Product Elements:
Citalopram hydrobromide citalopram hydrobromide citalopram hydrobromide citalopram tan oval, biconvex 2;0;1010 citalopram hydrobromide citalopram hydrobromide citalopram hydrobromide citalopram tan round, biconvex 10 citalopram hydrobromide citalopram hydrobromide citalopram hydrobromide citalopram tin oval,biconvex 4;0;1011
Drug Interactions:
7 drug interactions table 5 presents clinically important drug interactions with citalopram. table 5: clinically important drug interactions with citalopram monoamine oxidase inhibitors (maois) clinical impact concomitant use of ssris, including citalopram, and maois increases the risk of serotonin syndrome. intervention citalopram is contraindicated in patients taking maois, including maois such as linezolid or intravenous methylene blue [see dosage and administration ( 2.5 ), contraindications ( 4 ), warnings and precautions ( 5.3 )] . pimozide clinical impact: concomitant use of citalopram with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of qt prolongation and/or ventricular arrhythmias compared to use of citalopram alone [see clinical pharmacology ( 12.2 )]. intervention: citalopram is contraindicated in patients taking pimozide [see contraindications ( 4 ), warnings and precautions ( 5.2 )]. drugs that pro
Read more...long the qtc interval clinical impact: concomitant use of citalopram with drugs that prolong qt can cause additional qt prolongation compared to the use of citalopram alone [see clinical pharmacology ( 12.2 )]. intervention: avoid concomitant use of citalopram with drugs that prolong the qt interval (citalopram is contraindicated in patients taking pimozide) [see contraindications ( 4 ) , warnings and precautions ( 5.2 )]. cyp2c19 inhibitors clinical impact: concomitant use of citalopram with cyp2c19 inhibitors increases the risk of qt prolongation and/or ventricular arrhythmias compared to the use of citalopram alone [see clinical pharmacology ( 12.2 )]. intervention: the maximum recommended dosage of citalopram is 20 mg daily when used concomitantly with a cyp2c19 inhibitor [see dosage and administration ( 2.4 ), warnings and precautions ( 5.2 )]. serotonergic drugs clinical impact: concomitant use of citalopram and other serotonergic drugs increases the risk of serotonin syndrome. intervention: monitor patients for signs and symptoms of serotonin syndrome, particularly during citalopram initiation and dosage increases. if serotonin syndrome occurs, consider discontinuation of citalopram and/or concomitant serotonergic drugs [see warning and precautions ( 5.3 )]. drugs that interfere with hemostasis (antiplatelet agents and anticoagulants) clinical impact: concomitant use of citalopram and an antiplatelet or anticoagulant may potentiate the risk of bleeding. intervention: inform patients of the increased risk of bleeding associated with the concomitant use of citalopram and antiplatelet agents and anticoagulants. for patients taking warfarin, carefully monitor the international normalized ratio [see warning and precautions ( 5.4 )]. cyp2c19 inhibitors : citalopram tablets 20 mg daily is the maximum recommended dosage for patients taking concomitant cyp2c19 inhibitors ( 5.2 , 7 ) .
Boxed Warning:
Warning: suicidal thoughts and behaviors antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short- term studies. closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see warnings and precautions ( 5.1 )] . citalopram tablets are not approved for use in pediatric patients [see use in specific populations ( 8.4 )] . warning: suicidal thoughts and behaviors see full prescribing information for complete boxed warning . ⢠increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughs and behaviors ( 5.1 ) . ⢠citalopram tablets are not approved for use in pediatric patients ( 8.4 ) .
Indications and Usage:
1 indications and usage citalopram tablets are indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies ( 14 )] . citalopram is a selective serotonin reuptake inhibitor (ssri) indicated for the treatment of major depressive disorder (mdd) in adults ( 1 ) .
