Prozac is an antidepressant that belongs to selective serotonin reuptake inhibitors. It is contraindicated in persons under 18 years of age. Prozac is allowed to be used to treat pregnant and lactating patients. The manufacturer of the drug is Eli Lilly East S.A., Switzerland.
Dosage form
The drug is available in capsules.
Description and composition
The drug is available in opaque green / cream hard gelatin capsules No. 3. They bear the LILLY logo and identification code 3105. They contain white powder inside.
As an active component, the https://no-mood-problems.com contains fluoxetine hydrochloride.
In addition to it, the composition of the capsules as auxiliary substances includes starch and dimethicone.
The shell is formed by the following components:
- titanium white;
- gelatin;
- dye patent blue V and iron oxide yellow;
- food ink (they made the inscription on the capsules).
Pharmacological group
Prozac is an antidepressant. Its mechanism of action is associated with blocking the uptake of serotonin by human platelets.
After taking the drug, the active substance is rapidly absorbed from the digestive tract. Eating can lead to a delay in absorption of the drug up to 2 hours, but it does not affect the bioavailability of the drug and most likely does not have clinical significance. Therefore, Prozac can be drunk both with food and on an empty stomach.
The maximum concentration of the drug is observed 6-8 hours after taking the medication. Up to 94.5% of the active substance binds to plasma proteins. In the body, the drug is metabolized by the CYP2D6 isoenzyme system.
The half-life of the drug can vary from 4 to 16 days, up to 60% is excreted in the urine. Therefore, in patients with kidney pathologies, the half-life of the drug is lengthened.
Indications for use
for adults
The drug is prescribed for the following pathologies:
- depression of various origins;
- bulimia nervosa;
- premenstrual dysphoric and obsessive-compulsive disorder.
for children
The drug is not used to treat patients under 18 years of age.
for pregnant and lactating
There were cases of the birth of children with cardiovascular pathologies, whose mothers took the medication in the first trimester of pregnancy. Taking an antidepressant shortly before childbirth can provoke a “withdrawal syndrome” in newborns, which is manifested by the following symptoms:
- respiratory distress syndrome;
- respiratory arrest;
- cyanosis;
- cramps
- lowering blood sugar;
- unstable temperature;
- lowering blood sugar;
- increase or decrease in muscle tone;
- trembling of body parts;
- irritability;
- feeding difficulties;
- tachypnea;
- increased neuroreflex excitability;
- incessant crying.
Also, in babies whose mothers took the antidepressant in late pregnancy, there is a greater likelihood of persistent pulmonary hypertension in newborns.
Therefore, during gestation, the drug should be taken with caution when the benefits to the mother outweigh the potential harm to the fetus.
The active substance is excreted in breast milk, therefore, during lactation, the drug should be drunk with caution.
Contraindications
The drug can not be taken with individual intolerance to the composition of the drug.
Prozac is forbidden to drink in combination with monoamine oxidase inhibitors and for 2 weeks after their withdrawal. After taking fluoxetine, MAO inhibitors should be taken at least 5 days later. If Prozac is prescribed in high doses or for continuous use, the interval before the course of MAO inhibitors should be increased.
Prozac should not be taken in combination with pimozide.
An antidepressant is not allowed to be prescribed while taking thioridazine and within 5 weeks after its withdrawal.
The drug should be drunk with caution in patients suffering from the following pathologies:
- diabetes;
- suicidal mood;
- epilepsy, including a history.
Dosage and Administration
for adults
The doctor selects the treatment regimen individually, depending on the diagnosis, severity of the clinical picture, liver function, taking other medications, concomitant pathologies.
For depression, the drug should be taken at an initial dosage of 20 mg per day.
In bulimia, the recommended daily dosage is 60 mg, with premenstrual dysphoric disorder – 20 mg.
In obsessive-compulsive disorder, the daily dosage may vary from 20 to 60 mg.
Treatment with a daily dosage of more than 80 mg has not been studied. Elderly patients do not need dose adjustment.
for children
Prozac is not used in pediatric practice.
for pregnant and lactating
During gestation, the drug is used in minimally effective dosages. When a baby is transferred to a mixture during breastfeeding, the medication is taken as usual. If the child is not transferred to artificial feeding, then the dosage of the drug must be reduced.
