Nervaid 50 & 75

Presentation

Nervaid 50 capsule: Each capsule contains Pregabalin BP 50 mg.

Nervaid 75 capsule: Each capsule contains Pregabalin BP 75 mg.

 

Description

Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-amino butyric acid (GABA). It does not bind directly to GABAA, GABAB, or benzodiazepine receptor. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake. Pregabalin binds with high affinity to the alpha-2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Pregabalin oral bioavailability is _90% and is independent of dose. It is eliminated from the systemic circulation primarily by renal excretion as unchanged drug with a mean elimination half-life of 6.3 hours in subjects with normal renal function.

 

Indication

• 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.

• Generalized Anxiety Disorder: Pregabalin is indicated for the treatment of Generalized Anxiety Disorder (GAD) in adults.

 

Dosage and administration

The dose range is 150 to 600 mg per day given in either two or three divided doses. Pregabalin may be taken with or without food.

• 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 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.

• 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 dosage may be increased to 300 mg per day after 1 week. The maximum dosage of 600 mg per day may be achieved 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.

• 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 individualised according to creatinine clearance (CrCl), as indicated in following table:

  

Creatinine

Clearance (ml/min)

                           Total Pregabalin Daily Dose (mg/day)*

Dose

Regimen

60

 

150

 

300

 

450

 

600

 

BID or TID

 

60-30

 

75

 

150

225

300

 

BID or TID

 

15-30

 

25-50

 

75

100-150

150

 

QD or BID

 

<15

 

25

 

25-50

50-75

75

 

QD

TID= Three divided doses; BID = Two divided doses; QD = Single daily dose. *Total daily dose

(mg/day) should be divided as indicated by dose regimen to provide mg/dose.

• Use in patients with hepatic impairment: No dose adjustment is required for patients with hepatic impairment.

• Use in children and adolescents: Pregabalin is not recommended for use in children below the age of 12 years and adolescents (12-17 years of age) due to insufficient data on safety and efficacy.

• Use in the elderly (over 65 years of age): Elderly patients may require a dose reduction of pregabalin due to a decreased renal function.

 

Contraindication

Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.

 

Adverse effect

The most common side effects include dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and abnormal thinking.

 

Use in special group

There are no adequate data from the use of Pregabalin in pregnant women. The potential risk to humans is unknown. Pregabalin should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus). Effective contraception must be used in women of child bearing potential (It is not known if Pregabalin is excreted in the breast milk of humans; however, it is present in the milk of rats). Therefore, breast-feeding is not recommended during treatment with Pregabalin.

 

Precaution

In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medications. Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population. 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.

 

Storage

Keep out of the reach of children. Keep below 300 C, protect from light.

 

How supplied

Nervaid 50 capsule: Each box contains 5x6’s capsule in blister pack.

Nervaid 75 capsule: Each box contains 5x6’s capsule in blister pack.