Celexa 20 mg
| PACKAGE | PRICE | PER PILL | SAVINGS |
| 360 tablet | £ 121.46 | £ 0.34 | £ 266.85 |
| 180 tablet | £ 65.57 | £ 0.36 | £ 128.59 |
| 120 tablet | £ 50.99 | £ 0.42 | £ 78.45 |
| 90 tablet | £ 45.32 | £ 0.50 | £ 51.76 |
| 60 tablet | £ 36.41 | £ 0.61 | £ 28.31 |
| start ordering | |||
Celexa
Celexa (Citylopram) is a type of antidepressant called a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of depression.Celexa is available in a generic form.It is also available as an antidepressant, and is indicated for the treatment of depression.
What are the side effects of Celexa?
The usual side effects of Celexa include
- Constipation,
- Motion sickness,
- Diarrhea,
- stomach problems,
- decreased sexual desire
- impotence,
- difficulty having orgasms,
- dizziness,
- drowsiness,
- fatigue,
- Sleep disturbances (insomnia),
- Dry mouth
- Increased sweating or urination,
- Changes in weight or cold symptoms, such as a stuffy nose,
- sneezing, sore throat, or
- cough.
Dosage of CELEXA
The recommended dose of CELEXA should be administered at an initial dose of 20 mg once daily, increasing to a maximum dose of 40 mg/day. Usually, increasing doses should be made at additional charges of 20 mg at intervals of a week or more.
Which drugs, substances, or supplements interact with Celexa?
Celexa may interact with other medications that make it easier to fall asleep or hold your breath.
- Sleeping pills,
- Drugs,
- Muscle relaxants,
- Anxiety, depression, and seizure medications,
- Nonsteroidal anti-inflammatory drugs (NSAIDS),
- other antidepressants,
- Lithium,
- balsamic glass,
- Tacrolimus,
- tramadol,
- l-abuse,
- Male trioxide,
- Vantanibi,
- Antibiotics,
- Antimalarials,
- anticoagulants,
- heart rate drugs,
- HIV or AIDS drugs,
- Medications to prevent or treat nausea and vomiting,
- Medications to treat mental disorders,
- Medications for migraine headaches,
- drugs for epileptic seizures or
- stomach acid
Tell your doctor about all medications and supplements you use.
Use of Celexa in Children
There is no documented safe use of Celexa for use by children.
Celexa During Pregnancy and Breastfeeding
In treating a pregnant woman with Celexa during the third trimester of pregnancy, the physician should carefully examine the potential risks and benefits of treatment. The physician may consider reducing Celexa during the third trimester of pregnancy. Celexa may pass breast milk and damage the nursing baby; breastfeeding is not recommended when using Celexa.
Additional Information
The Celexa Side Effects Center provides a comprehensive view of available information about the drug regarding possible side effects of taking this medication.
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Suicide and Antidepressants
Antidepressants increased the risk of suicidal thoughts and behaviors (suicide) in children, adolescents, and young adults in short-term studies of major depressive disorder (ICDS) and other mental disorders compared to placebo. Anyone examining the use of Celexa or other antidepressants in children, teenagers, or young adults should weigh this risk against their clinical needs. Short-term studies have shown no increased risk of suicide with antidepressants compared to placebo in adults over 24 years; a decreased risk with antidepressants compared to placebo in adults 65 years and older; and a decreased risk with antidepressants compared to placebo in children and young adults. Depression and other psychiatric disorders are associated with an increased risk of suicide. Patients of all ages who begin antidepressant treatment should be appropriately monitored and closely observed for clinical deterioration, suicide, or changes in abnormal behavior. Families and caregivers should be informed of the need for close monitoring and communication with patients.Celexa is not approved for use in pediatric patients. (See WARNING: Clinical Deterioration and Risk of Suicide, Patient Information and Precautions: Pediatric Use).
Description.
CELEXA® (citalopram HBR) is an oral serotonin (SSRI) fold reuptake inhibitor with a chemical structure not related to that of other SSRIs or tricyclics, tetracyclics, or other antidepressants. Citalopram HBR is a racist double-incorporated phthalate characterized as (±)-1-(3-dimethylaminopropyl)-1-(4-phthlogein)-1, 3-didrobenzopuene-5-carboniter, HBB.
The molecular form is c20H22brfn2O and its molecular weight is 405.35.
The HBR caller appears as a thin, white to off-white dust. Citalopram HBR is slightly soluble in water and soluble in ethanol.
Celexa (Citalopram Aquifer) is available only in tablet form.
Celexa 10 mg is coated with an oval tablet containing citalopram HBR with a content equivalent to 10 mg citalopram base; Celexa 20 mg and 40 mg contain citalopram HBB with a content equivalent to 20 mg or 40 mg citalopram base coated with a thin, oval perforated tablet. The tablets also contain sympathomimetic bidone, corn starch, croscarmellose sodium, glycerin, glycerol, lactose monohydrate, magnesium stearate, hypomellose, microcrystalline cellulose, and polyethylene. Iron oxide is used as pigment in beige (10 mg) and pink (20 mg) tablets.
Indications
CELEXA is indicated for the treatment of major depressive disorder (MSD) in adults [see Clinical Studies].
Dosage and Administration
Recommended Dosage
Administer Celexa once daily with or without food at a starting dose of 20 mg once daily, with a maximum dose increase of once daily.
Doses greater than 40 mg once daily are not recommended due to the risk of prolonged QT [see Reference Precautions and Prophylaxis].
Check for bipolar disorder before Celexa is started
Before starting treatment with CELEXA or any other antidepressant, check the patient for a staff or family history of bipolar disorder, mania or mild mania illness [see Warnings and Precautions].
Recommended doses for specific populations
The maximum recommended dose of CELEXA for patients 60 years of age and older, patients with hepatic dysfunction, and patients with inadequate CYP2C19 metabolism is 20 mg once daily [see paragraph Warnings and Precautions, Clinical Pharmacology].
Dose Modification with Concurrent Use of CYP2C19 Inhibitors
The maximum recommended dose of CELEXA when used concomitantly with a CYP2C19 inhibitor is 20 mg once daily [see Warnings and Precautions, Drug Interactions, in the reference paragraph].
Changing patients to or from antidepressants accompanied by monoaminexidase inhibitors
They should mediate at least 14 days between antidepressant monoamine oxidase (MAOI) antidepressant discontinuation and CELEXA treatment initiation. Conversely, at least 14 days after CELEXA stops prior to initiation of antidepressant MAOI [see meetings and warnings and precautions].
Cessation of treatment with CELEXA
Undesirable reactions may occur during Celexa suspension [see Warnings and Precautions]. Whenever possible, reduce the dose of Celexa gradually rather than abruptly discontinuing Celexa.
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- 10 mg: beige, oval with "fp" engraved on one side and "10 mg" on the other side.
- 20 mg: pink, oval, engraved "f" on left side of line, "p" on right side of line, "20 mg" on unengraved side.
- 40 mg: white, oval, engraved "f" on left side of line, "p" on right side of line, "40 mg" on "not engraved" side.
Celexa Tablets (Citalopram) is offered as follows:1:
| Strength | Color/ Shape | Engraved | Package Configuration | NDC No. |
| 10 mg | Beige, oval shape | FP" on one side, "10 mg" on the other side | Bottle of 100 | NDC # 0456-4010-01 |
| 20 mg | Pink, oval | F" on the left side of the note line and "P" on the right side of the note 20 mg line are not marked. | Bottle of 100 | NDC #0456-4020-01 |
| 10 x 10 unit dose | NDC #0456-4020-63 | |||
| 40 mg | White, oval shape | Rated "F" on the left side of the rating line and "P" on the right side of the rating line. | Bottle of 100 | NDC #0456-4040-01 |
| 10 x 10 unit dose | NDC #0456-4040-63 |
Storage and Handling
Selexa tablets should be stored at 20-25°C (68-77°F) - discontinuation of 15-30°C (59-86°F) is permitted [see USP controlled room temperature].
Dispersion: Allergan USA, Inc. Review: February 2022
Adverse Reactions
The following adverse reactions are analyzed in more detail elsewhere in the label
- Hypersensitivity reactions [Ref].