Warnings and Cautions:
5 warnings and precautions ⢠qt-prolongation and torsade de pointes: dose-dependent qtc prolongation, torsade de pointes, ventricular tachycardia, and sudden death have occurred. avoid use of citalopram tablets in patients with congenital long qt syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure and patients taking other drugs that prolong the qtc interval. monitor electrolytes in patients at high risk for hypokalemia or hypomagnesemia. discontinue citalopram tablets in patients with persistent qtc measurements > 500 ms ( 5.2 , 7 ) . ⢠serotonin syndrome: increased risk when co-administered with other serotonergic agents (e.g., ssri, snri, triptans), but also when taken alone. if occurs, discontinue citalopram tablets and initiate supportive measures ( 5.3 ) . ⢠increased risk of bleeding: concomitant use of aspirin, nonsteroidal anti- inflammatory drugs, other antiplatelet drugs, warfarin and other a
Read more...nticoagulants may increase this risk ( 5.4 ) . ⢠activation of mania/hypomania: screen patients for bipolar disorder ( 5.5 ) . ⢠seizures: use with caution in patients with seizure disorder ( 5.7 ) . ⢠angle-closure glaucoma: avoid use of citalopram tablets in patients with untreated anatomically narrow angles ( 5.8 ) . ⢠hyponatremia: can occur in association with syndrome of inappropriate antidiuretic hormone secretion ( 5.9 ) . ⢠sexual dysfunction: citalopram tablets may cause symptoms of sexual dysfunction. ( 5.10 ) .
Dosage and Administration:
2 dosage and administration ⢠administer once daily with or without food ( 2 ) . ⢠initial dosage is 20 mg once daily; after one week may increase to maximum dosage of 40 mg once daily ( 2.1 ) . ⢠patients greater than 60 years of age, patients with hepatic impairment, and cyp2c19 poor metabolizers: maximum recommended dosage is 20 mg once daily ( 2.2 ) . ⢠when discontinuing citalopram tablets, reduce dosage gradually ( 2.4 , 5.6 ) .
Dosage Forms and Strength:
3 dosage forms and strengths citalopram tablets, usp are available as: ⢠10 mg: tan coloured, round shaped, biconvex film coated tablets with â10â debossed on one side and plain on the other side. ⢠20 mg: tan coloured, oval shaped, biconvex film coated tablets with â2â0â debossed (â2â on left side and â0â on right side of the break line) on one side and â1010â on the other side. ⢠40 mg: tan coloured, oval shaped, biconvex film coated tablets with â4â0â debossed (â4â on left side and â0â on right side of the break line) on one side and â1011â on the other side tablets: 10 mg; 20 mg, scored; and 40 mg, scored ( 3 )
Contraindications:
4 contraindications citalopram tablets are contraindicated in patients: ⢠taking, or within 14 days of stopping, maois (including maois such as linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.3 ), drug interactions ( 7 )] . ⢠taking pimozide because of risk of qt prolongation [see drug interactions ( 7 )] . ⢠with known hypersensitivity to citalopram or any of the inactive ingredients in citalopram tablets. reactions have included angioedema and anaphylaxis [see adverse reactions ( 6.2 )] . ⢠concomitant use of monoamine oxidase inhibitors (maois) or use within 14 days of discontinuing a maoi ( 4 ) . ⢠concomiant use of pimozide ( 4 ) . ⢠known hypersensitivity to citalopram or any of the inactive ingredients of citalopram tablets ( 4 ) .
Adverse Reactions:
6 adverse reactions the following adverse reactions are discussed in greater detail in other sections of the labeling: ⢠hypersensitivity reactions [see contraindications ( 4 )] ⢠suicidal thoughts and behaviors in adolescents and young adults [see warnings and precautions ( 5.1 )] ⢠qt-prolongation and torsade de pointes [see warnings and precautions ( 5.2 )] ⢠serotonin syndrome [see warnings and precautions ( 5.3 )] ⢠increased risk of bleeding [see warnings and precautions ( 5.4 )] ⢠activation of mania or hypomania [see warnings and precautions ( 5.5 )] ⢠discontinuation syndrome [see warnings and precautions ( 5.6 )] ⢠seizures [see warnings and precautions ( 5.7 )] ⢠angle-closure glaucoma [see warnings and precautions ( 5.8 )] ⢠hyponatremia [see warnings and precautions ( 5.9 )] ⢠sexual dysfunction [see warnings and precautions ( 5.10 )] most common adverse reaction (incidence ⥠5% and twice placebo) is ejaculation d
Read more...isorder (primarily ejaculation delay) ( 6.1 ) . to report suspected adverse reactions, contact torrent pharma inc . at 1-800-912-9561 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Drug Interactions:
7 drug interactions table 5 presents clinically important drug interactions with citalopram. table 5: clinically important drug interactions with citalopram monoamine oxidase inhibitors (maois) clinical impact concomitant use of ssris, including citalopram, and maois increases the risk of serotonin syndrome. intervention citalopram is contraindicated in patients taking maois, including maois such as linezolid or intravenous methylene blue [see dosage and administration ( 2.5 ), contraindications ( 4 ), warnings and precautions ( 5.3 )] . pimozide clinical impact: concomitant use of citalopram with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of qt prolongation and/or ventricular arrhythmias compared to use of citalopram alone [see clinical pharmacology ( 12.2 )]. intervention: citalopram is contraindicated in patients taking pimozide [see contraindications ( 4 ), warnings and precautions ( 5.2 )]. drugs that pro
