Prenervanex 75 or 150 mg H.G. caps-أدوية

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Prenervanex 75 or 150 mg H.G. caps

المحتويات Contents

مصدر الموضوع

COMPOSITION

Each H.G. capsule contains: Pregabalin75 or 150 mg.

Inactive ingredients in Prenervanex

Lactose monohydrate, maize starch, talc purified, gelatin, sorbitol, glycerin, titanium dioxide and yellow iron oxide.

Prenervanex : PHARMACEUTICAL FORM

Hard gelatin capsule.

Prenervanex : THERAPEUTIC INDICATIONS

Neuropathic pain

Prenervanex is indicated for the treatment of peripheral and central neuropathic pain in adults.

Epilepsy

Prenervanex is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Generalised Anxiety Disorder

Prenervanex is indicated for the treatment of Generalized Anxiety Disorder (GAD) in adults.

POSOLOGY AND METHOD OF ADMINISTRATION

Posology

The dose range is 150 to 600 mg per day given in either two or three divided doses.

Dosage in Neuropathic pain

Pregabalin treatment can be started at a dose of 150 mg per day given as two or three divided doses.

Based on individual patient response and tolerability, the dose 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 additional7-day interval.

Dosage in Epilepsy

 Pregabalin treatment can be started with a dose of 150 mg per day given as two or three divided doses.

Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week.

The maximum dose of 600 mg per day may beachieved after an additional week.

Dosage in generalized anxiety disorder

The dose range is 150 to 600 mg per day given as two or three doses . then need for treatment should be reassessed regularly .

Pegabalin treatment can be started with dose of 150 mg per day .

Based on individual patient respone 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.

Dosage in Patients with 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 individualized according to creatinine clearance (CLcr), as indicated in Table 1 determined using the following formula:

CLcr (ml/min) = . [ 1.23 x [140 – age (years)] x weight (kg) ] / serum creatinine (micro mol/l) * (0.85 for female patients)

Pregabalan 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 – hours haemodialysis treatment (see the following table).

Pregabalin dose adjustment based on renal function

Creatinine clearance (CLcr) (Ml/min) Total pregabalin daily dose” Dose regimen
  Starting dose ( mg / day ) Maximum dose (mg/day)  
> 60 150 600 BID or TID
> 30 – < 60 75 300 BID or TID
>15 – < 30 25 – 50 150 Once daily  or BID
< 15 25 75 Once daily
Supplementary dosage following haemodialysis ( mg )      
25 100 Single dose
  • TID = Three divided doses, BID = Two divided doses .
  • Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose.
  • Supplementary dose is a single additional dose.

Dosage in Patients with hepatic impairment

No dose adjustment is required for patients with hepatic impairment.

Dosage in Paediatric population

The safety and efficacy of Prenervanex in children below the age of 12 years and in adolescents (12-17 years of age) have not been established. No data are available.

Dosage in Elderly (over 65 years of age) population

Elderly patients may require a dose reduction of pregabalin due to a decreased renal function (see patients with renal impairment).

Method of administration

Prenervanex may be taken with or without food.

Prenervanex is for oral use only.

CONTRAlNDICATIONS

Hypersensitivily to the active substance or to any of the excipients. ,

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

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 reations

There have been reports in post marketing experience of hypersensitivity reactions, including cases of angioedema. Pregabalin should be discountinued immediatialy if symptoms of angioedema, such as facial perioral or upper airway swelling occur.

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 post-marketing 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 post-marketing 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 antiepileptic medicinal products

There are insufficient data for the withdrawal of concomitant antiepileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.

Withdrawal symptoms

After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed in some patients. The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depresson, pain, convulsion, hyperhidrosis and dizziness, The patient should be informed about this at the start of the treatment. Convulsions, including status epilepticus and grand mal convulsions, may occur during pregabalin use or shortly after discontinuing pregabalin. Concering discontinuation of long-term treatment of pregabalin there are no data of the incidence and severity of withdrawal symptoms in relation to duration of use and dose of pregabalin.

Congestive heart failure

There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin. These reactions are mostiy 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, centeral 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 randormze 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 and the available data do not exclude the possibility of an increased risk for pregabalin. Therefore patients should be monitored for signs of suicidal ideation, behaviours and for emergency or worsening of depression appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge .

Reduced lower gastrointestinal tract function

There are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralyic 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).

Abuse potential

Cases of abuse have been reported. Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of pregabalin abuse.

Encephalopathy

Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may precipitate encephalopathy.

Lactose intolerance

Pregabalin contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp-Iactase deficiency or glucose – galactose malabsorption should not take this medicinal product.

INTERACTION WITH OTHER MEDICINAL PRODUCTS

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 clnically significant effect on pregabalin clearance.

Oral contraceptives, norethisterone and/or ethinyloestradiol : Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyloestradiol does not influence the steady-state pharmacokinetics of either substance.

CNS influencing medical products: Pregabalin may potentiate the effects of ethanol and lorazeparn.In controlled clinical triaIs, multiple oral doses of pregabalin co-administered with oxycodone, lorazepam, or ethanol did not resutt in clinically important effects on respiration. In the post-marketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other 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

Women of childbearing potential! Contraception in males and females:

As the potential risk for humans is unknown, effective contraception must be used in women of child bearing potential.

