Gablin Plus

Gablin Plus

Manufacturer:

Unison Pharmaceutical

Distributor:

Cathay YSS
Concise Prescribing Info
Contents
Per 75 mg/750 mcg cap Pregabalin 75 mg, mecobalamin 750 mcg
Indications/Uses
Neuropathic pain in patients w/ diabetic peripheral neuropathy & postherpetic neuralgia.
Dosage/Direction for Use
Diabetic peripheral neuropathy Max recommended pregabalin dose: 300 mg/day. Begin dosing at 150 mg/day, may be increased to 300 mg/day w/in 1 wk. Postherpetic neuralgia Recommended pregabalin dose: 75-150 mg bid, or 150-300 mg/day. Begin dosing at 75 mg bid or 150 mg/day, may be increased to 300 mg/day w/in 1 wk. Patients who do not experience sufficient pain relief following 2-4 wk w/ 300 mg/day, & who are able to tolerate pregabalin, may be treated w/ up to 300 mg bid or 600 mg/day. Management of fibromyalgia Recommended pregabalin dose: 300-450 mg/day. Begin dosing at 75 mg bid (150 mg/day), may be increased to 300 mg/day w/in 1 wk based on efficacy & tolerability. Patients who do not experience sufficient benefit w/ 300 mg/day may be further increased to 450 mg/day. Neuropathic pain associated w/ spinal cord injury Recommended pregabalin dose: 150-600 mg/day. Recommended starting dose is 75 mg bid (150 mg/day), may be increased to 300 mg/day w/in 1 wk based on efficacy & tolerability. Patients who do not experience sufficient pain relief after 2-3 wk of treatment w/ 150 mg bid & who tolerate pregabalin may be treated w/ up to 300 mg bid. Patient w/ renal impairment: CrCl ≥60 mL/min Initially 150 mg/day, then 300 mg/day, & followed by 450 mg/day given as bid or tid. Max: 600 mg/day, 30-60 mL/min Initially 75 mg/day, then 150 mg/day, & followed by 225 mg/day given as bid or tid. Max: 300 mg/day, 15-30 mL/min Initially 25-50 mg/day, then 75 mg/day, & followed by 100-150 mg/day given as a single daily dose or bid. Max: 150 mg/day, <15 mL/min Initially 25 mg/day, then 25-50 mg/day, & followed by 50-75 mg/day given as a single daily dose. Max: 75 mg/day. Supplementary dosage following hemodialysis Patient on 25 mg single daily dose regimen: 1 supplemental dose of 25 mg or 50 mg. Patient on 25-50 mg single daily dose regimen: 1 supplemental dose of 50 mg or 75 mg. Patient on 50-75 mg single daily dose regimen: 1 supplemental dose of 75 mg or 100 mg. Patient on 75 mg single daily dose regimen: 1 supplemental dose of 100 mg or 150 mg.
Administration
Should be taken with food.
Special Precautions
Gradually taper over a min of 1 wk when discontinuing treatment. May cause dizziness & somnolence & therefore may influence ability to drive or use machines. Not to be given to pregnant & lactating women. Safety has not been established in childn. Pregabalin: Discontinue use immediately if symptoms of hypersensitivity eg, angioedema (eg, facial, perioral, or upper airway swelling) occur. May cause blurred vision. Increased incidence of adverse reactions in general, CNS adverse reactions & especially somnolence in the treatment of central neuropathic pain due to spinal cord injury due to additive effect w/ concomitant medicinal products (eg, anti-spasticity agents) needed for the condition. Adjust hypoglycemic medicinal products in diabetic patients who gain wt during treatment. Increased occurrence of accidental injury (fall) in the elderly. Mecobalamin: May mask folate deficiency. Dose adjustment in patients w/ reduced renal function or undergoing hemodialysis is necessary.
Adverse Reactions
Pregabalin: Dizziness & somnolence. Hypersensitivity, increase in appetite, euphoric mood, confusion, irritability, disorientation, insomnia. Mecobalamin: Rarely, itching & allergic reactions.
Drug Interactions
Pregabalin: May potentiate effects of ethanol & lorazepam. Reports of resp failure & coma w/ other CNS depressants. Additive effect in the impairment of cognitive & gross motor function caused by oxycodone.
MIMS Class
Drugs for Neuropathic Pain
ATC Classification
N02BF02 - pregabalin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.
Presentation/Packing
Form
Gablin Plus 75 mg/750 mcg cap
Packing/Price
100's;30's