DESCRIPTION
BOXED WARNING SECTION
DESCRIPTION
Citalopram hydrobromide 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 hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, hydrobromide with the following structural formula:
The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available as tablets. Citalopram 10 mg tablets are biconvex, round shaped film coated tablets in strengths equivalent to 10 mg citalopram base. Citalopram 20 mg and 40 mg tablets are scored biconvex capsule shaped film coated tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets.
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
Citalopram tablets are indicated for the treatment of depression. The efficacy of citalopram tablets 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 CLINICAL PHARMACOLOGY). 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 citalopram tablets in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram tablets 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 CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
CONTRAINDICTIONS
Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see WARNINGS). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS). Citalopram tablets are contraindicated in patients with a hypersensitivity to citalopram or any of the inactive ingredients in citalopram tablets.
WARNINGS
| Increases Compared to Placebo | |
| Less than 18 | 14 additional cases |
| 18-24 | 5 additional cases |
| Decreases Compared to Placebo | |
| 25-64 | 1 fewer case |
| Greater than or equal to 65 | 6 fewer cases |
PRECAUTIONS
ADVERSE REACTIONS
The premarketing development program for citalopram tablets 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 citalopram tablets 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.
| General | ||
| Asthenia | 1% | less than 1% |
| Gastrointestinal Disorders | ||
| Nausea | 4% | 0% |
| Dry Mouth | 1% | less than 1% |
| Vomiting | 1% | 0% |
| Central and Peripheral Nervous System Disorders | ||
| Dizziness | 2% | less than 1% |
| Psychiatric Disorders | ||
| Insomnia | 3% | 1% |
| Somnolence | 2% | 1% |
| Agitation | 1% | less than 1% |
| (Percentage of Patients | Reporting Event) | |
| Body System/Adverse Event | Citalopram Tablets(N=1063) | Placebo (N=446) |
| Autonomic NervousSystem Disorders | ||
| Dry Mouth | 20% | 14% |
| Sweating Increased | 11% | 9% |
| Central and PeripheralNervous 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% | less than 1% |
| Musculoskeletal SystemDisorders | ||
| Arthralgia | 2% | 1% |
| Myalgia | 2% | 1% |
| Psychiatric Disorder | ||
| Somnolence | 18% | 10% |
| Insomnia | 15% | 14% |
| Anxiety | 4% | 3% |
| Anorexia | 4% | 2% |
| Agitation | 3% | 1% |
| Dysmenorrhea (1) | 3% | 2% |
| Libido Decreased | 2% | less than 1% |
| Yawning | 2% | less than 1% |
| Respiratory SystemDisorders | ||
| Upper Respiratory Tract Infection | 5% | 4% |
| Rhinitis | 5% | 3% |
| Sinusitis | 3% | less than 1% |
| Urogenital | ||
| Ejaculation Disorder (2,3) | 6% | 1% |
| Impotence (3) | 3% | less than 1% |
| Treatment | Citalopram Tablets(425 males) | Placebo(194 males) |
| Abnormal Ejaculation(mostly ejaculatory delay) | 6.1%(males only) | 1%(males only) |
| Libido Decreased | 3.8%(males only) | less than 1%(males only) |
| Impotence | 2.8%(males only) | less than 1%(males only) |
DRUG ABUSE AND DEPENDENCE
OVERDOSAGE
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
Citalopram tablets are supplied as:10 mg Tablets – Peach coloured, biconvex, round shaped film coated tablets debossed with ‘A’ on one side and ‘05’ on the other side.
20 mg Tablets – Light pink coloured, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘0’ and ‘6’ on other side.
40 mg Tablets – White coloured, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘0’ and ‘7’ on other side.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
| Bottles of 30 | NDC 54868-5275-0 |
| Bottles of 60 | NDC 54868-5275-2 |
| Bottles of 90 | NDC 54868-5275-1 |
| Bottles of 15 | NDC 54868-5178-1 |
| Bottles of 30 | NDC 54868-5178-0 |
| Bottles of 60 | NDC 54868-5178-2 |
| Bottles of 90 | NDC 54868-5178-4 |
| Bottles of 100 | NDC 54868-5178-3 |
| Bottles of 135 | NDC 54868-5178-5 |
| Bottles of 15 | NDC 54868-1239-1 |
| Bottles of 30 | NDC 54868-1239-0 |
| Bottles of 60 | NDC 54868-1239-4 |
| Bottles of 90 | NDC 54868-1239-3 |
| Bottles of 100 | NDC 54868-1239-2 |
ANIMAL TOXICOLOGY
MEDICATION GUIDE
Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions Read the Medication Guide that comes with you or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about:
- all risks and benefits of treatment with antidepressant medicines
- all treatment choices for depression or other serious mental illness