Wednesday, October 5, 2016

Ponstel


Pronunciation: me-fe-NAM-ik
Generic Name: Mefenamic Acid
Brand Name: Ponstel

Ponstel is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Ponstel for a long time. Do not use Ponstel right before or after bypass heart surgery.


Ponstel may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.





Ponstel is used for:

Treating menstrual pain. It may be used for short term (not more than 7 days) treatment of mild to moderate pain. It may also be used for other conditions as determined by your doctor.


Ponstel is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.


Do NOT use Ponstel if:


  • you are allergic to any ingredient in Ponstel

  • you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, celecoxib)

  • you have recently had or will be having bypass heart surgery

  • you have kidney problems, ulcers, or inflammation of the stomach or bowel

  • you are in the last 3 months of pregnancy

Contact your doctor or health care provider right away if any of these apply to you.



Before using Ponstel:


Some medical conditions may interact with Ponstel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)

  • if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation

  • if you have high blood pressure, blood disorders (eg, porphyria), bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases

  • if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you drink alcohol, or you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Ponstel. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased

  • Magnesium hydroxide (eg, antacids) or probenecid because they may increase the risk of Ponstel's side effects

  • Cyclosporine, lithium, methotrexate, quinolones (eg, ciprofloxacin), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Ponstel

  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Ponstel

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ponstel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Ponstel:


Use Ponstel as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Ponstel comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ponstel refilled.

  • Take Ponstel by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.

  • Take Ponstel with a full glass of water (8 oz/240 mL) as directed by your doctor.

  • If you miss a dose of Ponstel and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ponstel.



Important safety information:


  • Ponstel may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Ponstel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Serious stomach ulcers or bleeding can occur with the use of Ponstel. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Ponstel with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • Ponstel is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Do not take aspirin while you are using Ponstel unless your doctor tells you to.

  • Ponstel may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take Ponstel.

  • Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be performed while you use Ponstel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Ponstel with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.

  • Ponstel should be used with extreme caution in CHILDREN younger than 14 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Ponstel may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ponstel while you are pregnant. Ponstel is found in breast milk. Do not breast-feed while taking Ponstel.


Possible side effects of Ponstel:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach upset.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Ponstel side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.


Proper storage of Ponstel:

Store Ponstel at 68 to 77 degrees F (20 to 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ponstel out of the reach of children and away from pets.


General information:


  • If you have any questions about Ponstel, please talk with your doctor, pharmacist, or other health care provider.

  • Ponstel is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is summary only. It does not contain all information about Ponstel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ponstel resources


  • Ponstel Side Effects (in more detail)
  • Ponstel Use in Pregnancy & Breastfeeding
  • Drug Images
  • Ponstel Drug Interactions
  • Ponstel Support Group
  • 11 Reviews for Ponstel - Add your own review/rating


  • Ponstel Prescribing Information (FDA)

  • Ponstel Advanced Consumer (Micromedex) - Includes Dosage Information

  • Ponstel Concise Consumer Information (Cerner Multum)

  • Ponstel Monograph (AHFS DI)

  • Mefenamic Acid Prescribing Information (FDA)

  • Mefenamic Acid Professional Patient Advice (Wolters Kluwer)



Compare Ponstel with other medications


  • Pain
  • Period Pain

Paxil



Generic Name: Paroxetine Hydrochloride
Class: Selective Serotonin-reuptake Inhibitors
VA Class: CN609
Chemical Name: trans-(-)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride hemihydrate
Molecular Formula: C19H20FNO3•HCl•½H2O
CAS Number: 110429-35-1


Special Alerts:


[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: , and .


[Posted 07/19/2006] FDA notified healthcare professionals and consumers of important information from two recent studies that should be considered when making treatment decisions in pregnant women who take antidepressants. The studies included pregnant women who were treated with selective serotonin reuptake inhibitors (SSRIs), or in a few cases, other antidepressant medications.


One study illustrated the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. In this study, women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were women who continued to take their antidepressant medicine while pregnant.


The second study suggests there may be additional, though rare, risks of taking SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth. Babies born with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. In this study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk of one drug compared to another. The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing.


Additionally, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiologic study that suggests that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects.


Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant medication without first consulting their physician. The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN. For more information visit the FDA website at: and .


[Posted 07/19/2006] FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.


Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea.


Healthcare professionals prescribing a triptan, SSRI or SNRI should keep in mind that triptans are often used intermittently and either the triptan, SSRI or SNRI may be prescribed by a different physician; weigh the potential risk of serotonin syndrome with the expected benefit of using the above combination; discuss the possibility of serotonin syndrome with patients if a triptan and an SSRI or SNRI will be used together; and follow patients closely during treatment if a triptan and an SSRI or SNRI are used together.


Patients taking a triptan along with an SSRI or SNRI should talk to their doctor before stopping their medication and should immediately seek medical attention if they experience any of the above symptoms. FDA requested that all manufacturers of triptans, SSRIs and SNRIs update their prescribing information to warn of the possibility of serotonin syndrome when these medications are taken together. For more information visit the FDA website at: and .




  • Suicidality in Children and Adolescents


  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder and other psychiatric disorders (see Pediatric Use under Cautions); balance this risk with clinical need.1 311 312 314 315 Paroxetine is not approved for use in pediatric patients.1 312




  • Closely monitor pediatric patients who are started on paroxetine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.1 312 314 (See Worsening of Depression and Suicidality Risk under Cautions.)




Introduction

Antidepressant; selective serotonin-reuptake inhibitor (SSRI).1 2 5 6


Uses for Paxil


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Major Depressive Disorder


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Management of major depressive disorder.1 5 8 9 10 11 12 13 14 15 16 17 18 19 20 21 26 30 39 42 74 76 131 132 134 135 155


Efficacy in hospital settings not established.1


Obsessive-Compulsive Disorder (OCD)


Management of OCD;1 49 50 SSRIs reduce but do not completely eliminate obsessions and compulsions.1


Panic Disorder


Management of panic disorder with or without agoraphobia.1 48 53 54 180 186 187 190 192 272


Social Phobia


Management of social phobia (social anxiety disorder).1 155 158 159 160 161


Anxiety Disorders


Management of generalized anxiety disorder.1


Posttraumatic Stress Disorder (PTSD)


Management of PTSD (alone or in combination with psychotherapy).1 168 296 297 298


Premenstrual Dysphoric Disorder (PMDD)


Management of PMDD.79 80 155 162


Premature Ejaculation


Has been used for the management of premature ejaculation.169 170 171 172 173 174


Diabetic Neuropathy


Has been used for the management of diabetic neuropathy.24 136


Chronic Headache


Has been used for the management of chronic headache.155 163 164


Paxil Dosage and Administration


General



  • Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of paroxetine, and vice versa.1




  • Monitor for possible worsening of depression or suicidality, especially at the beginning of therapy or during periods of dosage adjustments.1 312 314 (See Worsening of Depression and Suicidality Risk under Cautions.)




  • Sustained therapy may be required;1 42 51 52 101 102 103 104 129 130 133 monitor periodically for need for continued therapy.1




  • Avoid abrupt discontinuance of therapy;24 184 197 198 200 204 to avoid withdrawal reactions, taper dosage gradually over a period of several weeks.184 194 197 198 200 (See Withdrawal of Therapy under Cautions.)




  • Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery.1 312 329 330 331 332 (See Pregnancy under Cautions.)



Administration


Oral Administration


Administer orally once daily (in the morning) without regard to meals;1 7 8 19 92 312 however, administration with food may minimize adverse GI effects.8 19


Shake oral suspension well just prior to administration.1


Swallow extended-release tablets whole; do not chew or crush.304


Dosage


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Available as paroxetine hydrochloride; dosage expressed in terms of paroxetine.1


Adults


Major Depressive Disorder

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Oral

Conventional tablets or suspension: Initially, 20 mg once daily.1 304 If no improvement, dosage may be increased in 10-mg increments at weekly intervals.1 304


Extended-release tablets: Initially, 25 mg once daily.1 304 If no improvement, dosage may be increased in 12.5-mg increments at weekly intervals.1 304


Optimum duration not established; may require several months of therapy or longer.1 22 42 101 102 103 104 129 130 133 304 Antidepressant efficacy demonstrated for up to 1 year at mean dosage of 30 mg daily as conventional tablets or suspension, which corresponds to a 37.5 mg daily dosage as extended-release tablets.1 133


Obsessive-Compulsive Disorder

Oral

Conventional tablets or suspension: Initially, 20 mg once daily.1 If no improvement, dosage may be increased in 10-mg increments at weekly intervals, to 40 mg daily.1


Optimum duration not established; efficacy has been demonstrated in a 6-month relapse prevention trial.1 Obsessive-compulsive disorder is chronic and requires several months or longer of sustained therapy.1 51 52 May continue therapy in responding patients, 1 51 52 but use lowest effective dosage and periodically reassess need for continued therapy.1


Panic Disorder

Oral

Conventional tablets or suspension: Initially, 10 mg once daily.1 48 If no improvement, dosage may be increased in 10-mg increments at weekly intervals, to 40 mg daily.1 48


Extended-release tablets: Initially, 12.5 mg once daily.312 If no improvement, dosage may be increased in 12.5-mg increments at weekly intervals.312


Optimum duration not established; efficacy demonstrated in a 3-month relapse prevention trial.1 48 54 184 May continue therapy in responding patients,1 48 54 184 but use lowest effective dosage and periodically reassess need for continued therapy.1


Social Phobia

Oral

Conventional tablets or suspension: 20 mg once daily; no additional clinical benefit was observed with higher dosages.1


Extended-release tablets: Initially, 12.5 mg once daily.312 If dosage is increased, use increments of 12.5-mg increments at weekly intervals.312


Long-term efficacy (>12 weeks) not demonstrated; may consider continuation in patient who responds, but use lowest effective dosage and periodically reassess need for continued therapy.1


