Product Details
CAPLYTA 42 MG CAP 30
Manufacturer: INTRA-CELLULAR THERAPIES INC
MFG#: 72060-0142-40
NDC: 72060-0142-40
PID: 233267
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Product Properties:
| Description | S |
|---|---|
| Description | S |
| Description | - |
| DESI Drug Ind | - |
| DESI Drug Ind | -; - |
| DESI Drug Ind | -; - |
| DESI2 Drug Ind | - |
| Drug Category | S |
| Drug Category | USES: Lumateperone is used to treat certain mental/mood disorders (such as schizophrenia, episodes of depression associated with bipolar disorder). This medication helps you to think more clearly, feel less nervous, and take part in everyday life. It may help to decrease hallucinations (hearing/seeing things that are not there). It may also improve your mood, sleep, appetite, and energy level. Lumateperone belongs to a class of drugs known as atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain. |
| Drug Category | USES: Lumateperone is used to treat certain mental/mood disorders (such as schizophrenia, episodes of depression associated with bipolar disorder). This medication helps you to think more clearly, feel less nervous, and take part in everyday life. It may help to decrease hallucinations (hearing/seeing things that are not there). It may also improve your mood, sleep, appetite, and energy level. Lumateperone belongs to a class of drugs known as atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain. |
| Drug Type Code | COMMON BRAND NAME(S): Caplyta |
| Drug Type Code | 1 |
| Drug Type Code | COMMON BRAND NAME(S): Caplyta |
| FDA Approval Date | 12/20/2019 |
| FDA Therap Equiv | NR |
| HCPCS | - |
| HCPCS | 1 |
| HCPCS | 1 |
| Market Entry Date | 02/01/2020 |
| Medical Coverage | - |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | (LOO-ma-TE-per-one) |
| Termination Date | (LOO-ma-TE-per-one) |
| Termination Date | - |
| Unit | CAP |
| Units Per Pkg | 1 |
| Active Ingredients | 18247 lumateperone tosylate |
| Active Ingredients | 18247 lumateperone tosylate |
| Active Ingredients | 18247 lumateperone tosylate |
| AHFS Class | 28160804 ATYPICAL ANTIPSYCHOTICS |
| AHFS Class | 28160804 ATYPICAL ANTIPSYCHOTICS |
| AHFS Class | 28160804 ATYPICAL ANTIPSYCHOTICS |
| DEA Class | NC |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | CAPSULE |
| Dose Form | CAPSULE |
| Dose Form | CAPSULE |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 80599 lumateperone tosylate ORAL CAPSULE 42 MG |
| Gen Code and Des | 80599 lumateperone tosylate ORAL CAPSULE 42 MG |
| Gen Code and Des | 80599 lumateperone tosylate ORAL CAPSULE 42 MG |
| Inactive Ingredients | 10138 blue dye; 10141 red dye; 2272 mannitol 69658; 2549 gelatin 9000708 |
| Inactive Ingredients | 10138 blue dye; 10141 red dye; 2272 mannitol 69658; 2549 gelatin 9000708 |
| Inactive Ingredients | 10138 blue dye; 10141 red dye; 2272 mannitol 69658; 2549 gelatin 9000708 |
| OMP Family | - |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 42MG |
| Strength | 42MG |
| Strength | 42MG |
| Common Brand Name | - |
| Common Brand Name | - |
| Common Brand Name | COMMON BRAND NAME(S): Caplyta |
| Drug Interaction | - |
| Drug Interaction | DRUG INTERACTIONS: See also How to Use section. 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. Other medications can affect the removal of lumateperone from your body, which may affect how lumateperone works. Examples include rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others. 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. |
| Drug Interaction | - |
| Allocation Period | - |
| Allocation Period | - |
| Allocation Period | - |
| Case Quantity | 12 |
| Case Quantity | 12 |
| Case Quantity | 12 |
| Drug Form Pack Size | 30 |
| Drug Form Pack Size | 30 |
| Drug Form Pack Size | 30 |
| Form | CAPSULES |
| Form | CAPSULES |
| Form | CAPSULES |
| Hazard Code | - |
| Hazard Code | - |
| Hazard Code | - |
| Listed Chemical | - |
| Listed Chemical | - |
| Listed Chemical | - |
| NIOSH Code | - |
| NIOSH Code | - |
| NIOSH Code | - |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Special Storage Cond | 00 None |
| Special Storage Cond | 00 None |
| Special Storage Cond | 00 None |
| Temp Zone | 10 Room Temperature |
| Temp Zone | 10 Room Temperature |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit | EA |
| Unit | EA |
| Unit Size | 30 |
| Unit Size | 30 |
| Unit Size | 30 |
| How to Use | - |
| How to Use | - |
| How to Use | HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking lumateperone 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. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue taking this medication exactly as prescribed, even if you are feeling better and thinking more clearly. Do not increase your dose or take this drug more often than prescribed. Your symptoms will not improve any faster, and your risk of side effects will increase. Do not stop taking this medication without consulting your doctor. Tell your doctor if your condition does not get better or if it gets worse. |
| 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. |
| Missed Dose | 1 |
| Missed Dose | 1 |
| Notes | CAP |
| Notes | CAP |
| 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) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details. |
| 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. |
| Overdose | NR |
| Overdose | NR |
| Phonetic Pronunciation | - |
| Phonetic Pronunciation | (LOO-ma-TE-per-one) |
| Phonetic Pronunciation | - |
| Precautions | - |
| Precautions | PRECAUTIONS: Before taking lumateperone, 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 disease, seizures, difficulty swallowing, low white blood cell count, Parkinson's disease, dementia, 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 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. Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, and lightheadedness. Drowsiness, 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) 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, discuss with your doctor right away the benefits and risks of using this medication during pregnancy. 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. 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 | SIDE EFFECTS: Drowsiness, dizziness, lightheadedness, dry mouth, or nausea 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, interrupted breathing during sleep (sleep apnea), signs of infection (such as sore throat that doesn't go away, fever, chills). This medication 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. 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.) Lumateperone 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). 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: 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 | 12/20/2019 |
| 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 | 12/20/2019 |
| Uses | - |
| Uses | USES: Lumateperone is used to treat certain mental/mood disorders (such as schizophrenia, episodes of depression associated with bipolar disorder). This medication helps you to think more clearly, feel less nervous, and take part in everyday life. It may help to decrease hallucinations (hearing/seeing things that are not there). It may also improve your mood, sleep, appetite, and energy level. Lumateperone belongs to a class of drugs known as atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain. |
| Uses | - |
Frequently Asked Questions (FAQs)
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CAPLYTA 42 MG CAP 30 is manufactured by INTRA-CELLULAR THERAPIES INC.
You can purchase CAPLYTA 42 MG CAP 30 on our website at https://supplies.pipelinemedical.com/product/detail/caplyta-42-mg-cap-30-233267