Tuesday, October 11, 2016

Zyprexa Zydis


Generic Name: olanzapine (Oral route)

oh-LAN-za-peen

Oral route(Tablet;Tablet, Disintegrating)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .



Commonly used brand name(s)

In the U.S.


  • Zyprexa

  • Zyprexa Zydis

Available Dosage Forms:


  • Tablet

  • Tablet, Disintegrating

Therapeutic Class: Antipsychotic


Chemical Class: Thienobenzodiazepine


Uses For Zyprexa Zydis


Olanzapine is used to treat nervous, emotional, and mental conditions (e.g., schizophrenia). It may also be used alone or with other medicines (e.g., lithium or valproate) to treat bipolar disorder (manic-depressive illness) or mania that is part of bipolar disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer's disease.


This medicine is available only with your doctor's prescription.


Before Using Zyprexa Zydis


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of olanzapine in teenagers 13 to 17 years of age. However, safety and efficacy of olanzapine in children younger than 13 years of age have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olanzapine in the elderly. However, elderly patients are more likely to have dementia or age-related liver, kidney, or heart problems, which may require caution or an adjustment in the dose for patients receiving olanzapine.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Levomethadyl

  • Metoclopramide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Clomipramine

  • Hydromorphone

  • Lithium

  • Milnacipran

  • Mirtazapine

  • Tetrabenazine

  • Tramadol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Betel Nut

  • Carbamazepine

  • Ciprofloxacin

  • Fluvoxamine

  • Haloperidol

  • Valproic Acid

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Blood vessel disease or circulation problems or

  • Dehydration or

  • Heart attack or stroke, history of or

  • Heart disease or

  • Heart failure or

  • Heart rhythm problems or

  • Hypotension (low blood pressure) or

  • Hypovolemia (low blood volume)—May cause side effects to become worse.

  • Breast cancer, prolactin-dependent or

  • Glaucoma, narrow-angle or

  • Hyperlipidemia (high cholesterol or fat in the blood) or

  • Hyperprolactinemia (high prolactin in the blood) or

  • Liver disease or

  • Paralytic ileus (severe intestinal problem), history of or

  • Prostatic hypertrophy (enlarged prostate) or

  • Seizures, history of—Use with caution. This medicine may make these conditions worse.

  • Diabetes or

  • Hyperglycemia (high blood sugar)—This medicine may raise your blood sugar levels.

  • Phenylketonuria (PKU, a genetic disease of metabolism)—The orally disintegrating tablet (Zyprexa® Zydis®) contains phenylalanine, which can make this condition worse.

Proper Use of olanzapine

This section provides information on the proper use of a number of products that contain olanzapine. It may not be specific to Zyprexa Zydis. Please read with care.


Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.


This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the medication guide if you do not have one.


If you are using the orally disintegrating tablet (Zyprexa® Zydis®), make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.


You may take this medicine with or without food.


Tell your doctor if you smoke tobacco. You might need a different amount of this medicine if you smoke.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (orally disintegrating tablets, regular tablets):
    • For treatment of schizophrenia:
      • Adults—At first, 5 to 10 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.

      • Teenagers and children 13 to 17 years of age—At first, 2.5 or 5 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.

      • Children younger than 13 years of age—Use and dose must be determined by your doctor.


    • For treatment of bipolar disorder:
      • Adults—At first, 5 to 15 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.

      • Teenagers and children 13 to 17 years of age—At first, 2.5 or 5 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.

      • Children younger than 13 years of age—Use and dose must be determined by your doctor.


    • For treatment of mania with bipolar disorder:
      • Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.

      • Teenagers and children 13 to 17 years of age—At first, 2.5 or 5 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.

      • Children younger than 13 years of age—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Zyprexa Zydis


It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.


For some patients, this medicine can increase thoughts of suicide. Tell your doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive illness) or has tried to commit suicide.


This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you or your child have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.


This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you or your child some medicines that can lower the amount of cholesterol and fats in the blood.


This medicine may increase your weight. Your doctor may need to check your or your child's weight on a regular basis while you are using this medicine.


Stop taking this medicine and check with your doctor right away if you or your child have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).


This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you or your child have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.


Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.


This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you or your child think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


Olanzapine may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.


This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for allergies or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicines or narcotics; medicines for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you are taking this medicine.


This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.


