Why is Librax not a controlled substance
- Generic name: Citalopram hydrobromide
- Brand Name: Celexa
Pharmacy editor: Dr. med. Melissa Conrad Stöppler
What is Celexa?
Celexa (citalopram hydrobromide) is a type of antidepressant called a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of depression. Celexa is available in generic make up.
What are the side effects of Celexa?
Common side effects of Celexa are:
- Stomach problems,
- decreased sexual desire,
- Difficulty having an orgasm,
- Difficulty sleeping (insomnia),
- dry mouth ,
- increased sweating or urination,
- Weight changes and cold symptoms such as nasal congestion,
- Sneezing, sore throat, or
- To cough.
Dosage for Celexa
The recommended dose of Celexa should be administered as a starting dose of 20 mg once a day, increasing to a maximum of 40 mg / day. The dose should normally be increased in 20 mg increments at intervals of at least one week.
Tylenol cold and flu side effects
Which drugs, substances or dietary supplements interact with Celexa?
Celexa may interact with other drugs that may make you sleepy or slow your breathing, such as:
- Sleeping pills,
- Muscle relaxants,
- Medicine for anxiety, depression, or seizures,
- nonsteroidal anti-inflammatory drugs (NSAIDs),
- other antidepressants,
- Johannis herbs ,
- Arsenic trioxide,
- Anti-malaria drugs,
- Blood thinner,
- Heart rhythm medication,
- HIV or AIDS medication,
- Medicine to prevent or treat nausea and vomiting,
- Drugs used to treat psychiatric disorders,
- Migraine medication,
- Seizure medication or
- Gastric acid reducer
Let your doctor know about all medications and supplements you use.
Use of Celexa in children
Safe use of Celexa for use by children has not been established.
Celexa during pregnancy and breastfeeding
When treating pregnant women with Celexa during the third trimester, the doctor should carefully weigh the potential risks and benefits of treatment. The doctor may consider tapering Celexa in the third trimester. Celexa passes into breast milk and can harm a breastfeeding baby. Breastfeeding while using Celexa is not recommended.
additional informationOur Celexa Side Effects Drug Center provides a comprehensive overview of the drug information available about the possible side effects of taking this drug.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.Celexa consumer information
Get emergency medical help if you have Signs of an allergic reaction: Rash or hives; Difficulty breathing; Swelling of the face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor B. Changes in mood or behavior, anxiety, panic attacks, insomnia or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts of suicide or injury to yourself.
Call your doctor right away if you:
- a light-headed feeling, as if you might pass out;
- blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Headache with chest pain and being very dizzy, faint, fast or pounding heartbeat;
- severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeat, tremors, fainting;
- high levels of serotonin in the body - agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; or
- low levels of sodium in the body - Headache, confusion, blurred speech, severe weakness, vomiting, insecurity.
Common side effects can include:
- Problems with memory or concentration;
- Headache, drowsiness;
- dry mouth, increased sweating;
- Numbness or tingling sensation;
- increased appetite, nausea, diarrhea, gas;
- fast heartbeat, shaky;
- Difficulty sleeping (insomnia), tiredness;
- Cold symptoms such as nasal congestion, sneezing, sore throat;
- Weight changes; or
- Difficulty having orgasm.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Celexa (Citalopram Hydrobromide)Find out more 'Celexa Professional Information
The Celexa premarketing development program included citalopram exposures in patients and / or normal subjects from 3 different study groups: 429 normal subjects in clinical pharmacological / pharmacokinetic studies; 4422 exposures of patients in controlled and uncontrolled clinical studies, corresponding to approximately 1370 years of exposure. In addition, there were over 19,000 exposures from mostly open European post-marketing studies. The conditions and duration of treatment with Celexa varied widely and included (in overlapping categories) open and double blind studies, inpatient and outpatient studies, fixed dose and dose titration studies, and short and long term exposure. Side effects were assessed by collecting adverse events, physical exam results, vital signs, weights, laboratory analysis, EKGs, and ophthalmic exam results.
