Anafranil - instructions for use and indications, dosage, form of release, composition and price

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Composition and Form of Release

Anaphranil( Anafranil) is a format of tablets, long-acting tablets( SR) and a solution for parenteral administration. Tablets

Tablets

Tablets SR

Solution

Description

Light yellow tablets with sugar coating

Pink tablets of prolonged action

Transparent colorless liquid

Clomipramine hydrochloride concentration, mg

25 per pc.

75 on pcs.

12.5 per ml( 25 per ampoule)

Auxiliary Ingredients

Microcrystalline cellulose, lactose, polyethylene glycol( macrogol), corn starch, dispersed yellow anlist( yellow ferric oxide and titanium dioxide), colloidal silicon dioxide, polyvinylpyrrolidone, stearic acid, crystallinesucrose, talc, titanium dioxide, magnesium stearate, vinylpyrrolidone-vinyl acetate copolymer, glycerol, hydroxypropylmethylcellulose

Red iron oxide, calcium hydrogen phosphate dihydrate, hydrogenated hydrogenated polyoxylateoil, polyacrylate, titanium dioxide, calcium stearate, talc, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, copovidone

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Water, glycerol

Packaging

Blisters for 10 pcs., 2 or 3 blisters per pack with instructions for use

Blisters 10pcs., 1 or 2 blisters in the pack

Ampoules of 2 ml, 10 pcs. each.in the pack

Pharmacodynamics and pharmacokinetics

The drug belongs to the group of tricyclic antidepressants, inhibits the reuptake of serotonin and norepinephrine. The therapeutic effect of anaphranil is carried out by suppressing these substances released into the synaptic cleft. Also, the drug has alpha-adrenolytic, antiserotonergic, antihistamine and anticholinergic actions.

The drug affects the depressive syndrome, especially its manifestations in the form of psychomotor retardation, anxiety, depressed mood. After 2-3 weeks of taking a clinical effect. Clomipramine is rapidly absorbed, has a 50% bioavailability, has a "first pass" effect through the liver - a desmethylclomipramine metabolite is formed. The bioavailability of the substance is not affected by food intake, it only slightly slows down absorption and increases the time to reach the maximum concentration in the plasma.

Tablets of both types are bioequivalent. Clomipramine penetrates into the cerebrospinal fluid, breast milk. The metabolism of the component occurs by demethylation under the action of cytochrome isoenzymes. Metabolites are excreted in the urine.2/3 of the dose is excreted in the form of conjugates and glucuronides, and a third with feces. The half-life is 12-36 hours. In the elderly, the concentration of the active component is higher than in the young.

Indications for use

Anaphranil refers to antidepressants, therefore it has specific indications for use. They are indicated in the instruction:

  • depression of reactive, endogenous, involutional, neurotic, masked, organic type;
  • depressive state on the background of schizophrenia and psychopathy, in old age;
  • depression caused by chronic pain syndromes or somatic diseases;
  • neurotic, psychopathic depressive mood disorders;
  • phobia, panic attacks;
  • obsessive-compulsive syndrome( OCD), including in children;
  • catalepsy with narcolepsy;
  • nocturnal enuresis in children.

Application and dosage

For each type of drug developed its own instruction for the use of Anafranil. So, tablets and prolonged-action tablets are taken orally, the solution is intended for intramuscular injection and intravenous infusion( parenteral administration). Dosage is determined by the type of disease, the severity of its course, age and other individual characteristics of the patient.

Tablets Anafranil

The aim of Anafranil treatment is to achieve the optimal effect against minimal doses, a cautious increase in dosage with increased sensitivity to clomipramine( in elderly patients, adolescents).Before the start of therapy, hypokalemia is eliminated. With depression, OCD and phobia , the initial dose is 75 mg in 2-3 doses per day or 75 mg once of the CP tablets. In the first week, the dosage is increased by 25 mg every few days until daily diets of 100-150 mg are reached. After improvement, the patient receives a maintenance dose of 50-100 mg.

According to the instructions, panic disorders and agoraphobia are treated with an initial intake of 10 mg tablets per day. The daily dose gradually increases to 25-100 mg, but not more than 150 mg per day. Supportive treatment lasts six months. With cataplexy take 25-75 mg per day. For elderly patients appoint 10 mg per day, gradually for 10 days increasing it to 30-50 mg.

When OCD in children take 25 mg per day, the dose for two weeks increases to 100-200 mg, but not more than 3 mg / kg of body weight. When night enuresis, children 5-8 years are given 20-30 mg per day, 9-12 years - 25-50 mg, over 12 years - 25-75 mg. Higher doses are justified if the clinical effect is absent after a week of treatment. The daily dose of the drug is given once after dinner. If enuresis occurs in the early night hours, then the tablets are given at 16 hours. Supportive treatment lasts 1-3 months with a smooth dose reduction.

