Nondepres Uses

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What is Nondepres?

Nondepres is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Nondepres affects chemicals in the brain that may become unbalanced.

Nondepres is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

The Nondepres brand of Nondepres is used to treat hot flashes related to menopause. Nondepres is not for treating any other conditions.

Nondepres may also be used for purposes not listed in this medication guide.

Nondepres indications

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Nondepres Capsules are indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Limitation of Use:

Nondepres Capsules are not indicated for the treatment of any psychiatric condition. Nondepres Capsules contain a lower dose of Nondepres than that used to treat depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and efficacy of this lower dose of Nondepres in Nondepres Capsules have not been established for any psychiatric condition. Patients who require Nondepres for treatment of a psychiatric condition should discontinue Nondepres Capsules and initiate a Nondepres-containing medication that is indicated for such use.

How should I use Nondepres?

Use Nondepres controlled-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Nondepres controlled-release tablets.

Uses of Nondepres in details

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Nondepres is used to treat depression, panic attacks, anxiety disorders, and a severe form of premenstrual syndrome (premenstrual dysphoric disorder). It works by helping to restore the balance of a certain natural substance (serotonin) in the brain.

Nondepres is known as a selective serotonin reuptake inhibitor (SSRI). This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. Nondepres may lessen premenstrual symptoms such as irritability, increased appetite, and depression.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat other mental/mood disorders (such as obsessive-compulsive disorder-OCD, post-traumatic stress disorder). It may also be used to treat hot flashes that occur with menopause.

How to use Nondepres

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking Nondepres and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Taking this medication with food may decrease nausea. If this medication makes you sleepy during the day, talk to your doctor about taking it in the evening. Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If you are taking Nondepres for premenstrual problems, your doctor may direct you to take it every day of the month or just for the 2 weeks before your period through the first full day of your period.

It is important to continue taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as mood swings, headache, tiredness, sleep changes, and brief feelings similar to electric shock. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.

It may take up to several weeks before you get the full benefit of this drug.

Tell your doctor if your condition does not improve or if it worsens.

Nondepres description

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Nondepres hydrochloride and Nondepres mesylate belong to a class of antidepressant agents known as selective serotonin-reuptake inhibitors (SSRIs). Despite distinct structural differences between compounds in this class, SSRIs possess similar pharmacological activity. As with other antidepressant agents, several weeks of therapy may be required before a clinical effect is seen. SSRIs are potent inhibitors of neuronal serotonin reuptake. They have little to no effect on norepinephrine or dopamine reuptake and do not antagonize α- or β-adrenergic, dopamine D2 or histamine H1 receptors. During acute use, SSRIs block serotonin reuptake and increase serotonin stimulation of somatodendritic 5-HT1A and terminal autoreceptors. Chronic use leads to desensitization of somatodendritic 5-HT1A and terminal autoreceptors. The overall clinical effect of increased mood and decreased anxiety is thought to be due to adaptive changes in neuronal function that leads to enhanced serotonergic neurotransmission. Side effects include dry mouth, nausea, dizziness, drowsiness, sexual dysfunction and headache. Side effects generally occur during the first two weeks of therapy and are usually less severe and frequent than those observed with tricyclic antidepressants. Nondepres hydrochloride and mesylate are considered therapeutic alternatives rather than generic equivalents by the US Food and Drug Administration (FDA); both agents contain the same active moiety (i.e. Nondepres), but are formulated as different salt forms. Clinical studies establishing the efficacy of Nondepres in various conditions were performed using Nondepres hydrochloride. Since both agents contain the same active moiety, the clinical efficacy of both agents is thought to be similar. Nondepres may be used to treat major depressive disorder (MDD), panic disorder with or without agoraphobia, obsessive-compulsive disorder (OCD), social anxiety disorder (social phobia), generalized anxiety disorder (GAD), post-traumatic stress disorder (PTSD) and premenstrual dysphoric disorder (PMDD). Nondepres has the most evidence supporting its use for anxiety-related disorders of the SSRIs. It has the greatest anticholinergic activity of the agents in this class and compared to other SSRIs, Nondepres may cause greater weight gain, sexual dysfunction, sedation and constipation.

