Land: Singapore
Sprog: engelsk
Kilde: HSA (Health Sciences Authority)
Pregabalin
GLORIOUS DEXA SINGAPORE PTE. LTD.
N03AX16
CAPSULE
Pregabalin 75mg
ORAL
Prescription Only
PT. Dexa Medica
ACTIVE
2021-01-05
67795-02XX-YY Last revised: dd/mm/yyyy LEPTICA Capsule COMPOSITIONS: LEPTICA 75 MG Each capsule contains Pregabalin 75 mg LEPTICA 150 MG Each capsule contains Pregabalin 150 mg LIST OF EXCIPIENTS: LEPTICA 75 MG Spray dried lactose DCL 11, corn starch, talc, capsule shells Leptica 75 mg size 3 (cap scarlet and body white). LEPTICA 150 MG Spray dried lactose DCL 11, corn starch, talc, capsule shells Leptica 150 mg size 2 (body and cap white op. (44.700)) PRODUCT DESCRIPTIONS: LEPTICA 75 MG Hard gelatin capsule, cap scarlet, body white, contain white crystalline powder. Cap printed DXM logo in black, body unmark. LEPTICA 150 MG Hard gelatin capsule, body and cap white op. (44.700), contain white crystalline powder. Cap printed DXM logo in black, body unmark. PHARMACODYNAMICS: ATC CODE: N03AX16 Mechanism of action Pregabalin binds to an auxiliary subunit ( α 2- δ protein) of voltage-gated calcium channels in the central nervous system. Evidence from animal models with nerve damage has shown that pregabalin reduces calcium dependent release of pronociceptive neurotransmitters in the spinal cord possibly by disrupting calcium trafficking and/or reducing calcium currents. Evidence from other animal models of nerve damage suggests the antinociceptive activities of pregabalin may also be mediated through interactions with the descending noradrenergic and serotonergic pathways. Clinical experience _Neuropathic pain_ Efficacy has been shown in studies in diabetic neuropathy and postherpetic neuralgia. Efficacy has not been studied in other models of neuropathic pain. Pregabalin has been studied in 9 controlled clinical studies of up to 13 weeks with twice a day dosing and up to 8 weeks with three times a day dosing. Overall, the safety and efficacy profiles for twice a day and three times a day dosing regimens were similar. In clinical trials up to 13 weeks, a reduction in pain was seen by week 1 and was maintained throughout the treatment period. In controlled clinical trials, 35% of the pregabalin treated patients and 1 Læs hele dokumentet