Solution

Intramuscular injections of the solution begin with the administration of 25-50 mg, then the daily dosage is increased by 25 mg to a daily dosage of 100-150 mg. After improvement, the number of injections decreases, the patient is transferred to oral tablets. According to the instructions, intravenous infusions are administered drip in a dose of 50-75 mg once a day.

To prepare the solution, the contents of the ampoules are diluted in 250-500 ml of a solution of sodium chloride or glucose. Infusions last 1,5-3 hours, during the course of their monitoring the patient is carefully observed. After the improvement is achieved, the solution is administered intravenously for another 3-5 days.2 tablets 75 mg are equivalent to 1 ampoule with solution. The maximum dose of the drug is 150 mg per day.

Specific instructions

The instructions for use indicate specific instructions for taking the drug. These include the rules:

  1. The drug is used with caution in cardiovascular diseases, heart failure, impaired intracardiac conduction, arrhythmia, epilepsy.
  2. Before starting therapy in schizophrenics, the pressure is measured because it can be drastically reduced with lability in the heart system or orthostatic hypotension.
  3. The drug has anti-cholinergic properties, so it is used with caution in patients who have previously suffered from increased intraocular pressure, angle-closure glaucoma, and urinary retention due to prostate disease.
  4. During therapy, corneal epithelial damage may occur in patients wearing contact lenses.
  5. In cyclical affective disorders, taking antidepressants during the depressive phase can lead to manic or hypomanic conditions.
  6. Predisposed and elderly patients may suffer from medicinal delirious psychosis, especially at night.
  7. In the first months of treatment, the level of leukocytes may increase, throat pain and fever may appear.
  8. If a patient suffers from chronic constipation, Anafranil can cause paralytic intestinal obstruction. This is especially true for the elderly or those who comply with bed rest.
  9. Exceeding the dose of the drug leads to the development of ventricular tachycardia. The risk increases when the drug is combined with selective serotonin or norepinephrine reuptake inhibitors.
  10. At the onset of clomipramine treatment, anxiety may increase. This phenomenon takes place on its own in two weeks.
  11. Patients with schizophrenia on the background of therapy may suffer from activation of psychosis.
  12. The combination of the device with electroconvulsive therapy is carried out in a hospital under careful medical supervision.
  13. The antidepressant is capable of increasing the risk of developing suicidal thoughts, the frequency of tooth decay with prolonged use.
  14. Abrupt withdrawal of the drug is undesirable, because it leads to adverse reactions.
  15. Tablets contain lactose and sucrose, are contraindicated for intolerance to galactose-fructose, lactase and sugar-isomaltase deficiency, malabsorption of glucose-galactose.
  16. During therapy, there may be drowsiness, blurred vision, so it is forbidden to drive or dangerous machines.

When pregnancy

Instructions for use of the drug does not advise to use it during pregnancy, unless otherwise prescribed by a doctor. Before treatment, the doctor conducts an analysis of the benefits to the mother and the risk to the child, and if she exceeds the negative effects, she prescribes the medication. The active component of the composition of the product is excreted in breast milk, so treatment is prohibited when lactation.

If antidepressants were taken while carrying the baby up to the time of delivery, the newborn can suffer from shortness of breath, drowsiness, irritability, colic, arterial hypo- or hypertension, spastic phenomena, tremors, seizures( withdrawal symptoms).To avoid this, you need to cancel taking tablets and solution at least a week before the birth.

Anaphranil and Alcohol

Almost all antidepressants, including Anafranil, are prohibited when used together with alcohol. Ethanol intensifies undesirable phenomena from the central nervous system, leads to drowsiness, blurred vision. Complications are pathologies and damage to the work of all internal organs and body systems. After the termination of treatment to drink spirits it is impossible some more weeks.

Drug Interaction

The instructions say about the possible drug interaction of Anafranil with other drugs. These are the combinations:

  1. A combination of drugs with diuretics can lead to hypokalemia.
  2. The combination of the drug with serotonergic drugs can lead to serotonin toxicity.
  3. The drug lowers the action of reserpine, guanethidine, betanidine, clonidine, alpha-methyldopa. To eliminate arterial hypertension, it is better to use vasodilators or beta-adrenomimetics.
  4. Combination of treatment with anaphranil with drugs of thyroid hormones against a background of hyperthyroidism can lead to cardiotoxicity.
  5. Antidepressant can potentiate the effect of phenothiazines, Atropine, antihistamines, antiparkinsonian drugs, Biperidine, enhance the effect of barbiturates, anesthetics, isoprenaline, analgesics, anesthetics, Diclofenac, Disulfiram, Zolpidem, Clopyramide, Procainamide, Furazolidone, neuroleptics.
  6. Between taking Anafranil and monoamine oxidase inhibitors, it should take two weeks to avoid the occurrence of hypertensive crisis, seizures, delirium, coma, oppression of the adrenal glands.
  7. Combinations of the drug with Quinidine, Propafenone, Paroxetine, Setralin, Fluvoxamine, Thioridazine, Methylphenidate, m-holinoblokatorami are prohibited - there is a risk of increasing the concentration of clomipramine in the blood, the development of violation of the heart rhythm, which is noticeable on the electroencephalogram.
  8. Cimetidine increases the level of antidepressant in the blood, Rifampicin, Carbamazepine, Phenyton, Phenobarbital, nicotine - lower.
  9. No negative effect of combination of Anafranil with oral contraceptives based on ethinylestradiol, estrogen.
  10. Clomipramine enhances the anticoagulant effect of coumarins, warfarin, and ephedrine.

