Universal reference book for medicines
Product name: LORAFEN (LORAFEN)

Active substance: lorazepam

Type: Tranquilizer (anxiolytic)

Manufacturer: TARCHOMIN PHARMACEUTICAL WORKS POLFA (Poland)
Composition, form of production and packaging
Dragee
1 dragee

lorazepam 1 mg

Auxiliary substances: potato starch, gelatin, talc, magnesium stearate, lactose.

Sheath composition: polyvinyl alcohol, maltodextrin, talc, titanium dioxide, sucrose.

25 pcs.
- packings of cellular contour (1) - packs cardboard.
Dragee 1 dragee

lorazepam 2.5 mg

Auxiliary substances: potato starch, gelatin, talc, magnesium stearate, lactose.

Sheath composition: polyvinyl alcohol, maltodextrin, talc, titanium dioxide, aluminum varnish, sucrose.

25 pcs.
- packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

Tranquilizer from the benzodiazepine group.

Has anxiolytic, sedative, hypnotic, anticonvulsant, central muscle relaxant, antiemetic effect.
The mechanism of sedation and hypnotism is due to the increased inhibitory effect of GABA in the central nervous system by increasing the sensitivity of GABA receptors to the mediator as a result of the excitation of benzodiazepine receptors.
Anticonvulsant action is probably due to increased presynaptic inhibition and suppression of the spread of epileptogenic activity in epileptogenic foci in the cortex, thalamus, and limbic structures.

The miorelaksiruyuschee action is associated primarily with the suppression of the spinal polysynaptic afferent pathways and, apparently, with the inhibition of monosynaptic afferent pathways;
perhaps also a direct inhibitory effect on the motor nerves and muscle function.
PHARMACOKINETICS

Suction

After taking Lorafen, lorazepam is rapidly absorbed from the gastrointestinal tract.
C max is reached within 2 hours. Bioavailability is 90-93% and does not depend on the dose.
Distribution

Binding to plasma proteins is about 85%.
Penetrates through the BBB and placental barrier, in the central nervous system reaches high concentrations. Has lipotropic properties, is deposited in adipose tissue, from which it is slowly released into the blood plasma.
Metabolism and excretion

Lorazepam is biotransformed in the liver by conjugation with glucuronic acid with the formation of inactive metabolites.
T 1/2 is an average of about 12 hours. It is excreted mostly by the kidneys, about 1% by the intestine.
INDICATIONS

- acute anxiety;

- emotional stress and anxiety;

- Preoperative preparation;

- nausea and vomiting during chemotherapy (in combination with antiemetics).

DOSING MODE

Install individually.

Adults with anxious conditions drug prescribed 1-2 mg 2-3 times / day, with insomnia - 1-4 mg for 30 minutes before sleep;
for premedication - 2.5-5 mg per hour before giving anesthesia.
Children for premedication appointed at the rate of 0.05 mg / kg body weight.

People over 65 years of age are prescribed half the dose used in adult patients.

SIDE EFFECT

From the side of the central nervous system: drowsiness, fatigue, dizziness, decreased libido;
rarely - violations of orientation, depression, headache, sleep disorders, transient memory disorders, confusion. The next day after taking the drug, symptoms of excessive sedation may manifest (more pronounced in the elderly).
From the digestive system: nausea, vomiting.

Dermatological reactions: erythema, urticaria.

Side effects, as a rule, are weakly expressed and disappear on subsequent days of taking the drug or after a dose reduction.

CONTRAINDICATIONS

- disorders of central respiration;

- severe respiratory failure;

- impaired consciousness;

- Myasthenia gravis;

- an angle-closure glaucoma;

- Pregnancy;

- lactation (breastfeeding);

- Hypersensitivity to benzodiazepines.

The drug is not prescribed to patients prone to abuse of medicines.

PREGNANCY AND LACTATION

The drug is contraindicated for use in pregnancy.
If it is necessary to prescribe the drug during lactation, the question of stopping breastfeeding should be solved.
Laurafen can cause breathing disorder and suppressing the sucking reflex in newborns whose mothers used Lorafen during pregnancy.

SPECIAL INSTRUCTIONS

With caution appoint the drug to patients with a tendency to suicide attempts;
patients with impaired renal or hepatic function.
Older or weakened patients should consider the possibility of more frequent undesirable side effects.

Patients with impaired liver and kidney function are recommended to lower the dose.

Constant and prolonged (for many weeks) taking the drug in high doses can lead to the formation of psychophysical dependence, and with a sharp cancellation - to the development of the withdrawal syndrome.
Abstinence syndrome is characterized by psychomotor agitation, vegetative disorders, in severe cases, convulsions and impaired consciousness may develop. Sudden abolition of the drug may also lead to a sharp return of the symptoms of the disease. To abolish Laurafen follows gradually.
The use of lorazepam, like other benzodiazepines, can lead to the formation of drug dependence.
To prevent this, you should avoid constant use of the drug for a long time (more than 4-6 weeks); if necessary, prolonged treatment, do periodically intermittent breaks during therapy; avoid the use of lorazepam in persons in whose anamnesis there is evidence of drug dependence.
Do not drink alcohol while taking this medication.

Impact on the ability to drive vehicles and manage mechanisms

During the period of application of Laurafen and within 2 days after drug discontinuation, do not engage in potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

OVERDOSE

Symptoms: drowsiness, confusion, impaired orientation;
in severe cases - coma (when an overdose of the drug against the background of taking other drugs with oppressive effects on the central nervous system, as well as with the simultaneous use of alcohol).
Treatment: artificial vomiting, gastric lavage;
if necessary, conduct symptomatic therapy. The specific antagonist of lorazepam is flumazenil.
When using flumazenil it is necessary to make sure the patency of the airways.
Observing the patient's condition should be carried out until the symptoms of an overdose disappear completely.
DRUG INTERACTION

With the simultaneous use of lorafen with anticonvulsant, antihistamine drugs, antipsychotics, tricyclic antidepressants, opioid analgesics, ethanol and ethanol-containing drugs, the oppressive effect of drugs on the central nervous system increases.

After the simultaneous use of lorazepam and ethanol, the development of psychomotor agitation, aggression, and pathological intoxication is possible (the development of such a state does not depend on the amount of ethanol).

With the combined use of Lorafen and hormonal oral contraceptives, the concentration of lorazepam in serum is reduced.

With simultaneous application, Lorafen enhances the effect of depolarizing muscle relaxants.

When combined, nicotine accelerates the biotransformation of lorazepam and suppresses its activity.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a dry, dark place at room temperature below 25 ° C.
Shelf life - 2 years.
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