PAXIL CR 25 MG (Paroxetine CR) - Generic

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PEXEP CR is the international generic and equivalent of PAXIL CR

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PAXIL CR 25 MG  (Paroxetine CR) - Generic

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What is Generic PAXIL CR (Paroxetine CR)?
Paroxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paroxetine affects chemicals in the brain that may become unbalanced.Paroxetine is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).Paroxetine may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Generic PAXIL CR (Paroxetine CR)?
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Paroxetine may cause heart defects or serious, life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking paroxetine, do not stop taking the medication without first talking to your doctor. Do not take paroxetine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).


What should I discuss with my healthcare provider before taking Generic PAXIL CR (Paroxetine CR)?
Do not use paroxetine if you are using pimozide (Orap), thioridazine (Mellaril), or an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam). Serious and sometimes fatal reactions can occur when these medicines are taken with paroxetine. You must wait at least 14 days after stopping an MAO inhibitor before you can take paroxetine. After you stop taking paroxetine, you must wait at least 14 days before you start taking an MAOI.


Before taking paroxetine, tell your doctor if you are allergic to any drugs, or if you have:
liver or kidney disease;a bleeding or blood clotting disorder;seizures or epilepsy; orbipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts.If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.
You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
FDA pregnancy category D. Paroxetine may cause heart defects or serious, life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking paroxetine, do not stop taking the medication without first talking to your doctor. Paroxetine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. 


How should I take Generic PAXIL CR (Paroxetine CR)?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from the medication.Try to take the medicine at the same time each day. Follow the directions on your prescription label.
Do not crush, chew, or break a controlled-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. Shake the liquid form of paroxetine well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. It may take up to 4 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment.You may have withdrawal symptoms (such as agitation, dizziness, numbness or tingling, ringing in your ears, confusion, or behavior changes) after you stop taking paroxetine. Do not stop taking this medication suddenly without first talking to your doctor.


Store paroxetine at room temperature away from moisture and heat.


What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.
 


What happens if I overdose?
Seek emergency medical attention if you think you have taken too much of this medication. Overdose symptoms may include nausea, vomiting, tremor, sweating, decreased urination, blurred vision, rapid heartbeat, confusion, aggression, seizures, and coma.


What should I avoid while taking Generic PAXIL CR (Paroxetine CR)?
Avoid drinking alcohol, which can increase some of the side effects of paroxetine. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, or anxiety can add to sleepiness caused by paroxetine. Tell your doctor if you regularly use any of these medicines, or any other antidepressant. Paroxetine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.


Side effects of Generic PAXIL CR (Paroxetine CR):
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/or physical hyperactivity), thoughts of suicide or hurting yourself.


Call your doctor at once if you have any of these serious side effects:
easy bruising or bleeding (such as a nosebleed);very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats, tremors, overactive reflexes;nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; orheadache, trouble concentrating, memory problems, weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops.


Less serious side effects may include:
feeling nervous;drowsiness, dizziness;sleep problems (insomnia);mild nausea, constipation;weight changes;decreased sex drive, impotence, or difficulty having an orgasm; ordry mouth, yawning, or ringing in your ears.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.


What other drugs will affect Generic PAXIL CR (Paroxetine CR)?
Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin and NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with paroxetine may cause you to bruise or bleed easily.
Many drugs can interact with paroxetine.


Below is just a partial list. Tell your doctor if you are using:
a blood thinner such as warfarin (Coumadin);cimetidine (Tagamet);fosamprenavir (Lexiva);linezolid (Zyvox);ritonavir (Norvir);St. John's wort;tamoxifen (Nolvadex, Soltamox);theophylline (Elixophyllin, Theo-24, Uniphyl);tramadol (Ultram);tryptophan (also called L-tryptophan);heart medication such as digoxin (digitalis, Lanoxin), disopyramide (Norpace), flecaininde (Tambocor), mexiletine (Mexitil), morizicine (Ethmozine), propafenone, (Rythmol), procainamide (Procan, Procanbid, Pronestyl), quinidine (QuinaGlute, Quinidex, Quin-Release), or risperidone (Risperdal);any other antidepressant such as amitriptyline (Elavil), citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), or sertraline (Zoloft);medicine to treat psychiatric disorders, such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), lithium (Lithobid, Eskalith), or perphenazine (Trilafon); oralmotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig).
This list is not complete and there may be other drugs that can interact with paroxetine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



Generic Name Paroxetine CR
Search Name PAXIL CR Generic 25 MG Tab
Supply Name PEXEP CR
Brand Generic GENERIC
Presentation Foil in Box
Dosage Tab
USA Brand PAXIL CR
Manufacture Intas Pharma
Strength 25 MG
Search Terms PAXIL CR ,PEXEP CR ,Paroxetine CR
Origin India

Use spaces to separate tags. Use single quotes (') for phrases.

