Fluanxol Depot

The active ingredient in Fluanxol Depot is Flupentixol decanoate, a thioxanthene derivative. It is a first-generation antipsychotic that acts on dopamine pathways in the brain to correct chemical imbalances that cause symptoms of schizophrenia.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Fluanxol depot. However, the following is a synopsis of the general guidelines for the use of Fluanxol depot:

-Fluanxol depot is typically used for maintenance dosing, after stabilization on an oral Fluanxol dose.

-It should be administered by a health professional as a deep intramuscular injection in the buttock, every 2-4 weeks.

-Your doctor may require you to get bloodwork done when initiating treatment with Fluanxol and throughout treatment.

Some mild or common side effects of Fluanxol depot seen in clinical trials as compared to placebo include:

-Injection-site reactions (usually mild pain at the injection site)

-Dry mouth, constipation, urinary retention (difficulty urinating), drowsiness, or somnolence.

-Parkinsonism, dystonia, hypertonia, akathisia, hyperreflexia, and tardive dyskinesia. These are movement disorders that can include tremors, muscle spasms, muscle stiffness, shaking, restlessness, or uncontrolled muscle contractions or body movements.

-Low blood pressure

-Metabolic changes (with long-term use), including weight gain, high blood glucose, and elevated cholesterol.

-Reduced sex drive, or erectile dysfunction.

-Vomiting, nausea, dyspepsia (indigestion).

-Blurred vision.

Some individuals may experience serious side effects while using Fluanxol depot. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or go to the nearest hospital:

-Signs of neuroleptic malignant syndrome like muscle stiffness, fever, confusion, reduced consciousness, irregular heart rate, changes in blood pressure, and sweating.

-Increased risk of a blood clot, with symptoms like swelling, redness, and pain in your legs or feet.

-Signs of liver disease like yellowing of the skin, called jaundice. Your doctor may also require you to do regular blood work to assess your liver function while taking Fluanxol.

-Rarely, Fluanxol can cause low platelet levels, low white blood cell levels, or low neutrophil levels. Your doctor will likely require you to do regular blood work while taking this medication.

-High prolactin levels that can lead to breast tenderness, growth of breast tissue, and small production of breast milk. This may also increase the risk of developing osteoporosis.

-A skin rash, hives, swelling of the face or tongue, or difficulty breathing. These may be signs of a serious allergic reaction.

These are not all of the possible side effects of Fluanxol depot. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

The use of Fluanxol injection has not been studied in people older than 65 or younger than 18 years of age.

Fluanxol may rarely cause blood disorders like leukopenia, granulocytopenia, and agranulocytosis. Your doctor may require you to do blood work before initiation of Fluanxol, and throughout treatment.

Long-term use of antipsychotic medicines can cause a movement disorder called tardive dyskinesia, which may be irreversible.

Before starting Fluanxol depot, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

-A heart condition or an irregular heartbeat (arrhythmia).

-A naturally prolonged QTc interval of the heart, or a condition for which you take medications that can prolong the QTc interval.

-History of, or risk factors for, a stroke or blood clots.

-Diabetes: Fluanxol may increase the risk of high blood sugar.

-Parkinson’s disease: Fluanxol may cause worsening symptoms.

-Epilepsy or a history of seizures.

-Narrow-angle glaucoma.

-Dementia.

-Kidney or liver disease.

-An allergy to phenothiazines. Cross-reaction with flupentixol may occur.

Boxed Warning

-Fluanxol may cause a rare, potentially fatal disorder called neuroleptic malignant syndrome.

Do not use Fluanxol Depot if you:

-Are allergic to flupentixol, thioxanthenes, or other components of the formulation.

-Have psychosis and are severely agitated.

-Have ingested excessive amounts of alcohol, barbiturates, or opiates.

-Are in a coma or have brain damage.

-Have liver, kidney, or heart damage.

Fluanxol Depot is typically used after someone has responded to oral Fluanxol and requires maintenance dosing.

When Fluanxol depot is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

-Alcohol, barbiturates, and other sedatives.

-Thioridazine, haloperidol, and other antipsychotic medicines.

-Amitriptyline, nortriptyline, and other tricyclic antidepressants.

-Metoclopramide may increase the risk of movement disorders.

-Levodopa and other dopamine agonists used to treat Parkinson’s disease.

Antiarrhythmics (ie, quinidine, amiodarone), some antibiotics (ie, erythromycin, moxifloxacin), mood stabilizers (ie, lithium), and other medications that can cause QT prolongation.

-Medications that can affect electrolyte (potassium, sodium) balance, like thiazide diuretics (water pills).

-Piperazine, a medicine used to treat worm infections.

Fluanxol Depot is packaged in ampoules which contain 2% (20mg/mL) or 10% (100mg/mL) Flupentixol decanoate.

Fluanxol is also available in a tablet formulation, which contains flupentizol dihydrochloride.

Fluanxol Depot injection should be stored at room temperature, protected from light.

Fluanxol Depot is manufactured by Lundbeck Canada Inc.

No, Fluanxol Depot is only available as a brand-name medication.

Do not stop taking Fluanxol until instructed by your doctor. Although withdrawal symptoms are less likely with Fluanxol Depot compared to Fluanxol tablets, discontinuation may still cause your symptoms of schizophrenia to recur.

The use of flupentixol in pregnancy has not been studied. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Flupentixol is excreted in breast milk. It is unlikely to impact a child; however, talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.