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• Dosage of Paronex in details
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Dosage of Paronex in details

Paronex Dosage

Generic name: Paronex HEMIHYDRATE 12.5mg

Dosage form: tablet, film coated, extended release

See also:

• Paxil tablet, film coated, oral suspension

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Major Depressive Disorder

Usual Initial Dosage

Paronex should be administered as a single daily dose, usually in the morning, with or without food. The recommended initial dose is 25 mg/day. Patients were dosed in a range of 25 mg to 62.5 mg/day in the clinical trials demonstrating the effectiveness of Paronex in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 25-mg dose may benefit from dose increases, in 12.5-mg/day increments, up to a maximum of 62.5 mg/day. Dose changes should occur at intervals of at least 1 week.

Patients should be cautioned that Paronex should not be chewed or crushed, and should be swallowed whole.

Maintenance Therapy

There is no body of evidence available to answer the question of how long the patient treated with Paronex should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose of an antidepressant needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.

Systematic evaluation of the efficacy of immediate-release Paronex has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg, which corresponds to a 37.5-mg dose of Paronex, based on relative bioavailability considerations.

Panic Disorder

Usual Initial Dosage

Paronex should be administered as a single daily dose, usually in the morning. Patients should be started on 12.5 mg/day. Dose changes should occur in 12.5-mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 12.5 to 75 mg/day in the clinical trials demonstrating the effectiveness of Paronex. The maximum dosage should not exceed 75 mg/day.

Patients should be cautioned that Paronex should not be chewed or crushed, and should be swallowed whole.

Maintenance Therapy

Long-term maintenance of efficacy with the immediate-release formulation of Paronex was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to immediate-release Paronex demonstrated a lower relapse rate compared to patients on placebo. Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. 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.

Social Anxiety Disorder

Usual Initial Dosage

Paronex should be administered as a single daily dose, usually in the morning, with or without food. The recommended initial dose is 12.5 mg/day. Patients were dosed in a range of 12.5 mg to 37.5 mg/day in the clinical trial demonstrating the effectiveness of Paronex in the treatment of social anxiety disorder. If the dose is increased, this should occur at intervals of at least 1 week, in increments of 12.5 mg/day, up to a maximum of 37.5 mg/day.

Patients should be cautioned that Paronex should not be chewed or crushed, and should be swallowed whole.

Maintenance Therapy

There is no body of evidence available to answer the question of how long the patient treated with Paronex should remain on it. Although the efficacy of Paronex beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. 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.

Premenstrual Dysphoric Disorder

Usual Initial Dosage

Paronex should be administered as a single daily dose, usually in the morning, with or without food. Paronex may be administered either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment. The recommended initial dose is 12.5 mg/day. In clinical trials, both 12.5 mg/day and 25 mg/day were shown to be effective. Dose changes should occur at intervals of at least 1 week.

Patients should be cautioned that Paronex should not be chewed or crushed, and should be swallowed whole.

Maintenance/Continuation Therapy

The effectiveness of Paronex for a period exceeding 3 menstrual cycles has not been systematically evaluated in controlled trials. However, women commonly report that symptoms worsen with age until relieved by the onset of menopause. Therefore, it is reasonable to consider continuation of a responding patient. Patients should be periodically reassessed to determine the need for continued treatment.

Special Populations

Treatment of Pregnant Women During the Third Trimester

Neonates exposed to Paronex and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. When treating pregnant women with Paronex during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.

Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic Impairment

The recommended initial dose of Paronex is 12.5 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 50 mg/day.

Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Paronex. Conversely, at least 14 days should be allowed after stopping Paronex before starting an MAOI intended to treat psychiatric disorders.

Use of Paronex With Other MAOIs, Such as Linezolid or Methylene Blue

Do not start Paronex in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered.

In some cases, a patient already receiving therapy with Paronex may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Paronex should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Paronex may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Paronex is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use.

