Generic Luvox ( Fluvoxamine )

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Luvox is a selective serotonin reuptake inhibitor (SSRI) used to treat obsessive-compulsive disorder (OCD) in adults and children aged 8 and older. It is also prescribed for depression and social anxiety disorder. The medication works by increasing the amount of serotonin in the brain, which helps reduce obsessive thoughts and compulsive behaviours.
The usual starting dose for adults is 50 mg once daily, taken at bedtime. Your doctor may increase the dose by 50 mg every 4 to 7 days as tolerated, up to a maximum of 300 mg per day. Doses above 100 mg per day are usually divided into two doses, with the larger dose taken at bedtime. For children aged 8 to 11, the starting dose is 25 mg at bedtime, with a maximum of 200 mg per day. For adolescents aged 12 to 17, the starting dose is 25 mg at bedtime, with a maximum of 300 mg per day.
The administration form is film-coated, scored tablets in 50 mg and 100 mg strengths. The tablets can be swallowed whole or broken in half along the score line, but they should not be chewed or crushed.
Luvox does not work overnight. It may take several weeks of steady dosing before you notice the full benefit for OCD or depression. Do not stop taking it just because you do not feel better in the first few days.
Alcohol should be avoided during treatment. It adds to the drowsiness and dizziness that fluvoxamine can cause, and it can increase the risk of serotonin syndrome.
The most common side effects are nausea, somnolence, insomnia, and asthenia. Sexual side effects such as decreased libido or difficulty reaching orgasm are also common, though often not discussed.
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Common Use Luvox

Fluvoxamine is a selective serotonin reuptake inhibitor. It works by blocking the reuptake of serotonin at nerve endings, which increases its availability in the spaces between nerve cells. This is thought to improve mood and reduce the anxiety and repetitive behaviours associated with OCD. Health Canada has approved fluvoxamine for the symptomatic relief of depressive illness in adults. It is also indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD). The Canadian clinical practice guidelines list fluvoxamine as a first-line medication for OCD and social anxiety disorder. Fluvoxamine is not approved for use in children under 8 years of age.

Basic Luvox Information

• INN (International Nonproprietary Name): Fluvoxamine maleate
• Brand names available in Canada: Luvox® (BGP Pharma ULC); generics include Apo-Fluvoxamine (Apotex Inc.), Teva-Fluvoxamine (Teva Canada Limited), Riva-Fluvox (Laboratoire Riva Inc.), and Sandoz Fluvoxamine (Sandoz Canada Inc., status cancelled post-market)
• ATC Code: N06AB08
• Forms and dosages: Film-coated, scored tablets – 50 mg and 100 mg. An extended-release capsule is available in some markets but is not currently marketed in Canada.
• Manufacturers in Canada: BGP Pharma ULC (Luvox, DIN 01919342 for 50 mg, DIN 01919369 for 100 mg), Apotex Inc. (Apo-Fluvoxamine, DIN 02231193 for 100 mg, DIN 02231329 for 50 mg), Teva Canada Limited (Teva-Fluvoxamine, DIN 02255529 for 50 mg, DIN 02255537 for 100 mg), and Laboratoire Riva Inc. (Riva-Fluvox, DIN 02240723 for 50 mg)
• Registration status in Canada: Approved by Health Canada. Multiple DINs exist, including 01919342 (Luvox 50 mg), 01919369 (Luvox 100 mg), 02231193 (Apo-Fluvoxamine 100 mg), 02231329 (Apo-Fluvoxamine 50 mg), 02255529 (Teva-Fluvoxamine 50 mg), 02255537 (Teva-Fluvoxamine 100 mg), and 02240723 (Riva-Fluvox 50 mg). Sandoz Fluvoxamine (DIN 02247055) was cancelled post-market in 2019
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Take Luvox exactly as your doctor prescribes. The recommended starting dose for adults with OCD is 50 mg once daily at bedtime. Your doctor may increase the dose by 50 mg every 4 to 7 days as tolerated, until the best response is achieved. The usual effective dose range is 100 mg to 300 mg per day. If your daily dose is above 100 mg, it should be divided into two doses, with the larger portion taken at bedtime. The maximum recommended dose for adults is 300 mg per day. For children aged 8 to 11 years, the starting dose is 25 mg at bedtime, increased by 25 mg every 4 to 7 days as tolerated. The maximum is 200 mg per day, and doses above 50 mg should be divided. For adolescents aged 12 to 17 years, the starting dose is 25 mg at bedtime, increased by 25 mg every 4 to 7 days. The maximum is 300 mg per day, and doses above 50 mg should be divided. For depression, the usual adult dose is 50 mg to 100 mg daily, taken at bedtime. Take the tablet with or without food. If it upsets your stomach, take it with a meal. Swallow the tablet whole or break it in half along the score line. Do not chew or crush it. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once. Do not stop taking Luvox suddenly without talking to your doctor. Stopping abruptly can cause discontinuation syndrome, with symptoms such as flu-like feelings, dizziness, and "electric-shock" sensations. Your doctor will taper the dose gradually, usually by about 25 percent per week.

