Needed to read PDF's

Adobe Reader |
Citalopram

US Brand Name: CeleXA
Description
Citalopram is used to treat depression, including major depressive
disorder (MDD). It is an antidepressant that belongs to a group of
medicines known as selective serotonin reuptake inhibitors (SSRIs).
These medicines are thought to work by increasing the activity of a
chemical called serotonin in the brain.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
How is citalopram supplied (dosage forms)?
Citalopram is available in the following dosage forms that
are taken by mouth.
- 30 mg oral capsules
- 10 mg/5mL oral solution
- 10 mg, 20 mg, 40 mg oral tablets
How should I store citalopram?
Oral Capsules and Tablets. Citalopram oral
capsules or oral tablets should be stored at room temperature,
between 68 F to 77 F (20 C to 25 C). They can be exposed to
temperatures between 59 F to 86 F (15 C to 30 C), for shorter
periods of time, such as when transporting them. Store in a
cool, dry place.
Oral Liquid. Citalopram oral solution should
be stored at room temperature, between 68 F to 77 F (20 C to 25
C).
Before Using
In deciding to use a medicine, the risks of taking the medicine must
be weighed against the good it will do. This is a decision you and your
doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic
reaction to this medicine or any other medicines. Also tell your health
care professional if you have any other types of allergies, such as to
foods, dyes, preservatives, or animals. For non-prescription products,
read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of
age to the effects of citalopram in the pediatric population. Safety and
efficacy have not been established.
Geriatric
Citalopram capsules is not recommended for use in the elderly because
an adjustment in the dose is not possible with the available dose
strength of this medicine.
Appropriate studies performed to date have not demonstrated
geriatric-specific problems that would limit the usefulness of
citalopram in the elderly. However, elderly patients are more likely to
have hyponatremia (low sodium in the blood), which may require caution
and an adjustment in the dose for patients receiving citalopram.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant
effects. An alternative to this medication should be prescribed or you
should stop breastfeeding while using this medicine.
Drug Interactions
Although certain medicines should not be used together at all, in
other cases two different medicines may be used together even if an
interaction might occur. In these cases, your doctor may want to change
the dose, or other precautions may be necessary. When you are taking
this medicine, it is especially important that your healthcare
professional know if you are taking any of the medicines listed below.
The following interactions have been selected on the basis of their
potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not
recommended. Your doctor may decide not to treat you with this
medication or change some of the other medicines you take.
Bepridil
Bromopride
Cisapride
Dronedarone
Fluconazole
Isocarboxazid |
Levoketoconazole
Linezolid
Mesoridazine
Methylene Blue
Metoclopramide
Ozanimod |
Phenelzine
Pimozide
Piperaquine
Posaconazole
Procarbazine
Rasagiline |
Safinamide
Selegiline
Sparfloxacin
Terfenadine
Thioridazine
Tranylcypromine
Ziprasidone |
Using this medicine with any of the following medicines is usually
not recommended, but may be required in some cases. If both medicines
are prescribed together, your doctor may change the dose or how often
you use one or both of the medicines.
Abciximab
Aceclofenac
Acemetacin
Acenocoumarol
Adagrasib
Alfentanil
Alfuzosin
Almotriptan
Amineptine
Amiodarone |
Amisulpride
Amitriptyline
Amitriptylinoxide
Amoxapine
Amphetamine
Amtolmetin Guacil
Anagrelide
Anileridine
Apixaban
Apomorphine |
Ardeparin
Argatroban
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Arsenic Trioxide
Artemether
Asenapine
Aspirin
Astemizole |
Atazanavir
Azathioprine
Azithromycin
Bedaquiline
Bemiparin
Benzhydrocodone
Benzphetamine
Betrixaban
Bivalirudin
Bromfenac |
Using this medicine with any of the following medicines may cause an
increased risk of certain side effects, but using both drugs may be the
best treatment for you. If both medicines are prescribed together, your
doctor may change the dose or how often you use one or both of the
medicines.
Ginkgo |
Irinotecan |
Mavacamten |
Rifampin |
Other Interactions
Certain medicines should not be used at or around the time of eating
food or eating certain types of food since interactions may occur. Using
alcohol or tobacco with certain medicines may also cause interactions to
occur. The following interactions have been selected on the basis of
their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this
medicine. Make sure you tell your doctor if you have any other medical
problems, especially:
- Bipolar disorder (mood disorder with mania and depression), or
risk of or
- Bleeding problems or
- Glaucoma, angle-closure or
- Hyponatremia (low sodium in the blood) or
- Mania, history of or
- Seizures, history of or
- Sexual problems—Use with caution. May make these conditions
worse.