Nondepres dosage

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Nondepres Dosage

Generic name: Nondepres MESYLATE 7.5mg

Dosage form: capsule

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

2.1 Dosage Information

The recommended dosage of Nondepres for the treatment of moderate to severe VMS is 7.5 mg once daily, at bedtime, with or without food.

2.2 Use of Nondepres Before or After a Monoamine Oxidase Inhibitor (MAOI)

Wait at least 14 days after discontinuation of an MAOI before initiating therapy with Nondepres. Conversely, allow at least 14 days after stopping Nondepres before starting an MAOI.

More about Nondepres (Nondepres)

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Related treatment guides

Nondepres interactions

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What other drugs will affect Nondepres?

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

Potential for Nondepres to Affect Other Drugs

Nondepres is a strong CYP2D6 inhibitor. Clinical drug interaction studies have been performed with substrates of CYP2D6 and show that Nondepres 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 Nondepres. 10

Table 2 : Effects of Nondepres on Other Drugs

Concomitant Drug Name Effect of Nondepres on Other Drugs Clinical Recommendations
Thioridazine Increased plasma concentrations of thioridazine Concomitant use of thioridazine and Nondepres is contraindicated.
Potential QTc prolongation
Pimozide Increased plasma concentrations of pimozide. Potential QTc prolongation Concomitant use of pimozide and Nondepres is contraindicated.
Tamoxifen Reduced plasma concentrations of active tamoxifen metabolite Consider avoiding concomitant use of tamoxifen and Nondepres.
Tricyclic Antidepressant (TCA) (e.g., Desipramine) Increased plasma concentrations and elimination half-life Plasma TCA concentrations may need to be monitored and the dose of TCA may need to be reduced if a TCA is co-administered with Nondepres. Monitor tolerability.
Risperidone Increased plasma concentrations of risperidone A lower dosage of risperidone may be necessary. Monitor tolerability.
Atomoxetine Increased exposure of atomoxetine A lower dosage of atomoxetine may be necessary. Monitor tolerability.
Drugs Highly Bound to Plasma Protein (e.g., Warfarin) Increased free plasma concentrations The dosage of warfarin may need to be reduced. Monitor tolerability and the International Normalized Ratio.
Digoxin Decreased plasma concentrations of digoxin Dosage of digoxin may need to be increased. Monitor digoxin concentrations and clinical effect.
Theophylline Increased plasma concentrations of theophylline Dosage of theophylline may need to be decreased. Monitor theophylline concentrations and tolerability.

Use caution if co-administering Nondepres 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 Nondepres

The metabolism and pharmacokinetics of Nondepres 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 Nondepres when administered concomitantly.

Table 3 : Effects of Other Drugs on Nondepres

Concomitant Drug Name Effect of Concomitant Drug on Nondepres Clinical Recommendations
Phenobarbital Decreased Nondepres exposure No dose adjustment for Nondepres.
Phenytoin Decreased Nondepres exposure Monitor clinical effect of Nondepres.
Fosamprenavir/ Ritonavir Decreased plasma concentration of Nondepres
Cimetidine Increased plasma concentration of Nondepres

Use caution if co-administering Nondepres 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 Nondepres or use of Nondepres and an MAOI within 14 days of each other is contraindicated.

Serotonergic Drugs

If concomitant use of Nondepres 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 Nondepres 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 Nondepres. Consequently, concomitant use of Nondepres with tryptophan is not recommended.

If concomitant use of Nondepres 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.

Nondepres contains Paroxetine, which is also the active ingredient in other drugs. The concomitant use of Nondepres with other Nondepres 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 Nondepres and warfarin that causes an increased bleeding diathesis despite unaltered prothrombin time. Carefully monitor patients receiving warfarin therapy when Nondepres is initiated or discontinued.

Nondepres side effects

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What are the possible side effects of Nondepres?

The following serious adverse reactions are discussed elsewhere in labeling:

Suicidality
Serotonin syndrome
Abnormal bleeding
Angle-Closure Glaucoma
Hyponatremia
Bone Fracture
Mania/Hypomania
Seizure
Akathisia

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot directly be compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Nondepres Capsules in the one 8-week Phase 2 randomized, placebo-controlled trial and the two Phase 3 randomized, placebo-controlled, 12-week and 24-week trials for the treatment of moderate to severe VMS. In these trials, a total of 635 women were exposed to Nondepres Capsules 7.5 mg administered orally once daily and 641 women received placebo. The majority of Nondepres Capsules-treated patients were Caucasian (68%) and African American (30%), with a mean age of 55 years (range 40 to 73 years). Women with a history of suicidal ideation or suicidal behavior were excluded from these studies.

