What is Celexa (Citalopram)?

What is Celexa (Citalopram)?
Celexa (Citalopram) is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). It affects a naturally occuring chemical in the brain called serotonin, which helps to improve certain mood problems, but may become unbalanced and cause depression.Celexa (Citalopram) is used to treat depression.Celexa (Citalopram) may also be used for purposes other than those listed in this medication guide.

Important information about Celexa (Citalopram)
Do not take Celexa (Citalopram) together with a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take Celexa (Citalopram). After you stop taking this medication, you must wait at least 14 days before you start taking an MAOI.You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment with Celexa (Citalopram).Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Some antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking Celexa (Citalopram), do not stop taking the medication without first talking to your doctor.
 

Before taking Celexa (Citalopram)
Do not use Celexa (Citalopram) if you are using an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam). Serious and sometimes fatal reactions can occur when these medicines are taken with Celexa (Citalopram). You must wait at least 14 days after stopping an MAO inhibitor before you can take Celexa (Citalopram). After you stop taking this medication, you must wait at least 14 days before you start taking an MAOI.Before taking this medicine, tell your doctor if you are allergic to any drugs, or if you have:liver or kidney disease; seizures or epilepsy;bipolar disorder (manic depression); ora history of drug abuse or suicidal thoughts.If you have any of these conditions, you may need a dose adjustment or special tests to safely take Celexa (Citalopram).

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment with Celexa (Citalopram).FDA pregnancy category C. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking this medication, do not stop taking the medication without first talking to your doctor. Celexa (Citalopram) can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to anyone younger than 18 years old without the advice of a doctor.

How should I take Celexa (Citalopram)?
Take Celexa (Citalopram) exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from the medication.Try to take Celexa (Citalopram) at the same time each day. Follow the directions on your prescription label.To be sure you get the correct dose of liquid Celexa (Citalopram), measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.It may take 4 weeks or longer before you start feeling better. Do not stop using Celexa (Citalopram) without first talking to your doctor. You may have unpleasant side effects if you stop taking Celexa (Citalopram) suddenly.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention if you think you have taken too much of Celexa (Citalopram). Symptoms of a Celexa (Citalopram) overdose may include nausea, vomiting, tremor, sweating, rapid heartbeat, confusion, dizziness, seizures, and coma.

What should I avoid while taking Celexa (Citalopram)?
Avoid drinking alcohol, which can increase some of the side effects of Celexa (Citalopram).Celexa (Citalopram) can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety). They can add to sleepiness caused by Celexa (Citalopram).


Side effects of Celexa (Citalopram) 
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.Call your doctor at once if you have any of these serious side effects:very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats, tremors, overactive reflexes;nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; orheadache, trouble concentrating, memory problems, weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops.


Less serious Celexa (Citalopram) side effects may include:
drowsiness;sleep problems (insomnia);mild nausea, gas, upset stomach;weight changes;urinating more than usual;decreased sex drive, impotence, or difficulty having an orgasm;dry or watery mouth, yawning; orcold symptoms such as stuffy nose, sneezing, sore throat.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Celexa (Citalopram)?
Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin and NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with Celexa (Citalopram) may cause you to bruise or bleed easily.

Before taking Celexa (Citalopram), tell your doctor if you are using any of the following medicines:
carbamazepine (Tegretol); cimetidine (Tagamet);lithium (Lithobid, Eskalith);a blood thinner such as warfarin (Coumadin);any other antidepressants such as amitriptyline (Elavil), esCelexa (Citalopram) (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), or sertraline (Zoloft); oralmotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig).If you are using any of these drugs, you may not be able to use Celexa (Citalopram), or you may need dosage adjustments or special tests during treatment.There may be other drugs not listed that can affect Celexa (Citalopram). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Xeljanz Helps in RA Before or After Anti-TNF

Numerically more biologic-naive patients responded to the JAK inhibitor

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• by Nancy Walsh 
  Senior Staff Writer, MedPage Today

Action Points

Oral tofacitinib (Xeljanz) was an effective treatment for rheumatoid arthritis (RA) in patients who had previously received biologic therapies and also in those who were biologic-naive, although numerically more biologic-naive patients responded in the drug's clinical trials, researchers said.

Pooled data from nine trials showed that, at 3 months, scores on the Clinical Disease Activity Index (CDAI) among biologic-naive patients were below 10, indicating low disease activity, in 14.3% (95% CI 11.5 to 17.4) of patients on placebo compared with 32.4% (95% CI 29.5 to 35.4) of those receiving 5 mg tofacitinib twice daily and 39.8% (95% CI 36.8 to 42.9) of those on 10 mg twice daily (P<0.0001 versus placebo), according to Christina Charles-Schoeman, MD, of the University of California Los Angeles, and colleagues.