Discontinuation of Treatment With Paronex

Symptoms associated with discontinuation of immediate-release Paronex or Paronex have been reported. Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which Paronex is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

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What other drugs will affect Paronex?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Paronex with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Paronex, especially:

• atomoxetine, cimetidine (Tagamet), metoprolol, procyclidine, St. John's wort, tamoxifen;

• tryptophan (sometimes called L-tryptophan);

• a blood thinner (warfarin, Coumadin, Jantoven);

• heart rhythm medicine;

• HIV or AIDS medications;

• narcotic pain medicine - fentanyl, tramadol;

• medicine to treat mood disorders, thought disorders, or mental illness - such as lithium, other antidepressants, or antipsychotics;

• migraine headache medicine - sumatriptan, rizatriptan, zolmitriptan, and others; or

• seizure medicine - carbamazepine, phenytoin.

This list is not complete. Other drugs may interact with Paronex, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Paronex interactions

No drug-drug interaction studies have been conducted with Paronex.

Potential for Paronex to Affect Other Drugs

Paronex is a strong CYP2D6 inhibitor. Clinical drug interaction studies have been performed with substrates of CYP2D6 and show that Paronex can inhibit the metabolism of drugs metabolized by CYP2D6. Table 2 contains examples of drugs with a metabolism that may be affected by co-administration with Paronex. 10

Table 2 : Effects of Paronex on Other Drugs

Use caution if co-administering Paronex with other drugs that are metabolized by CYP2D6, including nortriptyline, amitriptyline, imipramine, desipramine, fluoxetine, phenothiazines, risperidone, and Type 1C antiarrhythmics (e.g., propafenone, flecainide, and encainide).

Potential for Other Drugs to Affect Paronex

The metabolism and pharmacokinetics of Paronex may be affected by the induction and inhibition of drug metabolizing enzymes such as CYP2D6. Table 3 contains a list of drugs that may affect the pharmacokinetics of Paronex when administered concomitantly.

Table 3 : Effects of Other Drugs on Paronex

Use caution if co-administering Paronex with other drugs that inhibit CYP2D6 (e.g., quinidine).

Other Potentially Significant Drug Interactions

Monoamine Oxidase Inhibitors (MAOIs)

Serious adverse reactions such as serotonin syndrome have been reported in patients receiving a concomitant SSRI and MAOI, in patients started on an SSRI who recently received an MAOI and in patients started on an MAOI who recently received an SSRI. Therefore, concomitant use of MAOIs with Paronex or use of Paronex and an MAOI within 14 days of each other is contraindicated.

Serotonergic Drugs

If concomitant use of Paronex with other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) is clinically warranted, consider the increased risk of serotonin syndrome and carefully observe the patient, particularly during treatment initiation.

An interaction between Paronex and tryptophan may occur when they are co-administered. Adverse experiences, consisting primarily of headache, nausea, sweating, and dizziness, have been reported when tryptophan was administered to patients taking Paronex. Consequently, concomitant use of Paronex with tryptophan is not recommended.

If concomitant use of Paronex with a serotonergic drug is warranted, carefully observe the patient, particularly during treatment initiation. There have been postmarketing reports of serotonin syndrome with the use of an SSRI and a triptan.

Paronex contains Paroxetine, which is also the active ingredient in other drugs. The concomitant use of Paronex with other Paronex products is not recommended.

Drugs that Interfere with Homeostasis (e.g., NSAIDs, Aspirin, and Warfarin)

Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs are co-administered with NSAIDs, aspirin, and warfarin or other drugs that affect coagulation. There may be a pharmacodynamic interaction between Paronex and warfarin that causes an increased bleeding diathesis despite unaltered prothrombin time. Carefully monitor patients receiving warfarin therapy when Paronex is initiated or discontinued.

References

1. DailyMed. "PAROXETINE MESYLATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. FDA/SPL Indexing Data. "41VRH5220H: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
3. MeSH. "Cytochrome P-450 CYP2D6 Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology