Celexa

August 14, 1999

In a message dated 7/30/99 1:44:26 PM Eastern Daylight Time, pattymcd@...

writes:

> Hi Sharon,

>

> I took 2 doses of Celexa (at bedtime) - for pain & sleeping. I had a

> really weird feeling too - can't explain it exactly, but strange. It

> also affected my vision senses - objects I looked at seem to pulsate!

> UGH! And in the morning, my whole body, especially my hands, trembled.

> I called my LLD and he said to stop the Celexa - some just can't handle

> it and I guess I'm one of them. I hope the weird " feelings " stop for

> you since it is helping so much with your energy.

>

> Patty

Hi Sharon

just curious, how much were you on?

best,

lea

October 20, 1999

In a message dated 10/20/99 7:31:48 PM EDT, mellillo1@... writes:

<< , I used to be the same way on all the other antidepressents,

Effexor too. Went through them all for the past 6 years. Finally, this

spring went on Celexa. I don't cry anymore unless it is a big thing. It is

wonderful! I used to be so embarrassed, I would lose it at the wrong time,

in the wrong place and couldn't stop. Now, even when I brought my precious

daughter to college, I was able to stay in control and only shed a few

tears. I had asked my dr. specifically for something to stop the crying

jags. So maybe you might want to check into it. It also helps the dead

libido problem that many of the antid's give you. I finally have a little

sex drive which I havent' in years.

Congrats on your son's wedding. In this day and age it is nice to see >>

Hi Guys,

Hope everyone is well . I am reading so much about Celexa on here, but am

wondering if any of you who are on celexa have gained any weight from it ??

It sounds great , but I can't afford to gain the weight.

Thanks in advance for your response

October 21, 1999

Actually no, I have not gained weight. But,

then one has to eat to gain weight! I don't

have any hunger at all and eat when my hubby

puts something in front of me and not before.

The only time I had an appetite to speak of

in the last year or so was when I was on the

Rocephin IV and so many symptoms started

changing that were positive. But, cannot get

$^%^^ insurance company to let me have them

again so possibly go into remission. Slowly the

symptoms are returning....but, thus far a bit better

than before. The worst of the symptoms pain,

fatigue (really exhaustion), and difficulty breathing

(asthma) remain unchanged. If it weren't for the

jackass Alan Steere's in this world spewing their

mantra of over diagnosed and over treated, the

people with Lyme Disease would not be refused

the necessary medical treatment we need. Grr....

BearyPrety@... wrote:

> From: BearyPrety@...

>

> In a message dated 10/20/99 7:31:48 PM EDT, mellillo1@... writes:

>

> << , I used to be the same way on all the other antidepressents,

> Effexor too. Went through them all for the past 6 years. Finally, this

> spring went on Celexa. I don't cry anymore unless it is a big thing. It is

> wonderful! I used to be so embarrassed, I would lose it at the wrong time,

> in the wrong place and couldn't stop. Now, even when I brought my precious

> daughter to college, I was able to stay in control and only shed a few

> tears. I had asked my dr. specifically for something to stop the crying

> jags. So maybe you might want to check into it. It also helps the dead

> libido problem that many of the antid's give you. I finally have a little

> sex drive which I havent' in years.

> Congrats on your son's wedding. In this day and age it is nice to see >>

>

> Hi Guys,

> Hope everyone is well . I am reading so much about Celexa on here, but am

> wondering if any of you who are on celexa have gained any weight from it ??

> It sounds great , but I can't afford to gain the weight.

> Thanks in advance for your response

>

> > Send to -Offtopiconelist messages unrelated to lyme, please.

> /archive/lyme-aid

> /archives.cgi/Lyme-Documents

> To unsubscribe, send email to -unsubscribeonelist

> You may substitute " subscribe " , or " digest " or " normal " for

> the word " unsubscribe " ( " normal " is the opposite of " digest " ). Leave blank

both the message and subject header.

October 22, 1999

I swear by low carb. I guess I'm in between Atkins and Protein Power. I

just love it.

Hope it helps you, good luck!!

