Aleval - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Aleval

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 329 rub.

Buy

Aleval is a drug with an antidepressant effect.

Release form and composition

Aleval is released in the form of film-coated tablets, round, biconvex, blue, on one side of the risk; at the break - white core (14 pcs. in strips, 1 or 2 strips in a cardboard box).

Composition of 1 tablet:

• Active substance: sertraline - 25, 50 or 100 mg (sertraline hydrochloride - 28, 56 or 112 mg);
• Auxiliary components: hypromellose 2910, calcium hydrogen phosphate dihydrate, indigo carmine, microcrystalline cellulose, corn starch, crospovidone, purified talc, magnesium stearate, anhydrous colloidal silicon dioxide;
• Film casing: macrogol 6000, indigo carmine, hypromellose 2910, purified talc, titanium dioxide.

Indications for use

• Depression of various etiologies (for treatment and prevention);
• Panic disorder with / without agoraphobia;
• Post-traumatic stress disorder (PTSD);
• Obsessive Compulsive Disorder (OCD).

Contraindications

Absolute:

• Uncontrolled epilepsy;
• Combined use with monoamine oxidase inhibitors and pimozide (when changing drugs, a break of 14 days must be observed);
• Combined use with fenfluramine or tryptophan;
• Age under 6 (for depression and OCD) or under 18 (for PTSD and panic disorder);
• Pregnancy and lactation;
• Hypersensitivity to drug components.

Relative (Aleval should be used with caution in the presence of the following diseases / conditions):

• Organic brain diseases (including mental retardation);
• Manic states;
• Epilepsy;
• Hepatic and / or renal failure;
• Decrease in body weight;
• Age under 18 (for OCD and depression).

Women of reproductive age need to use effective methods of contraception while using Aleval.

Method of administration and dosage

Aleval tablets are taken orally, in the morning or evening, regardless of the meal. Frequency rate of admission - 1 time per day.

The starting adult dose for depression and OCD is 50 mg. With an interval of no more than 1 time per week, the dose can be gradually increased to the maximum - 200 mg.

The initial effect can be expected within 7 days, the full - after 2-4 weeks from the start of therapy (with OCD, the effect may develop later). The maintenance dose for a long course should be the least effective. It is adjusted depending on the therapeutic effect.

Recommended dosing regimen for treating OCD in children:

• 6-12 years old: the initial daily dose is 25 mg, after a week it may be increased to 50 mg;
• 12-17 years old: initial daily dose - 50 mg. Gradually, not earlier than a week later, it can be increased to a maximum of 200 mg. In order to avoid an overdose, it is necessary to take into account the lower body weight in children compared to adults (with an increase in the daily dose, the condition of this category of patients is carefully monitored, in case of the development of symptoms of an overdose, the drug is canceled).

The starting adult dose for the treatment of panic disorder and PTSD is 25 mg. Perhaps its gradual (no more than 1 time per week) increase by 25 mg to a maximum of 200 mg (taking into account the tolerance and therapeutic effect).

The initial effect can be expected within 7 days, the full one - after 2-4 weeks from the start of therapy. The maintenance dose for a long course should be the least effective.

In case of functional disorders of the kidneys, as well as in elderly patients, correction of the dosage regimen is not required.

Patients with severely impaired liver function need to reduce the dose of Aleval or increase the intervals between doses.

Side effects

• Cardiovascular system: tachycardia, heart palpitations, decreased blood pressure;
• Digestive system: dry mouth, decreased appetite up to anorexia, dyspeptic symptoms (in the form of flatulence, nausea, vomiting, diarrhea), pancreatitis, abdominal pain, hepatitis, liver failure, jaundice; rarely - increased appetite;
• Musculoskeletal system: muscle cramps, arthralgia;
• Urinary system: enuresis, urinary retention or incontinence;
• Central and peripheral nervous system: extrapyramidal disorders (in the form of dyskinesias, akathisias, bruxism, gait disturbances), paresthesias, involuntary muscle contractions, drowsiness, fainting, migraine, headache, dizziness, euphoria, tremor, anxiety, insomnia, convulsions, agitation manic disorders, hallucinations, decreased libido, nightmares, psychosis, suicide, coma;
• Endocrine system: hypothyroidism, hyperprolactinemia, syndrome of inappropriate antidiuretic hormone secretion;
• Respiratory system: yawning, bronchospasm;
• Reproductive system: priapism, sexual dysfunction (in the form of delayed ejaculation, decreased potency), gynecomastia, menstrual irregularities, galactorrhea;
• Sense organs: ringing in the ears, visual impairment, periorbital edema, mydriasis;
• Laboratory tests: rarely (with a long course) - an asymptomatic reversible increase in the activity of transaminases in the blood serum. Cancellation of the drug in this case leads to normalization of enzyme activity, leukopenia, thrombocytopenia, increased serum cholesterol concentration;
• Allergic reactions: anaphylactoid reaction, urticaria, facial edema, itching, angioedema;
• Dermatological reactions: purpura, alopecia, flushing or redness of the skin, photosensitivity, increased sweating; rarely - toxic epidermal necrolysis, Stevens-Johnson syndrome;
• Others: weakness, increase or decrease in body weight, bleeding (including gastrointestinal, nasal, or hematuria), peripheral edema.

Due to the termination of Aleval, in rare cases, withdrawal syndrome develops, the signs of which are hypesthesia, paresthesia, psychomotor agitation, symptoms of depression, aggressive reactions, hallucinations, anxiety or symptoms of psychosis (cannot be distinguished from the symptoms of the underlying disease).

special instructions

The combined use of Aleval with monoamine oxidase inhibitors is not recommended (a break of at least 14 days must be observed).

