What is Malicon?
Malicon (Malicon) is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs).
Malicon is used to treat depression.
Malicon may also be used for purposes not listed in this medication guide.
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Malicon Uses |
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Malicon (Malicon) is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs).
Malicon is used to treat depression.
Malicon may also be used for purposes not listed in this medication guide.
Malicon (Malicon HBr) is indicated for the treatment of depression.
The efficacy of Malicon in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R 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 or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest 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 Malicon in hospitalized depressed patients has not been adequately studied.
The efficacy of Malicon in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials. Nevertheless, the physician who elects to use Malicon for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Use Malicon solution 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 Malicon solution.
Major depressive disorder (unipolar): Treatment of unipolar major depressive disorder
Data from a randomized, double-blind, placebo-controlled study support the use of Malicon in the treatment of agitation associated with dementia.
Based on the American Association of Clinical Endocrinologists and American College of Endocrinology position statement on menopause, the Endocrine Society guideline on the treatment of symptoms of menopause, and the North American Menopause Society position statement on nonhormonal management of menopause-associated vasomotor symptoms, SSRIs (including Malicon) are an effective and recommended alternative for the management of vasomotor symptoms associated with menopause in patients with contraindications to hormonal therapy or who prefer not to use hormonal therapy. Based on the American Cancer Society/American Society of Clinical Oncology breast cancer survivorship care guideline, SSRIs may be used to help mitigate vasomotor symptoms of premature menopause in women previously treated for breast cancer.
Malicon hydrobromide belongs to a class of antidepressant agents known as selective serotonin-reuptake inhibitors (SSRIs). Malicon and its N-demethylated metabolites exist as a racemic mixture but its effects are largely due to the S-enantiomer, S-Malicon and S-demthylcitalopram. 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 within the first two weeks of therapy and are usually less severe and frequent than those observed with tricyclic antidepressants. Malicon is approved for treatment of depression. Unlabeled indications include mild dementia-associated agitation in nonpsychotic patients, smoking cessation, ethanol abuse, obsessive-compulsive disorder (OCD) in children, and diabetic neuropathy. Malicon has the fewest drug-drug interactions of the SSRIs.
Generic name: Malicon hydrobromide 10mg
Dosage form: tablets, film coated; oral suspension
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Malicon should be administered once daily, in the morning or evening, with or without food.
Malicon (Malicon HBr) should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg/day at an interval of no less than one week. Doses above 40 mg/day are not recommended due to the risk of QT prolongation. Additionally, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose.
20 mg/day is the maximum recommended dose for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers or those patients taking cimetidine or another CYP2C19 inhibitor.
No dosage adjustment is necessary for patients with mild or moderate renal impairment. Malicon should be used with caution in patients with severe renal impairment.
Neonates exposed to Malicon 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 Malicon during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of Malicon in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of Malicon (20-60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of Malicon 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups. Based on these limited data, it is not known whether the dose of Malicon needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.
Symptoms associated with discontinuation of Malicon and other SSRIs and SNRIs have been reported. Patients should be monitored for these symptoms when discontinuing treatment. 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.
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Malicon. Conversely, at least 14 days should be allowed after stopping Malicon before starting an MAOI intended to treat psychiatric disorders.
Do not start Malicon 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 Malicon 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, Malicon 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 Malicon 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 Malicon 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 Malicon?
There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant treatment of Malicon with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
CNS Drugs - Given the primary CNS effects of Malicon, caution should be used when it is taken in combination with other centrally acting drugs.
Alcohol - Although Malicon did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as with other psychotropic medications, the use of alcohol by depressed patients taking Malicon is not recommended.
Monoamine Oxidase Inhibitors (MAOIs) - See CONTRAINDICATIONS, WARNINGS and DOSAGE AND ADMINISTRATION.
Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.) - Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when Malicon is initiated or discontinued.
Cimetidine - In subjects who had received 21 days of 40 mg/day Malicon, combined administration of 400 mg twice a day cimetidine for 8 days resulted in an increase in Malicon AUC and Cmax of 43% and 39%, respectively.
Malicon 20 mg/day is the maximum recommended dose for patients taking concomitant cimetidine because of the risk of QT prolongation.
