Geanex®
Pregabalin
capsule
Fibromyalgia (immediate release only): Management of fibromyalgia
Neuropathic pain associated with diabetic peripheral neuropathy (immediate release and extended release): Management of neuropathic pain associated with diabetic peripheral neuropathy
Neuropathic pain associated with spinal cord injury (immediate release only): Management of neuropathic pain associated with spinal cord injury
Postherpetic neuralgia (immediate release and extended release): Management of postherpetic neuralgia
Seizures, focal (partial) onset (immediate release only): Adjunctive therapy in patients ≥1 month of age with focal onset (partial-onset) seizures
Mechanism of Action:
Binds to alpha-2-delta subunit of voltage-gated calcium channels within the CNS and modulates calcium influx at the nerve terminals, thereby inhibiting excitatory neurotransmitter release including glutamate, norepinephrine (noradrenaline), serotonin, dopamine, substance P, and calcitonin generelated peptide.
Method of Administration:
Fibromyalgia:
Initial: 75 mg twice daily; may increase to 150 mg twice daily within 1 week based on response and tolerability; maximum dose: 450 mg/day
Generalized anxiety disorder:
Initial: 150 mg/day in 2 to 3 divided doses; may increase based on response and tolerability at weekly intervals in increments of 150 mg/day up to a usual dose of 300 mg/day. May further increase up to 600 mg/day
Neuropathic pain:
Initial: 25 to 150 mg/day in 2 to 3 divided doses; may increase in increments of 25 to 150 mg/day at weekly intervals based on response and tolerability up to a usual dose of 300 to 600 mg/day in 2 to 3 divided doses
Notes
Contraindications:
Hypersensitivity (eg, angioedema) to pregabalin or any component of the formulation
Interactions:
Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of Pregabalin. Specifically, the risk of angioedema may be increased. Risk C: Monitor therapy
HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Metoclopramide: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification
Pregnancy and Lactation:
Pregabalin crosses the placenta and is present in breast milk. Use with caution.
Warning and Precaution:
- Angioedema: Angioedema has been reported during initial and chronic treatment. Use with caution in patients with a history of angioedema episodes. Concurrent use with other drugs known to cause angioedema (eg, ACE inhibitors) may increase risk. Discontinue treatment immediately if angioedema occurs.
- Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required.
Adverse Reactions:
Dose-dependent CNS depression may occur and present as somnolence, dizziness, and/or drowsiness. In addition, serious, life-threatening, and fatal respiratory depression may occur; most cases occurred with concomitant use of CNS depressants (especially opioids) in the setting of underlying respiratory impairment or in the elderly
Storage:
Store below 30ºC and protect from light and moisture.