Pramital medicine 20mg Anfarm treat depression (2 blisters x 14 tablets)

citalopram is a selective Serotonin reabsorption inhibitor (SSRI), without affecting, or very little effect on the absorption of noradrenalin (Na), dopamine (da) and gamma aminobutyric acid (GABA).

In contrast to three-round antidepressants and some new SSRIs, citalopram does not have or have very low affinity with a range of receptors including 5-HT 1A, 5-HT2, D1 and D2, A1-, A2, B-controlptors, H1, H1, Muscarin Cholinergic, Benzodiazepin, and OPIID receptors. The absence of receptors can explain why citalopram has less common side effects such as dry lips, bladder and intestinal disorders, blurred vision, drowsiness, heart toxicity and posture hypotension.

Preventing fast eye movements (REM) when sleeping is considered a sign of antidepressant activity. Like three -round antidepressants, SSRIs and other Mao inhibitors, citalopram prevents Rem for sleeping and increases deep waves when sleeping. Although citalopram does not combine with opioid receptors, these receptors have anti -pain effects of opioid analgesic commonly used. It is possible that excessive activities caused by d-amphetamine after using citalopram.

The main metabolites of citalopram are all SSRIs, although their potential and selective rate are lower than that of citalopram. However, the selection rate of metabolites is higher than that of new SSRIs. In humans, citalopram does not reduce awareness (intellectual function) and mentally and have little or no sedative characteristics, both used alone or in combination with alcohol.

citalopram does not reduce saliva flow in a single dose study in volunteers and no research in healthy volunteers proves that citalopram has a significant influence on cardiovascular parameters. Citalopram does not affect the concentration of prolactin and growth hormones in serum.

Dynamic pharmacokinetics

absorption

Absorbing almost completely and depending on the amount of food (maximum/ average average time of 3.8 hours) oral bioavailability is about 80%.

distribution

Expression absorption volume (VD) ß is about 12.3 l/kg. Citalopram and its metabolites are associated with plasma proteins below 80%.

transformation

citalopram is converted into Demethyl citalopram, Didemethyl Citalopram, Citalopram-N-Oxide activated and an amino reducing derivative of propionic acid does not work. All metabolites work as well as SSRIs, although weaker than the original compound. Citalopram is constant is the main compound in plasma.

excretion

Selling time (t v b) is about 1.5 days and the whole body citalopram clearance (CLS) is about 0.33 l/ min, and oral clearance (CL Oral) is about 0.41 l/ min. Citalopram is excreted mainly through the liver (85%) and the rest (15%) through the kidneys. About 12% of daily dose is excreted in urine is constant citalopram. The clearance of the liver (remaining) is about 0.35 l/ min and the clearance of the kidney is about 0.068 l/ min. Dynamic is linear. Stable plasma concentrations achieved in 1-2 weeks. The average concentration is 250 nmol/l (100-500 nmol/l) achieved at daily doses of 40 mg. There is no clear relationship between plasma citalopram concentration and treatment response and side effects.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

suicide suicide or clinical thoughts: depression associated with increasing the risk of suicide thoughts, harming themselves, and suicide (events related to suicide). This risk remains until the disease is significantly improved. When the disease cannot improve in the first few weeks of treatment, the patient should be closely monitored until improved. The risk of suicide can increase during the healing phase.

Other mental conditions when using pramital may also be associated with increasing the risk of suicidal events. In addition, these conditions may be a combination with severe depression. Therefore, similar precautions are considered when treating patients with severe depression disorders with other mental disorders.

Patients with a history of suicide -related events, or those who have significant suicide significant appearance before starting treatment are at risk of suicide or suicidal thoughts, and should be monitored in the need for kidneys during the treatment stage.

Strict monitoring of patients, especially high -risk patients, should be treated with drugs, especially in early treatment and the following dose changes. Patients (and patient care) should be warned of the need to monitor any deteriorating clinical condition, suicide behavior, or abnormal changes in behavior and need medical advice immediately if these symptoms are present.

Used in children and teenagers under 18 years of age: Pramital should not be used to treat children and teenagers under 18 years old. Acts related to suicide (trying to commit suicide and suicide thoughts) and hostility (mainly acts of aggression, opposition and anger) have been recorded more often in clinical trials in children and adolescents treated with antidepressants compared to placebo. If treated according to clinical needs, patients should be carefully monitored with suicide symptoms.

In addition, there is currently no long -term safety data in children and young people in growth, growth, cognitive development and behavior.

Older patients: Be cautious when using older patients.