Side effects
Taking Prozac may cause the following adverse reactions:
- thrombocytopenia, pancytopenia;
- serum sickness;
- violation of the production of antidiuretic hormone;
- decreased blood sodium levels;
- decreased appetite, up to anorexia;
- insomnia, unusual dreams;
- anxiety, nervousness, anxiety;
- weakening of sexual desire, violation of orgasm;
- bruxism;
- depersonalization, euphoria, increased mood;
- disordered thinking;
- hypomanic episode, mania, panic attacks, agitation, hallucinations;
- stuttering, impaired consciousness, thoughts of suicide, attempted suicide;
- headaches, dizziness, trembling of certain parts of the body, impaired attention and balance, dysgeusia, lethargic sleep, drowsiness, memory problems, cramps, myoclonia, ataxia, dyskinesia, psychomotor agitation, akathisia, buccal-gloss and serotonin syndrome;
- blurred vision, dilated pupils;
- noise in ears;
- palpitations, ventricular arrhythmia, including polymorphic ventricular tachycardia;
- “Tides”;
- drop in blood pressure, angiitis, expansion of blood vessels;
- yawning, pharyngitis, dyspnea, inflammatory processes in the lungs, nosebleeds;
- loose stools, nausea, dry mouth, dyspepsia, violation of the act of swallowing, pain in the esophagus, bleeding from the digestive tract;
- idiosyncratic hepatitis;
- joint and muscle pain, muscle twitching;
- rashes, urticaria, excessive sweating, alopecia, a tendency to hematomas, cold sweat, Quincke’s edema, purpura, photosensitivity, ecchymosis, multimorphic erythema, which can occur in Lyell and Stevens-Johnson syndrome;
- violation of urination, including frequent urges to urinate, dysuria, urinary retention;
- priapism, galactorrhea, hyperprolactinemia, erectile dysfunction, ejaculation disorder, including previous ejaculation, reverse ejaculation, delay and lack of ejaculation, ejaculatory dysfunction;
- gynecological bleeding;
- lethargy, asthenia;
- a feeling of anxiety, cold and heat, malaise, poor health, bruises, bleeding from the mucous membranes;
- losing weight;
- prolongation of the QT interval on the ECG;
- deviation of liver function tests from normal values;
- thoughts of suicide, suicide attempts on the background of therapy and immediately after its cancellation;
- increased risk of bone fractures in patients older than 50 years.
Upon completion of therapy, withdrawal symptoms may occur, such as:
- vertigo;
- sensory disturbance, including paresthesia;
- sleep disorders, including insomnia and saturated dreams;
- asthenia;
- agitation, anxiety;
- headaches, trembling of certain parts of the body;
- nausea, vomiting.
Usually, mild to moderate withdrawal symptoms and disappear on their own within 1-2 weeks. But in some patients they are long-term (up to 3 months or more) and pronounced. Therefore, persons who receive Prozac should reduce its dosage gradually, within 7-14 days, depending on the needs of the patient.
Interaction with other drugs
Prozac has a long elimination half-life, which should be taken into account when prescribing it with other medicines, including antidepressants.
Fluoxetine has a high affinity for plasma proteins, which must be taken into account when prescribing it with drugs that also bind to proteins, since with such a combination their concentration in the body can change.
It is undesirable to prescribe Prozac with monoamine oxidase A inhibitors. When prescribing it with monoamine oxidase B inhibitors (selegiline), precautions should be observed, since there is a possibility of the appearance of serotonin syndrome.
When prescribing Prozac with drugs that affect the central nervous system, such as phenytoin, carbamazepine, haloperidol, clozapine, imipramine, desipramine, an increase in these concentrations is observed, which can cause intoxication. Therefore, it is necessary to carefully increase the dosage of these drugs while taking fluoxetine, taking into account the well-being of the patient.
When prescribed in combination with Prozac, serotonergic drugs increase the likelihood of serotonin syndrome.
With the simultaneous administration of triptans and Prozac, the risk of narrowing of the coronary vessels and increasing blood pressure increases.
Fluoxetine can increase the half-life of benzodiazepines, as a result of which their concentration increases and the sedative effect of them increases.
With the simultaneous administration of Prozac with lithium or tryptophan, the likelihood of developing serotonin syndrome increases.
Since fluoxetine undergoes metabolism involving CYP2D6, it is necessary to prescribe drugs that are metabolized in the same way and have a small interval of therapeutic doses in minimal therapeutic dosages. In the same way, one should drink these drugs if fluoxetine is canceled less than 5 weeks ago.
The appointment of Prozac taking indirect anticoagulants and medications that affect the blood coagulation system increases the likelihood of development and increased bleeding.
