MAXXNEURO^® 75

COMPOSITION: Each capsule contains:

Pregabalin...................................................... …………………75 mg

Excipients: lactose, corn starch, copovidone, talc, pure water q.s. one capsule.   

INDICATIONS:

• Management of neuropathic pain associated with diabetic peripheral neuropathy.
• Management of postherpetic neuralgia.
• Adjunctive therapy for adult patients with partial onset seizures.
• Management of fibromyalgia.
• Management of neuropathic pain associated with spinal cord injury.

DOSAGE AND ADMINISTRATION:

MAXXNEURO^® is given orally with or without food.

When discontinuing MAXXNEURO^®, taper gradually over a minimum of 1 week.

Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

The maximum recommended dose of MAXXNEURO^® is 100mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three times a day (150 mg/day). The dose may be increased after 1 week according to patient’s response to 300 mgdaily.

Postherpetic Neuralgia

The recommended dose of MAXXNEURO^® is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased after 1 week according to patient’s response to 300 mg daily.

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 MAXXNEURO^®, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day).

Adjunctive Therapy for Adult Patients with Partial Onset Seizures

It is recommended that patients be started on a total daily dose no greater than 150 mg/day (75 mg two times a day, or 50 mg three times a day). The dose may be increased after 1 week according to patient’s response to 300 mg daily and then to maximum dose 600 mg daily after another 7 days.

Management of Fibromyalgia

The recommended dose of MAXXNEURO^® for fibromyalgia is 300 to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) after 1 week according to response.

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). Although MAXXNEURO^® was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated.

Neuropathic Pain Associated with Spinal Cord Injury

The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) after 1 week according to patient’s response.

Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate MAXXNEURO^® may be treated with up to 300 mg two times a day.

Patients with Renal Impairment

Table 1: Pregabalin Dosage Adjustment Based on Renal Function

Dosage reduction in patients with renal dysfunction is necessary.

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:

Males:Clcr (mL/min) = (weight in kg) x (140 – age).

(72) x serum creatinine (mg/100 mL)

Females:Clcr (mL/min) = (0.85) x (above value)

For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediatelyfollowing every 4-hour hemodialysis treatment (see Table 1).

CONTRAINDICATIONS:

Hypersensitivity to pregabalin or to any of the excipients listed in the composition.

WARNINGS AND PRECAUTIONS:

Monitor for emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in behavior.

Monitor for weight gain and/or fluid retention, possibly exacerbating or leading to heart failure. Carefully evaluate patients for a history of drug abuse and observe them for signs of pregabalin misuse or abuse.

Children:Safety and efficacy not established.

Elderly:Because of age-related renal function impairment, dosage adjustment may be needed.

CHF:Use with caution in patients with New York Heart Association class III or IV cardiac status.

Creatine kinase elevations have been reported. Discontinue pregabalin if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.

Clinically significant decreases in platelets have been documented.

Discontinuation of therapy:Withdraw gradually (over at least 1 wk) to minimize potential of increased seizure frequency in patients with seizure disorders. Upon abrupt or rapid discontinuation, insomnia, nausea, headache, and diarrhea have been reported.

Ophthalmic effects:Reduction in visual acuity, visual field changes, and funduscopic changes have been reported.

Peripheral edema: has been reported. It occurs more frequently in patients taking pregabalin and a thiazolidinedione antidiabetic agent.

PR interval prolongation (3 to 6 msec) has been reported; the mean change difference was not associated with an increased risk of PR increase more than 25% from baseline, on-treatment PR more than 200 msec, or increased risk of second- or third-degree AV block.

The risk of suicidal thoughts or behavior may be increased. This was observed as early as 1 week after starting treatment and persisted for the duration of treatment.

Weight gain has been reported.

PREGNANCY:there are no adequate and well-controlled studies in pregnant women. Use pregabalin during pregnancy only if the potential benefit justifies the potential risk to the fetus

NURSING MOTHERS:It is not known if pregabalin is excreted in human milk; it is, however, present in the milk of rats. Because of the potential for tumorigenicity shown for pregabalin in animal studies, decide whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

PRESENTATION: Blister of 10 capsules; box of  3 blisters.                                                                                                  

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

Manufactured and distributed by: AMPHARCO U.S.A - PJSC

Nhon Trach 3 IP, Hiep Phuoc Ward, Nhon Trach District, Dong Nai Province

Tel: 02513 566 202    -     Fax: 02513 566 203