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Cyclosporine 0.05% Opth Eml 30X0.4 Ml

  • Manufacturer Name : KVK-TECH, INC.
  • MFG # : 10702080803
  • NDC : 10702080803
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category I
Drug Type Code 1
FDA Approval Date 12/23/2002
FDA Therap Equiv AB
HCPCS -
Market Entry Date 04/01/2003
Medical Coverage -
Termination Date -
Unit ML
Units Per Pkg 12
Active Ingredients 3420 cyclosporine 59865133
AHFS Class 52089200 EENT ANTI-INFLAMMATORY AGENTS, MISC.
DEA Class NC
Dose Form DROPPERETTE, SINGLE-USE DROP DISPENSER
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 51820 cyclosporine OPHTHALMIC DROPERETTE 0.05 %
Inactive Ingredients 2551 polysorbates 9005645
OMP Family -
Product Category RX Pharmaceuticals
Strength 0.05%
Common Brand Name COMMON BRAND NAME(S): Cequa, Restasis
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.
Allocation Period -
Case Quantity 24
Drug Form Pack Size 12
Form EMULSION
Hazard Code -
Listed Chemical -
NIOSH Code NT2 NON-ANTINEOPLASTIC DRUGS THAT MEET 1 OR MORE OF NIOSH CRITERIA FOR HAZARDOUS DRUG INCLUDING (MSHG)
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 30X0.4
How to Use HOW TO USE: Read the Instructions for Use if available from your pharmacist before you start using cyclosporine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Use this medication in the affected eye(s) as directed by your doctor, usually twice a day (about 12 hours apart). To apply eye drops, wash hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface. There are different brands of this medication available. Some brands should be mixed before use. If your brand does not need to be mixed before use, the liquid is clear and colorless. If your brand should be mixed, evenly mix the eye drops by turning the vial upside down a few times before using your dose. The mixed drops should look milky and white. Ask your doctor or pharmacist if you have any questions about your brand. If you have dry eyes, contact lens wear is usually not recommended. If you are wearing contact lenses, remove them before using eye drops. Wait at least 15 minutes before replacing your contact lenses. Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward, gently close your eyes, and place one finger at the corner of your eye (near the nose). Apply gentle pressure for 1 to 2 minutes before opening your eyes. This will prevent the medication from draining out. Try not to blink or rub your eye. If directed to use this medication in both eyes, repeat these steps for your other eye. Do not rinse the dropper. Replace the dropper cap after each use. If you are using another kind of eye medication (such as drops or ointments), wait at least 15 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye. Wait several minutes for your vision to clear before driving or operating machinery. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. If you are using the single-use form of this medication, throw away the opened vial after use. Do not save for later use. Tell your doctor if your condition gets worse.
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others.
Overdose OVERDOSE: This medicine may be harmful if swallowed. 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 (SYE-kloe-SPOR-in)
Precautions PRECAUTIONS: Before using this medication, 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: current/recent eye infection. After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you can do it safely. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Eye discomfort/redness/itching, feeling as if something is in the eye, or temporary blurred vision 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. 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: Cyclosporine eye drops are used to treat a certain type of dry eyes. They work by increasing the amount of tears you make.

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Cyclosporine 0.05% Opth Eml 30X0.4 Ml is manufactured by KVK-TECH, INC..
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