Liver and kidney failure: Precautions when using the treatment of patients with liver function.

Paradoxic anxiety: Some patients with panic disorders may increase anxiety symptoms when they start treatment with antidepressants. This paradoxical reaction decreased within the first two weeks of treatment. Use the starting low doses to reduce the paradoxical anxiety.

Hypotenia hyponatremia: Hypoglyc sodium, may be due to the inappropriate anti -urinary hormone excretion (SIADH), which has been reported as a rare adverse reaction when using SSRIs and often recovered when stopped treatment. Elderly female patients seem to be extremely high risk.

Sitting restlessly: The use of SSRIs/SNRIS is associated with restless sitting, characterized by subjective discomfort or restless anxiety and need to move, often with unable to sit or stand still. These manifestations may occur within the first few weeks of treatment. In patients with symptoms, increasing the dose may be harmful.

Heart: In patients with disease - depression, they can change to the stage of manic. If the patient is in a period of manic, should stop pramital.

epilepsy: seizures are a potential risk to antidepressants. Pramital should be stopped in any patient with seizures. Pramital should avoid in unstable epilepsy patients and patients who have been controlled should be carefully monitored. Pramital should be stopped if there is an increase in the frequency of seizures.

Diabetes: In patients with diabetes, treatment with SSRI may change blood sugar control. The dose of insulin and / or oral hypoglycemic drug may need to be adjusted.

Tabeleting: Like other SSRIs, pramital can cause pupils to dilate and should be used cautiously in patients with narrow angle glaucoma or a history of glaucoma.

Serotonin syndrome: In some rare cases, Serotonin syndrome has been reported in SSRIs. The combination of symptoms such as agitation, tremor, muscle contraction and body temperature can determine this condition. Pramital should be stopped immediately and symptomatic treatment.

Serotonin secretion: Pramital should not be used simultaneously with drugs that secreted serotonin such as sumatriptan or other triptans, tramadol, oxitriptan and tryptophan.

Hemorrhagic: There have been reports on prolonged time of bleeding and/or abnormal bleeding such as hemorrhage, gynecological bleeding, gastrointestinal bleeding and other skin or mucous bleeding other than SSRIs. Be careful in patients using SSRIs, especially when using the active ingredients, it is known to affect platelet function or other active ingredients that can increase the risk of bleeding, as well as in patients with a history of hemorrhage disorders.

ECT (Convulsions): Clinical experience is limited when using SSRI and ECT at the same time, so be cautious.

Selective inhibitors inhibitors: The combination of pramital with Mao-A inhibitors is generally not recommended due to the risk of Serotonin syndrome.

St John's Wort: Unwanted effects can be more popular while using pramital simultaneously and herbal preparations containing St. John's Wort (Hypericum Perforatum). So should not use pramital simultaneously and St John's Wort.

Symptoms of quitting smoking when stopping SSRI treatment: Symptoms of quitting smoking when stopping treatment are common, especially if sudden stopped. In a clinical trial to prevent recurrence from citalopram, adverse events after actively stopped treatment were recorded in 40% of patients compared to 20% in patients who continue citalopram.

The risk of smoking symptoms may depend on many factors including the time and treatment dose and the dose reduction speed. Dizziness, sensory disorders (including paresthesia), sleep disorders (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhea, emotional drum, stimulation, and visual disorders are the most common reactions that have been reported. In general, these symptoms are mild to medium, however, some patients may be serious. These symptoms usually occur in the first few days of stopping treatment, but there are very rare reports on these symptoms in patients who accidentally forgot a dose. In general, these symptoms are self-limited and usually within 2 weeks, although some patients may last (2-3 months or more). Therefore, pramital recommendation should be gradually reduced when discontinued for a few weeks or months, according to patient needs.

Mental disease: Treatment of mental patients with depression can increase mental symptoms.

Prolonged QT: The high concentration of auxiliary metabolites (Didemethyl citalopram) Theoretically can extend the QT range in patients with susceptible, patients with congenital QT syndrome or in patients with hypokalemia/hypoglycemia. The electrocardiogram should be monitored in case of overdose, or metabolic changes with an increase in peak concentration, such as liver failure.

Colonel: The drug contains lactose monohydrate. Patients with rare genetic problems, galactose intolerance, lapp or glucose - Galactose are not used by this drug.

The effect of the drug on the ability to drive and operate machinery

Pramital has a slight or moderate effect on the ability to control the train and operate machinery. Patients using mental medicine may reduce attention and concentration of the disease, and mental medications can reduce the ability to judge and respond to emergencies. Patients should be informed about these effects and warns that the ability to control trains or operate machines may be affected.

