Luvox CR: Black Box Warnings

Luvox CR: Adult Dosing

Dosage forms: 100,150 ER

obsessive-compulsive disorder

100-300 mg PO qhs

Start: 100 mg PO qhs, incr. 50 mg/day qwk; Max: 300 mg/day; Info: titrate slowly in elderly; use min. effective dose; periodically reassess need for tx; taper dose gradually to D/C

social anxiety disorder

100-300 mg PO qhs

Start: 100 mg PO qhs, incr. 50 mg/day qwk; Max: 300 mg/day; Info: titrate slowly in elderly; use min. effective dose; periodically reassess need for tx; taper dose gradually to D/C

renal dosing

no adjustment

hepatic dosing

see below

hepatic impairment: titrate slowly

Luvox CR: Peds Dosing

This information is currently unavailable or not applicable for this drug.

Luvox CR: Contraindications/Cautions

• hypersens. to drug/class/compon.
• see Drug Interactions
• MAO inhibitor use w/in 14 days
• caution if <25 yo
• caution if impaired liver fxn
• caution if volume depletion
• caution in elderly pts
• caution if diuretic use
• caution if seizure disorder
• caution if mania/hypomania
• avoid abrupt withdrawal
• caution if alcohol use
• caution in pregnancy >20wk gestation
• caution if bleeding risk

