Paroxetine

(pa rox' e teen)

PCaution when used during lactation / LCaution when used during lactation : Caution during pregnancy and lactation

Molecule Info

 
WARNING

Antidepressants increased the risk of suicidal tendency (when compared to placebo) in children, adolescents, and young adults in short-term Studies of major depressive disorder (MDD) and other psychiatric disorders.

Anyone considering the use of paroxetine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Paroxetine tablets are not approved for use in pediatric patients.
Indication(s) & Dosage Depression
Adult: 20 mg daily, increase gradually, if necessary, by 10-mg increments wkly; max: 50 mg/day. 
Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily. 
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary. 
Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.

Obsessive compulsive disorder
Adult: Initially, 20 mg daily, increase wkly in 10-mg increments. Maintenance: 40-60 mg daily.
Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily.
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary. 

Panic disorder with or without agoraphobia
Adult: Initially, 10 mg daily, increase wkly in 10-mg increments according to clinical response. Maintenance: 40-60 mg daily.
Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily. 
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary. 
Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary. 

Social anxiety disorder
Adult: Initially, 20 mg daily, increase after several wk by 10-mg increments; max dose: 50-60 mg/day. 
Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily. 
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary. 
Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.

Anxiety
Adult: Initially, 20 mg daily, increase in wkly increments of 10 mg; max dose: 50 mg/day.
Elderly: Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily. 
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary. 
Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.

Posttraumatic stress disorder
Adult: 20 mg daily, may be increased in 10-mg increments if necessary; max dose: 50 mg/day.
Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily. 
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.

Premenstrual dysphoric disorder
Adult: As hydrochloride, modified-release preparation: Initially, 12.5 mg once daily, usually in the morning; may increase up to 25 mg once daily after at least 1 wk, if necessary; given throughout the menstrual cycle or limited to the luteal phase. 
Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily. 
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Hepatic impairment: Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.

Special Populations: Patient with severe renal/hepatic impairment: 10 mg daily.
Administration May be taken with or without food. May be taken w/ meals to minimise GI upset.
Overdose Somnolence, nausea, vomiting, hepatic dysfunction, drowsiness, sinus tachycardia, urinary retention, renal failure (acute), dilated pupils, convulsions, status epilepticus, ventricular arrhythmias (including torsade de pointes), serotonin syndrome and manic reaction. No specific antidotes; treatment is supportive; cardiac monitoring is recommended.
Contraindications Use with or within 14 days of MAOIs; concurrent use with thioridazine or pimozide.
Special Precautions Epilepsy, glaucoma, history of mania, cardiac disease, DM, history of bleeding disorders, on drugs with increased risk of bleeding; renal and hepatic impairment; patients receiving electroconvulsive therapy; achlorhydria or high gastric pH (reduced absorption of oral suspension). Pregnancy and lactation. The risk of suicidal behaviour may be higher in young adults, closely monitor. May impair ability to drive or perform tasks. Avoid abrupt withdrawal.
Adverse Drug Reaction(s) Somnolence, insomnia, headache, dizziness; decreased libido; nausea, xerostomia, constipation, diarrhoea; ejaculatory disturbances; weakness, tremor, diaphoresis; vasodilation, chest pain, palpitation, hypertension, tachycardia, nervousness, anxiety , agitation, abnormal dreams, impaired concentration, yawning, depersonalisation, amnesia, emotional lability, vertigo, confusion, chills; rash, pruritus; orgasmic disturbance, dysmenorrhoea; anorexia, decreased appetite, dyspepsia, flatulence, abdominal pain, appetite increased, vomiting, taste perversion, weight gain; impotence, genital disorder, urinary frequency, UTI; paresthesia, myalgia, back pain, myoclonus, myopathy, myasthenia, arthralgia; blurred vision, abnormal vision; tinnitus; respiratory disorder, pharyngitis, sinusitis, rhinitis; infection.
Drug Interactions Levels/effects inhibited by cyproheptadine, phenytoin. Levels/effects increased by carbamazepine, cimetidine, CYP2D6 inhibitors (e.g. chlorpromazine, delavirdine, fluoxetine, miconazole, pergolide, quinidine, quinine, ritonavir, ropinirole). Increases levels/effects of atomoxetine, carvedilol, clozapine, CYP2B6 substrates (e.g. bupropion, promethazine, propofol, selegiline, sertraline), CYP2D6 substrates (e.g. amphetamines, selected beta-blockers, dextromethorphan, fluoxetine, lidocaine, mirtazapine, nefazodone, risperidone, ritonavir, thioridazine, TCAs, venlafaxine), duloxetine, galantamine, mexilitine, pimozide, procyclidine, propafenone. Decreases levels/effects of CYP2D6 prodrug substrates (e.g. codeine, hydrocodone, oxycodone, tramadol). Inhibits the metabolism of dextromethorphan, haloperidol, thioridazine. Enhances bradycardic effect of beta-blockers. Enhances toxic effects of other CNS depressants. Increased risk of serotonin syndrome with amphetamines, SSRIs, meperidine, nefazodone, trazodone, serotonin agonists, sibutramine, sympathomimetics, tramadol, venlafaxine. Increases risk of bleeding with NSAIDs, aspirin, warfarin, or other drugs affecting coagulation. Increases sensitivity to amphetamines. Neurotoxicity with lithium. Additive hyponatraemia with loop diuretics. Mania or hypertension with selegiline.
Potentially Fatal: Fatal reactions with nonselective MAOI. Please consult detailed drug interactions before prescribing.
Food Interaction Peak concentration increased; bioavailability not significantly altered. Avoid valerian, St John's wort, SAMe, kava kava. Ethanol may increase CNS depression.
Pregnancy Category (US FDA) Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Storage Store at ≤25°C for suspensions or 15-30°C for tablets.
Pharmacology Paroxetine selectively inhibits the reuptake of serotonin. It has limited direct action at other neurotransmitter sites including muscarinic receptors.
Absorption: Absorbed readily from the GI tract (oral); peak plasma concentrations after 5 hr.
Distribution: Enters breast milk. Protein-binding: 95%.
Metabolism: Extensive hepatic first-pass metabolism; by oxidation followed by methylation then formation of glucuronide and sulfate conjugates.
Excretion: Via urine (64%) and faeces (36%), mainly as metabolites; elimination half-life: 21 hr.
ATC Classification N06AB05 - paroxetine; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.

