Andante
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Andante is a drug with hypnotic, sedative, anxiolytic, muscle relaxant, anticonvulsant action.
Release form and composition
Dosage form Andante - capsules: gelatinous solid, opaque blue cap; the contents of the capsules are a light blue powder with a grayish tint; 5 mg each - size No. 4, light blue opaque body; 10 mg - size No. 2, blue opaque body (7 pcs. in blisters, 1-2 blisters in a cardboard box).
Composition of 1 capsule:
- active substance: zaleplon - 5 or 10 mg;
- auxiliary components (5/10 mg): titanium dioxide (CI77891, E171) - 0.55 / 1.1 mg, microcrystalline cellulose - 22.5 / 45 mg, magnesium stearate - 1.1 / 2.2 mg, colloidal dioxide silicon - 0.55 / 1.1 mg, indigo carmine (CI73015, E132) - 1.1 / 2.2 mg, sodium lauryl sulfate - 0.55 / 1.1 mg, starlak (lactose monohydrate - 66.85 / 133, 7 mg, corn starch - 11.8 / 23.6 mg) - 78.65 / 157.3 mg;
- gelatinous cap: indigo carmine (CI73015, E132) - 0.0471%, titanium dioxide (CI77891, E171) - 1%, gelatin - up to 100%;
- gelatinous body (5/10 mg): indigo carmine (CI73015, E132) - 0.0086 / 0.2513%, titanium dioxide (CI77891, E171) - 4 / 1.5%, gelatin - up to 100%.
Indications for use
Andante is prescribed for the treatment of severe sleep disturbances (difficulty falling asleep) that lead to excessive fatigue, decreased performance, and hinder daily activities.
Contraindications
Absolute:
- severe hepatic / pulmonary failure;
- severe myasthenia gravis;
- sleep apnea syndrome;
- pregnancy and lactation;
- age up to 18 years (there is no safety profile for this category of patients);
- hypersensitivity to the components of the drug.
Relative (Andante is prescribed with caution in the following diseases / conditions):
- renal / hepatic impairment;
- chronic pulmonary failure;
- drug dependence (including anamnestic data);
- chronic alcoholism;
- depression.
When planning and the onset of pregnancy during the period of therapy, you should immediately consult a doctor.
Method of administration and dosage
Andante is taken orally just before going to bed, 2 hours after a meal, or after the patient feels that he cannot sleep.
The recommended adult daily (maximum) dose is 10 mg in 1 dose. Do not take a repeated dose within one night.
A dose of 5 mg is prescribed for the following diseases / conditions:
- old age (due to greater sensitivity to sleeping pills);
- hepatic impairment of mild / moderate severity (due to a slowdown in the excretion of Andante from the body).
With mild / moderate severity of renal failure, dose adjustment is not performed, severe - the safety profile has not been studied.
The maximum duration of taking the drug is 14 days.
Side effects
- central and peripheral nervous system: very often - dizziness, headache, weakness, increased drowsiness, depression, anterograde amnesia (occurs with behavioral disorders), mental / paradoxical reactions (in most cases in old age): nightmares, paresthesias, anxiety, aggressiveness, increased excitability, psychosis, fits of rage, behavioral disturbances, hallucinations; the onset of physical dependence, accompanied by the development of withdrawal symptoms even when taking therapeutic doses (in the form of a return of the original symptoms of sleep disorders in a more severe form, mood changes, anxiety, anxiety), the onset of mental dependence, leading to the abuse of Andante, withdrawal syndrome (in the form of a headache, myalgia, increased irritability, confusion), tremor, ataxia,increased irritability, impaired perception; in severe cases - hearing loss, depersonalization, autoaggression, epileptic seizures, increased reaction to physical / light / sound stimuli;
- digestive system: diarrhea, abdominal pain, vomiting, nausea;
- allergic reactions: itching, skin rash.
special instructions
Andante is not intended for long-term use (the maximum duration of taking the drug is 14 days). Longer courses may be prescribed by a doctor after a thorough clinical examination. It is necessary to take into account the likelihood of a withdrawal syndrome at the end of therapy.
Sleep disorders can be associated with a variety of medical conditions, including mental health. If after a short intake of Andante, normalization of sleep does not occur, or the disorders progress, it is necessary to re-evaluate the clinical situation.
If the patient wakes up shortly after midnight (due to the short half-life (T 1/2) of zaleplon), it may be necessary to use a different drug with a longer T 1/2. Do not take more than 1 capsule per day.
Taking Andante for several weeks can help reduce the hypnotic effect, lead to mental / physical dependence (the risk increases with high doses, long-term therapy, a history of drug dependence and chronic alcoholism).
Abrupt withdrawal of the drug in the presence of a formed physical dependence can lead to withdrawal symptoms in the form of myalgia, headache, severe anxiety, irritability, increased tension, confusion, psychomotor agitation. In severe cases, hallucinations, depersonalization, autoaggression, hearing loss, paresthesia in the extremities, epileptic seizures, increased reaction to physical / sound / light stimuli can be observed.
After the end of taking Andante, transient and more pronounced symptoms of insomnia (withdrawal syndrome) may appear than at the beginning of therapy. Against their background, other accompanying phenomena may appear in the form of mood changes, anxiety, sleep disturbances, anxiety.
To avoid the development of impaired psychomotor functions and anterograde amnesia, Andante should be taken only in cases where the patient has the possibility of uninterrupted sleep for at least 4 hours after taking the drug.
The reasons for discontinuation of treatment are the following symptoms: hyperexcitability, hallucinations, irritability, aggressiveness, nightmares, impaired perception, psychotic disorders and, in particular, behavioral disorders. Children and elderly patients are most prone to these disorders.
Andante is not intended for the treatment of depression / anxiety, since it can be used to implement suicidal intentions that often accompany depressive disorders. In order to avoid deliberate overdose, in case of depression, the drug can be prescribed in minimal doses.
Because of the risk of encephalopathy in severe liver failure, Andante is not prescribed.
In cases of lactose intolerance, it should be borne in mind that a 5 mg capsule contains 67 mg of lactose, a 10 mg capsule - 134 mg of lactose.
During the period of use of the drug, it is necessary to refrain from driving a car and types of work, which require a high concentration of attention and quick psychomotor reactions (associated with sedation, amnesia, decreased concentration and muscle weakness, which adversely affect the ability to perform such work).
Drug interactions
With the combined use of Andante with certain drugs / substances, the following effects may develop:
- ethanol, ethanol-containing drugs, antipsychotics (neuroleptics), other hypnotics, anxiolytics, sedatives, antidepressants, antiepileptic, antihistamines, anesthetics, opioid analgesics: enhancing the sedative effect of zaleplon;
- opioid analgesics: the manifestation of their euphoric effect, which can lead to drug dependence;
- cimetidine: increased plasma concentration of zaleplon;
- selective inhibitors of CYP3A4 (erythromycin, ketoconazole): an increase in the plasma concentration of zaleplon, an increase in its sedative effect (with combined use, it is possible to adjust the dose of zaleplon);
- CYP3A4 inducers (carbamazepine, rifampicin, phenobarbital derivatives): a significant decrease in the efficacy of zaleplon.
Analogs
Andante's analogues are: Zopiclon, Sonovan, Somnol, Selofen, Sonnat.
Terms and conditions of storage
Keep out of reach of children at a temperature of 15-30 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