Luvox CR: Drug Interactions

Contraindicated

• alfuzosin

• alosetron

• cisapride

• conivaptan

• eletriptan

• eplerenone

• ergot alkaloids

• ergotamine/caffeine

• MAOIs, all

• pimozide

• ramelteon

• ranolazine

• thioridazine

• tizanidine

Avoid/Use Alternative

• almotriptan

• amiodarone

• bendamustine

• clarithromycin

• clozapine

• cyclosporine

• dasatinib

• delavirdine

• desvenlafaxine

• duloxetine

• erythromycins

• frovatriptan

• irinotecan

• ixabepilone

• lansoprazole/amoxicillin/clarithromycin

• lapatinib

• midazolam

• naratriptan

• nefazodone

• niacin/lovastatin

• niacin/simvastatin

• olanzapine/fluoxetine

• rifabutin

• rizatriptan

• sibutramine

• sildenafil

• sirolimus

• SSRIs, all

• statins, 3A4 substrates

• sumatriptan

• sumatriptan/naproxen sodium

• sunitinib

• tacrine

• tacrolimus

• tamoxifen

• temsirolimus

• triazolam

• zolmitriptan

Monitor/Modify Tx

• acetaminophen/caffeine/CNS depressant combos

• alfentanil

• amlodipine/A2R blocker combos

• amlodipine/atorvastatin

• aripiprazole

• aspirin/butalbital/caffeine

• aspirin/butalbital/caffeine/codeine

• aspirin/caffeine/dihydrocodeine

• aspirin/caffeine/orphenadrine

• beta blockers, 2D6 substrates

• budesonide

• buprenorphine

• bupropion

• caffeine

• carbamazepine

• CCBs, dihydropyridines

• CCBs, others

• cilostazol

• cinacalcet

• cyproheptadine

• darifenacin

• erlotinib

• eszopiclone

• ethosuximide

• fentanyl

• maraviroc

• mexiletine

• nateglinide

• paricalcitol

• phenytoins

• polyethylene glycol/electrolytes

• propafenone

• ropinirole

• sodium phosphate

• solifenacin

• sufentanil

• tadalafil

• theophyllines

• tolterodine

• trazodone

• warfarin

Caution Advised

• acetaminophen/propoxyphene

• acetaminophen/tramadol

• aliskiren

• alprazolam

• ambrisentan

• amprenavir

• anagrelide

• antihist/decongest/DM combos

• aprepitant

• aspirin

• aspirin, buffered/pravastatin

• aspirin/carisoprodol/codeine

• aspirin/codeine

• aspirin/dipyridamole

• aspirin/muscle relaxant combos

• aspirin/opiate combos

• atazanavir

• bexarotene

• bortezomib

• bosentan

• bromocriptine

• budesonide inhaled

• budesonide nasal

• budesonide/formoterol inhaled

• buspirone

• BZDs, partial 3A4 substrates

• cabergoline

• ciclesonide nasal

• cocaine topical

• colchicine

• darunavir

• dextromethorphan

• diclofenac topical

• disopyramide

• docetaxel

• dofetilide

• doxazosin

• esomeprazole

• ethanol

• etonogestrel subdermal implant

• fluticasone inhaled

• fluticasone nasal

• fosamprenavir

• galantamine

• gefitinib

• HRT, estrogen

• HRT, estrogen/progestin combo

• hydrocodone/ibuprofen

• ibuprofen/oxycodone

• imatinib

• indinavir

• lansoprazole

• lansoprazole/naproxen

• linezolid

• lithium

• lopinavir/ritonavir

• meperidine

• meperidine/promethazine

• methadone

• methylphenidate

• metoclopramide

• mifepristone

• mirtazapine

• mometasone inhaled

• nelfinavir

• NSAIDs

• olanzapine

• omeprazole

• oxcarbazepine

• oxybutynin

• paclitaxel

• pantoprazole

• pentazocine

• pergolide

• propoxyphene

• quetiapine

• quinidine

• rabeprazole

• repaglinide

• riluzole

• ritonavir

• ropivacaine

• rotigotine transdermal

• saquinavir

• telithromycin

• terbinafine

• tinidazole

• tipranavir

• tramadol

• trazodone

• tretinoin

• tricyclic antidepressants

• vardenafil

• venlafaxine

• vinca alkaloids

• voriconazole

• zileuton

• zonisamide

Luvox CR: Adverse Reactions

Serious Reactions

• suicidality
• depression, worsening
• serotonin syndrome
• withdrawal syndrome
• mania
• seizures
• hyponatremia
• SIADH
• priapism
• abnormal bleeding/altered platelet fxn (rare)
• neonatal persistent pulm. HTN (>20 wk gest)
• neonatal serotonin syndrome (3rd trimester)
• neonatal withdrawal (3rd trimester)

Common Reactions

• nausea
• headache
• insomnia
• somnolence
• asthenia
• diarrhea
• dizziness
• anorexia
• xerostomia
• ejaculatory dysfxn
• dyspepsia
• nervousness
• decr. libido
• anxiety
• tremor
• sweating
• constipation
• vomiting
• abdominal pain
• myalgia
• yawning
• anorgasmia
• ecchymosis
• sexual dysfxn
• chest pain
• palpitations
• abnormal dreams
• agitation
• paresthesia
• others: see pkg insert

Luvox CR: Safety Monitoring

Pregnancy: C, see Contraind/Caut.

Lactation: Probably Safe

Monitoring Parameters: sx suicidality, clinical worsening, and/or unusual behavior changes, especially during initial tx or after dose changes

Avoid Abrupt Cessation: taper dose gradually to D/C (abrupt cessation of SSRIs or SNRIs may cause a discontinuation syndrome including headache, lethargy, GI upset, insomnia, nightmares, dizziness, vertigo, electric shock sensations and other parethesias, tremor, agitation, anxiety, irritability, hypomania, dysphoria, emotional lability, confusion)

Luvox CR: Pharmacology

Metabolism: liver extensively; CYP450: 1A2, 2D6 substrate; 1A2, 2C9 (weak), 2C19, 3A4 inhibitor

Excretion: urine primarily (2% unchanged); Half-life: 16.3h, 25.9h (elderly)

Class: SSRI

Mechanism Of Action
selectively inhibits serotonin reuptake

Luvox CR: Manufacturer/Pricing

Manufacturer: Jazz Pharmaceuticals, Inc. DEA/FDA: Rx

Luvox CR: Patient Education

• Generic Name: fluvoxamine

• Pronounced: floo VOX a meen

• Brand Name: Luvox

What is the most important information I should know about fluvoxamine?

Do not take fluvoxamine together with thioridazine (Mellaril), terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), pimozide (Orap), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take fluvoxamine. After you stop taking fluvoxamine, you must wait at least 14 days before you can start taking an MAOI.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Fluvoxamine is FDA-approved for children with obsessive-compulsive disorder (OCD). It is not approved for treating depression in children. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluvoxamine, do not stop taking the medication without first talking to your doctor.

What is fluvoxamine?

Fluvoxamine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors. Fluvoxamine affects chemicals in the brain that may become unbalanced and cause obsessive-compulsive symptoms.