Anita

[Lyme-aid] celexa

>From: " melillo " <mellillo1@...>

>

>diana, i have not gained weight on the celexa but i have not lost weight

>either. the positive is that i am not crying and eating out of comfort

>seeking. so, maybe in the long run it will help the obsessive urge i have

>to eat.

>interestingly, i started to cut back on carbos this week and it has helped

>my appetite. i saw a blurb on oprah about carbo addicts and thought it

>sounded like me. so i read the book, " carbohydrate addicts diet " by the

>hellers. it made sense for me individually. so i have been trying to

>follow it for a week. i'll let you know how it goes but my hunger is

>diminished. i tried atkins a while ago but it was too much meat!

>i am now on plaquenil and i don't know why but all i want to do is sleep.

i

>slept 14 hours yesterday and could go back to bed now. weird!

>sharon

>

>>Send to -Offtopiconelist messages unrelated to lyme, please.

>/archive/lyme-aid

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>You may substitute " subscribe " , or " digest " or " normal " for

>the word " unsubscribe " ( " normal " is the opposite of " digest " ). Leave blank

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>

April 8, 2000

Hi, connie,

Glad you are feeling better. I hope this will last

elizabeth

April 9, 2000

Thanks ..............I just hope it continues............I felt a

little tired today.............Connie

July 5, 2000

Eliza:

My son takes 40 mg of Celexa, and it seems to work pretty well for him.

Unfortunately, the medication and/or dosage that works for one individual may be

completely ineffective in another. Ditto for BSEs. Aiden had been on 60 mg of

Prozac, the same as my 6'1 " husband -- and he is turning 12 at the end of the

month. I would discuss your concerns with the prescribing physician before

coming to any conclusion. Remember, to be effective in treating OCD, the meds

have to be prescribed in higher doses than in treatment of depression. Also

keep in mind that children have higher metabolic rates than adults and therefore

process the meds quicker -- i.e. they enter and leave the system faster. Hope

this helps.

Jule in Cleveland

November 3, 2000

My son recently titered off Prozac (40 mg.) and on to

Celexa. We started with 20 mg. in the hopes that less

is better. Within a 6 week period and 20 mg. later it

became clear that Celexa was not the way to go for

him. All of his sensory issues returned along with

OCD symptoms that we had not seen in 2 years. We have

not had experience with anafranil yet, so I can't

speak to that medication. We had a VERY HYPERACTIVE

reaction to Paxil. Medication stuff can be so tricky.

I always have to gear myself up for medication

changes...I do not like the fact that my child must

try different medications in order to find the best

combination.

--- Judy Lovchik <jlovchik@...> wrote:

> Jule and others experienced with Celexa:

>

> My 15 yo son is titering up on Celexa and titering

> down on anafranil. After 2 weeks, he is up to 40mg

> Celexa and down to 25mg anafranil. He's very

> depressed and extremely anxious. I added another

> 10mg Celexa yesterday, but he became even worse, so

> I'll stay at 40 awhile longer. Jule, how much

> Celexa is Aiden taking? And how much Wellbutrin and

> Risperodol? I'm going to suggest them to his

> doctor.

>

> Judy

> Re: advice please

>

> Nan:

>

> My son (now 12) had terrible BSE's from Luvox --

> not at first, but after a

> couple months he became oppositional and

> aggressive, something he had NEVER

> been. He was then placed on Prozac with good

> results until it pooped out this

> spring and we had to switch to Celexa. He also

> has ADHD, and depression. In

> unipolar depression people may suffer from

> repeated episodes of depression.

> However, their mood returns to normal at the end

> of an episode of depression.

>

> Aiden also takes Risperdal and Wellbutrin as an

> adjunct to the Celexa. He has a

> great deal of anxiety on top of the ocd, and the

> Risperdal helps to keep him

> under better control. The Wellbutrin is to boost

> the antidepressant effect of

> the Celexa. Currently he is not taking anything

> for the ADHD, although he has

> been on Adderall and Ritalin in the past. I think

> that perhaps the Risperdal

> helps with some of the inattentiveness.

>

> As a side note to Noelle: Aiden took 60 mg of

> Prozac -- our shrink did not want

> to put him up any higher due to the greatly

> increase risk of side effects such

> as tremors and stomach problems. That is why we

> opted to change SSRIs, and

> we've been happy with the Celexa.

