Zyprexa Relprevv

DRUG DESCRIPTION

ZYPREXA RELPREVV (olanzapine extended release injectable suspension) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 10H-thieno[2,3-b][1,5]benzodiazepine, 2-methyl-4-(4-methyl-1-piperazinyl)-,4,4??naphthalenecarboxylate] (1:1), monohydrate. The formula is C17H22N4SC23H14O6H2O, which corresponds to a molecular weight of 718.8. The chemical structure is:

ZYPREXA RELPREVV (olanzapine) Structural Formula Illustration

ZYPREXA RELPREVV is a long-acting form of olanzapine and is intended for deep intramuscular gluteal injection only.

ZYPREXA RELPREVV (olanzapine extended release injectable suspension) includes a vial of the drug product and a vial of the sterile diluent for ZYPREXA RELPREVV. The drug product is olanzapine pamoate monohydrate, present as a yellow solid in a glass vial equivalent to 210, 300, or 405 mg olanzapine base per vial. The diluent for ZYPREXA RELPREVV (olanzapine extended release injectable suspension) is a clear, colorless to slightly yellow solution in a glass vial and is composed of carboxymethylcellulose sodium, mannitol, polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. The drug product is suspended in the diluent for ZYPREXA RELPREVV to a target concentration of 150 mg olanzapine per mL prior to intramuscular injection.

What are the possible side effects of olanzapine (Zyprexa, Zyprexa Zydis)?

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 olanzapine and call your doctor at once if you have any of these serious side effects:

  • fever, stiff muscles, sweating, fast or uneven heartbeats;
  • jerky muscle movements you cannot control;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech,...

Read All Potential Side Effects and See Pictures of Zyprexa Relprevv

What are the precautions when taking olanzapine extended release injectable suspension (Zyprexa Relprevv)?

Before using olanzapine, 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: liver problems, low blood pressure, breast cancer, stroke, dementia, Alzheimer's disease, seizures, prostate problems, glaucoma (narrow angle type), intestinal disease (such as bowel obstruction, paralytic ileus), difficulty swallowing, neuroleptic malignant syndrome (see also Side Effects section), tardive dyskinesia (see also Side Effects section), low white blood cell count.

Also tell your doctor or pharmacist if...

Read All Potential Precautions of Zyprexa Relprevv


Zyprexa Relprevv Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, nausea, constipation, increased appetite, weight gain, dry mouth, headache, or redness/pain/swelling at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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

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.

Olanzapine extended-release injection is designed to release medication slowly over 2 to 4 weeks. If the medication releases too quickly, your drug levels may be too high. Seek immediate medical attention if any of these symptoms of high olanzapine levels occur: very drowsy/hard to wake up, severe dizziness, slowed breathing, new or worsening mental/mood changes (such as confusion, agitation, nervousness, aggression), restlessness, muscle stiffness/spasm, shaking (tremor), unusual weakness, difficulty walking or speaking, balance problems, seizure.

This drug may rarely make your blood sugar level rise, which can cause or worsen diabetes. Weight gain from this drug may increase the risk of this side effect. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst and urination, breath smells fruity, feel very hungry/weak/tired. If you already have diabetes, be sure to check your blood sugar level regularly.

This drug may cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels, especially in teenagers. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)

Tell your doctor immediately if any of these unlikely but serious side effects occur: yellowing of the eyes/skin, severe abdominal pain, difficulty swallowing, signs of infection (such as fever, persistent sore throat).

Seek immediate medical attention if any of these unlikely but serious side effects occur: chest pain, weakness on one side of body, sudden vision changes, severe headache.

This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop the following: fever, muscle stiffness, severe confusion, sweating, fast or irregular heartbeat.

Olanzapine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face or tongue).

In rare cases, olanzapine may increase your level of a certain substance 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.

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: Before using olanzapine, 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: liver problems, low blood pressure, breast cancer, stroke, dementia, Alzheimer's disease, seizures, prostate problems, glaucoma (narrow angle type), intestinal disease (such as bowel obstruction, paralytic ileus), difficulty swallowing, neuroleptic malignant syndrome (see also Side Effects section), tardive dyskinesia (see also Side Effects section), low white blood cell count.

Also tell your doctor or pharmacist if either you or a family member has a history of the following: diabetes, heart disease, high blood cholesterol/triglyceride levels, high blood pressure, obesity.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Do not drive for the rest of the day after receiving your injection.

This medication can make you prone to heat stroke. Avoid activities that might cause you to overheat (such as doing strenuous work, exercising in hot weather, or using hot tubs).

Teenagers may be more sensitive to the side effects of this drug, especially weight gain, diabetes, and increased amounts of cholesterol, triglycerides and prolactin. See also Side Effects section for more details.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, drowsiness, or seizures.

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.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Zyprexa Relprevv Patient Information Including Side Effects

Brand Names: Zyprexa, Zyprexa Zydis

Generic Name: olanzapine (Pronunciation: oh LANZ a peen)

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

What is olanzapine (Zyprexa Relprevv)?

Olanzapine is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Olanzapine is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Olanzapine is sometimes used together with another medication called fluoxetine (Prozac, Sarafem). This combination is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

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

What are the possible side effects of olanzapine (Zyprexa Relprevv)?

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 olanzapine and call your doctor at once if you have any of these serious side effects:

  • fever, stiff muscles, sweating, fast or uneven heartbeats;
  • jerky muscle movements you cannot control;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • fever, chills, body aches, flu symptoms;
  • white patches or sores inside your mouth or on your lips;
  • increased thirst, frequent urination, excessive hunger, or weakness;
  • feeling light-headed, fainting;
  • unusual thoughts or behavior, hallucinations, or thoughts about hurting yourself; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • dizziness, drowsiness, or weakness;
  • constipation;
  • dry mouth;
  • swelling in your hands or feet;
  • back pain;
  • weight gain, increased appetite; or
  • upset stomach.

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 olanzapine (Zyprexa Relprevv)?

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

Olanzapine may cause you to have high blood sugar (hyperglycemia). Symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. If you are diabetic, check your blood sugar levels on a regular basis while you are taking olanzapine.

It may take up to 4 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment.

Olanzapine 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, which can increase some of the side effects of olanzapine.

Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking olanzapine.

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