Citalopram Hydrobromide description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Home SubjectClassCompaniesIngredientsNames A-Z
Search
Home – Citalopram Hydrobromide

Citalopram Hydrobromide

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

Suicidality and Antidepressant Drugs

WARNINGS: Clinical Worsening and Suicide RiskPRECAUTIONS: Information for PatientsPRECAUTIONS: Pediatric Use

CITALOPRAM HYDROBROMIDE DESCRIPTION



Citalopram Hydrobromide




CLINICAL PHARMACOLOGY


PHARMACODYNAMICS




PHARMACOKINETICS



Absorption and Distribution


Metabolism and Elimination




Population Subgroups

Age


Gender


Reduced hepatic function


Reduced renal function


Drug-Drug Interactions



Clinical Efficacy Trials




Comparison of Clinical Trial Results


INDICATIONS & USAGE






CITALOPRAM HYDROBROMIDE CONTRAINDICATIONS





WARNINGS

Clinical Worsening and Suicide Risk













Screening Patients for Bipolar Disorder


Potential for Interaction With Monoamine Oxidase Inhibitors


Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like Reactions




PRECAUTIONS

General

Discontinuation of Treatment With Citalopram



Abnormal Bleeding



Hyponatremia



Activation of Mania/Hypomania


Seizures


Interference With Cognitive and Motor Performance


Use in Patients With Concomitant Illness





INFORMATION FOR PATIENTS













Clinical Worsening and Suicide Risk


LABORATORY TESTS



DRUG INTERACTIONS

Serotonergic Drugs


Triptans


CNS Drugs


Alcohol


Monoamine Oxidase Inhibitors (MAOIs)


Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.)


Cimetidine


Digoxin


Lithium


Pimozide


Theophylline


Sumatriptan


Warfarin


Carbamazepine


Triazolam


Ketoconazole


CYP3A4 and 2C19 Inhibitors


Metoprolol


Imipramine and Other Tricyclic Antidepressants (TCAs)


Electroconvulsive Therapy (ECT)


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis


Mutagenesis


Impairment of Fertility


PREGNANCY





Nonteratogenic Effects



LABOR & DELIVERY



NURSING MOTHERS


Nursing Mothers


PEDIATRIC USE



GERIATRIC USE







CITALOPRAM HYDROBROMIDE ADVERSE REACTIONS





Adverse Findings Observed in Short-Term, Placebo-Controlled Trials

Adverse Events Associated With Discontinuation of Treatment



Percentage of Patients DiscontinuingDue to Adverse EventBody System/Adverse EventCitalopramPlacebo(N = 1063)(N = 446)GeneralGastrointestinal DisordersCentral and Peripheral Nervous System DisordersPsychiatric Disorders
Adverse Events Occurring at an Incidence of 2% or More Among Citalopram-Treated Patients




*
(Percentage of Patients Reporting Event)Body System/CitalopramPlaceboAdverse Event(N = 1063)(N = 446)Autonomic Nervous System DisordersCentral & Peripheral Nervous System DisordersGastrointestinal DisordersGeneralMusculoskeletal System DisordersPsychiatric DisordersRespiratory System DisordersUrogenital*




Dose Dependency of Adverse Events
The potential relationship between the dose of citalopram administered and the incidence of adverse events was examined in a fixed-dose study in depressed patients receiving placebo or citalopram 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
Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that SSRIs can cause such untoward sexual experiences.
Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling, are likely to underestimate their actual incidence.
The table below displays the incidence of sexual side effects reported by at least 2% of patients taking citalopram in a pool of placebo-controlled clinical trials in patients with depression.

TreatmentCitalopramPlacebo(425 males)(194 males)Abnormal Ejaculation6.1%1%(mostly ejaculatory delay)(males only)(males only)Libido Decreased3.8%< 1%(males only)(males only)Impotence2.8%< 1%(males only)(males only)In female depressed patients receiving citalopram, the reported incidence of decreased libido and anorgasmia was 1.3% (n = 638 females) and 1.1% (n = 252 females), respectively.
There are no adequately designed studies examining sexual dysfunction with citalopram treatment.
Priapism has been reported with all SSRIs.
While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.

Vital Sign Changes
Citalopram 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 citalopram treatment. In addition, a comparison of supine and standing vital sign measures for citalopram and placebo treatments indicated that citalopram treatment is not associated with orthostatic changes.

Weight Changes
Patients treated with citalopram in controlled trials experienced a weight loss of about 0.5 kg compared to no change for placebo patients.

Laboratory Changes
Citalopram 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 citalopram treatment.

ECG Changes
Electrocardiograms from citalopram (N = 802) and placebo (N = 241) groups were compared with respect to (1) mean change from baseline in various ECG parameters, and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. The only statistically significant drug-placebo difference observed was a decrease in heart rate for citalopram of 1.7 bpm compared to no change in heart rate for placebo. There were no observed differences in QT or other ECG intervals.

