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  • Provigil
    / Abic


    Active Ingredient
    Modafinil 100 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Caplets

    30 X 100 mg

    partial basket chart 29835 16423

    Related information


    Dosage

    The recommended starting daily dose is 200 mg. The total daily dose may be taken as a single dose in the morning or as two doses, one in the morning and one at noon, according to physician assessment of the patient and the patient’s response. Doses of up to 400mg in one or two divided doses can be used in patients with insufficient response to the initial 200mg modafinil dose.
    Long-term use: Physicians prescribing modafinil for an extended time should periodically re-evaluate the long-term use for the individual patients as the long-term efficacy of modafinil has not been evaluated (> 9 weeks).
    Patients with renal impairment: There is inadequate information to determine safety and efficacy of dosing in patients with renal impairment.
    Patients with hepatic impairment: The dose of modafinil should be reduced by half in patients with severe hepatic impairment.
    Elderly: There are limited data available on the use of modafinil in elderly patients. In view of the potential for lower clearance and increased systemic exposure, it is recommended that patients over 65 years of age commence therapy at 100 mg daily.
    Paediatric population: Modafinil should not be used in children aged less than 18 years old because of safety and efficacy concerns.


    Indications

    To improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy (with or without cataplexy); idiopathic hypersomnia when other causes of hypersomnia have been excluded; obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD).


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients. Uncontrolled moderate to severe hypertension and in patients with cardiac arrhythmias.


    Special Precautions

    Diagnosis of sleep disorders: Modafinil should be used only in patients who have had a complete evaluation of their excessive sleepiness, and in whom a diagnosis of narcolepsy, has been made in accordance with ICSD diagnostic criteria. Such an evaluation usually consists, in addition to the patient’s history, sleep measurements testing in a laboratory setting and exclusion of other possible causes of the observed hypersomnia.
    Serious rash, including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Drug Rash with Eosinophilia and Systemic Symptoms: Serious rash requiring hospitalisation and discontinuation of treatment has been reported with the use of modafinil occurring within 1 to 5 weeks after treatment initiation. Isolated cases have also been reported after prolonged treatment (e.g., 3 months). In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in paediatric patients (age <17 years); this includes serious rash. No serious skin rashes have been reported in adult clinical trials (0 per 4,264) of modafinil. Modafinil should be discontinued at the first sign of rash and not restarted. Rare cases of serious or life-threatening rash, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in worldwide post-marketing experience.
    Paediatric use: Because safety and effectiveness in controlled studies in children have not been established and because of the risk of serious cutaneous hypersensitivity and psychiatric adverse reactions, the use of modafinil is not recommended.
    Multi-organ hypersensitivity reaction: Multi-organ hypersensitivity reactions, including at least one fatality in post-marketing experience, have occurred in close temporal association to the initiation of modafinil. 3 Although there have been a limited number of reports, multi-organ hypersensitivity reactions may result in hospitalization or be life-threatening. There are no factors that are known to predict the risk of occurrence or the severity of multi-organ hypersensitivity reactions associated with modafinil. Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement. Other associated manifestations included myocarditis, hepatitis, liver function test abnormalities, haematological abnormalities (e.g., eosinophilia, leukopenia, thrombocytopenia), pruritus, and asthenia. Because multi-organ hypersensitivity is variable in its expression, other organ system symptoms and signs, not noted here, may occur. If a multi-organ hypersensitivity reaction is suspected, modafinil should be discontinued.
    Psychiatric disorders: Patients should be monitored for the development of de novo or exacerbation of pre-existing psychiatric disorders at every adjustment of dose and then regularly during treatment. If psychiatric symptoms develop in association with modafinil treatment, modafinil should be discontinued and not restarted. Caution should be exercised in giving modafinil to patients with a history of psychiatric disorders including psychosis, depression , mania, major anxiety, agitation, insomnia or substance abuse.
    Anxiety: Modafinil is associated with the onset or worsening of anxiety. Patients with major anxiety should only receive treatment with modafinil in a specialist unit.
    Suicide-related behaviour: Suicide-related behaviour (including suicide attempts and suicidal ideation) has been reported in patients treated with modafinil. Patients treated with modafinil should be carefully monitored for the appearance or worsening of suicide-related behaviour. If suicide-related symptoms develop in association with modafinil, treatment should be discontinued.
    Psychotic or manic symptoms: Modafinil is associated with the onset or worsening of psychotic symptoms or manic symptoms (including hallucinations, delusions, agitation or mania). Patients treated with modafinil should be carefully monitored for the appearance or worsening of psychotic or manic symptoms. If psychotic or manic symptoms occur, discontinuation of modafinil may be required.
    Bipolar disorders: Care should be taken in using modafinil in patients with co-morbid bipolar disorder because of concern for possible precipitation of a mixed/manic episode in such patients.
    Aggressive or hostile behaviour: The onset or worsening of aggressive or hostile behaviour can be caused by treatment with modafinil. Patients treated with modafinil should be carefully monitored for the appearance or worsening of aggressive or hostile behaviour. If symptoms occur, discontinuation of modafinil may be required.
    Cardiovascular risks:
    An ECG is recommended in all patients before Modafinil treatment is initiated. Patients with abnormal findings should receive further specialist evaluation and treatment before Modafinil treatment is considered. Blood pressure and heart rate should be regularly monitored in patients receiving modafinil. Modafinil should be discontinued in patients who develop arrhythmia or moderate to severe hypertension and not restarted until the condition has been adequately evaluated and treated. 4 Modafinil caplets are not recommended in patients with a history of left ventricular hypertrophy or cor pulmonale and in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome when previously receiving CNS stimulants. This syndrome may present with ischaemic ECG changes, chest pain or arrhythmia.
    Insomnia: Because modafinil promotes wakefulness, caution should be paid to signs of insomnia.
    Maintenance of sleep hygiene: Patients should be advised that modafinil is not a replacement for sleep and good sleep hygiene should be maintained. Steps to ensure good sleep hygiene may include a review of caffeine intake.
    Patients using steroidal contraceptives: Sexually active women of child-bearing potential should be established on a contraceptive programme before taking modafinil. Since the effectiveness of steroidal contraceptives may be reduced when used with modafinil, alternative or concomitant methods of contraception are recommended, and for two months after discontinuation of modafinil.
    Abuse, misuse, diversion: Whilst studies with modafinil have demonstrated a potential for dependence, the possibility of dependence with long-term use cannot be entirely excluded. Caution should be exercised in administering modafinil to patients with history of alcohol, drug or illicit substance abuse.
    Lactose intolerance: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.