For the Consumer

Applies to paroxetine: oral capsule, oral suspension, oral tablet, oral tablet extended release

Along with its needed effects, paroxetine (the active ingredient contained in Paxil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking paroxetine:

Less common
- Agitation
- chest congestion
- chest pain
- chills
- cold sweats
- confusion
- difficulty with breathing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- muscle pain or weakness
- skin rash

Rare
- Absence of or decrease in body movements
- bigger, dilated, or enlarged pupils (black part of the eye)
- convulsions (seizures)
- difficulty with speaking
- dry mouth
- fever
- inability to move the eyes
- incomplete, sudden, or unusual body or facial movements
- increased sensitivity of the eyes to light
- poor coordination
- red or purple patches on the skin
- restlessness
- shivering
- sweating
- talking, feeling, and acting with excitement and activity you cannot control
- trembling or shaking, or twitching

Incidence not known
- Back, leg, or stomach pains
- blindness
- blistering, peeling, or loosening of the skin
- blue-yellow color blindness
- blurred vision
- constipation
- cough or hoarseness
- dark urine
- decreased frequency or amount of urine
- decreased vision
- difficulty with swallowing
- electric shock sensations
- eye pain
- fainting
- general body swelling
- headache
- high fever
- hives
- inability to move the arms and legs
- inability to sit still
- increased thirst
- incremental or ratchet-like movement of the muscle
- itching skin
- joint pain
- light-colored stools
- lockjaw
- loss of appetite
- loss of bladder control
- low blood pressure
- lower back or side pain
- muscle spasm, especially of the neck and back
- muscle tension or tightness
- painful or difficult urination
- painful or prolonged erection of the penis
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- raised red swellings on the skin, the buttocks, legs, or ankles
- red, irritated eyes
- sensitivity to the sun
- skin redness or soreness
- slow heart rate
- sores, ulcers, or white spots on the lips or in the mouth
- spasms of the throat
- stiff muscles
- stomach pain
- sudden numbness and weakness in the arms and legs
- swelling of the breasts
- swelling of the face, fingers, or lower legs
- swollen or painful glands
- tightness in the chest
- unexpected or excess milk flow from the breasts
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- weight gain
- yellowing of the eyes or skin

Some side effects of paroxetine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
- Acid or sour stomach
- belching
- decreased appetite
- decreased sexual ability or desire
- heartburn
- pain or tenderness around the eyes and cheekbones
- passing gas
- problems in urinating
- runny or stuffy nose
- sexual problems, especially ejaculatory disturbances
- sleepiness or unusual drowsiness
- stomach discomfort or upset
- trouble with sleeping

Less common
- Abnormal dreams
- change in sense of taste
- congestion
- discouragement, feeling sad, or empty
- drugged feeling
- fast or irregular breathing
- feeling of unreality
- headache, severe and throbbing
- increased appetite
- itching of the vagina or genital area
- itching, pain, redness, or swelling of the eye or eyelid
- lack of emotion
- loss of interest or pleasure
- lump in the throat
- menstrual changes
- pain during sexual intercourse
- problems with memory
- sense of detachment from self or body
- sneezing
- thick, white vaginal discharge with no odor or with a mild odor
- tightness in the throat
- tingling, burning, or prickling sensations
- trouble concentrating
- voice changes
- watering of the eyes
- weight loss
- yawn
USUAL ADULT DOSE FOR DEPRESSION

Immediate release tablets and suspension:
Initial dose: 20 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 20 to 50 mg orally once a day with or without food, usually in the morning.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