Adverse Reactions Leading to Study Discontinuation: A total of 4.7% of women taking Nondepres Capsules discontinued from the clinical trials due to an adverse reaction, compared to 3.7% of women on placebo; the most frequent adverse reactions leading to discontinuation among Nondepres-treated women were: abdominal pain (0.3%), attention disturbances (0.3%), headache (0.3%), and suicidal ideation (0.3%).

Common Adverse Reactions: Overall, based on investigators’ determinations about what events were likely to be drug-related, about 20% of women treated with Nondepres Capsules reported at least 1 adverse reaction in the three controlled studies. The most common adverse reactions (≥ 2% and more common among Nondepres Capsules-treated women) reported in these studies were headache, fatigue/malaise/lethargy, and nausea/vomiting. Of these commonly reported adverse reactions, nausea occurred primarily within the first 4 weeks of treatment and fatigue occurred primarily within the first week of treatment, and decreased in frequency with continued therapy.

The adverse reactions that occurred in at least 2% of patients in the Nondepres Capsules group and at a higher incidence than placebo are shown in Table 1 for the pooled Phase 2 and Phase 3 trials.

Table 1 Frequency of Adverse Reactions in the Phase 2 and Phase 3 Trials (≥ 2% and at a higher incidence than placebo)
Frequency n (%)

Nondepres Capsules (n = 635)

Placebo (n = 641)

Nervous system disorders

Headache

40 (6.3)

31 (4.8)

General disorders and administration site conditions

Fatigue, malaise, lethargy

31 (4.9)

18 (2.8)

Gastrointestinal disorders

Nausea, vomiting

27 (4.3)

15 (2.3)

Certain symptoms were seen more frequently in women at the time of discontinuation of Nondepres Capsules compared to women discontinuing placebo, and have also been reported upon discontinuation of other formulations of Nondepres, particularly when abrupt. These include increased dreaming/nightmares, muscle cramps/spasms/twitching, headache, nervousness/anxiety, fatigue/tiredness, restless feeling in legs, and trouble sleeping/insomnia. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms with other formulations of Nondepres.

Serious Adverse Reactions: In the pooled Phase 2 and Phase 3 trials, three Nondepres Capsules-treated patients reported a serious adverse reaction of suicidal ideation and one Nondepres Capsules-treated patient reported a serious adverse reaction of suicide attempt. There were no serious adverse reactions of suicidal ideation or suicide attempt reported among the placebo-treated patients.

Postmarketing Experience

The following adverse reactions have been identified from clinical studies of Nondepres and during post-approval use of other formulations of Nondepres. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Idiopathic thrombocytopenic purpura, Events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, agranulocytosis).

Cardiac Disorders: Atrial fibrillation, Pulmonary edema, Ventricular fibrillation, Ventricular tachycardia (including torsades de pointes).

Gastrointestinal Disorders: Pancreatitis, Pancreatitis hemorrhagic, Vomiting.

General Disorders and Administration Site Conditions: Death, Drug withdrawal syndrome, Malaise.

Hepatobiliary Disorders: Drug-induced liver injury, Hepatic failure, Jaundice.

Immune System Disorders: Anaphylactoid reaction, Angioedema, Toxic epidermal necrolysis.

Investigations: Elevated liver tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction).

Metabolism and Nutrition Disorders: Diabetes mellitus inadequate control, Type 2 diabetes mellitus.

Nervous System Disorders: Neuroleptic malignant syndrome, Paresthesia, Somnolence, Tremor.

Psychiatric Disorders: Aggression, Agitation, Anxiety, Confusional state, Depression, Disorientation, Homicidal ideation, Insomnia, Restlessness.

Respiratory, Thoracic and Mediastinal Disorders: Pulmonary hypertension.

Skin and Subcutaneous Tissue Disorders: Hyperhidrosis, Stevens-Johnson syndrome.

Nondepres contraindications

See also:
What is the most important information I should know about Nondepres?

