CLOMIPRAMINE - ORAL

CLOMIPRAMINE - ORAL

PHONETIC PRONUNCIATION: (klo-MIP-ruh-meen)

COMMON BRAND NAME(S): Anafranil

GENERIC NAME(S): clomipramine HCl

Uses

USES: Clomipramine is used to treat obsessive compulsive disorder (OCD). It helps decrease persistent/unwanted thoughts (obsessions), and it helps reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, checking) that interfere with daily living. This medication belongs to a class of medications called tricyclic antidepressants. It works by restoring the balance of certain natural substances (serotonin, among others) in the brain.


How to use CLOMIPRAMINE - ORAL

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking clomipramine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor. To lessen side effects such as stomach upset, clomipramine may be started at a low dose, given in several doses during the day with meals, and slowly increased as your body gets used to it. After you have reached the best dose for you, the total dose can be taken once daily, usually at bedtime to prevent daytime drowsiness or as directed by your doctor. Usually, the daily dose will not be more than 250 milligrams for adults and 200 milligrams for children and teenagers. Follow your doctor's instructions carefully. Do not take more or less medication or take it more frequently than prescribed. Your condition will not improve any faster and your risk of side effects such as seizures may be increased. Dosage is based on your medical condition and response to therapy. Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details. Use this medication regularly in order to get the most benefit from it. Continue to take it even if you feel well. To help you remember, use it at the same time(s) each day. Do not suddenly stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. You may experience sweating, dizziness, nausea, vomiting, headache, or irritability if you suddenly stop taking this drug. Your dose may need to be gradually decreased. It may take 2 to 3 weeks or longer before the full effects of this medication are noticed. Inform your doctor if your condition persists or if it worsens.

Side Effects

SIDE EFFECTS: See also Warning section. Dizziness, drowsiness, dry mouth, constipation, stomach upset, nausea, vomiting, changes in appetite/weight, flushing, sweating, tiredness and blurred vision may occur. Anxiety symptoms may temporarily worsen when you first start taking clomipramine. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener). Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., confusion, depression, memory problems), enlarged/painful breasts, unwanted breast milk production, irregular/painful menstrual periods, muscle stiffness, ringing in the ears, sexual problems (e.g., decreased sexual ability, changes in desire), shakiness (tremors), numbness/tingling of the hands/feet, trouble urinating, easy bruising/bleeding, unusual/uncontrolled movements (especially of the tongue/face/lips), severe stomach/abdominal pain, dark urine, yellowing of eyes/skin. This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take. Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness. Get medical help right away if you have any very serious side effects, including: black stools, chest pain, fainting, slow/fast/irregular heartbeat, seizures, vomit that looks like coffee grounds, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking clomipramine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (e.g., imipramine, nortriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., purpura, thrombocytopenia), breathing problems (e.g., asthma, chronic bronchitis), personal or family history of glaucoma (angle-closure type), eating disorders (e.g., bulimia), heart problems (e.g., arrhythmias, coronary artery disease, recent heart attack), intestinal problems (e.g., chronic constipation, ileus), liver problems, kidney problems, personal or family history of other mental/mood conditions (e.g., bipolar disorder, schizophrenia), history of hospitalization for a very serious reaction to certain medications (neuroleptic malignant syndrome), heartburn/stomach acid in the esophagus (e.g., due to hiatal hernia), seizures, overactive thyroid (hyperthyroidism), trouble urinating (urinary retention, enlarged prostate), any condition that may increase your risk of seizures (e.g., alcohol/sedative dependency, use of electroconvulsive therapy, brain injury/disease), certain types of tumors (e.g., pheochromocytoma, neuroblastoma). Clomipramine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using clomipramine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using clomipramine safely. This drug may make you dizzy or drowsy or temporarily blur your vision. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. To decrease dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Before having surgery, tell your doctor or dentist that you are taking this medication. Caution is advised when using this drug in children who participate in active sports because it may increase the risk of heart problems. (See also the Warning section.) Older adults may be more sensitive to the side effects of this drug, especially bleeding, confusion, dizziness, and QT prolongation (see above). This medication should be used only when clearly needed during pregnancy. Newborns exposed to clomipramine during pregnancy may experience withdrawal symptoms or side effects. Tell your doctor right away if you notice jitteriness, shaking, feeding problems, fast breathing, or seizures in your newborn. Since untreated mental/mood problems (such as obsessive compulsive disorder, depression, panic attack) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: See also the How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: anticholinergics (e.g., atropine, belladonna alkaloids, scopolamine), certain drugs for high blood pressure (e.g., clonidine, guanethidine), cisapride, digoxin, thyroid supplements, valproic acid, drugs that can cause bleeding/bruising (e.g., "blood thinners" such as warfarin/heparin, anti-platelet drugs including aspirin or NSAIDs such as ibuprofen). Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication. The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. Many drugs besides clomipramine may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, quinidine, sotalol, pimozide, procainamide, macrolide antibiotics (such as erythromycin), among others. Therefore, before using clomipramine, report all medications you are currently using to your doctor or pharmacist. Other medications can affect the removal of clomipramine from your body, which may affect how clomipramine works. Examples include artemether/lumefantrine, barbiturates (such as phenobarbital), cimetidine, haloperidol, certain drugs for heart rhythm (such as flecainide/propafenone), certain HIV protease inhibitors (such as fosamprenavir), phenothiazines (such as thioridazine), certain anti-seizure drugs (such as phenytoin), terbinafine. Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and narcotic pain relievers (such as codeine, hydrocodone). Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, naproxen) that, if taken together with this drug, may increase your risk for bleeding. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-containing ingredients or decongestants that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products. Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, severe dizziness, fainting, delirium, seizures, loss of consciousness.

