Description Of Product
Description: Tricyclic Antidepressant; Tertiary Amine
“ALERT: US Boxed Warning
Suicidality and antidepressant drugs:
Compared with placebo, antidepressants increase the risk 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 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 with placebo in adults older than 24 years; there was a reduction in risk with antidepressants compared with placebo in adults 65 years and older. Depression and certain other psychiatric disorders are associated with increased risk of suicide. Appropriately monitor patients of all ages who are started on antidepressant therapy and observe closely for clinical worsening, suicidality, or unusual changes in behavior. Advise families and caregivers of the need for close observation and communication with the prescriber. Clomipramine is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder (OCD).”
CSA NA – FDA Approved – REMS (N) – Can Ship
How Does It Work
Clomipramine/Anafranil enhances serotonergic neurotransmission by selectively inhibiting the reuptake of serotonin, its potency for this effect is greater than that of other tricyclic antidepressants. Anafranil/Clomipramine also blocks muscarinic cholinergic receptors as well as alpha-1 and alpha-2 adrenergic, histamine-1 and opiate receptors.
Indications For Use
Clomipramine/Anafranil is officially indicated for use in the treatment of obsessive-compulsive disorder. It may also be used off-label for use in major depressive disorder, panic disorder, and for treatment of premature ejaculation.
Premature ejaculation (PE) is also known as rapid or early ejaculation and is characterized by the following features:
Ejaculation that always or nearly always occurs prior to or within approximately one minute of vaginal penetration.
The inability to delay ejaculation on all or nearly all vaginal penetrations.
Personal feelings of distress, frustration, anxiety, and/or the avoidance of sexual intimacy.
Do not use in patients with a known hypersensitivity to clomipramine or structurally related TCAs.
Do not use during the acute recovery phase of a myocardial infarction (within 6 weeks).
Do not use in patients with congestive heart failure.
Do not use in patients receiving monoamine oxidase inhibitors currently or within 2 weeks because of the risk of serotonin syndrome.
Do not use in patients with active liver or kidney disease.
Do not use in patients with a history of blood dyscrasias and glaucoma.
Avoid using in patients 65 years of age and older.
Premature ejaculation (off-label use) – Second-Line Therapy
If SSRIs are ineffective or not tolerated: Take 12.5mg to 50mg daily
Points To Consider
Can increase risk of suicidal thoughts and behavior
Like other antidepressants, does not work for everyone
High risk medication and cannot be used in persons older than 65 years of age
Many adverse and side effects
Should be medically monitored for pulse rate and blood pressure prior and during use, ECG/cardiac status in older patients and patients with cardiac disease
Pharmacist Tips On Using
How to Take Clomipramine, Anafranil: Should be taken with food as this medication can cause stomach upset. Take the medication total daily dose at bedtime to reduce daytime sedation.
Be Careful When Starting Clomipramine, Anafranil: It can make you drowsy or dizzy. Do not drive a car or operate dangerous machinery until you know how it affects you.
Get up Slowly When Using Clomipramine, Anafranil: Dizziness, light headedness or fainting can occur when getting up from a lying or sitting position. Get up slowly.
Contact Your Doctor if You Ever Experience: Nausea, headache, agitation, weakness, confusion, and difficulty sleeping should decrease over time. If they become more severe or persist, contact your doctor. Blurred vision, constipation, irregular heartbeat, difficulty urinating, eye pain, hallucinations, shakiness, unusually slow pulse, skin rash, itching, sore throat, fever, yellowing of eyes or skin, unusual bleeding or bruising have occurred. If you notice any of these side effects, contact your doctor.
Some of the more common side effects include:
Central nervous system: Dizziness (54%), drowsiness (46% to 54%), headache (52%), fatigue (35% to 39%), insomnia (25%), nervousness (18%), myoclonus (13%)
Dermatologic: Diaphoresis (29%)
Endocrine and Metabolic: Change in libido (21%), weight gain (18%)
Gastrointestinal: Xerostomia (84%), constipation (47%), nausea (33%), dyspepsia (13% to 22%), anorexia (12% to 22%), diarrhea (7% to 13%), abdominal pain (11%), increased appetite (11%)
Genitourinary: Ejaculation failure (42%), impotence (20%), difficulty in micturition (14%)
Neuromuscular and Skeletal: Tremor (54%), myalgia (13%)
Ophthalmic: Visual disturbance (18%)
Respiratory: Pharyngitis (14%), rhinitis (12%)
Frequently Asked Questions
Do you take Clomipramine/Anafranil with food or on an empty stomach?
Take Anafranil/Clomipramine with food to reduce the likelihood of an upset stomach.
Can you drink alcohol when you are on Clomipramine/Anafranil?
You should limit or completely avoid alcohol consumption when taking Anafranil/Clomipramine because it can enhance drowsiness.
What if you miss a dose?
If you miss taking a dose, take it as soon as you remember. Take any remaining doses for that day at evenly spaced intervals. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses to make for a missed dose.
How quickly will you experience an improvement?
If you are taking this medication it may take up to 2 to 4 weeks before you notice any improvement.