REGISTRATION NUMBER
R N000807/01 (Р N000807/01)
TRADE NAME
Picamilon®
INTERNATIONAL NON-PROPRIETARY NAME (INN)
Nicotinoyl gamma-aminobutyric acid
DOSAGE FORM
tablets
COMPOSITION
Picamilon either 20.00 mg or 50.00 mg N-nicotinoyl-gamma-aminobutyric acid sodium salt
Excipients: potato starch – 18.70 mg or 46.78 mg, corn starch – 0.60 mg or 1.47 mg, magnesium hydroxycarbonate (basic magnesium carbonate) – 15.53 mg or 38.82 mg, sucrose – 42.55 mg or 106.38 mg, calcium stearate – 1.00 mg or 2.50 mg, talc – 1.62 mg or 4.05 mg.
DESCRIPTION
White flat-cylindrical tablets with a beveled edge (20 mg dosage) and with beveled edge and score line (50 mg dosage).
PHARMACOTHERAPEUTIC GROUP
nootropic agent
ATC CODE
N06BX
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
Nootropic agent that dilates cerebral vessels.
Has tranquilizing, psychostimulating, antiplatelet, and antioxidant effects. Improves brain function by normalizing tissue metabolism and affecting cerebral circulation (increases volumetric and linear cerebral blood flow, reduces vascular resistance, inhibits platelet aggregation, improves microcirculation).
With course administration, increases physical and mental performance, reduces headache, improves memory, normalizes sleep; helps reduce or eliminate anxiety, tension, fear; improves condition of patients with motor and speech disorders, reduces depressive effects of ethanol on the central nervous system. Improves circulation in retinal and optic nerve vessels.
PHARMACOKINETICS
Absorption is rapid and complete. Penetrates blood-brain barrier, retained in body tissues for long periods. Bioavailability – 50-88%. Mainly excreted unchanged through kidneys. Half-life – 0.51 h.
INDICATIONS
- Complex therapy of mild to moderate ischemic cerebrovascular disorders
- Chronic cerebrovascular insufficiency
- Post-traumatic brain injury conditions
- Treatment of chronic alcoholism (to reduce asthenic, astheno-neurotic, post-psychotic, pre-relapse conditions, and alcoholic encephalopathy)
- As part of complex migraine prevention therapy
- Primary open-angle glaucoma with compensated pressure
- Retinal and optic nerve diseases of vascular origin
- In urology (for children over 3 years and adults with urination disorders)
- Complex therapy of dystonia syndrome with anxiety, fear, irritability, emotional lability
CONTRAINDICATIONS
- Hypersensitivity
- Chronic renal failure
- Pregnancy
- lactation
- Children under 3 years
METHOD OF ADMINISTRATION AND DOSAGE
Taken orally, with or without food.
For cerebrovascular diseases: 20-50 mg 2-3 times daily, total daily dose 60-150 mg. Treatment course 1-2 months. Repeat after 5-6 months.
For migraine prevention: 50 mg 3 times daily, for attack relief – 100 mg once.
Late-age depression: 40-200 mg daily in 2-3 doses, optimal dosage 60-120 mg daily, for 1.5-3 months.
As asthenic and anxiolytic agent: 40-80 mg daily, if needed up to 200-300 mg daily, for 1-1.5 months.
For alcoholism during abstinence: 100-150 mg daily for 6-7 days; for persistent disorders outside abstinence 40-60 mg daily for 4-5 weeks.
For performance recovery and increased loads: 60-80 mg daily for 1-1.5 months, same dose for athletes during 2-week training period.
Primary open-angle glaucoma: 50 mg 3 times daily for 1 month.
For retinal and optic nerve diseases: first 12 days intramuscularly, then 20-50 mg 3 times daily (60-150 mg total) for 1 month.
For urination disorders:
| Age Group | Single Dose | Frequency | Daily Total |
| 3-10 years | 20 mg | Twice daily | 40 mg |
| 11-15 years | 50 mg | Twice daily | 100 mg |
| Over 15 years | 50 mg | Three times daily | 150 mg |
SIDE EFFECTS
Allergic reactions (skin rash, itching), dizziness, headache, mild nausea, irritability, anxiety, agitation.
OVERDOSE
Increased severity of side effects. Treatment is symptomatic.
INTERACTIONS
Shortens barbiturate effects, enhances opioid analgesic effects.
DOSAGE FORM/STRENGTH
Tablets of 20 or 50 mg. 30 or 60 tablets in polymer container. Each container with usage instructions in cardboard box.
PACKAGING
30 tablets in 1 polymer container – cardboard box
60 talets in 1 polymer container – cardboard box
STORAGE CONDITIONS
Store at temperature not above 25°C. Keep out of reach of children.
SHELF LIFE
3 years. Do not use after expiration date on package.
DISPENSING CONDITIONS
Prescription only
MANUFACTURER
Pharmstandard, Russia. https://pharmstd.com/