Zyprexa Zydis Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet

  • blurred vision

  • change in vision

  • change in walking and balance

  • clumsiness or unsteadiness

  • difficulty with speaking

  • difficulty with swallowing

  • drooling

  • impaired vision

  • inability to sit still

  • loss of balance control

  • mask-like face

  • muscle trembling, jerking, or stiffness

  • need to keep moving

  • rapid weight gain

  • restlessness

  • shakiness in the legs, arms, hands, or feet

  • shuffling walk

  • slowed movements

  • slurred speech

  • stiffness of the arms and legs

  • tic-like (jerky) movements of the head, face, mouth, and neck

  • tingling of the hands or feet

  • trembling or shaking of the fingers, hands, or feet

  • twisting movements of the body

  • uncontrolled movements, especially of the face, neck, and back

  • unusual weight gain or loss

Less common
  • Bladder pain

  • bloody or cloudy urine

  • bruising

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • chest pain

  • difficult or labored breathing

  • difficult, burning, or painful urination

  • dizziness

  • excessive muscle tone

  • frequent urge to urinate

  • headache

  • inability to move the eyes

  • increased blinking or spasms of the eyelid

  • itching of the vagina or genital area

  • lack of coordination

  • large, flat, blue, or purplish patches in the skin

  • loss of bladder control

  • loss of memory

  • lower back or side pain

  • muscle tension or tightness

  • nervousness

  • pain during sexual intercourse

  • pounding in the ears

  • problems with memory

  • rhythmic movement of the muscles

  • shortness of breath

  • slow, fast, pounding, or irregular heartbeat or pulse

  • speaking is less clear than usual

  • sticking out the tongue

  • thick, white vaginal discharge with no odor or with a mild odor

  • tightness in the chest

  • trouble with breathing, speaking, or swallowing

  • twitching

  • uncontrolled twisting movements of the neck, trunk, arms, or legs

  • unusual or incomplete body or facial movements

  • weakness of the arms and legs

  • wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Anxiety

  • attacking, assaulting, or using force

  • change in consciousness

  • change in patterns and rhythms of speech

  • confusion as to time, place, or person

  • convulsions (seizures)

  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

  • drowsiness

  • dry mouth

  • fainting

  • hallucinations

  • heart stops beating

  • high fever

  • high or low blood pressure

  • holding false beliefs that cannot be changed by fact

  • increased sweating

  • irregular, fast or slow, or shallow breathing

  • irritability

  • lightheadedness

  • loss of consciousness

  • mood or mental changes

  • no breathing

  • no pulse or blood pressure

  • pale or blue lips, fingernails, or skin

  • rapid breathing

  • relaxed and calm

  • severe muscle stiffness

  • shaking or trembling

  • sleepiness

  • trouble with sleeping

  • unconscious

  • unusual excitement, nervousness, or restlessness

  • unusual tiredness or weakness

  • unusually pale skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Acid or sour stomach

  • back pain

  • belching

  • change in personality

  • difficulty having a bowel movement (stool)

  • discouragement

  • feeling sad or empty

  • fever

  • heartburn

  • increased appetite

  • increased cough

  • indigestion

  • lack of appetite

  • lack or loss of strength

  • loss of interest or pleasure

  • runny nose

  • sleeplessness

  • sneezing

  • stomach discomfort, upset, or pain

  • stuffy nose

  • thirst

  • trouble with concentrating

  • unable to sleep

  • watering of the mouth

  • weight gain

Less common
  • Blemishes on the skin

  • body aches or pain

  • chills

  • cold sweats

  • congestion

  • cough

  • dry skin

  • dryness or soreness of the throat

  • false or unusual sense of well-being

  • joint pain

  • heavy menstrual bleeding (periods)

  • hoarseness

  • lack of feeling or emotion

  • leg cramps

  • pain in the arms or legs

  • pimples

  • sweating

  • tender, swollen glands in the neck

  • uncaring feelings

  • voice change

  • vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Zyprexa Zydis side effects (in more detail)



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More Zyprexa Zydis resources


  • Zyprexa Zydis Side Effects (in more detail)
  • Zyprexa Zydis Use in Pregnancy & Breastfeeding
  • Drug Images
  • Zyprexa Zydis Drug Interactions
  • Zyprexa Zydis Support Group
  • 12 Reviews for Zyprexa Zydis - Add your own review/rating


  • Zyprexa Zydis Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Olanzapine Monograph (AHFS DI)

  • Olanzapine Professional Patient Advice (Wolters Kluwer)

  • Olanzapine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zyprexa MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zyprexa Consumer Overview

  • Zyprexa Prescribing Information (FDA)

  • Zyprexa Relprevv Prescribing Information (FDA)

  • Zyprexa Relprevv MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zyprexa Relprevv Consumer Overview



Compare Zyprexa Zydis with other medications


  • Anorexia
  • Asperger Syndrome
  • Bipolar Disorder
  • Body Dysmorphic Disorder
  • Borderline Personality Disorder
  • Depression
  • Insomnia
  • Obsessive Compulsive Disorder
  • Paranoid Disorder
  • Schizoaffective Disorder
  • Schizophrenia
  • Tourette's Syndrome

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