PREGAPAIN Capsule 150 mg.

Category:

COMPOSITIONS :

Pregapain® Capsule 150 mg, each capsule contains : Pregabalin 150 mg.

INDICATIONS :
−Neuropathic pain : Pregabalin is indicated for the treatment of peripheral and central neuropathic pain in adults.
−Epilepsy : Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalization.
−Generalised anxiety disorder : Pregabalin is indicated for the treatment of Generalised Anxiety Disorders (GAD) in adults.
−Fibromyalgia : Pregabalin is indicated to reduce pain in the management of fibromyalgia.

DOSAGE AND ADMINISTRATION :

  • The dose range is 150 – 600 mg per day given in either two or three divided doses. Pregabalin is given with or without food.
  • Neuropathic pain: The recommended starting dose for Pregabalin is 75 mg two times a day (150 mg/day), with or without food. The efficacy of Pregabalin was demonstrated in patients dosed in a range 150 – 600 mg/day. For the majority of patients, 150 mg two times a day will be the optimal dose. Efficacy of Pregabalin has been demonstrated within the first week. However, based on individual patient response and tolerability, the dose may be increased to 150 mg two times a day after an interval of 3 – 7 days and if needed, to a maximum dose of 300 mg two times a day after an additional week.
  • Epilepsy: The recommended effective starting dose for Pregabalin is 75 mg two times a day (150 mg/day), with or without food. The efficacy of Pregabalin was demonstrated in patients dosed in a range 150 – 600 mg/day. Efficacy of Pregabalin has been demonstrated as early as 1 week. However, based on individual patient response and tolerability, the dose may be increased to 150 mg two times a day after 1 week and if needed, to a maximum dose of 300 mg two times a day after an additional week.
  • Generalised Anxienty Disorder: The dose range is 150 – 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 dosage may be increased to 300 mg per day after 1 week. Following an additional week the dosage may be increased to 450 mg per day. The maximum dosage of 600 mg per day may be achieved after an additional week.
  • Fibromyalgia: The recommended dose of Pregabalin is 300 – 450 mg/day given in two divided doses. 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). Although Pregabalin was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose dependent adverse reactions, treatment with dose above 450 mg/day is not recommended. Because Pregabalin is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function.
  • Discontinuation of Pregabalin: In accordance with current clinical practice, if Pregabalin has to be discontinued either in neuropathic pain or epilepsy. It is recommended this should be done gradually over a minimum of 1 week.
  • Use in patients with hepatic impairment: No dosage adjustment is required for patients with hepatic impairment.
  • Use in children and adolescents (12 – 17 years of age): The safety and effectiveness of Pregabalin in pediatric patients below the age of 12 years and adolescents has not been established. The use in children is not recommended.
  • Use in the elderly (over 65 years of age): Elderly patients may require a dose reduction of Pregabalin due to decreased renal function.

OVERDOSAGE :

In overdose up to 15 g, no unexpected adverse events were reported. Treatment of Pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see DOSAGE AND ADMINISTRATIONS).

 

 CONTRAINDICATIONS :

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

WARNING AND PRECAUTIONS :

  • Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicine.
  • In accordance with current clinical practice, some diabetic patients who gain weight on Pregabalin treatment may need to adjust hypoglycemic medications.
  • There have been reports in the post-marketing 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.
  • 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 medication.
  • In the post marketing experience, transient visual blurring and other changes in visual acuity have been reported in patients treated with Pregabalin. Discontinuation of Pregabalin may result in resolution or improvement of these visual symptoms.
  • 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.
  • 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, diarrhea, hyperhidrosis, flu syndrome, nervousness, depression, pain sweating and dizziness. The patients should be informed about this at the start of treatment.
  • Pregabalin is not known to be active at receptor sites associated with drugs of abuse. Cases of misuse or abuse have been reported in the post marketing database. As with any CNS active drug, carefully evaluate patients for history of drug misuse and abuse and observe them for signs of Pregabalin abuse (e.g., development of tolerance, dose escalation, drug seeking behavior).
  • Although the effects of discontinuation on the reversibility of renal failure have not been systematically studied, improved renal function following discontinuation or dose reduction of Pregabalin has been reported.
  • Concerning 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 dosage of Pregabalin.
  • Although there has been no causal relationship identified between exposure to Pregabalin and congestive heart failure, there have been post marketing reports of congestive heart failure in some patients receiving Pregabalin. In short term trials of patients without clinically significant heart of peripheral vascular disease, there was no apparent association between peripheral edema and cardiovascular complications such as hypertension or congestive heart failure. Because there are limited data on congestive heart failure patients, Pregabalin should be used with caution in these patients (see ADVERSE REACTIONS).
  • In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse events in general, CNS adverse events and especially somnolence was increased. This may be attributed to an additive effect due to concomitant medication (e.g., anti spasticity agents) needed for this condition. This should be considered when prescribing Pregabalin in this condition.
  • Pregnancy and lactation :Pregnancy : There are no adequate data on the use of Pregabalin in pregnant women. The potential risk to human is unknown. Therefore, Pregabalin should not be used during pregnancy unless the benefit to the mother clearly outweights the potential risk to the foetus. Effective contraception must be used in women of childbearing potential. Lactation : Pregabalin is excreted in the milk of lactating women. As the safety of Pregabalin in infants is not known, breast-feeding is not recommended during treatment with Pregabalin. A decision must be made whether to discontinue breast-feeding or to discontinue from Pregabalin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
  • Effects on ability to drive and use machines : Pregabalin may have minor or moderate influence on the ability to drive and use machines. Pregabalin 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 medication affects their ability to perform these activities

PRESENTATIONS :

Pregapain® 150 mg is available in capsule dosage form, colored Red-Red, size number 2, with the marking BERNO-BERNO (white), packaged in :

Box, 3 blisters @ 10 capsules                                        Reg. No. : DKL2202366801A1

STORAGE :

STORE BELOW 30°C

ON MEDICAL PRESCRIPTION ONLY

Manufactured by:

BERNOFARM

Sidoarjo – Indonesia