>

> Jule

>

> You may subscribe to the OCD-L by emailing

> listserv@... . In the body of your

> message write: subscribe OCD-L your name. You may

> subscribe to the Parents of Adults with OCD List at

> parentsofadultswithOCD

> . You may access the files, links, and archives

> for our list at

> . Our

> list advisors are Tamar Chansky, Ph.D., and Aureen

> Pinto Wagner, Ph.D. Our list moderators are

> Birkhan, Kathy Hammes, Jule Monnens, Gail Pesses,

> Kathy , Roman, and Jackie Stout.

> Subscription issues, problems, or suggestions may be

> addressed to Louis Harkins, list owner, at

> harkins@... .

>

__________________________________________________

November 3, 2000

My son recently titered off Prozac (40 mg.) and on to

Celexa. We started with 20 mg. in the hopes that less

is better. Within a 6 week period and 20 mg. later it

became clear that Celexa was not the way to go for

him. All of his sensory issues returned along with

OCD symptoms that we had not seen in 2 years. We have

not had experience with anafranil yet, so I can't

speak to that medication. We had a VERY HYPERACTIVE

reaction to Paxil. Medication stuff can be so tricky.

I always have to gear myself up for medication

changes...I do not like the fact that my child must

try different medications in order to find the best

combination.

--- Judy Lovchik <jlovchik@...> wrote:

> Jule and others experienced with Celexa:

>

> My 15 yo son is titering up on Celexa and titering

> down on anafranil. After 2 weeks, he is up to 40mg

> Celexa and down to 25mg anafranil. He's very

> depressed and extremely anxious. I added another

> 10mg Celexa yesterday, but he became even worse, so

> I'll stay at 40 awhile longer. Jule, how much

> Celexa is Aiden taking? And how much Wellbutrin and

> Risperodol? I'm going to suggest them to his

> doctor.

>

> Judy

> Re: advice please

>

> Nan:

>

> My son (now 12) had terrible BSE's from Luvox --

> not at first, but after a

> couple months he became oppositional and

> aggressive, something he had NEVER

> been. He was then placed on Prozac with good

> results until it pooped out this

> spring and we had to switch to Celexa. He also

> has ADHD, and depression. In

> unipolar depression people may suffer from

> repeated episodes of depression.

> However, their mood returns to normal at the end

> of an episode of depression.

>

> Aiden also takes Risperdal and Wellbutrin as an

> adjunct to the Celexa. He has a

> great deal of anxiety on top of the ocd, and the

> Risperdal helps to keep him

> under better control. The Wellbutrin is to boost

> the antidepressant effect of

> the Celexa. Currently he is not taking anything

> for the ADHD, although he has

> been on Adderall and Ritalin in the past. I think

> that perhaps the Risperdal

> helps with some of the inattentiveness.

>

> As a side note to Noelle: Aiden took 60 mg of

> Prozac -- our shrink did not want

> to put him up any higher due to the greatly

> increase risk of side effects such

> as tremors and stomach problems. That is why we

> opted to change SSRIs, and

> we've been happy with the Celexa.

>

> Jule

>

> You may subscribe to the OCD-L by emailing

> listserv@... . In the body of your

> message write: subscribe OCD-L your name. You may

> subscribe to the Parents of Adults with OCD List at

> parentsofadultswithOCD

> . You may access the files, links, and archives

> for our list at

> . Our

> list advisors are Tamar Chansky, Ph.D., and Aureen

> Pinto Wagner, Ph.D. Our list moderators are

> Birkhan, Kathy Hammes, Jule Monnens, Gail Pesses,

> Kathy , Roman, and Jackie Stout.

> Subscription issues, problems, or suggestions may be

> addressed to Louis Harkins, list owner, at

> harkins@... .

>

__________________________________________________

November 4, 2000

Judy:

Aiden takes 40 mg of Celexa, 2 mg of Risperdal in a split dose, and 150 mg of

Wellbutrin. I have to tell you, though, that the month we spent tapering off

Prozac and up on Celexa was awful -- just like you're describing with your son.