- Suicidal ideation and behavior in adolescents and young adults [see Precautions and precautions].
- Growth in Qt and Torsade de Points [see Precautions and Preventive Measures].
- Serotonin syndrome [see Precautions and precautions].
- Increased risk of bleeding [see Precautions and precautions].
- Activation of mania or light mania [see paragraph Warnings and Precautions].
- Interruption syndrome [see Precautions and precautions].
- Seizures [see Precautions and precautions].
- Glaucoma of the angle closure [ref precautions and preventive measures].
- Hyponatremia [see Precautions and precautions].
- Sexual dysfunction [see Prophylaxis and Precautions].
Clinical Trial Experience
Because clinical trials are conducted under very different conditions, the rates of adverse effects observed in clinical trials for one drug cannot be directly compared to rates in clinical studies for another drug and may not reflect rates observed in clinical practice.
The safety of CELEXA included citalopram exhibits in patients and/or healthy individuals from three different study groups: 4, 422 exhibits from patients to controlled and uncontrolled clinical trials. Approximately 1, 370 years of patient exposure were addressed. In addition, there were more than 19, 000 reports from European post-market studies, mostly open-labeling: the conditions and duration of treatment with CELEXA varied widely, with open-label studies (in overlapping categories) and double-blind studies, internal and external patient studies, stable dose studies and dose securitization studies, and short- and short-term - duration studies.
Side effects associated with treatment interruptions
Of the 1,063 patients with MDD who received CELEXA at doses in the once-daily once-per-day range in placebo-controlled studies, 16% discontinued treatment due to unwanted energy, compared to 8% of the 446 patients who received placebo. Adverse reactions associated with discontinuation (i.e., at least 1% of patients treated with Celexa were associated with twice as many discontinuations as placebo) are shown in Table 2.
Table 2: Unwanted Reactions Associated with CELEXA Treatment in Short-Term Placebo-Controlled MDD Studies
| Body System/ Unwanted Reactions | CELEXA (n = 1. 063) %. | Placebo (n = 446) %. |
| General | ||
| Disease | 1 | |
| Gastrointestinal disorders | ||
| Motion sickness | 4 | 0 |
| Dry mouth | 1 | |
| Vomiting | 1 | 0 |
| Central and peripheral nervous system disorders | ||
| Dizziness | 2 | |
| Mental disorders | ||
| Insomnia | 3 | 1 |
| Drowsiness | 2 | 1 |
| Agitation | 1 | |
| *Patients reported more than one method of interruption and may have been counted multiple times in this table. | ||
Table 3 shows the incidence of unwanted actions occurring among 1, 063 patients with MDD who received CELEXA at doses ranging from once daily for up to 6 weeks in a placebo-controlled study.
(The most common side effect occurring in patients treated with CELEXA at a frequency greater than 5% of those receiving placebo and at least twice the incidence of those receiving placebo was ejaculation disturbance (primarily delayed ejaculation).
Table 3: Side effects in patients treated with Celexa (2% more than placebo)*
| Body System/ Unwanted Reactions | CELEXA (n = 1. 063) %. | Placebo (n = 446) %. |
| Gastrointestinal disorders | ||
| Motion sickness | 21 | 14 |
| Diarrhea | 8 | 5 |
| Indigestion | 5 | 4 |
| Vomiting | 4 | 3 |
| abdominal pain | 3 | 2 |
| Autonomic nervous system disorders | ||
| Dry mouth | 20 | 14 |
| Increased sweating | 11 | 9 |
| Mental disorders | ||
| Drowsiness | 18 | 10 |
| Insomnia | 15 | 14 |
| Anxiety | 4 | 3 |
| Anorexia | 4 | 2 |
| Agitation | 3 | 1 |
| Dysmenorrhea 1 | 3 | 2 |
| Decreased libido | 2 | |
| absence of appetite | 2 | |
| Disorders of the central and peripheral nervous system | ||
| Tremor | 8 | 6 |
| Urinary and reproductive system | ||
| Ejaculation disorder 2. 3 | 6 | 1 |
| Incapacity 3 | 3 | |
| Respiratory system disorders | ||
| Upper respiratory tract infection | 5 | 4 |
| Rhinitis | 5 | 3 |
| Sinusitis | 3 | |
| General | ||
| Fatigue | 5 | 3 |
| Fever | 2 | |
| Musculoskeletal disorders | ||
| joint pain | 2 | 1 |
| Myalgia | 2 | 1 |
| *Adverse reactions reported by at least 2% of patients treated with CELEXA are listed, excluding the following adverse reactions for which the placebo incidence was greater than CELEXA: headache, feeling sick, dizziness, constipation, palpitations, abnormal vision, sleep disturbances, irritability, pharyngitis, dysuria, back pain.1 Denominator used was women only (N=638 CELEXA, N=252 placebo).2 Mainly delayed ejaculation.3 Denominator used was men only (N=425 CELEXA, N=194 placebo). | ||
Dose-Dependent Adverse Effects
The potential relationship between CELEXA dose and incidence of adverse events was tested in a fixed-dose study of MDD patients receiving placebo or CELEXA 10 mg, 20 mg, 40 mg, or 60 mg (1.5 times the maximum recommended dose). A positive dose-response (p<0.05) was revealed for the following adverse reactions: fatigue, impotence, insomnia, increased sweating, somnolence, and yawning.
SSRI-induced sexual dysfunction in men and women
Alterations in sexual desire, sexual performance, and sexual satisfaction are often seen as symptoms of psychiatric disorders, but may also be the result of SSRI treatment. However, it is difficult to obtain reliable estimates of the frequency and severity of adverse experiences related to sexual desire, performance, and satisfaction because patients and health care providers may be reluctant to discuss them. Thus, estimates of the frequency of adverse sexual experiences and sexual behaviors reported in labeling may underestimate the actual frequency.
Table 4 shows the incidence of adverse sexual experiences reported by at least 2% of male patients treated with CELEXA in a series of placebo-controlled clinical trials in depressed patients.
Table 4: Side effects associated with sexual dysfunction (≥2%) in male patients treated with CELEXA in a series of placebo-controlled collaborative clinical trials in patients with MDD
| CELEXA | Placebo | |
| n (male) | 425 (%) | 194 (%) |
| Abnormal ejaculation (mainly delayed ejaculation) | 6.1 | 1 |
| Decreased libido | 3.8 | |
| Anorexia | 2.8 |
In depressed female patients treated with CELEXA, the reported incidence of decreased libido and anorgasmia were 1.3% (n=638 women) and 1.1% (n=252 women), respectively.
Weight Change.
Patients treated with Celexa in the control test lost approximately 0.5 kg compared to no change in placebo patients.
ECG Changes
In an in-depth QT study, CELEXA was found to be associated with a dose-dependent increase in QTC interval.
Electrocardiograms from CELEXA (N=802) and placebo (N=241) groups were compared with respect to outliers defined as subjects with QTc changes over 60 msec from baseline or absolute values over 500 msec post-dose, and subjects with heart rate increases to over 100 bpm or decreases to less than 50 bpm with a 25% change from baseline (tachycardic or bradycardic outliers, respectively). In the CELEXA group 1.9% of the patients had a change from baseline in QTcF >60 msec compared to 1.2% of the patients in the placebo group. None of the patients in the placebo group had a post-dose QTcF >500 milliseconds compared to 0. 5% of patients in the Celexa group. The incidence of tachycardia was 0.5% in the Celexa team and 0.4% in the placebo group; the frequency of Bradycardia was 0.9% in the Celexa team and 0.4% in the placebo group.
Other Side Effects Observed During Pre-Circulatory Celexa
The following list of unwanted actions does not include the following reactions: 1) included in Table 3 or elsewhere on the label, 2) caused by the drug product remotely, and 3) were so common in a single patient that they are not beneficial and are those indicated.
Adverse reactions are classified by the system system and listed in a decreasing frequency series according to the following definition: A frequent adverse reaction is one that occurs in at least one case in at least 1/100 patients. Rare adverse reactions are those occurring in less than 1/1000 patients to 1/100 patients - Rare adverse reactions are those occurring in less than 1/1000 patients.
Cardiovascular - Frequent: tachycardia, attitude, hypotension, hypotension. Rare: hypertension, bradycardia, edema, edema (extremities), angina pectoris, extractables, heart failure, washout, myocardial infarction, cerebrovascular accident, myocardial ischemia. Rare: temporary ischemic episodes, varicose veins, vaginal fibrillation, cardiac arrest, combined exclusion.
Disorders of the central and peripheral nervous system - Frequent: paralysis, migraine. Rare: hyperactivity, dizziness, hypertension, extrapyramidal disorders, leg cramps, involuntary muscle contractions, motility, neuralgia, dystonia, abnormal gait, hypervolemia, disability. Rare: abnormal coordination, secretion, falls, lethargy.
Endocrine Disorders - Pillar: hypothyroidism, bronchial cells, gynecomastia.
Gastrointestinal Disorders - Frequency: increased saliva, flatulence. Rare: gastritis, gastroenteritis, stomatitis, erythema, hemo, dysphagia, tooth grinding, gingivitis, esophagitis. Rare: colitis, gastric ulcer, cholecystitis, gallstones, duodenal ulcer, gastroesophageal reflux, glip, yellow und, diplitis, rectal bleeding, hiccups.
Common: hot flashes, rigidity, alcohol intolerance, syncope, flu symptoms. Rare: allergic rhinitis.
Hemic and lymphatic disorders - often: purpura, anemia, efficiency, leukocytosis, leukopenia, lymph node tumors. Rare: pulmonary embolism, granulocytosis, lymphocytosis, lymphopenia, hypochromic anemia, coagulopathy, gum hemorrhage.
Metabolic and feeding disorders - Frequency: weight loss, weight gain. Rare: increased liver enzymes, thirst, dry eyes, increased alkaline phosphatase, abnormal glucose tolerance. Rare: bilirubinia, hypokalemia, obesity, hypoglycemia, hepatitis, dehydration.
Musculoskeletal disorders - very frequent: arthritis, muscle weakness, skeletal pain. Rare: folliculitis, osteoporosis.
Mental Disorders - Frequent: concentration disorder, amnesia, apathy, depression, increased appetite, worsening depression, suicide attempts, confusion. Rare: increased libido, aggressive reactions, parades, drug dependence, depersonalization, hallucinations, euphoria, psychotic depression, illusions, delusional reactions, emotional instability, panic reactions, psychosis. Rare: catastrophic reactions, melancholy.
Reproductive Disorders / Female* - Options: amenorrhea. Rare: lactation, breast pain, breast enlargement, vaginal bleeding. (*Based on % female only: 2955)
Respiratory disorders - often: cough. Rare: bronchitis, shortness of breath, pneumonia. Rare: asthma, laryngitis, bronchospasm, pneumonia, elevated sput.
Skin and parts disorders - Frequent: rash, itching. Rare: photosensitive reactions, ur measles, acne, skin discoloration, eczema, alopecia, dermatitis, dry skin, psoriasis. Rare: hyperhydrosis, decreased sweating, melancholy, keratitis, cellulite, itching ANI.
Special sensations - Frequent: abnormal adaptation, perversion of taste. Rare: tinnitus, conjunctivitis, eye pain. Rare: myopathy, photophobia, bifidus muscle, abnormal tearing, falls, loss of flavor.
Urinary tract disturbances - Frequent: polyuria. Rare: urinary frequency, urinary incontinence, urinary deposits, dysuria. Rare: facial edema, hematuria, oliguria, renal lo nephritis, kidney stones, kidney pain.
Post market traffic experience.
Following approval of the S-Anti Intermediates Citalopram, Racate, or Eskitalopram, the following adverse reactions have been identified during use. Because these reactions have been spontaneously mentioned by populations of uncertain size, it is not always possible to reliably assess their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders: hemolytic anemia, thrombocytopenia, decreased prothrombin
Cardiac disorders: torsade de pointes, abdominal arrhythmias, QT dilation
Endocrine disorders: hyperprolactinemia
Ophthalmologic disorders: glaucoma of the angle closure
Gastrointestinal disorders: gastrointestinal bleeding, pancreatitis
Common disorders and diseases in the management area: reduced syndromes
Hepatic transformation disorders: hepatic necrosis
Immune system disorders: anaphylaxis, allergic reactions
Musculoskeletal and connective tissue disorders: rhabdomyolysis
Nervous system disorders: seizures, myoclonia, dancing, dyskinesia, wasting, nystagmus
Pregnancy, lottery, perinatal conditions: no automatic
Mental disorders: delirium
Renal and urinary tract disorders: acute renal failure
Reproductive and breast disorders: priapism
Skin and subcutaneous tissue disorders: Johnson, epidermal necrosis, angioedema, variegated erythema, epididymitis
Vascular disorders: thrombosis
Drug Interactions
Table 5 lists clinically significant drug interactions with Celexa.
Table 5: Clinically important drug interactions with Celexa
| Monoaminoxidase inhibitors (MAOO) | |
| Clinical Incidence | Concurrent use of Celexa and SSRIs, including MAOIs, increases the risk of serotonin syndrome. |
| Intervention. | Celexa is contraindicated in patients receiving MAUS containing MAOIs such as linzolid or intravenous blue methylene [reference dosage and advance, meeting, warning, precautions]. |
| Pimozide | |
| Clinical Effects: | Concurrent use of Celexa with pimozide may increase the concentration of pimozide plasma, a drug with a narrow therapeutic index, and may increase the risk of QT dilation and/or abdominal arrhythmias. Clinical Pharmacology]. |
| Intervention: | Celexa is contraindicated in patients who have received pimozide [see Conjunctions, Warnings, and Precautions]. |
| Drugs that prolong the QTC interval | |
| Clinical Effects: | Concomitant use of CELEXA with a drug that prolongs the QT may cause additional dilation of the QT compared to use of CELEXA alone [see Clinical Pharmacology]. |
| Intervention: | Avoid concurrent use of CELEXA with medications that prolong QT (CELEXA is contraindicated in patients receiving pimozide) [see Discrepancies, Warnings, and Precautions]. |
| CYP2C19 Inhibitors | |
| Clinical Effects: | Concomitant use of CELEXA with a CEP2C19 inhibitor increases the risk of QT dilation and/or abdominal arrhythmias compared to the use of CELEXA alone [see Clinical Pharmacology]. |
| Intervention: | The maximum recommended dose of CELEXA is 20 mg daily when used concomitantly with a CYP2C19 inhibitor [see Dosage and Advances, Warnings and Prevention]. |
| Seroacids | |
| Clinical Effects: | Concomitant use of CELEXA and other serotonergic medications increases the risk of serotonin syndrome. |
| Intervention: | Monitor patients for signs and symptoms of serotonin syndrome, especially at the start of CELEXA, and monitor for dose increases. If serotonin syndrome occurs, consider discontinuation of Celexa and/or concurrent serotonin agonists [see Warnings and Precautions]. |
| Drugs that interfere with hemostasis (antiplatelet agents and anticoagulants) | |
| Clinical Effects: | The concomitant use of CELEXA and antiplatelet or anticoagulant medications can increase the risk of bleeding. |
| Intervention: | Inform the patient about the increased risk of bleeding associated with the concurrent use of Celexa and antiplatelet and anticoagulant medications. For patients receiving warfarin, closely monitor international normalized ratios [see Precautions and precautions]. |
Drug Abuse and Dependence
Controlled Substances
Celexa (Citalopram HBR) is not a controlled substance.
Abuse.
Animal studies show low abuse of Celexa. Celexa has not been systematically studied for humans in terms of abuse, tolerance, or physical dependence; clinical experience prior to Celexa's release did not reveal drug-seeking behavior. However, these observations are not systematic, and based on this limited experience, it is not possible to predict the extent to which drugs with CNS effects are abused, diverted, and/or mistreated on the market. As a result, health care providers should carefully evaluate Celexa patients for a history of substance abuse, closely monitor these patients, and observe evidence of abuse or mistreatment (e.g., growth in tolerance, increased doses, drug-seeking behavior behaviors).
Warning.
Included as part of the module module.