- Bradycardia (slow heart rate) or
- Heart attack, recent or
- Heart failure or
- Heart rhythm problems (eg, congenital long QT syndrome) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood)—Use with caution.
May cause side effects to become worse.
- Kidney disease, severe or
- Liver disease—Use with caution. The effects may be increased
because of slower removal of the medicine from the body.
Proper Use
Take this medicine only as directed by your doctor, to benefit your
condition as much as possible. Do not take more of it, do not take it
more often, and do not take it for a longer time than your doctor
ordered.
This medicine should come with a Medication Guide. Read and follow
these instructions carefully. Ask your doctor or pharmacist if you have
any questions.
Citalopram may be taken with or without food. If your doctor tells
you to take it at a specific time, follow your doctor's instructions.
If you are using the oral liquid, shake the bottle well before
measuring each dose. Use a marked measuring spoon, oral syringe or
medicine cup to measure each dose. The average household teaspoon may
not hold the right amount of liquid.
You may have to take citalopram for a month or longer before you
begin to feel better.
Dosing
Usual Adult Dose for Depression:
- Initial dose: 20 mg orally once a day
- Maintenance dose: 20 to 40 mg orally once a day
- Maximum dose: 40 mg orally per day
Comments:
- -The initial dose may be increased if necessary to 40 mg
once a day after at least 1 week of therapy.
- -Doses of 60 mg/day did not demonstrate an advantage in
efficacy over 40 mg/day doses.
- -Acute episodes of depression may require several months
or more of sustained pharmacologic therapy
Use: Treatment of depression
Usual Geriatric Dose for Depression:
Over 60 years of age:
- Recommended dose: 20 mg orally once a day
Comments:
- -Doses of 60 mg/day did not demonstrate an advantage in
efficacy over 40 mg/day doses.
- -Acute episodes of depression may require several months
or more of sustained pharmacologic therapy.
Use: Treatment of depression
Missed Dose
If you miss a dose of this medicine, take it as soon as possible.
However, if it is almost time for your next dose, skip the missed dose
and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away
from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any
medicine you do not use.
Precautions
It is very important that your doctor check your progress at
regular visits, to allow for changes in your dose and to help reduce
any side effects. Blood tests may be needed to check for unwanted
effects.
Do not take citalopram with a monoamine oxidase (MAO) inhibitor (eg,
isocarboxazid [Marplan®], linezolid (Zyvox®), methylene blue injection,
phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]).
Do not start taking citalopram during the 14 days after you stop a MAO
inhibitor. Wait 14 days after stopping citalopram before you start
taking a MAO inhibitor. If you take them together or do not the proper
amount of time, you may develop confusion, agitation, restlessness,
stomach or intestinal symptoms, a sudden high body temperature, an
extremely high blood pressure, or severe seizures.
Do not take pimozide (Orap®) while you are taking this medicine.
Using these medicines together can cause very serious heart problems.
Citalopram may cause a serious condition called serotonin syndrome if
taken together with some medicines. Do not use citalopram with buspirone
(Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®),
methylene blue injection, tryptophan, St John's wort, amphetamines, or
some pain or migraine medicines (eg, meperidine, methadone, rizatriptan,
sumatriptan, tramadol, Demerol®, Frova®, Imitrex®, Maxalt®, Methadose®,
Relpax®, Ultram®, Zomig®). Check with your doctor first before taking
any other medicines with citalopram.
Citalopram may cause some teenagers and young adults to be agitated,
irritable, or display other abnormal behaviors. It may also cause some
people to have suicidal thoughts and tendencies or to become more
depressed. Some people may have trouble sleeping, get upset easily, have
a big increase in energy, or start to act reckless. If you or your
caregiver notice any of these unwanted effects, tell your doctor right
away. Let the doctor know if you or anyone in your family has bipolar
disorder (manic-depressive) or has tried to commit suicide.
Contact your doctor right away if you have any changes to your heart
rhythm. You might feel dizzy or faint, or you might have a fast,
pounding, or irregular heartbeat. Make sure your doctor knows if you or
anyone in your family has ever had a heart rhythm problem including QT
prolongation or slow heartbeat.
