Pregabalin , Celecoxib, Methylcobalamin
Following Information is for the use only of a Registered Medical Practitioner or Hospital or a Laboratory or Healthcare Personnel only.
The maximum recommended dose of LAVICA-M PLUS is 4 capsules a day in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 2 capsules per day. The dose may be increased to 4 capsules per day within 1 week based on efficacy and tolerability. Because LAVICA M PLUS is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see Patients with Renal Impairment].
Although LAVICA M PLUS was also studied at 8 capsules per day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 4 capsules per day is not recommended.
Management of Fibromyalgia: The recommended dose of LAVICA-M PLUS for fibromyalgia is 4 to 6 capsules per day. Begin dosing at 2 capsule per day. The dose may be increased to 4 capsules per day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 4 capsules per day may be further increased to 6 capsules per day. Although LAVICA M PLUS was also studied at 8 capsules per day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 6 capsules per day is not recommended. Because LAVICA-M PLUS is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see Patients with Renal Impairment.
Neuropathic Pain Associated With Spinal Cord Injury: The recommended dose range of LAVICA-M PLUS for the treatment of neuropathic pain associated with spinal cord injury is 2 to 6 capsules per day. The recommended starting dose is 2 capsules per day. The dose may be increased to 4 capsules per day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 4 capsules per day and who tolerate LAVICA-M PLUS may be treated with up to 8 capsules per day. Because LAVICA-M PLUS is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see Patients with Renal Impairment].
Patients With Renal Impairment: In view of dose-dependent adverse reactions and since Pregabalin contained in LAVICA-M PLUS is eliminated primarily by renal excretion, adjust the dose of pregabalin in patients with reduced renal function. Base the dose adjustment in patients with renal impairment on creatinine clearance (Clcr), as indicated in Table 1. To use this dosing table, an estimate of the patient’s CLcr in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the Cockcroft and Gault equation:
CLCr = [140-age (years)] x weight (kg)/ 72 x serum creatinine (mg/dL) (x 0.85 for female patients)
Next, refer to the Dosage and Administration section to determine the recommended total daily dose based on indication, for a patient with normal renal function (CLcr greater than or equal to 60 mL/min). Then refer to Table 1 to determine the corresponding renal adjusted dose.
(For example: A patient initiating LAVICA-M PLUS therapy for postherpetic neuralgia with normal renal function (CLcr greater than or equal to 60 mL/min), receives a total daily dose of 2 capsules (150 mg/day pregabalin). Therefore, a renal impaired patient with a CLcr of 50 mL/min would receive a total daily dose of 1 capsule (75 mg/day pregabalin) administered in two or three divided doses.)
