LEPTICA 75

Manufacturer

PT. Dexa Medica, Indonesia

Applicant company

PT Dexa Medica

Active ingredient

Pregabalin

Content

75mg

Shelf life

24 months

Dosage Form

Hard Capsules

Package

Box of 3 blisters x 10 tablets

Visa Number

899110348925

Issuing Date

14/08/2025

Therapeutic area

Anxiety/Neuralgia

Indication

- Neuropathic pain: Pregabalin is indicated for the treatment of neuropathic pain in adults.
- Epilepsy: Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalization.
- Generalized Anxiety Disorder: Pregabalin is indicated for the treatment of Generalized Anxiety Disorder (GAD) in adults.
- Fibromyalgia: Pregabalin is indicated for the treatment of fibromyalgia.

Dosage

The dose range is 150 mg to 600 mg per day given in either two or three divided doses. Pregabalin may be taken with or without food.
Neuropathic pain
Treatment with pregabalin can be started at a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg/day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg/day after an additional 7-day interval.
Fibromyalgia
The usual dose for most patients is 300 mg to 450 mg/day given in two divided doses. Some patients may achieve good treatment efficacy with a dose of 600 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day) and may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with a 300 mg/day dose may be further increased to 225 mg two times a day (450 mg/day). If needed, in some patients, based on individual response and tolerability, the dose may be increased to a maximum of 600 mg/day after an additional week of treatment.
Epilepsy
Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg/day after 1 week. It can be increased to a maximum dose of 600 mg/day after an additional week of treatment.
Generalized
Anxiety Disorder The dose range is 150 mg to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly. Pregabalin treatment can be started with a dose of 150 mg/day. Based on individual patient response and tolerability, the dose may be increased to 450 mg/day. It can be increased to a maximum dose of 600 mg/day after an additional week of treatment.
Discontinuation of pregabalin
If pregabalin has to be discontinued, it should be tapered gradually over a minimum of 1 week.
Patients with renal impairment
Dose reduction in patients with compromised renal function must be individualized according to creatinine clearance (CLcr) (see Pharmacokinetic properties, Pharmacokinetics in special patient groups, renal impairment), as presented in Table 1 using the following formula:

Clcr(ml/min) =

[140 − age(years)] × weight(kg)

72 × serum creatinin(mg/dl)

(× 0,85 female patients)

For patients receiving hemodialysis, the pregabalin daily dose should be adjusted based on renal function. In addition to the daily dose, a supplementary dose should be given immediately following every 4-hour hemodialysis treatment (see Table 1).
Table 1. Pregabalin Dose Adjustment Based on Renal Function

Creatinine clearance (Clcr) (ml/min)	Total pregabalin daily dose (mg/day)*				Dose regimen
≥ 60	150	300	450	600	BID or TID
30 – 60	75	150	225	300	BID or TID
15 – 30	25 – 50	75	100 – 125	150	QD or BID
< 15	25	25 - 50	50 - 75	75	QD
Supplementary dose following hemodialysis (mg)**
Patients taking a single dose of 25 mg/day: take an additional supplemental dose of 25 mg or 50 mg. Patients taking a single dose of 25 – 50 mg/day: take an additional supplemental dose of 50 mg or 75 mg. Patients taking a single dose of 50 – 75 mg/day: take an additional supplemental dose of 75 mg or 100 mg. Patients taking a single dose of 75 mg/day: take an additional supplemental dose of 100 mg or 150 mg.

TID = Divided into 3 doses/day.
BID = Divided into 2 doses/day.
QD = Single dose/day.
*Total daily dose (mg/day) should be divided according to the dose regimen mentioned above to provide mg/dose.
**The supplementary dose is a single additional dose.
Use in patients with hepatic impairment
No dose adjustment is required for patients with hepatic impairment.
Use in children and adolescents (12-17 years of age)
The safety and efficacy of pregabalin for children under 12 years of age and adolescents have not been established. The use of this medication in children is not recommended.
Use in the elderly (over 65 years of age)
Elderly patients may require a dose reduction of pregabalin due to decreased renal function.