Do not suddenly stop taking this medicine without checking first
with your doctor. Your doctor may want you to gradually reduce the
amount you are using before stopping it completely. This will decrease
the chance of having withdrawal symptoms including agitation, breathing
problems, chest pain, confusion, diarrhea, dizziness or lightheadedness,
fast heartbeat, headache, increased sweating, muscle pain, nausea,
restlessness, runny nose, trouble in sleeping, trembling or shaking,
unusual tiredness or weakness, vision changes, or vomiting.
This medicine may increase your risk for bleeding problems. Make sure
your doctor knows if you are also taking other medicines that thin the
blood, including aspirin, NSAIDs (eg, diclofenac, ibuprofen, naproxen,
Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).
This medicine may cause hyponatremia (low sodium in the blood). This
is more common in elderly patients, those who are taking diuretic
medicines for high blood pressure, or those who have decreased amounts
of fluid in the body due to severe diarrhea or vomiting. Check with your
doctor right away if you have confusion, headache, memory problems,
trouble concentrating, weakness, or feel unsteady when standing.
The use of alcohol is not recommended in patients who are taking this
medicine.
This medicine may cause some people to become drowsy, have trouble
thinking, or to have problems with movement. Make sure you know how
you react to this medicine before you drive, use machines, or do
anything else that could be dangerous if you are not alert or
well-coordinated.
Your doctor may want to monitor your child's weight and height,
because this medicine may cause decreased appetite and weight loss in
children.
Check with your doctor right away if you have decreased interest in
sexual intercourse, delayed or inability to have an orgasm, inability to
have or keep an erection, or loss in sexual ability, desire, drive, or
performance. These could be symptoms of sexual dysfunction.
Do not take other medicines unless they have been discussed with your
doctor. This includes prescription or nonprescription (over-the-counter
[OTC]) medicines and herbal (eg, St. John's wort) or vitamin
supplements.
What happens if I miss a
dose?
Take the medicine as soon as you can, but skip the missed
dose if it is almost time for your next dose. Do not take two
doses at one time.
What happens if I
overdose?
Seek emergency medical attention or call the
Poison Control Help line
at 800-222-1222.
Side Effects
Get emergency medical help if you have signs of an
allergic reaction to citalopram: hives, difficult breathing,
swelling of your face, lips, tongue, or throat.
Tell your doctor right away if you have new or sudden changes
in mood or behavior, including new or worse depression or
anxiety, panic attacks, trouble sleeping, or if you feel
impulsive, irritable, agitated, hostile, aggressive, restless,
more active or talkative, or have thoughts about suicide or
hurting yourself.
Citalopram may cause serious side effects. Call your
doctor at once if you have:
- a light-headed feeling, like you might pass out;
- blurred vision, eye pain or redness, seeing halos around
lights;
- fast or pounding heartbeats, pain or fluttering in your
chest, shortness of breath, and sudden dizziness (like you
might pass out);
- a seizure;
- unusual bleeding - nosebleeds, bleeding gums,
abnormal vaginal bleeding, any bleeding that will not stop;
- manic episodes - racing thoughts, increased
energy, decreased need for sleep, risk-taking behavior,
being agitated or talkative;
- severe nervous system reaction - very stiff
(rigid) muscles, high fever, sweating, confusion, fast or
uneven heartbeats, tremors; or
- low blood sodium - headache, confusion, problems
with thinking or memory, weakness, feeling unsteady.
Seek medical attention right away if you have symptoms of
serotonin syndrome, such as: agitation, hallucinations,
fever, sweating, shivering, fast heart rate, muscle stiffness,
twitching, loss of coordination, nausea, vomiting, or diarrhea.
Citalopram can affect growth in children. Tell your doctor if
your child is not growing at a normal rate while using this
medicine.
Common citalopram side effects may include:
- sexual problems;
- dizziness, drowsiness;
- dry mouth, thirst, increased sweating or urination;
- loss of appetite, nausea, diarrhea, constipation;
- feeling anxious, agitated, or shaky;
- feeling weak or tired, sleep problems (insomnia),
yawning;
- increased muscle movement;
- nosebleed, heavy menstrual bleeding; or
- cold 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.
You may report side effects to FDA at 800-FDA-1088.
|