Loxitane

(Generic versions may still be available.)

DRUG DESCRIPTION

LOXITANE loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)-dibenz[ b,f ] [1,4]oxazepine. It is present in capsules as the succinate salt, and in the concentrate and parenteral primarily as the hydrochloride salt.

CAPSULES Each capsule contains loxapine succinate equivalent to 5, 10, 25, or 50 mg of loxapine base and the following inactive ingredients: Blue 1, Gelatin, Lactose, Magnesium Stearate, Titanium Dioxide, and Yellow 10. Additionally, the 5 mg capsule contains Red 33, the 10 mg capsule contains Red 28 and Red 33, and the 25 mg capsule contains FD&C Yellow No. 6.

ORAL CONCENTRATE Each mL contains loxapine hydrochloride equivalent to 25 mg of loxapine base and propylene glycol as an inactive ingredient.

Hydrochloric acid and, if necessary, sodium hydroxide are used to adjust pH to approximately 5.8 during manufacture.

INTRAMUSCULAR (Sterile) - Not for Intravenous Use - Each mL contains loxapine hydrochloride equivalent to 50 mg of loxapine base. Inactive Ingredients: Polysorbate 80 NF 5% w/v, Propylene Glycol 70% v/v, and Water for Injection qs ad 100% v.

Hydrochloric acid and, if necessary, sodium hydroxide are used to adjust pH to approximately 5.5 during manufacture.

What are the possible side effects of loxapine (Loxitane, Loxitane C)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking loxapine and call your doctor at once if you have a serious side effect such as:

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • tremor (uncontrolled shaking);
  • trouble...

Read All Potential Side Effects and See Pictures of Loxitane

What are the precautions when taking loxapine (Loxitane)?

See also Warning section.

Before taking this medication, 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: blood problems (such as low red/white/platelet blood cell counts), a certain eye condition (glaucoma), heart problems (such as fast/irregular heartbeat, low blood pressure), liver disease, a brain disorder/tumor/injury, drug/alcohol/substance abuse, breast cancer, Parkinson's disease, seizures, a certain severe reaction to other antipsychotic-type medications (neuroleptic malignant...

Read All Potential Precautions of Loxitane


Loxitane Consumer (continued)

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, constipation, dry mouth, weight gain, or blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This drug may cause muscle/nervous system problems (extrapyramidal symptoms-EPS). Your doctor may prescribe another medication to lessen these side effects. Therefore, tell your doctor immediately if you notice any of the following side effects: stiff muscles, severe muscle spasms/cramping (such as twisting neck, arching back, eyes rolling up), restlessness/constant need to move, shaking (tremor), slow/shuffling walk, drooling/trouble swallowing, mask-like expression of the face.

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, fainting, fast heartbeat, depression/suicidal thoughts, difficulty urinating.

This medication may cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any involuntary/repetitive muscle movements such as lip smacking/puckering, tongue thrusting, chewing, or finger/toe movements.

In rare cases, loxapine may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (such as fever, persistent sore throat), seizures, severe stomach/abdominal pain.

This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop the following: fever, stiff muscles, sweating, fast/irregular heartbeat, sudden mental/mood changes (such as confusion, loss of consciousness), change in the amount of urine.

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: See also Warning section.

Before taking this medication, 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: blood problems (such as low red/white/platelet blood cell counts), a certain eye condition (glaucoma), heart problems (such as fast/irregular heartbeat, low blood pressure), liver disease, a brain disorder/tumor/injury, drug/alcohol/substance abuse, breast cancer, Parkinson's disease, seizures, a certain severe reaction to other antipsychotic-type medications (neuroleptic malignant syndrome-NMS), difficulty urinating (such as due to prostate problems).

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

This medication may rarely make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery or imaging procedures (such as certain X-rays, CT scans) requiring the use of contrast dye (such as metrizamide), tell your doctor or dentist that you are using this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Loxapine may decrease your ability to sweat, making you more likely to get heat stroke. Avoid activities that may cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs). Drink plenty of fluids and dress lightly. If you become overheated, promptly seek cooler shelter and stop exercising. Seek immediate medical attention if you develop fever, mental/mood changes, headache or dizziness.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, extrapyramidal symptoms (EPS), and tardive dyskinesia (TD) (see Side Effects).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

It is not known whether this drug passes into breast milk. Discuss the risk and benefits with your doctor before breast-feeding.


Loxitane Patient Information Including Side Effects

Brand Names: Loxitane, Loxitane C

Generic Name: loxapine (Pronunciation: LOX a peen)

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

What is loxapine (Loxitane)?

Loxapine is an antipsychotic medication. It affects the actions of chemicals in your brain.

Loxapine is used to treat schizophrenia.

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

What are the possible side effects of loxapine (Loxitane)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking loxapine and call your doctor at once if you have a serious side effect such as:

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • tremor (uncontrolled shaking);
  • trouble swallowing;
  • seizure (convulsions);
  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • vision changes;
  • severe constipation; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • dizziness or drowsiness;
  • blurred vision;
  • puffiness in your face;
  • feeling restless or agitated;
  • sleep problems (insomnia);
  • breast swelling or discharge;
  • changes in your menstrual periods;
  • nausea, vomiting, constipation;
  • changes in weight;
  • dry mouth, stuffy nose; or
  • mild skin rash, itching, or flaking.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about loxapine (Loxitane)?

Loxapine is not for use in psychotic conditions related to dementia. Loxapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to loxapine, or if you have decreased alertness caused by taking certain medications or drinking alcohol.

Call your doctor at once if you have restless muscle movements in your eyes, tongue, jaw, or neck.

Loxapine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. You should not take loxapine if you are under the effects of alcohol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Loxapine can decrease perspiration and you may be more prone to heat stroke.

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