After about 4 weeks we saw a great deal of improvement. That was in the spring.

I have tried several times to lower his Risperdal dose, but he gets too anxious

when I go lower than the 2 mg. We added Wellbutrin last month due to increased

depression. Give the Celexa a chance to work, but do ask the doc about adding

something to supplement. He might want to wait until your son has been on the

Celexa a couple more weeks.

Jule

November 7, 2000

Can someone tell me about Celexa? I havebeen hearing a lot about it

recently an d only recently heard the name . Terry

Re: celexa

>

> Judy:

>

> Aiden takes 40 mg of Celexa, 2 mg of Risperdal in a split dose, and 150 mg

of

> Wellbutrin. I have to tell you, though, that the month we spent tapering

off

> Prozac and up on Celexa was awful -- just like you're describing with your

son.

> After about 4 weeks we saw a great deal of improvement. That was in the

spring.

> I have tried several times to lower his Risperdal dose, but he gets too

anxious

> when I go lower than the 2 mg. We added Wellbutrin last month due to

increased

> depression. Give the Celexa a chance to work, but do ask the doc about

adding

> something to supplement. He might want to wait until your son has been on

the

> Celexa a couple more weeks.

>

> Jule

>

> You may subscribe to the OCD-L by emailing listserv@... . In

the body of your message write: subscribe OCD-L your name. You may

subscribe to the Parents of Adults with OCD List at

parentsofadultswithOCD . You may access the

files, links, and archives for our list at

. Our list advisors are Tamar

Chansky, Ph.D., and Aureen Pinto Wagner, Ph.D. Our list moderators are

Birkhan, Kathy Hammes, Jule Monnens, Gail Pesses, Kathy ,

Roman, and Jackie Stout. Subscription issues, problems, or

suggestions may be addressed to Louis Harkins, list owner, at

harkins@... .

>

November 7, 2000

Can someone tell me about Celexa? I havebeen hearing a lot about it

recently an d only recently heard the name . Terry

Re: celexa

>

> Judy:

>

> Aiden takes 40 mg of Celexa, 2 mg of Risperdal in a split dose, and 150 mg

of

> Wellbutrin. I have to tell you, though, that the month we spent tapering

off

> Prozac and up on Celexa was awful -- just like you're describing with your

son.

> After about 4 weeks we saw a great deal of improvement. That was in the

spring.

> I have tried several times to lower his Risperdal dose, but he gets too

anxious

> when I go lower than the 2 mg. We added Wellbutrin last month due to

increased

> depression. Give the Celexa a chance to work, but do ask the doc about

adding

> something to supplement. He might want to wait until your son has been on

the

> Celexa a couple more weeks.

>

> Jule

>

> You may subscribe to the OCD-L by emailing listserv@... . In

the body of your message write: subscribe OCD-L your name. You may

subscribe to the Parents of Adults with OCD List at

parentsofadultswithOCD . You may access the

files, links, and archives for our list at

. Our list advisors are Tamar

Chansky, Ph.D., and Aureen Pinto Wagner, Ph.D. Our list moderators are

Birkhan, Kathy Hammes, Jule Monnens, Gail Pesses, Kathy ,

Roman, and Jackie Stout. Subscription issues, problems, or

suggestions may be addressed to Louis Harkins, list owner, at

harkins@... .

>

November 8, 2000

Hi Vivian:

What good news that J. is taking Celexa. It is amazing how the SSRIs can

take the edge of symptoms enough to really allow CBT (with E & RP) to

proceed. Good luck, I can't wait for your next update. You deserve more

good news. Take care, aloha, Kathy (H)

kathyh@...

At 04:39 AM 11/09/2000 -0000, you wrote:

>

> Since we are new to this drug, I thought I would post what I

>know of it so far. The name of it is CITALOPRAM (sye TAL oh pram)

>with the U.S. brand name being 'Celexa'. It is used to treat

>depression. It is an SSRI. It inhibits the reuptale of a chemical in

>the brain called serotonin.