Anxiety Disorders

Oral

Conventional tablets or suspension: Initially, 20 mg daily; no additional clinical benefit was observed with higher dosages.1 If needed, dosage may be increased in 10-mg increments at weekly intervals.1


Optimum duration not established; efficacy has been demonstrated in a 24-week relapse prevention trial.1 321 Generalized anxiety disorder is chronic.1 321 May continue therapy in responding patients.1 321 If used for extended periods, adjust dosage so that patients are maintained on lowest effective dosage and periodically reassess need for continued therapy.1


Posttraumatic Stress Disorder

Oral

Conventional tablets or suspension: 20 mg daily; insufficient evidence to suggest greater clinical benefit with higher dosages.1 If needed, dosage may be increased in 10-mg increments at weekly intervals.1


Consider alternative therapy if patient fails to achieve ≥25% reduction in PTSD symptoms at week 8.300 If >75% reduction in PTSD symptoms and response maintained for ≥3 months, may consider up to 24 months of drug therapy.300 If used for extended periods, adjust dosage so that patients are maintained on lowest effective dosage and periodically reassess need for continued therapy.1


Premenstrual Dysphoric Disorder

Oral

Conventional tablets or suspension: 5–30 mg daily.79


Extended-release tablets: Initially, 12.5 mg once daily; may be administered daily throughout menstrual cycle or only during luteal phase.312 Dosage may be increased in intervals of ≥1 week.312 Dosages of 12.5–25 mg were effective in clinical studies.312


Premature Ejaculation

Oral

Conventional tablets or suspension: 10–40 mg once daily.172 173 279 280 281 Alternatively, 20 mg taken 3–4 hours before planned intercourse on an “as needed” basis.280 281


Diabetic Neuropathy

Oral

Conventional tablets or suspension: 40 mg daily.24 136


Chronic Headache

Oral

Conventional tablets or suspension: 10–50 mg daily for 3–9 months.164


Prescribing Limits


Adults


Major Depressive Disorder

Oral

Conventional tablets or suspension: Maximum 50 mg daily.


Extended-release tablets: 62.5 mg daily.1 304


Obsessive-Compulsive Disorder

Oral

Conventional tablets or suspension: Maximum 60 mg daily.1


Panic Disorder

Oral

Conventional tablets or suspension: Maximum 60 mg daily.1


Extended-release tablets: 75 mg daily.312


Social Phobia

Oral

Extended-release tablets: 37.5 mg daily.312


Special Populations


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Hepatic Impairment


Oral

In patients with severe hepatic impairment, an initial dosage of 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets).1 304 If no clinical improvement is apparent, dosage may be titrated with caution up to a maximum of 40 mg daily (for conventional tablets or suspension) or 50 mg (for extended-release tablets).1 98 99 304


Renal Impairment


Oral

In patients with severe renal impairment, an initial dosage of 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets).1 304 If no clinical improvement is apparent, dosage may be titrated with caution up to a maximum of 40 mg daily (for conventional tablets or suspension) or 50 mg (for extended-release tablets).1 98 99 304


Geriatric or Debilitated Patients


Initially, 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets); if no clinical improvement is apparent, dosage may be titrated up to a maximum of 40 mg daily (as conventional tablets or suspension) or 50 mg daily (as extended-release tablets).1 95 304


Cautions for Paxil


Contraindications



  • Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.1 5




  • Concurrent therapy with thioridazine.1 (See Drug Interactions under Warnings.)




  • Concurrent pimozide therapy.1 312 (See Interactions.)




  • Known hypersensitivity to paroxetine or any ingredient in the formulation.1



Warnings/Precautions


Warnings


Drug Interactions

Concomitant use of some SSRIs with MAO inhibitor associated with serious, sometimes fatal reactions, including manifestations resembling serotonin syndrome (e.g., hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes) or neuroleptic malignant syndrome (NMS).1 (See Contraindications.)


May inhibit CYP2D6, resulting in increased risk of QT prolongation and/or ventricular tachycardia of the torsades de pointes type associated with elevated plasma concentrations of thioridazine.1 (See Contraindications.)


Worsening of Depression and Suicidality Risk

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) in both adult and pediatric patients with major depressive disorder; may persist until clinically important remission occurs with therapy.1 312 314


Possible increased risk of suicidal behavior in young adult patients (18–30 years of age), particularly those with major depressive disorder.a b c Increased risk of suicidal behavior and thoughts in patients with a history of suicidal behavior or thoughts and in patients exhibiting a substantial degree of suicidal ideation prior to initiating therapy.a b c Increased risk of suicidal behavior was observed despite evidence of paroxetine efficacy in patients being treated for major depressive disorder.b


Closely supervise pediatric patients receiving paroxetine for any reason and adult patients with major depressive disorder or other psychiatric illness with comorbid depression during initiation of therapy and during periods of dosage adjustments.1 312 314 (See Boxed Warning.) Carefully monitor all patients, particularly young adults and those that are improving, during paroxetine therapy regardless of the condition being treated.b


If anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and/or mania occur, consider changing or discontinuing therapy, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.1 312 314 If decision is made to discontinue therapy, taper paroxetine dosage as rapidly as is feasible but consider risks of abrupt discontinuance.1 312 314 (See General under Dosage and Administration.)


Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.1 312 314


Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.1 312 314


Bipolar Disorder

May unmask bipolar disorder.1 312 314 (See Activation of Mania or Hypomania under Cautions.) Paroxetine is not approved for use in treating bipolar depression.1 312


Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.1 312 314


Fetal/Neonatal Morbidity and Mortality

May increase risk of fetal defects (e.g., cardiovascular malformations, principally ventricular and atrial septal defects; other major congenital malformations) when administered to pregnant women.326 333 337 338 a c


If a patient becomes pregnant during treatment, advise patient of the potential hazard to the fetus.337 338 a c Unless the potential benefits to the mother justify continuing treatment, consider discontinuing paroxetine therapy or switching to another antidepressant.337 338 a c For women who intend to become pregnant or are in their first trimester of pregnancy, initiate paroxetine only after consideration of other available treatment options.337 338 a c


Possible complications, sometimes severe and requiring prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care in neonates exposed to paroxetine, other SSRIs, or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs) late in the third trimester; may arise immediately upon delivery.1 312 327 328 329 330 331 332


Increased risk of persistent pulmonary hypertension of the newborn (PPHN) in infants exposed to SSRIs during late pregnancy; associated with substantial neonatal morbidity and mortality.a c


Carefully consider both the potential risks and benefits of treatment when used during the third trimester of pregnancy.1 312 326 328 329 330 Be aware that in a longitudinal study involving women with a history of major depressive disorder who were euthymic while receiving antidepressant therapy at the beginning of pregnancy, women who discontinued antidepressant therapy during pregnancy were more likely to experience a relapse of depression than those who remained on antidepressant therapy.1 312 Consider cautiously tapering dose during third trimester prior to delivery.1 312 329 330 331 332


General Precautions


Activation of Mania or Hypomania

Possible activation of mania or hypomania.1 2 Use with caution in patients with a history of mania.1 312 (See Bipolar Disorder under Cautions.)


Seizures

Seizures have been reported.1 2 Limited experience with use of paroxetine in patients with a history of seizures; use with caution in such patients.1 Discontinue if seizures occur.1


Akathisia

Akathisia has been reported.1 226 227 312 Most likely to occur within the first few weeks of therapy.1 312


Hyponatremia

May occur secondary to SIADH;24 25 28 apparently reversible following discontinuance of the drug and/or fluid restriction.1 22 24 28 210 215 217 Occurs mainly in older patients1 22 24 25 28 and those receiving diuretics or otherwise volume depleted.1 (See Geriatric Use under Cautions.)


Abnormal Bleeding

Possible increased risk of bleeding, including upper GI bleeding;1 312 323 324 325 use with caution.a


Concomitant use of an NSAIA (e.g., aspirin) or warfarin may potentiate such risk.1 6 147 312 323 324 325


Concomitant Disease

May be less cardiotoxic than most older antidepressant agents but experience is limited in patients with recent MI or unstable heart disease.1 2 18 24 145 Use with caution.1 98 99 145 225


May cause mydriasis.1 299 Use with caution in patients with angle-closure glaucoma.1


Cognitive and Motor Performance

Does not appear to produce substantial cognitive or motor impairment,1 2 3 18 19 24 62 72 73 but patients should be cautioned to avoid activities requiring alertness or physical coordination until effects on individual are known.1 62


Withdrawal of Therapy

Possible withdrawal reactions following abrupt discontinuance or intermittent noncompliance with therapy.1 23 24 32 33 46 47 196 197 198 199 200 201 202 203 204 205 206 Avoid abrupt discontinuance of therapy;24 184 197 198 200 204 taper dosage gradually over a period of several weeks.184 194 197 198 200


If intolerable symptoms occur, reinstitute at the previously prescribed dosage until such symptoms abate.1 304 Clinicians may resume dosage reductions at that time but at a more gradual rate.1 304


Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT have not been systematically evaluated.1


Specific Populations


Pregnancy

Category D.337 338 a c See Fetal/Neonatal Morbidity and Mortality under Cautions.


Lactation

Distributed into human milk;1 100 use with caution.1


Pediatric Use

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Safety and efficacy not established in children <18 years of age.1 271 312


Greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, obsessive-compulsive disorder, or other psychiatric disorders based on pooled analyses of short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).1 312 314 315 No suicides occurred in these trials.1 312 314 315 If considering use of paroxetine in a child or adolescent, balance potential risks with clinical need.1 311 312 314 315 (See Worsening of Depression and Suicidality Risk under Cautions.)


Geriatric Use

Possible decreased clearance; however, efficacy and adverse effects similar to those in younger adults.1 2 4 7 18 24 83 95 96 97 Initiate therapy at a lower dosage.1 8 95 (See Geriatric or Debilitated Patients under Dosage and Administration.)