Brand/Product Info


Total Products : 4    
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
MELEV Beximco Pharmaceuticals Ltd Paroxetine Hydrochloride USP eq. to 20mg Tablet 30's: 286.20 MRP
OXAT 20 Square Pharmaceuticals Ltd. Paroxetine 20mg Tablet 3x10's: 360.90 MRP
PAROTIN ACI Ltd. Paroxetine hydrochloride 10mg & 20mg Tablet 30's each: 180.60 & 301.20 MRP
PAROXET-20 Jayson Pharmaceuticals Ltd. Paroxetine Hydrochloride USP equivalent to 20mg Tablet 30's: 270.90 MRP

Gen. MedInfo

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as paroxetine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take paroxetine, but in some cases, a doctor may decide that paroxetine is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take paroxetine or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking paroxetine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with paroxetine. Read the information carefully and ask your doctor if you have any questions. You can also obtain the Medication Guide from the FDA website:http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.

No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

 

Why is this medication prescribed?

Paroxetine tablets, suspension (liquid), and extended-release (long-acting) tablets are used to treat depression, panic disorder (sudden, unexpected attacks of extreme fear and worry about these attacks), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). Paroxetine tablets and suspension are also used to treat obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), generalized anxiety disorder (GAD; excessive worrying that is difficult to control), and posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience). Paroxetine extended-release tablets are also used to treat premenstrual dysphoric disorder (PMDD, physical and psychological symptoms that occur before the onset of the menstrual period each month). Paroxetine is in a class of medications called selective serotonin-reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

How should this medicine be used?

Paroxetine may come as a tablet, a suspension (liquid), and a controlled-release (long-acting) tablet to take by mouth. It is usually taken once daily in the morning or evening, with or without food. You may want to take paroxetine with food to prevent stomach upset. Take paroxetine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take paroxetine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the liquid well before each use to mix the medication evenly.

Swallow the extended-release and regular tablets whole; do not chew or crush them.

Your doctor may start you on a low dose of paroxetine and gradually increase your dose, not more than once a week.

Paroxetine controls your condition but does not cure it. It may take several weeks or longer before you feel the full benefit of paroxetine. Continue to take paroxetine even if you feel well. Do not stop taking paroxetine without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking paroxetine, you may experience withdrawal symptoms such as depression; mood changes; frenzied or abnormally excited mood; irritability; anxiety; confusion; dizziness; headache; tiredness; numbness or tingling in the arms, legs, hands, or feet; unusual dreams; difficulty falling asleep or staying asleep; nausea; or sweating. Tell your doctor if you experience any of these symptoms when your dose of paroxetine is decreased.

 

Other uses for this medicine

Paroxetine is also sometimes used to treat chronic headaches, tingling in the hands and feet caused by diabetes, and certain male sexual problems. Paroxetine is also used with other medications to treat bipolar disorder (mood that changes from depressed to abnormally excited). Talk to your doctor about the possible risks of using this drug for your condition.

This medication may be prescribed for other uses; ask your doctor for more information.

What special precautions should I follow?

Before taking paroxetine,

  • tell your doctor if you are allergic to paroxetine , any other medications, or any of the ingredients in paroxetine tablets or liquid. Ask your pharmacist or check the Medication Guide for a list of the ingredients
  • tell your doctor if you are taking monoamine oxidase (MAO) inhibitors, including isocarboxazid, linezolid, methylene blue, phenelzine, selegiline and tranylcypromine; if you have stopped taking them within the past 2 weeks; or if you are taking thioridazine or pimozide. Your doctor will probably tell you not to take paroxetine. If you stop taking paroxetine, you should wait at least 2 weeks before you start to take an MAO inhibitor.
  • tell your doctor what other prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: anticoagulants  such as warfarin; antidepressants  such as amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, and trimipramine; antihistamines; aspirin and other nonsteroidal anti-inflammatory drugs  such as ibuprofen, and naproxen; atomoxetine; atazanavir; bromocriptine; bupropion; buspirone; celecoxib; chlorpromazine; cimetidine; clopidogrel; codeine; dexamethasone; dextromethorphan; diazepam; dicloxacillin; digoxin; dipyridamole; diuretics; fentanyl; haloperidol; isoniazid; lithium; medications for irregular heartbeat such as amiodarone, encainide, flecainide, mexiletine, moricizine, propafenone, and quinidine; medications for mental illness and nausea; medications for migraine headaches such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan; medications for seizures such as phenobarbital and phenytoin; meperidine; methadone; metoclopramide; metoprolol; ondansetron; other selective serotonin-reuptake inhibitors such as citalopram, fluoxetine, fluvoxamine, and sertraline; procyclidine; propoxyphene; propranolol; ranitidine; rifampin; risperidone; ritonavir; sibutramine; tamoxifen; terbinafine; theophylline; ticlopidine; timolol; tramadol; trazodone; and venlafaxine . Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products and nutritional supplements you are taking, especially St. John's wort and tryptophan.
  • tell your doctor if you use or have ever used street drugs or have overused prescription medications, if you have recently had a heart attack, and if you have or have ever had glaucoma (an eye disease); seizures; bleeding from your stomach or esophagus (tube that connects the mouth and stomach) or liver, kidney, or heart disease.
  • tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking paroxetine, call your doctor. Paroxetine may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking paroxetine.
  • you should know that paroxetine may make you drowsy and affect your judgment and thinking. Do not drive a car or operate machinery until you know how this medication affects you.
  • ask your doctor about the safe use of alcoholic beverages while you are taking paroxetine.

 

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Paroxetine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
  • headache

  • dizziness

  • weakness

  • difficulty concentrating

  • nervousness

  • forgetfulness

  • confusion

  • sleepiness or feeling ''drugged''

  • nausea

  • vomiting

  • diarrhea

  • constipation

  • gas

  • stomach pain

  • heartburn

  • changes in ability to taste food

  • decreased appetite

  • weight loss or gain

  • changes in sex drive or ability

  • dry mouth

  • sweating

  • yawning

  • sensitivity to light

  • lump or tightness in throat

  • pain in the back, muscles, bones, or anywhere in the body

  • tenderness or swelling of joints

  • muscle weakness or tightness

  • flushing

  • sore teeth and gums

  • unusual dreams

  • painful or irregular menstruation

 

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • blurred vision

  • seeing things or hearing voices that do not exist (hallucinating)

  • fainting

  • rapid, pounding, or irregular heartbeat

  • chest pain

  • difficulty breathing

  • seizure

  • fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness or twitching

  • abnormal bleeding or bruising

  • tiny red spots directly under the skin

  • peeling or blistering of skin

  • sore throat, fever, chills, cough, and other signs of infection

  • uncontrollable shaking of a part of the body

  • unsteady walking that may cause falling

  • sudden muscle twitching or jerking that you cannot control

  • numbness or tingling in your hands, feet, arms, or legs

  • difficult, frequent, or painful urination

  • swelling, itching, burning, or infection in the vagina

  • painful erection that lasts for hours

  • sudden nausea, vomiting, weakness, cramping, bloating, swelling, tightness in hands and feet, dizziness, headache and/or confusion

  • hives

  • skin rash

  • itching

  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

  • hoarseness

  • black and tarry stools

  • red blood in stools

  • bloody vomit

  • vomit that looks like coffee grounds

 

Paroxetine may decrease appetite and cause weight loss in children. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight while he or she is taking this medication. Talk to your child's doctor about the risks of giving paroxetine to your child.

Paroxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

 

In case of emergency/overdose

In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.

Symptoms of overdose may include the following:

  • drowsiness

  • coma

  • uncontrollable shaking of a part of the body

  • fast, pounding, irregular, or slow heartbeat

  • confusion

  • nausea

  • vomiting

  • dizziness

  • seizures

  • fainting

  • blurred vision

  • extreme tiredness

  • unusual bruising or bleeding

  • lack of energy

  • loss of appetite

  • pain in the upper right part of the stomach

  • flu-like symptoms

  • yellowing of the skin and eyes

  • aggressive behavior

  • muscle pain, stiffness, or weakness

  • sudden muscle twitching or jerking that you cannot control

  • dark red or brown urine

  • difficulty urinating

  • diarrhea

  • frenzied, abnormally excited mood

  • sweating

  • fever

  • difficulty walking

     


What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Ref:  U.S. National Library of Medicine.


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

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