Use drugs for women during pregnancy and lactation

Pregnant women:

A large number of data on pregnant women (observations of 2500 pregnant patients using drugs) shows that there is no pregnancy/toxicity in newborns. Pramital can be used during pregnancy if necessary, after careful consideration of benefits - risks. Babies should be monitored if the mother uses pramital continues to the final stage of pregnancy, especially in the third trimester. Should avoid sudden stopping drugs during pregnancy.

The following symptoms can occur in newborns after mothers use SSRI/SNRI in the final stages of pregnancy: respiratory failure, cyanosis, apnea, convulsions, unstable temperature, difficulty feeding, vomiting, hypoglycemia, muscle tone, increased reflexes, tremor, panic, irritation, indifference, crying continuously, sleepy and difficult to sleep. These symptoms may be caused by serotonin secretions or suspension symptoms. In most cases, complications start immediately or early (

Epidemiological data shows that the use of SSRI during pregnancy, especially at the end of pregnancy, can increase the risk of continuous pulmonary hypertension in newborns.

breastfeeding women:

Pramital is excreted into breast milk. It is estimated that breastfed babies will receive about 5% of daily doses of mothers related to weight (mg/kg). No or only small events are recorded in babies. However, existing research is not enough to assess the risk of children. Recommendations should be cautious. If treatment with pramital is considered necessary, should consider stopping breastfeeding.

Drug interaction

Pharmacological interactions

At the pharmacokinetic level of cases of serotonin syndrome with citalopram and moclobemid and bulliron have been reported.

Contraindications combinations

Mao inhibitors: Concomitant use of citalopram and Mao inhibitors can lead to serious unwanted effects, including serotonin syndrome.

Serious and sometimes fatal reaction cases have been reported in SSRI patients in combination with Monoamin Oxidase inhibitors (MAII), including negative Selegillin and Maoi Linezolid and Moclobemid and in patients who have stopped SSRI recently and have begun with a Maoi.

Some cases have similar symptoms like serotonin syndrome. The symptoms of the active ingredient with Maoi include: agitation, tremor, muscle contraction, and body temperature.

Pimozid: simultaneously use a single 2mg of pimozid for those treated with racemic citalopram 40 mg / day for 11 days to increase AUC and CMAX of pimozid, although inconsistent in research. Simultaneous use of pimozid and citalopram increases the average QTC time about 10 milliseconds. Because the interaction has been noted at a low -dose Pimozid, simultaneous use of citalopram and pimozid is contraindicated.

The combination should be cautious

Selegillin (MA-B selective inhibitor): A study of pharmacokinetic/pharmacokinetic interaction with simultaneous use of citalopram (20 mg daily) and Selegillin (10 mg daily) (a selective MA-B inhibitor) has proven that there is no clinical related interaction. The simultaneous use of citalopram and Selegillin (at a dose of over 10 mg per day) is not recommended.

Serotonin secretion

Lithium and Tryptophan: No pharmacological interaction has been found in clinical studies, of which Citalopram has been used simultaneously with lithium. However, there have been increased effects when using SSRIs with lithium or tryptophan and thus simultaneous use of citalopram with these drugs must be cautious. Periodic monitoring of lithium concentration should be continued as usual.

Concentrated with serotonin secretion (such as tramadol, sumatriptan) can lead to increased effects related to 5-HT. Until there are many new studies, the simultaneous use of citalopram and 5-HT transportation drugs, such as Sumatriptan and other triptans are not recommended.

St Johns Wort: Interactive between SSRIs and herbal St. John's Wort (Hypericum Perforatum) may occur, resulting in an increase in unwanted effect. Pharmacokinetic interaction has not been investigated.

Hemorrhage: Be cautious in patients being treated simultaneously with anticoagulants, drugs that affect platelet function, such as nonsteroidal anti -inflammatory drugs (NSAIDs), acetylsalicylic acid, dipyridamol, ticlopidin or other drugs (such as non -typical anti -psychotic drugs, phenothiazine, anti -irrigation drugs that can increase the risk of bleeding.

ECT (Convulsions): There is no clinical research to establish the risks or benefits of the use of ECT and Citalopram.

Alcohol: There is no pharmacokinetic interaction or pharmacological energy that has been proven between citalopram and alcohol. However, citalopram and alcohol should not be combined.