Other Events Observed During the Premarketing Evaluation of Citalopram HBr
Following is a list of WHO terms that reflect treatment-emergent adverse events, as defined in the introduction to the ADVERSE REACTIONS section, reported by patients treated with citalopram at multiple doses in a range of 10 to 80 mg/day during any phase of a trial within the premarketing database of 4422 patients. All reported events are included except those already listed in TABLE 3 or elsewhere in labeling, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and those occurring in only one patient. It is important to emphasize that, although the events reported occurred during treatment with citalopram, they were not necessarily caused by it.
Cardiovascular - Frequent: tachycardia, postural hypotension, hypotension. Infrequent: hypertension, bradycardia, edema (extremities), angina pectoris, extrasystoles, cardiac failure, flushing, myocardial infarction, cerebrovascular accident, myocardial ischemia. Rare: transient ischemic attack, phlebitis, atrial fibrillation, cardiac arrest, bundle branch block.
Central and Peripheral Nervous System Disorders - Frequent: paresthesia, migraine. Infrequent: hyperkinesia, vertigo, hypertonia, extrapyramidal disorder, leg cramps, involuntary muscle contractions, hypokinesia, neuralgia, dystonia, abnormal gait, hypesthesia, ataxia. Rare: abnormal coordination, hyperesthesia, ptosis, stupor.
Endocrine Disorders - Rare: hypothyroidism, goiter, gynecomastia.
Gastrointestinal Disorders - Frequent: saliva increased, flatulence. Infrequent: gastritis, gastroenteritis, stomatitis, eructation, hemorrhoids, dysphagia, teeth grinding, gingivitis, esophagitis. Rare: colitis, gastric ulcer, cholecystitis, cholelithiasis, duodenal ulcer, gastroesophageal reflux, glossitis, jaundice, diverticulitis, rectal hemorrhage, hiccups.
General - Infrequent: hot flushes, rigors, alcohol intolerance, syncope, influenza-like symptoms. Rare: hay fever.
Hemic and Lymphatic Disorders - Infrequent: purpura, anemia, epistaxis, leukocytosis, leucopenia, lymphadenopathy. Rare: pulmonary embolism, granulocytopenia, lymphocytosis, lymphopenia, hypochromic anemia, coagulation disorder, gingival bleeding.
Metabolic and Nutritional Disorders - Frequent: decreased weight, increased weight. Infrequent: increased hepatic enzymes, thirst, dry eyes, increased alkaline phosphatase, abnormal glucose tolerance. Rare: bilirubinemia, hypokalemia, obesity, hypoglycemia, hepatitis, dehydration.
Musculoskeletal System Disorders - Infrequent: arthritis, muscle weakness, skeletal pain. Rare: bursitis, osteoporosis.
Psychiatric Disorders - Frequent: impaired concentration, amnesia, apathy, depression, increased appetite, aggravated depression, suicide attempt, confusion. Infrequent: increased libido, aggressive reaction, paroniria, drug dependence, depersonalization, hallucination, euphoria, psychotic depression, delusion, paranoid reaction, emotional lability, panic reaction, psychosis. Rare: catatonic reaction, melancholia.
Reproductive Disorders/Female* - Frequent: amenorrhea. Infrequent: galactorrhea, breast pain, breast enlargement, vaginal hemorrhage.
* % based on female subjects only: 2955
Respiratory System Disorders - Frequent: coughing. Infrequent: bronchitis, dyspnea, pneumonia. Rare: asthma, laryngitis, bronchospasm, pneumonitis, sputum increased.
Skin and Appendages Disorders - Frequent: rash, pruritus. Infrequent: photosensitivity reaction, urticaria, acne, skin discoloration, eczema, alopecia, dermatitis, skin dry, psoriasis. Rare: hypertrichosis, decreased sweating, melanosis, keratitis, cellulitis, pruritus ani.
Special Senses - Frequent: accommodation abnormal, taste perversion. Infrequent: tinnitus, conjunctivitis, eye pain. Rare: mydriasis, photophobia, diplopia, abnormal lacrimation, cataract, taste loss.
Urinary System Disorders - Frequent: polyuria. Infrequent: micturition frequency, urinary incontinence, urinary retention, dysuria. Rare: facial edema, hematuria, oliguria, pyelonephritis, renal calculus, renal pain.

Other Events Observed During the Postmarketing Evaluation of Citalopram HBr
It is estimated that over 30 million patients have been treated with citalopram since market introduction. Although no causal relationship to citalopram treatment has been found, the following adverse events have been reported to be temporally associated with citalopram 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, 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.

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class


Physical and Psychological Dependence


OVERDOSAGE

Human Experience



Management of Overdose



DOSAGE & ADMINISTRATION

Initial Treatment



Special Populations



Treatment of Pregnant Women During the Third Trimester


Maintenance Treatment


Discontinuation of Treatment With Citalopram Tablets USP


Switching Patients to or From a Monoamine Oxidase Inhibitor


STORAGE AND HANDLING




ANIMAL PHARMACOLOGY & OR TOXICOLOGY

Retinal Changes in Rats



Cardiovascular Changes in Dogs


SPL MEDGUIDE

MEDICATION GUIDE



  • ●all risks and benefits of treatment with antidepressant medicines
  • ●all treatment choices for depression or other serious mental illness
  • ●What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?




  • ●Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • ●Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
  • ●Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  • ●attempts to commit suicide
  • ●new or worse depression
  • ●new or worse anxiety
  • ●feeling very agitated or restless
  • ●panic attacks
  • ●trouble sleeping (insomnia)
  • ●new or worse irritability
  • ●acting aggressive, being angry, or violent
  • ●acting on dangerous impulses
  • ●an extreme increase in activity and talking (mania)
  • ●other unusual changes in behavior or mood
  • ●What else do I need to know about antidepressant medicines?

  • ●Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • ●Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • ●Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • ●Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.
  • ●Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Citalopram Hydrobromide



Citalopram Hydrobromide



Citalopram Hydrobromide

Citalopram Hydrobromide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-192(NDC:13668-011)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
citalopram hydrobromide CITALOPRAM 40 mg

Inactive Ingredients

Ingredient Name Strength
COPOVIDONE
STARCH, CORN
CROSCARMELLOSE SODIUM
lactose monohydrate
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
cellulose, microcrystalline
PEG-8 DIOLEATE
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white 11 mm 4;0;1011 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-192-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078216 2011-04-20


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.
Designed by Tank
Developed by KB.MD