Nitrust - instructions for use, dose, side effects, contraindications

Excipientslactose monohydrate, starch, microcrystalline cellulose, methyl parahydroxybenzoate sodium (sodium methyl paraben), magnesium stearate, silicon dioxide colloid, sodium carboxymethyl starch (sodium starch glycolate type B), hypromellose 2910 (metocel E5), macrogol 6000 (polyethylene glycol 6000), talc, titanium dioxide, dye sunset yellow.

Description:

Round biconvex tablets covered with a film membrane, orange, having a risk on one side.

View of the break: The core is white, surrounded by an orange shell.

Pharmacotherapeutic group:Sleeping pills.

ATX: & nbsp

N.05.C.F.02 Zolpidem

Pharmacodynamics:

Nitrust is a hypnotic from the group of imidazopyridines. Zolpidem selectively interacts with benzodiazepine receptors, increasing their affinity for gamma-aminobutyric acid (GABA).

Nitrust has a sedative, slightly expressed anxiolytic effect, reduces the time of falling asleep, reduces the number of nocturnal awakenings, prolongs the duration of sleep, improves its quality. Central miorelaxing and anticonvulsant effects are also characteristic.

Pharmacokinetics:

Nitrust is quickly absorbed. Sleeping effect is also fast. Bioavailability of the drug after oral administration is 70%, pharmacokinetic parameters are linearly dependent on the dose taken. The maximum level of the drug in the plasma is reached after 0.5 - 3 hours. The half-life period on the average is 2.4 hours (from 0.7 to 3.5), and the duration of the drug is up to 6 hours. The connection with plasma proteins is 92.5% +/- 0.1% and remains constant irrespective of the level of the drug in the plasma.

At the "first passage" through the liver, about 35% of the dose of the drug is metabolized.All the forming metabolites are pharmacologically inactive and excreted by the kidneys (56%) and through the intestine (37%).

The level of the drug in plasma in elderly patients and in patients with impaired liver function is lowered. In patients with renal insufficiency (regardless of dialysis), the clearance is slightly reduced. Other pharmacokinetic parameters remain unchanged.

Indications:

Sleep disorders: difficulty falling asleep, nocturnal awakenings, early awakenings.

Contraindications:

Individual intolerance of the drug, children under 18 years of age, pregnancy, breastfeeding, myasthenia gravis, severe respiratory failure, sleep apnea syndrome, severe liver function disorders.

Carefully:

Chronic obstructive pulmonary disease (COPD) (at the point of exacerbation), hepatic / renal failure, alcoholism, drug abuse or drug dependence in history, depression.

Dosing and Administration:

Nitrust is intended for oral administration.

Adults under the age of 65 years are prescribed a single dose of 10 mg; if necessary, the dose may be increased to 15-20 mg.For patients older than 65 years, the initial dose is 5 mg; the maximum dose is 10 mg. The drug should be taken immediately before bedtime (for 10 - 30 minutes). The course of treatment is no more than 4 weeks.

Side effects:

From the digestive system: abdominal pain, nausea, vomiting, diarrhea.

From the nervous system: confusion, memory impairment, hallucinations, dizziness, anxiety, "nightmarish" dream, severe headache, daytime sleepiness; disorders of coordination of movements, muscle weakness, diplopia, anterograde amnesia.

Allergic reactions: skin rash, itching.

Other: drug dependence (with prolonged use).

Overdose:

In cases of overdose Nitresta mostly observed signs of depression of the central nervous system (including impairment of consciousness from drowsiness to coma, tremors, incoordination), cardiovascular and respiratory disorders.

First aid is gastric lavage, activated charcoal, if necessary, symptomatic therapy in the hospital with the administration of flumazenil. Nitrust is not amenable to dialysis.

Interaction:

It is not recommended to apply Nitrust at the same time as alcohol. In combination with alcohol, the sedative effect of Nitrust can intensify.

Influence on the central nervous system can increase with combined use with antipsychotic, hypnotics, sedatives and antidepressants, narcotic analgesics, antiepileptic drugs and antihistamines with sedative effect.

Strengthening of euphoria under the influence of a narcotic anesthetic can lead to mental dependence.

Compounds that inhibit specific hepatic enzymes (especially cytochrome P450) can cause an increase in the activity of benzodiazepine and preparations similar to benzodiazepines.

Strengthens the action of imipramine and chlorpromazine, lengthens T_1/2chlorpromazine (chlorpromazine enhances drowsiness and incidence of anterograde amnesia), reduces C_max imipramine.

Special instructions:

Long-term use is not recommended because of the possible development of addiction and drug dependence (mental and physical).

The likelihood of developing addiction increases in patients who have a history of addiction to other drugs and a tendency to alcoholism.With the development of physical dependence to the drug at the abrupt cessation of therapy may occur drug withdrawal syndrome (headaches, muscle pain, increased levels of anxiety, confusion, irritability, increased motor activity). The following symptoms may occur in severe cases: derealization, depersonalization, numbness and tingling of extremities, hypersensitivity to light, noise, hallucinations or epileptic seizures. It is recommended to gradually reduce the dosage of the drug at the end of the course of treatment, since with a sharp abolition of Nitrust, the symptoms of insomnia may appear again.

To prevent the development of anterograde amnesia, patients should provide 7-8 hours of continuous sleep.

When prescribing the drug to patients with concomitant depressive conditions, it is necessary to consider the possibility of strengthening suicidal tendencies.

Effect on the ability to drive transp. cf. and fur:

Care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions,since the hypnotic effect may persist the next morning after taking Nitres.

Form release / dosage:

Tablets, film-coated, 10 mg.

Packaging:

10 tablets per blister, made of PVC and aluminum foil. For 1, 2 or 3 blisters together with instructions for use are placed in a cardboard box.

A transparent film of polyolefin (sticker) with a printed logo is applied to the cardboard pack on both sides to ensure control of the first opening.

Storage conditions:

It refers to the list of the III list of narcotic drugs, psychotropic substances and their precursors, which are subject to control in the Russian Federation.

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years

Do not use the drug after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N014002 / 01

Date of registration:07.08.2008

The owner of the registration certificate:San Pharmaceutical Industries Co., Ltd.San Pharmaceutical Industries Co., Ltd. India

Manufacturer: & nbsp

Sun Pharmaceutical Industries, Ltd. India

Representation: & nbspSAN PHARMACEUTICAL INDUSTRIES LTD. SAN PHARMACEUTICAL INDUSTRIES LTD. India

Information update date: & nbsp10.09.2015

Illustrated instructions

Instructions

Nitrust (Nitrest)