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HOME >> API >> API List1 >> Clomipramine HCL >> Precautions

PRECAUTIONS
Clomipramine CAS number 17321-77-6

Epileptic seizures are the most important risk associated with clomipramine. Among patients taking the drug for six months or more, more than 1% may experience seizures. The risk of seizure increases with larger doses, and seizures have been reported to occur following abrupt discontinuation of the medication. Caution and physician supervision is required if the patient has a history of epilepsy or some other condition associated with seizures, such as brain damage or alcoholism.

Clomipramine and other tricyclic antidepressants often cause drowsiness. Activities requiring alertness, such as driving, should be avoided until patients understand how the drug affects them. Dizziness or light-headedness may occur on arising from a seated position, due to sudden decreases in blood pressure. Fainting may also occur. Some patients, especially men with prostate enlargement, may experience difficulty urinating. Glaucoma may be worsened. Sensitivity to ultraviolet light may increase, and sunburns may occur more easily.

Tricyclic antidepressants, including clomipramine, should be used with caution and physician supervision in patients with heart disease, because of the possibility of adverse effects on heart rhythm. Adverse effects on the heart occur frequently when tricyclics are taken in overdose. Only small quantities of these drugs should be given to patients who may be suicidal.

Tricyclic antidepressants may cause dry mouth, due to decreased saliva, possibly contributing to the development of tooth decay, gum disease, and mouth infections. Patients should avoid sweets, sugary beverages, and chewing gum containing sugar.

It has not been determined whether clomipramine is safe to take during pregnancy, and the patient's need for this medicine should be balanced against the possibility of harm to the fetus. Tricyclic antidepressants may be secreted in breast milk and may cause sedation and depress breathing of a nursing infant.

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as clomipramine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take clomipramine, but in some cases, a doctor may decide that clomipramine is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take clomipramine or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking clomipramine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with clomipramine. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/cder/drug/antidepressants/antidepressants_MG_2007.pdf.

No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

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