Merit Uses

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What is Merit?

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

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

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

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

Merit indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Major Depressive Disorder

Merit is indicated for the treatment of major depressive disorder.

The efficacy of Merit in the treatment of a major depressive episode was established in two 12-week controlled trials of outpatients whose diagnoses corresponded to the DSM-IV category of major depressive disorder.

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least 5 of the following 9 symptoms during the same 2-week period: Depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.

The antidepressant action of Merit in hospitalized depressed patients has not been adequately studied.

Merit has not been systematically evaluated beyond 12 weeks in controlled clinical trials; however, the effectiveness of immediate-release Merit hydrochloride in maintaining a response in major depressive disorder for up to 1 year has been demonstrated in a placebo-controlled trial. The physician who elects to use Merit for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Panic Disorder

Merit is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

The efficacy of Merit controlled-release tablets was established in two 10-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IV category of panic disorder.

Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.

Long-term maintenance of efficacy with the immediate-release formulation of Merit was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to immediate-release Merit demonstrated a lower relapse rate compared to patients on placebo. Nevertheless, the physician who prescribes Merit for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Social Anxiety Disorder

Merit is indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in DSM-IV (300.23). Social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.

The efficacy of Merit as a treatment for social anxiety disorder has been established, in part, on the basis of extrapolation from the established effectiveness of the immediate-release formulation of Merit. In addition, the efficacy of Merit was established in a 12-week trial, in adult outpatients with social anxiety disorder (DSM-IV). Merit has not been studied in children or adolescents with social phobia.

The effectiveness of Merit in long-term treatment of social anxiety disorder, i.e., for more than 12 weeks, has not been systematically evaluated in adequate and well-controlled trials. Therefore, the physician who elects to prescribe Merit for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Premenstrual Dysphoric Disorder

Merit is indicated for the treatment of PMDD.

The efficacy of Merit in the treatment of PMDD has been established in 3 placebo-controlled trials.

The essential features of PMDD, according to DSM-IV, include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating, and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following the onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant.

The effectiveness of Merit in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Merit for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

How should I use Merit?

Use Merit 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 Merit controlled-release tablets.

Uses of Merit in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Merit 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.

Merit 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. Merit 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 Merit

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking Merit 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 Merit 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.

Merit description

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Merit hydrochloride and Merit 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. Merit 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. Merit), but are formulated as different salt forms. Clinical studies establishing the efficacy of Merit in various conditions were performed using Merit hydrochloride. Since both agents contain the same active moiety, the clinical efficacy of both agents is thought to be similar. Merit 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). Merit 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, Merit may cause greater weight gain, sexual dysfunction, sedation and constipation.

Merit dosage

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Merit Dosage

Generic name: Merit HYDROCHLORIDE HEMIHYDRATE 12.5mg

Dosage form: tablet, film coated, extended release

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

Major Depressive Disorder

Usual Initial Dosage

Merit 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 Merit 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 Merit 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 Merit 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 Merit hydrochloride 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 Merit, based on relative bioavailability considerations.

Panic Disorder

Usual Initial Dosage

Merit 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 Merit. The maximum dosage should not exceed 75 mg/day.

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

Maintenance Therapy

Long-term maintenance of efficacy with the immediate-release formulation of Merit was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to immediate-release Merit 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

Merit 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 Merit 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 Merit 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 Merit should remain on it. Although the efficacy of Merit 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

Merit should be administered as a single daily dose, usually in the morning, with or without food. Merit 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 Merit should not be chewed or crushed, and should be swallowed whole.

Maintenance/Continuation Therapy

The effectiveness of Merit 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 Merit 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 Merit 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 Merit 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 Merit. Conversely, at least 14 days should be allowed after stopping Merit before starting an MAOI intended to treat psychiatric disorders.

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

Do not start Merit 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 Merit 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, Merit 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 Merit 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 Merit is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use.

Discontinuation of Treatment With Merit

Symptoms associated with discontinuation of immediate-release Merit hydrochloride or Merit have been reported. Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which Merit 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.

More about Merit (Merit)

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Professional resources

Other formulations

Related treatment guides

Merit interactions

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What other drugs will affect Merit?