Side effects of lidocaine trigger point injections
Adverse events during exposure were obtained primarily through general examinations and recorded by clinical investigators using terminology of their choice. As a result, it is not possible to make a meaningful estimate of the proportion of people with adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tables below, standard World Health Organization (WHO) terminology has been used to classify reported adverse events.
The frequencies given indicate the proportion of people who have had a treatment-related adverse event of the listed type at least once. An event was considered treatment-related if it occurred for the first time or if it worsened during therapy after the baseline assessment.
Adverse findings in short-term, placebo-controlled studies
Adverse events related to discontinuation of treatment
Of 1,063 depressed patients who received Celexa at doses of 10 to 80 mg / day in placebo-controlled studies up to 6 weeks in duration, 16% discontinued treatment because of an adverse event, compared with 8% of 446 patients who received placebo received. Withdrawal related adverse events considered drug related (i.e. related to withdrawal in at least 1% of Celexa treated patients at a rate at least twice that of placebo) are in TABLE 2 listed. It should be noted that a patient can report more than one reason for the discontinuation and can be counted several times in this table.
TABLE 2: Treatment Discontinuation Adverse Events in Short Term Placebo Controlled Depression Studies
|Percentage of patients who drop out due to an adverse event|
(N = 1063)
(N = 446)
|Body Svstem / Adverse Event|
|Disorders of the central and peripheral nervous system|
Adverse events with an incidence of 2% or more in Celexa-treated patients
Table 3 shows the incidence of adverse events, rounded to the nearest percentage, that occurred in 1,063 depressed patients receiving Celexa at doses of 10 to 80 mg / day in placebo-controlled studies lasting up to 6 weeks. Includes events that occur in 2% or more of Celexa-treated patients and where the incidence in Celexa-treated patients was higher than the incidence in placebo-treated patients.
The prescribing physician should be aware that these numbers cannot be used to predict the occurrence of adverse events in the course of normal medical practice when patient characteristics and other factors differ from those prevalent in clinical trials. Similarly, the frequencies reported cannot be compared to numbers obtained from other clinical studies with different treatments, uses, and investigators. However, the figures presented provide a basis for the prescriber to estimate the relative contribution of drug and non-drug factors to the incidence rate of adverse events in the population studied.
The only commonly observed adverse event that occurred in Celexa patients with an incidence of 5% or more and at least twice the incidence in placebo patients was ejaculation disorder (mainly ejaculation delay) in males (see TABLE 3).
TABLE 3: Treatment Adverse Events: Incidence in Placebo-Controlled Clinical Trials *
|Body system / adverse event||(Percentage of patients reporting an event)|
(N = 1063)
(N = 446)
|Autonomous disorders of the nervous system|
|Disorders of the central and peripheral nervous system|
|Upper respiratory tract infections||5%||4%|
|* Events reported by at least 2% of Celexa treated patients are reported, with the exception of the following events where placebo ≥ Celexa: headache, asthenia, dizziness, constipation, palpitations, visual disturbances, insomnia, nervousness, pharyngitis, urination disorders, back pain. |
1The denominator used was only for women (N = 638 Celexa; N = 252 placebo).
twoMainly ejaculation delay.
3The denominator used was for men only (N = 4 25 Celexa; N = 194 placebo).
Dose dependence of adverse events
The possible relationship between the dose of Celexa administered and the frequency of adverse events was investigated in a fixed-dose study in depressed patients who received placebo or Celexa 10, 20, 40 and 60 mg. Jonckheere's trend test showed a positive dose reaction (p.
In depressed patients receiving Celexa, the reported incidence of decreased libido and anorgasmia were 1.3% (n = 638 women) and 1.1% (n = 252 women), respectively.
What doses does Xanax come in?
There are insufficiently designed studies investigating sexual dysfunction with citalopram treatment.
Priapism was reported with all SSRIs.