> Our son is taking it in the morning (on a full stomach) as it

>can cause nausea and inability to sleep. Some people can feel tired

>though, an example of how, as with all meds., some folks react

>differently. It can cause anxiety, and a change in sexual ability or

>desire. It is not supposed to be habit forming or cause wieght gain.

> We were told that these symtoms could improve after taking it

>for awhile. (4-6 weeks) Our son started out slow. 10mg for 6 days

>(1/2 a tablet) then uped it to one tab. 20mg. He will stay at that

>until we see the Dr. for a follow up on Nov. 21st. I guess it comes

>in 20mg and 40mg doses.

> Some of the things I have seen in J. are giddyness,and not

>as irritable. When he increased to 20mg he seemed to be tired and was

>more irritable , but

>I can't tell if it was from a class situation (assignment due) in

>school or not.

> I will let you know how this goes, it is still very new to

>us. I am just thankful that J is willng to try this, as it has taken

>alot of courage on his part, but I can't help but think that he

>deserves to be free of this and that our family deserves it too!

> Vivian in wa.st.

>

November 9, 2000

Vivian,

Yes, you all deserve to to be free of the control that J's OCD,..., has

over you!!! This is a nerve wracking time for all of you!

Keep us posted, and dont forget to take care of yourself!!

wendy, in canada

========================

> I will let you know how this goes, it is still very new to

>us. I am just thankful that J is willng to try this, as it has taken

>alot of courage on his part, but I can't help but think that he

>deserves to be free of this and that our family deserves it too!

> Vivian in wa.st.

_________________________________________________________________________

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March 20, 2001

Alley pat,

You are a wonder!!!! Where did you find this study? It is very interesting

and actually made me feel better about Celexa. sounds like the sides are

kinder and gentler than other anti-deps!

As usual, my friends here on the list are wonderful!!!!!

Thank you so much.

Staying Positive,

Lora

March 20, 2001

Alley pat,

You are a wonder!!!! Where did you find this study? It is very interesting

and actually made me feel better about Celexa. sounds like the sides are

kinder and gentler than other anti-deps!

As usual, my friends here on the list are wonderful!!!!!

Thank you so much.

Staying Positive,

Lora

March 20, 2001

Hey Lora,

I took Celexa for a while. I was on treatment and it didn't seem like it was

enough for me so I changed. But it is right for many people and from what

I've heard, has very few sides.

Course, there's http://www.celexa.com

Per the site:

You may start to feel relief from some symptoms, such as depressed mood,

after taking Celexa for only one week. Most people can expect to feel the

full benefits of Celexa in four weeks. It is important to continue taking

Celexa even if you begin to feel relief from your depression. Be patient.

You didn't suddenly become depressed, and full recovery takes time. Your

doctor may ask you to keep taking Celexa long after your depression has been

relieved, to help keep it from coming back.

To get the most out of Celexa, always take your medication exactly as

prescribed by your physician. Be sure to talk to your doctor promptly if you

have any side effects when taking Celexa. A simple adjustment in dosage may

be all that is required.

Celexa is well tolerated by many people. The most frequent side effects

reported with Celexa are nausea, dry mouth, drowsiness, insomnia, increased

sweating, tremor, diarrhea, and problems with ejaculation.

People taking Celexa generally do not suffer from insomnia, agitation,

nervousness, or anxiety any more than people not taking Celexa. Furthermore,

Celexa has not been associated with clinically significant weight changes.

-------------------

some specifics the site mentioned:

--------------------

CONTRAINDICATIONS

Concomitant use in patients taking monoamine oxidase inhibitors (MAOI's) is

contraindicated (see WARNINGS).

Celexa is contraindicated in patients with a hypersensitivity to citalopram

or any of the inactive ingredients in Celexa.

WARNINGS

Potential for Interaction with Monoamine Oxidase Inhibitors

In patients receiving serotonin reuptake inhibitor drugs in combination with

a monoamine oxidase inhibitor (MAOI), there have been reports of serious,

sometimes fatal, reactions including hyperthermia, rigidity, myoclonus,

autonomic instability with possible rapid fluctuations of vital signs, and

mental status changes that include extreme agitation progressing to delirium

and coma. These reactions have also been reported in patients who have

recently discontinued SSRI treatment and have been started on a MAOI. Some

cases presented with features resembling neuroleptic malignant syndrome.