May be more likely than younger patients to develop hyponatremia and transient SIADH.1 22 24 25 28 214 215 Periodically monitor serum sodium concentrations, especially during the first several months of therapy.181 217


Hepatic Impairment

Increased plasma concentrations1 4 98 99 and decreased clearance reported.1 137 Use with caution; use at a reduced initial dosage if impairment is severe.1 98 99 145 225 (See Hepatic Impairment under Dosage and Administration.)


Renal Impairment

Increased plasma concentrations1 4 98 99 and decreased clearance reported.1 137 Use with caution; use at a reduced initial dosage if impairment is severe.1 98 99 145 225 (See Renal Impairment under Dosage and Administration.)


Common Adverse Effects


Nervous system effects (e.g., asthenia, somnolence, dizziness, insomnia, tremor, nervousness), GI effects (e.g., nausea, decreased appetite, constipation, dry mouth), impotence, ejaculatory dysfunction, female genital disorders (e.g., anorgasmia or difficulty reaching climax/orgasm), sweating.1 2 3 24 76


Interactions for Paxil


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Metabolized partially by CYP2D6.1 Inhibits the activity of CYP2D6 and to a lesser extent CYP3A4.1 91


Drugs Metabolized by Hepatic Microsomal Enzymes


Substrates of CYP2D6 or CYP3A4: possible increased plasma concentrations of the substrates.1 91 277


Use with caution and consider reducing dosage of concomitantly administered CYP2D6 substrate, particularly those with a narrow therapeutic index, such as TCAs, class IC antiarrhythmics and some phenothiazines.1 91 277


Drugs Affecting Hepatic Microsomal Enzymes


Inhibitors or inducers of CYP isoenzymes (e.g., CYP2D6): potential pharmacokinetic interaction (altered paroxetine metabolism and plasma concentrations).a


Drugs Associated with Serotonin Syndrome


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Potential pharmacodynamic interaction (serotonin syndrome).1 229 230 231 232 233 234 235 Although usually mild, serious complications and death occasionally have been reported.1 230 231 233 236 237 238 239 Serotonin syndrome most commonly occurs when serotonergic agents with different mechanisms of action are given concurrently or in close succession.230 231 233 236 237 Avoid such use, or use with caution.237 239


Drugs Affecting Hemostasis


Potential pharmacologic interaction (increased risk of bleeding) with concomitant use of drugs that affect hemostasis.1 6 147 323 312 324 325 Use with caution.1


Specific Drugs


















Drug



Interaction



Comments



Alcohol



Does not potentiate cognitive and motor effects of alcohol;1 2 3 6 19 24 146 possible serotonergically mediated pharmacodynamic interaction in CNS146



Avoid concomitant use1



Antacids



Pharmacokinetic interactions unlikely6 19 92



Antiarrhythmic agents, class IC (e.g., encainide, flecainide, propafenone)



Possible inhibition of metabolism by paroxetinea



Use cautiona



Antidepressants, tricyclic (TCA)



Increased peak plasma concentrations, AUC, and elimination half-life of TCA1



Use with caution1


May need to monitor plasma tricyclic concentrations; consider reducing tricyclic dosage1



Atomoxetine

Primidone



Class: Barbiturates
VA Class: CN400
Chemical Name: 5-ethyldihydro-5-phenyl-4,6(1H, 5H)-pyrimidinedione
CAS Number: 125-33-7
Brands: Mysoline


REMS:


FDA approved a REMS for primidone to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().



Introduction

Anticonvulsant; a structural analog of phenobarbital; related to barbiturate-derivative anticonvulsants.a b c d


Uses for Primidone


Used alone or with other anticonvulsants (e.g., phenytoin, phenobarbital); a c d however, some clinicians do not recommend concurrent use of primidone and phenobarbital because of possible increased sedation.a


Generalized Seizures


Prophylactic management of tonic-clonic (grand mal) seizures, particularly those refractory to other anticonvulsant therapy.a c d


Prophylactic management of other partial seizures (e.g., those with autonomic symptoms), including atonic (also known as akinetic) seizures.a b


Partial Seizures


Prophylactic management of partial seizures with complex symptomatology (psychomotor seizures).a c d


Prophylactic management of other partial seizures, including focal seizures.a b c d


Primidone Dosage and Administration


General



  • Closely monitor patients receiving anticonvulsant therapy for notable changes in behavior that could indicate emergence or worsening of suicidal thoughts or behavior or depression.d g h i (See Suicidality Risk under Cautions.)