Precautions

Luvox carries a boxed warning about an increased risk of suicidal thoughts and behaviours in pediatric and young adult patients taking antidepressants. Close monitoring is required, especially during the first few weeks of treatment or after dose changes. If you or someone you care for notices worsening mood, new or increased thoughts of self-harm, or unusual behaviour changes, get help immediately. Fluvoxamine can cause serotonin syndrome, a potentially life-threatening condition caused by too much serotonin in the body. The risk is higher when fluvoxamine is taken with other serotonergic drugs, including MAO inhibitors, other SSRIs, SNRIs, tricyclic antidepressants, triptans, fentanyl, tramadol, and St. John's wort. Symptoms include agitation, confusion, rapid heartbeat, muscle rigidity, and sweating. Stop the medication and seek emergency care if these occur. Fluvoxamine can increase the risk of bleeding, especially when taken with aspirin, NSAIDs, warfarin, or other anticoagulants. Tell your doctor if you take any of these medications. The medication can cause hyponatremia (low sodium in the blood), especially in older adults and people taking diuretics. Symptoms include headache, difficulty concentrating, memory problems, confusion, and weakness. Fluvoxamine can cause angle-closure glaucoma in patients with untreated anatomically narrow angles. Tell your doctor if you have a history of glaucoma. Fluvoxamine is a strong inhibitor of CYP1A2 and CYP2C19 and a moderate inhibitor of CYP3A4 and CYP2D6. This means it can raise the levels of many other drugs and increase the risk of side effects. Your doctor may need to adjust the doses of other medications you take. Fluvoxamine can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how it affects you. Luvox is not recommended during pregnancy unless the benefit clearly outweighs the risk. It passes into breast milk, so breastfeeding is not recommended without medical advice. Women who could become pregnant should discuss the risks and benefits with their doctor. Fluvoxamine should not be used in children under 8 years of age. Older adults may be more sensitive to the side effects and may need lower doses. Tell your doctor if you have liver or kidney problems, as dose adjustments may be needed. Bone fractures have been reported with this class of medication.

Contraindications

Do not take Luvox if you have had an allergic reaction to fluvoxamine or any of the inactive ingredients in the tablet. Fluvoxamine is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), including phenelzine, tranylcypromine, moclobemide, and selegiline. Do not start an MAOI within 14 days of stopping fluvoxamine, and do not start fluvoxamine within 14 days of stopping an MAOI. This combination can cause a life-threatening condition called serotonin syndrome. Fluvoxamine is contraindicated in patients taking tizanidine, thioridazine, alosetron, or pimozide, because the combination can cause serious side effects including heart rhythm problems. Do not take fluvoxamine if you are breastfeeding. Fluvoxamine should not be used during pregnancy unless specifically directed by a doctor. If you are unsure whether any of these apply to you, check with your doctor or pharmacist.

Possible Side Effects

More than 10% of people experience nausea, somnolence, insomnia, and asthenia. Other common side effects include nervousness, dyspepsia, abnormal ejaculation, sweating, anorgasmia, decreased libido, dry mouth, rhinitis, taste perversion, and urinary frequency. In pediatric patients with OCD, agitation, depression, dysmenorrhea, flatulence, hyperkinesia, and rash have been reported. These effects are often most noticeable when starting treatment or increasing the dose, and they may fade as your body adjusts. Serious side effects require immediate medical attention. Serotonin syndrome presents with agitation, confusion, rapid heartbeat, muscle rigidity, and sweating. Hyponatremia can cause headache, confusion, and weakness. Angle-closure glaucoma presents with sudden eye pain, blurred vision, and redness. Increased bleeding risk can cause easy bruising or unusual bleeding. Severe allergic reactions, including rash, hives, swelling of the face or throat, and difficulty breathing, need emergency care. Severe skin reactions have been reported with fluvoxamine. If you develop a rash, blisters, peeling skin, or sores in the mouth or eyes, stop the medication and seek emergency care. If you develop any of these serious effects, stop the medication and seek medical help right away. Antidepressants, including Luvox, may increase suicidal thoughts or behaviour, especially in young people. If you notice worsening mood or new thoughts of self-harm, contact your doctor immediately. Discontinuation syndrome can occur if the medication is stopped suddenly, causing flu-like symptoms, dizziness, and "electric-shock" sensations.

Drug Interaction

Fluvoxamine interacts with a long list of medications because it is a strong inhibitor of CYP1A2 and CYP2C19, and a moderate inhibitor of CYP3A4 and CYP2D6. Do not take fluvoxamine with MAO inhibitors, tizanidine, thioridazine, alosetron, or pimozide. Other serotonergic drugs, including other SSRIs, SNRIs, tricyclic antidepressants (such as clomipramine, imipramine, amitriptyline), triptans, fentanyl, tramadol, and St. John's wort, can increase the risk of serotonin syndrome. Drugs metabolized by CYP1A2, including theophylline, tacrine, methadone, mexiletine, clozapine, olanzapine, and quetiapine, can build up in your body when taken with fluvoxamine. Your doctor may need to lower their doses. Benzodiazepines such as triazolam, midazolam, alprazolam, and diazepam are also affected, and their doses may need to be reduced. Propranolol and ropinirole levels can increase, requiring dose adjustments. Warfarin levels are significantly increased by fluvoxamine, and prothrombin time should be monitored closely. Clopidogrel, a prodrug activated by CYP enzymes, may be less effective when taken with fluvoxamine, and this combination should be avoided as a precaution. Tell your doctor and pharmacist about every medication you take, including over-the-counter products, vitamins, and herbal supplements.

Missed Dose

If you miss a dose of Luvox, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss several doses in a row, contact your doctor before restarting. Missing doses can cause your symptoms to return, so try to take the medication at the same time each day.

Overdose

Overdose with Luvox can cause drowsiness, nausea, vomiting, fast heart rate, and tremor. In severe cases, it can cause serotonin syndrome, seizures, and changes in heart rhythm. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and monitoring of vital signs. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store Luvox tablets at room temperature between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit). Keep the container tightly closed and protect it from light and moisture. Do not store in the bathroom or near a sink. Keep out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines. Do not flush fluvoxamine down the toilet or pour it down the sink.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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