Prevention
Suicide Ideation and Behavior in Adolescents and Young Adults
In an intensive test with placebo testing of antidepressants (SSRIs and other categories of antidepressants) involving approximately 77, 000 adult patients and 4, 500 pediatric patients, the incidence of suicidal thoughts and behaviors in patients was up to 24 years old in whatever patients who received a placebo. There was significant variation in the risk of suicidal thoughts and behaviors among medications, but the risk increased for new patients on most medications studied. there were differences in the absolute risk of suicidal thoughts and behaviors across the various indications, with the highest incidence in MDS patients. Differences between drugs and virtual drugs in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are shown in Table 1.
Table 1: Differences in risk in the number of patients with suicidal thoughts and behaviors on concentrated placebo-controlled antidepressants in pediatric and adult patients
| Age Group*. | Drug vs. Placebo Differences in Number of Patients with Suicidal Thoughts or Behaviors per 1000 Patients Receiving Treatment |
| Increase compared to placebo | |
| 14 additional patients | |
| 18-24 | 5 additional patients |
| Reduction compared to placebo | |
| 25-64 | 1 fewer patients |
| 65+ years old | 6 fewer patients |
| *CELEXA is not approved for use in pediatric patients. | |
It is not known whether the risk of suicidal ideation and behavior in children, adolescents, and young adults extends beyond 4 months of long-term use. However, there are significant indications from placebo-controlled maintenance studies in adults with MDS that antidepressants delay the reproduction of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.
Look at all patients treated with antidepressants for clinical deterioration and the emergence of suicidal thoughts and behaviors, especially during the first few months of pharmaceutical treatment and during periods of dosage changes. Advise family members and patient caregivers to monitor and alert health care providers to changes in behavior. Consider changing the treatment regimen, including discontinuing Celexa, in patients who insist that their depression will worsen or who are experiencing suicidal thoughts or behaviors.
QT and Torsade de Point growth
Celexa causes dose-dependent dilation of the QTC; Torsade De Pointes (TDP), abdominal tachycardia, and sudden death permeating the CG have been observed in post-cyclical references to citalopram [Ref. Unnecessary Action].
Due to the risk of QTC dilation at higher doses of CELEXA, it is recommended that CELEXA not be administered in doses greater than 40 mg once daily [see Dosage and Address, Clinical Pharmacology].
CELEXA should be avoided in patients with long QT Congress syndrome, bradycardia, hypokalemia or hypomagnesia, recent acute myocardial infarction or uncomplicated heart failure. Celexa should also be avoided in patients taking other medications that prolong QTC duration [see drug interactions]. Such medications include Category 1A (e.g., quinidine, preregional) or Class III (e.g., amiodarone, sotalol), antipsychotics (e.g., chloropromazine, thiridazine), antibiotics (gatifloxacin, chloropromazine, thiridazine) or other categories of or drugs known to prolong the QTC interval (e.g., pentamidine, levomelated acetate, methadone).
Citalopram doses should be limited to specific populations. Because of the anticipated higher exposure to citalopram, the maximum dose should be limited to 20 mg once daily in patients who are receiving CYP2C19 or simizide or other CYP2C19 inhibitors or who are receiving other CYP2C19 inhibitors. The maximum dose should also be limited to 20 mg once daily in patients with hepatic dysfunction and in patients over 60 years of age due to expected higher reporting [Reference Dosage and Addresses, Destruction Interpretation, Use in Special Populations, Clinical Pharmacology].
In some cases, electrolyte and ECG monitoring is recommended; baseline measurements of serum potassium and magnesium should be performed with regular monitoring in patients being considered for treatment with CELEXA and at risk for significant electrolyte disturbances. Hypokalemia (and/or hypomagnesemia) may increase the risk of QTc prolongation and arrhythmias and should be corrected and monitored regularly prior to initiation of therapy For patients for whom CELEXA is not recommended, the benefits clearly outweigh the risks for the individual patient ECG monitoring is recommended for patients for whom CELEXA is not recommended, except in cases where the benefits clearly outweigh the risks for the individual patient (see above). These include patients with the cardiac conditions listed above and patients taking other medications that may prolong the QTc interval.
Discontinue CELEXA in patients who are found to have persistent QTc measurements >If a patient receiving 500 millisecond CELEXA develops symptoms that may indicate the onset of arrhythmia, e.g., dizziness, palpitations, or syncope, the prescriber should initiate further evaluation, including cardiac monitoring.
Serotonin Syndrome.
SSRIs, including CELEXA, can cause serotonin syndrome, a potentially life-threatening condition. Risk is increased with concomitant use of other serotonin agonists (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's wort) or with drugs that affect serotonin metabolism MAOI [see indications, drug See Interactions]. Serotonin syndrome may also occur when these drugs are used alone. In pre-marketing clinical studies, symptoms of serotonin syndrome were observed in 0.1% of patients with MDD treated with CELEXA.
Signs and symptoms of serotonin syndrome may include altered mental status (e.g., agitation, hallucinations, delirium, coma), autonomic instability (e.g., tachycardia, unstable blood pressure, dizziness, sweating, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor , rigidity, myoclonus, hyperreflexia, dyscoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
The concomitant use of Celexa with Maus is contraindicated. Additionally, Celexa should not be initiated in patients receiving treatment with MAOIs, such as phosphorolide or intravenous blue methylene. No mention was made of administering other roads of methylene blue (e.g., oral tablets or local injection into tissues). If it is necessary to initiate treatment with an MAOI such as phosphorolide or intravenous blue methylene in a patient taking Celexa, discontinue CELEXA before initiating treatment with MAUS [see Meeting, Drug Interactions].
See all patients receiving CELEXA for the appearance of serotonin syndrome. If any of the above symptoms occur, immediately stop CELEXA therapy and its associated serotonergic agonists and initiate supportive symptom treatment. If incidental use of CELEXA with other seronanerics is clinically justified, inform the patient of the increased risk of serotonin syndrome and monitor symptoms.
Increased risk of bleeding
Medications that interfere with inhibition of serotonin reuptake, including CELEXA, increase the risk of bleeding episodes. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet agents, WARF alline and other anticoagulants may increase this risk. Case reports and epidemiologic studies (case-control and cotinuous cases) have shown a correlation between the use of drugs that interfere with serotonin reunion and the occurrence of gastrointestinal bleeding. Hemorrhagic incidents associated with drugs that interfere with serotonin reunion ranged from church, hematoma, ear, and thunderstorm to life-threatening bleeding.
Inform patients about the increased risk of bleeding associated with the concurrent use of CELEXA and antiplatelet or anticoagulant agents. For patients receiving warfarin, closely monitor international normalized ratios [see Drug Interactions].
Activation of mania or light mania
In patients with bipolar disorder, treatment of depressive episodes with Celexa or other antidepressants may accelerate mixed/mania episodes. In controlled clinical trials, patients with bipolar disorder were excluded, but symptoms of MANIA or light ema disease were reported in 0.1% of undiagnosed patients treated with CELEXA Before initiating CELEXA treatment, staff or family history of bipolar disorder, mania, or light mania disease Check patient [reference dosage and address].
Interruption Syndrome.
Adverse reactions after discontinuation of serotonergic antidepressants, especially after abrupt discontinuation, include nausea, sweating, discomfort, irritability, irritation, dizziness, sensory disturbances (e.g., electroshock), headache, lethargy, emotional instability, insomnia, and patronage. Tinnitus and seizures. When possible, it is recommended to gradually decrease the dosage and reduce abrupt interruptions [see Dosage and Address].
Epileptic Seizures.
Celexa has not been systematically evaluated in patients with epileptic disorders. Patients with a history of epileptic seizures were excluded from clinical trials. 0.3% of patients treated with CELEXA (rate of 1 patient per 98 years of exposure) and 0.5% of placebo patients (rate of 1 patient per 50 years of exposure) in the CELEXA clinical studies experienced epileptic seizures. CELEXA should be prescribed with caution to patients with seizure disorders.
Glaucoma of the angle closure
Daughter dilation, which occurs after use of many antidepressants, including CELEXA, can cause angle closure in patients with anatomically narrow angles without open iridium. Avoid use of antidepressants, including Celexa, in patients with unoccupied anatomically narrow angles.