  • When primidone therapy is discontinued, withdraw the drug slowly to avoid precipitating seizures or status epilepticus.a b c d




  • When a patient is transferred to primidone from another anticonvulsant, gradually increase primidone dosage over a period of at least 2 weeks while gradually decreasing dosage of the other anticonvulsant, to maintain adequate seizure control.a c



Administration


Oral Administration


Administer orally.a c d


Dosage


Adjust dosage carefully according to individual requirements and response.a c d In some cases, determination of blood concentrations of the drug may be needed to achieve optimal dosage adjustment.c d


May require several weeks of therapy before therapeutic efficacy can be assessed.c d


Pediatric Patients


Generalized and Partial Seizures

Oral

Anticonvulsant-naive children <8 years of age: Initially, 50 mg at bedtime (days 1–3), increase to 50 mg twice daily (days 4–6), then increase to 100 mg twice daily (days 7–9).a c d Follow with a maintenance dosage of 125–250 mg 3 times daily or 10–25 mg/kg daily given in divided doses.a c d Alternatively, some clinicians recommend 1.25 g/m2 daily in 2–4 divided doses.a


Anticonvulsant-naive children ≥8 years of age: Initially, 100–125 mg at bedtime (days 1–3), increase to 100–125 mg twice daily (days 4–6), then increase to 100–125 mg 3 times daily (days 7–9).a c d Follow with a maintenance dosage of 250 mg 3 or 4 times daily.a c d Do not exceed 500 mg 4 times daily.a c d


Children ≥8 years of age receiving other anticonvulsants: Initially, 100–125 mg (primidone) at bedtime; increase dosage (primidone) slowly to maintenance level while gradually decreasing dosage of other anticonvulsant.c d Continue this regimen until satisfactory dosage achieved with the combination, or the other drug is withdrawn.c d If primidone monotherapy is the objective, gradually increase primidone dosage while decreasing dosage of the drug being discontinued over a period of at least 2 weeks.a c d


Adults


Generalized and Partial Seizures

Oral

Anticonvulsant therapy-naive adults: Initially, 100–125 mg at bedtime (days 1–3), increase to 100–125 mg twice daily (days 4–6), then increase to 100–125 mg 3 times daily (days 7–9).a c d Follow with a maintenance dosage of 250 mg 3 or 4 times daily.a c d Do not exceed 500 mg 4 times daily.a c d


Adults receiving other anticonvulsants: Initially, 100–125 mg (primidone) at bedtime; increase dosage (primidone) slowly to maintenance level while gradually decreasing dosage of other anticonvulsant.c d Continue this regimen until satisfactory dosage is achieved with the combination, or the other drug is withdrawn.c d If primidone monotherapy is the objective, gradually increase primidone dosage while decreasing dosage of the drug being discontinued over a period of at least 2 weeks.a c d


Prescribing Limits


Pediatric Patients


Generalized and Partial Seizures

Oral

Children ≥8 years of age: Maximum 2 g daily given in divided doses (e.g., 500 mg 4 times daily).a c d


Adults


Generalized and Partial Seizures

Oral

Maximum 2 g daily given in divided doses (e.g., 500 mg 4 times daily).a c d


Special Populations


No special population dosage recommendations at this time.c d


Cautions for Primidone


Contraindications



  • Porphyria.c d




  • Known hypersensitivity to phenobarbital.c d



Warnings/Precautions


Warnings


Shares the toxic potentials of the barbiturate-derivative anticonvulsants; observe the usual precautions of anticonvulsant therapy.a


Suicidality Risk

Increased risk of suicidality (suicidal ideation or behavior) observed in an analysis of studies using various anticonvulsants in patients with epilepsy, psychiatric disorders (e.g., bipolar disorder, depression, anxiety), and other conditions (e.g., migraine, neuropathic pain); risk in patients receiving anticonvulsants (0.43%) was approximately twice that in patients receiving placebo (0.24%).d g h i j Increased suicidality risk was observed ≥1 week after initiation of anticonvulsant therapy and continued through 24 weeks.d g h j Risk was higher for patients with epilepsy compared with those receiving anticonvulsants for other conditions.d g h j


Closely monitor all patients currently receiving or beginning anticonvulsant therapy for changes in behavior that may indicate emergence or worsening of suicidal thoughts or behavior or depression.d g h i j Anxiety, agitation, hostility, hypomania, and mania may be precursors to emerging suicidality.g


Balance risk of suicidality with the risk of untreated illness.d g Epilepsy and other illnesses treated with anticonvulsants are themselves associated with morbidity and mortality and an increased risk of suicidality.d g If suicidal thoughts or behavior emerge during anticonvulsant therapy, consider whether these symptoms may be related to the illness itself.d i (See Advice to Patients.)