Read more...long the qtc interval clinical impact: concomitant use of citalopram with drugs that prolong qt can cause additional qt prolongation compared to the use of citalopram alone [see clinical pharmacology ( 12.2 )]. intervention: avoid concomitant use of citalopram with drugs that prolong the qt interval (citalopram is contraindicated in patients taking pimozide) [see contraindications ( 4 ) , warnings and precautions ( 5.2 )]. cyp2c19 inhibitors clinical impact: concomitant use of citalopram with cyp2c19 inhibitors increases the risk of qt prolongation and/or ventricular arrhythmias compared to the use of citalopram alone [see clinical pharmacology ( 12.2 )]. intervention: the maximum recommended dosage of citalopram is 20 mg daily when used concomitantly with a cyp2c19 inhibitor [see dosage and administration ( 2.4 ), warnings and precautions ( 5.2 )]. serotonergic drugs clinical impact: concomitant use of citalopram and other serotonergic drugs increases the risk of serotonin syndrome. intervention: monitor patients for signs and symptoms of serotonin syndrome, particularly during citalopram initiation and dosage increases. if serotonin syndrome occurs, consider discontinuation of citalopram and/or concomitant serotonergic drugs [see warning and precautions ( 5.3 )]. drugs that interfere with hemostasis (antiplatelet agents and anticoagulants) clinical impact: concomitant use of citalopram and an antiplatelet or anticoagulant may potentiate the risk of bleeding. intervention: inform patients of the increased risk of bleeding associated with the concomitant use of citalopram and antiplatelet agents and anticoagulants. for patients taking warfarin, carefully monitor the international normalized ratio [see warning and precautions ( 5.4 )]. cyp2c19 inhibitors : citalopram tablets 20 mg daily is the maximum recommended dosage for patients taking concomitant cyp2c19 inhibitors ( 5.2 , 7 ) .
Use in Specific Population:
8 use in specific populations pregnancy: ssri use, particularly late in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulties, hypotonia, tremor, irritability) in the neonate. ( 8.1 ).
Overdosage:
10 overdosage the following have been reported with citalopram tablet overdosage: seizures, which may be delayed, and altered mental status including coma. cardiovascular toxicity, which may be delayed, including qrs and qtc interval prolongation, wide complex tachyarrhythmias, and torsade de pointes. hypertension most commonly seen, but rarely can see hypotension alone or with coâingestants including alcohol. serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). prolonged cardiac monitoring is recommended in citalopram overdosage ingestions due to the arrhythmia risk. gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a citalopram overdose. consider contacting a poison center (1â800â221â2222) or a medical toxicologist for additional overdosage management recommendations.
Description:
11 description citalopram tablets, usp contain citalopram, a selective serotonin reuptake inhibitor (ssri). citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3Âdihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula: the molecular formula is c 20 h 22 brfn 2 o and its molecular weight is 405.35. citalopram hydrobromide, usp occurs as a fine, white to off-white powder. citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. citalopram, usp 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. citalopram hydrobromide, usp 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. the tablets also contain the following inactive ingredients: copovidone, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch, and titanium dioxide. image description
Clinical Pharmacology:
12 clinical pharmacology
Nonclinical Toxicology:
13 nonclinical toxicology
Clinical Studies:
14 clinical studies the efficacy of citalopram as a treatment for major depressive disorder was established in two placebo-controlled studies (of 4 to 6 weeks duration) in adult outpatients (ages 18 to 66) meeting dsm-iii or dsm-iii-r criteria for major depressive disorder (mdd) (studies 1 and 2). study 1, a 6-week trial in which patients received fixed citalopram doses of 10 mg, 20 mg, 40 mg, and 60 mg daily, showed that citalopram 40 daily and 60 mg daily (1.5 times the maximum recommended daily dosage) was effective as measured by the hamilton depression rating scale (hamd) total score, the primary efficacy endpoint. the hamd-17 is a 17-item, clinician-rated scale used to assess severity of depressive symptoms. scores on the hamd-17 range from 0 to 52, with higher scores indicating more severe depression. this study showed no clear effect of the 10 mg and 20 mg daily doses, and the 60 mg daily dose was not more effective than the 40 mg daily dose. due to the risk of qtc prolongation