Hyponatremia
Hyponatremia can occur as a consequence of SSRI therapy, including CELEXA; cases of serum sodium below 110 mmol/L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and instability, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases include hallucinations, fainting, seizures, com sleep, respiratory opposition, and death. In many cases, this hyponatremia appears to be the result of a syndrome of inappropriate antidiuretic hormone (SIADH).
In patients with symptomatic hyponatremia, CELEXA should be discontinued and appropriate medical intervention initiated. Elderly patients, patients receiving diuretics, and patients lacking tumors may be at higher risk for developing hyponatremia with SSRIs [see Use in Special Populations].
Sexual dysfunction
Use of SSRIs, including Celexa, can cause symptoms of sexual dysfunction [action not required for reference]. In male patients, use of SSRIs can lead to delayed or failed ejaculation, which can lead to decreased libido and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or nonexistent orgasm.
It is important that prescribers ask about sexual function prior to starting Celexa and specifically ask about changes in sexual function during treatment. When assessing changes in sexual function, it is important to take a detailed history (including onset of symptoms) because sexual symptoms may have other causes, including underlying psychiatric disorders. Discuss management strategies that may support the patient in making documented treatment decisions.
Information on patient counseling
Advise the patient to read the patient's FDA-approved label (Drug Guide).
Suicidal ideation and behavior
Counsel patients and caregivers to seek out suicidal thoughts and guide them to report such symptoms to their health care providers, especially during treatment and when doses are adjusted up or down [see Manipulating Alerts, Warnings, and Prevention].
Expanding Qt and Torsade de Points
Advise the patient to consult a health care provider immediately if he or she feels faint, loses sensation, or has tachycardia. Advise the patient to inform the health care provider that he/she is receiving CELEXA before taking the new medication [see Warnings and Precautions, Medication Interactions].
Serotonin Syndrome.
For the risk of developing serotonin syndrome, use CELEXA concurrently with other serotonergic drugs, such as tricyclic antidepressants, fentanyl, lithium, tramadol, and tricyclic balsam glass, as well as drugs that affect serotonin metabolism (especially drugs that involve with) mice, those intended to treat mental disorders, and others such as linazolide). Contact your health care provider or instruct them to contact emergency services if you show signs or symptoms of serotonin syndrome [see Warnings and Precautions, Drug Interactions].
Increased risk of bleeding
Inform the patient about the concurrent use of CELEXA with aspirin, NSAIDs, other antiplatelet medications, warfarin or other anticoagulants. Advise the patient to inform the health care provider if the patient receives or plans to receive any prescription or nonprescription medications that increase the risk of bleeding [see Precautions and Preventive Measures].
Activation of mania or light mania
Advise the patient and caregiver to observe activation points for mania/light mania syndrome and guide them to report such symptoms to their health care provider [see paragraph Warnings and Precautions].
Interruption Syndrome.
Advise patient not to abruptly discontinue Celexa and discuss reduction with health care provider; inform patient that side effects may occur when Celexa is interrupted [see Warnings and Precautions].
Sexual dysfunction
Advise patients that Celexa use can cause sexual dysfunction symptoms in both male and female patients. Inform patients that they should discuss changes in sexual function and possible management strategies with their health care provider [see Warnings and Precautions].
Pregnancy.
- Advise the patient to notify the health care provider if she becomes pregnant or intends to become pregnant during treatment with CELEXA [see Use of paragraphs in special populations].
- Inform the patient that use of CELEXA at advanced stages of pregnancy may increase the risk of neonatal complications requiring prolonged hospitalization, respiratory support, piped feeding, and/or persistent neonatal hypertension (PPHN).
- Tell the woman that there is a pregnancy registry that monitors the outcome of pregnancies [women exposed to citalopram during pregnancy [see Use in Special Populations]].
More frequent side effects
Adult side effects of this drug differ slightly from those of children. Adult side effects include
- motion sickness
- Drowsiness
- Weakness
- Dizziness
- Anxiety
- Sleep difficulties
- Sexual problems
- Sweating
- Tremors
- Hunger
- Dry mouth
- Constipation
- Diarrhea
- Respiratory infection
- Absence of sleep
Side effects in children may include the above plus
- Increased thirst
- Abnormal increase in muscle movement or stimulation
- Nosebleeds
- More generalized urination
- Intense menstruation
- Delayed growth rate and weight changes
If these effects are mild, they may regress within days or weeks. If they are more serious or do not regress, consult your physician or pharmacist.
Serious Side Effects
If you have serious side effects, call your doctor immediately. Call 100 if your symptoms appear to be threatening your life or if you think you have an urgent medical incident. Serious side effects and their symptoms may include
- Suicidal thoughts or behaviors. Symptoms may include
- Thoughts or attempts at suicide
- Behavioral responses to dangerous urges
- Acting aggressively or violently
- Thoughts about suicide or death
- New or worst depression
- New or worst anxiety or panic attacks
- Irritability, anxiety, anger, irritability
- Sleep difficulties
- Chest pain
- Fast or slow heart rate
- Dyspnea
- Dizziness or fainting
- Stimulation, hallucinations, com sleep, confusion and difficulty thinking
- Coordination problems or muscle contractions (overactive reflexes)
- Tachycardia or hypertension or hypotension
- Sweating or fever
- Nausea, vomiting or diarrhea
- Muscle stiffness
- Greatly increased energy
- Serious sleep problems
- Distressed thinking
- Reckless behavior
- Unusually brilliant ideas
- Excessive happiness or irritability
- Seizures
- Decreased or sudden loss of muscle tone
- Sudden loss of environmental awareness
- Sudden loss of urinary or bowel control
- Eye pain
- Blurred vision
- Double vision
- Swelling or redness in or around your eyes
- Headache
- Weakness or instability
- Confusion, problems concentrating or problems with thinking or memory
Disclaimer: Our goal is to provide the most relevant and current information. However, we cannot guarantee that this information will include all possible side effects, as medications affect each person differently. This information is not intended to replace medical advice. Always discuss side effects with a health care professional who knows your medical history.
Oral citalopram tablets can interact with other drugs, vitamins, or herbs that you may receive. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from functioning properly.
To avoid interactions, physicians must carefully administer all medications. Inform your doctor about any medications, vitamins, or herbs you are taking. Consult your doctor or pharmacist to learn how this medication can interact with anything else you are taking.
Examples of drugs that may interact with citalopram include
Drugs that increase serotonin levels
A potentially life-threatening condition called serotonin syndrome can occur when citalopram is used in conjunction with other medications that may increase serotonin levels in your body. This may be more likely when one of the medications is started for the first time or after the dosage has been increased. Examples of these drugs are
- Buspirone
- Fentanyl
- Linezolid
- Lithium
- Migraine medications called triptans:
- Armotriptan
- sumatripetan
- Zolmitriptan
- dextrphhetamine
- amphetamine
- lisdexamfetamine
- Amitriptyline
- Imipramine
- Nortriptyline
- ISOCARBOBSAZID
- Phenelzine
- selegiline
- Tranylcypromine
Breastfeeding.
Advise women who are breastfed to watch their infants for excessive depression, anxiety, disturbance, poor feeding, and decreased weight gain and seek medical care if they observe any of these points [see Use in Special Populations].
Non-clinical toxicology
Carcinogenesis, mutation, damage to fertility
Carcinogenesis
Citalopram increased the incidence of small intestinal cancer in rats treated with doses of 8 and 24 mg/kg/day for 24 months in the diet. based on a body surface of mg/m². No zero effect (noel) level was set for this finding.
Citalopram did not increase the incidence of tumors in mice treated for 18 months with up to 240 mg/kg/day in the diet, which is about 30 times the 40 mg MRDH based on the Mg/m² surface.
Mutation.
Citalopram was mutagenic in vitro in the reverse mutation test (AMES test) in two bacterial strains (Salmonella Ta98 and Ta1537) without metabolic activation present in five bacterial strains (Salmonella Ta98 and Ta1537). It was tender in the Testo test for the presence of chromosomal aberrations and lack of metabolic activation in Chinese hamster lung cells. Citalopram was not mutagenic mammalian mammalian translation test (HPRT) in mouse lymphoma cells or in vitro/in vivo test DNA (UDS) test. It was not in vitro chromosome bypass in human lymphocytes or in vivo in mice in two tests of education.
