Bosrontin

POSOLOGY AND METHOD OF ADMINISTRATION

Method of administration: 

Gabapentin for oral use, it can be given with or without food. Gabapentin is used as an adjunct to other antiepileptic drugs.

Posology

1. Treatment of peripheral neuropathic pain and post-herpetic neuralgia 

Adults: The dose is not more than 1800 mg/day, given in three divided doses. Or used as follows: Day 1 – 300 mg once a day, day 2 – 300 mg two times a day, day 3 –  300 mg three times a day.

Then increased in steps of  300 mg everyday, based on individual patient response, up to a maximum daily dose of 1800 mg/day, divided into 3 times.

2.Epilepsy

Patients 12 years of age and above:

+ The starting dose is: Day 1 – 300 mg once a day, day 2 – 300 mg two times a day, day 3 – 300 mg three times a day. Then increased in steps of  300 mg daily until reaching an effective dose (approximately 900-1800 mg daily) (in 3 divided doses/day). The maximum dose is 2400 mg/day.

+ The maximum time interval between the doses should not exceed 12 hours. Four times daily dosing may be needed for children receiving a high dosage.

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

Patients with renal impairment: Care should be taken in dose selection and dose should be adjusted based on creatinine clearance (CC) values in these patients. Total daily dose should be administered as three divided doses. Total recommended dose for patients with renal insufficiency:

+ CC 50 - 70 ml/min: 600 - 1200 mg/day.

+ CC 30 - 49 ml/min: 300 - 600 mg/day.

+ CC 15 -29 ml/min: 300 mg every other day.

+ CC less than 15 ml/min: 150 mg every other day.

Patients undergoing hemodialysis: For patients undergoing hemodialysis who have never received gabapentin, a loading dose of  300 to 400 mg, then 200 to 300 mg of gabapentin following each 4 hours of hemodialysis, is recommended.

Elderly: The kidney function and general health status of the patient must be tested to choose the right dose and treatment regimen for each patient.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients.

WARNINGS AND PRECAUTIONS

Caution should be exercised in people with a history of mental disorders, people with impaired renal function and hemodialysis, and people who operate vehicles or machinery.

The drug may cause a false positive in proteinuria.

Pregnant and breast-feeding.

SHELF-LIFE

36 months from the manufacturing date. Do not use after the expiry date.

Box of 10 blisters x 10 hard capsules.