Generic Loxitane ( Loxapine )

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Loxitane is a typical antipsychotic used to treat schizophrenia and other psychotic disorders. It helps reduce hallucinations, delusions, and disorganized thinking by blocking dopamine and serotonin receptors in the brain. The medication is also sometimes used for acute agitation and aggression. In Canada, loxapine is marketed under the brand name Xylac and as generic Apo-Loxapine.
The usual starting dose for adults is 10 mg twice daily. Your doctor will increase the dose slowly based on how you respond, usually to a total daily dose of 60 mg to 100 mg. The maximum daily dose is 250 mg. Some people need a higher dose, but doses above 250 mg per day are not recommended without close supervision.
The administration form is capsules containing 10 mg or 25 mg of loxapine (as loxapine succinate). A 5 mg, 25 mg, and 50 mg capsule and an oral solution are also available in Canada.
Loxitane does not work overnight. Some calming effects may appear within the first few days, but the full benefit for psychotic symptoms usually takes several weeks of steady dosing.
Alcohol should be avoided during treatment. It adds to the drowsiness and dizziness that loxapine can cause, and it can increase the risk of low blood pressure and breathing problems.
The most common side effects are drowsiness, dizziness, dry mouth, blurred vision, and constipation. Movement side effects such as tremor, stiffness, and restlessness are also common.
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Common Use Loxitane

Loxapine is a dibenzoxazepine antipsychotic. It blocks dopamine D2 receptors and serotonin 5-HT2A receptors in the brain, which helps reduce hallucinations, delusions, and disorganized thinking. It also binds to noradrenergic, histaminergic, and cholinergic receptors, which explains its sedative and anticholinergic effects. Loxapine has a higher affinity for D3 than D2 receptors, and some researchers have suggested it may be more effective than other typical antipsychotics for the negative symptoms of schizophrenia, though the evidence is not conclusive. Health Canada has approved loxapine for the treatment of schizophrenia and other psychotic disorders in adults and adolescents 16 years and older. It is not approved for treating behavioural problems in older adults with dementia, and it carries a boxed warning about increased mortality in that population.

Basic Loxitane Information

• INN (International Nonproprietary Name): Loxapine (as loxapine succinate)
• Brand names available in Canada: Xylac® (Pendopharm); generics include Apo-Loxapine (Apotex Inc.), Dom-Loxapine (Dominion Pharmacal, discontinued), Nu-Loxapine (Nu-Pharm Inc.), and PHL-Loxapine (Pharmel Inc.). Loxitane is the U.S. brand name and is not marketed in Canada.
• ATC Code: N05AH01
• Forms and dosages: Capsules – 2.5 mg, 5 mg, 10 mg, 25 mg, and 50 mg. Oral solution – 25 mg/mL. Injection – 50 mg/mL.
• Manufacturers in Canada: Pendopharm (Xylac), Apotex Inc. (Apo-Loxapine), Nu-Pharm Inc. (Nu-Loxapine), Pharmel Inc. (PHL-Loxapine), and MM Therapeutics Inc. (Loxapine).
• Registration status in Canada: Approved by Health Canada. Multiple DINs exist, including 02230838 (Xylac 10 mg, Pendopharm), 02230839 (Xylac 25 mg, Pendopharm), 02242868 (Xylac 2.5 mg, Pendopharm), 02237653 (Apo-Loxapine 25 mg, Apotex), 02237652 (Apo-Loxapine 10 mg, Apotex), 02237537 (Loxapine 50 mg, Apotex), and 02232968 (Loxapine Hydrochloride Oral Concentrate 25 mg/mL).
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

The usual recommended starting dose of loxapine is 10 mg twice daily. Your doctor will increase the dose over time until the best results occur with the least amount of side effects. The maximum daily dose should not exceed 250 mg. Most people need between 60 mg and 100 mg daily, but your doctor will decide on the ideal dose based on your response. Some individuals may be on higher doses, but this requires close medical supervision. Take the capsule with a full glass of water (250 mL or 8 oz). You can take it with or without food. It is often taken twice daily, but can also be taken once daily. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. Do not stop taking this medication without consulting your doctor. Stopping suddenly can cause withdrawal symptoms or a relapse of your condition.

