Andante

Andante – drug with somnolent, sedative, anxiolytic, myorelaxation, anticonvulsant action.

Form of release and structure

Dosage form of release of the Andante – the capsule: gelatinous firm, opaque blue lid; contents of capsules – powder, light blue with a grayish shade; on 5 mg – the size No. 4, the light blue opaque case; on 10 mg – the size No. 2, the blue opaque case (on 7 pieces in blisters, on 1-2 blisters in a cardboard pack).

Structure of 1 capsule:

• active agent: залеплон – 5 or 10 mg;
• auxiliary components (5/10 mg): titanium dioxide (C.I.77891, E171) – 0,55/1,1 mg, microcrystallic cellulose – 22,5/45 mg, magnesium stearate – 1,1/2,2 mg, colloid silicon dioxide – 0,55/1,1 mg, indigo carmine (C.I.73015, E132) – 1,1/2,2 mg, sodium lauryl sulfate – 0,55/1,1 mg, старлак (monohydrate of lactose – 66,85/133,7 mg, corn starch – 11,8/23,6 mg) – 78,65/157,3 mg;
• gelatinous lid: indigo carmine (C.I.73015, E132) – 0,0471%, titanium dioxide (C.I.77891, E171) – 1%, gelatin – to 100%;
• gelatinous case (5/10 mg): indigo carmine (C.I.73015, E132) – 0,0086/0,2513%, titanium dioxide (C.I.77891, E171) – 4/1,5%, gelatin – to 100%.

Indications to use

The andante is appointed for treatment of severe forms of a sleep disorder (backfilling difficulty) which result in excessive fatigue, reduce working capacity and complicate daily activity.

Contraindications

Absolute:

• liver/pulmonary failure in a heavy current;
• heavy myasthenia;
• syndrome of a night apnoea;
• pregnancy and period of a lactation;
• age up to 18 years (the safety profile for this category of patients is absent);
• hypersensitivity to drug components.

Relative (The andante is appointed with care at the following diseases / states):

• renal/liver failure;
• chronic pulmonary insufficiency;
• medicinal dependence (including anamnestic data);
• alcoholism;
• depression.

During the planning and approach of pregnancy during therapy it is necessary to see a doctor immediately.

Route of administration and dosage

Andantes accept inside just before withdrawal to a dream, 2 hours later after meal or after the patient feels that he cannot fall asleep.

The recommended adult daily (maximum) dose – 10 mg in 1 reception. The repeated dose within one night cannot be accepted.

The dose of 5 mg is appointed at the following diseases / states:

• advanced age (because of bigger sensitivity to somnolent drugs);
• liver failure of easy/average of severity (because of delay of removal of the Andante from an organism).

At easy/average severity of a renal failure dose adjustment is not carried out, heavy degree – the profile of safety is not studied.

The maximum duration of administration of drug – 14 days.

Side effects

• central and peripheral nervous system: very often – dizziness, a headache, weakness, the increased drowsiness, a depression, an ecmnesia (proceeds with behavior disorders), mental/paradoxical reactions (in most cases at advanced age): dreadful dreams, paresthesias, concern, aggression, hypererethism, psychosis, attacks of rage, behavior disorder, hallucination; the emergence of physical dependence which is followed by development of symptoms of cancellation even at reception of therapeutic doses (in the form of return of initial symptoms of sleep disorders in more severe form, changes of mood, alarm, concern), the emergence of mental dependence leading to abuse of the Andante, a withdrawal (in the form of a headache, a mialgiya, an acrimony, confusion of consciousness), a tremor, an ataxy, an acrimony, perception disturbances; in hard cases – decrease in hearing, depersonalization, an autoaggression, epileptic seizures, the increased reaction to physical/light/sound irritants;
• alimentary system: diarrhea, abdominal pains, vomiting, nausea;
• allergic reactions: itch, skin rash.

Special instructions

For long use of the Andante it is not intended (the maximum duration of administration of drug – 14 days). Longer courses can be appointed by the doctor after carrying out careful clinical inspection. It is necessary to consider probability of emergence upon termination of therapy of a withdrawal.

Sleep disorders can be connected with various diseases, including mental. If after short reception of the Andante normalization of a dream does not happen, or disturbances progress, it is necessary to carry out assessment of a clinical situation once again.

If the patient wakes up soon after midnight (it is connected with a short elimination half-life _(T1/2) of a zaleplon), there can be a need for use of other medicine with longer _T1/2. It is impossible to accept more than 1 capsule a day.

Reception of the Andante for several weeks can promote decrease in somnolent effect, lead to emergence of mental/physical dependence (the risk increases at reception of high doses, long therapy, medicinal dependence in the anamnesis and an alcoholism).

Sharp drug withdrawal in case of existence of the created physical dependence can lead to emergence of symptoms of cancellation in the form of a mialgiya, the headache which is sharply expressed to uneasiness, irritability, the increased tension, confusion of consciousness, psychomotor excitement. In hard cases can be observed: hallucinations, depersonalization, an autoaggression, decrease in hearing, paresthesia in extremities, epileptic seizures, the increased reaction to physical/sound/light irritants.

After the end of reception of the Andante symptoms of sleeplessness (withdrawal) can appear passing and more expressed, than at the beginning of therapy. On their background emergence of other epiphenomena in the form of change of mood, concern, sleep disorders, alarms is possible.

To avoid development of disturbances of psychomotor functions and an ecmnesia, the Andante should be accepted only when the patient has a possibility of a continuous dream for at least 4 hours after administration of drug.

The following symptoms are the reason of cancellation of treatment: hyperexcitability, hallucinations, irritability, aggression, dreadful dreams, perception disturbances, psychotic frustration and, in particular, behavior disorders. Children and elderly patients are most inclined to emergence of these disturbances.

For treatment of a depression / alarming conditions of the Andante it is not intended as it can be used for implementation of suicide intentions which often accompany depressive frustration. In order to avoid conscious overdose, at a depression drug can be appointed in the minimum doses.

Because of danger of development of encephalopathy at a heavy liver failure of the Andante do not appoint.

In cases of existence of a lactose intolerance it is necessary to consider that as a part of the capsule of 5 mg there are 67 mg of lactose, capsules of 10 mg – 134 mg of lactose.

During use of drug it is necessary to abstain from driving of the car and types of works when which performing high concentration of attention and bystry psychomotor reactions are required (it is connected with sedation, amnesia, decrease in concentration of attention and muscular weakness which adversely influence ability to perform such works).

Medicinal interaction

At the combined use of the Andante with some medicinal means / substances development of the following effects is possible:

• ethanol, etanolsoderzhashchy drugs, antipsychotic means (neuroleptics), other hypnotic drugs, anxiolytic, sedative, antidepressive, antiepileptic, antihistaminic medicines, means for anesthesia, opioid analgetics: strengthening of sedative action of a zaleplon;
• opioid analgetics: manifestation of their euphoric effect that can lead to emergence of medicinal dependence;
• Cimetidinum: increase in plasma concentration of a zaleplon;
• the selection CYP3A4 inhibitors (erythromycin, кетоконазол): increase in plasma concentration of a zaleplon, strengthening of its sedation (at the combined use carrying out dose adjustment of a zaleplon is possible);
• inductors CYP3A4 (carbamazepine, rifampicin, phenobarbital derivatives): significant reduction of efficiency of a zaleplon.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature of 15-30 °C.

Period of validity – 2 years.