Read more... and ventricular arrhythmias, the maximum recommended dosage of citalopram is 40 mg once daily. in study 2, a 4-week, placebo-controlled trial in patients with mdd, the initial dose was 20 mg daily, followed by titration to the maximum tolerated dose or a maximum dose of 80 mg daily (2 times the maximum recommended daily dosage). patients treated with citalopram showed statistically significantly greater improvement than placebo patients on the hamd total score, the primary efficacy endpoint. in three additional placebo-controlled trials in patients with mdd, the difference in response to treatment between patients receiving citalopram and patients receiving placebo was not statistically significant. in two long-term studies, patients with mdd who had responded to citalopram during an initial 6 or 8 weeks of acute treatment were randomized to continuation of citalopram or placebo. in one study, patients received fixed doses of citalopram 20 mg or 40 mg daily and in the second study, patients received flexible doses of citalopram 20 mg daily to 60 mg daily (1.5 times the maximum recommended daily dosage). in both studies, patients receiving continued citalopram treatment experienced statistically significantly lower relapse rates over the subsequent 6 months compared to those receiving placebo. in the fixed-dose study, the decreased rate of depression relapse was similar in patients receiving 20 mg or 40 mg daily of citalopram. due to the risk of qtc prolongation and ventricular arrhythmias, the maximum recommended dosage of citalopram is 40 mg once daily. analyses of the relationship between treatment outcome and age, gender, and race did not suggest any differential responsiveness on the basis of these patient characteristics.
How Supplied:
16 how supplied/storage and handling product: 50090-0892 ndc: 50090-0892-0 30 tablet in a bottle ndc: 50090-0892-1 60 tablet in a bottle ndc: 50090-0892-2 100 tablet in a bottle ndc: 50090-0892-3 90 tablet in a bottle product: 50090-1298 ndc: 50090-1298-0 100 tablet in a bottle ndc: 50090-1298-1 30 tablet in a bottle ndc: 50090-1298-2 90 tablet in a bottle product: 50090-3208 ndc: 50090-3208-0 30 tablet in a bottle ndc: 50090-3208-1 100 tablet in a bottle ndc: 50090-3208-2 90 tablet in a bottle
Information for Patients:
17 patient counseling information advise the patient to read the fda-approved patient labeling (medication guide). suicidal thoughts and behaviors advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see boxed warning, warnings and precautions ( 5.1 )] . qt prolongation and torsade de pointes advise patients to consult their health care provider immediately if they feel faint, lose consciousness, or have heart palpitations. instruct patients to inform their health care provider that they are taking citalopram before taking any new medications [see warnings and precautions ( 5.2 ), drug interactions ( 7 )] . serotonin syndrome caution patients about the risk of serotonin syndrome, particularly with the concomitant use of citalopram with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lith
Read more...ium, tramadol, tryptophan, buspirone, amphetamines, st. johnâs wort, and with drugs that impair metabolism of serotonin (in particular, maois, both those intended to treat psychiatric disorders and also others, such as linezolid). instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see warnings and precautions ( 5.3 ), drug interactions ( 7 )] . increased risk of bleeding inform patients about the concomitant use of citalopram with aspirin, nsaids, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the counter medications that increase the risk of bleeding [see warnings and precautions ( 5.4 )] . activation of mania or hypomania advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see warnings and precautions ( 5.5 )] . discontinuation syndrome advise patients not to abruptly discontinue citalopram and to discuss any tapering regimen with their healthcare provider. inform patients that adverse reactions can occur when citalopram is discontinued [see warnings and precautions ( 5.6 )] . sexual dysfunction advise patients that use of citalopram may cause symptoms of sexual dysfunction in both male and female patients. inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see warnings and precautions ( 5.10 )] . pregnancy advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with citalopram [see use in specific populations ( 8.1 )] . advise patients that citalopram use late in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension of the newborn (pphn) [see use in specific populations ( 8.1 )] . advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to citalopram during pregnancy [see use in specific populations ( 8.1 )] . lactation advise breastfeeding women to monitor infants for excess sedation, restlessness, agitation, poor feeding and poor weight gain and to seek medical care if they notice these signs [see use in specific populations ( 8.2 )] . manufactured by: torrent pharmaceuticals ltd., india. manufactured for: torrent pharma inc., basking ridge, nj 07920 8088041 revised july 2022 image description
Package Label Principal Display Panel:
Citalopram hydrobromide label image
Citalopram hydrobromide label image
Citalopram hydrobromide label image