OLANZAPINE - olanzapine tablet
Ascend Laboratories, LLC
Olanzapine (oh-LAN-za-peen) Tablets USP
Read the Medication Guide that comes with olanzapine tablets USP before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about olanzapine tablets.
What is the most important information I should know about olanzapine tablets USP?
Olanzapine tablets USP may cause serious side effects, including:
1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis).
2. High blood sugar (hyperglycemia).
3. High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to 17.
4. Weight gain, especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to 17.
These serious side effects are described below.
1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). Olanzapine tablets USP are not approved for treating psychosis in elderly people with dementia.
2. High blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to:
Your doctor should do tests to check your blood sugar before you start taking olanzapine tablets USP and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when olanzapine tablets USP are stopped. People with diabetes and some people who did not have diabetes before taking olanzapine tablets USP need to take medicine for high blood sugar even after they stop taking olanzapine tablets USP.
If you have diabetes, follow your doctor’s instructions about how often to check your blood sugar while taking olanzapine tablets USP.
Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking olanzapine tablets USP:
3. High fat levels in your blood (cholesterol and triglycerides). High fat levels may happen in people treated with olanzapine tablets USP, especially in teenagers (13 to 17 years old) or when used in combination with fluoxetine in children age 10 to 17. You may not have any symptoms, so your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking olanzapine tablets USP and during treatment.
4. Weight gain. Weight gain is very common in people who take olanzapine tablets USP. Teenagers (13 to 17 years old) are more likely to gain weight and to gain more weight than adults. Children (10 to 17 years old) are also likely to gain weight and to gain more weight than adults when olanzapine tablets are used in combination with fluoxetine.
Some people may gain a lot of weight while taking olanzapine tablets USP, so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.
What are olanzapine tablets USP?
Olanzapine tablets USP are a prescription medicine used to treat:
Olanzapine tablets USP has not been approved for use in children under 13 years of age. Olanzapine tablets USP in combination with fluoxetine has not been approved for use in children under 10 years of age.
Safety and effectiveness information for pediatric patients (10-17 years) is approved for Eli Lilly and Company’s olanzapine tablets and olanzapine orally disintegrating tablets. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
The symptoms of schizophrenia include hearing voices, seeing things that are not there, having beliefs that are not true, and being suspicious or withdrawn.
The symptoms of bipolar I disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.
Some of your symptoms may improve with treatment. If you do not think you are getting better, call your doctor.
What should I tell my doctor before taking olanzapine tablets USP?
Olanzapine tablets USP may not be right for you. Before starting olanzapine tablets USP, tell your doctor if you have or had:
Tell your doctor if you exercise a lot or are in hot places often.
The symptoms of bipolar I disorder or schizophrenia may include thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your doctor or go to an emergency room right away.
Tell your doctor about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Olanzapine tablets USP and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take olanzapine tablets USP with your other medicines. Do not start or stop any medicine while taking olanzapine tablets USP without talking to your doctor first.
How should I take olanzapine tablets USP?
What should I avoid while taking Olanzapine tablets USP?
What are the possible side effects of olanzapine tablets USP?
Serious side effects may happen when you take olanzapine tablets USP, including:
Common side effects of olanzapine tablets USP include: lack of energy, dry mouth, increased appetite, sleepiness, tremor (shakes), having hard or infrequent stools, dizziness, changes in behavior, or restlessness.
Other common side effects in teenagers (13‑17 years old) include: headache, stomach-area (abdominal) pain, pain in your arms or legs, or tiredness. Teenagers experienced greater increases in prolactin, liver enzymes, and sleepiness, as compared with adults.
Tell your doctor about any side effect that bothers you or that does not go away.
These are not all the possible side effects with olanzapine tablets USP. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.
How should I store olanzapine tablets USP?
Keep olanzapine tablets USP and all medicines out of the reach of children.
General information about olanzapine tablets USP
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use olanzapine tablets USP for a condition for which it was not prescribed. Do not give olanzapine tablets USP to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about olanzapine tablets USP. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about olanzapine tablets USP that was written for healthcare professionals. For more information about olanzapine tablets USP call 1-877-ASC-RX01 (877-272-7901)
What are the ingredients in olanzapine tablets USP?
Active ingredient: Olanzapine USP
Inactive ingredients: lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured in India by:
Alkem Laboratories Limited
Mumbai – 400 013, INDIA
Ascend Laboratories, LLC
Montvale, NJ 07645
Revised: October, 2015