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Fluoxetine HCl
Overview
What is Fluoxetine HCl?
Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)--methyl-3-phenyl-3-[(α,α,α-trifluoro--tolyl)oxy]propylamine hydrochloride and has the empirical formula of CHFNO•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 scored tablet contains fluoxetine hydrochloride equivalent to 60 mg (194 μmol) of fluoxetine. In addition, each scored tablet also contains the following inactive ingredients: mannitol, microcrystalline cellulose, maize starch, povidone, hypromellose, magnesium stearate, titanium dioxide, sucrose, glycerol, and polysorbate.
What does Fluoxetine HCl look like?
What are the available doses of Fluoxetine HCl?
Fluoxetine tablets, USP 60 mg, are available as 60-mg (fluoxetine base equivalent), film coated, functionally scored, capsule-shaped, white tablets debossed with “FL 60” on one side (“FL” above the score and “60” below the score).
What should I talk to my health care provider before I take Fluoxetine HCl?
How should I use Fluoxetine HCl?
Fluoxetine is indicated for the treatment of:
This product is only available in a 60-mg dosage form. A 30-mg dose may be achieved with one-half of the scored tablet. Use of this product requires initial titration with another fluoxetine product according to the dosing guidelines indicated below.
What interacts with Fluoxetine HCl?
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What are the warnings of Fluoxetine HCl?
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What are the precautions of Fluoxetine HCl?
Sorry No Records found
What are the side effects of Fluoxetine HCl?
Sorry No records found
What should I look out for while using Fluoxetine HCl?
Monoamine Oxidase Inhibitors (MAOIs):
Pimozide
Thioridazine:
•
What might happen if I take too much Fluoxetine HCl?
How should I store and handle Fluoxetine HCl?
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Clindamycin hydrochloride capsules, USP (equivalent to 150 mg of clindamycin) are opaque gray and opaque pink capsules imprinted supplied in bottles of 100.Clindamycin hydrochloride capsules, USP (equivalent to 300 mg of clindamycin) are opaque pink capsules imprinted supplied in bottles of 100.Dispense in a tight container with a child-resistant closure.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Clindamycin hydrochloride capsules, USP (equivalent to 150 mg of clindamycin) are opaque gray and opaque pink capsules imprinted supplied in bottles of 100.Clindamycin hydrochloride capsules, USP (equivalent to 300 mg of clindamycin) are opaque pink capsules imprinted supplied in bottles of 100.Dispense in a tight container with a child-resistant closure.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Clindamycin hydrochloride capsules, USP (equivalent to 150 mg of clindamycin) are opaque gray and opaque pink capsules imprinted supplied in bottles of 100.Clindamycin hydrochloride capsules, USP (equivalent to 300 mg of clindamycin) are opaque pink capsules imprinted supplied in bottles of 100.Dispense in a tight container with a child-resistant closure.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Clindamycin hydrochloride capsules, USP (equivalent to 150 mg of clindamycin) are opaque gray and opaque pink capsules imprinted supplied in bottles of 100.Clindamycin hydrochloride capsules, USP (equivalent to 300 mg of clindamycin) are opaque pink capsules imprinted supplied in bottles of 100.Dispense in a tight container with a child-resistant closure.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Although the exact mechanism of fluoxetine is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.
Non-Clinical Toxicology
Monoamine Oxidase Inhibitors (MAOIs):Pimozide
Thioridazine:
•
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.
In vitro
Antagonism has been demonstrated between clindamycin and erythromycin . Because of possible clinical significance, these two drugs should not be administered concurrently.
Patients with 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 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, 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 .
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, ie, 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 MDD 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 MDD 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. Prescriptions for fluoxetine should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
It should be noted that fluoxetine is approved in the pediatric population only for MDD and OCD.
The following adverse reactions are discussed in more detail in other sections of the labeling:
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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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. 315.72Tips
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Interactions
Interactions
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