    Side Effects

    Nausea, gastric discomfort, pruritic skin reactions as well as rare cases of urticaria, headache, dry mouth, excessive sweating, palpitations, tachycardia.
    For full details see prescribing information.


    Drug interactions

    Estroprogestational hormonal contraceptives, MAOIs, inducers of CYP3A4 (e.g. carbamazepine, phenobarbital, rifampicin) or inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole). Drugs that depend on CYP1A2, CYP2B6 and CYP3A4 for their clearance. Phenytoin, tricyclic antidepressants.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy: There is limited data on the use of modafinil in pregnant women. Studies in animals have shown reproductive toxicity. Modafinil is not recommended for use during pregnancy or in women of childbearing potential unless they are using effective contraception. As modafinil may reduce the effectiveness of oral contraception alternative additional methods of contraception are required.
    Breastfeeding; Available pharmacodynamic/toxicological data in animals have shown excretion of Modafinil/metabolites in milk. Modafinil should not be used during breast feeding.
    Fertility: No data on fertility are available.


    Overdose

    Death has occurred with modafinil overdose alone or in combination with other drugs. Symptoms most often accompanying modafinil overdose, alone or in combination with other drugs have included: insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, agitation, anxiety, excitation and hallucination; digestive changes such as nausea and diarrhoea; and cardiovascular changes such as tachycardia, bradycardia, hypertension and chest pain.
    Management: Induced emesis or gastric lavage should be considered. Hospitalisation and surveillance of psychomotor status; cardiovascular monitoring or surveillance until the patient’s symptoms have resolved are recommended.


    Manufacturer
    Teva Pharma B.V., The Netherlands
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