Digoxin - In subjects who had received 21 days of 40 mg/day Malicon, combined administration of Malicon and digoxin (single dose of 1 mg) did not significantly affect the pharmacokinetics of either Malicon or digoxin.
Lithium - Coadministration of Malicon (40 mg/day for 10 days) and lithium (30 mmol/day for 5 days) had no significant effect on the pharmacokinetics of Malicon or lithium. Nevertheless, plasma lithium levels should be monitored with appropriate adjustment to the lithium dose in accordance with standard clinical practice. Because lithium may enhance the serotonergic effects of Malicon, caution should be exercised when Malicon and lithium are coadministered.
Pimozide - In a controlled study, a single dose of pimozide 2 mg co-administered with Malicon 40 mg given once daily for 11 days was associated with a mean increase in QTc values of approximately 10 msec compared to pimozide given alone. Malicon did not alter the mean AUC or Cmax of pimozide. The mechanism of this pharmacodynamic interaction is not known.
Theophylline - Combined administration of Malicon (40 mg/day for 21 days) and the CYP1A2 substrate theophylline (single dose of 300 mg) did not affect the pharmacokinetics of theophylline. The effect of theophylline on the pharmacokinetics of Malicon was not evaluated.
Sumatriptan - There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of a SSRI and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, Malicon) is clinically warranted, appropriate observation of the patient is advised.
Warfarin - Administration of 40 mg/day Malicon for 21 days did not affect the pharmacokinetics of warfarin, a CYP3A4 substrate. Prothrombin time was increased by 5%, the clinical significance of which is unknown.
Carbamazepine - Combined administration of Malicon (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate. Although trough Malicon plasma levels were unaffected, given the enzyme-inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of Malicon should be considered if the two drugs are coadministered.
Triazolam - Combined administration of Malicon (titrated to 40 mg/day for 28 days) and the CYP3A4 substrate triazolam (single dose of 0.25 mg) did not significantly affect the pharmacokinetics of either Malicon or triazolam.
Ketoconazole - Combined administration of Malicon (40 mg) and ketoconazole (200 mg) decreased the Cmax and AUC of ketoconazole by 21% and 10%, respectively, and did not significantly affect the pharmacokinetics of Malicon.
CYP2C19 Inhibitors - Malicon 20 mg/day is the maximum recommended dose for patients taking concomitant CYP2C19 inhibitors because of the risk of QT prolongation.
Metoprolol - Administration of 40 mg/day Malicon for 22 days resulted in a two-fold increase in the plasma levels of the beta-adrenergic blocker metoprolol. Increased metoprolol plasma levels have been associated with decreased cardioselectivity. Coadministration of Malicon and metoprolol had no clinically significant effects on blood pressure or heart rate.
Imipramine and Other Tricyclic Antidepressants (TCAs) - In vitro studies suggest that Malicon is a relatively weak inhibitor of CYP2D6. Coadministration of Malicon (40 mg/day for 10 days) with the TCA imipramine (single dose of 100 mg), a substrate for CYP2D6, did not significantly affect the plasma concentrations of imipramine or Malicon. However, the concentration of the imipramine metabolite desipramine was increased by approximately 50%. The clinical significance of the desipramine change is unknown. Nevertheless, caution is indicated in the coadministration of TCAs with Malicon.
Electroconvulsive Therapy (ECT) - There are no clinical studies of the combined use of electroconvulsive therapy (ECT) and Malicon.
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What are the possible side effects of Malicon?
More than 15% of patients develop insomnia while taking Malicon. Nausea and dry mouth occur in about 20% patients being treated with Malicon. Patients also experience tremor, anxiety, agitation, yawning, headaches, dizziness, restlessness, and sedation with Malicon therapy. These side effects usually diminish or disappear with continued use of the drug, although it may take up to four weeks for this to occur.
A drop in blood pressure and increased heart rate have been associated with Malicon use. In general, patients do not experience weight gain or loss after starting Malicon.
Sexual dysfunction, which includes decreased sex drive in women and difficulty ejaculating in men, is also associated with the use of Malicon. In some patients, it may take up to 12 weeks for these side effects to disappear. In some patients these sexual side effects never resolve. If sexual side effects continue, the dose of Malicon may be reduced, patients can also have drug holidays where the weekend dose is either decreased or skipped, or they can discuss with their physician the risks and benefits of switching to another antidepressant.
