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Celexa
Overview
What is Celexa?
Celexa® (citalopram HBr) is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula:
The molecular formula is CHBrFNO and its molecular weight is 405.35.
Citalopram HBr occurs as a fine, white to off-white powder. Citalopram HBr is sparingly soluble in water and soluble in ethanol.
Celexa (citalopram hydrobromide) is available only in tablet dosage form.
Celexa 10 mg are film-coated, oval tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Celexa 20 mg and 40 mg are film-coated, oval, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copolyvidone, corn starch, crosscarmellose sodium, glycerin, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the beige (10 mg) and pink (20 mg) tablets.
What does Celexa look like?
What are the available doses of Celexa?
Sorry No records found.
What should I talk to my health care provider before I take Celexa?
Sorry No records found
How should I use Celexa?
Celexa (citalopram HBr) is indicated for the treatment of depression.
The efficacy of Celexa in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see ).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
The antidepressant action of Celexa in hospitalized depressed patients has not been adequately studied.
The efficacy of Celexa in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see ). Nevertheless, the physician who elects to use Celexa for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Celexa should be administered once daily, in the morning or evening, with or without food.
What interacts with Celexa?
The use of MAOIs intended to treat psychiatric disorders with Celexa or within 14 days of stopping treatment with Celexa is contraindicated because of an increased risk of serotonin syndrome. The use of Celexa within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see ).
Starting Celexa in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see ).
Concomitant use in patients taking pimozide is contraindicated (see ).
Celexa is contraindicated in patients with a hypersensitivity to citalopram or any of the inactive ingredients in Celexa.
What are the warnings of Celexa?
Sorry No Records found
What are the precautions of Celexa?
General
During marketing of Celexa and other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms.
Patients should be monitored for these symptoms when discontinuing treatment with Celexa. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate (see ).
Information for Patients
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Clinical Worsening and Suicide Risk:
Laboratory Tests
There are no specific laboratory tests recommended.
Drug Interactions
CNS Drugs - Given the primary CNS effects of citalopram, caution should be used when it is taken in combination with other centrally acting drugs.
Alcohol - Although citalopram did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as with other psychotropic medications, the use of alcohol by depressed patients taking Celexa is not recommended.
Monoamine Oxidase Inhibitors (MAOIs) - See , .
Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.) - Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when Celexa is initiated or discontinued.
Digoxin - In subjects who had received 21 days of 40 mg/day Celexa, combined administration of Celexa and digoxin (single dose of 1 mg) did not significantly affect the pharmacokinetics of either citalopram or digoxin.
Lithium - Coadministration of Celexa (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. Nevertheless, plasma lithium levels should be monitored with appropriate adjustment to the lithium dose in accordance with standard clinical practice. Because lithium may enhance the serotonergic effects of citalopram, caution should be exercised when Celexa and lithium are coadministered.
Pimozide - In a controlled study, a single dose of pimozide 2 mg co-administered with citalopram 40 mg given once daily for 11 days was associated with a mean increase in QTc values of approximately 10 msec compared to pimozide given alone. Citalopram did not alter the mean AUC or C of pimozide. The mechanism of this pharmacodynamic interaction is not known.
Theophylline - Combined administration of Celexa (40 mg/day for 21 days) and the CYP1A2 substrate theophylline (single dose of 300 mg) did not affect the pharmacokinetics of theophylline. The effect of theophylline on the pharmacokinetics of citalopram was not evaluated.
Sumatriptan - There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of a SSRI and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram) is clinically warranted, appropriate observation of the patient is advised.
Warfarin - Administration of 40 mg/day Celexa for 21 days did not affect the pharmacokinetics of warfarin, a CYP3A4 substrate. 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 CYP3A4 substrate. Although trough citalopram plasma levels were unaffected, given the enzyme-inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of citalopram should be considered if the two drugs are coadministered.
Triazolam - Combined administration of Celexa (titrated to 40 mg/day for 28 days) and the CYP3A4 substrate triazolam (single dose of 0.25 mg) did not significantly affect the pharmacokinetics of either citalopram or triazolam.
Ketoconazole - Combined administration of Celexa (40 mg) and ketoconazole (200 mg) decreased the C and AUC of ketoconazole by 21% and 10%, respectively, and did not significantly affect the pharmacokinetics of citalopram.
