Clomipramine is a tricyclic antidepressant that is used to treat symptoms of obsessive-compulsive disorder (OCD), such as recurrent thoughts or feelings and repetitive actions.

Clomipramine is for use in adults and children at least 10 years old.

Clomipramine may also be used for purposes not listed in this medication guide.

You should not use clomipramine if you have recently had a heart attack.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Call your doctor if your symptoms do not improve, or if they get worse.

If you need surgery, tell your surgeon you currently use clomipramine. You may need to stop for a short time.

Do not stop using clomipramine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Obsessive Compulsive Disorder:

Initial dose: 25 mg orally once a day at bedtime
Maintenance dose: 100 mg orally per day
Maximum dose: 250 mg/day

Comments:
-The dose should be increased gradually, as tolerated, to 100 mg during the first 2 weeks. After the initial titration, the dose may be increased gradually over the next several weeks to a maximum of 250 mg/day.
-During initial titration, this drug should be given in divided doses with meals to reduce gastrointestinal side effects.
-During maintenance, the total daily dose may be given once a day at bedtime to minimize daytime sedation.
-Dosage adjustments should be made to maintain the patient on the lowest effective dosage.

Use: Treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD) who have obsessions/compulsions that must cause marked distress, be time consuming, or significantly interfere with social/occupational functioning

Usual Pediatric Dose for Obsessive Compulsive Disorder:

10 to 17 years:
-Initial dose: 25 mg orally once a day at bedtime
-Maintenance dose: May increase to 3 mg/kg or 100 mg orally per day, whichever is the smaller dose
-Maximum dose: 3 mg/kg/day or 200 mg/day, whichever is the smaller dose

Comments:
-During initial titration, this drug should be given in divided doses with meals to reduce gastrointestinal side effects.
-After titration, the total daily dose may be given once a day at bedtime to minimize daytime sedation.
-Dosage adjustments should be made to maintain the patient on the lowest effective dosage.

Use: Treatment of obsessions and compulsions in patients with OCD who have obsessions/compulsions that must cause marked distress, be time consuming, or significantly interfere with social/occupational functioning

You should not use clomipramine if you are allergic to it, or if you have:

• you have recently had a heart attack; or

• you are allergic to antidepressants such as amitriptyline, amoxapine, trimipramine, desipramine, doxepin, imipramine, nortriptyline, or protriptyline.

Do not use clomipramine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone.

Tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• bipolar disorder (manic-depression), schizophrenia or other mental illness;

• alcoholism;

• a seizure or a head injury;

• heart disease;

• low blood pressure;

• narrow-angle glaucoma;

• overactive thyroid or adrenal gland tumor (pheochromocytoma or neuroblastoma); or

• urination problems.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with clomipramine and cause a serious condition called serotonin syndrome.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your doctor if you are pregnant or plan to get pregnant. Taking this medicine during late pregnancy may cause withdrawal symptoms in the newborn.

You should not breastfeed while using clomipramine.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of clomipramine can be fatal.

Overdose symptoms may include irregular heartbeats, feeling restless or agitated, confusion, severe sweating, slow or jerky muscle movements, extreme drowsiness, slow breathing, feeling like you might pass out, seizure, or coma.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your usual diet.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how clomipramine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, 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.

Clomipramine may cause serious side effects. Call your doctor at once if you have:

• low sodium level --headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• confusion, extreme fear, thoughts of hurting yourself;

• pain or burning when you urinate; or

• a seizure (convulsions).

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.

Common side effects of clomipramine may include:

• feeling dizzy, drowsy, tired, or nervous;

• tremors, jerking muscle movements;

• sweating;

• changes in appetite or weight;

• urination problems;

• vision changes; or

• decreased sex drive, impotence, or difficulty having an orgasm.

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 1-800-FDA-1088.

Using clomipramine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can affect clomipramine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.