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Olanzapine 20 Mg Odt Tab 30 (3X10) Ud

  • Manufacturer Name : STRIDES PHARMA, INC
  • MFG # : 64380017502
  • NDC : 64380017502
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
Description N
DESI Drug Ind -; -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category N
Drug Category USES: Olanzapine is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder). It may also be used in combination with other medication to treat depression. This medication can help to decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life. Olanzapine belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain. Talk to the doctor about the risks and benefits of treatment (especially when used in teenagers). See also Precautions section.
Drug Type Code 1
Drug Type Code COMMON BRAND NAME(S): Zyprexa
FDA Approval Date 10/24/2011
FDA Therap Equiv AB
HCPCS -
HCPCS 1
Market Entry Date 10/24/2011
Medical Coverage -
Medical Coverage -
Termination Date (oh-LAN-za-peen)
Termination Date -
Unit TAB
Units Per Pkg 30
Active Ingredients 6204 olanzapine 132539061
Active Ingredients 6204 olanzapine 132539061
AHFS Class 28160804 ATYPICAL ANTIPSYCHOTICS; 28280000 ANTIMANIC AGENTS
AHFS Class 28160804 ATYPICAL ANTIPSYCHOTICS; 28280000 ANTIMANIC AGENTS
DEA Class NC
DEA Class NC
Dose Form TABLET,DISINTEGRATING
Dose Form TABLET,DISINTEGRATING
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 47286 olanzapine ORAL TAB RAPDIS 20 MG
Gen Code and Des 47286 olanzapine ORAL TAB RAPDIS 20 MG
Inactive Ingredients 2272 mannitol 69658; 2537 povidone 9003398; 2599 sorbitol 50704; 2605 aspartame 22839470
Inactive Ingredients 2272 mannitol 69658; 2537 povidone 9003398; 2599 sorbitol 50704; 2605 aspartame 22839470
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 20MG ODT
Strength 20MG ODT
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Zyprexa
Drug Interaction -
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: metoclopramide. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
Allocation Period -
Allocation Period -
Case Quantity 24
Case Quantity 24
Drug Form Pack Size 30
Drug Form Pack Size 30
Form TABLET
Form TABLET
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 30
Unit Size 30
How to Use -
How to Use HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking olanzapine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. This medication comes in a blister or a bottle. Do not remove the tablet from the packaging until you are ready to take it. Make sure your hands are dry before handling the tablet. If your tablet comes in a blister, peel back the foil to carefully remove the tablet. Do not push the tablet through the foil because doing so can damage the tablet. Place the tablet in your mouth right away and allow it to dissolve. After the tablet has melted, it can be swallowed with or without liquid. The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Tell your doctor if your condition lasts or gets worse.
Missed Dose 30
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as blood sugar, weight, blood pressure, blood cholesterol/triglyceride levels, liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes TAB
Overdose AB
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/dizziness, fast/irregular heartbeat, unusual/uncontrolled movements, seizures.
Phonetic Pronunciation (oh-LAN-za-peen)
Phonetic Pronunciation -
Precautions PRECAUTIONS: Before taking 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, seizures, difficulty swallowing, low white blood cell count, dementia, difficulty urinating (for example, due to enlarged prostate), glaucoma (narrow angle), stomach/intestinal problems (such as blockage, chronic constipation, paralytic ileus), smoking, personal or family history of diabetes, heart disease, high cholesterol/triglyceride levels, breathing trouble during sleep (sleep apnea). This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely. This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness. Teenagers may be more sensitive to the side effects of this drug, especially weight gain, and also 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 drowsiness, constipation, trouble urinating, confusion, dizziness, and lightheadedness. Drowsiness, confusion, dizziness, and lightheadedness can increase the risk of falling. During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away. Since untreated mental/mood problems (such as schizophrenia, bipolar disorder, depression) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy. This drug passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops symptoms such as muscle stiffness or shakiness, unusual sleepiness, or difficulty feeding. Consult your doctor before breast-feeding.
Precautions -
Side Effects -
Side Effects SIDE EFFECTS: Drowsiness, dizziness, lightheadedness, stomach upset, dry mouth, constipation, increased appetite, or weight gain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position. Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: difficulty swallowing, shaking (tremor), slow heartbeat, fainting, mental/mood changes (such as confusion, restlessness), numbness/tingling of arms/legs, yellowing eyes/skin, severe stomach/abdominal pain, trouble urinating, interrupted breathing during sleep. This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet. This drug may also 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.) Olanzapine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual/uncontrolled movements (especially of the face, lips, mouth, tongue, arms or legs). This medication may increase a certain natural substance (prolactin) made by your body. 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 right away. Get medical help right away if you have any very serious side effects, including: seizures. This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage 10/24/2011
Uses -
Uses USES: Olanzapine is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder). It may also be used in combination with other medication to treat depression. This medication can help to decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life. Olanzapine belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain. Talk to the doctor about the risks and benefits of treatment (especially when used in teenagers). See also Precautions section.

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Olanzapine 20 Mg Odt Tab 30 (3X10) Ud is manufactured by STRIDES PHARMA, INC.
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