Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

PAROXETINE SUSPENSION - ORAL

(pair-OX-eh-teen)

COMMON BRAND NAME(S): Paxil

Uses

This medication is a selective serotonin reuptake inhibitor (SSRI) used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), social anxiety disorder (social phobia), post-traumatic stress disorder (PTSD), and generalized anxiety disorders (GAD). Paroxetine should not be used in children less than 18 years of age. It has not been shown to be effective for depression in children and teenagers. Also, it may cause serious side effects in this age group (see Side Effects section). Consult the doctor or pharmacist for more details. SSRI's work by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

OTHER

Uses

This medication has also been used to treat a severe form of premenstrual syndrome (premenstrual dysphoric disorder- PMDD), sexual function problems in men (premature ejaculation), nerve problems associated with diabetes (diabetic neuropathy), and chronic headaches.

How To Use

Shake the bottle well before each dose. Take this medication by mouth usually once daily in the morning, with or without food; or as directed by your doctor. The dosage is based on your medical condition and response to therapy. It is important to continue taking this medication as prescribed even if you feel well. Also, do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased. It may take up to several weeks before the full benefit of this drug takes effect.

Side Effects

Nausea, drowsiness, dizziness, diarrhea, trouble sleeping, constipation, or dry mouth may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: loss of appetite, unusual or severe mental/mood changes, increased sweating/flushing, unusual fatigue, uncontrolled movements (tremor), decreased interest in sex. Tell your doctor immediately if any of these unlikely but serious side effects occur: blurred vision, changes in sexual ability, change in amount of urine. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: fainting, irregular heartbeat, tingling or numbness of hands/feet, muscle pain, trouble swallowing, unusual swelling, seizures, easy bruising or bleeding. Paroxetine may infrequently cause suicidal thoughts or self-harm urges in children or teenagers up to 18 years of age. Tell the doctor immediately should this occur (see Uses section). Males - in the very unlikely event you have a painful, prolonged erection, stop using this drug and seek immediate medical attention or permanent problems could occur. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: liver problems, kidney problems, seizures, heart problems, other mental/mood disorders (e.g., bipolar disorder), thyroid problems, any allergies. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Caution is advised when using this product in the elderly because they may be more sensitive to the effects of the drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

Certain medications taken with this product could result in serious, even fatal, drug interactions. Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) within 2 weeks, and avoid taking thioridazine within 5 weeks, before or after treatment with this medication. Consult your doctor or pharmacist for additional information. This drug is not recommended for use with: weight loss drugs (e.g., sibutramine, phentermine), thioridazine, terfenadine, astemizole. Ask your doctor or pharmacist for more details. Tell your doctor of all prescription and nonprescription medication you may use, especially: other SSRI antidepressants (e.g., citalopram, fluoxetine), nefazodone, trazodone, tramadol, venlafaxine, "triptan" migraine drugs (e.g., sumatriptan, zolmitriptan), tricyclic antidepressants (e.g., amitriptyline, nortriptyline), cimetidine, digoxin, flecainide, propafenone, clozapine, lithium, tryptophan, "blood thinners" (e.g., warfarin), theophylline, herbal/natural products (e.g., St John's wort, melatonin, ayahuasca). Tell your doctor if you take any drugs that cause drowsiness such as: medicine for sleep, sedatives, tranquilizers, anti- anxiety drugs (e.g., diazepam), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine), anti-seizure drugs (e.g., carbamazepine), muscle relaxants, certain antihistamines (e.g., diphenhydramine). Other drugs besides paroxetine which may affect the heart rhythm (QTc prolongation in the EKG) include dofetilide, pimozide, quinidine, sotalol, procainamide, and sparfloxacin among others. QTc prolongation can infrequently result in serious, rarely fatal, irregular heartbeats. Consult your doctor or pharmacist for details. Ask for instructions about whether you need to stop any other QTc-prolonging drugs you may be using in order to minimize the risk of this effect. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: irregular heartbeat, fainting, severe dizziness or lightheadedness.

Notes

Do not share this medication with others. Laboratory and/or medical tests may be performed to monitor your progress.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at, or below room temperature (77 degrees F or 25 degrees C) away from light and moisture.