Selofen (zaleplon) capsules 0.01g. №10

Description

Selofen (zaleplon) capsules 0.01g. №10

Composition

active substance: zaleplon;

1 capsule contains zaleplon 10 mg;

excipients: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silicon dioxide, sodium lauryl sulfate, sodium starch glycolate (type A), magnesium stearate; capsule composition: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), erythrosine (E 127), indigo carmine (E 132).

Medicinal form

Capsules.

The main physical and chemical properties: hard gelatin capsules with a pink body and a blue cap of size “3”, containing a white powder.

Pharmacotherapeutic group

Sleeping pills and sedatives.
ATX code N05C F03.

Pharmacological properties

The active ingredient of the drug – zaleplon refers to drugs of the pyrazolpyrimidine group, which differ in benzodiazepines, as well as other hypnotics. The active substance of the drug enters into action with the benzodiazepine GABA-a receptors, which are contained in the neural structures of the brain.

Indications

Selofen capsules is used in the treatment of sleep disorders associated with difficulty falling asleep. The use of the drug is justified only in the treatment of severe forms of sleep disorders.

Contraindications

Contraindicated in case of hypersensitivity to zaleplon, as well as severe forms of hepatic or renal failure, myasthenia gravis, severe forms of respiratory failure. The drug is not prescribed to children who are under 18 years of age and women during breastfeeding.

Application during pregnancy and lactation

The period of breastfeeding and pregnancy are important contraindications for the use of Selofen.
The drug is not prescribed to patients whose work activity requires increased concentration of attention and quick psychomotor reactions.

Method of administration and dosage

The drug Selofen capsules can be prescribed only in the shortest possible courses, which do not exceed two weeks. The use of the drug is advisable for the treatment of problems with falling asleep. The capsules should be swallowed immediately before going to bed. Do not combine taking the drug with food intake, as this can cause a delayed development of its effect.
The recommended maximum dose of zaleplon is 10 mg. When prescribing Selofen capsules, it is necessary to warn the patient that it is strictly forbidden to take the drug twice during one night.
Due to the fact that elderly people and patients suffering from liver dysfunction may be more sensitive to the effects of zaleplon, in order to prevent the occurrence of negative consequences from taking it, the recommended starting dose of the drug for this category of patients is 5 mg.
When the drug is prescribed to patients with severe renal impairment, no dosage adjustment is performed.

Overdose

There is no information on acute overdose with zaleplon. However, it can be assumed that taking Selofen in high doses can cause depression of the central nervous system, increased drowsiness, decreased blood pressure, confusion, respiratory failure, coma, and in especially difficult cases, death.
At the same time taking the drug in a high dosage, the patient undergoes gastric lavage and provides activated carbon.
In severe cases, the introduction of the antidote zaleplon – flumazenil is indicated.

Side effects

Anorexia, somnambulism, apathy, hallucinations, depression, amnesia, angioedema, confusion, ataxia, visual impairment, dyspeptic disorders.