USANEURO 100

COMPOSITION: Each hard capsule contains:

Gabapentin ......................................... 100 mg

Excipients: Lactose, Colloidal anhydrous silica, Magnesium stearate q.s. one hard capsule.

INDICATIONS

Epilepsy

• USANEURO is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy.
• USANEURO is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3-12 years. Safety and effectiveness of gabapentin as adjunctive therapy in pediatric patients below the age of 3 years has not been established.

Neuropathic pain

• USANEURO is also indicated for the management of neuropathic pain in adults over 18 years of age.

DOSAGE AND ADMINISTRATION

Gabapentin is given orally with or without food.

Epilepsy

Patients > 12 years of age:

Day 1: 300 mg, once a day

Day 2: 300 mg, twice daily

Day 3: 300 mg, three times a day

Then increase the dose according to response in steps of 300 mg daily to usual effective dose, 900 to 1800 mg/day, not greater than 2400 mg daily in three divided doses. Daily maintenance doses should be given in 3 equally divided doses and the maximum time between doses should not exceed 12 hours.

If USANEURO dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week.

Dosage in Renal Impairment

Dosage adjustment in patients with compromised renal function or undergoing hemodialysis is recommended as follows:

* Loading dose is 300 – 400 mg at the first time for gabapentin, then 200 – 400 mg after each 4 hours of hemodialysis.

Dosage in Pediatric Patients

Age 6-12 years:

Day 1: 10 mg/kg/day, in 3 divided doses

Day 2: 20 mg/kg/day, in 3 divided doses

Day 3: 25-35 mg/kg/day, in 3 divided doses

Maintenance dose is 900 mg daily (body weight 26-36 kg) or 1200 mg daily (body weight 37-50 kg) in 3 divided doses.

Age 3 - < 6 years: the starting dose: 10-15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of USANEURO in pediatric patients ages 3 and 4 years is 40 mg/kg/day or  25-35 mg/kg/day in patients 5 years of age and older and given in 3 divided doses.

The use of gabapentin in patients < 12 years of age with compromised renal function has not been studied.

Neuropathic pain, postherpetic Neuralgia

Adults: dose is not greater than 1800 mg/day, divided three times a day or as follows:

Day 1: 300 mg, once a day

Day 2: 300 mg, twice daily

Day 3: 300 mg, three times a day

Then increase the dose according to response in steps of 300 mg daily to maximal dose, 1800 mg/day, in three divided doses.

Dosage in Elderly

Dosage reduction in elderly patients due to declining renal function.

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

Gabapentin should be used with caution in people with a history of psychosis, renal failure, people on hemo-dialysis, driving or operating machinery.

Gabapentin may cause false positive readings for urinary protein test.

Pregnancy: Gabapentin has been shown to be fetotoxic in rodents. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in Nursing Mothers: Gabapentin is secreted into human milk following oral administration. Because the effect on the nursing infant is unknown, gabapentin should be used in women who are nursing only if the benefits clearly outweigh the risks.

PRESENTATION: Blister of 10 hard capsules. Box of 1, 3 or 10 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, Nhon Trach, Dong Nai

Tel: 02513 566 202    -     Fax: 02513 566 203