Withdrawal Effects

Abrupt withdrawal may result in increased seizure frequency or status epilepticus.a b c d


Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.c d


Reports suggest an association between use of anticonvulsants in pregnant, epileptic women and an increased incidence of birth defects in children born to these women; however, causal relationship to many anticonvulsants not established.c d f


Neurologic manifestations (overactivity, tumors) reported in neonates whose mothers received primidone during pregnancy.f


Do not discontinue anticonvulsants in pregnant women in whom the drugs are administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.c d


Carefully weigh these considerations when treating or counseling epileptic women of childbearing potential.c d


Neonatal hemorrhage (with a coagulation defect resembling vitamin K deficiency) reported in newborns whose mothers were receiving primidone during pregnancy.b c d f Administer prophylactic vitamin K to pregnant women taking primidone for one month prior to and during delivery.b c d Additionally, administer vitamin K to the neonate immediately after birth.b f


General Precautions


Laboratory Monitoring

Perform baseline CBC and a sequential multiple analysis-12 (SMA-12) test every 6 months during primidone therapy.a c d


Hematologic Effects

Granulocytopenia, agranulocytosis, red-cell hypoplasia and aplasia rarely reported; may require discontinuance of primidone.c d


Megaloblastic anemia may occur as a rare idiosyncrasy.c d Administer folic acid.c d


Specific Populations


Pregnancy

Category D.f Safety during pregnancy not established.a c d (See Fetal/Neonatal Morbidity and Mortality under Cautions.)


North American Antiepileptic Drug (NAAED) Pregnancy Registry at 888-233-2334 (for patients); registry information also available on the website .d


Lactation

Distributed into milk.a c d f Discontinue nursing or drug if excessive somnolence or drowsiness is observed in nursing infants of women receiving the drug.a c d


Pediatric Use

Safety and efficacy established in pediatric patients.c d


Possible paradoxical excitement and hyperactivity or an exacerbation of existing hyperactivity in children.b


Geriatric Use

Possible excitement, confusion, or depression.b


Common Adverse Effects


Drowsiness, ataxia, vertigo, lethargy, anorexia, nausea, vomiting.a c d


Interactions for Primidone


Specific Drugs


















Drug



Interaction



Comments



Contraceptives (oral)



Possible increased metabolism of both the estrogenic and progestinic components of oral contraceptivesb



Consider alternate methods of contraceptionb



Phenobarbital



Possible increased sedationa b



Use with caution,a if at all b



Phenytoin



Possible increase in amount of primidone converted to phenobarbital and increased sedationb



Valproic acid



Increased plasma phenobarbital concentrations and excessive somnolenceb



Observe patient for possible neurologic toxicity and monitor plasma concentrations of phenobarbital; decrease dosage of primidone if neededb


Primidone Pharmacokinetics


Absorption


Bioavailability


Approximately 60–80% absorbed from GI tract.a


Onset


Following oral administration, peak serum concentrations are reached in about 4 hours.a


Plasma Concentrations


Limited data indicate that serum primidone concentrations should be maintained at 5–12 mcg/mL to adequately control seizures and minimize risk of adverse effects.a c d


Distribution


Extent


Distributed into milk in substantial quantities.a c d


Elimination


Metabolism


Slowly metabolized by the liver.a Approximately 15–25% of an oral dose metabolized to phenobarbital.a


Elimination Route


Slowly excreted in urine as phenylethylmalonamide (PEMA), phenobarbital, and p-hydroxyphenobarbital.a


During chronic therapy, approximately 15–25% excreted in urine unchanged and approximately 50–70% excreted as PEMA.a


Half-life


Primidone: One manufacturer stated 21 hours; other clinicians suggested 10–12 hours.a


PEMA: 24–48 hours.a


Special Populations


Removed by hemodialysis.a


Stability


Storage


Oral


Tablets

Tight, light-resistant containers at 20–25°C.c d


Actions



  • Shares the actions of barbiturate-derivative anticonvulsants and has sedative properties similar to phenobarbital.a




  • Exact mechanism of antiepileptic action is unknown; primidone and its metabolites (phenobarbital and PEMA) have anticonvulsant activity.c d




  • Effective in subhypnotic doses.a



Advice to Patients



  • Risk of suicidality (anticonvulsants may increase risk of suicidal thoughts or actions in about 1 in 500 people).d g h i j Importance of patients, family, and caregivers being alert to day-to-day changes in mood, behavior, and actions and immediately informing clinician of any new or worrisome behaviors (e.g., talking or thinking about wanting to hurt oneself or end one’s life, withdrawing from friends and family, becoming depressed or experiencing worsening of existing depression, becoming preoccupied with death and dying, giving away prized possessions).d g h j




  • Importance of informing patients that several weeks of therapy may be required before therapeutic efficacy can be assessed.c d




  • Importance of informing patients not to stop primidone therapy abruptly; may precipitate seizures or status epilepticus.a b c d




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products, as well as any concomitant illnesses.c




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed; advise pregnant women of possible risk to fetus.a d f Importance of clinicians informing women about the existence of and encouraging enrollment in pregnancy registries (see Pregnancy under Cautions).d




  • Importance of informing patients of other important precautionary information.c d (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name




























Primidone

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets



50 mg*



Mysoline (scored)



Valeant



Primidone Tablets



250 mg*



Mysoline (scored)



Valeant



Primidone Tablets


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Mysoline 250MG Tablets (VALEANT): 30/$209.99 or 90/$602.66


