Anafranil

Pronunciation

Generic Name: clomipramine (Oral route)

kloe-MIP-ra-meen

Oral route(Capsule)

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) .

Commonly used brand name(s)

In the U.S.

  • Anafranil

Available Dosage Forms:

  • Tablet
  • Capsule

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tricyclic

Uses For Anafranil

Clomipramine is used to treat obsessive compulsive disorder (OCD). OCD is a nervous condition where a person has recurring thoughts or ideas, or does repetitive things because they are anxious.

Slideshow: Flashback: FDA Drug Approvals 2013

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 Anafranil

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 clomipramine in children younger than 10 years of age. Safety and efficacy have not been established.

Geriatric

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 an adjustment in the dose for patients receiving clomipramine.

Pregnancy

Pregnancy Category Explanation
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.

Breast Feeding

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.

Interactions with Medicines

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.

  • Amifampridine
  • Bepridil
  • Cisapride
  • Dronedarone
  • Furazolidone
  • Grepafloxacin
  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Mesoridazine
  • Methylene Blue
  • Metoclopramide
  • Moclobemide
  • Pargyline
  • Phenelzine
  • Pimozide
  • Piperaquine
  • Procarbazine
  • Ranolazine
  • Rasagiline
  • Selegiline
  • Sparfloxacin
  • Thioridazine
  • Toloxatone
  • Tranylcypromine

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.

  • Alfuzosin
  • Almotriptan
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Amprenavir
  • Apomorphine
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Bromocriptine
  • Bupropion
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clonidine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Desipramine
  • Desvenlafaxine
  • Dextromethorphan
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Epinephrine
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Etilefrine
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Frovatriptan
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Hydroxytryptophan
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indacaterol
  • Iobenguane I 123
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Levalbuterol
  • Levofloxacin
  • Levomilnacipran
  • Levothyroxine
  • Lopinavir
  • Lorcaserin
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Methoxamine
  • Midodrine
  • Mifepristone
  • Moricizine
  • Moxifloxacin
  • Naratriptan
  • Nefopam
  • Nilotinib
  • Norepinephrine
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Oxilofrine
  • Paliperidone
  • Pazopanib
  • Perflutren Lipid Microsphere
  • Phenylephrine
  • Pixantrone
  • Posaconazole
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Saquinavir
  • Sertraline
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sunitinib
  • Tapentadol
  • Telavancin
  • Telithromycin
  • Terfenadine
  • Tetrabenazine
  • Toremifene
  • Tramadol
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Vandetanib
  • Vardenafil
  • Vasopressin
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vortioxetine
  • Ziprasidone

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.

  • Acenocoumarol
  • Arbutamine
  • Atomoxetine
  • Cannabis
  • Dicumarol
  • Enalaprilat
  • Enalapril Maleate
  • Fluvoxamine
  • Modafinil
  • Paroxetine
  • Phenprocoumon
  • S-Adenosylmethionine
  • Valproic Acid
  • Yohimbine

Interactions with Food/Tobacco/Alcohol

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.

  • 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
  • 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 or
  • Liver disease or
  • Mania or hypomania, history of or
  • Narrow-angle glaucoma, 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 Anafranil

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.

It is best to take this medicine with food.

Dosing

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 per day. Your doctor may adjust your dose if needed. Higher doses may be given in evenly divided portions during the day. The dose is usually not more than 250 mg per day.
      • Teenagers and children 10 years of age and older—At first, 25 mg once per day. Your doctor may adjust your dose if needed. Higher doses may be given in evenly divided portions during the day. 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.

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 While Using Anafranil

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.

For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourselves. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or are getting worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. 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®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking clomipramine during the 2 weeks after you stop a MAO inhibitor and wait 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 intestinal 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®), linezolid (Zyvox®), lithium (Eskalith®, Lithobid®), methylene blue, 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 will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines, medicines for hay fever, other allergies or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicine or narcotics; medicines for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines with clomipramine.

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 a 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.

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. .

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.

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.

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.

Anafranil Side Effects

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:

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
  • confusion
  • congestion
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cough
  • difficult, burning, or painful urination
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dryness or soreness of the throat
  • excessive muscle tone
  • fear or nervousness
  • feeling sad or empty
  • fever
  • frequent urge to urinate
  • hearing loss
  • hoarseness
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • lower back or side pain
  • muscle stiffness
  • muscle tension or tightness
  • muscle twitching or jerking
  • pain or tenderness around the eyes and cheekbones
  • poor concentration
  • problems in urination or increase in the amount of urine
  • rhythmic movement of muscles
  • runny nose
  • shortness of breath or troubled breathing
  • sneezing
  • stuffy nose
  • sweating
  • tender, swollen glands in the neck
  • tightness of the chest or wheezing
  • tiredness
  • trouble concentrating
  • trouble remembering
  • trouble sleeping
  • trouble swallowing
  • unusual tiredness or weakness
  • voice changes
Less common
  • Anger that is hard to control
  • anxiety
  • bloody nose
  • breast enlargement
  • burning, dry, or itching eyes
  • burning while urinating
  • changes in vision
  • chills
  • crying
  • decrease in the frequency of urination
  • decrease in urine volume
  • depersonalization
  • difficulty in passing urine (dribbling)
  • difficulty in speaking
  • discharge or excessive tearing
  • dry mouth
  • dysphoria
  • earache
  • euphoria
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of unreality
  • headache, severe and throbbing
  • hyperventilation
  • increased clear or white vaginal discharge
  • increased watering of the mouth
  • irregular heartbeats
  • irritability
  • itching of the vagina or genital area
  • mental depression
  • nausea or vomiting
  • numbness, tingling, pain, or weakness in the hands or feet
  • pain during sexual intercourse
  • pale skin
  • panic attacks
  • paranoia
  • partial or slight paralysis
  • quick to react or overreact emotionally
  • rapidly changing moods
  • redness or swelling in the ear
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • restlessness
  • sense of detachment from self or body
  • shaking
  • swelling of the face, fingers, feet, or lower legs
  • thick, white vaginal discharge with no odor or with a mild odor
  • troubled breathing with exertion
  • unusual bleeding or bruising

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:

More common
  • Acid or sour stomach
  • bad, unusual, or unpleasant aftertaste
  • belching
  • blemishes on the skin
  • blistering, crusting, irritation, itching, or reddening of the skin
  • bloated
  • change in taste
  • change or problem with discharge of semen
  • changes in vision
  • constipation
  • cracked, dry, or scaly skin
  • cramps
  • darkening or lightening of skin color
  • decreased interest in sexual intercourse
  • diarrhea
  • difficulty with moving
  • dry skin
  • excess air or gas in the stomach or intestines
  • feeling of warmth
  • full feeling
  • heartburn
  • heavy bleeding
  • hives or welts
  • inability to have or keep an erection
  • increased appetite
  • increased in sexual ability, desire, drive, or performance
  • increased interest in sexual intercourse
  • indigestion
  • joint pain
  • loss in sexual ability, desire, drive, or performance
  • pain
  • passing gas
  • pimples
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • shakiness in the legs, arms, hands, or feet
  • skin rash
  • stomach discomfort, upset, or pain
  • swelling
  • swollen joints
  • trembling or shaking of the hands or feet
Less common
  • Absent, missed, or irregular menstrual periods
  • breast pain
  • increased yawning
  • pinpoint red or purple spots on the skin
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • stopping of menstrual bleeding

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.

See also: Side effects (in more detail)

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