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-(2aminoethyl)oxime maleate (1:1) and has the empirical formula C₁₅H₂₁O₂N₂F₃•C₄H₄O₄. 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 (porcineor bovine-derived), and Opacode Grey. LUVOX CR Capsules are gluten-free.

Nausea, vomiting, loss of appetite, upset stomach, drowsiness, dizziness, diarrhea, trouble sleeping, and sweating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, unusual or severe mental/mood changes (e.g., agitation, thoughts of suicide), weakness, muscle stiffness/pain, uncontrolled movements (e.g., shaking), decrease in sexual interest/ability, fast/pounding heartbeat, unusual tiredness, increased/painful urination, tingling or numbness of the hands/feet.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, seizures, black/bloody stools, vomit that looks like coffee grounds, fainting.

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs (See Drug Interactions section). Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hearing/seeing things that are not there (hallucinations), unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitchy muscles.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking fluvoxamine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of bipolar/manic-depressive disorder, personal or family history of suicide attempts, liver disease, seizures, low sodium in the blood, severe loss of body water (dehydration), stomach/intestinal ulcers.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Liver function declines as you grow older. This medication is removed by the liver. Therefore, older adults may be at greater risk for side effects while using this drug. Older adults are also more likely to develop a type of mineral imbalance (hyponatremia), especially if they are also taking "water pills" (diuretics) with this medication.

Children may be more sensitive to the side effects of the drug, especially loss of appetite and weight loss. It is important to monitor weight and growth in children who are taking this drug.

Use this medication only when clearly needed during pregnancy. It may harm an unborn baby. Also, babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.

Since untreated depression can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.