Anafranil – composition, action, precautions, side effects

Proven content

Anafranil is a psychotropic preparation used in psychiatry and neurology. The drug is used in the treatment of, inter alia, depression of various causes, obsessions, anxiety and phobias. Anafranil acts on the central nervous system, thanks to which it has an antidepressant effect. The drug is also applicable in the treatment of chronic pain. Anafranil is available only in prescription pill form.

Anafranil – composition

Anafranil is in the form of film-coated tablets, which contain 10 mg or 25 mg of clomipramine hydrochloride and prolonged-release tablets, which contain 75 mg of the substance.

Anafranil – action

Anafranil is a drug with psychotropic properties, belonging to the group of tricyclic antidepressants. It works by inhibiting the reuptake of norepinephrine and serotonin, which are released into the synaptic clefts.

Anafranil has α1-adrenolytic, antihistamine, cholinolytic and antiserotonergic properties. The active substance of Anafranil affects all components of the depressive syndrome, i.e. psychomotor slowing down, depressed mood and drug, and OCD. The effects of using Anafranil can be observed after 2-3 weeks of use.

After oral administration, the drug is completely absorbed from the digestive system, its bioavailability is approx. 50%. The active substance of Anafranil is metabolized in the liver. In addition, the substance passes into breast milk, where it may reach concentrations close to those in plasma.

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Anafranil – indications

Anafranil is an antidepressant drug. In adults, the drug is used to treat:

1. depressive states with various causes and symptoms (including endogenous, reactive, neurotic, organic, masked, involutional forms of depression, depression related to schizophrenia, personality disorders);
2. depressive syndromes in the elderly;
3. in the course of chronic pain conditions;
4. chronic somatic diseases;
5. compulsive syndromes;
6. phobias and anxiety attacks.

For children and adolescents:

1. bedwetting – this only applies to children over 5 years of age, if the problem is not due to organic causes.

Anafranil – contraindications

Even if they exist indications for the use of Anafranil it cannot always be used. The main contraindication is hypersensitivity, i.e. allergy to the active substance or any other component of the drug. In addition, the contraindications also include:

1. cross-sensitivity to benzodiazepine tricyclic antidepressants;
2. time immediately after myocardial infarction;
3. congenital syndrome of long QT interval;
4. simultaneous use or the first 14 days before or after taking MAO inhibitors;
5. simultaneous use of selective, reversible MAO-A inhibitors.

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Anafranil – precautions

Certain precautions should be taken while taking Anafranil. It should be remembered not to administer the drug to children and adolescents aged 0-17 years during the treatment of depressive states of various causes and symptoms, phobias, anxiety attacks, as well as in the treatment of chronic pain in patients in this age group.

Particular care should be taken when administering Anafranil to people:

1. with diseases of the cardiovascular system, especially patients with heart failure, conduction disorders, cardiac arrhythmia;
2. with epilepsy, and in other situations that may lead to seizures, i.e. brain damage, simultaneous administration of neuroleptics, withdrawal from alcohol or anticonvulsants;
3. with a history of elevated intraocular pressure, narrow-angle glaucoma;
4. with diseases related to urinary retention as a result of e.g. prostate enlargement;
5. with severe liver diseases;
6. with tumors of the adrenal medulla, e.g. neuroblastoma;
7. with hyperthyroidism in patients who are taking thyroid medications;
8. with chronic constipation.

Some situations require close medical supervision, e.g. they are simultaneous treatment with Anafranil and electric shocks. Adults and children with depressive disorders who take the drug may experience worsening of depression, and may even develop thoughts of suicide or worsening of psychotic symptoms. This can happen regardless of the antidepressants you are taking.

These drugs increase the risk of suicidal thoughts and behavior in children and adolescents struggling with depressive disorders and other mental disorders, as well as in patients with severe depression. In their case, the risk may persist even during remission of the disease.

Patients with mania or mild manic states in the depressive phase in patients with cyclical affective disorder who are treated with tricyclic antidepressants may require dose reduction or discontinuation and administration of antipsychotics.

People who wear contact lenses should also exercise caution because tricyclic antidepressants have anticholinergic properties that reduce tear production and mucus build-up, which can damage the corneal epithelium.

Patients struggling with panic attacks may notice more pronounced symptoms of anxiety during the first days of using Anafranil. These symptoms disappear after about 2 weeks.