Decline in fertility
Citalopram was administered orally to female rats and male mice at doses of 32, 48, and 72 mg/kg/day during pregnancy and ongoing until conception. These doses are approximately 8, 12, and 17 times the 40 mg of MRHD, based on a body surface of mg/m². Mating and fertility were reduced at doses above 32 mg/kg/day. This is approximately 8 times that of MRHD.
Gestation duration increased at doses of 48 mg/kg/day, which is about 12 times that of MRHD.
For use in special populations
Pregnancy.
Pregnancy Exposure Registry
The Pregnancy Symptom Registry monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Health care providers can call the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit https: //womensmentalhealth. org/research/pregnancyregistry/antidepressants to register their patients to register your patient.
Overview.
Available data from published epidemiologic studies and references following market circulation of citalopram use during pregnancy do not document an increased risk of serious genetic abnormalities or miscarriage. Published studies have shown that levels of citalopram as both umbilical cord and amniotic fluid are similar to those observed in maternal serum. There is a risk of neonatal (PPHN) persistent pulmonary hypertension (see data) and/or inadequate neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs) including Celexa during pregnancy. There is also a risk associated with unsecured depression during pregnancy (see clinical estimates).
In animal reproduction studies, citalopram caused adverse effects on the fetus/fetal system at doses that caused maternal toxicity (see data).
The estimated background risk of major genetic abnormalities and miscarriages in appropriate populations is unknown. All pregnancies are at background risk for genetic abnormalities, loss, or other undesirable outcomes. In the general U.S. population, the estimated background risks of major genetic anomalies and elimination in clinically recognized pregnancies are 2%-4% and 15%-20%, respectively.
Clinical estimates
Risk associated with maternal and/or fetal/embryonic disease
Women who discontinue antidepressants during pregnancy are more likely to reproduce major depression than women who continue antidepressants. This finding comes from the outlook of 201 pregnant women with a history of major depressive disorder who were taking antidepressants cheerfully during early pregnancy. The risk of unnecessary depression should be borne in mind when discontinuing or changing antidepressant treatment during pregnancy and after delivery.
Undesirable Reactions to Fetal/Newborn Age
Newborns exposed to Celexa and other SSRIs late in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and piped feedings. These complications can occur shortly after delivery. Reported clinical findings included dyspnea, cyanosis, apnea, seizures, temperature instability, feeding difficulties, vomiting, hypoglycemia, hypoglycemia, hypertension, hyperactivity, tremors, tension, and irritability. These findings are in line with either a direct toxic effect of the SSRI or possibly a drug break syndrome. It should be noted that in some cases, the clinical picture is more in line with serotonin syndrome [see Warnings and Precautions].
Exposure to SSRIs late in pregnancy may increase the risk of persistent pulmonary hypertension (PPHN), which occurs in 1-2 per 1, 000 births in the general population and is associated with significant neonatal morbidity and mortality.
Animal Data
Citalopram was orally administered to pregnant rats during organogenesis at doses of 32, 56, and 112 mg/kg/day, approximately 8, 14, and 27 times the maximum recommended human (MRHD) dose of 40 mg, based on Mg/m². Body surface. Calcine causes maternal toxicity of CNS clinical manifestations and reduces body weight gain to 112 mg/kg/day, which is 27 times the MRHD. At this maternal toxic dose, citalopram reduced fetal/foetal growth and survival and reduced the increase in fetal abnormalities (including cardiovascular and skeletal abnormalities). The level of maternal and fetal toxicity non-observed adverse effects (NOAEL) is 56 mg/kg/day, which is approximately 14 times that of MRHD.
Citalopram was administered orally to pregnant rabbits during organogenesis at doses up to 16 mg/kg/day. This is approximately 8 times the MRHD, based on a body surface of mg/m². No toxicity was observed in the mother or fetus. The NOAEL for maternal and fetal toxicity is 16 mg/kg/day, which is approximately 8 times the MRHD.
Citalopram was administered orally to pregnant rats at the end of gestation and the birth period at doses of 4.8, 12.8, and 32 mg/kg/day. Body surface. Citalopram increased offspring mortality during the first 4 days of birth and reduced offspring incidence at doses of 32 mg/kg/day. This is approximately 8 times the MRHD. The NOAEL for developmental toxicity is 12.8 mg/kg/day, which is about three times that of MRHD. In another study, when mothers were treated during pregnancy and the onset of lactation at a dose ≥24 mg/kg/day was about 6 times that of MRHD, there were similar effects on offspring mortality and development. This study did not identify NOAEL.
Breastfeeding.
Overview.
Data from the published literature report that the presence of citalopram in himaloc at relative doses for infants ranging from 0.7 to 9.4% of maternal weight and milk/plasma ratio ranges from 0.78 to 4, 3. There have been reports of breastfed infants being exposed to citalopram and exhibiting irritability, anxiety, excessive sleepiness, decreased feeding, and weight loss (see clinical observations). There is no information on the effects of citalopram on milk production.
The developmental and health benefits of breastfeeding require consideration of the mother's clinical need for Celexa and the potential side effects of Celexa on the child's breastfeeding or the mother's underlying condition.
Clinical estimates
See nursing infant for side effects such as irritation, anxiety, excessive sleepiness, decreased feeding, and weight loss.
Pediatric Use
Safety and efficacy of CELEXA have not been documented in pediatric patients; two placebo-controlled studies of 407 pediatric patients with MDD have been conducted with CELEXA and the data were insufficient to support its use in pediatric patients.
Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see WARNINGS, WARNINGS, and PREVENTION OPERATIONS]. Decreased appetite and weight loss have been observed in association with SSRI use in pediatric patients.
use in geriatric patients
Of the 4422 patients in the CELEXA clinical trial, 1357 were 60 years of age or older, 1034 were 65 years of age, and 457 were 75 years of age or older.In two pharmacokinetic studies, the AUC of citalopram increased by 23% and 30%, respectively, in individuals 60 years of age and older compared to younger individuals, and its half-life was increased by 30% and 50%, respectively [see. Clinical Pharmacology]. Thus, the maximum recommended dose for patients over 60 years of age is lower than for younger patients [see Dosage and Advancement, Warnings and Prevention].
SSRIs, including CELEXA, have been associated with cases of clinically significant hyponatremia in older patients at high risk for this unwanted energy [see paragraph Warnings and Precautions].
Hepatic dysfunction
Increased exposure to citalopram occurs in patients with hepatic dysfunction. The maximum recommended dose of CELEXA is lower in patients with hepatic dysfunction [see Dosage and Address, Clinical Pharmacology].
Overdose.
The following have been reported in overdose with Celexa tablets
- Epileptic seizures, which may be delayed, and changes in mental status, including com sleep.
- Cardiovascular toxicity, which may be delayed, including QRS and QTC interval dilation, wide complex tachyarrhythmias, and torsades de pointes. Hypertension is most commonly observed, but rarely have hypotension with alcohol alone or with coats alone.
- Serotonin syndrome (patients who have multiple overdoses with other diarrheal drugs may be at higher risk).
Because of the risk of arrhythmia, long-term cardiac monitoring is recommended in cases of Celexa overdose; patients who develop early after a Celexa overdose should be tested for gastrointestinal disinfection with activated charcoal. For additional overdose management recommendations, consider contacting a poison center (1-800-221-2222) or a medical toxicologist.
Contraindications.
Celexa is contraindicated in patients:
- Receive or within 14 days of discontinuation of MAUS (including MAOIs, including MAOIs such as linazolide and methylene vein blue) due to increased risk of serotonin syndrome [see Precautions and Precautions, Drug Interactions].
- Download pimozide because of the risk of prolonged QT [reference drug interactions].
- Known hypersensitivity to inactive ingredients of Citalopram or Celexa. Reactions include angioedema and anaphylaxis [see Unnecessary Action].
Clinical Pharmacology
Mechanism of Action.
The mechanism of action of citalopram is not clear, but may be related to enhanced serotonergic activity in the central nervous system (CNS) due to inhibition of serotonin reuptake (5-HT) by CNS neurons.
