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    Active Ingredient
    Milnacipran (HCl) 25 mg, 50 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Capsules

    56 X 25 mg

    partial basket chart 21317 9195

    Capsules

    56 X 50 mg

    partial basket chart 21318 9196

    Related information


    Dosage

    100 mg a day in two divided 50 mg doses, 1 capsule morning and evening preferably during meals. In this case, use the 50 mg capsules.
    In patients with renal failure, dosage adjustment is necessary: The recommended dosage is reduced to 50 or 25 mg depending on the degree of alteration of renal function. In this case, use 25 mg capsules.
    For dosage adjustment in patients with renal failure: See prescribing information for full details.
    Duration of treatment: Treatment with antidepressants is symptomatic. As with all antidepressants, the efficacy of Milnacipran only becomes apparent after a certain delay which can vary from 1 to 3 weeks. For one episode treatment should last for several months (usually about 6 months) in order to prevent relapses.
    Milnacipran treatment should be discontinued gradually.
    Associated psychotropic treatments: Concomitant prescription of a sedative or anxiolytic medication can be useful at the start of treatment to prevent occurrence or worsening of symptoms of anxiety. But anxiolytics do not necessarily protect the patient from suicide attempts.


    Indications

    Treatment of major depressive episodes in adults over 18 years old.


    Contra-Indications

    Hypersensitivity, children under 18 years, concomitant use with MAOI’s or sumatriptan.


    Special Precautions

    This medication can diminish mental and physical capacities necessary to perform certain dangerous tasks, such as operating machinery or driving motor vehicles.
    Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
    Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions: The development of a potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including Milnacipran treatment, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptom Pregnancy, operating machinery or driving motor vehicles. See prescribing information for full details.
    Use in children and adolescents under 18 years of age: Milnacipran is not recommended in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking. Patients with insomnia or nervousness at the beginning of treatment may require transient symptomatic therapy. If a patient experiences a switch into frank mania, treatment with Milnacipran should be discontinued and in most cases a sedative antipsychotic agent prescribed.
    Although no interaction with alcohol has been evidenced, it is recommended to avoid alcohol intake, just as with any psychotropic medication. Systemic body exposure to Milnacipran is increased by 20% when combined with levomepromazine in healthy volunteers. A higher increase may be suspected in elderly or renal impairment patients if the drugs are to be combined.
    See prescribing information for full details.


    Side Effects

    Observed mainly during the first week or two, and subsequently regress. Generally mild and only rarely result in discontinuation of therapy. Excessive sweating, anxiety, hot flush and dysuria, vertigo. Less frequent: Nausea, vomiting, dry mouth, constipation, tremor and palpitations, headache, urticaria, rash, and sometimes maculo-papular, erythematous, pruritus, agitation. Patients with a history of cardiovascular disorder might have a higher incidence of cardiovascular adverse events.


    Drug interactions

    With non selective MAO inhibitors (iproniazide): Risk of a serotoninergic syndrome. There should be an interval of two weeks between the end of treatment with a MAO inhibitor and the beginning of treatment with Milnacipran, and at least one week between the end of treatment with Milnacipran and the beginning of treatment with a MAO inhibitor.
    Serotoninergic syndrome: Serotonin syndrome, In rare cases, serotonin syndrome has been reported in patients using SSRIs (e.g. paroxetine, fluoxetine) or SNRIs concomitantly with serotonergic medicinal products. Caution is advisable if it  is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline,Lithium, St John’s wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan. Serotoninergic syndrome requires immediate termination of therapy with Milnacipran. The serotoninergic syndrome consists of the simultaneous or sequential development (sometimes sudden) of a constellation of symptoms which may require hospitalization or even cause death.
    The following symptoms may occur:
    – Psychiatric (agitation, hallucinations, confusion, hypomania, possibly coma),
    – Motor (myoclonus, tremor, hyperreflexia, rigidity, hyperactivity),
    – Vegetative (hypo-or hypertension, tachycardia, chills, hyperthermia, sweating),
    – Gastrointestinal (nausea, vomiting, diarrhea).
    Strict compliance with the dosage prescribed is an essential factor in preventing the onset of this syndrome.
    With B Selective MAO inhibitors (selegiline): Risk of paroxystic hypertension. There should be an interval of two weeks between the end of treatment with a B selective-MAO inhibitor and the beginning of treatment with Milnacipran and at least one week between the end of treatment with Milnacipran and the beginning of treatment with a B-MAO inhibitor.
    With 5 HT1D agonists (sumatriptan…): By extrapolation with selective inhibitors of serotonin re-uptake. Risk of hypertension, coronary artery vasoconstriction by additive serotoninergic effects. Wait one week between the end of treatment with Milnacipran and the beginning of treatment with 5 HT1D agonists.
    With digitalis (digoxin…):  Risk of potentiation of haemodynamic effects, in particular by parenteral route.
    For full details see prescribing information


    Pregnancy and Lactation

    Pregnancy: There are no adequate data from the use of Milnacipran in pregnant women. Animal studies do not indicate direct or indirect harmfull effects with respects to pregnancy, embryonal/foetal development, parturition or postnatal development. Neonatal risk after pregnancy exposure with serotonin re-uptake inhibitors have been reported and may be related to either withdrawal syndrome or serotonin toxicity: tachypnea, feeding difficulties, tremors, hypertonicity or hypotonia, sleeping disorders, hyperexcitability or more rarely longlasting crying. All these signs appear in the first days of life and are generally of short duration and not severe. Consequently, as a precautionary measure, it is preferable not to administer Milnacipran during pregnancy.
    Lactation: Because small amounts of Milnacipran are excreted in breast-milk, breast-feeding is contraindicated.


    Overdose

    A few cases of overdose have been observed with Milnacipran.
    With high doses, the emetic effect can considerably limit the risk of overdose.
    With a 200 mg dose, the following events have commonly been observed (> 10%): nausea, excessive sweating, and constipation.
    With doses of 800 mg to 1 g in single-drug therapy, the main symptoms observed are vomiting, respiratory difficulties (apneic spells), and tachycardia.
    After a massive dose (1.9 g to 2.8 g), in combination with other drugs (in particular, benzodiazepines), the following additional symptoms occur: drowsiness, hypercapnia and alterations of consciousness.
    Treatment of overdose: There is no specific antidote for Milnacipran.
    Treatment is symptomatic, with gastric lavage and activated charcoal as soon as possible after oral ingestion. Medical monitoring should be continued for at least 24 hours.


    Manufacturer
    Pierre Fabre, France
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