In addition, Anafranil should not be used by people suffering from rare, hereditary galactose intolerance, fructose intolerance, severe lactose deficiency (Lapp type), sucrose-isomaltase deficiency or malabsorption of glucose-galactose.

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Anafranil – pregnancy

Anafranil is a drug that should not be used by pregnant women. However, it should be remembered that there are situations in which the expected benefits of using the preparation outweigh the possible risk to the fetus.

After birth, babies of women who took Anafranil during pregnancy, experienced sudden withdrawal symptoms, such as shortness of breath, coma, abdominal colic, irritability, pressure disorders, tremors and cramps during the first hours or days of life.

To avoid this, a woman at the end of pregnancy should gradually discontinue the preparation for at least the last 7 weeks before the expected date of birth. This decision is made by the doctor on the basis of the patient’s condition.

Breastfeeding women should gradually wean their babies or stop breastfeeding.

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Anafranil – side effects

Anafranil, like any other drug, may cause various side effects. However, it should be remembered that side effects do not appear in every patient, and in addition, the benefits of using the preparation most often outweigh the possible risks associated with side effects. In the case of Anafranil, side effects are usually mild and transient the longer the treatment lasts or when the dose is reduced.

Very common side effects are:

1. somnolence;
2. anxiety;
3. tiredness;
4. increased appetite;
5. dizziness;
6. trembling;
7. headaches;
8. seizures;
9. eye accommodation disorders;
10. blurred vision;
11. urination disorders;
12. nausea;
13. dry mouth;
14. constipation;
15. clonic seizures;
16. libido and potency disorders;
17. sweating;
18. weight gain.

Common Anafranil side effects have:

1. entanglement;
2. confusion;
3. hallucinations;
4. anxiety;
5. stimulation;
6. sleep disturbance;
7. mania;
8. mild manic states;
9. aggression;
10. problems with memory;
11. depersonalization;
12. worsening of depression symptoms;
13. problems with concentration;
14. insomnia and nightmares;
15. speech disorders;
16. paresthesia;
17. pupil dilation;
18. orthostatic hypotension;
19. sinus tachycardia;
20. palpitations;
21. clinically insignificant ECG changes in patients with normal heart function;
22. vomiting, diarrhea and other digestive ailments;
23. eating disorders;
24. muscle tone disorders (weakened or worsened);
25. increased activity of transaminases;
26. skin reactions;
27. sensitivity to light;
28. itching;
29. breast enlargement and sometimes galactorrhea;
30. taste disturbance;
31. Tinnitus;
32. hot flushes.

Not really common side effects of Anafranil have:

1. psychotic symptoms;
2. ataxia;
3. increase in blood pressure;
4. irregular heartbeat.

Rare side effect of Anafranil are conduction disturbances. On the other hand, EEG changes, glaucoma, urinary retention, hepatitis (both with and without jaundice), edema, alopecia, syndrome of inappropriate antidiuretic hormone secretion, allergic alveolitis (with or without eosinophilia), systemic alveolitis occur very rarely. anaphylactic or anaphylactoid reactions including hypotension, hyperpyrexia, leukopenia, agranulocytosis, thrombocytopenia, eosinophilia and purpura.

People withdrawing Anafranil they should also be aware of the symptoms of withdrawal occurring when discontinuing or reducing the dose is abruptly. These are:

1. nausea;
2. vomiting;
3. stomach pain;
4. diarrhea;
5. insomnia;
6. Headache;
7. nervousness;
8. bow.

The incidence of fractures and suicidal behavior following withdrawal or treatment is unknown Anafranil dose modification. In addition, people with schizophrenia who take the drug may experience psychosis. Anafranil can also induce pharmacogenic psychosis, that is, with delirium. They most often appear at night in patients with such tendencies and in the elderly. These symptoms should disappear within a few days of stopping treatment. Anafranil can also lead to paralytic intestinal obstruction in the elderly and bedridden patients, and increase the frequency of tooth decay.

