Composition, form of production and packaging
The tablets covered with a film cover of light pink color; round, biconcave.
1 tab.
zolpidem tartrate 5 mg
[PRING] lactose monohydrate - 55 mg, microcrystalline cellulose - 42.4 mg, sodium carboxymethyl starch - 4.8 mg, povidone - 1.8 mg, silicon colloid dioxide - 400 Ојg, magnesium stearate - 600 Ојg.
The composition of the membrane: hypromellose 1.28 mg, giprolose 1.28 mg, macrogol 400-400 Ојg, talc 200 Ојg, iron dye red oxide 8 Ојg, titanium dioxide 832 Ојg, carnauba wax 90 Ојg.
10 pieces. - blisters (2) - packs of cardboard.
The tablets covered with a film cover of white or almost white color, round, biconcave, with risk on one side.
1 tab.
zolpidem tartrate 10 mg
[PRING] lactose monohydrate - 60 mg, microcrystalline cellulose - 42.4 mg, sodium carboxymethyl starch - 4.8 mg, povidone - 1.8 mg, silicon dioxide colloid - 400 Ојg, magnesium stearate - 600 Ојg.
The composition of the membrane: hypromellose - 1.28 mg, giprolose - 1.28 mg, macrogol 400 - 400 Ојg, talc - 200 Ојg, titanium dioxide - 840 Ојg, carnauba wax - 90 Ојg.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
A hypnotic drug belonging to the group of imidazopyridines. Has a sedative effect, while anxiolytic, central muscle relaxant and anticonvulsant effects are not very pronounced.
Excites benzodiazepine? -receptors in the alpha subunit of GABA-receptor complexes located in the region of the IV plate of the sensory-motor cortical zones, the reticular parts of the black substance, the visual tubercles of the ventral thalamic complex, the bridge, the pale ball, etc. Interaction with the? -receptors leads to discovery of neuronal ionoform channels for chloride ions.
Application of the drug shortens the time of falling asleep, reduces the number of nocturnal awakenings, increases the total duration of sleep and improves its quality.Lengthens the II stage of sleep and the stage of deep sleep (III and IV).
Sleeping effect develops quickly. Does not cause drowsiness during the day.
PHARMACOKINETICS
Suction and distribution
After ingestion, zolpidem is rapidly absorbed from the digestive tract. The time to reach C max in blood plasma is 0.5 to 3 hours. Bioavailability of zolpidem reaches 70%.
There is a linear relationship between the dose of the drug and its concentrations in the plasma.
The binding with plasma proteins is 92%.
Metabolism and excretion
Metabolized in the liver with the formation of three inactive metabolites. Does not induce liver enzymes.
Metabolites are excreted in the urine (56%) and with feces (37%). T 1/2 is 0.7 - 3.5 hours.
Pharmacokinetics in special clinical cases
In elderly people, clearance in the blood plasma can decrease without a significant increase in T 1/2 (an average of 3 hours), while C max increases by 50%.
With pronounced violations of kidney function, the clearance does not increase significantly.
In case of violations of liver function, bioavailability increases, T 1/2 increases to 10 hours.
INDICATIONS
Sleep disorders:
- difficulty falling asleep;
- early and nocturnal awakenings.
DOSING MODE
The drug is taken orally. Doses and duration of treatment are set individually.
The usual daily dose is 10 mg at bedtime; If necessary, the dose can be increased to 15 mg, however, it should not exceed 20 mg.
For patients over the age of 65 years and with violations of the liver function, the initial dose is 5 mg; if necessary, it can be increased to 10 mg.
Sanvall В® should be taken immediately before bedtime. The course of treatment should not exceed 4 weeks.
SIDE EFFECT
From the digestive system: often (> 1%) - abdominal pain, nausea, vomiting, diarrhea.
From the side of the central nervous system: headache, confusion, memory impairment, drowsiness, impaired coordination of movements, euphoria, nightmares, dizziness and diplopia; rarely (<1%) - excitation, hallucinations, paresthesia, stupor.
Allergic reactions : skin rash, itching.