Side effects of Anafranil

Side effects may occur when taking tablets or injecting Anafranil solution. The instruction identifies the following:

  • drowsiness, fatigue, anxiety, confusion, hallucinations, disorientation, anxiety, agitation, sleep disorders, aggression, memory impairment;
  • insomnia, nightmares, impaired concentration, yawning, speech impairment;
  • mydriasis( dilated pupil), glaucoma;
  • tides of blood to the face;
  • urinary retention;
  • sinus tachycardia, arrhythmia, palpitations, bundle bundle branch block;
  • increased appetite, constipation, nausea, hepatitis, jaundice, vomiting, indigestion, diarrhea, anorexia;
  • skin allergy, rash, hives, itching, photosensitivity, swelling, hair loss;
  • syndrome of increased secretion of antidiuretic hormone, a violation of potency, libido, galactorrhea;
  • anaphylactic reactions, eosinophilia;
  • leukopenia, purpura, agranulocytosis, thrombocytopenia.

Overdose of

Symptoms of an overdose of Anaphranil SR, conventional tablets or solution are cardiac arrhythmias, neurological disorders of .In children, exceeding the dose is fatal. Signs of an overdose develop within 4-24 hours after admission, the patient's risk area lasts 4-6 days. Symptoms:

  • drowsiness, coma, stupor, delirium, ataxia, restlessness, rigidity of muscles;
  • epigastric pain;
  • pressure reduction, arrhythmia, heart failure;
  • anuria, cyanosis, oliguria, vomiting, sweating, mydriasis, fever.

No special antidote has been identified, treatment is symptomatic. The patient is washed with a stomach, causes a vomiting at consciousness, without consciousness - spend intubation of a trachea. The patient is given activated charcoal or other enterosorbents. It is not recommended to use the drug Physostigmine( causes bradycardia, seizures, asystia), hemodialysis or peritoneal dialysis.

Contraindications

P The use of a medicament is contraindicated in a number of cases. The instruction identifies the following:

  • hypersensitivity to the components of the formulation, tricyclic antidepressants from the dibenzazepine group;
  • recently suffered myocardial infarction;
  • of neuroblastoma, pheochromocytoma;
  • pregnancy, breastfeeding;
  • children under five.

Conditions of sale and storage

The drug is prescription, stored at temperatures up to 30 degrees for five years.

Analogs Anafranil

You can replace the remedy with drugs with the same antidepressant effect with a similar or different formulation. These include:

  • Clofranil - tablets with the same active component;
  • Doxepine is a sedative capsule with the same active ingredient;
  • Anaphranil SR is a drug with prolonged action;
  • Amitriptyline - tablets, dragees and amitriptyline-based solution;
  • Melipramine is a sedative dragee, solution and tablet based on imipramine.

Price Anafranil

The cost of the drug depends on the type of release, the volume of packaging and the trade mark-up. For Moscow, the approximate prices for medicines will be:

Type of release, volume of packaging, concentration of active component

Internet value, rubles

Pharmacy price list, rubles

Tablets 25 mg 30 pcs.

297

315

Solution 2 ml 10 ampoules

640

680

Tablets SR 75 mg 20 pcs. Tablets SR 75 mg 10 pcs.

430

455

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Reviews

Alena, 38 years old

Antidepressant Anafranil I took after the death of her husband. I did not want to do anything, I lay in a stupor all the days. With an incredible effort, I forced myself to come to a psychiatrist who prescribed this medicine. I took the pill according to the instructions, the treatment was long, but six months later I had no hint of depression.

Vitaliy, 29 years old

I have panic attacks - I'm afraid to stop by the metro at rush hour. I have a feeling that my body will be crushed there. The doctor said that this obsession can be eliminated by taking antidepressants. I took Anafranil tablets, the course lasted two months. It was enough to overcome my fear. I'm no longer afraid of my obsession, I stopped thinking about it.

According to the accepted classification, Anafranil is a drug from the group of antidepressants. Its active substance clomipramine has the properties of suppression of some centers of the brain. The drug is manufactured by the pharmaceutical company Novartis( Switzerland), read its instructions for use.

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