Izvarino Pharma produces medicines used for the treatment of such widespread diseases of the central nervous system as acute and chronic cerebrovascular accident, dementia, Alzheimer's disease, neuropathic pain, fibromyalgia, etc.

Vinpocetine Izvarino Pharma

Vinpocetin

Composition

1 tablet 5 mg contains:
Active substance: vinpocetine - 5.00 mg;
1 tablet 10 mg contains:
Active substance: vinpocetine - 10.00 mg;

 

Presentation

Tablets 5 mg, 10 mg. 10 or15 tablets in a blister of polyvinyl chloride film and aluminum printed and glazed foil.
3, 5, or 9 blisters of 10 tablets each, or 2, 4, or 6 blisters of 15 tablets each, together with patient leaflets, are placed in a carton pack.

 

Therapeutic indications

Neurology: symptomatic treatment of the consequences of ischemic stroke, vertebrobasilar vascular insufficiency, vascular dementia, cerebral arteriosclerosis, post-traumatic, hypertensive encephalopathy.
Ophthalmology: chronic vascular diseases of the retina and choroid.
Otology: perceptual hearing loss, Meniere's disease, tinnitus.
In order to avoid complications, use strictly as directed by the physician.

 

Route of administration

The course of treatment and dosage are determined by the physician.
Orally, after meal.
Generally, the daily dose is 15-30 mg (5-10 mg 3 times a day).
The initial daily dose is 15 mg. The maximum daily dose is 30 mg.
The therapeutic effect develops in about a week from the therapy start. The course of treatment is 1-3 months.
In renal and hepatic impairment, vinpocetine is prescribed in the usual dose, the absence of cumulation allows for long treatment courses.

 

Pregabalin Izvarino Pharma

Pregabalin

Composition

1 capsule 25 mg contains:
Active substance: pregabalin - 25.00 mg;


1 capsule 75 mg contains:
Active substance: pregabalin - 75.00 mg;


1 capsule 100 mg contains:
Active substance: pregabalin - 100.00 mg;


1 capsule 150 mg contains:
Active substance: pregabalin - 150.00 mg;


1 capsule 300 mg contains:
Active substance: pregabalin - 300.00 mg;

 

Presentation

Capsules 25 mg, 75 mg, 100 mg, 150 mg, 300 mg. 7, 10 or 14 tablets in a blister of PVC film and aluminum foil or 30 or 60 tablets in a glass or polyethylene bottle or jar sealed with a tamper-evident or ordinary cap.
1 bottle or jar or 2, 4 or 8 blisters 7 capsules each or 1, 2, 3, 4, 5 or 6 blisters 10 capsules each or 1, 2 or 4 blisters 14 capsules each with a patient leaflet are placed in a carton pack.

 

Therapeutic indications

Neuropathic pain
Treatment of neuropathic pain in adults
Epilepsy
Adjunctive therapy for adult patients with partial seizures associated or not associated with secondary generalization.
Generalized Anxiety Disorder
Treatment of generalized anxiety disorder in adult patients.
Fibromyalgia
Treatment of fibromyalgia in adult patients.

 

Route of administration

Oral, regardless of the meal.
The product is administered in a dose from 150 to 600 mg/day given in two or three divided doses.
Neuropathic pain
The starting dose for pregabalin is 150 mg/day. Based on the demonstrated efficacy and tolerability, the dose may be increased to 300 mg/day in 3-7 days, and, where necessary, in another week - to the maximum daily dose of 600 mg.
Epilepsy
The starting dose for pregabalin is 150 mg/day. Based on the demonstrated efficacy and tolerability, the dose may be increased to 300 mg/day in a week, and in another week - to the maximum daily dose of 600 mg.
Fibromyalgia
The starting dose for pregabalin is 75 mg twice a day (150mg/day). Based on the demonstrated efficacy and tolerability, in 7 days the dose can be increased to 150 mg twice a day (300 mg/day). Patients who do not experience sufficient benefit may be increased to 225 mg twice daily (450 mg/day), and where necessary in another week - to the maximum daily dose of 600 mg. It should be noted that the dose of 600 mg/kg does not provide additional significant efficacy but is worse tolerated.
Generalized Anxiety Disorder
The starting dose for pregabalin is 150 mg/day. Based on the demonstrated efficacy and tolerability, in 7 days the dose can be increased to 300 mg/day. Patients who do not experience sufficient benefit in 7 days may be increased to 450 mg/day, and where necessary in another week - to the maximum daily dose of 600 mg.
The rationale for further therapy should be regularly evaluated.
Discontinuation of pregabalin
If pregabalin therapy should be discontinued, the withdrawal should be gradual during at least 1 week.
Patients with Renal Impairment
In patients with renal impairment, the dose should be adjusted based on creatinine clearance (CC) (Table 1) calculated using the equation:
CC (ml/min)=([140-age (years)] × weight (kg))/(72 × serum creatinine (mg/dl)) (× 0.85 for female patients)
For patients receiving hemodialysis, pregabalin daily dose should be adjusted based on renal function. Over a 4-hour hemodialysis treatment, plasma pregabalin concentrations are reduced by approximately 50%. A supplemental dose should be given immediately following every 4-hour hemodialysis treatment (see Table 1).


