• Dosage of Naxdu in details
• Naxdu interactions
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Dosage of Naxdu in details

Naxdu Dosage

Generic name: Naxdu HYDROCHLORIDE 40mg

Dosage form: capsule, delayed release

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

Swallow Naxdu whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Naxdu can be given without regard to meals. If a dose of Naxdu is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of Naxdu at the same time.

Dosage for Treatment of Major Depressive Disorder

Administer Naxdu at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated. Periodically reassess to determine the need for maintenance treatment and the appropriate dose for such treatment.

Dosage for Treatment of Generalized Anxiety Disorder

Adults

For most patients, initiate Naxdu 60 mg once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dose for such treatment.

​ Elderly

​ Initiate Naxdu at a dose of 30 mg once daily for 2 weeks before considering an increase to the target dose of 60 mg. Thereafter, patients may benefit from doses above 60 mg once daily. If a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The maximum dose studied was 120 mg per day. Safety of doses above 120 mg once daily has not been adequately evaluated.

​ Children and Adolescents (7 to 17 years of age)

​ Initiate Naxdu at a dose of 30 mg once daily for 2 weeks before considering an increase to 60 mg. The recommended dose range is 30 to 60 mg once daily. Some patients may benefit from doses above 60 mg once daily. If a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The maximum dose studied was 120 mg per day. The safety of doses above 120 mg once daily has not been evaluated.

Dosage for Treatment of Diabetic Peripheral Neuropathic Pain

Administer Naxdu 60 mg once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated. For patients for whom tolerability is a concern, a lower starting dose may be considered.

Since diabetes is frequently complicated by renal disease, consider a lower starting dose and gradual increase in dose for patients with renal impairment.

Dosage for Treatment of Chronic Musculoskeletal Pain

Administer Naxdu 60 mg once daily. Begin treatment at 30 mg for one week, to allow patients to adjust to the medication before increasing to 60 mg once daily. There is no evidence that higher doses confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions.

Dosing in Special Populations

Hepatic Impairment

Avoid use in patients with chronic liver disease or cirrhosis.

Severe Renal Impairment

Avoid use in patients with severe renal impairment, GFR <30 mL/min.

Discontinuing Naxdu

Adverse reactions after discontinuation of Naxdu, after abrupt or tapered discontinuation, include: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.

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 Naxdu. Conversely, at least 5 days should be allowed after stopping Naxdu before starting an MAOI intended to treat psychiatric disorders.

Use of Naxdu with Other MAOIs such as Linezolid or Methylene Blue

Do not start Naxdu in a patient who is being treated with linezolid or intravenous methylene blue because there is an 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 Naxdu therapy 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, Naxdu should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Naxdu 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 Naxdu is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use.

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What other drugs will affect Naxdu?

Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen, naproxen, celecoxib, diclofenac, indomethacin, piroxicam, nabumetone, etodolac, and others. Taking any of these drugs with Naxdu may cause you to bruise or bleed easily.

Taking Naxdu with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking Naxdu with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with Naxdu. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Naxdu, especially:

• a blood thinner such as warfarin, Coumadin;
• buspirone;
• cimetidine;
• a diuretic or "water pill";
• fentanyl;
• lithium;
• St. John's wort;
• tramadol;
• tryptophan (sometimes called L-tryptophan);
• an antibiotic such as ciprofloxacin;
• almotriptan, frovatriptan, sumatriptan, naratriptan, rizatriptan, or zolmitriptan; or
• any other antidepressant such as desipramine, fluoxetine, fluvoxamine, paroxetine, and others.

This list is not complete and many other drugs can interact with Naxdu. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Naxdu interactions

Potential for Other Drugs to Affect Naxdu

Both CYP1A2 and CYP2D6 are responsible for Naxdu metabolism

Inhibitors of CYP1A2 Concomitant use of Naxdu with fluvoxamine, an inhibitor of CYP1A2, results in approximately a 6-fold increase in AUC and about a 2.5-fold increase in Cmax of Naxdu. Some quinolone antibiotics would be expected to have similar effects and these combinations should be avoided

Inhibitors of CYP2D6 Because CYP2D6 is involved in Naxdu metabolism, concomitant use of Naxdu with potent inhibitors of CYP2D6 may result in higher concentrations of Naxdu. Paroxetine (20 mg QD) increased the concentration of Naxdu (40 mg QD) by about 60%, and greater degrees of inhibition are expected with higher doses of paroxetine. Similar effects would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine).

Potential for Naxdu to Affect Other Drugs

Drugs Metabolized by CYP1A2 In vitro drug interaction studies demonstrate that Naxdu does not induce CYP1A2 activity, and it is unlikely to have a clinically significant effect on the metabolism of CYP1A2 substrates.

Drugs Metabolized by CYP2D6 Naxdu is a moderate inhibitor of CYP2D6. When Naxdu was administered (at a dose of 60 mg BID) in conjunction with a single 50-mg dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold. Therefore, co-administration of Naxdu with other drugs that are extensively metabolized by this isozyme and which have a narrow therapeutic index, including certain antidepressants (tricyclic antidepressants [TCAs], such as nortriptyline, amitriptyline, and imipramine), phenothiazines and Type 1C antiarrhythmics (e.g., propafenone, flecainide), should be approached with caution. Plasma TCA concentrations may need to be monitored and the dose of the TCA may need to be reduced if a TCA is co-administered with Naxdu. Because of the risk of serious ventricular arrhythmias and sudden death potentially associated with elevated plasma levels of thioridazine, Naxdu and thioridazine should not be co-administered.

Drugs Metabolized by CYP3A Results of in vitro studies demonstrate that Naxdu does not inhibit or induce CYP3A activity.

Naxdu May Have a Clinically Important Interaction with the Following Other Drugs:

Alcohol When Naxdu and ethanol were administered several hours apart so that peak concentrations of each would coincide, Naxdu did not increase the impairment of mental and motor skills caused by alcohol.

In the Naxdu clinical trials database, three Naxdu-treated patients had liver injury as manifested by ALT and total bilirubin elevations, with evidence of obstruction. Substantial intercurrent ethanol use was present in each of these cases, and this may have contributed to the abnormalities seen

CNS Acting Drugs Given the primary CNS effects of Naxdu, it should be used with caution when it is taken in combination with or substituted for other centrally acting drugs, including those with a similar mechanism of action.

Potential for Interaction with Drugs that Affect Gastric Acidity Naxdu has an enteric coating that resists dissolution until reaching a segment of the gastrointestinal tract where the pH exceeds 5.5. In extremely acidic conditions, Naxdu, unprotected by the enteric coating, may undergo hydrolysis to form naphthol. Caution is advised in using Naxdu in patients with conditions that may slow gastric emptying (e.g., some diabetics). Drugs that raise the gastrointestinal pH may lead to an earlier release of Naxdu. However, co-administration of Naxdu with aluminum- and magnesium-containing antacids (51 mEq) or Naxdu with famotidine, had no significant effect on the rate or extent of Naxdu absorption after administration of a 40-mg oral dose. It is unknown whether the concomitant administration of proton pump inhibitors affects Naxdu absorption.

References

1. FDA/SPL Indexing Data. "O5TNM5N07U: 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).
2. MeSH. "Serotonin and Noradrenaline Reuptake Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/20... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "N-Methyl-gama-(1-naphthalenyloxy)-2-thiophenepropanamine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology