Composition, form of production and packaging
Capsules of prolonged action hard gelatinous, size 2, opaque, with a body and lid of a red-brown color; the contents of capsules - pellets from almost white to yellowish color.
1 caps.
amitriptyline hydrochloride 56.55 mg,
which corresponds to the content of amitriptyline 50 mg
[PRING] sugar grits (sugar spheres) - 123.074 mg, stearic acid - 0.123 mg, shellac (uncoated shellac) 8.480-14.14 mg, talcum - 16.016-29.610 mg, povidone - 0.724-1.086 mg.
The composition of the capsule shell: gelatin - 65 mg, iron oxide red (E172) - 0.98 mg, titanium dioxide (E171) - 0.33 mg.
30 pcs. - plastic containers (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2005.
PHARMACHOLOGIC EFFECT
It equally inhibits the reuptake of norepinephrine and serotonin. Has cholinolytic and antihistaminic activity. Has a powerful antidepressant, sedative, anxiolytic and analgesic effect.
PHARMACOKINETICS
Bioavailability of amitriptyline for oral administration is about 60%. Binding to plasma proteins is about 95%. The maximum concentration of amitriptyline in the serum reaches a slower rate than when taking Saroten in tablets, after 4-10 hours, after which, however, it remains relatively longer for a relatively stable.
At equal doses, the maximum plasma concentration in the plasma is lower when taking capsules, which is associated with a less cardiotoxic side effect of Saroten Retard.
The metabolism of amitriptyline is carried out through demethylation and hydroxylation. The main metabolite of amitriptyline is nortriptyline. T 1/2 amitriptyline averages 25 h (16-40 h), T 1/2 nortriptyline - about 27 h. C ss is established after 1-2 weeks. Amitriptyline is excreted mainly with urine and, in part, with feces. Amitriptyline and nortriptyline penetrate the placental barrier and in small amounts are excreted in breast milk.
INDICATIONS
Depression, especially with anxiety, agitation and sleep disorders:
- treatment of endogenous depressions of mono- and bipolar type, involutional, masked and climacteric depressions;
- dysphoria and alcoholic depression;
- reactive depression;
- Depressive neuroses;
- treatment of schizophrenic depressions (in combination with neuroleptics);
- chronic pain disorders.
DOSING MODE
When taking Saroten Retard capsules are recommended to be taken with water. Capsules, however, can be opened and their contents (granules) can be taken orally with water. Granules can not be chewed at the same time.
For the treatment of depression is prescribed 1 time / day for 3-4 hours before sleep at doses corresponding to 2/3 of the dosage of Saroten in tablets.
Adults start treatment Saroten Retard followed with one 50 mg capsule in the evening. If necessary, after 1-2 weeks the daily dose can be increased to 2-3 capsules in the evening (100-150 mg). After achieving a pronounced improvement, the daily dose can be reduced to the minimum effective, usually up to 1-2 capsules (50-100 mg / day). In the treatment of depression, it is recommended to continue the use of antidepressants, including Saroten Retard, after achieving a pronounced effect for another 4-6 months. In maintenance doses that have an anti-relapse effect, Saroten Retard can be taken for a long time, up to several years.
The elderly to start treatment with Saroten should be from the tablets - 30 mg / day (3 times / day for 10 mg). In a few days, you can switch to taking Saroten Retard capsules. The daily dose is 1-2 capsules (50-100 mg) taken in the evening.
In chronic pain disorders adults daily dose is 1-2 capsules (50-100 mg) taken in the evening. You can start treatment with taking Saroten in tablets of 25 mg once in the evening.
SIDE EFFECT
Side effects associated with anticholinergic action: dryness and / or bitter taste in the mouth, nausea, vomiting, stomatitis; rarely - cholestatic jaundice, visual impairment, increased intraocular pressure, tachycardia, constipation; much less often - a delay in urination. Occur usually at the beginning of treatment, then, as a rule, decrease.
From the cardiovascular system: tachycardia, arrhythmias, orthostatic hypotension, intracardiac conduction disorders, recorded only on the ECG, but not manifested clinically.
From the side of the central nervous system: drowsiness, weakness, impaired concentration, headaches, dizziness. These disorders, often occurring at the beginning of therapy with amitriptyline, decrease during treatment. More rarely, especially when high initial doses are used, somnolence, disorientation, confusion, excitement, hallucinations, extrapyramidal disorders, tremors and convulsions may occur; rarely - anxiety.
Allergic reactions: skin rash, itching are possible.
Others: nausea, increased sweating, weight gain, decreased libido may occur.
CONTRAINDICATIONS
- recently transferred myocardial infarction;
- violation of intracardiac conduction
- Acute poisoning with alcohol, barbiturates or opiates;
- an angle-closure glaucoma;
- use in conjunction with MAO inhibitors and up to 2 weeks after their withdrawal;
hypersensitivity to amitriptyline.
PREGNANCY AND LACTATION
Saroten Retard is not recommended for use during pregnancy and lactation.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
It should be prescribed with caution to patients with severe liver disease.
APPLICATION IN ELDERLY PATIENTS
Start treatment Saroten should be taken from tablets - 30 mg / day (3 times / day for 10 mg). In a few days, you can switch to taking Saroten Retard capsules. The daily dose is 1-2 capsules (50-100 mg) taken in the evening.
SPECIAL INSTRUCTIONS
Saroten Retard should be administered with caution to patients with convulsive disorders, urinary retention, prostatic hypertrophy, severe liver or cardiovascular disease, thyroid hyperfunction.
Having a sedative effect, can affect the ability to drive and other mechanisms . Patients taking Saroten Retard should be warned in advance by the doctor about this aspect of the drug.
OVERDOSE
Symptoms. Inhibition or excitation of the central nervous system. Pronounced manifestations of anticholinergic (tachycardia, dry mucous membranes, delayed urination) and cardiotoxic (arrhythmias, arterial hypotension, heart failure). Convulsive disorders. Hyperthermia.
Treatment. Is symptomatic. Must be carried out in a hospital. When taking amitriptyline orally, it is necessary to wash the stomach as soon as possible and administer activated charcoal. Measures should be taken to maintain the respiratory and cardiovascular systems. It is desirable to monitor cardiac activity within 3-5 days. Epinephrine (adrenaline) should not be prescribed in such cases. With convulsive disorders, diazepam may be used.
DRUG INTERACTION
Amitriptyline can enhance the action of ethanol, barbiturates and other substances that depress the central nervous system.
Joint use with MAO inhibitors can lead to hypertensive crisis.
Since amitriptyline enhances the action of anticholinergic drugs, simultaneous administration with them should be avoided.
Strengthens the action of sympathomimetics epinephrine (adrenaline), norepinephrine (noradrenaline), as a result of this, local anesthetics containing these substances should not be used simultaneously with amitriptyline.
Can reduce the antihypertensive effect of clonidine, betanidine and guanethidine.
When co-administered with neuroleptics, it should be borne in mind that tricyclic antidepressants and neuroleptics mutually inhibit each other's metabolism, reducing the threshold of convulsive readiness.
With simultaneous use with cimetidine, it is possible to slow the metabolism of amitriptyline, increase its concentration in the blood plasma and develop toxic effects.
TERMS OF RELEASE FROM PHARMACY
Requires a doctor's prescription.
TERMS AND CONDITIONS OF STORAGE
List B. Capsules Saroten Retard should be stored at a temperature of no higher than 30 В° C in a dry place.
Each package shows the expiry date. Keep out of the reach of children.