While it is difficult to know the exact risk of sexual dysfunction associated with the use of SSRIs, doctors should routinely ask about such possible side effects.
Vital sign changes
Celexa and placebo groups were compared for (1) the mean change from baseline in vital signs (pulse, systolic blood pressure, and diastolic blood pressure) and (2) the incidence of patients who met criteria for potentially clinically significant changes from baseline fulfilled variables. These analyzes did not reveal any clinically important changes in vital functions associated with Celexa treatment. In addition, a comparison of supine and standing vital signs for Celexa and placebo treatments revealed that Celexa treatment was not associated with orthostatic changes.
Patients treated with Celexa in controlled studies showed approximately 0.5 kg weight loss compared with no change in placebo patients.
Celexa and placebo groups were compared for (1) the 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 in these variables from baseline . These analyzes did not reveal any clinically important changes in laboratory test parameters associated with Celexa treatment.
In a thorough QT study, Celexa was found to be associated with a dose-dependent increase in the QTc interval (see WARNINGS - - QT extension and torsade de pointes ).
Electrocardiograms from Celexa (N = 802) and placebo groups (N = 241) were compared for outliers defined as subjects with QTc changes over 60 ms from baseline or absolute values over 500 ms after dose, and subjects with heart rate increases to over 100 beats per minute or drops to less than 50 beats per minute with a change of 25% compared to the initial value (tachycardic or bradycardic outliers). In the Celexa group, 1.9% of patients had a change in QTcF> 60 ms from baseline compared to 1.2% of patients in the placebo group. None of the patients in the placebo group had QTcF> 500 ms after the dose compared to 0.5% of the patients in the Celexa group. The incidence of tachycardial outliers was 0.5% in the Celexa group and 0.4% in the placebo group. The incidence of bradycardial outliers was 0.9% in the Celexa group and 0.4% in the placebo group.
Other events observed during the premarketing evaluation of Celexa (Citalopram HBr)
The following is a list of WHO terms reflecting treatment-related adverse events, as defined in the introduction to the SIDE EFFECTS section, reported by patients taking Celexa at multiple doses ranging from 10 to 80 mg / day for one Any phase of a study within the premarketing database of 4422 patients were treated. All reported events are included except for those already listed in Table 3 or elsewhere on the label, events for which a drug cause was removed, event terms that were so general that they were not meaningful, and of events that only occurred in one patient. It is important to emphasize that although the reported events occurred during treatment with Celexa, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: Common adverse events occur once or more than once in at least 1/100 of the patient; rare adverse events occur in less than 1/100 patients but at least 1/1000 patients; rare events occur in less than 1/1000 patients.
Cardiovascular-Often : Tachycardia, postural hypotension, hypotension. Rare : Hypertension, bradycardia, edema (extremities), angina pectoris, extrasystoles, heart failure, flushing, myocardial infarction, cerebrovascular accident, myocardial ischemia. Rare : transient ischemic attack, phlebitis, atrial fibrillation, cardiac arrest, bundle branch block.
Disorders of the central and peripheral nervous system -Often : Paresthesia, migraines. Rare : Hyperkinesia, dizziness, hypertension, 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 -Often : Increased saliva, flatulence. Rare : Gastritis, gastroenteritis, stomatitis, belching, hemorrhoids, dysphagia, teeth grinding, gingivitis, esophagitis. Rare : Colitis, gastric ulcer, cholecystitis, cholelithiasis, duodenal ulcer, gastroesophageal reflux, glossitis, jaundice, diverticulitis, rectal hemorrhage, hiccups.
General -Rare : Hot flashes, rigor, intolerance to alcohol, syncope, flu-like symptoms. Rare : Hay fever.
Hemic and Lymphatic Disorders -Rare : Purpura, anemia, epistaxis, leukocytosis, leukopenia, lymphadenopathy. Rare : Pulmonary embolism, granulocytopenia, lymphocytosis, lymphopenia, hypochromic anemia, coagulation disorder, bleeding gums.
