Saroten (amitriptyline) coated tablets 25 mg. №100

Description

Saroten (amitriptyline) coated tablets 25 mg. №100

Composition

active substance: amitriptyline;

1 tablet contains amitriptyline hydrochloride, corresponding to 25 mg of amitriptyline;

auxiliary substances: corn starch; lactose, monohydrate; colloidal anhydrous silicon dioxide; microcrystalline cellulose; copovidone; croscarmellose sodium; magnesium stearate; macrogol 400; OPADRY OY-S-9470 red-brown.

Medicinal form

Film-coated tablets.

Main physicochemical properties: round biconvex tablets, covered with a film shell, red-brown in color.

Pharmacotherapeutic group

Antidepressants. Non-selective monoamine reuptake inhibitors.
ATX code N06A A09.

Pharmacological properties

It is a tricyclic antidepressant. It belongs to the group of non-selective inhibitors of neuronal uptake of monoamines. It has some central analgesic (analgesic), H2-histamine-blocking, antiserotonin effect.

Indications

Saroten tablets is shown:

• with depression with anxiety, sleep disturbance, agitation (endogenous, involutional, reactive, neurotic, drug);
• with organic brain lesions;
• with alcohol withdrawal;
• with schizophrenic psychosis;
• with mixed emotional disorders;
• for behavioral disturbances;
• with nocturnal enuresis (with the exception of enuresis caused by hypotension of the bladder);
• with bulimia nervosa;
• with chronic pain syndrome (migraine, pain with cancer, rheumatic diseases, atypical pain in the face, post-traumatic neuropathy, postherpetic neuralgia, diabetic peripheral neuropathy).

Contraindications

Saroten tablets is not used:

• with intolerance to the components;
• when taking MAOI;
• with myocardial infarction (in the acute and recovery period);
• with acute alcohol intoxication;
• in case of acute intoxication with analgesic, hypnotic, psychoactive drugs;
• with angle-closure glaucoma;
• with severe violations of atrioventricular and intraventricular conduction;
• when breastfeeding;
• children under 7 years old.

Saroten tablets is used with caution:

• with alcoholism;
• with bronchial asthma;
• with manic-depressive psychosis;
• with epilepsy;
• with oppression of bone marrow hematopoiesis;
• with hyperthyroidism;
• with angina pectoris;
• with heart failure;
• with intraocular hypertension;
• with schizophrenia;
• during pregnancy.

Application during pregnancy and lactation

Application in pregnant women is possible only on the recommendation of a doctor.
Breastfeeding for the period of treatment is stopped.

Method of administration and dosage

Saroten tablets is used internally.
The standard dose is 25 mg 3 times a day, gradually increasing the dose (maximum 300 mg / day).

Overdose

Symptoms: drowsiness, confusion, disorientation, depression of consciousness, dilated pupils, shortness of breath, fever, dysarthria, hallucinations, agitation, respiratory depression, convulsive seizures, vomiting, muscle stiffness, arterial hypotension, arrhythmia, heart failure.
Therapeutic measures: drug withdrawal, symptomatic therapy, maintenance of hemodynamics, water-electrolyte balance, ECG monitoring.

Side effects:

• Cardiovascular disorders: tachycardia, conduction disturbance, arrhythmia, lability of blood pressure, symptoms of heart failure, expansion of the QRS complex on the ECG, fainting.
• Neurological disorders: ataxia, headache, fatigue, irritability, weakness, dizziness, drowsiness / insomnia, tinnitus, impaired concentration, dysarthria, nightmares, confusion, motor agitation, hallucinations, disorientation, paresthesias, tremors, peripheral neuropathy , extrapyramidal disorders, EEG changes, anxiety, convulsions.
• Digestive disorders: heartburn, nausea, stomatitis, vomiting, anorexia, taste disturbances, epigastric discomfort, darkening of the tongue, gastralgia, diarrhea, cholestatic jaundice, dry mouth, intestinal obstruction, constipation.
• Endocrine disorders: an increase in the size of the mammary glands, galactorrhea, changes in libido, changes in the secretion of antidiuretic hormone (ADH), impaired potency, hypo / hyperglycemia, impaired glucose tolerance, glucosuria, testicular edema.
• Allergic reactions: urticaria, rash, photosensitivity, itching, angioedema.
• Ophthalmic disorders: blurred vision, increased intraocular pressure, accommodation paresis.
• Others: purpura, eosinophilia, agranulocytosis, leukopenia, thrombocytopenia, hair loss, weight gain, sweating, swollen lymph nodes, pollakiuria, withdrawal syndrome, fever, urinary retention.