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SARAFEM

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Overview

What is SARAFEM?

SARAFEM (fluoxetine hydrochloride tablets) is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α, α, α -trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NO•HCl. Its molecular weight is 345.79. The structural formula is:

Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.

Each SARAFEM tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 15 mg (48.5 µmol) or 20 mg (64.7 µmol) of fluoxetine. Each tablet also contains microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, FD&C Yellow No. 6 aluminum lake (10 mg and 20 mg tablets) and D&C Yellow No. 10 aluminum lake (10 mg and 20 mg tablets).



What does SARAFEM look like?



What are the available doses of SARAFEM?

What should I talk to my health care provider before I take SARAFEM?

How should I use SARAFEM?

SARAFEM is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD) ()

The recommended dose of SARAFEM for the treatment of PMDD is 20 mg/day given continuously (every day of the menstrual cycle) or intermittently (defined as starting a daily dose 14 days prior to the anticipated onset of menstruation through the first full day of menses and repeating with each new cycle). The dosing regimen should be based on individual patient characteristics. In a study comparing continuous dosing of fluoxetine 20 and 60 mg/day to placebo, both doses were proven to be effective, but there was no statistically significant added benefit for the 60 mg/day compared with the 20 mg/day dose. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with PMDD. The maximum fluoxetine dose should not exceed 80 mg/day

Systematic evaluation of SARAFEM has shown that its efficacy in PMDD is maintained for periods of up to 6 months at a dose of 20 mg/day given continuously and up to 3 months at a dose of 20 mg/day given intermittently   Patients should be periodically re-assessed to determine the need for continued treatment.


What interacts with SARAFEM?

Sorry No Records found


What are the warnings of SARAFEM?

Sorry No Records found


What are the precautions of SARAFEM?

Sorry No Records found


What are the side effects of SARAFEM?

Sorry No records found


What should I look out for while using SARAFEM?

Serotonin Syndrome and MAOIs: Do not use with MAOIs intended to treat psychiatric disorders with SARAFEM or within 5 weeks of stopping treatment with SARAFEM. Do not use SARAFEM within 14 days of stopping an MAIO intended to treat psychiatric disorders. In addition, do not start SARAFEM in a patient who is being treated with linezolid or intravenous methylene blue ()

Do not use with pimozide due to risk of drug interaction or QT prolongation (, )

Do not use with thioridazine due to QTc interval prolongation or potential for elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing SARAFEM (, )

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 SARAFEM 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. SARAFEM is not approved for use in pediatric patients

[see

and

].


What might happen if I take too much SARAFEM?


How should I store and handle SARAFEM?