Fluvoxamine is used to treat obsessive-compulsive disorders involving recurring thoughts or actions.

Fluvoxamine may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking fluvoxamine?

Do not use fluvoxamine if you are using any of the following drugs:

• thioridazine (Mellaril);
• terfenadine (Seldane);
• astemizole (Hismanal);
• cisapride (Propulsid); or
• pimozide (Orap); or
• an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam).

Serious and sometimes fatal reactions can occur when these medicines are taken with fluvoxamine. You must wait at least 14 days after stopping an MAO inhibitor before you can take fluvoxamine. After you stop taking fluvoxamine, you must wait at least 14 days before you can start taking an MAOI.

Before taking fluvoxamine, tell your doctor if you have:

• liver disease;
• seizures or epilepsy;
• bipolar disorder (manic depression); or
• a history of drug abuse or suicidal thoughts.

You may not be able to take fluvoxamine, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluvoxamine, do not stop taking the medication without first talking to your doctor.

Fluvoxamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give fluvoxamine to anyone younger than 18 years old without the advice of a doctor. Fluvoxamine is FDA-approved for children with obsessive-compulsive disorder (OCD). It is not approved for treating depression in children.

How should I take fluvoxamine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from the medication.

Take each dose with water.

Try to take the medicine at the same time each day. Follow the directions on your prescription label.

It may take 4 weeks or more for you to start feeling better. Do not stop using fluvoxamine without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.

Store fluvoxamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have taken too much of this medication. Symptoms of a fluvoxamine overdose may include nausea, vomiting, blurred vision, rapid heartbeat, lack of coordination, trouble breathing, drowsiness, fainting, and coma.

What should I avoid while taking fluvoxamine?

Do not take fluvoxamine together with thioridazine (Mellaril), terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), pimozide (Orap), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

Avoid drinking alcohol, which can increase some of the side effects of fluvoxamine.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, other medication for depression or anxiety). They can add to sleepiness caused by fluvoxamine.

Fluvoxamine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What are the possible side effects of fluvoxamine?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• tremors, shivering, muscle stiffness or twitching;
• seizure (convulsions);
• problems with balance or coordination;
• unusual thoughts or behavior; or
• agitation, confusion, sweating, fast heartbeat.

Other less serious side effects are more likely to occur, such as:

• feeling nervous, restless, or unable to sit still;
• sleep problems (insomnia);
• drowsiness, weakness;
• urinating more than usual;
• loss of appetite, weight gain or loss;
• nausea, vomiting, diarrhea, gas, constipation, or upset stomach;
• decreased sex drive, impotence, or difficulty having an orgasm; or
• dry mouth, unpleasant taste in your mouth.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

You may have some side effects after you stop using fluvoxamine, including headache, nausea, vomiting, sleepiness or insomnia, nervousness, or agitation.

What other drugs will affect fluvoxamine?

Before taking fluvoxamine, tell your doctor if you are using any of the following medicines:

• clozapine (Clozaril);
• lithium (Lithobid, Eskalith);
• propranolol (Inderal, Inderal LA) or metoprolol (Lopressor, Toprol XL);
• carbamazepine (Carbatrol, Tegretol);
• warfarin (Coumadin);
• tryptophan (also called L-tryptophan);
• mexiletine (Mexitil);
• theophylline (Aerolate, Bronkodyl, Slo-Bid, Theo-Dur);
• methadone (Dolophine, Methadose);
• tacrine (Cognex);
• almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig);
• a benzodiazepine such as diazepam (Valium), alprazolam (Xanax), midazolam (Versed), or triazolam (Halcion); or
• any other antidepressants such as amitriptyline (Elavil), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), or sertraline (Zoloft).

If you are using any of these drugs, you may not be able to use fluvoxamine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect fluvoxamine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has additional information about fluvoxamine written for health professionals that you may read.

What does my medication look like?

Fluvoxamine is available with a prescription under the brand name Luvox. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Luvox 25 mg--elliptical, white, film-coated tablets
• Luvox 50 mg--elliptical, yellow, scored, film-coated tablets
• Luvox 100 mg--elliptical, beige, scored, film-coated tablets

---

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.

Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Luvox CR: Pill Pictures

This information is currently unavailable or not applicable for this drug.