Pregabalin should not be used dering pregnancy unless clearly necessary ( if the benfit to the mother clearly outweights the potential risk to the foetus ).

Breastfeeding

 It is not known if pregabalin is excreted in the breast milk. of humans; Therefore. breast-feeding is not recommended during treatment with pregabalin.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Prenervanex may have minor or moderate influence on the ability to drive and use machines. Prenervanex may cause dizziness and somnolence and therefore may influence the ability to drive or use machines. Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities.

UNDESIRABLE EFFECTS

The most common adverse reactions resulting in discontinuation from pregabalin treatment groups were dizziness and somnolence.

In the table below all adverse reactions, which are listed by frequency

(very common  ≥ 1/10) ; (common ≥1/100 to  <1/10); (uncommon ≥1/10000 to <1/100): rare ( ≥1/ 10000 to < 1/1000) ; very rare (  <1/10,000 ) , not known (can not be estimated from the available data ).

Side effect frequency
Nasopharyngitis Common
Appetite increased Common
Euphoric mood , confusion , rritability , libido decreased , disorientation,insomnia Common
Ataxia , coordination abnormal , tremor , dysarthria , memory impairment , disturbance in attention , sedation , balance disorder , lethargy Common
Vision blurred , diplopia Common
Vertigo Common
Vomiting , nausea , diarrhea , dry mouth , constipation , flatulence , abdominal distension Common
Muscle cramp , arthralgia , back pain , pain in limb , cervical spasm Common
Erectile dysfunction Common
Weight increased Common
Oedema peripheral , fall ,gait abnormal , feeling drunk , feeling abnormal , fatigue common
Angioedema , allergic reations Rare
Disinhibition Rare
Convulsion , hypokinesia , parosmia , dysgraphia Rare
Vision loss , keratitis , mydriasis Rare
Ascitis , pancreatitis ,swollen of tonge Rare
Neutropenia Uncommon
Hypersensitivity , angioedema , allergic reations Uncommon
Anorexia , hypoglycaemia Uncommon
Hallucination , panic attack , restlessness , agitation , depression , depressed mood , depersonalisation , word finding difficulty , abnormal dreams , libido increased , mood swings , anorgasmia , apathy uncommon
Syncope , stupor , myoclonus , psychomotor hyperactivity , ageusia , dyskinesia , dizziness postural , intention tremor , nystagmus , cognitive disorder , speecj disorder , hyporeflexia , hyperaesthesia , burning sensation , aguesia , malaise Uncommon
Peripheral vision loss , eye swelling , visual field defect , visual acuity Uncommon
Eye pain , dry eye , lacrimation increased , eye irritation Uncommon
Hyperacusis Uncommon
Tachycardia , sinus bradycardia , congestive heart failure Uncommon
Flushing , hypotension , hypertension Uncommon
Dyspnoea , nasal dryness , rhinitis , snoring , cough , epistaxis , nasal congestion Uncommon
Salivary hypersecrtion , GERD , hypoesthesia Uncommon
Rash popular , urticaria, pruritus Uncommon
Ejaculation delayed , sexual dysfunction , dysmenorrhea , brast pain Uncommon
Dizziness , somnolence , headache Very commom

OVERDOSE

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

Mechanism of action

Pregabalin binds to an auxiliary subunit (2 – protein) of voltage-gated calcium channels in the central nervous system,

Clinical Efficacy and safety

 Neuropathic pain: Efficacy has been shown in trials in diabetic neuropathy, post herpetic neuralgia and spinal cord injury . Efficacy has not been studied in other  models of neuropathic pain.

Adjunctive treatment with Pregabalin has been studied in 3 controlled clinical trials of 12 week duration with either twice a day dosing (BID) or three times a day ( TID ) dosing. Overall, the safety and efficacy profiles for BID and TID dosing regimens were similar.

pharmacokinitic

Absorption

Pregabalin is rapidly absorbed when administered in the fasted state, with peak plasma concentrations occurring within 1 hour following both single and multiple dose administration. Pregabalin oral bioavailability is estimated to be ≥ 90% and is independent of dose. Following repeated administration, steady state is achieved within 24 to 48 hours. The rate of pregabalin absorption is decreased when given with food resulting in a decrease in Cmax by approximately 25-30% and a delay in Tmax to approximately 2.5 hours. However, administration of pregabalin with food has no clinically significant effect on the extent of pnegabalin absorption.

Distribution

In preclinical studies, pregabalin has been shown to cross the blood brain barrier in mice, rats, and monkeys. Pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats.

Company

Manufactured by SANDOZ – NOVARTIS .

Prenervanex Price in EGYPT

Name Package Price in L.E.
Prenervanex 25 mg H.G. capsule N/A N/A
Prenervanex 50 mg H.G. capsule N/A N/A
Prenervanex 75 mg H.G. capsule 20capsule 50
Prenervanex 100 mg H.G. capsule N/A N/A
Prenervanex 150 mg H.G. capsule 20 capsules 63
Prenervanex 200 mg H.G. capsule N/A N/A
Prenervanex 300 mg H.G. capsule N/A N/A

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