Furthermore, limited animal data on the effects of combined use of SSRI's

and MAOI's suggest that these drugs may act synergistically to elevate blood

pressure and evoke behavioral excitation. Therefore, it is recommended that

Celexa should not be used in combination with a MAOI, or within 14 days of

discontinuing treatment with a MAOI. Similarly, at least 14 days should be

allowed after stopping Celexa before starting a MAOI.

PRECAUTIONS

General

Hyponatremia

Several cases of hyponatremia and SIADH (syndrome of inappropriate

antidiuretic hormone secretion) have been reported in association with

Celexa treatment. All patients with these events have recovered with

discontinuation of Celexa and/or medical intervention.

Activation of Mania/Hypomania

In placebo-controlled trials of Celexa, some of which included patients with

bipolar disorder, activation of mania/hypomania was reported in 0.2% of 1063

patients treated with Celexa and in none of the 446 patients treated with

placebo. Activation of mania/hypomania has also been reported in a small

proportion of patients with major affective disorders treated with other

marketed antidepressants. As with all antidepressants, Celexa should be used

cautiously in patients with a history of mania.

Seizures

Although anticonvulsant effects of citalopram have been observed in animal

studies, Celexa has not been systematically evaluated in patients with a

seizure disorder. These patients were excluded from clinical studies during

the product's premarketing testing. In clinical trials of Celexa, seizures

occurred in 0.3% of patients treated with Celexa (a rate of one patient per

98 years of exposure) and 0.5% of patients treated with placebo (a rate of

one patient per 50 years of exposure). Like other antidepressants, Celexa

should be introduced with care in patients with a history of seizure

disorder.

Suicide

The possibility of a suicide attempt is inherent in depression and may

persist until significant remission occurs. Close supervision of high risk

patients should accompany initial drug therapy. Prescriptions for Celexa

should be written for the smallest quantity of tablets consistent with good

patient management, in order to reduce the risk of overdose.

Interference with Cognitive and Motor Performance

In studies in normal volunteers, Celexa in doses of 40 mg/day did not

produce impairment of intellectual function or psychomotor performance.

Because any psychoactive drug may impair judgement, thinking, or motor

skills, however, patients should be cautioned about operating hazardous

machinery, including automobiles, until they are reasonably certain that

Celexa therapy does not affect their ability to engage in such activities.

Use in Patients with Concomitant Illness

Clinical experience with Celexa in patients with certain concomitant

systemic illnesses is limited. Caution is advisable in using Celexa in

patients with diseases or conditions that produce altered metabolism or

hemodynamic responses.

Celexa has not been systematically evaluated in patients with a recent

history of myocardial infarction or unstable heart disease. Patients with

these diagnoses were generally excluded from clinical studies during the

product's premarketing testing. However, the electrocardiograms of 1116

patients who received Celexa in clinical trials were evaluated and the data

indicate that Celexa is not associated with the development of clinically

significant ECG abnormalities.

In subjects with hepatic impairment, citalopram clearance was decreased and

plasma concentrations were increased. The use of Celexa in hepatically

impaired patients should be approached with caution and a lower maximum

dosage is recommended (see DOSAGE AND ADMINISTRATION).

Because citalopram is extensively metabolized, excretion of unchanged drug

in urine is a minor route of elimination. Until adequate numbers of patients

with severe renal impairment have been evaluated during chronic treatment

with Celexa, however, it should be used with caution in such patients (see

DOSAGE AND ADMINISTRATION).

Information for Patients

Physicians are advised to discuss the following issues with patients for

whom they prescribe Celexa.

Although in controlled studies Celexa has not been shown to impair

psychomotor performance, any psychoactive drug may impair judgment, thinking

or motor skills, and so patients should be cautioned about operating

hazardous machinery, including automobiles, until they are reasonably

certain that Celexa therapy does not affect their ability to engage in such

activities.

Patients should be told that, although Celexa has not been shown in

experiments with normal subjects to increase the mental and motor skill

impairments caused by alcohol, the concomitant use of Celexa and alcohol in

depressed patients is not advised.