Mysoline 50MG Tablets (VALEANT): 90/$194.24 or 270/$551.20


Primidone 250MG Tablets (AMNEAL PHARMACEUTICALS): 90/$69.99 or 270/$191.98


Primidone 50MG Tablets (LANNETT): 90/$39.99 or 270/$109.97



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



a. AHFS drug information 2007. McEvoy GK, ed. Primidone. Bethesda, MD: American Society of Health-System Pharmacists; 2008.



b. AHFS drug information 2007. McEvoy GK, ed. Anticonvulsants General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2254-8.



c. Mutual Pharmaceuticals. Primidone tablets prescribing information. Philadelphia, PA; 2006 Nov.



d. Valeant Pharmaceuticals North America. Mysoline (primidone) tablets prescribing information. Aliso Viejo, CA; 2009 May.



e. Food and Drug Administration. Drugs or vaccines used in registries for specific diseases. From the FDA web site. Rockville, MD; Undated. Accessed 2008 Mar 20.



f. Primidone. In: Briggs GG, Freeman RK, Yaffe SJ. Drug in pregnancy and lactation: a reference guide to fetal and neonatal risk. 8th ed. Philadelphia: Lippincott Williams & Wilkins; 2008;1525-8.



g. US Food and Drug Administration. Information for healthcare professionals: suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA web site.



h. US Food and Drug Administration. FDA News: FDA alerts health care providers to risk of suicidal thoughts and behavior with antiepileptic medications. Rockville, MD; 2008 Jan 31. From the FDA website.



i. US Food and Drug Administration. Suicidal behavior and ideation and antiepileptic drugs: update 5/5/2009. Rockville, MD; 2009 May 5. From the FDA website. Accessed 2009 Oct 21.



j. US Food and Drug Administration. FDA Alert: Suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA website.



More Primidone resources


  • Primidone Side Effects (in more detail)
  • Primidone Dosage
  • Primidone Use in Pregnancy & Breastfeeding
  • Drug Images
  • Primidone Drug Interactions
  • Primidone Support Group
  • 15 Reviews for Primidone - Add your own review/rating


  • Primidone MedFacts Consumer Leaflet (Wolters Kluwer)

  • Primidone Prescribing Information (FDA)

  • Primidone Professional Patient Advice (Wolters Kluwer)

  • primidone Concise Consumer Information (Cerner Multum)

  • primidone Advanced Consumer (Micromedex) - Includes Dosage Information

  • Mysoline Prescribing Information (FDA)



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  • Benign Essential Tremor
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PR Otic


Pronunciation: a-SEE-tik AS-id/AN-tee-PYE-reen/BEN-zoe-kane/POL-ee-COHS-an-ol
Generic Name: Acetic Acid/Antipyrine/Benzocaine/U-Polycosanol
Brand Name: PR Otic


PR Otic is used for:

Relieving pain and inflammation in the ear caused by certain ear conditions. It may be used with antibiotics given by mouth to treat certain ear infections. It may also be used to help remove a buildup of earwax.


PR Otic is an antibacterial, analgesic, and anesthetic combination. It works by relieving pressure and reducing inflammation, congestion, pain, and discomfort.


Do NOT use PR Otic if:


  • you are allergic to any ingredient in PR Otic or to similar medicines

  • your eardrum is perforated or you have discharge from your ear

Contact your doctor or health care provider right away if any of these apply to you.



Before using PR Otic:


Some medical conditions may interact with PR Otic. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with PR Otic. However, no specific interactions with PR Otic are known at this time.


Ask your health care provider if PR Otic may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use PR Otic:


Use PR Otic as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • PR Otic is for topical use in the ear canal only. Do not get PR Otic in the eyes, nose, or mouth. If you get PR Otic in any of these areas, rinse right away with cool water.

  • Before using, hold the ear drop container in your hand for 1 or 2 minutes to avoid dizziness that may result from putting cold drops into the ear. To use ear drops, lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. Moisten a clean cotton plug with PR Otic and gently insert into the ear canal to prevent medicine from leaking out.

  • To prevent germs from contaminating the medicine, do not touch the applicator to any surface, including the ear. Do not rinse dropper after use. Keep the container tightly closed.

  • If PR Otic is brown or contains particles, do not use it.

  • If you miss a dose of PR Otic, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use PR Otic.



Important safety information:


  • PR Otic may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using PR Otic while you are pregnant. It is not known if PR Otic is found in breast milk. If you are or will be breast-feeding while you use PR Otic, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of PR Otic:


All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with PR Otic. Seek medical attention right away if any of these SEVERE side effects occur:



Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); irritation not present when you began using PR Otic.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .


See also: PR Otic side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of PR Otic:

Store PR Otic at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Protect from freezing. Keep the container tightly closed. Store away from heat, moisture, and light. Keep PR Otic out of the reach of children and away from pets.


General information:


  • If you have any questions about PR Otic, please talk with your doctor, pharmacist, or other health care provider.

  • PR Otic is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about PR Otic. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More PR Otic resources


  • PR Otic Side Effects (in more detail)
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  • 0 Reviews for PR Otic - Add your own review/rating


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