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CLOMIPRAMINE 25 MG CAPSULE

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MYLAN 3025, MYLAN 3025
CLOMIPRAMINE 50 MG CAPSULE

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MYLAN 3050, MYLAN 3050
CLOMIPRAMINE 75 MG CAPSULE

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MYLAN 3075, MYLAN 3075

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M, 25 mg

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M, 50 mg

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M, 75 mg
ANAFRANIL 25 MG CAPSULE

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ANAFRANIL 25 mg, M
ANAFRANIL 50 MG CAPSULE

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ANAFRANIL 50 mg
ANAFRANIL 75 MG CAPSULE

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ANAFRANIL 75 mg, M

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Faq for CLOMIPRAMINE - ORAL

Clomipramine is used to treat obsessive-compulsive disorder (OCD) and symptoms such as recurrent thoughts or feelings and repetitive behaviors.

Clomipramine works by balancing certain natural substances in the brain, called neurotransmitters, which are involved in mood and behavior regulation.

Individual response to Clomipramine can vary, but it may take several weeks for the medication to improve symptoms. It is important to follow your doctor's instructions and continue taking the medication as prescribed.

Common side effects of Clomipramine may include drowsiness, dizziness, dry mouth, constipation, blurred vision, or weight changes. Notify your doctor if these side effects persist or worsen.

Clomipramine can interact with certain medications, such as monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs). Inform your doctor of all medications you are taking, including over-the-counter drugs and herbal supplements, to avoid potential interactions.

It is important to consult your doctor before using Clomipramine during pregnancy or breastfeeding. The potential risks and benefits must be carefully evaluated.

No, Clomipramine should not be stopped suddenly without consulting your doctor. A gradual dose reduction is usually recommended to minimize withdrawal symptoms.

Clomipramine is typically taken orally with or without food. The dosage and frequency will be determined by your doctor based on your condition and response to treatment.

No, Clomipramine is not known to be habit-forming. However, sudden discontinuation may lead to withdrawal symptoms, so it is important to follow your doctor's instructions for proper discontinuation.


Warning

WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition. Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.