Patients should be advised to inform their physician if they are taking, or

plan to take, any prescription or over-the-counter drugs, as there is a

potential for interactions.

Patients should be advised to notify their physician if they become pregnant

or intend to become pregnant during therapy.

Patients should be advised to notify their physician if they are breast

feeding an infant.

While patients may notice improvement with Celexa therapy in 1 to 4 weeks,

they should be advised to continue therapy as directed.

Laboratory Tests

There are no specific laboratory tests recommended.

Drug Interactions

CNS Drugs - Given the primary CNS effects of citalopram, caution should be

used when it is taken in combination with other centrally acting drugs.

Alcohol - Although citalopram did not potentiate the cognitive and motor

effects of alcohol in a clinical trial, as with other psychotropic

medications, the use of alcohol by depressed patients taking Celexa is not

recommended.

Monoamine Oxidase Inhibitors (MAOI's) - See CONTRAINDICATIONS and WARNINGS.

Cimetidine - In subjects who had received 21 days of 40 mg/day Celexa,

combined administration of 400 mg/day cimetidine for 8 days resulted in an

increase in citalopram AUC and Cmax of 43% and 39%, respectively. The

clinical significance of these findings is unknown.

Digoxin - In subjects who had received 21 days of 40 mg/day Celexa, combined

administration of Celexa and digoxin (single dose of 1 mg) did not

significantly affect the pharmacokinetics of either citalopram or digoxin.

Lithium - Coadministration of Celexa (40 mg/day for 10 days) and lithium (30

mmol/day for 5 days) had no significant effect on the pharmacokinetics of

citalopram or lithium. Nevertheless, plasma lithium levels should be

monitored with appropriate adjustment to the lithium dose in accordance with

standard clinical practice. Because lithium may enhance the serotonergic

effects of citalopram, caution should be exercised when Celexa and lithium

are coadministered.

Sumatriptan - There have been rare postmarketing reports describing patients

with weakness, hyperreflexia, and incoordination following the use of a

selective serotonin reuptake inhibitor (SSRI) and sumatriptan. If

concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine,

fluvoxamine, paroxetine, sertraline, citalopram) is clinically warranted,

appropriate observation of the patient is advised.

Warfarin - Administration of 40 mg/day Celexa for 21 days did not affect the

pharmacokinetics of warfarin, a CYP3A4 substrate. Prothrombin time was

increased by 5%, the clinical significance of which is unknown.

Carbamazepine - Combined administration of Celexa (40 mg/day for 14 days)

and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly

affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate. Although

trough citalopram plasma levels were unaffected, given the enzyme inducing

properties of carbamazepine, the possibility that carbamazepine might

increase the clearance of citalopram should be considered if the two drugs

are coadministered.

CYP3A4 and 2C19 Inhibitors - In vitro studies indicated that CYP3A4 and 2C19

are the primary enzymes involved in the metabolism of citalopram. As data

are not available from clinical pharmacokinetic studies, the possibility

that the clearance of citalopram will be decreased when citalopram is

administered with a potent inhibitor of CYP3A4 (e.g., ketoconazole,

itraconazole, fluconazole, or erythromycin), or a potent inhibitor of

CYP2C19 (e.g., omeprazole), should be considered.

Metoprolol - Administration of 40 mg/day Celexa for 22 days resulted in a

two-fold increase in the plasma levels of the beta-adrenergic blocker

metoprolol. Increased metoprolol plasma levels have been associated with

decreased cardioselectivity. Coadministration of Celexa and metoprolol had

no clinically significant effects on blood pressure or heart rate.

Imipramine and Other Tricyclic Antidepressants (TCAs) - In vitro studies

suggest that citalopram is a relatively weak inhibitor of CYP2D6.

Coadministration of Celexa (40 mg/day for 10 days) with the tricyclic

antidepressant imipramine (single dose of 100 mg), a substrate for CYP2D6,

did not significantly affect the plasma concentrations of imipramine or

citalopram. However, the concentration of the imipramine metabolite

desipramine was increased by approximately 50%. The clinical significance of

the desipramine change is unknown. Nevertheless, caution is indicated in the

coadministration of TCA's with Celexa.

