Gabica

Pregabalin (Gabica) 50 mg Capsule is a hard gelatin capsule with pink opaque cap and yellow opaque body printed Getz logo and 50 mg in black containing white powder.
Pregabalin (Gabica) 75 mg Capsule is a hard gelatin capsule with ivory opaque cap and yellow opaque body printed Getz logo and 75 mg in black containing white powder.
Pregabalin (Gabica) 150 mg Capsule is a hard gelatin capsule with dark blue opaque cap and yellow opaque body printed Getz logo and 150 mg in black containing white powder.
Pregabalin (Gabica) 50 mg Capsule: Each capsule contains: Pregabalin 50 mg.
Pregabalin (Gabica) 75 mg Capsule: Each capsule contains: Pregabalin 75 mg.
Pregabalin (Gabica) 150 mg Capsule: Each capsule contains: Pregabalin 150 mg.

Pharmacology: Pharmacodynamics: Pregabalin reduces neuronal calcium currents by binding to the alpha-2-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.
Pharmacokinetics: Absorption and Distribution: Following oral administration of pregabalin capsules under fasting conditions, peak plasma concentrations occur within 1 hour following both single and multiple dose administration. Pregabalin oral bioavailability is ≥90% and is independent of dose. Following single (25 to 300 mg) and multiple-dose (75 to 900 mg/day) administration, maximum plasma concentrations (C_max), and area under the plasma concentration-time curve (AUC) values increase linearly. Following repeated administration, steady state is achieved within 24 to 48 hours. The rate of pregabalin absorption is decreased when given with food resulting in a decrease in C_max by approximately 25%-30% and a delay in t_max to approximately 2.5 hours. However, administration of pregabalin with food has no clinically significant effect on the extent of pregabalin absorption.
Pregabalin does not bind to plasma proteins. The apparent volume of distribution of pregabalin following oral administration is approximately 0.56 L/kg.
Metabolism and Elimination: Pregabalin undergoes negligible metabolism in humans. About 98% of the dose is excreted in the urine as unchanged drug. The N-methylated derivative of pregabalin, found in urine, accounted for 0.9% of the dose. Pregabalin mean elimination half-life is 6.3 hours and is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. Pregabalin is removed by hemodialysis.
Special Populations: Renal Insufficiency: Pregabalin plasma clearance and renal clearance are directly proportional to creatinine clearance. Pregabalin clearance is reduced in patients with impaired renal function. Dose adjustments are required in patients with renal impairment (CL_CR ≤60 mL/min). Pregabalin is effectively removed by hemodialysis (following a 4-hour hemodialysis treatment plasma pregabalin concentrations are reduced by approximately 50%). Dose adjustments are required for patients on hemodialysis.
Elderly (Over 65 years of age): Pregabalin clearance tends to decrease with increasing age. This decrease in pregabalin oral clearance is consistent with decreases in creatinine clearance associated with increasing age. Reduction of pregabalin dose may be required in patients who have age related compromised renal function.

Neuropathic Pain: Pregabalin (Gabica) is indicated for the treatment of neuropathic pain in adults, including neuropathic pain associated with spinal cord injury.
Epilepsy: Pregabalin (Gabica) is indicated as adjunctive therapy in adults with partial seizures, with or without secondary generalization.
Generalized Anxiety Disorder: Pregabalin (Gabica) is indicated for the treatment of Generalized Anxiety Disorder (GAD) in adults.
Fibromyalgia: Pregabalin (Gabica) is indicated for the management of fibromyalgia.

Pregabalin (Gabica) is given orally with or without food.
When discontinuing Pregabalin (Gabica), taper gradually over a minimum of 1 week irrespective of the indication.
Neuropathic Pain Associated with Diabetic Peripheral Neuropathy: Pregabalin (Gabica) treatment can be started at a dose of 150 mg per day, given as 2-3 divided doses. Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day, given as 2 divided doses, after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7 days interval.
Postherpetic Neuralgia: The recommended dose of Pregabalin (Gabica) is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day). 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. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin (Gabica), may be treated with up to 300 mg two times a day (600 mg/day).
Adjunctive therapy in adults with partial seizure with or without secondary generalization: Pregabalin (Gabica) treatment can be started with a dose of 150 mg per day given as 2-3 divided doses. Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after 1 week. The maximum dosage of 600 mg per day may be achieved after an additional week.
Pregabalin (Gabica) does not alter the plasma concentrations of other commonly used anti-convulsant drugs. Similarly, commonly used anticonvulsant drugs do not alter plasma concentrations of Pregabalin (Gabica).
General Anxiety Disorder: The dose range is 150 to 600 mg/day given as two or three divided doses. The need for treatment should be reassessed regularly. Pregabalin (Gabica) treatment can be started with a dose of 150 mg/day given as 2-3 divided doses. Based on individual patient response and tolerability, the dosage may be increased to 300 mg/day after 1 week. Following an additional week the dosage may be increased to 450 mg/day. The maximum dosage of 600 mg/day may be achieved after an additional week.
Fibromyalgia Syndrome (FMS): The recommended dose of Pregabalin (Gabica) for fibromyalgia is 300 to 450 mg/day given in two divided doses. Some patients may derive additional benefit at 600 mg per day. 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. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). If needed, in some patients, based on individual response and tolerability, the dose may be increased to maximum dosage of 600 mg/day after an additional week.
Renally Impaired Patients: As Pregabalin (Gabica) clearance is directly proportional to creatinine clearance, dosage reduction in patients with compromised renal function must be individualised according to creatinine clearance, as indicated in table as follows determined using the following formula: see equation and table.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

In the post-marketing experience, the most commonly reported adverse reactions observed when Pregabalin was taken in overdose included somnolence, confusional state, depression, agitation, and restlessness. Seizures were also reported. In rare occasions, cases of coma have been reported.
Treatment of Pregabalin overdose should include general supportive measures and may include haemodialysis if necessary.

