GABICA Capsule

Indicated:

- For the management of neuropathic pain associated with diabetic peripheral neuropathy.

- For the management of post herpetic neuralgia.

-As adjunctive therapy in adults with partial seizures with or without secondary generalization.

- For the treatment of Generalized Anxiety Disorder in adults.

- For the treatment of fibromyalgia syndrome.

DOSAGE AND ADMINISTRATION

(See the package insert about details.)

GABICA is given orally with or without food.

When discontinuing GABICA, taper gradually over a minimum of 1 week irrespective of the indication.

Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

Initial dose: 150mg per day, given as 2-3 divided doses.

Increased dose: 300mg/day, given as 2 divided doses, after an interval of 3-7 days.

Maximum dose: 600mg/day after an additional 7 day interval.

Post herpetic Neuralgia

75-150mg two times a day or 50-100mg three times a day.

Dosing should begin at 75mg two times a day or 50mg three times a day.

Increased dose: 300mg/day within 1 week.

Maximum dose: 600mg/day (300mg two times a day).

Adjunctive therapy in adults with partial seizure with or without secondary generalization

Initial dose: 150mg/day given as 2-3 divided doses.

Increased dose: 300mg/day after 1 week.

Maximum dose: 600mg/day after an additional week.

General Anxiety Disorder

150-600mg/day given as 2-3 divided doses.

Fibromyalgia Syndrome

Recommended dose: 300-450mg/day.

Renally Impaired Patients

- In patients with a known hypersensitivity to Pregabalin or any of its components.

- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Very common: dizziness, drowsiness, somnolence.

Common: appetite increased, euphoric mood, confusion, irritability, libido decreased, ataxia, coordination abnormal, tremor, dysarthria, memory impairment, disturbance in attention, paresthesia, vision blurred, diplopia, vertigo, vomiting, dry mouth, constipation, flatulence, erectile dysfunction, gait abnormal, feeling drunk, fatigue, edema peripheral, weight increased.

Uncommon: anorexia, hallucination, panic attack, restlessness, agitation, depression, depressed mood, mood swings, depersonalization, insomnia exacerbated, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy, syncope, stupor, myoclonus, psychomotor hyperactivity, visual field defect, ageusia, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, speech disorder, hyporeflexia, hypoesthesia, amnesia, hyperaesthesia, burning sensation, eye swelling, visual acuity reduced, eye pain, asthenopia, dry eye, lacrimation increased, tachycardia, flushing, hot flushes, dyspnea, nasal dryness, abdominal distension, gastroesophageal reflux disease, salivary hypersecretion, hypoesthesia, rash popular, sweating, muscle twitching, joint swelling, muscle cramp, myalgia, arthralgia, back pain, pain in limb, muscle stiffness, urinary incontinence, dysuria, ejaculation delayed, sexual dysfunction, fall, chest tightness, asthenia, thirst, blood creatinine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased.

Rare: neutropenia, hypoglycemia, disinhibition, elevated mood, hypokinesia, parosmia, dysgraphia, peripheral vision loss, oscillopsia, altered visual depth perception, photopsia, eye irritation, mydriasis, strabismus, visual brightness, hyperacusis, atrioventricular block first degree, sinus tachycardia, sinus arrhythmia, sinus bradycardia, hypotension, hypertension, peripheral coldness, epistaxis, throat tightness, nasopharyngitis, cough, nasal congestion, rhinitis, snoring, ascites, pancreatitis, dysphagia, urticaria, cold sweat, rhabdomyolysis, cervical spasm, neck pain, real failure, oliguria, amenorrhea, breast discharge, breast pain, dysmenorrhea, hypertrophy breast, anasarca, pyrexia, rigors, pain exacerbated, blood glucose increased, blood potassium decreased, white blood cell count decreased, blood creatinine increased, weight decreased.

Unknown Frequency: hypersensitivity, angioedema, allergic reaction, loss of consciousness, mental impairment, headache, congestive heart failure, swollen tongue, diarrhea, nausea, pruritus, urinary retention, Stevens Johnson syndrome, keratitis, face edema.

- Patients who require concomitant treatment with CNS depressants such as opiates or benzodiazepines should be informed that they may experience additive CNS side effects such as somnolence.

- Pregabalin may potentiate the effects of ethanol and lorazepam. There are also some reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medications.

- Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone.

Pediatrics

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

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Pregabalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether pregabalin is excreted into human milk. Because many drugs are excreted in human milk, caution should be exercised when pregabalin is administered to a nursing woman.

See the package insert about details.

- Withdrawal of Antiepileptic Drugs (AEDs)

- Angioedema

- Weight Gain

- Discontinuation

- Creatinine Kinase Elevation

- Congestive Heart Failure

- Alcohol

- Effects on Ability to Drive and Use Machines and Injuries

Pregabalin reduces neuronal calcium currents by binding to the alpha-w-delta subunit of voltage gated calcium channels in CNS tissues and this particular mechanism may be responsible for effects in neuropathic pain, anxiety and other pain syndromes. Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake.