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Otezla- Apremilast Tablet, Film Coated 30Mg (60 Tablets)

  • Manufacturer Name : AMGEN
  • MFG # : 55513013760
  • NDC : 55513013760
  • Distributor Name : AmeriSource Bergen
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Description

Indications and Usage:

1.1 Psoriatic Arthritis

OTEZLA is indicated for the treatment of adult patients with active psoriatic arthritis.

1.2 Plaque Psoriasis

OTEZLA is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

1.3 Oral Ulcers Associated with Behçet's Disease

OTEZLA is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.

Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind NR
Drug Category -
Drug Type Code S
FDA Approval Date 04/09/2014
FDA Therap Equiv TAB
HCPCS -
Market Entry Date -
Medical Coverage -
Termination Date 1
Unit 60
Units Per Pkg 03/21/2014
Active Ingredients 15411 apremilast 608141419
AHFS Class 92360000 DISEASE-MODIFYING ANTIRHEUMATIC AGENTS; 84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.; 92200000 IMMUNOMODULATORY AGENTS
DEA Class NC
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 72075 apremilast ORAL TABLET 30 MG
Inactive Ingredients 2432 lactose 64044515
OMP Family -
Product Category RX Pharmaceuticals
Strength 30MG
Common Brand Name COMMON BRAND NAME(S): Otezla
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. Other medications can affect the removal of apremilast from your body, which may affect how apremilast works. Examples include certain drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin, primidone), rifamycins (such as rifampin, rifabutin), among others.
Allocation Period -
Case Quantity 252
Drug Form Pack Size 60
Form TABLET
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 60
How to Use HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually twice daily. The manufacturer directs not to crush, split, or chew the tablet before taking it. However, many similar drugs (immediate-release tablets) can be crushed, split, or chewed. Follow your doctor's directions on how to take this medication. 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. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Tell your doctor if your condition does not improve or if it worsens.
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. Since this medication can cause weight loss, check your weight regularly while taking this drug. Tell your doctor of any unusual weight loss.
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.
Phonetic Pronunciation (a-PRE-mi-last)
Precautions PRECAUTIONS: Before taking apremilast, 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: kidney disease, mental/mood disorders (such as depression). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Diarrhea, nausea/vomiting, loss of appetite, headache, or weight loss may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. 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: severe nausea/vomiting/diarrhea. Rarely, people who take this medication may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself. 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 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.
Uses USES: This medication is used to treat a certain type of arthritis (psoriatic arthritis). Apremilast is also used to treat a certain type of skin condition (moderate to severe plaque psoriasis). Apremilast belongs to a class of drugs known as phosphodiesterase 4 (PDE4) inhibitors. For the treatment of psoriatic arthritis, it decreases pain and swelling, and may help improve flexibility in the affected joints. For the treatment of plaque psoriasis, it may help to reduce the redness, thickening, and scaling of the skin that occurs with this condition. Apremilast is also used to treat mouth sores in people who have Behcet's disease. It helps to reduce the pain and improve the healing of these mouth sores.

Frequently Asked Questions(FAQs)

The cost of Otezla- Apremilast Tablet, Film Coated 30Mg (60 Tablets) is available for registerd members only .
Otezla- Apremilast Tablet, Film Coated 30Mg (60 Tablets) is manufactured by AMGEN.
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