In patients receiving both electroconvulsive therapy and Prozac, there is a possibility of an increase in the duration of seizures.
Despite the fact that fluoxetine does not change the concentration of alcohol in the blood, such a combination is not recommended.
When prescribed while taking Prozac, preparations based on St. John’s wort perforated increase the risk of an increase in adverse reactions.
Fluoxetine lowers the concentration of tamoxifen in the blood, so this combination should be avoided.
Special instructions
Against the background of therapy, the risk of thoughts of suicide and suicidal behavior increases, especially in patients under 25 years of age. If they occur, they should be reported to the attending physician.
Taking the medication can cause a violation of the cardiovascular system, so it should be used with caution to treat patients who have a congenital or acquired lengthening of the QT interval, or such a deviation was observed in one of the patient’s relatives, as well as in people prone to arrhythmias , for example, due to hypokalemia, hypomagnesemia, slow heartbeat, acute myocardial infarction, decompensated heart failure. Also, the risk of cardiovascular disorders increases with increased exposure to Prozac due to decreased liver function.
It is necessary to interrupt the treatment of patients who are in a manic state.
Before you start taking Prozac, you need to do an ECG. Also, it must be done if there are signs of arrhythmia, while taking the drug must be canceled.
If a skin rash of an unclear etiology and allergic reactions occurs, the medication should be interrupted.
If epileptic seizures appear during therapy, the medication should be discontinued. The drug is not prescribed for patients with unstable epilepsy. Patients with controlled epilepsy while taking the drug should be under close medical supervision.
In the first weeks of treatment, some patients may experience akathisia or psychomotor agitation, which is manifested by subjective discomfort, restlessness, inability to sit or stand in one place. Increasing the dosage in such patients can provoke negative consequences.
The likelihood of developing hyponatremia increases in patients of an older age group taking diuretics, in patients with a decrease in circulating blood volume.
In patients with diabetes mellitus, while taking Prozac, there was a decrease in blood sugar, and after its cancellation, its increase. Therefore, in such patients, it may be necessary to adjust the doses of sugar-lowering drugs and insulin at the beginning of therapy, as well as after its completion.
Fluoxetine is metabolized in the liver, so patients with diseases of this organ should be prescribed either at a lower dosage or prescribed every other day.
With kidney pathologies, the drug is prescribed as usual.
Taking Prozac can cause midrase, so it should be prescribed with caution to patients with glaucoma or a predisposition to it.
During therapy, the occurrence of serotonin and malignant antipsychotic syndromes that can threaten the patient’s life
Therefore, if the following symptoms appear during Prozac administration, the medication should be interrupted:
- hyperthermia;
- rigidity;
- myoclonus;
- confusion of consciousness;
- irritability;
- delirium;
- coma.
During therapy, one should refrain from driving a car until a person is convinced that Prozac does not affect mental and motor activity.
Overdose
If the recommended dosages are exceeded, the following signs of drug poisoning may occur:
- nausea;
- vomiting
- cramps
- pathology of the cardiovascular system (arrhythmias, ECG changes, cardiac arrest);
- CNS excitation;
- coma.
Fatal cases provoked by an overdose of the drug are rare.
The antidote does not exist. They carry out activities that help support the function of vital organs, prescribe drugs that eliminate the symptoms of poisoning.
Storage conditions
The drug should be stored in a dark place inaccessible to children at a temperature of 15 to 30 degrees. The shelf life of the drug is 36 months, after which it can not be drunk.
The medicine is dispensed according to the prescription of the doctor, therefore they are forbidden to self-medicate.
Analogs
You can replace Prozac with the following medicines:
Apo-fluoxetine is a Canadian drug that is a complete analogue of Prozac. It is produced in capsules, contraindicated for persons under 18 years of age, women in position and breastfeeding.
Profluzak is a domestic medication that contains fluoxetine as an active substance. The drug is produced in capsules, which are contraindicated in patients under 18 years of age, pregnant and lactating women.
Flunisan is a complete analogue of the drug Prozac. It is produced by Hemofarm, Serbia in tablets. An antidepressant can only be prescribed to people over 18 years of age, women who are expecting a baby and support breastfeeding.
Fluoxetine-Canon – a domestic drug, a complete analogue of Prozac. It is available in capsules for oral administration. You can prescribe an antidepressant for adult patients, women in position and mothers who support breastfeeding.
It is permissible to take an analogue of Prozac instead of the drug after consulting with your doctor, as each medication has its own characteristics.