Luvox Tablets

DRUG DESCRIPTION

Fluvoxamine maleate (fluvoxamine maleate) is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones.

It is chemically designated as 5-methoxy-4'-(trifluoromethyl)valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the empirical formula C15H21O2N2F3C4H4O4.Its molecular weight is 434.41.

The structural formula is:

Fluvoxamine Maleate Structural Formula Illustration

Fluvoxamine maleate (fluvoxamine maleate) is a white to off white, odorless, crystalline powder which is sparingly soluble in water, freely soluble in ethanol and chloroform and practically insoluble in diethyl ether.

Fluvoxamine Maleate (fluvoxamine maleate) Tablets are available in 25 mg, 50 mg and 100 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate (fluvoxamine maleate) , each tablet contains the following inactive ingredients: carnauba wax, hydroxypropyl methylcellulose, mannitol, polyethylene glycol, polysorbate 80, pregelatinized starch (potato), silicon dioxide, sodium stearyl fumarate, starch (corn), and titanium dioxide. The 50 mg and 100 mg tablets also contain synthetic iron oxides.

What are the possible side effects of fluvoxamine (Luvox, Luvox CR)?

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), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have...

Read All Potential Side Effects and See Pictures of Luvox Tablets

What are the precautions when taking fluvoxamine maleate (Luvox Tablets)?

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 psychiatric disorder (e.g., bipolar/manic-depressive disorder), personal or family history of suicide attempts, liver disease, seizures, low sodium in the blood, 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...

Read All Potential Precautions of Luvox Tablets


Luvox Tablets Consumer (continued)

SIDE EFFECTS: See also Warning section.

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.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, 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 psychiatric disorder (e.g., bipolar/manic-depressive disorder), personal or family history of suicide attempts, liver disease, seizures, low sodium in the blood, 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, elderly people may be at greater risk for side effects while using this drug. The elderly are also more likely to develop a type of mineral imbalance (hyponatremia), especially if they are also taking "water pills" (diuretics) with this medication.

Caution is advised when using this drug in children because they 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.


Luvox Tablets Patient Information Including Side Effects

Brand Names: Luvox, Luvox CR

Generic Name: fluvoxamine (Pronunciation: floo VOX a meen)

  • What is fluvoxamine (Luvox Tablets)?
  • What are the possible side effects of fluvoxamine (Luvox Tablets)?
  • What is the most important information I should know about fluvoxamine (Luvox Tablets)?
  • What should I discuss with my healthcare provider before taking fluvoxamine (Luvox Tablets)?
  • How should I take fluvoxamine (Luvox Tablets)?
  • What happens if I miss a dose (Luvox Tablets)?
  • What happens if I overdose (Luvox Tablets)?
  • What should I avoid while taking fluvoxamine (Luvox Tablets)?
  • What other drugs will affect fluvoxamine (Luvox Tablets)?
  • Where can I get more information?

What is fluvoxamine (Luvox Tablets)?

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

Fluvoxamine is used to treat social anxiety disorder (social phobia), or obsessive-compulsive disorders involving recurring thoughts or actions.

Fluvoxamine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fluvoxamine (Luvox Tablets)?

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), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

  • seizure (convulsions);
  • unusual thoughts or behavior;
  • anxiety, restlessness, memory problems, trouble concentrating, hallucinations, feeling like you might pass out;
  • high fever, chills or goose bumps, loss of coordination, overactive reflexes, stiff muscles; or
  • confusion, sweating, fast or uneven heartbeats, and rapid breathing.

Less serious side effects may include:

  • loss of appetite, weight loss;
  • dry mouth, mild nausea or upset stomach, diarrhea, constipation;
  • sleep problems (insomnia);
  • dizziness, drowsiness;
  • decreased sex drive, impotence, trouble having an orgasm; or
  • unusual dreams.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fluvoxamine (Luvox Tablets)?

Do not take this medication if you are allergic to fluvoxamine, or if you are also taking alosetron (Lotronex), tizanidine (Zanaflex), thioridazine (Mellaril), pimozide (Orap), or an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam). Some of these medications can cause serious or life-threatening drug interactions when taken within 14 days before or after taking fluvoxamine.

You may have thoughts about suicide when you first start taking an this medication, especially if you are younger than 24 years old. 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), depressed, or have thoughts about suicide or hurting yourself.

There are many other medicines that can cause serious medical problems if you take them together with 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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  • Luvox
  • Luvox CR


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