Pharmacodynamics
In vitro and in vivo studies in animals indicate that citalopram is a selective serotonin reuptake inhibitor (SSRI) with minimal effect on neuronal responses (NE) and dopamine (DA).
Citalopram does not do so at all or 5-HT1A, 5-HT2A, dopamine and D2, A1-, A2-, and B-adrenergic, histamine H1, gamma-aminobutyric acid (GABA), and muscular and muscular bile dorsalis benzodiazinin acidic drug receptors of very low affinity.
Cardiac electrophysiology
Individually modified QTC (QTCNI) intervals were evaluated in a randomized, placebo-controlled and active (400 mg moxifloxacin) cross-over, scalable, multivariate study in 119 healthy individuals. The maximum mean (upper limit of 95%1 passing confidence) differences from placebo were 8.5 (10.8) and 18.5 (21.0) MSEC at 20 mg and 60 mg (1.5 times the maximum recommended dose) citalopram. Based on the established exposure-response ratios, the predicted change in qtcni from placebo below the cmax at the 40 mg dose is 12.6 (14.3) msec [see Warnings and Precautions].
Pharmacokinetics.
The one off and multiple dose citalopram pharmacokinetics are linear in the dose range of 10-40 mg/day and is dosage. Citalopram biomedicine is primarily hepatic, with a mean half-life final of approximately 35 h. Once daily, plasma constant concentrations are achieved within approximately one week. Under stable conditions, the degree of accumulation of citalopram in plasma based on half-life would be expected to be 2.5 times the plasma concentration observed after a single dose.
Absorption
Following oral administration of citalopram (40 mg tablets), maximum blood concentrations appear in approximately 4 hours. The absolute bioavailability of citalopram is approximately 80% compared to intravenous administration, and absorption is not affected by food.
Distribution
The volume of citalopram distribution is about 12 L/kg, and the commitment of citalopram (CT), demethylcosalpram (DCT) and thythythythythythyloscope (DDCT) in human plasma proteins is about 80%. It is.
Exclusion.
Citalopram is metabolized to demethyloscopram (DCT), tweeemthythythythylopram (DDCT), citalopram-N-oxide, and a deafening propionic acid derivative. In humans, unchanged citalopram is the dominant living association. In the stable state, plasma concentrations of metabolites of citalopram, DCT, and DDCT are about half and one-tenth, respectively, of those of the parent drug; in vitro studies have shown that citalopram is at least eight times as potent as the suspension metabolite in serotonin reuptake and have evaluated metabolite likely does not contribute significantly to the antidepressant effects of citalopram.
In vitro studies using human liver microsomes have shown that CYP3A4 and CYP2C19 are the major isoenzymes involved in the N degradation of citalopram.
After intravenous administration of citalopram, the drug fractions recovered in urine as citalopram and DCT were approximately 10% and 5%, respectively. Systematic clearance of citalopram was 330 ml/min, approximately 20% by renal clearance.
Specialized Population
Geriatric Patients
Citalopram pharmacokinetics in persons 60 years of age and older were compared to younger populations in two studies involving regular volunteers. In the single-dose study, the AUC and half-life of citalopram increased by more than 60% and 30% and 50%, respectively, while in the high-dose study they increased by 23% and 30%, respectively [see Use in Special Populations, Warnings and Prerequisites Dose and Give, Warnings and Prerequisites].
Male and female patients
In three pharmacokinetic studies (total n = 32), citalopram AUCs for women were one to two times higher than for men. This difference was not observed in the other five pharmacokinetic studies (total n = 114). No difference in serum citalopram levels was observed in stable conditions between men (n = 237) and women (n = 388) in the clinical studies; there was no difference in pharmacokinetics between DCT and DDCT by gender.
Patients with hepatic dysfunction
Oral clearance of citalopram was reduced by 37% and the half-life was twice as long in patients with impaired hepatic function compared to normal individuals [reference dose and administration, warning and prevention, use in special populations].
Patients with renal impairment
In patients with mild to moderate renal impairment, oral clearance of citalopram was reduced by 17% compared to normal individuals. Dose adjustment is not recommended for these patients. There is no information on citalopram pharmacokinetics in patients with severe renal impairment (creatinine clearance< 20 mL/min).
CYP2C19 Poor Metabolizer
In CYP2C19 poor metabolizers, stable state CMAX and AUC of citalopram were increased by 68% and 107%, respectively [cf. Dose and Advancement, Warning and Prevention].
Poor metabolizers of CYP2D6
Steady state citalopram levels were not significantly different between poor metabolizers and extensive CYP2D6 metabolizers.
Drug Studies
In vitro enzyme inhibition data did not reveal an inhibitory effect of CyalopRAM on CYP3A4, -2C9 o r-2E1, but indicated that it is a weak inhibitor of CYP1A2, -2D6 an d-2C19. Citalopram would be expected to have a slight inhibitory effect on in vivo metabolism mediated by these enzymes. However, there is limited in vivo data to address this query.
CYP3A4 and CYP2C19 Inhibitors
Since CYP3A4 and CYP2C19 are the primary enzymes involved in citalopram metabolism, it is recommended that strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, macrolide antibiotics) and CYP2C19 inhibitors (EG omepep; however, CYP3A4 ketoconazole inhibitors Co-tiered agents did not significantly affect citalopram pharmacokinetics; 20 mg/day is the maximum recommended dose of citalopram in patients receiving cimizide or other CYP2C19 inhibitors because of the risk of prolonged QT [reference dose and advance, warning and prevention].
Cimetidine.
In those receiving 40 mg/day CELEXA for 21 days, cimetidine at 400 mg twice daily for 8 days increased citalopram AUC and CMAX by 43% and 39%, respectively [reference dose and administration, warnings and precautions, medication interactions].
CYP2D6 Inhibitors.
Co-titration of drugs that inhibit CYP2D6 with citalopram is unlikely to have a clinically significant effect on citalopram metabolism, based on the results of studies on poor metabolizers of CYP2D6.
Digoxin.
In those receiving 40 mg/day of Celexa for 21 days, the combined dose of Celexa and digoxin (one 1 mg dose) had no significant effect on the pharmacokinetics of either citalopram or digoxin.
Lithium
Coelxa C o-administration (40 mg/day for 10 days) and lithium (30 mmol/day for 5 days) had no significant effect on the pharmacokinetics of citalopram or lithium.
Pimozide.
In a controlled study, a single dose of 2 mg pimozide given once daily in a wheelchair for 11 days was associated with an average increase in QTC price of approximately 10 ms compared to pimozidis given by itself. Citalopram did not alter the mean AUC or cmax of pimozidis. The mechanism of this pharmacodynamic interaction is not known [see Meetings, Warnings, and Precautions].
Theophylline.
Conjugated doses of CELEXA (40 mg/day for 21 days) and CYP1A2 theophylline (300 mg single dose) substrates did not affect theophylline pharmacokinetics. The effect of theophylline on the pharmacokinetics of citalopram has not been evaluated.
Warfarin.
Administration of 40 mg/day Celexa for 21 days did not affect the pharmacokinetics of warfarin, a substrate of CYP3A4. Prothrombin time was increased by 5%, the clinical significance of which is unknown.
Carbamazepine
Combined administration of CELEXA (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a substrate of CYP3A4. Given the enzymatic properties of carbamazepine, plasma citalopram levels were not affected, but carbamazepine may increase the clearance of citalopram when the two drugs are employed.
Triazolam.
Combined CELEXA (securitized to 40 mg/day for 28 days) and CYP3A4 triazolam (0. 25 mg single dose) substrates had no significant effect on citalopram or triazolam pharmacokinetics.
Ketoconazole.
Combined administration of Celexa (40 mg) and ketoconazole (200 mg) reduced the CMAX and AUC of ketoconazole by 21% and 10%, respectively, with no significant effect on citalopram pharmacokinetics.
Metoprolol.
Administration of 40 mg/day CELEXA for 22 days resulted in a 2-fold increase in plasma levels of beta-adrenergic metoprolol inhibitors. The increase in plasma metoprolol was associated with a decrease in cardiovascular CELEXA and metoprolol co-titration had no clinically significant effect on blood pressure or heart rate.
Imipramine and Other Tricyclic Antidepressants (TCAs)
In vitro studies indicate that citalopram is a relatively weak CYP2D6 inhibitor; C o-administration of Colexa (40 mg/day for 10 days) with the TCA imipramine (100 mg single dose), a substrate of CYP2D6, resulted in a plasma concentrations of imipramine or citalopram were not significantly affected. However, concentrations of desipramine, a metabolite of imipramine, increased by approximately 50%. The clinical significance of the changes in desgramine is unknown.
Animal toxicology and/or pharmacology
Retinal changes in rats
In a 2-year carcinogenesis study, pathological changes (degeneration/atrophy) were observed in albino rats; both male and female rats receiving 80 mg/kg/day had increased retinal pathology effects and severity, which is approximately 19 times greater than approximately 40 mg of MRHD based on mg/m² body surface. Similar findings were not present in rats treated for 2 years at a dose of 24 mg/kg/day, in rats treated for 18 months with mouse therapy at up to 240 mg/kg/kg, or in dogs treated for 1 year. Based on a body surface of mg/m², the maximum dose is 20 mg/kg/day, which is approximately 6, 29, and 17 times the MRHD, respectively.
No additional studies have been conducted to investigate the mechanism of this pathology and the possible significance of this effect on humans has not been established.
Clinical Trials
The efficacy of CELEXA as a treatment for major depressive disorder was documented in two placebo-controlled studies (4-6 weeks) of adult external patients (18-66 years) who met DSM-III or DSM-III-R criteria for major depressive disorder (MSDS) (Studies 1 and 2).
Study 1, a 6-week test in which patients received fixed doses of Celexa 10 mg, 20 mg, 40 mg, and 60 mg daily, showed that 40 mg daily and 60 mg daily (1.5 times the maximum recommended daily dose) were effective. The primary end of efficiency, as measured by the overall score on the Hamilton Depression Scale (HAMD).The HAMD-17 is a 17-factor scale, rated by clinicians, used to assess the severity of depressive symptoms.HAMD-17 ratings range from 0 to 52, with higher rating indicates more severe depression. In this study, daily doses of 10 mg and 20 mg did not show a clear effect, and a daily dose of 60 mg was no more effective than a daily dose of 40 mg. because of the risk of QTC and increased abdominal arrhythmia, the maximum recommended dose of CELEXA is 40 mg once a day.
Study 2, a 4-week placebo-controlled study of patients with MDD, used an initial dose of 20 mg daily, followed by maximum tolerated dose securitization, or a maximum dose of 80 mg daily (twice the maximum recommended daily dose). Patients treated with CELEXA have a statistically significant improvement in overall HAMD scores over patients who received placebo, the primary end of efficiency. three additional placebo-controlled studies in patients with MDD showed that the difference in response to treatment between patients who received CELEXA and those who received placebo was The difference in response between patients receiving Celexa and those receiving placebo was not statistically significant.
In two long-term studies, patients with MDD responded to CELEXA during the first 6 or 8 weeks of acute treatment and were randomized to continue on CELEXA or placebo. In one study, patients received a constant dose of 20 mg or 40 mg of Celexa daily; in the second study, patients received a flexible dose of 20 mg daily up to 60 mg daily (1.5 times the maximum recommended daily dose). In both studies, patients who received continuous treatment with Celexa had statistically significantly lower recurrence rates over the next six months compared to patients who received placebo. In a constant dose study, the lower recurrence rate of depression was similar for patients receiving either 20 mg or 40 mg of Celexa daily; due to the risk of QTC and increased abdominal arrhythmia, the maximum recommended dose of CELEXA is 40 mg once daily.
Analysis of the relationship between treatment outcomes and age, gender, and race did not indicate a different response based on these characteristics of the patients.
Drugs that affect heart rate
Citalopram should not be used with other medications that affect heart rate. Taking both citalopram and these medications can increase the risk of dangerous heart rate changes. Examples of these medications are
- amiodarone
- chloroprazine
- Methadone
- Pentamidine
- Pimozide
- Procainamide
- thioridazine
Drugs that increase the risk of bleeding
Citalopram and other antidepressants may increase the risk of bleeding and bruising, especially when taken with other medications that increase the risk of bleeding.
Other medications that increase the risk of bleeding include
- Anticoagulants:
- Warfarin
- Enoxaparin
- Dalteparin
- Heparin
- Ibuprofen
- Naproxen
- Ketorolaki
Tricyclic antidepressants (TCAs)
Caution should be exercised when using citalopram with TCAs. This may result in higher levels of TCAs in the body and more side effects. Tricyclic antidepressants include
- Amitriptyline
- Imipramine
- Nortriptyline
Drugs that cause inhibition or drowsiness
Drugs that cause inhibition or drowsiness may have an increased effect when taken with citalopram. Examples of these medications are
- Lorazepam
- Diazepam
- Midazolam
- Shopam
- Zolpidem
Cytochrome inhibitor P450 2C19
Cyatochrom P450 2C19 is a protein in our bodies that often helps break down drugs, including citalopram. Some drugs are known to slow or inhibit the effects of this protein. If the drug is taken with citalopram, which slows down the effects of this protein, the amount of citalopram in the body may be too high. Examples of cytochrome inhibitors P450 2C19 include
- cimetidine
- Clopidogrel
- Chloramphenicol
- Fluvoxamine
- Modafinil
Disclaimer: Our goal is to provide the most relevant and current information. However, because drugs interact differently with each other, we cannot guarantee that all possible interactions are included in this information. This information is not intended to replace medical advice. Always consult your health care provider about possible interactions with all prescription drugs, vitamins, herbs, supplements, and non-prescription drugs you are taking.
Several warnings accompany this medication.
Allergy Warning.
Citalopram can cause serious allergic reactions. Symptoms include
- difficulty breathing
- Swelling of the face, tongue, eyes, or mouth
- Rash, itching (ur measles) or blistering, together with or fever or joint pain
If you have an allergic reaction, call your doctor or local poison center immediately. If symptoms are severe, call 911 or go to the nearest emergency section.
Do not take this medication again if you have ever had an allergic reaction to it. It can be fatal (cause death).
Interact with alcohol.
Do not use alcohol with citalopram. Citalopram can cause drowsiness. May affect the ability to make decisions, think clearly, and react quickly. Alcohol consumption may enhance these effects.
Warning for people with certain health conditions
For people with heart problems: do not take citalopram if you have heart problems, including a condition called Long QT syndrome. Taking citalopram increases the risk of a serious heart rate change called QT dilation, which can cause sudden death. People with a slow heart rate, recent heart attack, or severe heart failure should also not receive citalopram.
For persons with low potassium levels: do not take citalopram if you have low potassium levels. Calcine and low potassium levels increase the risk of severe heart rate changes, called QT dilation, which can cause sudden death.
For people with low magnesium levels: do not take Citalopram if you have low magnesium levels; Cititalopram intake and low magnesium levels increase the risk of a serious heart rate change called QT dilation, which can cause sudden death.
For people with kidney disease: If you have kidney disease, consult your doctor before using Cititalopram. This drug can accumulate and cause more side effects in people with severe kidney disease.
In people with liver disease: citalopram is treated in the liver. If you have liver disease, the levels of this drug in your body may increase. There may be more side effects. People with liver disease should not receive more than 20 mg of citalopram per day.
In people with a history of epileptic seizures: citalopram can increase the risk of epileptic seizures. If you have a history of seizures, consult your physician before using this medication.
Other Group Warnings
FOR PREGNANT WOMEN: Citalopram is a Class C drug for pregnancy. This means two things
- Animal studies show adverse effects on the fetus when the mother takes the drug.
- Not enough research has been done in humans to see how the drug affects the fetus.
Consult your physician if you are pregnant or plan to become pregnant. This medication should only be used when the potential benefit justifies the potential risk to the fetus.
For breastfeeding women: citalopram is transferred to breast milk and can cause side effects in breastfed children. If you are breastfeeding your child, consult your physician. You may need to decide whether to stop breastfeeding or stop taking this medication.
Children: Citalopram may cause changes in appetite and weight. Children and adolescents should be monitored for height and weight during treatment.