Drug Interaction:
Selective serotonin reuptake inhibitors include
- Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Citalopram, Escitalopram
Refer- Fluoxetine
Interacting drugs- summary
+ Paroxetidine
Cimetidine
Cimetidine increased steady-state paroxetine concentration
Phenobarbital
Phenobarbirtal decreased the AUC and half-life of paroxetine
Phenytoin
Phenytoin reduced the AUC and half-life of paroxetine
Digoxin
Paroxetine decreased the AUC of digoxin by 15%
L-tryptophan
Concurrent use with fluoxetine produce symptoms of toxicity
Procyclidine
Paroxetine increased the AUC , Cmax and Cmin of procylidine
Warfarin
A pharmacodynamic interaction (increased bleeding)
Indication:
Depression
Selective serotonin reuptake inhibitors include-
- Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Citalopram, Escitalopram
Refer- Fluoxetine
Approved by FDA on December 29,1992.
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing (Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Paroxetene Hcl Anti-depressant 04-10-2000
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Paroxetine CNS GlaxoSmithKline 24-09-2008
Paroxetine CNS SmithKlineBeecham 4-12-2005
Adverse Reaction:
Adverse Reactions-
PAROXETINE-
BODY AS A WHOLE -
Headache, Asthenia, Abdominal pain, Fever ,Chest pain
CARDIOVASCULAR -
Palpitations ,Postural hypotens, Hypertension, Syncope, Tachycardia
CNS -
Insomina 13%, Somnolence 21%, Nervousness 5%, Anxiety,5%Dizziness 13%,
Tremor 13%
GI
Nausea 25% Vomiting 2% Diarrhea 11% Dyspepsia 2% Dry mouth 18%
Anorexia 6% Constipation 13% Flatulance 4%
RESPIRATORY
Yawn 3% Respiratory disorder 6%
SKIN
Sweating 11% Rash 1% Pruritus 1%
SPECIAL SENSES
Blurred vision 4% Taste perversion 2.5%
GU Urinary frequency 3% Abnormal ejaculation 12% Urinary disorder 3%
Female genital disoder 2%
Contra-Indications:
Selective serotonin reuptake inhibitors include-
Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Citalopram, Escitalopram
Refer- Fluoxetine
Dosages/ Overdosage Etc:
Approved by FDA in december 29,1992.
Indications:
Depression
Dosage:
Initial; 20mg/day. Administer a single daily dose,usually in the morning.
Usual range is 20 to 50mg/day.
Some patients not responding to a 20mg dose may benefit from dose increases in 10mg/day increments,upto a maximum of 50mg/day.
Dose changes should not occur at intervals of at least 1 week.
Other Information:
EVIDENCE BASED MEDICINE (MIMS- April 2003)
Generalised Anxiety Disorder (GAD)
Comparative effectiveness of various Interventions
Definition
1. Excessive worry and tension on most days or atleast for six months
2. With increased motor tension - fatiguability, trembling, restlessness, muscle tension
3. With automatic hyperactivity shortness of breath, rapid heart rate, dry mouth, cold hands and dizziness, but not
panic attacks
4. With increased vigilance and scanning- feeling keyed up, increased startling, impaired concentration
Beneficial
1. Cognitive therapy
Likely to be beneficial
1. Buspirone
2. Certain antidepressants ( paroxetine, imipramine,trazodone, venlafaxine )
Trade-off between benefits and harms
1. Benzidiapines
Unknown effectiveness
1. Anti-psychotivc drugs
2. Beta-blockers
KEY BLOCKERS
1. A systemic review of randomised clinical trials (RCTs) has found cognitive therapy with behavoiural interventions is more effective than no treatment, anxiety management training alone, or non-directive therapy. No adverse effects were noticed.
2. One systermic review of randomised clinical trials (RCTs) has found that benzodiapines are clinically effective and rapid treatment for generalised anxiety disorder. One RCT found no significant difference in the effects of slow release alprozolam and bromozepam.
3. RCTs have found that buspirone is effective in GAD. Slower onset compared with benzodiapines is counter balanced by few side effects
4. RCTs have found that imipramine, trazodone, venlafaxine and paroxetine are effective treatments for GAD. One trial has found that paraxetine was more effective than benzodiapines. There is a significant risk of side effects with these drugs.
5. It was found that beta-blockers had not been adequately evaluated in GAD.
Patient Information:
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 eweeks, advise patients to continue theraoy as directed.
7. Allergies- Tell your doctor if you ever had any unusual or allergic reaction to Paroxetine. Also tell your doctor if you are allergic to any other substances such as preservatives, foods, or dyes. etc.
8. Pregnancy- Studies have not been done on pregnant women. However studies in animals have shown that Paroxeine may cause miscrriages and decreased survival rates of offspring when given in doses many times the usual human dose. Before taking this medcine make sure that your doctor knows if you are pregnant or if you become pregnant.
9. Breast feedng- Paroxetine passes into breast milk. However this medicine has not been reported to cause problems in nursing babies
10. Children- Studies have been done only in adult patients,and there is no specific information comparing use of paroxetine with use in other age groups.
11. Older adults- Studies done on elderly people did not cause different side effects or problems in older people than it did in younger adults.
12. Other medicines- Tell your doctor if your taking any of the following medicines- MAOI - taking Paroxetine while you are taking or within 2 weeks of taking MAOI may cause confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extrmely high blood pressure, and severe convulsions, At least 14 days should be allowed between stopping treatment with one medicine and starting treatment with the other.
13. Other medical problems- Tell your doctor if you had any of the following medical problems- Drug abuse or dependence - because paroxetnie is a new drug it is known if it could be habit forming., causing mental or physical dependence Kidney disease or Liver diseases - higher blood levels of paroxetie may occur, increasing the chance of side effects. Seizures , history of- risk of sezures may be increased
13. Missed dose- if you miss a dose and dosing is Once a day at bed time- do not take mised dose in the morning since it may cause disturbing side efects during waking hours. check with your doctor More than one dose a day- take the mised dose as soon as possible. However if it is almost time for the next dose , skip the missedcdose and go back to your regular schedule. Do not double doses.
14. Storage- Keep out of reach of children. Overdose of this medicine is too dangerous for children. Store away from heat and direct light. Do not store the tablet or capsule form of this medicine in the bathroom,near the kitchen sink or in other damp places Keep the liquid formof this medicine from freezing Do not keep outdated medicines. Be sure that discarded medicine is out of reach of children
Pharmacology/ Pharmacokinetics:
Refer Fluoxetine
Interaction with Food:
Not reported.
Pregnancy and lactation:
Refer fluoxetine