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Luvox CR
Overview
What is Luvox CR?
LUVOX CR is an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones.
Fluvoxamine maleate is chemically designated as 5-methoxy-4'-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the empirical formula CHONF•CHO. Its molecular weight is 434.41.
The structural formula is:
Fluvoxamine maleate is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether.
LUVOX CR Capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate, each capsule contains the following inactive ingredients: talc, sugar spheres, ammonio methacrylate copolymer type B, dibutyl sebacate, red iron oxide, FD&C Blue No. 2, titanium dioxide, gelatin (porcine- or bovine-derived), and Opacode Grey. LUVOX CR Capsules are gluten-free.
What does Luvox CR look like?
What are the available doses of Luvox CR?
LUVOX CR Capsules are available as:
100 mg Extended-Release Capsules: a two-piece gelatin capsule (dark blue opaque cap/white opaque body) imprinted with on one side of the cap and LCR 100 on the other side of the cap.
150 mg Extended-Release Capsules: a two-piece gelatin capsule (dark blue opaque cap/powder blue opaque body) imprinted with on one side of the cap and LCR 150 on the other side of the cap.
What should I talk to my health care provider before I take Luvox CR?
Specific populations not discussed in or include:
How should I use Luvox CR?
LUVOX CR Capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) .
Efficacy was demonstrated in:
The recommended starting dose is 100 mg at bedtime, with weekly increases of 50 mg as tolerated to maximum therapeutic benefit, not to exceed 300 mg per day.
Capsules should not be crushed or chewed.
What interacts with Luvox CR?
Sorry No Records found
What are the warnings of Luvox CR?
Sorry No Records found
What are the precautions of Luvox CR?
Sorry No Records found
What are the side effects of Luvox CR?
Sorry No records found
What should I look out for while using Luvox CR?
Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with LUVOX CR Capsules is contraindicated (see ).
What might happen if I take too much Luvox CR?
How should I store and handle Luvox CR?
StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See .] StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See .] Metronidazole tablets USP, 250 mg are available as round, convex, white compressed tablets debossed with “WPI” on one side and “3969” on the other side. Metronidazole tablets USP, 500 mg are available as oblong, scored, white compressed tablets debossed with “WPI” on one side and “39” - “70” on the other side. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).500mg - NDC: 35356-890-30 Bottles of 30NDC: 35356-890-60 Bottles of 60NDC: 35356-890-90 Bottles of 90Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by: Verna, Salcette Goa 403 722 INDIA Distributed by: Parsippany, NJ 07054 USARevised: April 2013Metronidazole tablets USP, 250 mg are available as round, convex, white compressed tablets debossed with “WPI” on one side and “3969” on the other side. Metronidazole tablets USP, 500 mg are available as oblong, scored, white compressed tablets debossed with “WPI” on one side and “39” - “70” on the other side. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).500mg - NDC: 35356-890-30 Bottles of 30NDC: 35356-890-60 Bottles of 60NDC: 35356-890-90 Bottles of 90Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by: Verna, Salcette Goa 403 722 INDIA Distributed by: Parsippany, NJ 07054 USARevised: April 2013Metronidazole tablets USP, 250 mg are available as round, convex, white compressed tablets debossed with “WPI” on one side and “3969” on the other side. Metronidazole tablets USP, 500 mg are available as oblong, scored, white compressed tablets debossed with “WPI” on one side and “39” - “70” on the other side. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).500mg - NDC: 35356-890-30 Bottles of 30NDC: 35356-890-60 Bottles of 60NDC: 35356-890-90 Bottles of 90Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by: Verna, Salcette Goa 403 722 INDIA Distributed by: Parsippany, NJ 07054 USARevised: April 2013Metronidazole tablets USP, 250 mg are available as round, convex, white compressed tablets debossed with “WPI” on one side and “3969” on the other side. Metronidazole tablets USP, 500 mg are available as oblong, scored, white compressed tablets debossed with “WPI” on one side and “39” - “70” on the other side. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).500mg - NDC: 35356-890-30 Bottles of 30NDC: 35356-890-60 Bottles of 60NDC: 35356-890-90 Bottles of 90Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by: Verna, Salcette Goa 403 722 INDIA Distributed by: Parsippany, NJ 07054 USARevised: April 2013Metronidazole tablets USP, 250 mg are available as round, convex, white compressed tablets debossed with “WPI” on one side and “3969” on the other side. Metronidazole tablets USP, 500 mg are available as oblong, scored, white compressed tablets debossed with “WPI” on one side and “39” - “70” on the other side. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).500mg - NDC: 35356-890-30 Bottles of 30NDC: 35356-890-60 Bottles of 60NDC: 35356-890-90 Bottles of 90Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by: Verna, Salcette Goa 403 722 INDIA Distributed by: Parsippany, NJ 07054 USARevised: April 2013Metronidazole tablets USP, 250 mg are available as round, convex, white compressed tablets debossed with “WPI” on one side and “3969” on the other side. Metronidazole tablets USP, 500 mg are available as oblong, scored, white compressed tablets debossed with “WPI” on one side and “39” - “70” on the other side. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).500mg - NDC: 35356-890-30 Bottles of 30NDC: 35356-890-60 Bottles of 60NDC: 35356-890-90 Bottles of 90Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by: Verna, Salcette Goa 403 722 INDIA Distributed by: Parsippany, NJ 07054 USARevised: April 2013Metronidazole tablets USP, 250 mg are available as round, convex, white compressed tablets debossed with “WPI” on one side and “3969” on the other side. Metronidazole tablets USP, 500 mg are available as oblong, scored, white compressed tablets debossed with “WPI” on one side and “39” - “70” on the other side. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).500mg - NDC: 35356-890-30 Bottles of 30NDC: 35356-890-60 Bottles of 60NDC: 35356-890-90 Bottles of 90Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by: Verna, Salcette Goa 403 722 INDIA Distributed by: Parsippany, NJ 07054 USARevised: April 2013Metronidazole tablets USP, 250 mg are available as round, convex, white compressed tablets debossed with “WPI” on one side and “3969” on the other side. Metronidazole tablets USP, 500 mg are available as oblong, scored, white compressed tablets debossed with “WPI” on one side and “39” - “70” on the other side. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).500mg - NDC: 35356-890-30 Bottles of 30NDC: 35356-890-60 Bottles of 60NDC: 35356-890-90 Bottles of 90Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by: Verna, Salcette Goa 403 722 INDIA Distributed by: Parsippany, NJ 07054 USARevised: April 2013Metronidazole tablets USP, 250 mg are available as round, convex, white compressed tablets debossed with “WPI” on one side and “3969” on the other side. Metronidazole tablets USP, 500 mg are available as oblong, scored, white compressed tablets debossed with “WPI” on one side and “39” - “70” on the other side. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).500mg - NDC: 35356-890-30 Bottles of 30NDC: 35356-890-60 Bottles of 60NDC: 35356-890-90 Bottles of 90Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by: Verna, Salcette Goa 403 722 INDIA Distributed by: Parsippany, NJ 07054 USARevised: April 2013
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of fluvoxamine maleate in obsessive compulsive disorder is presumed to be linked to its specific serotonin reuptake inhibition in brain neurons. Fluvoxamine has been shown to be a potent inhibitor of the serotonin reuptake transporter in preclinical studies, both and .
Non-Clinical Toxicology
Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with LUVOX CR Capsules is contraindicated (see ).Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when metronidazole is prescribed for patients on this type of anticoagulant therapy.
The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma levels; impaired clearance of phenytoin has also been reported.
The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole. In patients stabilized on relatively high doses of lithium, short-term metronidazole therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Serum lithium and serum creatinine levels should be obtained several days after beginning metronidazole to detect any increase that may precede clinical symptoms of lithium intoxication.
Alcoholic beverages should not be consumed during metronidazole therapy and for at least one day afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur.
Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. Metronidazole should not be given to patients who have taken disulfiram within the last two weeks.
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. The 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 18-24) 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 age 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 vs 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 the drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., 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.
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 (see , for a description of the risks of discontinuation of ).
. Prescriptions for LUVOX CR Capsules should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that LUVOX CR Capsules are not approved for use in treating bipolar depression.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
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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