Pregabalin is contraindicated 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.

Withdrawal of Antiepileptic Drugs (AEDs): As with all AEDs, pregabalin should be withdrawn gradually to minimize the potential of increased seizure frequency in patients with seizure disorders. If pregabalin is discontinued this should be done gradually over a minimum of 1 week.
Angioedema: Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial, perioral or upper airway swelling occur.
Weight Gain: Pregabalin associated weight gain is related to dose and duration of exposure. Some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycemic medications.
Discontinuation: After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed in some patients. The following events have been mentioned: insomnia, headache, nausea and diarrhea, flu syndrome, nervousness, depression, pain, sweating and dizziness.
Creatinine Kinase Elevation: Pregabalin should be discontinued if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.
Congestive Heart Failure: There have been reports of congestive heart failure in some patients receiving pregabalin. These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication. Pregabalin should be used with caution in these patients. Discontinuation of pregabalin may resolve the reaction.
Alcohol: Patients should be told to avoid consuming alcohol while on pregabalin, as it may potentiate the impairment of motor skills and sedation of alcohol.
Effects on Ability to Drive and Use Machines and Injuries: Pregabalin may cause dizziness and somnolence and therefore may have an influence on the ability to drive or use machines or may increase the occurrence of accidental injuries especially in the elderly population.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use in Children: 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.
Lactation: Pregabalin is excreted in the milk of lactating women. As the safety of pregabalin in infants is not known, breast-feeding is not recommended during treatment with pregabalin. A decision must be made whether to discontinue breast-feeding or to discontinue from pregabalin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Infections and Infestations: Common: Nasopharyngitis.
Blood and lymphatic system disorders: Uncommon: Neutropenia.
Metabolism and nutrition disorders: Common: Appetite increased.
Uncommon: Anorexia, hypoglycemia.
Psychiatric disorders: Common: Euphoric mood, confusion, irritability, depression, disorientation, insomnia, libido decreased.
Uncommon: Hallucinations, restlessness, agitation, depressed mood, elevated mood, mood swings, depersonalization, abnormal dreams, word finding difficulty, libido increased, anorgasmia.
Rare: Panic attack, disinhibition, apathy.
Nervous system disorders: Very common: Dizziness, somnolence, headache.
Common: Ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paresthesia, hypoesthesia, sedation, balance disorder, lethargy.
Uncommon: Syncope, myoclonus, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, speech disorder, hyporeflexia, hyperesthesia, burning sensation, loss of consciousness, mental impairment.
Rare: Stupor, parosmia, hypokinesia, ageusia, dysgraphia.
Eye disorders: Common: Vision blurred, diplopia.
Uncommon: Peripheral vision loss, visual disturbances, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, photopsia, dry eye, lacrimation increased, eye irritation.
Rare: Oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness, keratitis.
Ear and labyrinth disorders: Common: Vertigo.
Uncommon: Hyperacusis.
Cardiac disorders: Uncommon: Tachycardia, atrioventricular block first degree, sinus bradycardia.
Rare: Sinus tachycardia, sinus arrhythmia, congestive heart failure.
Vascular disorders: Uncommon: Hypotension, hypertension, hot flushes, flushing, peripheral coldness.
Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnea, epistaxis, cough, nasal congestion, rhinitis, snoring.
Rare: Throat tightness, nasal dryness, pulmonary edema.
Gastrointestinal disorders: Common: Vomiting, constipation, flatulence, abdominal distention, dry mouth, nausea, diarrhea.
Uncommon: Gastroesophageal reflux disease, salivary hypersecretion, hypoesthesia oral.
Rare: Ascites, pancreatitis, dysphagia, swollen tongue.
Skin and subcutaneous tissue disorders: Uncommon: Rash papular, urticaria, sweating, face swelling, pruritus.
Rare: Cold sweat.
Musculoskeletal and connective tissue disorders: Common: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm.
Uncommon: Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness.
Rare: Rhabdomyolysis.
Renal and urinary disorders: Uncommon: Urinary incontinence, dysuria.
Rare: Renal failure, oliguria, urinary retention.
Reproductive system and breast disorders: Uncommon: Erectile dysfunction, sexual dysfunctions, ejaculation delayed, dysmenorrhea.
Rare: Breast pain, amenorrhea, breast discharge, breast enlargement, gynecomastia.
General disorders and administration site conditions: Common: Edema peripheral, edema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue.
Uncommon: Generalized edema, chest tightness, pain, pyrexia, thirst, chills, asthenia.
Immune system disorders: Uncommon: Hypersensitivity.
Rare: Angioedema, allergic reaction.
Investigations: Common: Weight increased.
Uncommon: Blood creatine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood glucose increased, platelet count decreased, blood potassium decreased, weight decreased.
Rare: White blood cell count decreased, blood creatinine increased.

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.

Store at temperatures not exceeding 30°C.
Protect from sunlight and moisture.

Anticonvulsants / Anxiolytics / Drugs for Neuropathic Pain

N02BF02 - pregabalin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.

Rx