Store at 25˚ C (77˚ F); excursions permitted to 15˚ - 30˚ C (59˚ - 86˚ F) [see USP Controlled Room Temperature]Fenofibric acid delayed-release capsules 45 mg have a brown opaque cap/ yellow opaque body size ‘3’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘138’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-244-30                30 Capsules HDPE Bottle Pack NDC 46708-244-90                90 Capsules HDPE Bottle PackNDC 46708-244-91                1000 Capsules HDPE Bottle Pack Fenofibric acid delayed-release capsules 135 mg have a blue opaque cap/ yellow opaque body size ‘0’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘139’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-245-30                30 Capsules HDPE Bottle Pack NDC 46708-245-90                90 Capsules HDPE Bottle PackNDC 46708-245-91                1000 Capsules HDPE Bottle Pack Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. Fenofibric acid delayed-release capsules 45 mg have a brown opaque cap/ yellow opaque body size ‘3’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘138’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-244-30                30 Capsules HDPE Bottle Pack NDC 46708-244-90                90 Capsules HDPE Bottle PackNDC 46708-244-91                1000 Capsules HDPE Bottle Pack Fenofibric acid delayed-release capsules 135 mg have a blue opaque cap/ yellow opaque body size ‘0’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘139’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-245-30                30 Capsules HDPE Bottle Pack NDC 46708-245-90                90 Capsules HDPE Bottle PackNDC 46708-245-91                1000 Capsules HDPE Bottle Pack Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. Fenofibric acid delayed-release capsules 45 mg have a brown opaque cap/ yellow opaque body size ‘3’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘138’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-244-30                30 Capsules HDPE Bottle Pack NDC 46708-244-90                90 Capsules HDPE Bottle PackNDC 46708-244-91                1000 Capsules HDPE Bottle Pack Fenofibric acid delayed-release capsules 135 mg have a blue opaque cap/ yellow opaque body size ‘0’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘139’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-245-30                30 Capsules HDPE Bottle Pack NDC 46708-245-90                90 Capsules HDPE Bottle PackNDC 46708-245-91                1000 Capsules HDPE Bottle Pack Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. Fenofibric acid delayed-release capsules 45 mg have a brown opaque cap/ yellow opaque body size ‘3’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘138’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-244-30                30 Capsules HDPE Bottle Pack NDC 46708-244-90                90 Capsules HDPE Bottle PackNDC 46708-244-91                1000 Capsules HDPE Bottle Pack Fenofibric acid delayed-release capsules 135 mg have a blue opaque cap/ yellow opaque body size ‘0’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘139’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-245-30                30 Capsules HDPE Bottle Pack NDC 46708-245-90                90 Capsules HDPE Bottle PackNDC 46708-245-91                1000 Capsules HDPE Bottle Pack Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. Fenofibric acid delayed-release capsules 45 mg have a brown opaque cap/ yellow opaque body size ‘3’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘138’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-244-30                30 Capsules HDPE Bottle Pack NDC 46708-244-90                90 Capsules HDPE Bottle PackNDC 46708-244-91                1000 Capsules HDPE Bottle Pack Fenofibric acid delayed-release capsules 135 mg have a blue opaque cap/ yellow opaque body size ‘0’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘139’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-245-30                30 Capsules HDPE Bottle Pack NDC 46708-245-90                90 Capsules HDPE Bottle PackNDC 46708-245-91                1000 Capsules HDPE Bottle Pack Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. Fenofibric acid delayed-release capsules 45 mg have a brown opaque cap/ yellow opaque body size ‘3’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘138’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-244-30                30 Capsules HDPE Bottle Pack NDC 46708-244-90                90 Capsules HDPE Bottle PackNDC 46708-244-91                1000 Capsules HDPE Bottle Pack Fenofibric acid delayed-release capsules 135 mg have a blue opaque cap/ yellow opaque body size ‘0’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘139’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-245-30                30 Capsules HDPE Bottle Pack NDC 46708-245-90                90 Capsules HDPE Bottle PackNDC 46708-245-91                1000 Capsules HDPE Bottle Pack Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. Fenofibric acid delayed-release capsules 45 mg have a brown opaque cap/ yellow opaque body size ‘3’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘138’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-244-30                30 Capsules HDPE Bottle Pack NDC 46708-244-90                90 Capsules HDPE Bottle PackNDC 46708-244-91                1000 Capsules HDPE Bottle Pack Fenofibric acid delayed-release capsules 135 mg have a blue opaque cap/ yellow opaque body size ‘0’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘139’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-245-30                30 Capsules HDPE Bottle Pack NDC 46708-245-90                90 Capsules HDPE Bottle PackNDC 46708-245-91                1000 Capsules HDPE Bottle Pack Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. Fenofibric acid delayed-release capsules 45 mg have a brown opaque cap/ yellow opaque body size ‘3’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘138’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-244-30                30 Capsules HDPE Bottle Pack NDC 46708-244-90                90 Capsules HDPE Bottle PackNDC 46708-244-91                1000 Capsules HDPE Bottle Pack Fenofibric acid delayed-release capsules 135 mg have a blue opaque cap/ yellow opaque body size ‘0’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘139’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-245-30                30 Capsules HDPE Bottle Pack NDC 46708-245-90                90 Capsules HDPE Bottle PackNDC 46708-245-91                1000 Capsules HDPE Bottle Pack Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. Fenofibric acid delayed-release capsules 45 mg have a brown opaque cap/ yellow opaque body size ‘3’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘138’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-244-30                30 Capsules HDPE Bottle Pack NDC 46708-244-90                90 Capsules HDPE Bottle PackNDC 46708-244-91                1000 Capsules HDPE Bottle Pack Fenofibric acid delayed-release capsules 135 mg have a blue opaque cap/ yellow opaque body size ‘0’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘139’ on the body in black ink, filled with white to off white mini tablets. NDC 46708-245-30                30 Capsules HDPE Bottle Pack NDC 46708-245-90                90 Capsules HDPE Bottle PackNDC 46708-245-91                1000 Capsules HDPE Bottle Pack Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. 


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology
Serotonin Syndrome and MAOIs: Do not use with MAOIs intended to treat psychiatric disorders with SARAFEM or within 5 weeks of stopping treatment with SARAFEM. Do not use SARAFEM within 14 days of stopping an MAIO intended to treat psychiatric disorders. In addition, do not start SARAFEM in a patient who is being treated with linezolid or intravenous methylene blue ()

Do not use with pimozide due to risk of drug interaction or QT prolongation (, )

Do not use with thioridazine due to QTc interval prolongation or potential for elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing SARAFEM (, )

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 SARAFEM 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. SARAFEM is not approved for use in pediatric patients

[see

and

].

The following drug interactions were studied with ketoprofen doses of 200 mg/day. The possibility of increased interaction should be kept in mind when ketoprofen capsule doses greater than 50 mg as a single dose or 200 mg of ketoprofen per day are used concomitantly with highly bound drugs.

Patients with Major Depressive Disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) 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; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, Obsessive Compulsive Disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug versus placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, that is, beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for Major Depressive Disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms

Families and caregivers of patients being treated with antidepressants for Major Depressive Disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers.

It should be noted that SARAFEM is not approved for treating any indication in the pediatric population.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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