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    / Pfizer


    Active Ingredient
    Pregabalin 25, 50, 75, 100, 150, 200, 225, 300 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Capsules

    56 X 25 mg

    partial basket chart 32210 12454

    Capsules

    56 X 50 mg

    partial basket chart 32216 12455

    Capsules

    56 X 75 mg

    partial basket chart 65301 12337

    Capsules

    56 X 100 mg

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    Capsules

    56 X 150 mg

    partial basket chart 65303 12339

    Capsules

    56 X 200 mg

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    Capsules

    56 X 225 mg

    partial basket chart 36627 12478

    Capsules

    56 X 300 mg

    partial basket chart 65305 12341

    Related information


    Dosage

    The dose range is 150 to 600 mg per day given in either two or three divided doses. May be taken with or without food.
    Neuropathic pain: Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.
    Fibromyalgia: The usual dose for most fibromyalgia patients is 300 to 450 mg/day given in two divided doses. Some patients may derive additional benefit at 600 mg per day. Dosing should begin at 75 mg two times a day (150 mg/day) and may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). If needed, in some patients, based on individual response and tolerability, the dose may be increased to maximum dosage of 600 mg/day after an additional week.
    Generalised anxiety disorder: The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly. Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. Following an additional week the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week.
    Discontinuation of pregabalin: In accordance with current clinical practice, if pregabalin has to be discontinued, it is recommended this should be
    done gradually over a minimum of 1 week independent of the indication.
    Renal impairment: Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As pregabalin clearance is directly proportional to creatinine clearance, dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr) ), as indicated in Table 1 at the attached doctor’s leaflet determined using the following formula:
    CLcr(ml/min) = [ 140-age(years)] x weight (kg) / 72 x serum creatinine (mg/dl) ( x 0.85 for female patients)

    Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, the pregabalin daily dose should be adjusted based on renal function. In addition to the daily dose, a supplementary dose should be given immediately following every 4-hour haemodialysis treatment (see Table 1 at the attached doctor’s leaflet).
    Use in patients with hepatic impairment: No dosage adjustment is required for patients with hepatic impairment.
    Paediatric population: The safety and efficacy in children below the age of 12 years and in adolescents (12-17 years of age) have not been established. No recommendation on a posology can be made.
    Elderly : Elderly patients may require a dose reduction of pregabalin due to a decreased renal function.
    See prescribing information for full details.


    Indications

    Treatment of peripheral and central neuropathic pain in adults.
    Management of fibromyalgia.
    Treatment of Generalised Anxiety Disorder (GAD) in adults.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Diabetic patients:
    In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medicinal products.
    Hypersensitivity reactions:
    There have been reports in the postmarketing experience of hypersensitivity reactions, including cases of angioedema. Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur.
    Severe cutaneous adverse reactions (SCARs):
    SCARs including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported rarely in association with pregabalin treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, pregabalin should be withdrawn immediately and an alternative treatment considered (as appropriate).
    Dizziness, somnolence, loss of consciousness, confusion, and mental impairment:
    Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population. There have also been postmarketing reports of loss of
    consciousness, confusion, and mental impairment. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicinal product.
    Vision-related effects:
    In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing. In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients.
    In the postmarketing experience, visual adverse reactions have also been reported, including loss of vision, visual blurring or other changes of visual acuity, many of which were transient. Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms.
    Renal failure:
    Cases of renal failure have been reported and in some cases discontinuation of pregabalin did show reversibility of this adverse reaction.
    Withdrawal of concomitant anti-epileptic medicinal products: There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
    Withdrawal of concomitant anti-epileptic medicinal products:
    There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
    Congestive heart failure: There have been postmarketing reports of congestive heart failure in some patients receiving pregabalin. These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication. Pregabalin should be used with caution in these patients. Discontinuation of pregabalin may resolve the reaction.
    Treatment of central neuropathic pain due to spinal cord injury:
    In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased. This may be attributed to an additive effect due to concomitant medicinal products (e.g. anti-spasticity agents) needed for this condition. This should be considered when prescribing pregabalin in this condition.
    Suicidal ideation and behaviour:
    Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled studies of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known.
    Cases of suicidal ideation and behaviour have been observed in patients treated with pregabalin in the postmarketing experience. An epidemiological study using a self-controlled study design (comparing treatment periods with non-treatment periods within an individual) showed evidence of an increased risk of new onset of suicidal behaviour and death by suicide in patients treated with pregabalin.
    Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Discontinuation of pregabalin treatment should be considered in case of suicidal ideation and behaviour.
    Reduced lower gastrointestinal tract function: 
    There are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g. intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics. When pregabalin and opioids will be used in combination, measures to prevent constipation may be considered (especially in female patients and elderly).
    Concomitant use with opioids: Caution is advised when prescribing pregabalin concomitantly with opioids due to risk of CNS depression. In a case-control study of opioid users, those patients who took pregabalin concomitantly with an opioid had an increased risk for opioid-related death compared to opioid use alone (adjusted odds ratio [aOR], 1.68 [95% CI, 1.19 – 2.36]). This increased risk was observed at low doses of pregabalin (≤ 300 mg, aOR 1.52 [95% CI, 1.04 – 2.22]) and there was a trend for a greater risk at high doses of pregabalin (> 300 mg, aOR 2.51 [95% CI 1.24 – 5.06]).
    Concomitant use with opioids:
    Caution is advised when prescribing pregabalin concomitantly with opioids due to risk of CNS depression. In a case-control study of opioid users, those patients who took pregabalin concomitantly with an opioid had an increased risk for opioid-related death compared to opioid use alone (adjusted odds ratio [aOR], 1.68 [95% CI, 1.19 – 2.36]). This increased risk was observed at low doses of pregabalin (≤ 300 mg, aOR 1.52 [95% CI, 1.04 – 2.22]) and there was a trend for a greater risk at high doses of pregabalin (> 300 mg, aOR 2.51 [95% CI 1.24 – 5.06]).
    Misuse, abuse potential or dependence:
    Pregabalin can cause drug dependence, which may occur at therapeutic doses. Cases of abuse and misuse have been reported. Patients with a history of substance abuse may be at higher risk for pregabalin misuse, abuse and dependence, and pregabalin should be used with caution in such patients. Before prescribing pregabalin, the patient’s risk of misuse, abuse or dependence should be carefully evaluated.
    Patients treated with pregabalin should be monitored for symptoms of pregabalin misuse, abuse or dependence, such as development of tolerance, dose escalation and drug-seeking behaviour.
    Withdrawal symptoms
    After discontinuation of short-term and long-term treatment with pregabalin, withdrawal symptoms have been observed. The following symptoms have been reported: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness. The occurrence of withdrawal symptoms following discontinuation of pregabalin may indicate drug dependence. The patient should be informed about this at the start of the treatment. If pregabalin should be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication.
    Convulsions, including status epilepticus and grand mal convulsions, may occur during pregabalin use or shortly after discontinuing pregabalin.
    Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.
    Encephalopathy:

    Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may precipitate encephalopathy.
    Respiratory depression
    There have been reports of severe respiratory depression in relation to pregabalin use. Patients with compromised
    respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly may be at higher risk of experiencing this severe adverse reaction. Dose adjustments may be necessary in these patients.
    Women of childbearing potential/Contraception:
    Use in the first-trimester of pregnancy may cause major birth defects in the unborn child. Pregabalin should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus. Women of childbearing potential have to use effective contraception during treatment.
    Lactose intolerance: Contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
    Sodium content
    Pregabalin contains less than 1 mmol sodium (23 mg) per hard capsule. Patients on low sodium diets can be informed that this medicinal product is essentially ‘sodium-free’.


    Side Effects

    The most commonly reported adverse reactions were dizziness and somnolence.
    See prescribing information for full details.


    Drug interactions

    Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (<2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, pharmacokinetic interactions.
    In vivo studies and population pharmacokinetic analysis: Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol. Population pharmacokinetic analysis indicated that oral antidiabetics, diuretics, insulin, phenobarbital,
    tiagabine and topiramate had no clinically significant effect on pregabalin clearance.
    Oral contraceptives, norethisterone and/or ethinyl oestradiol: Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance.
    Central nervous system influencing medical products: Pregabalin may potentiate the effects of ethanol and lorazepam. In the postmarketing experience, there are reports of respiratory failure, coma and deaths in patients taking pregabalin and opioids and/or other central nervous system (CNS) depressant medicinal products. Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone.
    Interactions and the elderly: No specific pharmacodynamic interaction studies were conducted in elderly volunteers. Interaction studies have only been performed in adults.


    Pregnancy and Lactation

    Pregnancy:
    Studies in animals have shown reproductive toxicit. The potential risk for humans is unknown.
    Pregabalin has been shown to cross the placenta in rats. Pregabalin may cross the human placenta.
    Major congenital malformations: Data from a Nordic observational study of more than 2700 pregnancies exposed to pregabalin in the first trimester showed a higher prevalence of major congenital malformations (MCM) among the paediatric population (live or stillborn) exposed to pregabalin compared to the unexposed population (5.9% vs. 4.1%).
    The risk of MCM among the paediatric population exposed to pregabalin in the first trimester was slightly higher compared to unexposed population (adjusted prevalence ratio and 95% confidence interval: 1.14 (0.96-1.35)), and compared to population exposed to lamotrigine (1.29 (1.01–1.65)) or to duloxetine (1.39 (1.07–1.82)).
    The analyses on specific malformations showed higher risks for malformations of the nervous system, the eye, orofacial clefts, urinary malformations and genital malformations, but numbers were small and estimates imprecise.
    Should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
    Breast-feeding:
    Pregabalin is excreted into human milk. The effect of pregabalin on newborns/infants is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue pregabalin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
    Fertility:
    There are no clinical data on the effects of pregabalin on female fertility.
    In a clinical trial to assess the effect of pregabalin on sperm motility, healthy male subjects were exposed to pregabalin at a dose of 600 mg/day. After 3 months of treatment, there were no effects on sperm motility.
    A fertility study in female rats has shown adverse reproductive effects. Fertility studies in male rats have shown adverse reproductive and developmental effects. The clinical relevance of these findings is unknown.


    Overdose

    In the postmarketing experience, the most commonly reported adverse reactions observed when pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness. Seizures were also
    reported.
    In rare occasions, cases of coma have been reported.
    Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary.


    Important notes

    Storage: Store below 25°C.


    Manufacturer
    Pfizer Pharmaceuticals Ltd
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