ANAFRANIL- clomipramine hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOMIPRAMINE HYDROCHLORIDE (UNII: 2LXW0L6GWJ) (CLOMIPRAMINE - UNII:NUV44L116D)

Available from:

SpecGx LLC

INN (International Name):

CLOMIPRAMINE HYDROCHLORIDE

Composition:

CLOMIPRAMINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Anafranil™ (clomipramine hydrochloride) Capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Anafranil for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of Anafranil for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Anafranil for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Anafranil is contraindicated in patients with a history of hypersensitivity to Anafranil or other tricyclic antidepressants. Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with Anafranil or within 14 days of stopping treatment with Anafranil is contraindicated because of an increased risk of serotonin syndrome.  The use of Anafranil within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see  WARNINGS   and DOSAGE AND ADMINISTRATION ). Starting Anafranil in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see  WARNINGS   and DOSAGE AND ADMINISTRATION ). Myocardial Infarction Anafranil is contraindicated during the acute recovery period after a myocardial infarction. Anafranil has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. While a variety of withdrawal symptoms have been described in association with Anafranil discontinuation (see PRECAUTIONS, Withdrawal Symptoms ), there is no evidence for drug-seeking behavior, except for a single report of potential Anafranil abuse by a patient with a history of dependence on codeine, benzodiazepines, and multiple psychoactive drugs. The patient received Anafranil for depression and panic attacks and appeared to become dependent after hospital discharge. Despite the lack of evidence suggesting an abuse liability for Anafranil in foreign marketing, it is not possible to predict the extent to which Anafranil might be misused or abused once marketed in the U.S. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.

Product summary:

Anafranil™ (clomipramine hydrochloride) Capsules USP Capsules 25 mg – ivory body imprinted in black with "" and melon-yellow cap imprinted in black with "ANAFRANIL 25 mg"       Bottles of 30………....………...……….....………… NDC 0406-9906-03 Capsules 50 mg – ivory body imprinted in black with "" and aqua blue cap imprinted in black with "ANAFRANIL 50 mg"       Bottles of 30………..………....………...……….....…NDC 0406-9907-03 Capsules 75 mg – ivory body imprinted in black with "" and yellow cap imprinted in black with "ANAFRANIL 75 mg"        Bottles of 30………..………...……….....………....…NDC 0406-9908-03 Storage – Store at 20º to 25ºC (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers with a child-resistant closure. Protect from moisture.

Authorization status:

New Drug Application

Patient Information leaflet

ANAFRANIL- CLOMIPRAMINE HYDROCHLORIDE CAPSULE
SpecGx LLC
----------
MEDICATION GUIDE - ANAFRANIL™
(CLOMIPRAMINE HYDROCHLORIDE)
CAPSULES USP
ANTIDEPRESSANT MEDICINES,
DEPRESSION AND OTHER SERIOUS MENTAL
ILLNESSES, AND SUICIDAL THOUGHTS OR
ACTIONS
Read the Medication Guide that comes with you or your family member's
antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant medicines.
Talk to your, or your family member's, healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers,
and young adults within the first few months of treatment.
2.
Depression and other serious mental illnesses are the most important
causes of suicidal thoughts
and actions. Some people may have a particularly high risk of having
suicidal thoughts or actions.
These include people who have (or have a family history of) bipolar
illness (also called manic-
depressive illness) or suicidal thoughts or actions.
3.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family
member?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors,
thoughts, or feelings. This is very important when an antidepressant
medicine is started or
when the dose is changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call a healthcare provider right away if you or your family member has
any of the following symptoms,
especially i

Summary of Product characteristics

ANAFRANIL- CLOMIPRAMINE HYDROCHLORIDE CAPSULE
SPECGX LLC
----------
ANAFRANIL
(CLOMIPRAMINE HYDROCHLORIDE) CAPSULES USP
(25 MG, 50 MG, AND 75 MG)
RX ONLY
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) (_SEE _WARNINGS, CLINICAL
WORSENING AND SUICIDE RISK; PRECAUTIONS, INFORMATION FOR PATIENTS;
_AND _PRECAUTIONS, PEDIATRIC USE).
DESCRIPTION
Anafranil
(clomipramine hydrochloride) Capsules USP is an antiobsessional drug
that
belongs to the class (dibenzazepine) of pharmacologic agents known as
tricyclic
antidepressants. Anafranil is available as capsules of 25, 50, and 75
mg for oral
administration.
Clomipramine hydrochloride USP is
3-chloro-5-[3-(dimethylamino)propyl]-10,11-
dihydro-_5H_-dibenz[_b,f_] azepine monohydrochloride, and its
structural formula is:
™
™
Clomipramine hydrochloride USP is a white to off-white crystalline
powder. It is freely