Prega 75

Prega 75

pregabalin

Manufacturer:

Hetero Labs

Distributor:

Royal Distribution

Marketer:

ESTI Pharma
Concise Prescribing Info
Contents
Pregabalin
Indications/Uses
Peripheral & central neuropathic pain; generalised anxiety disorder (GAD) in adults. Adjunctive therapy in adults w/ partial seizures w/ or w/o secondary generalisation.
Dosage/Direction for Use
Dose range: 150-600 mg/day given in either 2 or 3 divided doses. Neuropathic pain Initially 150 mg/day as 2 or 3 divided doses. May be increased to 300 mg/day after 3-7 day interval. Max: 600 mg/day after an additional 7-day interval. GAD Initially 150 mg/day. May be increased to 300 mg/day after 1 wk; to 450 mg/day following an additional 1 wk. Max: 600 mg/day after an additional 1 wk. Epilepsy Initially 150 mg/day as 2 or 3 divided doses. May be increased to 300 mg/day after 1 wk. Max: 600 mg/day after an additional 1 wk. Renal impairment CrCl ≥60 mL/min Initially 150 mg daily bd or tds. Max: 600 mg/day bd or tds, ≥30 to <60 mL/min Initially 75 mg/day bd or tds. Max: 300 mg/day bd or tds, ≥15 to <30 mL/min Initially 25-50 mg once daily or bd. Max: 150 mg once daily or bd, <15 mL/min Initially 25 mg once daily. Max: 75 mg/day. Supplementary dosage following haemodialysis: Initially 25 mg/day as single dose. Max: 100 mg/day as single dose.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Hypersensitivity reactions may occur; immediately discontinue use if symptoms of angioedema (eg, facial, perioral or upper airway swelling) occur. Adjust hypoglycemic medications in diabetic patients who gain wt on treatment. Increased occurrence of accidental injuries in elderly due to dizziness & somnolence; loss of consciousness, confusion, renal impairment may occur. Blurred vision; or other changes of visual acuity may occur. W/drawal symptoms including insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion (eg, status epilepticus, grand mal convulsions), hyperhidrosis & dizziness, may occur after use. Suicidal ideation & behaviour have been reported w/ anti-epileptic agents; patients should be monitored for signs of suicidal ideation & behaviours & appropriate treatment should be considered. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Increased CNS adverse events, especially somnolence during treatment of central neuropathic pain due to spinal cord injury. Reduced lower GIT function (eg, intestinal obstruction, paralytic ileus, constipation) when co-administered w/ medications that have potential to produce constipation eg, opioid analgesics; measures to prevent constipation may be considered especially in female & elderly. Exercise caution in patients w/ history of substance abuse & monitor patient for symptoms of pregabalin abuse. Encephalopathy. May impair ability to drive & operate machinery. Reversible renal failure may occur. Pregnancy. Not recommended during lactation. Women of childbearing potential. CHF may occur in CV-compromised elderly patients. May reduce dosage for the elderly (>65 yr). Adolescent (12-17 yr). Childn <12 yr.
Adverse Reactions
Dizziness, somnolence, headache; nasopharyngitis; increased appetite; euphoric mood, confusion, irritability, decreased libido; ataxia, abnormal coordination, tremor, dysarthria, memory impairment, attention disturbance, paraesthesia, sedation, balance disorder, lethargy; blurred vision, diplopia; vertigo; vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth; muscle cramp, arthralgia, back pain, limb pain, cervical spasm; erectile dysfunction; peripheral oedema, oedema, abnormal gait, fall, feeling drunk, feeling abnormal, fatigue; increased wt. Stevens-Johnson syndrome.
Drug Interactions
May potentiate ethanol & lorazepam effects. Resp failure & coma in concomitant use w/ other CNS depressants. Additive cognitive & gross motor function impairment w/ oxycodone.
MIMS Class
ATC Classification
N03AX16 - pregabalin ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Prega 75 cap 75 mg
Packing/Price
10 × 10's
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