Medications that cause long -lasting QT or hypokalemia/Hype blood hypotension

Be careful when using the medication simultaneously extends the QT interval or other drugs that lower potassium/hypoglycemia due to them, as well as citalopram, capable of extending the QT range.

Medications that reduce epilepsy threshold: SSRIs can reduce epilepsy threshold. Caution should be careful when using the drugs that are likely to lower epilepsy threshold (such as 3 -round antidepressants, SSRIs, sedatives [Phenothiazin, thioxanthenes and butyrophenones]), Mefloquin, Bupropion and Tramadol).

Desipramin, imipramin: In a pharmacokinetics research, it has been shown to have an impact on both citalopram and imipramin concentrations, although the concentration of desipramine, the main metabolitus of imipramin is increased. When desipramine is combined with citalopram, it increases plasma desipramin levels. Desipramin dose should be reduced.

Sedatives: Experience with citalopram did not show any clinical interaction related to sedatives. However, as with other SSRIs, not excluding the ability to interact with pharmacokinetics.

Pharmacokinetic interaction

citalopram converted into Demethyl citalopram via CYP2C19 intermediaries (about 38%), CYP3A4 (about 31%) and CYP2D6 (about 31%) of isomers of the Cytochrom P450 system. In essence, citalopram is metabolized by more than one CYP, which means that its metabolic inhibitor is less than the inhibition of a enzyme that can be offset by another enzyme. Therefore, simultaneous use of citalopram with other drugs in clinical practice has very little ability to cause pharmacokinetic interaction.

Food: The absorption and other pharmacokinetic properties of citalopram are not reported as affected by food.

The effect of other drugs on pharmacokinetics of citalopram

Concentrated with ketoconazole (strong CYP3A4 inhibitor) does not change the pharmacokinetics of citalopram.

A pharmacokinetic interaction study of lithium and citalopram does not show any pharmacokinetic interaction.

cimetidine: cimetidine, an enzyme inhibitor known, causes slight increase in the average concentration in the stable state of citalopram. Caution should be used when using high -dose citalopram in combination with high -dose cimetidine. Simultaneous use of Escitalopram (active enantiomer of citalopram) with 30 mg of Omeprazol once a day (a CYP2C19 inhibitor) leads to an average increase in plasma concentration of Escitalopram (about 50%). Therefore, it is necessary to be cautious when used simultaneously with CYP2C19 inhibitors (such as omeprazol, esomeprazol, fluvoxamine, lansoprazol, ticlopidine) or cimetidine. Reducing the dose of citalopram may be necessary based on the monitoring of unwanted effects during simultaneous treatment.

metoprolol: Escitalopram (active enantiomer of citalopram) is a CYP2D6 enzyme inhibitor. Caution should be careful when used simultaneously citalopram with drugs mainly metabolized by this enzyme, and has a narrow treatment scope, such as flecainid, propafenon, and metoprolol (when used in heart failure), or some medications on the central nervous system are mainly metabolized by CYP2D6, such as anti -threat drugs such as Desidpramin, Clomiline, NorlIPLIN, NorrIPLIN, NorrIPLIN, NorrIPLIN Anti -psychotic drugs such as Risperidon, Thioridazin and Haloperidol. Adjusting the dose may be allowed. Simultaneous use with Metoprolol doubles the concentration of Metoprolol in plasma, but increases the effects of metoprolol on blood pressure and heart rate is not statistically significant.

The effect of citalopram on other drugs

A study of pharmacokinetics/pharmacokinetic interaction with simultaneous use of citalopram and metoprolol (a CYP2D6 substrate) shows that the level of metoprolol, but increases the effects of metoprolol on blood pressure and heart rate is not statistically significant in healthy volunteers.

citalopram and Demethyl citalopram are negligible inhibitors of CYP2C9, CYP2E1 and CYP3A4, and only weak inhibitors of CYP1A2, CYP2C19, CYP2D6 compared to other SSRIs are identified as strong inhibitors.

levomepromazin, digoxin, carbamazepin: due to unchanged or only very small changes that are not important in terms of clinical recorded when using citalopram with CYP1A2 (clozapin and theophyllin), CYP2C9 (Warfarin), CYP2C19 (Imipramin and Mephenytoin), CYP2D6 (SPATREIN, SPARTE2D6) Imipramin, Amitriptylin, Risperidon) and CYP3A4 (Warfarin, Carbamazepin (and Epoxid Carbamazepin) and Triazolam).

There is no pharmacokinetic interaction between citalopram and levomepromazin, or digoxin, (identifying citalopram does not cause p-glycoprotein inhibitors).