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Anafranil – interactions

Anafranil interacts with:

1. antiarrhythmic drugs;
2. guanethidine, betanidine, reserpine, clonidine and α-methyldopa – reduction or elimination of their hypotensive effect;
3. adrenaline, noradrenaline, isoprenaline, ephedrine, phenylephrine – Anafranil may increase the effects on the cardiovascular system;
4. alcohol and CNS depressants – may intensify their effects;
5. neuroleptic and anticholinergic drugs – enhances their action;
6. thioridazine – this can seriously disturb your heart rhythm;
7. selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors and lithium – such a combination may lead to an additive effect on the serotoninergic system and the appearance of a serotonin syndrome;
8. SSRIs and inhibitors of CYP1A2 and CYP2C19 – this may increase the plasma concentration of clomipramine;
9. diuretics – this can lead to hypokalaemia;
10. cimetidine – it may increase the plasma concentration of the preparation;
11. estrogens – there are no data on Anafranil interaction with estrogenshowever, due to the interactions of other drugs in this group, it is recommended to monitor the treatment process and modify the dose;
12. methylphenidate – may increase Anafranil concentration, it may also inhibit their metabolism, so it may be necessary to change the dose to a lower one;
13. anticoagulants from the coumarin group (e.g. warfarin) – Anafranil may increase their effect;
14. drugs inducing cytochrome P-450 enzymes – intensification of metabolism and reduction of drug effectiveness;
15. drugs that induce CYP3A and CYP2C;
16. anticonvulsants;
17. cigarette smoke – can lower the concentration of tricyclic drugs.

It should also be remembered that the active ingredient of Anafranil may increase the concentration of compounds that are removed by CYP2D6 in patients with rapid metabolism of these compounds. Therefore, an interval of 2-3 weeks should be maintained between the use of these preparations.

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Anafranil – dosage

Anafranil is a drug intended for oral use. The dosage method is determined individually and adjusted to the patient’s condition. However, remember to start treatment as soon as possible the lowest Anafranil dose and, if necessary, gradually increase it, which will allow you to achieve optimal treatment results. This is especially true of the youngest and oldest patients.

Anafranil dosage regimen is addicted to the condition. In the case of depression, obsessive compulsive disorders and phobias, initially one 1 mg tablet is given 25 or 2 times a day, or one 3 mg tablet once a day. It is best to take the drug in the evening. During the first week of treatment, the dose may be increased gradually, e.g. by 75 mg every few days. It depends on the patient’s individual tolerance of the drug. The maximum daily dose is 25-4 tablets of 6 mg or 25 tablets of 2 mg. However, the most severe cases may require an increase in the daily dose to 75 mg. When the patient’s condition improves, the doctor should determine a maintenance dose. It is usually 250 to 2 tablets of 4 mg or 25 tablet of 1 mg once a day.

In the case of anxiety attacks or agoraphobia, the initial dose is 10 mg per day. This dose can be gradually increased to 25-100 mg depending on the patient’s individual tolerance to the drug. The dose is increased until the desired therapeutic effect is achieved. In special cases, it is allowed to increase the dose to 150 mg. Treatment should last for at least 6 months without interruption. During this time, the maintenance dose should be gradually reduced.

Older people should initially take 1 tablet of 10 mg once a day, and then increase it until a dose of 10-30 mg per day is reached after 50 days. This dose level should be maintained throughout treatment.

In the case of bedwetting for children over 5 years of age and adolescents, the dose depends on the patient’s age:

1. children 5-8 years old should initially use 2-3 tablets of 10 mg;
2. children 9-12 years old should initially use 1-2 tablets of 25 mg;
3. children over 12 years of age should initially use 1-3 tablets of 25 mg.

Higher doses may be used when the patient has not fully responded after 1 week of use. Anafranil should be administered:

1. in the evening after a meal;
2. in case of soaking – give part of the dose around 16 p.m., the remainder in the evening;
3. Once an adequate clinical response has been achieved, treatment should be continued for 1-3 months and the dose should be gradually tapered over this period.

There are no data on the use of the drug in people under 5 years of age.

Anafranil – comments

In the event of starting application Anafranil in children and adolescents With bedwetting, the doctor needs to weigh the benefits and risks of using the drug in the individual patient. Consider using alternative therapies first.

Before starting Anafranil, potassium levels should be leveled and blood pressure monitored, as the drug may lead to pressure drops. People taking the drug should also have their blood counts checked regularly and liver enzymes tested in people with liver disease, and for fever and sore throats.

If during treatment you experience side effects such as decreased visual acuity, drowsiness and other CNS symptoms, it is worth giving up driving, operating machinery and performing other activities that require concentration.

Before use, read the leaflet, which contains indications, contraindications, data on side effects and dosage as well as information on the use of the medicinal product, or consult your doctor or pharmacist, as each drug used improperly is a threat to your life or health. Do you need a medical consultation or an e-prescription? Go to halodoctor.pl, where you will get online help – quickly, safely and without leaving your home. Now you can use e-consultation also free of charge under the National Health Fund.