Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
CLOMIPRAMINE HYDROCHLORIDE (UNII: 2LXW0L6GWJ) (CLOMIPRAMINE - UNII:NUV44L116D)
PD-Rx Pharmaceuticals, Inc.
CLOMIPRAMINE HYDROCHLORIDE
CLOMIPRAMINE HYDROCHLORIDE 25 mg
ORAL
PRESCRIPTION DRUG
Clomipramine hydrochloride capsules are 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 clomipramine hydrochloride capsules 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-
Clomipramine Hydrochloride Capsules, USP are available containing 25 mg of clomipramine hydrochloride, USP. The 25 mg capsules are hard shell gelatin capsules with a medium orange opaque cap and pink opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 3025 in black ink on both the cap and the body. They are available as follows: NDC 43063-257-30 bottles of 30 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
CLOMIPRAMINE HYDROCHLORIDE- clomipramine hydrochloride capsule PD-Rx Pharmaceuticals, Inc. ---------- Medication Guide Clomipramine Hydrochloride Capsules, USP (kloe mip' ra meen hye'' droe klor' ide) 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? 1. 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. 2. Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. 3. 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. 4. Call a healthcare provider right away if you or your Prečítajte si celý dokument
CLOMIPRAMINE HYDROCHLORIDE- CLOMIPRAMINE HYDROCHLORIDE CAPSULE PD-RX PHARMACEUTICALS, INC. ---------- 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 PEDIATRIC USE). DESCRIPTION Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belong to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride 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 or slightly yellow, crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble i Prečítajte si celý dokument