Electroconvulsive Therapy (ECT) - There are no clinical studies of the

combined use of electroconvulsive therapy (ECT) and Celexa.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Citalopram was administered in the diet to NMRI/BOM strain mice and COBS WI

strain rats for 18 and 24 months, respectively. There was no evidence for

carcinogenicity of citalopram in mice receiving up to 240 mg/kg/day, which

is equivalent to 20 times the maximum recommended human daily dose (MRHD) of

60 mg on a surface area (mg/m2) basis. There was an increased incidence of

small intestine carcinoma in rats receiving 8 or 24 mg/kg/day, doses which

are approximately 1.3 and 4 times the MRHD, respectively, on a mg/m2 basis.

A no-effect dose for this finding was not established. The relevance of

these findings to humans is unknown.

Mutagenesis

Citalopram was mutagenic in the in vitrobacterial reverse mutation assay

(Ames test) in 2 of 5 bacterial strains (Salmonella TA98 and TA1537) in the

absence of metabolic activation. It was clastogenic in the in vitro Chinese

hamster lung cell assay for chromosomal aberrations in the presence and

absence of metabolic activation. Citalopram was not mutagenic in the in

vitro mammalian forward gene mutation assay (HPRT) in mouse lymphoma cells

or in a coupled in vitro/in vivo unscheduled DNA synthesis (UDS) assay in

rat liver. It was not clastogenic in the in vitro chromosomal aberration

assay in human lymphocytes or in two in vivo mouse micronucleus assays.

Impairment of Fertility

When citalopram was administered orally to male and female rats prior to and

throughout mating and gestation at doses of 16/24 (males/females), 32, 48,

and 72 mg/kg/day, mating was decreased at all doses, and fertility was

decreased at doses >32 mg/kg/day, approximately 5 times the maximum

recommended human dose (MRHD) of 60 mg/day on a body surface area (mg/m2)

basis. Gestation duration was increased at 48 mg/kg/day, approximately 8

times the MRHD.

Pregnancy

Pregnancy Category C

In animal reproduction studies, citalopram has been shown to have adverse

effects on embryo/fetal and postnatal development, including teratogenic

effects, when administered at doses greater than human therapeutic doses.

In two rat embryo/fetal development studies, oral administration of

citalopram (32, 56, or 112 mg/kg/day) to pregnant animals during the period

of organogenesis resulted in decreased embryo/fetal growth and survival and

an increased incidence of fetal abnormalities (including cardiovascular and

skeletal defects) at the high dose, which is approximately 18 times the

maximum recommended human dose (MRHD) of 60 mg/day on a body surface area

(mg/m2) basis. This dose was also associated with maternal toxicity

(clinical signs, decreased BW gain). The developmental no effect dose of 56

mg/kg/day is approximately 9 times the MRHD on a mg/m2 basis. In a rabbit

study, no adverse effects on embryo/fetal development were observed at doses

of up to 16 mg/kg/day, or approximately 5 times the MRHD on a mg/m2 basis.

Thus, teratogenic effects were observed at a maternally toxic dose in the

rat and were not observed in the rabbit.

When female rats were treated with citalopram (4.8, 12.8, or 32 mg/kg/day)

from late gestation through weaning, increased offspring mortality during

the first 4 days after birth and persistent offspring growth retardation

were observed at the highest dose, which is approximately 5 times the MRHD

on a mg/m2 basis. The no effect dose of 12.8 mg/kg/day is approximately 2

times the MRHD on a mg/m2 basis. Similar effects on offspring mortality and

growth were seen when dams were treated throughout gestation and early

lactation at doses >24 mg/kg/day, approximately 4 times the MRHD on a mg/m2

basis. A no effect dose was not determined in that study.

There are no adequate and well-controlled studies in pregnant women;

therefore, citalopram should be used during pregnancy only if the potential

benefit justifies the potential risk to the fetus.

------------------------------------

/ Alley

alleypat@...

oshidori@...

http://www.alleypat.com

My ICQ#:12631861

I can't think of a worse way to start a day than by waking up

March 20, 2001