Imipramine and Other Tricyclic Antidepressants (TCAs) - studies suggest that citalopram is a relatively weak inhibitor of CYP2D6. Coadministration of Celexa (40 mg/day for 10 days) with the TCA imipramine (single dose of 100 mg), a substrate for CYP2D6, did not significantly affect the plasma concentrations of imipramine or citalopram. However, the concentration of the imipramine metabolite desipramine was increased by approximately 50%. The clinical significance of the desipramine change is unknown. Nevertheless, caution is indicated in the coadministration of TCAs with Celexa.
Electroconvulsive Therapy (ECT) - There are no clinical studies of the combined use of electroconvulsive therapy (ECT) and Celexa.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Citalopram was administered in the diet to NMRI/BOM strain mice and COBS WI strain rats for 18 and 24 months, respectively. There was no evidence for carcinogenicity of citalopram in mice receiving up to 240 mg/kg/day, which is equivalent to 20 times the maximum recommended human daily dose (MRHD) of 60 mg on a surface area (mg/m) basis. There was an increased incidence of small intestine carcinoma in rats receiving 8 or 24 mg/kg/day, doses which are approximately 1.3 and 4 times the MRHD, respectively, on a mg/m basis. A no-effect dose for this finding was not established. The relevance of these findings to humans is unknown.
Mutagenesis
Citalopram was mutagenic in the bacterial reverse mutation assay (Ames test) in 2 of 5 bacterial strains (Salmonella TA98 and TA1537) in the absence of metabolic activation. It was clastogenic in the Chinese hamster lung cell assay for chromosomal aberrations in the presence and absence of metabolic activation. Citalopram was not mutagenic in the mammalian forward gene mutation assay (HPRT) in mouse lymphoma cells or in a coupled unscheduled DNA synthesis (UDS) assay in rat liver. It was not clastogenic in the chromosomal aberration assay in human lymphocytes or in two mouse micronucleus assays.
Impairment of Fertility
When citalopram was administered orally to 16 male and 24 female rats prior to and throughout mating and gestation at doses of 32, 48, and 72 mg/kg/day, mating was decreased at all doses, and fertility was decreased at doses ≥ 32 mg/kg/day, approximately 5 times the MRHD of 60 mg/day on a body surface area (mg/m) basis. Gestation duration was increased at 48 mg/kg/day, approximately 8 times the MRHD.
Pregnancy
Pregnancy Category C
Pregnancy-Nonteratogenic Effects
Labor and Delivery
The effect of Celexa on labor and delivery in humans is unknown.
Nursing Mothers
As has been found to occur with many other drugs, citalopram is excreted in human breast milk. There have been two reports of infants experiencing excessive somnolence, decreased feeding, and weight loss in association with breastfeeding from a citalopram-treated mother; in one case, the infant was reported to recover completely upon discontinuation of citalopram by its mother and in the second case, no follow-up information was available. The decision whether to continue or discontinue either nursing or Celexa therapy should take into account the risks of citalopram exposure for the infant and the benefits of Celexa treatment for the mother.
Pediatric Use
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Geriatric Use
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What are the side effects of Celexa?
The premarketing development program for Celexa included citalopram exposures in patients and/or normal subjects from 3 different groups of studies: 429 normal subjects in clinical pharmacology/pharmacokinetic studies; 4422 exposures from patients in controlled and uncontrolled clinical trials, corresponding to approximately 1370 patient-exposure years. There were, in addition, over 19,000 exposures from mostly open-label, European postmarketing studies. The conditions and duration of treatment with Celexa varied greatly and included (in overlapping categories) open-label and double-blind studies, inpatient and outpatient studies, fixed-dose and dose-titration studies, and short-term and long-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.
Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse events.