And among those who had previously had an incomplete response to biologic treatment, low disease activity was achieved by 14.4% (95% CI 9.4 to 20.6), 29.5% (95% CI 23.8 to 35.8), and 35.9% (95% CI 29.7 to 42.5) of the placebo, 5 mg, and 10 mg dose groups, respectively. While the two active treatment groups had greater responses than placebo (P<0.001 and P<0.0001), the 95% confidence intervals overlapped, the researchers reported online in Annals of the Rheumatic Diseases.

Data have been lacking on comparative efficacy of biological therapies for RA among patients who have not yet received any of these agents and those who have previously had an inadequate response to agents such as tumor necrosis factor (TNF) inhibitors, meaning they stopped the treatment because of a lack of efficacy or because of adverse events.

"It is important that new RA therapies demonstrate efficacy and tolerability in RA patient populations with varying disease duration and prior treatment exposure to reflect the variability seen in clinical practice," wrote Charles-Schoeman and colleagues.

Tofacitinib differs from most of the newer RA treatments in that it is a small molecule JAK inhibitor rather than a biologic. To see how its efficacy and safety compare among biologic-naive and inadequate responders, the researchers analyzed data from four phase II and fivephase III studies that evaluated the drug as monotherapy or in combination with conventional disease-modifying anti-rheumatic drugs such as methotrexate.

In these studies, 1,071 biologic-naive patients received 5 mg tofacitinib twice daily, while 1,090 received 10 mg twice daily, and 651 were given placebo.

In the biologics inadequate responder group, the corresponding numbers were 259, 253, and 193, respectively.

Baseline demographics across the treatment groups were generally comparable, according to the authors.

In analyses that simply compared the efficacy of tofacitinib versus placebo, regardless of previous biologic exposure, outcomes favored the active treatment.

Compared with placebo, significantly more patients receiving the 5 mg dose of tofacitinib achieved 50% and 70% responses according to the criteria of the American College of Rheumatology (ACR50 and ACR70). Among the biologic-naive, 32.7% had ACR50 responses and 12.9% had ACR70 responses, while among inadequate responders the numbers were 24.4% and 9.7%, respectively.

Similarly, improvements in Disease Activity Score in 28 joints (DAS28) and on the Health Assessment Questionnaire Disability Index were greater among the patients receiving 5 mg of tofacitinib twice daily compared with placebo (P<0.05).

However, when comparing the efficacy according to previous biologic status, only numerical differences were found. For instance, DAS28 responses of 3.2 or lower (low disease activity) were achieved at 6 months by 16.3% (95% CI 13.9 to 19) of patients receiving 5 mg in the biologic-naive group and by 18.3% (95% CI 13.5 to 24) of inadequate responders.

For those given 10 mg twice daily, that degree of DAS28 response was seen among 23.3% (95% CI 20.5 to 26.2) of biologic-naive patients and by 23.0% (95% CI 17.6 to 29.1) of the biologic inadequate responders.

As in most of the efficacy endpoints, there were overlapping 95% CIs.

A few exceptions to the numerical superiority for biologic-naive patients were seen, such as in ACR20 responses at 3 months for both the 5 and 10-mg groups.

Another exception was the subgroup of patients who had been treated with two or more TNF blockers before receiving tofacitinib. Those patients "generally had poorer efficacy responses than biologic-naive patients and those with one previous TNF inhibitor exposure."

For adverse events, the incidence rates were numerically higher for patients receiving the active treatment compared with placebo.

Discontinuations because of adverse events were seen in 10.1%, 9.1%, and 9.6% of the placebo, 5 mg, and 10 mg groups who were biologic-naive, and for the inadequate responders, in 18.9%, 14.8%, and 15%, respectively.

Serious cases of herpes zoster were seen in none of the placebo patients in either biologic-naive or inadequate responder groups, and in 0.3% of both doses in the biologic-naive group as well as in 0.6% of the 5 mg tofacitinib group but in none of the 10 mg patients.

However, patients who were on concomitant glucocorticoids had higher rates of serious adverse events, herpes zoster, and serious infections, which is consistent with previous reports.

"In summary, tofacitinib was effective in reducing the signs and symptoms of RA when used before or after [biologic therapies]. With a few exceptions, tofacitinib treatment resulted in greater efficacy in biologic-naive versus biologic inadequate responder patients."