Care must be taken when combined with other drugs that enhance serotonergic neurotransmission (for example, tryptophan, fenfluramine, or serotonin 5-HT receptor agonists). If possible, such a combination is recommended to be avoided, since in this case the risk of developing serotonin syndrome and neuroleptic malignant syndrome increases. Symptoms of serotonin syndrome can be autonomic instability (fluctuations in blood pressure, tachycardia, hyperthermia), changes in mental status (hallucinations, agitation, coma), changes in neuromuscular transmission (impaired coordination of movements, hyperreflexia) and / or disorders of the gastrointestinal tract (diarrhea, vomiting, nausea). Some symptoms (muscle stiffness, hyperthermia, changes in mental status,autonomous instability with the possibility of rapid fluctuations in the parameters of vital functions) may resemble the symptoms that arise as a result of neuroleptic malignant syndrome.

Care should be taken when switching from other antidepressants and drugs used to treat obsessive-compulsive disorders (especially from long-acting drugs such as fluoxetine) to sertraline, which is associated with limited clinical experience. The required interval for such a transition has not been established.

In patients undergoing electroconvulsive therapy, there is no sufficient experience with the use of Aleval. The possible risk or success of this combination therapy has not been studied. There is also no experience of using the drug for convulsive syndrome, and therefore it is recommended to avoid prescribing therapy in patients with unstable epilepsy, and in the case of controlled epilepsy, careful monitoring of the condition should be carried out. The appearance of seizures requires discontinuation of treatment.

In some patients, Aleval treatment provoked the development of manic disorders. Cases of activation of manic disorders in manic-depressive psychosis as a result of receiving other antidepressants or drugs used to treat obsessive-compulsive disorders have also been described.

In case of liver diseases Aleval should be used with caution, it may be necessary to reduce a single dose or increase the time between taking the drug. It is also necessary to be careful when prescribing therapy to patients with a history of hemorrhagic diseases and in combination with drugs that have an established ability to change the functions of platelets.

During Aleval therapy, transient hyponatremia may develop, most often in the case of combined use with diuretics or a number of other drugs, as well as in elderly patients. The onset of symptomatic hyponatremia requires discontinuation of the drug and the appointment of adequate therapy, which is aimed at correcting the sodium concentration in the blood. Symptoms of hyponatremia include headache, impaired concentration and memory, instability and weakness, which can lead to falls. In a more severe course, the development of hallucinations, fainting, seizures, coma, respiratory arrest and death may occur.

The risk group for suicidal attempts is depressed patients. This danger persists until the development of remission, and therefore, from the moment of initiation of therapy and until the optimal clinical effect is achieved, constant medical monitoring must be established for the patient's condition.

In children under 24 years of age with depression and other mental disorders, antidepressants increase the likelihood of developing suicidal behavior and suicidal thoughts. Before prescribing Aleval, this age group of patients should be weighed against the possible risk. It should also be borne in mind that any depressive disorder in itself increases the risk of suicide. Therefore, during the period of antidepressant therapy, for the early detection of behavioral changes or disorders, as well as suicidal tendencies, all patients should be monitored.

It is not recommended to drive vehicles, special equipment, and perform work associated with an increased risk during therapy.

Drug interactions

There is no need to change the course of therapy when replacing one inhibitor of neuronal serotonin uptake with another in the “washout period”.

With the combined use of Aleval with certain drugs / substances, the following effects may be observed:

• Pimozide (with a single appointment in a low dose (2 mg)): an increase in its concentration, not associated with any changes in the ECG (the combination is contraindicated);
• Tryptophan, fenfluramine: development of interaction (the combination is not recommended);
• Monoamine oxidase inhibitors (including selegiline, moclobemide, linezolid): development of serotonin syndrome (in the form of hyperthermia, rigidity, myoclonus, lability of the autonomic nervous system (rapid fluctuations in the parameters of the cardiovascular and respiratory systems), changes in mental status, including pronounced agitation, increased irritability confusion of consciousness, which in some cases can turn into a delirious state or coma);
• Drugs that have a depressing effect on the central nervous system: development of interaction; alcohol consumption is prohibited; on psychomotor and cognitive function in healthy people, potentiation of the action of carbamazepine, haloperidol or phenytoin, as well as ethanol was not observed (with combined use, careful monitoring is required);
• Indirect anticoagulants (warfarin): a slight but statistically significant increase in prothrombin time (when prescribing a combination at the beginning of treatment and after its end, it is recommended to control prothrombin time);
• Phenazone (at a dose of 200 mg): a significant decrease in its half-life (in some cases);
• Phenytoin: a change in its plasma concentration (clinically significant interaction does not develop, metabolism is not suppressed; it is recommended to carefully monitor its plasma concentration at the beginning of combined use and, if necessary, adjust the dose);
• Sumatriptan: development of confusion, excitement, anxiety, weakness, increased tendon reflexes (in extremely rare cases);
• Drugs that bind to plasma proteins (for example, diazepam, tolbutamide): the likelihood of developing an interaction;
• Cimetidine: significant decrease in sertraline clearance;
• Medicines, in the metabolism of which the isoenzyme CYP2D6 takes part (antiarrhythmic drugs of the IC class, tricyclic antidepressants; with prolonged therapy with sertraline in a daily dose of 50 mg): an increase in their plasma concentration;
• Tolbutamide: decrease in its clearance (it is necessary to control the level of glucose in the blood);
• Medicines affecting serotonergic transmission (e.g. lithium): development of tremor (combination requires caution).

Analogs

Aleval's analogues are: Zoloft, Surlift, Serenata, Thorin.

Terms and conditions of storage

Store in a dark, dry place out of reach of children at temperatures up to 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Aleval: prices in online pharmacies

Drug name Price Pharmacy

Aleval 50 mg film-coated tablets 28 pcs. 329 r Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!