The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Adverse Findings Observed in Short-Term, Placebo-Controlled Trials
Adverse Events Associated with Discontinuation of Treatment
Among 1063 depressed patients who received Celexa at doses ranging from 10 to 80 mg/day in placebo-controlled trials of up to 6 weeks in duration, 16% discontinued treatment due to an adverse event, as compared to 8% of 446 patients receiving placebo. The adverse events associated with discontinuation and considered drug-related (i.e., associated with discontinuation in at least 1% of Celexa-treated patients at a rate at least twice that of placebo) are shown in . It should be noted that one patient can report more than one reason for discontinuation and be counted more than once in this table.
| Percentage of Patients Discontinuing | Due to Adverse Event | |
| Citalopram | Placebo | |
| (N=1063) | (N=446) | |
| Body System/Adverse Event | ||
| General | ||
| Asthenia | 1% | <1% |
| Gastrointestinal Disorders | ||
| Nausea | 4% | 0% |
| Dry Mouth | 1% | <1% |
| Vomiting | 1% | 0% |
| Central and Peripheral | ||
| Nervous System Disorders | ||
| Dizziness | 2% | <1% |
| Psychiatric Disorders | ||
| Insomnia | 3% | 1% |
| Somnolence | 2% | 1% |
| Agitation | 1% | <1% |
Adverse Events Occurring at an Incidence of 2% or More Among Celexa -Treated Patients
| *Events reported by at least 2% of patients treated with Celexa are reported, except for the following events which had an incidence on placebo ≥ Celexa: headache, asthenia, dizziness, constipation, palpitation, vision abnormal, sleep disorder, nervousness, pharyngitis, micturition disorder, back pain. | ||
| 1 | ||
| 2 | ||
| 3 | (Percentage of Patients Reporting Event) | |
| Body System/Adverse Event | Celexa | Placebo |
| (N=1063) | (N=446) | |
| Autonomic Nervous System | ||
| Disorders | ||
| Dry Mouth | 20% | 14% |
| Sweating Increased | 11% | 9% |
| Central & Peripheral Nervous | ||
| System Disorders | ||
| Tremor | 8% | 6% |
| Gastrointestinal Disorders | ||
| Nausea | 21% | 14% |
| Diarrhea | 8% | 5% |
| Dyspepsia | 5% | 4% |
| Vomiting | 4% | 3% |
| Abdominal Pain | 3% | 2% |
| General | ||
| Fatigue | 5% | 3% |
| Fever | 2% | <1% |
| Musculoskeletal System | ||
| Disorders | ||
| Arthralgia | 2% | 1% |
| Myalgia | 2% | 1% |
| Psychiatric Disorders | ||
| Somnolence | 18% | 10% |
| Insomnia | 15% | 14% |
| Anxiety | 4% | 3% |
| Anorexia | 4% | 2% |
| Agitation | 3% | 1% |
| Dysmenorrhea | 3% | 2% |
| Libido Decreased | 2% | <1% |
| Yawning | 2% | <1% |
| Respiratory System Disorders | ||
| Upper Respiratory Tract Infection | 5% | 4% |
| Rhinitis | 5% | 3% |
| Sinusitis | 3% | <1% |
| Urogenital | ||
| Ejaculation Disorder | 6% | 1% |
| Impotence | 3% | <1% |
Dose Dependency of Adverse Events
The potential relationship between the dose of Celexa administered and the incidence of adverse events was examined in a fixed-dose study in depressed patients receiving placebo or Celexa 10, 20, 40, and 60 mg. Jonckheere's trend test revealed a positive dose response (p<0.05) for the following adverse events: fatigue, impotence, insomnia, sweating increased, somnolence, and yawning.
Male and Female Sexual Dysfunction with SSRIs
| Treatment | Celexa | Placebo |
| Abnormal Ejaculation(mostly ejaculatory delay) | 6.1%(males only) | 1%(males only) |
| Libido Decreased | 3.8%(males only) | <1%(males only) |
| Impotence | 2.8%(males only) | <1%(males only) |
Vital Sign Changes
Celexa and placebo groups were compared with respect to (1) mean change from baseline in vital signs (pulse, systolic blood pressure, and diastolic blood pressure) and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses did not reveal any clinically important changes in vital signs associated with Celexa treatment. In addition, a comparison of supine and standing vital sign measures for Celexa and placebo treatments indicated that Celexa treatment is not associated with orthostatic changes.
Weight Changes
Patients treated with Celexa in controlled trials experienced a weight loss of about 0.5 kg compared to no change for placebo patients.
Laboratory Changes
Celexa and placebo groups were compared with respect to (1) mean change from baseline in various serum chemistry, hematology, and urinalysis variables, and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses revealed no clinically important changes in laboratory test parameters associated with Celexa treatment.