Metabolism and nutrition disorders -Often : decreased weight, increased weight. Rare : increased liver enzymes, thirst, dry eyes, increased alkaline phosphatase, abnormal glucose tolerance. Rare : Bilirubinemia, hypokalemia, obesity, hypoglycemia, hepatitis, dehydration.
Musculoskeletal disorders -Rare : Arthritis, muscle weakness, skeletal pain. Rare : Bursitis, osteoporosis.
Mental disorders -Often : Difficulty concentrating, amnesia, apathy, depression, increased appetite, increased depression, attempted suicide, confusion. Rare : increased libido, aggressive reaction, paroniria, drug addiction, depersonalization, hallucination, euphoria, psychotic depression, delusion, paranoid reaction, emotional lability, panic reaction, psychosis. Rare : catatonic reaction, melancholy.
Reproductive disorders / female * - - Often : Amenorrhea. Rare : Galactorrhea, chest pain, breast enlargement, vaginal bleeding.
*% only for female subjects: 2955
Respiratory diseases -Often : To cough. Rare : Bronchitis, shortness of breath, pneumonia. Rare : Asthma, laryngitis, bronchospasm, pneumonitis, sputum increased.
Skin and appendix disorders -Often : Rash, itching. Rare : Photosensitivity reaction, urticaria, acne, skin discoloration, eczema, alopecia, dermatitis, dry skin, psoriasis. Rare : Hypertrichosis, decreased sweating, melanosis, keratitis, cellulitis, pruritus ani.
Special senses -Often : Accommodation abnormal, taste perversion. Rare : Tinnitus, conjunctivitis, eye pain. Rare : Mydriasis, photophobia, diplopia, abnormal lacrimation, cataract, loss of taste.
Urinary system disorders -Often : Polyuria. Rare : Micturition frequency, urinary incontinence, urinary retention, dysuria. Rare : Facial edema, hematuria, oliguria, pyelonephritis, kidney stone, kidney pain.
Other events observed during the post-marketing evaluation of Celexa (Citalopram HBr)
It is estimated that over 30 million patients have been treated with Celexa since it was launched. Although no causal relationship with Celexa treatment has been established, the following adverse events have been reported to be temporally related to Celexa treatment and not described elsewhere on the label: acute renal failure, akathisia, allergic reaction, anaphylaxis, angioedema , Choreoathetosis, chest pain, delirium, dyskinesia, ecchymosis, epidermal necrolysis, erythema multiforme, gastrointestinal bleeding, angular glaucoma, grand mal convulsions, hemolytic anemia, liver necrosis, myoclonus, nystagmus, pancreatitis, priapism, pancreatitis, priapism, Spontaneous abortion, thrombocytopenia, thrombosis, ventricular arrhythmia, torsade de pointes and withdrawal syndrome.
Substance Abuse and Dependence
Controlled class of substances
Celexa (Citalopram HBr) is not a controlled substance.
Physical and psychological addiction
Animal studies suggest that Celexa's liability for abuse is low. Celexa has not been systematically evaluated for its potential for abuse, tolerance, or physical dependence in humans. Pre-marketing clinical experience with Celexa revealed no drug search behavior. However, these observations have not been systematic and it is not possible, based on this limited experience, to predict the extent to which a CNS active drug will be abused, diverted and / or abused once it has been marketed. Consequently, doctors should carefully screen Celexa patients for a history of drug abuse and monitor these patients closely for signs of abuse or abuse (e.g., tolerance development, dose increases, drug addiction behavior).
Read full FDA prescribing information for Celexa (Citalopram Hydrobromide)
Sertraline hydrochloride 100 mg side effectsRead more '' Related Resources for Celexa
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Read the Celexa User Reviews »
Celexa patient information is provided by Cerner Multum, Inc. and Celexa consumer information is provided by First Databank, Inc., all of which are used under license and are subject to their respective copyrights.
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