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What is the most important information I should know about Malicon?
You should not use Malicon if you are allergic to it, or if you also take pimozide.
Do not use Malicon if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
Before taking Malicon, tell your doctor if you have a heart rhythm disorder, a personal or family history of Long QT syndrome, or an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).
Tell your doctor about all other medicines you use. There are many other medicines that can increase your risk of heart rhythm problems if you use them together with Malicon.
Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using Malicon. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Tell your doctor right away if you become pregnant while taking this medication. Do not start or stop taking Malicon during pregnancy without your doctor's advice.
Citalopram in Greece.
List of Malicon substitutes (brand and generic names) | Sort by popularity |
Unit description / dosage (Manufacturer) | Price, USD |
Mai Ke Wei (China) | |
Manipram (Pakistan) | |
Mar-Citalopram (Canada) | |
Mar-citalopram tablet 10 mg (Marcan Pharmaceuticals Inc (Canada)) | |
Mar-citalopram tablet 20 mg (Marcan Pharmaceuticals Inc (Canada)) | |
Mar-citalopram tablet 40 mg (Marcan Pharmaceuticals Inc (Canada)) | |
Marpram (Italy) | |
Maxapran (Brazil) | |
Merck-Citalopram (Luxembourg) | |
Mint-Citalopram (Canada) | |
Tablet; Oral; Citalopram Hydrobromide 20 mg | |
Tablet; Oral; Citalopram Hydrobromide 40 mg | |
Tablets; Oral; Citalopram Hydrobromide 20 mg | |
Tablets; Oral; Citalopram Hydrobromide 40 mg | |
Mint-citalopram tablet 40 mg (Mint Pharmaceuticals Inc (Canada)) | |
Mint-citalopram tablet 20 mg (Mint Pharmaceuticals Inc (Canada)) | |
Mint-citalopram tablet 10 mg (Mint Pharmaceuticals Inc (Canada)) | |
Mitra (Pakistan) | |
Mooylec (Poland) | |
Mylan-Citalopram (Canada) | |
Tablet; Oral; Citalopram Hydrobromide 20 mg | |
Tablet; Oral; Citalopram Hydrobromide 40 mg | |
Tablets; Oral; Citalopram Hydrobromide 20 mg | |
Tablets; Oral; Citalopram Hydrobromide 40 mg | |
Mylan-citalopram tablet 10 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
Mylan-citalopram tablet 20 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
Mylan-citalopram tablet 40 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
Nat-Citalopram (Canada) | |
Nat-citalopram tablet 10 mg (Natco Pharma (Canada) Inc) | |
Nat-citalopram tablet 20 mg (Natco Pharma (Canada) Inc) | |
Nat-citalopram tablet 40 mg (Natco Pharma (Canada) Inc) | |
Nepram (Cyprus) | |
Nevdep-20 (India) | |
Nevdep-20 20mg TAB / 100 (Constant) | |
20 mg x 100's (Constant) | |
NEVDEP-20 tab 20 mg x 10's (Constant) | |
NG Citalopram | |
Tablet; Oral; Citalopram Hydrobromide 20 mg | |
Tablet; Oral; Citalopram Hydrobromide 40 mg | |
Tablets; Oral; Citalopram Hydrobromide 20 mg | |
Tablets; Oral; Citalopram Hydrobromide 40 mg | |
Ng Citalopram tablet 20 mg (Next Generation Pharma Inc (Canada)) | |
Ng Citalopram tablet 40 mg (Next Generation Pharma Inc (Canada)) | |
Nitalapram | |
Novo-Citalopram | |
Tablet; Oral; Citalopram Hydrobromide 10 mg | |
Tablet; Oral; Citalopram Hydrobromide 20 mg | |
Tablet; Oral; Citalopram Hydrobromide 40 mg | |
Tablets; Oral; Citalopram Hydrobromide 10 mg | |
See 1393 substitutes for Malicon |
Users | % | ||
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> 60 | 1 | 50.0% | |
30-45 | 1 | 50.0% |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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