Other: rarely (<1%) - sweating, pallor, orthostatic hypotension.
With prolonged use, it is possible to develop drug dependence.
The frequency of side effects depends on the dose. Side effects are more common in women than in men.
CONTRAINDICATIONS
- Hypersensitivity to zolpidem.
Caution should be given to Sanval В® in chronic obstructive pulmonary diseases (acute), respiratory failure, myasthenia gravis, hepatic / renal insufficiency, alcoholism, drug abuse or drug dependence in history, depression.
PREGNANCY AND LACTATION
Caution is advised to use SangwalВ® during pregnancy and during breastfeeding.
In experimental studies on the study of reproduction in animals, there was no risk of adverse effects on the fetus.
Adequate and strictly controlled studies of the use of the drug SANVAL В® during pregnancy have not been conducted.
The patient should be warned that if she is planning a pregnancy or becomes pregnant during treatment with Sanval, and if she is breastfeeding, it is necessary to inform the doctor about it.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be given to Sanval with renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Caution should be given to SanvalВ® liver failure.
APPLICATION FOR CHILDREN
The drug is not prescribed for children under the age of 15 years .
APPLICATION IN ELDERLY PATIENTS
For patients over the age of 65 years and with violations of the liver function, the initial dose is 5 mg; if necessary, it can be increased to 10 mg.
SPECIAL INSTRUCTIONS
In connection with the depressing effect on the central nervous system and the rapid onset of the effect, Sanval В® should be taken immediately before bedtime.
Despite the fact that clinical studies have not revealed the overwhelming effect of zolpidem on respiration, caution should be exercised when prescribing the drug to patients with impaired respiratory function. Sanvall В® , as well as benzodiazepine group preparations, can cause breathing disorders in patients with sleep apnea.
Zolpidem can further reduce muscle tone in patients with myasthenia gravis, so these patients during the treatment of Sanval should be under careful medical supervision.
It is necessary to establish medical supervision for patients prone to depression, since the risk of suicidal behavior against the background of the use of Sanvale is increasing.
With prolonged use of Sanvala, the risk of addiction increases. The duration of taking sleeping pills should be limited, as a rule, to 2-3 weeks. The patient should be warned that if during this time the dream does not improve, you should again consult a doctor.
When used in recommended doses for more than 4 weeks, treatment should be withdrawn gradually.
During the period of treatment, Sanval should refrain from drinking alcohol.
Use in Pediatrics
The drug is not prescribed for children under the age of 15 years .
Impact on the ability to drive vehicles and manage mechanisms
In the period of treatment, Sanval should refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.
OVERDOSE
Symptoms: impaired consciousness (from drowsiness to coma), suppression of breathing, lowering blood pressure.
Treatment: gastric lavage, as an antidote is recommended the use of flumazenil. Even with severe excitation, the administration of any sedative drugs is unacceptable.Hemodialysis is ineffective. If necessary, conduct symptomatic therapy in a hospital.
DRUG INTERACTION
With simultaneous appointment of Sanvale and CNS depressant drugs, for example, opioid analgesics, antitussive drugs, neuroleptics, hypnotics (barbiturates), some tranquilizers and antidepressants, antihistamines, clonidine, their depressing effect on the central nervous system may be intensified.
Flumazenil eliminates the hypnotic effect of Sanvala.
The anxiolytic agents (tranquilizers) benzodiazepine derivatives, used against the background of Sanvala, increase the risk of drug dependence.
Sanval В®, when used simultaneously, enhances the action of imipramine and chlorpromazine and extends T 1/2 chlorpromazine (chlorpromazine increases drowsiness and incidence of anterograde amnesia), reduces C max imipramine.
Ketoconazole and ritonavir can enhance the sedative effect of SANVAL, t. they reduce the metabolism and clearance of zolpidem.
Rifampicin, on the contrary, reduces the concentration of zolpidem in the plasma and, consequently, its effect (possibly due to increased metabolism).
Alcohol enhances the depressing effect of Sanvall on the central nervous system.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription .
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
