Stelazine

DRUG DESCRIPTION

Tablets: Each round, blue, film-coated tablet contains trifluoperazine hydrochloride equivalent to trifluoperazine as follows: 1 mg imprinted SKF and S03; 2 mg imprinted SKF and S04; 5 mg imprinted SKF and S06; 10 mg imprinted SKF and S07. Inactive ingredients consist of cellulose, croscarmellose sodium, FD&C Blue No. 2, FD&C Yellow No. 6, FD&C Red No. 40, gelatin, iron oxide, lactose, magnesium stearate, talc, titanium dioxide and trace amounts of other inactive ingredients.

Multi-Dose Vials, 10 mL (2 mg/mL)—Each mL contains, in aqueous solution, trifluoperazine, 2 mg, as the hydrochloride; sodium tartrate, 4.75 mg; sodium biphosphate, 11.6 mg; sodium saccharin, 0.3 mg; benzyl alcohol, 0.75%, as preservative.

Concentrate—Each mL of clear, yellow, banana-vanilla-flavored liquid contains 10 mg of trifluoperazine as the hydrochloride. Inactive ingredients consist of D&C Yellow No. 10, FD&C Yellow No. 6, flavor, sodium benzoate, sodium bisulfite, sucrose and water.

N.B.: The Concentrate is for use in schizophrenia when oral medication is preferred and other oral forms are considered impractical.

What are the possible side effects of trifluoperazine (Stelazine)?

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 using trifluoperazine and call your doctor at once if you have a serious side effect such as:

  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
  • feeling restless, jittery, or agitated;
  • high...

Read All Potential Side Effects and See Pictures of Stelazine »

What are the precautions when taking trifluoperazine (Stelazine)?

See also Warning section.

Before taking trifluoperazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (such as chlorpromazine, perphenazine); 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.

This medication should not be used in a patient who is unconscious or intoxicated with alcohol/narcotics/other drugs that cause drowsiness/slowed breathing.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, heart problems (such as mitral valve insufficiency, abnormal heart rhythm, angina), low blood pressure, blockage of the...

Read All Potential Precautions of Stelazine »


Stelazine Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, dry mouth, blurred vision, tiredness, constipation, weight gain, and trouble sleeping 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 decrease these side effects. Tell your doctor immediately if you notice any of the following side effects: feelings of anxiety/agitation/jitteriness, drooling/trouble swallowing, restlessness/constant need to move, shaking (tremor), shuffling walk, stiff muscles, severe muscle spasms/cramping (such as twisting neck, arching back, eyes rolling up), 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: difficulty urinating, sunburn-like rash (sun sensitivity), decreased cough reflex, swelling of the feet/ankles, butterfly-shaped rash on nose and cheeks, joint/muscle pain, skin discoloration, eye/vision changes, feeling unusually cold or hot, muscle weakness.

Infrequently, this medication may cause face/muscle twitching and uncontrollable movements (tardive dyskinesia). In some cases, this condition may be permanent. Tell your doctor immediately if you develop any uncontrollable movements such as lip smacking, mouth puckering, tongue thrusting, chewing, or unusual arm/leg movements.

In rare cases, trifluoperazine 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.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and seek immediate medical attention, or permanent problems could occur.

Tell your doctor immediately if any of these rare but serious side effects occur: signs of liver problems (such as yellowing eyes/skin, dark urine, persistent nausea, vomiting, stomach/abdominal pain), signs of infection (such as fever, persistent sore throat), easy bruising/bleeding, signs of anemia (such as severe tiredness, fast breathing, pale skin, fast heartbeat), mental/mood changes (such as worsening psychosis, unresponsive/catatonic state).

Seek immediate medical attention if any of these rare but serious side effects occur: slowed breathing, chest pain, seizures.

This drug may rarely cause a serious (sometimes fatal) nervous system problem (neuroleptic malignant syndrome-NMS). Seek immediate medical attention if you notice any of the following side effects: fever, stiff muscles, increased 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 trifluoperazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (such as chlorpromazine, perphenazine); 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.

This medication should not be used in a patient who is unconscious or intoxicated with alcohol/narcotics/other drugs that cause drowsiness/slowed breathing.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, heart problems (such as mitral valve insufficiency, abnormal heart rhythm, angina), low blood pressure, blockage of the intestines, glaucoma, seizures, enlarged prostate, breathing problems (such as severe asthma, emphysema, lung infections), blood disorders (such as bone marrow depression, low red/white/platelet blood cell counts), low levels of calcium in the blood, loss of too much body water (dehydration), breast cancer, brain disorder/tumor/injury, exposure to organophosphate insecticides, pheochromocytoma, drug/alcohol/substance abuse, Parkinson's disease.

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.

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).

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

This medication 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). When the weather is hot, 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 a fever, mental/mood changes, headache, or dizziness.

Children with acute illnesses (such as a viral infection, dehydration) are at increased risk for serious muscle problems during trifluoperazine treatment. Consult the doctor for more details.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, drowsiness, uncontrollable movements, and anticholinergic effects (such as constipation, difficulty urinating, and blurred vision).

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 unknown if this medication passes into breast milk. However, similar drugs pass into breast milk, and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Stelazine Patient Information Including Side Effects

Brand Names: Stelazine

Generic Name: trifluoperazine (Pronunciation: trye floo oh PER a zeen)

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

What is trifluoperazine (Stelazine)?

Trifluoperazine is an anti-psychotic medication in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain.

Trifluoperazine is used to treat anxiety or psychotic disorders such as schizophrenia.

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

What are the possible side effects of trifluoperazine (Stelazine)?

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 using trifluoperazine and call your doctor at once if you have a serious side effect such as:

  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
  • feeling restless, jittery, or agitated;
  • high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing;
  • feeling like you might pass out;
  • decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;
  • seizure (black-out or convulsions);
  • nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • pale skin, easy bruising or bleeding, fever, sore throat, flu symptoms;
  • joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects may include:

  • dizziness, drowsiness, anxiety;
  • sleep problems (insomnia);
  • blurred vision, headache;
  • dry mouth, stuffy nose;
  • constipation;
  • breast swelling or discharge;
  • a missed menstrual period;
  • weight gain, swelling in your hands or feet;
  • mild itching or skin rash; or
  • impotence, trouble having an orgasm.

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 trifluoperazine (Stelazine)?

Stop using this medication and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects.

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

Do not use trifluoperazine if you have liver disease, brain damage, bone marrow depression, a blood cell disorder (such as low platelets or low red or white blood cell counts), or if you are also using large amounts of alcohol or medicines that make you sleepy. Do not use if you are allergic to trifluoperazine or other phenothiazines.

Before you take trifluoperazine, tell your doctor if you have heart disease, high blood pressure, angina (chest pain), severe asthma or breathing problems, glaucoma, a history of seizures, adrenal gland tumor, Parkinson's disease, enlarged prostate or urination problems, low levels of calcium in your blood, past or present breast cancer, or if you have ever had a serious side effect while using trifluoperazine or similar medicines.

Before taking trifluoperazine, tell your doctor about all other medications you use.

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