Myrica Capsule 50mg

Product Information

MYRICA

Myrica ®

Pregabalin

Presentation

Myrica-25 capsule: White opaque cap and orange opaque body, each capsule contains Pregabalin BP 25 mg.

Myrica-50 capsule: White cap and white body, each capsule contains Pregabalin BP 50 mg.

Myrica-75 capsule: White cap and pink body, each capsule contains Pregabalin BP 75 mg.

Myrica-100 capsule: Pink cap and pink body, each capsule contains Pregabalin BP 100 mg.

Indications

• Neuropathic pain associated with diabetic peripheral neuropathy

• Post herpetic neuralgia

• Adjunctive therapy for adult patients with partial onset

seizures

• Fibromyalgia

• Neuropathic pain associated with spinal cord injury

• Generalised Anxiety Disorder

Dosage and Administration

Neuropathic pain associated with diabetic peripheral neuropathy: The maximum recommended dose of MYRICA (Pregabalin) is 100 mg

three times a day (300 mg/day) ) in patients with creatinine clearance of at least 60 mL/min. Dosing should begin at 50 mg three

times a day (150 mg/day) and may be increased to 300 mg/day within 1 week based on efficacy and tolerability.

Post herpetic neuralgia : The recommended dose of MYRICA (Pregabalin) is 75 to 150 mg two times a day, or 50 to 100 mg three times

a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Dosing should begin at 75 mg two times a

day, or 50 mg three times a day (150 mg/day) and may be increased to 300 mg/day within 1 week based on efficacy and tolerability.

Adjunctive therapy for adult patients with partial onset seizures: In general, it is recommended that patients be started on a

total daily dose no greater than 150 mg/day (75 mg two times a day, or 50 mg three times a day). Based on individual patient

response and tolerability, the dose may be increased to a maximum dose of 600 mg/day.

Fibromyalgia: The recommended dose of MYRICA (Pregabalin) for fibromyalgia is 300 to 450 mg/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 300mg/day may be further increased to 225 mg two times a day

(450mg/day)

Neuropathic pain associated with spinal cord injury: The recommended dose range of MYRICA (Pregabalin) for the treatment of

neuropathic pain associated with spinal cord injury is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day

(150 mg/day). The dose may be increased to 150 mg two time a day (300 mg/day) within 1 week based on efficacy and tolerability.

Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate

MYRICA (Pregabalin) may be treated with up to 300 mg two times a day (600 mg/day) .

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 (CLcr), as indicated in following table:

Pregabalin Dosage Adjustment Based on Renal Function

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.

† Supplementary dose is a single additional 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.

Contra-indications, warnings, etc.

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

Precautions: 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.

Use in pregnancy and lactation: 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.

Drug interactions: 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. Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl

oestradiol does not influence the steady-state pharmacokinetics of either substance. Pregabalin may potentiate the effects of

ethanol and lorazepam. In controlled clinical trials, multiple oral doses of pregabalin co-administered with oxycodone, lorazepam,

or ethanol did not result in clinically important effects on respiration. 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.

Side-effects: Dry mouth, constipation, nausea, vomiting, flatulence, oedema, dizziness, drowsiness, irritability, attention

disturbance, disturbance in muscle control and movement, memory impairement, paraesthesia, euphoria, confusion, fatigue, appetite

changes, weight gain, change in sexual function, visual disturbances and ocular disorders, less commonly abdominal distension,

increased salivation, gastro oesophageal reflux disease, taste disturbances, depression, insomnia, abnormal dreams, hallucination,

agitation mood swings, panic attacks etc. rarely dysphasia, hypotension, AV block, congestive heart failure, angioedema, loss of

consciousness, headache and pruritus also reported.

Overdose: In overdoses up to 15 g, no unexpected adverse reactions were reported. The most commonly reported adverse reactions

observed when pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness. Treatment of

Pregabalin overdose should include general supportive measures and may include haemodialysis if necessary.

Pharmaceutical Precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Myrica-25 capsule: Carton containing 28 capsules in alu-alu blister.

Myrica-50 capsule: Carton containing 28 capsules in alu-alu blister.

Myrica-75 capsule: Carton containing 28 capsules in alu-alu blister.

Myrica-100 capsule: Carton containing 28 capsules in alu-alu blister.

Manufactured by

UniMed & UniHealth Manufacturers Ltd.

B K Bari, Gazipur, Bangladesh

® Registered trademark