Extended release tablets:
Initial dose:
Paroxetine- naive patients: 25 mg orally once a day with or without food, usually in the morning.
Conversion: 30 mg immediate release paroxetine corresponds to 37.5 mg extended release tablets.
Maintenance dose: The initial dose may be increased to a maximum of 62.5 mg per day.
Dosage change: Dose may be increased in 12.5 mg per day increments at intervals of at least one week.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

USUAL ADULT DOSE FOR ANXIETY

Immediate release tablets and suspension:
Initial dose: 20 mg orally once a day with or without food, usually in the morning.
Maintenance dose: Doses up to 60 mg orally once a day with or without food, usually in the morning, can be used.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

Extended release tablets:
Initial dose: 12.5 mg orally once a day with or without food, usually in the morning.
Maintenance dose: The initial dose may be increased in 12.5 mg increments weekly, to a maximum of 37.5 mg per day.
Dosage change: May occur at intervals of at least one week.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

USUAL ADULT DOSE FOR PANIC DISORDER

Immediate release tablets and suspension:
Initial dose: 10 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 40 mg orally once daily with or without food, usually in the morning. Doses up to 60 mg orally once a day in the morning can be used.
Dosage change: May occur in 10 mg per day increments at intervals of at least one week.

Extended release tablets:
Initial dose: Paroxetine naive patients: 12.5 mg orally once a day with or without food, usually in the morning.
Maintenance dose: The initial dose may be increased in 12.5 mg per day increments at intervals of at least one week, to a maximum of 75 mg per day.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

USUAL ADULT DOSE FOR PREMENSTRUAL DYSPHORIC DISORDER

Extended release tablets:
Initial: 12.5 mg orally once a day with or without food, usually in the morning continuously, or alternatively, 12.5 mg orally once a day with or without food, usually in the morning during the luteal phase of the menstrual cycle (the 14 days prior to the anticipated start of menses).
Maintenance: Doses up to 25 mg once a day with or without food, usually in the morning, have been shown to be effective in clinical trials. Effectiveness for a period exceeding 3 menstrual cycles has not been evaluated in controlled trials. However, it is reasonable to consider continuation in a responding patient.
Dosage change: May occur at intervals of at least one week.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

USUAL ADULT DOSE FOR OBSESSIVE COMPULSIVE DISORDER

Immediate release tablets and suspension:
Initial dose: 20 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 40 mg orally once a day with or without food, usually in the morning. Doses up to 60 mg orally once a day in the morning can be used.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

USUAL ADULT DOSE FOR POST TRAUMATIC STRESS DISORDER

Immediate release tablets and suspension:
Initial dose: 20 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 20 to 50 mg orally once a day with or without food, usually in the morning.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

USUAL ADULT DOSE FOR POSTMENOPAUSAL SYMPTOMS

Approved indication for paroxetine marketed as Brisdelle (R) only: Treatment of moderate to severe vasomotor symptoms associated with menopause:
7.5 mg orally once daily at bedtime with or without food

RENAL DOSE ADJUSTMENTS

CrCl 25 mL/min or less:
Immediate release tablets and suspension:
Initial dose: 10 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 10 mg to a maximum of 40 mg per day.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

Extended release tablets:
Initial dose: Paroxetine- naive patients: 12.5 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 12.5 mg to a maximum of 50 mg per day.
Dosage change: Dose may be increased in 12.5 mg per day increments at intervals of at least one week.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

LIVER DOSE ADJUSTMENTS

Immediate release tablets and suspension: Initially, 10 mg orally once a day with or without food, usually in the morning; dose may be increased in 10 mg/day increments at weekly intervals to a maximum of 40 mg per day.

Extended release tablets: Initially, 12.5 mg orally once a day with or without food, usually in the morning; dose may be increased in 12.5 mg/day increments at weekly intervals to a maximum of 50 mg per day.

DOSE ADJUSTMENTS

Dose changes in 10 mg per day increments should occur at intervals of at least 1 week. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

DIALYSIS

Data not available

OTHER COMMENTS

Evaluation of the efficacy of paroxetine has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg.

Patients should be maintained on the lowest effective dosage and periodically reassessed to determine the need for continued therapy.

Extended release tablets and immediate release tablets and suspension are usually administered in the morning without regard to food.

Extended release tablets should be swallowed whole and not chewed or crushed.