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Gabica

Gabica

pregabalin

Manufacturer:

Getz Pharma

Distributor:

Getz Pharma
Concise Prescribing Info
Contents
Pregabalin
Indications/Uses
Treatment of neuropathic pain in adults, including neuropathic pain associated w/ spinal cord injury. Adjunctive therapy in adults w/ partial seizures, w/ or w/o secondary generalization. Treatment of generalized anxiety disorder in adults. Management of fibromyalgia.
Dosage/Direction for Use
Adult Neuropathic pain associated w/ diabetic peripheral neuropathy Initially 150 mg/day given as 2-3 divided doses, may be increased to 300 mg/day as 2 divided doses after an interval of 3-7 days, & if needed, to a max dose of 600 mg/day after an additional 7 days interval. Postherpetic neuralgia Initially 75 mg bid or 50 mg tid (150 mg/day), may be increased to 300 mg/day w/in 1 wk. Patients w/ no sufficient pain relief after 2-4 wk w/ 300 mg/day may be treated w/ up to 300 mg bid (600 mg/day) if tolerated. Adjunctive therapy in partial seizures, w/ or w/o secondary generalization Initially 150 mg/day given as 2-3 divided doses, may be increased to 300 mg/day after 1 wk. Max of 600 mg/day may be achieved after an additional wk. Generalized anxiety disorder Initially 150 mg/day given as 2-3 divided doses, may be increased to 300 mg/day after 1 wk. May be increased to 450 mg/day following additional wk. Max of 600 mg/day may be achieved after an additional wk. Fibromyalgia syndrome Initially 75 mg bid or 50 mg tid (150 mg/day), may be increased to 300 mg/day w/in 1 wk. Patients w/ no sufficient benefit w/ 300 mg/day may be further increased to 225 mg bid (450 mg/day). May be increased to max of 600 mg/day, if needed, after an additional wk. Patient w/ renal impairment, CrCl ≥60 mL/min Initially 150 mg/day in 2 or 3 divided doses. Max: 600 mg/day, CrCl ≥30-<60 mL/min Initially 75 mg/day in 2 or 3 divided doses. Max: 300 mg/day, ≥15-<30 mL/min Initially 25-50 mg/day once daily or in 2 divided doses. Max: 150 mg/day, <15 mL/min Initially 25 mg/day once daily. Max: 75 mg/day. Patient on hemodialysis Supplementary dose following hemodialysis: Initially 25 mg/day single dose. Max: 100 mg/day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Special Precautions
Immediately discontinue if symptoms of angioedema occur. Discontinue if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur. Diabetic patients who gain wt on treatment may need to adjust hypoglycemic medications. Reports of w/drawal symptoms after discontinuation of short- & long-term treatment w/ pregabalin. If to be discontinued, gradually w/draw over a min of 1 wk. Reports of CHF, mostly seen in elderly CV-compromised patients during pregabalin treatment for a neuropathic indication. Avoid alcohol consumption while on treatment. Reduced clearance in patients w/ renal impairment. May cause dizziness & somnolence & may influence ability to drive or use machines or may increase occurrence of accidental injuries especially in the elderly. Should be used during pregnancy only if potential benefit justifies potential risk to the fetus. Breast-feeding is not recommended during treatment. Not recommended for use in childn & adolescents ≤17 yr.
Adverse Reactions
Dizziness, somnolence, headache. Nasopharyngitis; increased appetite; euphoric mood, confusion, irritability, depression, disorientation, insomnia, decreased libido; ataxia, abnormal coordination, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paresthesia, hypoesthesia, sedation, balance disorder, lethargy; blurred vision, diplopia; vertigo; vomiting, constipation, flatulence, abdominal distention, dry mouth, nausea, diarrhea; muscle cramp, arthralgia, back pain, pain in limb, cervical spasm; peripheral edema, edema, abnormal gait, fall, feeling drunk, abnormal feeling, fatigue; increased wt.
Drug Interactions
Additive CNS side effects eg, somnolence w/ CNS depressants eg, opiates or benzodiazepines. May potentiate effects of ethanol & lorazepam. Reports of resp failure & coma w/ other CNS depressant medications. May be additive in the impairment of cognitive & gross motor function caused by oxycodone.
MIMS Class
Anticonvulsants / Anxiolytics / Drugs for Neuropathic Pain
ATC Classification
N02BF02 - pregabalin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.
Presentation/Packing
Form
Gabica cap 150 mg
Packing/Price
35's (P1,590.91/box)
Form
Gabica cap 50 mg
Packing/Price
35's (P636.36/box)
Form
Gabica cap 75 mg
Packing/Price
35's (P986.36/box)
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