Anafranil

Anafranil is a prescription medication used to treat symptoms of obsessive-compulsive disorder (OCD). Anafranil belongs to a class of drugs called tricyclic antidepressants. These work by increasing the amount of serotonin in your brain, a naturally occurring chemical that is involved in mental balance.

This medication comes in an oral (by mouth) capsule form and is usually taken once a day, at bedtime. At the beginning of treatment with Anafranil, it is usually given in divided doses, with food.

Common side effects of Anafranil include dry mouth, headache, constipation, and uncontrollable shaking in a part of the body.

Anafranil can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Anafranil affects you.

Anafranil is a prescription medication used to treat symptoms of obsessive-compulsive disorder (OCD), a mental illness that causes people to have consistent worry and stressful thoughts that create a need to perform compulsive behaviors repeatedly. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Mallinckrodt Pharmaceutical Division

• Mallinckrodt, Inc.

Serious side effects have been reported with Anafranil. See the "Anafranil Precautions" section.

Common side effects of Anafranil include the following:

• dry mouth
• constipation
• nausea
• vomiting
• diarrhea
• dyspepsia (indigestion)
• drowsiness
• dizziness
• nervousness
• headache
• changes in weight or eating habits
• changes in sexual desire

This is not a complete list of Anafranil side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• anticoagulants ("blood thinners") such as warfarin (Coumadin, Jantoven)
• benztropine (Cogentin)
• cimetidine (Tagamet)
• clonidine (Catapres)
• dicyclomine (Bentyl)
• digoxin (Lanoxin)
• disulfiram
• flecainide (Tambocor)
• guanethidine (Ismelin)
• haloperidol (Haldol)
• levodopa (Sinemet, Dopar)
• linezolid (Zyvox)
• medications for nausea, dizziness, or mental illness
• methylene blue
• methylphenidate (Concerta, Metadate, Ritalin)
• oral contraceptives
• phenobarbital
• phenytoin
• propafenone (Rythmol)
• quinidine
• secobarbital (Seconal)
• sedatives
• selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac, Sarafem), sertraline (Zoloft), and paroxetine (Paxil)
• tranquilizers
• trihexyphenidyl (Artane)

This is not a complete list of Anafranil drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Anafranil, including the following:

• uncontrollable shaking
• fast, irregular, or pounding heartbeat
• difficulty urinating or loss of bladder control
• believing things that are not true
• hallucinations
• difficulty breathing or fast breathing
• severe muscle stiffness
• unusual tiredness or weakness
• sore throat, fever, and other signs of infection

Anafranil can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Anafranil affects you.

Do not take Anafranil if you:

• are allergic to Anafranil or to any of its ingredients
• have taken a monoamine oxidase inhibitor in the last 14 days
• are taking linezolid
• are taking methylene blue
• have recently had a heart attack

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Anafranil, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Anafranil, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Anafranil or to any of its ingredients
• are allergic to any other tricyclic antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), desipramine (Norpromin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
• have recently had a heart attack
• are being treated with electroshock therapy
• if you drink large amounts of alcohol
• if you have or have had seizures
• if you have or have had brain damage
• if you have problems with your urinary system
• if you have an irregular hearbeat
• if you have problems with your blood pressure
• if you have thyroid problems
• if you have heart disease
• if you have kidney disease
• if you have liver disease
• if you are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if yo are pregnant or plan to become pregnant. 

The FDA categorizes medication based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possibel risks to an unborn baby when a medication is taken during pregnancy.

Anafranil falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Anafranil has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Anafranil, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Anafranil exactly as prescribed.

Anafranil comes in oral capsule form and it is taken 1 to 3 times a day. At the beginning of treatment, take Anafranil with food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of Anafranil at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medications you are taking
• how you respond to this medication
• your weight
• your age

The initial recommended dose of Anafranil is 25 mg daily. The dose should be gradually increased, as tolerated, to approximately 100 mg daily during the first 2 weeks. The maximum recommended dose of Anafranil is 250 mg daily.

Initially, the medication should be divided into 3 doses and taken with meals. After the dose has been increased, the total daily dose may be given once daily, at bedtime.

If you take too much Anafranil, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Anafranil is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Anafranil at room temperature.
• Keep this and all medicines out of the reach of children.

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of clomipramine hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Clomipramine hydrochloride is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD).