Clomipramine (Oral route)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. These risks must be balanced with clinical need. Families and caregivers should closely observe the patient and stay in close contact with the prescriber. This drug is not approved for use in pediatric patients except for those with obsessive compulsive disorder (OCD) .
Uses of This Medicine:
Clomipramine is used to treat obsessive compulsive disorder (OCD). OCD is a nervous condition wherein a person has recurring thoughts or ideas or does repetitive things because they are anxious.
Clomipramine is a tricyclic antidepressant (TCA). It is thought to work in the brain by increasing the activity of the chemical serotonin.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clomipramine in children 10 years of age and older. Safety and efficacy have not been established in children younger than 10 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clomipramine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving clomipramine.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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.
- Methylene Blue
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.
- Amtolmetin Guacil
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Choline Salicylate
- Eslicarbazepine Acetate
- Flufenamic Acid
- Inotuzumab Ozogamicin
- Iobenguane I 123
- Mefenamic Acid
- Morphine Sulfate Liposome
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Peginterferon Alfa-2b
- Salicylic Acid
- Secretin Human
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Sodium Salicylate
- Tiaprofenic Acid
- Tolfenamic Acid
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.
- Enalapril Maleate
- Valproic Acid
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.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
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:
- Adrenal gland tumor (eg, neuroblastoma, pheochromocytoma) or
- Alcohol abuse, or history of or
- Brain disease, history of or
- Heart disease or
- Hyperthyroidism (overactive thyroid)—Use with caution. May cause side effects to become worse.
- Behavior or mood changes (eg, aggression, panic attacks) or
- Bipolar disorder (mood disorder with mania and depression), or risk of or
- Depression, history of or
- Glaucoma (angle-closure type) or
- Kidney disease or
- Liver disease or
- Mania or hypomania, history of or
- Psychosis (mental illness) or
- Schizophrenia (mental illness) or
- Seizures, history of or
- Urinary retention (trouble urinating), history of—Use with caution. May make these conditions worse.
- Heart attack, recent—Should not be used in patients with this condition.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. 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.
It is best to take this medicine with food. Take this medicine at bedtime to lessen drowsiness during the day.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For obsessive-compulsive disorder:
- Adults—At first, 25 milligrams (mg) once a day at bedtime. Your doctor may adjust your dose as needed. Higher doses may be given in evenly divided portions during the day. However, the dose is usually not more than 250 mg per day.
- Children 10 years of age and older—At first, 25 mg once a day at bedtime. Your doctor may adjust your dose as needed. Higher doses may be given in evenly divided portions during the day. However, the dose is usually not more than 200 mg per day.
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For obsessive-compulsive disorder:
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.
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 While Using This Medicine:
It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects. Blood tests may be needed to check for unwanted effects.
Clomipramine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some children, teenagers, and young adults 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. Also tell the doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, or your caregiver notice any of these side effects, tell your doctor right away. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
Do not take clomipramine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid (Zyvox®), methylene blue, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking clomipramine during the 2 weeks after you stop a MAO inhibitor. Wait for 2 weeks after stopping clomipramine before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or bowel symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.
Clomipramine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use clomipramine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, or some pain or migraine medicines (eg, sumatriptan, tramadol, Frova®, Maxalt®, Relpax®, Zomig®). Check with your doctor first before taking any other medicines with clomipramine.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. 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 dizzy, drowsy, or not alert.
Check with your doctor right away if you have a fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).
Clomipramine may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with clomipramine may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
This medicine may cause men to have problems with sex. Check with your doctor if you are having an abnormal ejaculation or decreased sexual performance or desire.
Weight changes may occur during treatment with this medicine. Talk with your doctor if this is a concern for you.
Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking clomipramine together with medicines used during surgery or emergency treatment may increase the risk of side effects.
Do not 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 may help prevent possible worsening of your condition and reduce the possibility of withdrawal symptoms such as dizziness, headache, nausea, vomiting, trouble sleeping, irritability, high fever, or a general feeling of discomfort or illness.
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 or vitamin supplements.
Side Effects of This Medicine:
- More common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- body aches or pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- difficult, burning, or painful urination
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- excessive muscle tone
- fear or nervousness
- feeling sad or empty
- hearing changes
- lower back or side pain
- muscle stiffness, tension, or tightness
- poor concentration
- rhythmic movement of muscles
- tightness of the chest
- trouble breathing
- unusual tiredness or weakness
- voice changes
- Less common
- Anger that is hard to control
- breast enlargement
- burning feeling while urinating
- changes in vision
- decrease in the frequency of urination
- difficulty in passing urine (dribbling)
- difficulty in speaking
- dry mouth
- fast, irregular, pounding, or racing heartbeat or pulse
- headache, severe and throbbing
- irregular heartbeats
- nausea or vomiting
- numbness, tingling, pain, or weakness in the hands or feet
- pain during sexual intercourse
- panic attacks
- rapidly changing moods
- swelling of the face, fingers, feet, or lower legs
- More common
- Blistering, crusting, irritation, itching, or reddening of the skin
- change in taste
- cracked, dry, or scaly skin
- change in interest in sexual intercourse
- dry skin
- hives or welts, skin rash
- inability to have or keep an erection
- increased interest in sexual intercourse
- joint pain
- redness of the face, neck, arms, and occasionally, upper chest
- shakiness in the legs, arms, hands, or feet
- stomach discomfort, upset, or pain
- swollen joints
- trembling or shaking of the hands or feet
- Less common
- Absent, missed, or irregular menstrual periods
- breast pain
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017