Table 1. Pregabalin Dosage Adjustment Based on Renal Function

CC (ml/min)

Pregabalin Daily Dose

Dose Regimen

Starting Dose

(mg/day)

Maximum dose (mg/day)

≥ 60

150

600

2-3

≥ 30 - < 60

75

300

2-3

≥ 15 - < 30

25-50

150

1-2

< 15

25

75

1

Supplementary dosage following hemodialysis (mg)

 

25

100

Single dose

 

Patients with Hepatic Impairment
In patients with impaired liver function, dose adjustment is not required (see section ‘Pharmacokinetics’).
Pediatric Patients (children below 12 years old and adolescents between 12 and 17 years old inclusively)
The safety and efficacy of pregabalin in pediatric patients below 12 years old and adolescents have not been established. Pregabalin use in children is not indicated.
Geriatric Patients (over 65 years old)
Reduction of pregabalin dose may be required in elderly patients due to compromised renal function (see section ‘Pharmacokinetics’, Renal Impairment Patients).
A missed dose of pregabalin should be taken as soon as possible. If the time of next dose is close, however, the missed dose should not be taken.

 

Memantine

Composition

Composition
1 film-coated tablet 10 mg contains:
Active ingredient: memantine hydrochloride - 10.0 mg.
1 film-coated tablet 20 mg contains:
Active ingredient: memantine hydrochloride - 20.0 mg.

 

Presentation

Film-coated tablets, 10 mg, 20 mg.
10 tablets in a blister of polyvinyl chloride film and aluminum printed glazed foil.
1, 3, 6, or 9 blisters with patient leaflets are placed in a carton pack.

 

Therapeutic indications

Moderate and severe dementia of the Alzheimer’s type.

Route of administration

Treatment should only be started and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient. Diagnosis should be made according to current guidelines. The tolerability and dosing of memantine should be reassessed on a regular basis, preferably within three months after start of treatment. Thereafter, the clinical benefit of memantine and the patient’s tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued indefinitely while therapeutic benefit is favorable and the patient tolerates treatment with memantine. Discontinuation of memantine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
The product should be taken orally once daily and always at the same time, with or without food.
In order to reduce the risk of side effects the maintenance dose is achieved by upward titration of 5 mg per week during the first 3 weeks as follows:
Week 1 (day 1-7): 5 mg/day (½ tablet 10 mg) for 7 days.
Week 2 (day 8-14): 10 mg/day (1 tablet 10 mg) for 7 days.
Week 3 (day 15-21): 15 mg/day (1½ tablet 10 mg) for 7 days.
Week 4 and beyond: 20 mg (1 tablet 20 mg or 2 tablets 10 mg) per day.
The maximum daily dose is 20 mg.
The recommended maintenance dose is 20 mg per day.
Special category of patients
Elderly Patients
In patients above 65 years old no dose adjustment is required.
Patients with Renal Impairment
In patients with mildly impaired renal function (creatinine clearance 50 – 80 ml/min) no dose adjustment is required. In patients with moderate renal impairment (creatinine clearance 30 – 49 ml/min) the daily dose should be 10 mg per day. If tolerated well after at least 7 days of treatment, the dose could be further increased up to 20 mg/day according to standard scheme. In patients with severe renal impairment (creatinine clearance 5 – 29 ml/min) daily dose should be 10 mg per day.
Patients with Hepatic Impairment
In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is required. Administration of memantine is not recommended in patients with severe hepatic impairment (Child-Pugh C).