ECG Changes
Other Events Observed During the Premarketing Evaluation of Celexa (citalopram HBr)
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*% based on female subjects only: 2955
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Other Events Observed During the Postmarketing Evaluation of Celexa (citalopram HBr)
It is estimated that over 30 million patients have been treated with Celexa since market introduction. Although no causal relationship to Celexa treatment has been found, the following adverse events have been reported to be temporally associated with Celexa treatment, and have not been described elsewhere in labeling: acute renal failure, akathisia, allergic reaction, anaphylaxis, angioedema, choreoathetosis, chest pain, delirium, dyskinesia, ecchymosis, epidermal necrolysis, erythema multiforme, gastrointestinal hemorrhage, angle closure glaucoma, grand mal convulsions, hemolytic anemia, hepatic necrosis, myoclonus, nystagmus, pancreatitis, priapism, prolactinemia, prothrombin decreased, QT prolonged, rhabdomyolysis, spontaneous abortion, thrombocytopenia, thrombosis, ventricular arrhythmia, torsade de pointes, and withdrawal syndrome.
What should I look out for while using Celexa?
The use of MAOIs intended to treat psychiatric disorders with Celexa or within 14 days of stopping treatment with Celexa is contraindicated because of an increased risk of serotonin syndrome. The use of Celexa within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see ).
Starting Celexa in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see ).
Concomitant use in patients taking pimozide is contraindicated (see ).
Celexa is contraindicated in patients with a hypersensitivity to citalopram or any of the inactive ingredients in Celexa.
What might happen if I take too much Celexa?
How should I store and handle Celexa?
Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.Primidone Tablets USP, 50 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1301, supplied in bottles of 100 and 500 tablets.100 Tablets NDC 0904-5559-60500 Tablets NDC 0904-5559-40Primidone Tablets USP, 250 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1231, supplied in bottles of 100 tablets.100 Tablets NDC 0904-0560-60Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP with a child-resistant closure.Manufactured by: Distributed by:Lannett Company, Inc. Major PharmaceuticalsPhiladelphia, PA 19136 Livonia, MI 48150 USAMade in the USARevised 07/12Primidone Tablets USP, 50 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1301, supplied in bottles of 100 and 500 tablets.100 Tablets NDC 0904-5559-60500 Tablets NDC 0904-5559-40Primidone Tablets USP, 250 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1231, supplied in bottles of 100 tablets.100 Tablets NDC 0904-0560-60Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP with a child-resistant closure.Manufactured by: Distributed by:Lannett Company, Inc. Major PharmaceuticalsPhiladelphia, PA 19136 Livonia, MI 48150 USAMade in the USARevised 07/12Primidone Tablets USP, 50 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1301, supplied in bottles of 100 and 500 tablets.100 Tablets NDC 0904-5559-60500 Tablets NDC 0904-5559-40Primidone Tablets USP, 250 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1231, supplied in bottles of 100 tablets.100 Tablets NDC 0904-0560-60Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP with a child-resistant closure.Manufactured by: Distributed by:Lannett Company, Inc. Major PharmaceuticalsPhiladelphia, PA 19136 Livonia, MI 48150 USAMade in the USARevised 07/12Primidone Tablets USP, 50 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1301, supplied in bottles of 100 and 500 tablets.100 Tablets NDC 0904-5559-60500 Tablets NDC 0904-5559-40Primidone Tablets USP, 250 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1231, supplied in bottles of 100 tablets.100 Tablets NDC 0904-0560-60Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP with a child-resistant closure.Manufactured by: Distributed by:Lannett Company, Inc. Major PharmaceuticalsPhiladelphia, PA 19136 Livonia, MI 48150 USAMade in the USARevised 07/12Primidone Tablets USP, 50 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1301, supplied in bottles of 100 and 500 tablets.100 Tablets NDC 0904-5559-60500 Tablets NDC 0904-5559-40Primidone Tablets USP, 250 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1231, supplied in bottles of 100 tablets.100 Tablets NDC 0904-0560-60Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP with a child-resistant closure.Manufactured by: Distributed by:Lannett Company, Inc. Major PharmaceuticalsPhiladelphia, PA 19136 Livonia, MI 48150 USAMade in the USARevised 07/12Primidone Tablets USP, 50 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1301, supplied in bottles of 100 and 500 tablets.100 Tablets NDC 0904-5559-60500 Tablets NDC 0904-5559-40Primidone Tablets USP, 250 