Pregabalin BSS

Pregabalin 25mg/50 mg/ 75 mg/ 150 mg/ 300 mg hard capsules. Each capsule, hard contains 25 mg/50 mg/75 mg/150 mg/300 mg pregabalin. Indications. Pregabalin is indicated for the treatment of peripheral and central neuropathic pain in adults. As adjunctive therapy in adults with partial seizures with or without secondary generalization. For the treatment of Generalized Anxiety Disorder (GAD) in adults. Posology. The dose range is 150 to 600 mg per day given in either two or three divided doses. Neuropathic pain. Treatment can be started at a dose of 150 mg per day given as two or three divided doses. The dose may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval. Epilepsy. Treatment can be started with a dose of 150 mg per day given as two or three divided doses. The dose may be increased to 300 mg per day after 1 week. The maximum dose of 600 mg per day may be achieved after an additional week. Generalized Anxiety Disorder. The dose range is 150 to 600 mg per day given as two or three divided doses. Treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. Following an additional week the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week. If pregabalin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication. Dose reduction in patients with compromised renal function must be individualised according to creatinine clearance. No dose adjustment is required for patients with hepatic impairment. The safety and efficacy of pregabalin in children below the age of 12 years and in adolescents (12-17 years of age) have not been established. Elderly patients may require a dose reduction of pregabalin due to a decreased renal function. Contraindications. Hypersensitivity to the active substance or to any of the excipients. Precautions for use. Some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycemic medicinal products. Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur. Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population. a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing. There are insufficient data for the withdrawal of concomitant antiepileptic medicinal products. After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed in some patients. There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin. In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased. Suicidal ideation and behavior have been reported in patients treated with anti-epileptic agents in several indications. There are post-marketing reports of events related to reduce lower gastrointestinal tract function when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics. Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of pregabalin misuse, abuse or dependence. Cases of encephalopathy have been reported. Pregabalin should not be used during pregnancy unless clearly necessary. The effect of pregabalin on newborns/infants is unknown. Adverse Events. Nasopharyngitis. Appetite increased. Euphoric mood, confusion, irritability, disorientation, insomnia, libido decreased. Dizziness, somnolence, headache. Ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoesthesia, sedation, balance disorder, lethargy. Vision blurred, diplopia. Vertigo. Vomiting, nausea, constipation, diarrhea, flatulence, abdominal distension, dry mouth. Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm. Erectile dysfunction. Oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue. Weight increased. After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed in some patients. CDS V2, 2015.