Precautions

Loxapine can cause drowsiness, dizziness, and problems with coordination, especially during the first few days of therapy. Until you know how it affects you, do not drive, operate heavy machinery, or do anything else that requires you to be alert. These effects may fade with time, but some people continue to feel drowsy. Taking loxapine with alcohol or other central nervous system depressants can increase the sedative effect and may cause severe breathing problems. Avoid alcohol and check with your doctor before taking other medications that cause drowsiness, such as benzodiazepines, opioids, or antihistamines. Loxapine can cause a drop in blood pressure when you stand up, leading to dizziness and falls, especially in older adults. Move slowly when getting up from a sitting or lying position. The medication can cause movement side effects called extrapyramidal symptoms, which include tremor, stiffness, restlessness, and involuntary muscle contractions. These are more common with loxapine than with some other antipsychotics. If you develop any abnormal movements, tell your doctor right away. Tardive dyskinesia is a serious movement disorder that can develop after months or years of treatment and may be irreversible. The risk increases with longer treatment and higher total doses. Neuroleptic malignant syndrome (NMS) is a rare but life-threatening reaction that has been reported with loxapine. It causes high fever, severe muscle rigidity, confusion, and autonomic instability. Stop the medication and seek emergency care if these symptoms occur. Loxapine can raise blood sugar and cholesterol levels. Your doctor should check your blood sugar and lipid levels before you start and periodically during treatment. Loxapine may increase prolactin levels, which can cause breast enlargement, milk production, and menstrual irregularities. It can also cause a condition called priapism, a prolonged and painful erection that requires emergency medical attention. Loxapine can cause a serious skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS), which involves a rash, fever, swollen lymph nodes, and organ inflammation. If you develop a rash with fever, stop the medication and seek medical attention. Tell your doctor if you have a history of seizures, heart disease, liver disease, kidney disease, or glaucoma. Loxapine is not recommended during pregnancy unless the benefit clearly outweighs the risk. It can cause extrapyramidal and/or withdrawal symptoms in a newborn if used in the third trimester. It passes into breast milk, so breastfeeding is not recommended during treatment. Women who could become pregnant should use effective contraception. Loxapine is not recommended for children under 16 years of age.

Contraindications

Do not take loxapine if you have had an allergic reaction to loxapine, other dibenzoxazepines, or any of the inactive ingredients in the capsule. The medication is contraindicated in patients with comatose states or severe central nervous system depression caused by alcohol, barbiturates, or other drugs. Loxapine should not be used in patients with pheochromocytoma, a tumour of the adrenal gland, because it can trigger a hypertensive crisis. It is contraindicated in patients with severe heart disease, including recent myocardial infarction or severe hypotension. Do not use loxapine in patients with a history of blood disorders such as agranulocytosis or bone marrow depression. It should not be used in patients with severe liver disease. Loxapine is contraindicated in children under 16 years of age. It should not be used during pregnancy or breastfeeding unless specifically directed by a doctor.

Possible Side Effects

More than 1 in 10 people experience drowsiness, dizziness, dry mouth, blurred vision, and constipation. These effects are often most noticeable when starting treatment or increasing the dose. Other common side effects include nausea, vomiting, headache, and increased sensitivity of the skin to sun. Some people experience movement side effects such as tremor, stiffness, restlessness, and involuntary muscle contractions. These are more common with loxapine than with some other antipsychotics. Weight gain is possible but less common with loxapine than with atypical antipsychotics. Serious side effects require immediate medical attention. Extrapyramidal symptoms, including akathisia, dystonia, and parkinsonism, can occur. Tardive dyskinesia causes involuntary movements of the face, tongue, or limbs. Neuroleptic malignant syndrome presents with high fever, severe muscle rigidity, confusion, and autonomic instability. Agranulocytosis, a severe drop in white blood cells, can cause fever, sore throat, and mouth ulcers. Torsades de pointes, a dangerous heart rhythm, can cause palpitations, fainting, or sudden collapse. Sudden cardiac death has been reported with loxapine. Low blood pressure can cause fainting. Severe skin reactions such as DRESS syndrome can cause fever, rash, swollen lymph nodes, and organ inflammation. If you develop any of these serious effects, stop the medication and seek medical help right away.

Drug Interaction

Loxapine is metabolized by several liver enzymes, including CYP1A2, CYP2D6, and CYP3A4. Drugs that inhibit CYP1A2, such as fluvoxamine, ciprofloxacin, enoxacin, propranolol, and rofecoxib, can increase loxapine levels and should be avoided if possible. Smoking and carbamazepine induce CYP1A2, which lowers loxapine levels and may require a higher dose. If you start or stop smoking while taking loxapine, tell your doctor. Loxapine can add to the sedative effects of alcohol, benzodiazepines, opioids, and other central nervous system depressants. It can also add to the blood pressure-lowering effects of antihypertensive medications. Concurrent use of loxapine and adrenaline can worsen hypotension. Do not take loxapine with other drugs that can cause agranulocytosis or bone marrow suppression. Avoid St. John's wort, because it can reduce loxapine levels. 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 Loxitane, 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 increase the risk of symptom relapse, so try to take the medication at the same times each day.

Overdose

Overdose with loxapine is a medical emergency. Symptoms include severe drowsiness, confusion, agitation, hallucinations, muscle rigidity, and seizures. The heart can develop dangerous arrhythmias, including QT prolongation and torsades de pointes, which can lead to cardiac arrest. Blood pressure can drop dangerously low, and breathing can slow. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and medications to control seizures and support blood pressure. Close monitoring of heart rhythm and vital signs is necessary. 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 Loxitane capsules 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 loxapine 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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