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Litotsell

Препарат Литоцелл. УП "Диалек" Республика Беларусь


Producer: Dialek Unitary Enterprise Republic of Belarus

Code of automatic telephone exchange: N05AN01

Release form: Firm dosage forms. Capsules.

Indications to use: Mental diseases. Maniacal excitement. Alcoholic psychosis.


General characteristics. Structure:

Active ingredient: 67,5 mg of lithium in the form of lithium of a poliuronat.

Structure of the capsule: gelatin pharmaceutical, glycerin, sodium lauryl sulfate, the water purified titanium dioxide, quinolinic yellow E-104, a sunset yellow E-110.

The lithium-containing medicine having normotimichesky, antipsychotic effect.




Pharmacological properties:

Pharmacodynamics. Litotsell has normotimichesky, antipsychotic effect. Treats group of lithium-containing medicines.

Has ability to stop affective states and maniac-depressive psychoses.

Lithium suppresses sympathetic activity and weakens action of catecholamines; influences opiate receptors of a brain.

Pharmacokinetics. At oral administration of lities it is well absorbed from a GIT, reaching the maximum concentration in blood approximately in 8-12 hours (T1/2 depends on quantity of ions of sodium in a blood plasma and makes 13-25 hours). Does not communicate proteins of plasma. Gets through a blood-brain and placental barrier, collects in tissues of a brain, heart, skeletal muscles.

Lithium is removed from an organism preferential by kidneys with urine, insignificant quantities with then, a stake.


Indications to use:

- treatment and prevention of the mental diseases which are followed by affective attacks;

- maniacal, hypomaniacal conditions of various genesis;

- affective disturbances at patients with alcohol addiction.


Route of administration and doses:

Accept inside, after food, for reduction of irritant action by a mucous membrane of a stomach. The dose is selected individually, under control of level of lithium in a blood plasma. Therapeutic concentration of lithium has to make 0,6-0,8 mmol/l (for children - 0,4-0,6 mmol/l) at its appointment as preventive therapy and 0,7-1,2 mmol/l at treatment of maniacal and hypomaniacal states. In an initiation of treatment concentration of lithium in blood is defined once a week, in the subsequent - from 1 time in 2 weeks to 1 time a month. Blood undertakes on an empty stomach in 10-12 hours after acceptance of the last drug dose.

Reception begin 1000-1500 mg (2-3 capsules) a day divided into 2-3 receptions with a dose. At good tolerance the dose is increased to 2000 mg (4 capsules) a day. In the subsequent, daily increasing a dose by 500 mg (1 capsule), bring to a daily dose 2500-3500 mg (5-7 capsules), as much as possible to 4000 mg (8 capsules) in 3-4 receptions. In the doses exceeding 3500 mg a day it is not recommended to accept more than 1-2 weeks.

Duration of reception of medicine depending on the diagnosis makes 2-8 weeks.


Features of use:

Before treatment by Litotsell it is necessary to define clearance of creatinine and size of residual nitrogen, to carry out the ECG analysis and the general blood test with definition of SOE. It is regularly necessary to control lithium level in blood. Within the first month of therapy concentration of lithium in plasma is defined weekly; on reaching stable concentration control is carried out monthly. Blood samples are taken always in the morning, i.e. in  12 h after reception of the last dose for the night or in 24 h after reception of an unary dose in the morning. Besides, it is necessary to define immediately lithium at displays of intoxication, a disease recurrence, changes of a salt metabolism. The passed Litotsell's doses do not compensate.

It is not necessary to appoint the patient with disturbances of water-salt balance (an electrolyte-deficient diet, deficit of sodium, diarrhea, vomiting) because of danger of strengthening of a reabsorption of lithium with kidneys.

With care apply at cardiovascular diseases, TsNS diseases (including epilepsy, parkinsonism, organic lesions, schizophrenia), severe dehydration, serious infectious diseases, an ischuria, a diabetes mellitus, a hyperparathyreosis, psoriasis, at the weakened patients and at a hyponatremia.

At the elderly and weakened patients correction of the mode of dosing is necessary.

Due to the lack of adequate data on safety and efficiency of medicine children are not recommended to appoint up to 12 years.

Not to allow during alcohol intake treatment.

During treatment to abstain from the types of activity requiring special attention and bystry psychomotor reactions.


Side effects:

From TsNS and peripheral nervous system: muscular weakness, tremor of hands, adynamia, drowsiness; at prolonged use disturbances of an articulation, a hyperreflexia are possible.

From cardiovascular system: disturbance of a cordial rhythm; at prolonged use the collapse, a coma are possible.

From the alimentary system: dispeptic phenomena.

From an urinary system: at prolonged use disturbance of concentration ability of kidneys and disturbance of a diuresis is possible.

Dermatological reactions: at prolonged use emergence of an alopecia, aggravation of an acne is possible.

From endocrine system: dysfunction of a thyroid gland is seldom possible.

Others: the polydipsia, is more often at the beginning of medicine use; hemopoiesis disturbance.


Interaction with other medicines:

At the combined appointment with neuroleptics and timoleptika increase in body weight is possible.

Co-administration with diuretics reduces a sodium reabsorption in renal tubules that is dangerous by development of a hyponatremia. Also the drugs influencing function of kidneys can affect serumal concentration of lithium that can lead to lithium intoxication as the therapeutic range of lithium is narrow.

Against the background of a combination of lithium and a levodopa development of diskineziya and hallucinations is possible; at a combination to metildopy neurotoxic side effects can develop disproportionately concentration of lithium in a blood plasma.

Urea, Aminophyllinum, caffeine, Diphyllinum, окстрифиллин, theophylline increase lithium removal by kidneys and reduce its pharmacological action.

Indometacin, ibuprofen and diclofenac slow down lithium excretion, thereby strengthen its toxic effects.

The combination to cardiac glycosides is not recommended because of strengthening of toxic effects of lithium and development of arrhythmias.

Antiinflammatory and laxative drugs increase loss of liquid and reduce portability of lithium.

Lithium does not influence activity of liver enzymes and itself is not exposed to biotransformation.


Contraindications:

- disturbance of secretory function of kidneys;

- cardiovascular diseases with the phenomena of a decompensation and disturbances of conductivity;

- dysfunction of a thyroid gland;

- leukosis;

- low level of sodium (including Addison's disease);

- pregnancy and period of a lactation.


Overdose:

At overdose of lities affects first of all the central nervous system and kidneys; the overdose by medicine can lead to a lethal outcome.

Early symptoms of overdose: diarrhea, drowsiness, dizziness, appetite loss, muscular weakness, nausea, vomiting, tremor. As the first displays of intoxication serve increase in deep tendon jerks and muscular twitchings, confusion of consciousness, a sight illegibility, concern, drowsiness and indistinctness of the speech, epileptic spasms, the syncopated breath, an oliguria; development of a sopor and coma is possible.

Treatment: symptomatic. Introduction in a large amount of liquid and Na+ is reasonable. In hard cases hospitalization is required. The period of biological half-decay of lithium in a human body makes 24 hours, and performing adequate treatment for days keeps the patient's life until kidneys do not begin to excrete lithium with the predicted speed. In cases when the overdose threatens with death, resort to a renal hemodialysis, but intoxication seldom happens so considerable that there was a need for this procedure.


Storage conditions:

In the place protected from moisture and light at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 2 years. Not to use after the period of validity specified on packaging.


Issue conditions:

According to the recipe


Packaging:

Banks on 30, 50 capsules in packaging No. 1.



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