And because the safety was similar across subgroups, "these results suggest that tofacitinib provides an effective treatment option for both biologic-naive and biologic inadequate responder patients," the researchers concluded.

A limitation of the study was the pooled analysis of studies with different designs and patient populations.

The study was sponsored by Pfizer. Some co-authors are employees of Pfizer.

Charles-Schoeman and co-authors disclosed relevant relationships with Pfizer.

• Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

New Agent for Female Sexual Dysfunction Has Promise

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• by Ed Susman 
  Contributing Writer, MedPage Today

Action Points

CHICAGO -- The melanocortin-receptor-4-agonist bremelanotide appeared to reduce distress and increase satisfaction among premenopausal women with female sexual dysfunction, researchers reported here.

In phase II studies, a 1.75-mg subcutaneous dose of the experimental bremelanotide lead to a mean reduction of about 1.1 points in Female Sexual Distress Scale-Desire/Arousal/Orgasm score compared with a mean reduction of about 0.6 points among placebo patients (P<0.001), said Sheryl Kingsberg, PhD, from Case Western Reserve University in Cleveland, and colleagues.

Combining the 1.25-mg dose and the 1.75-mg dose, the reduction was about 0.9 points (P<0.01 versus placebo), Kingsberg sad at a poster presentation at the American College of Obstetricians and Gynecologistsannual meeting.

"There are no approved drugs for hypoactive sexual desire disorder in women," she told MedPage Today.

"Female sexual dysfunction is a class of disorders that constitute the most prominent sexual disorders in women," she went on to explain. "You could still have sex and it would be pleasurable, but it is about wanting sex."

In a companion study that specifically looked at hypoactive sexual desire disorder, David Portman, MD, director of the Columbus Center for Women's Health Research in Ohio, said that treatment with bremelanotide resulted in women boosting the number of satisfactory sexual events in a month.

The study by Kingsberg's group focused on the evaluation of how at-home, self-administered bremelanotide relieved the stress attached to hypoactive sexual desire.

"The FDA requires that the treatment reduce stress on the Female Sexual Distress Scale-Desire/Arousal/Orgasm," Kingsberg said. "We demonstrated a dose-dependent efficacy for bremelanotide to reduce the distress of feeling bothered by low sexual desire."

The 12-week study had 97 women who were randomized to received placebo, 87 women who were treated with a 0.75 mg dose of bremelanotide, which was a dose that was not more effective than placebo, 75 women who were treated with 1.25 mg of bremelanotide, and 74 women on a high dose of 1.75 mg. The women self-administered the drug on an as-needed basis.

Responder rates for satisfying sexual events were 37% for placebo, 38% for 0.75-mg dose, 48% for 1.25-mg dose, 55% for 1.75-mg dose, and 51% for 1.25-mg and 1.75-mg pooled dose. Responder rates were 45%, 49%, 60%, 69%, and 64%, respectively, on the Female Sexual Distress Scale-Desire/Arousal/Orgasm.

Patients taking bremelanotide reported more nausea, flushing, and headaches than those on placebo. About 5% of the placebo patients and 10% of the 1.75-mg dose of bremelanotide patients withdrew from the study because of adverse events, but the drug was generally well tolerated, Kingsberg said.

"Bremelanotide has finished its phase II studies and designs for phase III are now awaiting approval from the FDA," she said.

In the phase IIB, 24-week study by Portman's group, women self-administered the drug about 45 minutes prior to anticipated sexual activity. Of the 327 participants, the majority had either mixed hypoactive sexual desire disorder and female sexual arousal disorder with a primary diagnosis of hypoactive sexual desire disorder.

The mean change in sexual satisfying events with was increased by 0.3 events per month among the 76 placebo patients; by 0.7 events a month among the 62 women assigned to the 1.75-mg dose (P<0.05); and by 0.7 events per month in the 128 patients in the pooled 1.25-mg and 1.75-mg dose (P<0.05).

"In premenopausal hypoactive sexual desire disorder, subcutaneous bremelanotide yielded improvements across all key hypoactive sexual desire disorder measures with robust dose-dependence attaining statistical significance at 1.75 mg," the authors concluded.

The studies were funded by Palatin Technologies.

Kingsberg disclosed relevant relationships with Palatin Technologies, Sprout Pharmaceuticals, BioSante, Novo Nordisk, Shionogi, Apricus, Emotional Brain, Pfizer, Trimel Pharmaceuticals, and Viveve.

Portman disclosed relevant relationships with Palatin Technologies, Apricus Bioscience, Bayer, Pfizer, Shionogi, and Sprout Pharmaceuticals.

• Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco