observing them for signs of misue or abuse.
Hazardous tasks- patients should be instructed to observe caution while driving or performing tasks requiring alertness,cordination and physical dexterity.
Long term use- Periodically reevaluate the SSRI used for extended periods to determin long term usefulness of the drug for the patient.
MAO inhibitors- periodically reevaluate te SSRI used for extended periods to determine long-term usefulness of the drug for the individual patient.
Renal function impairment- reduce initial dose of paroxetine in patients with severe renal impairment, upward titration if necessary should be increased at intervals
Hepatic function impairment- reduce initial dose of paroxetine in patients with severe renal impairment upward titration if necessary should be increased at intervals.
Fertility impairment- a decrease in fertility was seen with sertraline in one or two rats at a dose of 80mg/kg ( 20 timesthe maximum human dose.)
Pregnancy- There are no adequate and well controlled studies in pregnant women
Lactation- excercise caution when SSRIs are administered to a nursing woman
Children- safety and efficacy in children < 18 years have not been established
Dosages/ Overdosage Etc:
Approved by (DCI) Drug Controller GENERAL - India For Marketing (Ref- IDMA Publication)
: Initial - 20mg/day in the morning considering dose increase after several weeks if no clinical improvement is noticed.
Administer more than 20mg/day on a twice daily schedule. (Morning and noon). Do not exceed 80mg/day.
Fluoxetine- nausea and vomiting were prominent in overdose involving higher fluoxetine doses.
Other symptoms include agitation, restlessness,hypomania, and other sense of CNS excitation.
Fluvoxamine- common symptoms include drowsiness, vomiting, diarrhea, and dizziness,other signs include coma, tachycardia, bradycardia, hypotension, ECG abnormalities, liver function abnormalities and convulsions
Paroxetine- signs and symptoms of overdose include nausea, vomiting,drowsiness,sinus tachycardia and dilated pupils.
Sertaline- no specific therapy required
1. There are no specific antidotes.
2. Establish and maintain an airway,ensure adequate oxygenation and ventilation.
3. Activated charcoal which may be used with sorbitol, may be as or more efective than emesis or lavage
4. Monitor cardiac and vital signs along with general symptomatic and supportive measures.
5. SSRI-induced seizures which fail to remit spontaneously may respond to diazepam
6. Due to large volume of distribution of SSRIs forced diuresis dialysis, hemoperfusion and exchange transfusion are likely to be of benefit.
7. Treatment include supportive measures
1. If you miss a dose of this medicine, take it as soon as possible
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
EVIDENCE BASED MEDICINE ( MIMS April 2003)
Comparative effectiveness of various intreventions
Overall Premenstrual Syndrome Symptoms
1. Prostagalndin inhibitors (e.g. Indomethicin)
2. Selective serotonin Reuptake Inhibitors (e.g. Fluoxetine, Seratinine, Fluvoxamine)
Breast symptoms only
1. Leuteal phase control
Bloatedness and Swelling
1. Spironolactone/ diuretics
Likely to be beneficial
3. Vitamin B-6
4. Evening primrose B-6
Trade-off between Benefits and Harms
2. Gonodotropin-releasing hormone (GnRH analogues)
3. Non-SSRI antidepressants/ anxiolytics
4. Hysterectomy with/without oophorectomy
3. Oral contraceotives
4. Cognitive behaviour treatment
5. Dietary supplements
6. Relaxation treatment
7. Endometrial ablation
8. Laproscipic bilateral oophorectomy
1. Trials have found that SSRIs and prostagalndin inhibitors relieve premenstrual symptoms. Antidepressants and
ovulation suppression with danazol and GnRH analoges are also effective but have significant adverse effects,
including the masculanising effects of danazol and the menopausal effects of GnHR analogues.
2. There is a limited evidence suggesting that oestrogen, viatmin-B6 , evening Primrose Oil and excercise may also
3. Trials have found that bromocriptine is effective for breast symptoms and diuretics are effective for bloatedness
and swelling. Both can have adverse efects.
4. There is no good evidence to support the use of progesterone or oral contraceptives
5. Few treatments have been adequately validated in trials.
FLUOXETINE- SELECTIVE SEROTIN REUPTAKE INHIBITORS (SSRI)
1. May cause dizziness. Observe caution while driving or performing tasks requiring alertness, coordination or physical dexterity.
2.Avoid alcohol or other CNS depressants medicines.
3. Concomitant medication- Consult physician or pharmacist before taking concomittant OTC products or prescription drugs
4. Pregnancy or lactation- Notify physician of pregnancy, ofintent to become pregnant or if breast feeding
5. Rash- Notify physician if rash hives develop.
6.Completing course of therapy- While patients may notice improvement in therapy in 1 to 4 weeks, advise patients to continue therapy as directed.
7. Allergies- Tell your doctor if you have ever had any unusual or allergic reactions to fluoxetine or related medicines. Also tell your doctor if your are allergic to any other substances such as foods, preservatives or dyes.
8. Pregnancy- fluoxetine has not been shown to cause birth defects or other problems in animal studies
9.Breast feeding- be sure you have discussed the risk and benefits of this medicine with your doctor.
9.Children- not expected to cause different side effects or problems in children
10. Elderly- not shown to cause different problems in elderly people than in younger adults.
11. Other Medicines -Tell your doctor if you are taking any of the following- Anticoagulants or Digitalis glycosides- higher or lower blood levels of the these medicines or fluoxetine may occur- your doctor may need to change your dose CNS depressants-
11. Other medical problems- presence of other medical problems may affect the use of this medicine- Diabetes - the amount of insulin or oral antidiabettic medicine that you need mat change Kidney disease or Liver disease - higher blood levels of fluoxetine may occurincreasing the chance of side effects. Seizures- the risk of seizures may be increased
12. Missed dose- If you miss a dose of this medicine take it as soon as possible. However if it is almost time for your next dose go back to your regular dosing schedule. Do not double dose
Selective serotonin reuptake inhibitors(SSRIs) are oral antidepressant agents chemically unrelated to the tricyclic,tetracyclic or other available antidepressants.
. The antidepressant action of SSRIs is presumed to be linked to their inhibition of CNS neuronal uptake of serotonin.
Interaction with Food:
Reports not available.
Pregnancy and lactation:
There are no adequate and well controlled studies in pregnant women. Use during pregnancy only when needed.
Notify physician of intent to become pregnant or if beastfeeding.Excercise caution when SSRIs are administered to a nursing woman
Safety and efficacy in children < 18 years have not been established