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Aristada 441Mg Syg 1.6Ml

  • Manufacturer Name : ALKERMES INC
  • MFG # : 65757040103
  • NDC : 65757040103
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind NR
Drug Category -
Drug Type Code S
FDA Approval Date 10/06/2015
FDA Therap Equiv ML
HCPCS Aripiprazole lauroxil, 1 MG
Market Entry Date -
Medical Coverage J1944
Termination Date 1
Unit 1
Units Per Pkg 10/05/2015
Active Ingredients 16489 aripiprazole lauroxil
AHFS Class 28160804 ATYPICAL ANTIPSYCHOTICS; 28280000 ANTIMANIC AGENTS
DEA Class NC
Dose Form SUSPENSION,EXTENDED RELEASE SYRINGE (ML)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 74887 aripiprazole lauroxil INTRAMUSC SUSER SYR 441 MG/1.6
Inactive Ingredients 2551 polysorbates 9005645; 7543 sorbitan esters
OMP Family -
Product Category RX Pharmaceuticals
Strength 441MG
Common Brand Name COMMON BRAND NAME(S): Abilify Asimtufii, Abilify Maintena, Aristada
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 -
Case Quantity 12
Drug Form Pack Size 1
Form SYRINGE
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 1.6
How to Use HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using aripiprazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist. The extended-release injection should only be used if you have already taken aripiprazole by mouth without any serious side effects. Aripiprazole is given by injection into the buttock or upper arm muscle by a health care professional, usually once every month. Some doses may be given once every 6 weeks or once every 2 months. Do not rub/massage the injection site after your dose. After your first injection, your doctor may direct you to continue to take your antipsychotic medication by mouth (such as aripiprazole tablet/solution) for 2 to 3 weeks. This will help maintain the right level of medication in your body as you switch from receiving medication by mouth to receiving it by injection. Follow your doctor's instructions carefully. 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). It may take several weeks to get the full benefit of this medication. Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to receive the medication. Tell your doctor if your condition does not improve or if it worsens.
Missed Dose MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Your doctor may direct you to also take aripiprazole by mouth again for some time if more than a certain number of weeks have passed since your last injection. Follow your doctor's instructions carefully.
Notes NOTES: Lab and/or medical tests (such as blood sugar, weight, cholesterol/triglyceride levels) may be done while you are using 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. Symptoms of overdose may include: very fast heartbeat, loss of consciousness.
Phonetic Pronunciation (AR-i-PIP-ra-zole)
Precautions PRECAUTIONS: See also Warning and Side Effects sections. Before using aripiprazole, 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: problems with receiving injections into the buttocks, problems with blood flow in the brain (such as cerebrovascular disease, stroke), blood clotting problems (such as hemophilia, low platelets), diabetes (including family history), heart problems (such as low blood pressure, coronary artery disease), nervous system problems (such as dementia, NMS, seizures), obesity, low white blood cell count (including history of low white blood cell count caused by medications), swallowing problems, breathing trouble during sleep (sleep apnea). This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). 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. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially seizures, drowsiness, dizziness, lightheadedness, confusion, tardive dyskinesia, swallowing problems, and other serious (rarely fatal) side effects. (See also Warning section.) Drowsiness, dizziness, lightheadedness, and confusion 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, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy. This medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also Warning section. Dizziness, lightheadedness, drowsiness, tiredness, blurred vision, weight gain, shaking (tremors), and redness/pain/swelling at the injection site 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: fainting, trouble swallowing, restlessness (especially in the legs), seizures, trouble controlling certain urges (such as gambling, sex, eating or shopping), interrupted breathing during sleep. 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 medication 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, mouth, tongue, arms, or legs). This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you develop any of the following: fever, muscle cramps/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: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
Uses USES: Extended-release aripiprazole injection is used to treat a mental/mood disorder called schizophrenia. This medication can decrease hallucinations (hearing/seeing things that are not there) and improve your concentration. It also helps you to think more clearly, feel less nervous, and take a more active part in everyday life. Some brands of this medication are also used to treat bipolar disorder. It can help to decrease extreme changes in mood and help you feel less agitated. Extended-release aripiprazole injection is a long-acting psychiatric medication known as an atypical antipsychotic. It works by helping to restore the balance of certain natural substances in the brain.

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Aristada 441Mg Syg 1.6Ml is manufactured by ALKERMES INC.
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