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

Potential for Merit to Affect Other Drugs

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

Table 2 : Effects of Merit on Other Drugs

Concomitant Drug Name Effect of Merit on Other Drugs Clinical Recommendations
Thioridazine Increased plasma concentrations of thioridazine Concomitant use of thioridazine and Merit is contraindicated.
Potential QTc prolongation
Pimozide Increased plasma concentrations of pimozide. Potential QTc prolongation Concomitant use of pimozide and Merit is contraindicated.
Tamoxifen Reduced plasma concentrations of active tamoxifen metabolite Consider avoiding concomitant use of tamoxifen and Merit.
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 Merit. 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 Merit 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 Merit

The metabolism and pharmacokinetics of Merit 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 Merit when administered concomitantly.

Table 3 : Effects of Other Drugs on Merit

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

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

Serotonergic Drugs

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

If concomitant use of Merit 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.

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

Merit side effects

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What are the possible side effects of Merit?

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 Merit 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 Merit Capsules 7.5 mg administered orally once daily and 641 women received placebo. The majority of Merit 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 Merit 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 Merit-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 Merit Capsules reported at least 1 adverse reaction in the three controlled studies. The most common adverse reactions (≥ 2% and more common among Merit 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 Merit 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 (%)

Merit 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 Merit Capsules compared to women discontinuing placebo, and have also been reported upon discontinuation of other formulations of Merit, 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 Merit.

Serious Adverse Reactions: In the pooled Phase 2 and Phase 3 trials, three Merit Capsules-treated patients reported a serious adverse reaction of suicidal ideation and one Merit 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 Merit and during post-approval use of other formulations of Merit. 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.

Merit contraindications

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

Monoamine Oxidase Inhibitors

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

Starting Merit 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 Merit Capsules with thioridazine is contraindicated, because thioridazine prolongs the QT interval, and Merit can increase thioridazine levels.

Pimozide

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

Hypersensitivity to any Ingredient in Merit Capsules

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

Pregnancy

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



Active ingredient matches for Merit:

Paroxetine in Pakistan.


List of Merit substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Mint-paroxetine tablet 20 mg (Mint Pharmaceuticals Inc (Canada))
Mint-paroxetine tablet 30 mg (Mint Pharmaceuticals Inc (Canada))
Mint-paroxetine tablet 10 mg (Mint Pharmaceuticals Inc (Canada))
Mirdox-CR 12.5mg TAB / 10x10 (Intra Life (Doxis))$ 14.29
Mirdox-CR 25mg TAB / 10x10 (Intra Life (Doxis))$ 18.73
MIRDOX-CR tab 12.5 mg x 10's (Intra Life (Doxis))$ 1.43
MIRDOX-CR tab 25 mg x 10's (Intra Life (Doxis))$ 1.87
MOPART 12.5MG TABLET SR 1 strip / 10 tablet srs each (Mova Pharmaceutical Pvt Ltd)$ 1.83
Motivan 50 mg/1 mL x 1 mL x 50's (Faes)$ 5.15
Motivan 50 mg/1 mL x 5 mL x 6's (Faes)$ 3.33
Tablet; Oral; Paroxetine Hydrochloride 10 mg
Tablet; Oral; Paroxetine Hydrochloride 20 mg
Tablet; Oral; Paroxetine Hydrochloride 30 mg
Tablets; Oral; Paroxetine Hydrochloride 10 mg
Tablets; Oral; Paroxetine Hydrochloride 20 mg
Tablets; Oral; Paroxetine Hydrochloride 30 mg
Mylan-paroxetine tablet 10 mg (Mylan Pharmaceuticals Ulc (Canada))
Mylan-paroxetine tablet 20 mg (Mylan Pharmaceuticals Ulc (Canada))
Mylan-paroxetine tablet 30 mg (Mylan Pharmaceuticals Ulc (Canada))
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)$ 1.51
Onbixin 25mg TAB / 10 (Dycine)$ 2.06
Onbixin 37.5mg TAB / 10 (Dycine)$ 3.02
ONBIXIN 12.5MG TABLET 1 strip / 10 tablets each (Dycine)$ 1.66
ONBIXIN CR tab 12.5 mg x 10's (Dycine)$ 1.51
ONBIXIN CR tab 25 mg x 10's (Dycine)$ 2.06

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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