Monoamine Oxidase Inhibitors

Concomitant use of an MAOI with Nondepres Capsules or within 14 days of stopping treatment with Nondepres Capsules is contraindicated because of an increased risk of serotonin syndrome. The use of Nondepres Capsules within 14 days of stopping an MAOI is also contraindicated.

Starting Nondepres Capsules in a patient who is being treated with linezolid or intravenous methylene blue, both of which inhibit monoamine oxidase, is also contraindicated because of an increased risk of serotonin syndrome.

Thioridazine

Concomitant use of Nondepres Capsules with thioridazine is contraindicated, because thioridazine prolongs the QT interval, and Nondepres can increase thioridazine levels.

Pimozide

Concomitant use of Nondepres Capsules with pimozide is contraindicated because pimozide prolongs the QT interval, and Nondepres increases pimozide levels.

Hypersensitivity to any Ingredient in Nondepres Capsules

Nondepres Capsules are contraindicated in patients with a history of hypersensitivity to Nondepres or any of the other ingredients in Nondepres Capsules.

Pregnancy

Menopausal VMS does not occur during pregnancy and Nondepres Capsules may cause fetal harm.



Active ingredient matches for Nondepres:

Paroxetine in Georgia.


List of Nondepres substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tablet; Oral; Paroxetine Hydrochloride Acetone Solvate 10 mg
Tablet; Oral; Paroxetine Hydrochloride Acetone Solvate 20 mg
Tablet; Oral; Paroxetine Hydrochloride Acetone Solvate 30 mg
Tablets; Oral; Paroxetine Hydrochloride Acetone Solvate 10 mg
Tablets; Oral; Paroxetine Hydrochloride Acetone Solvate 20 mg
Tablets; Oral; Paroxetine Hydrochloride Acetone Solvate 30 mg
Onbixin 12.5mg TAB / 10 (Dycine)$ 1.14
Onbixin 25mg TAB / 10 (Dycine)$ 1.57
Onbixin 37.5mg TAB / 10 (Dycine)$ 2.29
ONBIXIN 12.5MG TABLET 1 strip / 10 tablets each (Dycine)$ 1.26
ONBIXIN CR tab 12.5 mg x 10's (Dycine)$ 1.14
ONBIXIN CR tab 25 mg x 10's (Dycine)$ 1.57
ONBIXIN CR tab 37.5 mg x 10's (Dycine)$ 2.29
Onbixin 12.5mg Tablet (Dycine)$ 0.13
Tablet, Film-Coated; Oral; Paroxetine Hydrochloride 20 mg (Awd)
Tablets, Film-Coated; Oral; Paroxetine Hydrochloride 20 mg (Awd)
OXET 100MG SUSPENSION 1 bottle / 60 ML suspension each (Awd)$ 0.43
OXET 200MG TABLET 1 strip / 10 tablets each (Awd)$ 0.54
Oxet 100mg Suspension (Awd)$ 0.43
Oxet 200mg Tablet (Awd)$ 0.05
Oxitine 25mg Tablet CR (Psycormedies)$ 0.14
Oxitine 37.5mg Tablet CR (Psycormedies)$ 0.21
Oxitine CR 12.5 mg Tablet (Psyco Remedies.)$ 0.10
Oxitine CR 37.5 mg Tablet (Psyco Remedies.)$ 0.21
Oxitine CR 25 mg Tablet (Psyco Remedies.)$ 0.14
OXITINE CR TABLET 1 strip / 10 tablets each (Psyco Remedies.)$ 2.11
Oxitine CR Plus Tablet (Psyco Remedies.)$ 0.11
Oxitine PR 20 mg Tablet (Psyco Remedies.)$ 0.13
Oxitine PR 30 mg Tablet (Psyco Remedies.)$ 0.19
Oxitine PR 10 mg Tablet (Psyco Remedies.)$ 0.09
OXITINE PR 10MG TABLET 1 strip / 10 tablets each (Psyco Remedies.)$ 0.89
Oxitine PR 10mg Tablet (Psyco Remedies.)$ 0.09
12.5 mg x 100's (Psycorem)$ 10.48
25 mg x 100's (Psycorem)$ 14.34

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. PubChem. "paroxetine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "paroxetine". http://www.drugbank.ca/drugs/DB00715 (accessed September 17, 2018).

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