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1231, supplied in bottles of 100 tablets.100 Tablets NDC 0904-0560-60Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP with a child-resistant closure.Manufactured by: Distributed by:Lannett Company, Inc. Major PharmaceuticalsPhiladelphia, PA 19136 Livonia, MI 48150 USAMade in the USARevised 07/12Primidone Tablets USP, 50 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1301, supplied in bottles of 100 and 500 tablets.100 Tablets NDC 0904-5559-60500 Tablets NDC 0904-5559-40Primidone Tablets USP, 250 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1231, supplied in bottles of 100 tablets.100 Tablets NDC 0904-0560-60Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP with a child-resistant closure.Manufactured by: Distributed by:Lannett Company, Inc. Major PharmaceuticalsPhiladelphia, PA 19136 Livonia, MI 48150 USAMade in the USARevised 07/12Primidone Tablets USP, 50 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1301, supplied in bottles of 100 and 500 tablets.100 Tablets NDC 0904-5559-60500 Tablets NDC 0904-5559-40Primidone Tablets USP, 250 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1231, supplied in bottles of 100 tablets.100 Tablets NDC 0904-0560-60Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP with a child-resistant closure.Manufactured by: Distributed by:Lannett Company, Inc. Major PharmaceuticalsPhiladelphia, PA 19136 Livonia, MI 48150 USAMade in the USARevised 07/12Primidone Tablets USP, 50 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1301, supplied in bottles of 100 and 500 tablets.100 Tablets NDC 0904-5559-60500 Tablets NDC 0904-5559-40Primidone Tablets USP, 250 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1231, supplied in bottles of 100 tablets.100 Tablets NDC 0904-0560-60Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP with a child-resistant closure.Manufactured by: Distributed by:Lannett Company, Inc. Major PharmaceuticalsPhiladelphia, PA 19136 Livonia, MI 48150 USAMade in the USARevised 07/12Primidone Tablets USP, 50 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1301, supplied in bottles of 100 and 500 tablets.100 Tablets NDC 0904-5559-60500 Tablets NDC 0904-5559-40Primidone Tablets USP, 250 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1231, supplied in bottles of 100 tablets.100 Tablets NDC 0904-0560-60Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP with a child-resistant closure.Manufactured by: Distributed by:Lannett Company, Inc. Major PharmaceuticalsPhiladelphia, PA 19136 Livonia, MI 48150 USAMade in the USARevised 07/12
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of citalopram HBr as an antidepressant is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT). and studies in animals suggest that citalopram is a highly selective serotonin reuptake inhibitor (SSRI) with minimal effects on norepinephrine (NE) and dopamine (DA) neuronal reuptake. Tolerance to the inhibition of 5-HT uptake is not induced by long-term (14-day) treatment of rats with citalopram. Citalopram is a racemic mixture (50/50), and the inhibition of 5-HT reuptake by citalopram is primarily due to the (S)-enantiomer.
Citalopram has no or very low affinity for 5-HT, 5-HT, dopamine D and D, α-, α-, and β-adrenergic, histamine H, gamma aminobutyric acid (GABA), muscarinic cholinergic, and benzodiazepine receptors. Antagonism of muscarinic, histaminergic, and adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects of other psychotropic drugs.
Non-Clinical Toxicology
The use of MAOIs intended to treat psychiatric disorders with Celexa or within 14 days of stopping treatment with Celexa is contraindicated because of an increased risk of serotonin syndrome. The use of Celexa within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see ).Starting Celexa in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see ).
Concomitant use in patients taking pimozide is contraindicated (see ).
Celexa is contraindicated in patients with a hypersensitivity to citalopram or any of the inactive ingredients in Celexa.
The premarketing development program for Celexa included citalopram exposures in patients and/or normal subjects from 3 different groups of studies: 429 normal subjects in clinical pharmacology/pharmacokinetic studies; 4422 exposures from patients in controlled and uncontrolled clinical trials, corresponding to approximately 1370 patient-exposure years. There were, in addition, over 19,000 exposures from mostly open-label, European postmarketing studies. The conditions and duration of treatment with Celexa varied greatly and included (in overlapping categories) open-label and double-blind studies, inpatient and outpatient studies, fixed-dose and dose-titration studies, and short-term and long-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.
Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse events.
The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).