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Cyclosporine Mod 25 Mg Sgc 30 Ud

  • Manufacturer Name : TEVA USA
  • MFG # : 00093901865
  • NDC : 00093901865
  • Distributor Name : AmeriSource Bergen
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Product Information

NDC Package Code0093-9018-65
Proprietary NameCyclosporine
Non-Proprietary NameCyclosporine
Package30 BLISTER PACK in 1 CARTON (0093-9018-65) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0093-9018-19)
Dosage FormCAPSULE, LIQUID FILLED
RouteORAL
Active Ingredient Strength25
Active Ingredient Unitsmg/1
Substance NameCYCLOSPORINE

Description

Cyclosporine Capsules USP MODIFIED are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine Capsules USP MODIFIED have been used in combination with azathioprine and corticosteroids.

Cyclosporine Capsules USP MODIFIED are an oral formulation of cyclosporine, USP that immediately forms an emulsion in an aqueous environment. Cyclosporine, USP, the active principle in Cyclosporine Capsules USP MODIFIED, is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Tolypocladium inflatum. Chemically, cyclosporine, USP is designated as [R-[R*,R*-(E)]]-cyclic-(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N,4-dimethyl-L-2-amino-6-octenoyl-L-a-amino-butyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl) and has the following structural formula. Each soft gelatin capsule for oral administration contains either 25 mg, 50 mg or 100 mg of Cyclosporine, USP MODIFIED and 15.8% v/v (12.4% wt./vol) dehydrated alcohol and has the following inactive ingredients: DL-alpha-tocopherol, gelatin, glycine, glycerol 99%, glyceryl monolinoleate, polyoxyl 40 hydrogenated castor oil, propylene glycol, sorbitol solution and titanium dioxide. In addition, the 25 mg and 50 mg contain ferric oxide (yellow) and the 100 mg contains ferric oxide (brown).

Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind AB
DESI2 Drug Ind AB
Drug Category -
Drug Category -
Drug Type Code N
Drug Type Code N
FDA Approval Date 03/29/2005
FDA Approval Date 03/29/2005
FDA Therap Equiv CAP
FDA Therap Equiv CAP
HCPCS Cyclosporine oral, 100 MG
HCPCS Cyclosporine oral, 100 MG
Market Entry Date -
Market Entry Date -
Medical Coverage J7502
Medical Coverage J7502
Termination Date 1
Termination Date 1
Unit 30
Unit 30
Units Per Pkg 03/29/2005
Units Per Pkg 03/29/2005
Active Ingredients 5038 cyclosporine, modified 59865133
Active Ingredients 5038 cyclosporine, modified 59865133
AHFS Class 92440000 IMMUNOSUPPRESSIVE AGENTS; 92200000 IMMUNOMODULATORY AGENTS; 92360000 DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
AHFS Class 92440000 IMMUNOSUPPRESSIVE AGENTS; 92200000 IMMUNOMODULATORY AGENTS; 92360000 DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
DEA Class NC
DEA Class NC
Dose Form CAPSULE
Dose Form CAPSULE
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 23882 cyclosporine, modified ORAL CAPSULE 25 MG
Gen Code and Des 23882 cyclosporine, modified ORAL CAPSULE 25 MG
Inactive Ingredients 1539 ethyl alcohol 64175; 2468 propylene glycol 57556; 2549 gelatin 9000708; 2599 sorbitol 50704; 9290 cremophor el (polyethoxlated castor oil)
Inactive Ingredients 1539 ethyl alcohol 64175; 2468 propylene glycol 57556; 2549 gelatin 9000708; 2599 sorbitol 50704; 9290 cremophor el (polyethoxlated castor oil)
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 25MG
Strength 25MG
Common Brand Name COMMON BRAND NAME(S): Gengraf, Neoral
Common Brand Name COMMON BRAND NAME(S): Gengraf, Neoral
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. Some products that may interact with this drug include: coal tar, orlistat, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab, tofacitinib), drugs that may increase potassium levels (such as potassium supplements, certain diuretics/"water pills" including amiloride, spironolactone), tacrolimus. Other medications can affect the removal of cyclosporine from your body, which may affect how cyclosporine works. Examples include bosentan, mifepristone, St. John's wort, ritonavir, among others. This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include aliskiren, dabigatran, dronedarone, elagolix, certain statins (such as pitavastatin, simvastatin), voxilaprevir, among others.
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. Some products that may interact with this drug include: coal tar, orlistat, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab, tofacitinib), drugs that may increase potassium levels (such as potassium supplements, certain diuretics/"water pills" including amiloride, spironolactone), tacrolimus. Other medications can affect the removal of cyclosporine from your body, which may affect how cyclosporine works. Examples include bosentan, mifepristone, St. John's wort, ritonavir, among others. This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include aliskiren, dabigatran, dronedarone, elagolix, certain statins (such as pitavastatin, simvastatin), voxilaprevir, among others.
Allocation Period -
Allocation Period -
Case Quantity 40
Case Quantity 40
Drug Form Pack Size 30
Drug Form Pack Size 30
Form CAPSULES
Form CAPSULES
Hazard Code UN3175 SOLIDS CONTAINING FLAMMABLE LIQUID, N.O.S.
Hazard Code UN3175 SOLIDS CONTAINING FLAMMABLE LIQUID, N.O.S.
Listed Chemical -
Listed Chemical -
NIOSH Code NT2 NON-ANTINEOPLASTIC DRUGS THAT MEET 1 OR MORE OF NIOSH CRITERIA FOR HAZARDOUS DRUG INCLUDING (MSHG)
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.
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 30
Unit Size 30
How to Use HOW TO USE: Take this medication by mouth as directed by your doctor, usually twice daily. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose. The dosage is based on your weight, medical condition, lab tests, and response to treatment. 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. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. It may take up to 4 months before you get the full benefit of this drug for the treatment of rheumatoid arthritis and psoriasis. Tell your doctor if your condition does not get better (in 4 to 8 weeks for arthritis and in 2 to 4 weeks for psoriasis) or if it gets worse.
How to Use HOW TO USE: Take this medication by mouth as directed by your doctor, usually twice daily. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose. The dosage is based on your weight, medical condition, lab tests, and response to treatment. 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. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. It may take up to 4 months before you get the full benefit of this drug for the treatment of rheumatoid arthritis and psoriasis. Tell your doctor if your condition does not get better (in 4 to 8 weeks for arthritis and in 2 to 4 weeks for psoriasis) 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 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. Lab and/or medical tests (such as kidney/liver function, blood pressure, blood mineral levels, cyclosporine blood levels, complete blood count, uric acid levels, lipid levels, skin exam) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details. If you have had an organ transplant, it is recommended that you attend a transplant education class or support group. Learn the symptoms of organ rejection such as a feeling of being ill, fever, pain around the transplanted organ, and signs of a failing transplanted organ (a decrease in the amount of urine with kidney transplant, yellowing of the skin/eyes with liver transplant, shortness of breath/inability to exercise with heart transplant). Get medical help right away if these symptoms of rejection occur.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as kidney/liver function, blood pressure, blood mineral levels, cyclosporine blood levels, complete blood count, uric acid levels, lipid levels, skin exam) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details. If you have had an organ transplant, it is recommended that you attend a transplant education class or support group. Learn the symptoms of organ rejection such as a feeling of being ill, fever, pain around the transplanted organ, and signs of a failing transplanted organ (a decrease in the amount of urine with kidney transplant, yellowing of the skin/eyes with liver transplant, shortness of breath/inability to exercise with heart transplant). Get medical help right away if these symptoms of rejection occur.
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 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 (SYE-kloe-SPOR-in MY-crow-ee-MULL-shun)
Phonetic Pronunciation (SYE-kloe-SPOR-in MY-crow-ee-MULL-shun)
Precautions PRECAUTIONS: Before taking cyclosporine, 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, liver disease, high blood pressure, cancer, skin lesions of unknown cause, radiation treatment (including light treatment with PUVA or UVB), mineral imbalance (such as low level of magnesium or high level of potassium), recent/current infections, high cholesterol/triglycerides levels. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). This medication may contain alcohol. Caution is advised if you are pregnant or breastfeeding or have liver disease, alcohol dependence, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor or pharmacist about using this product safely. Cyclosporine can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details. Tell your health care professional that you are using cyclosporine before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). This medication may increase your risk of developing skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Your doctor may direct you to avoid phototherapy while you use this product. Ask your doctor for details. This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist. 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 at greater risk for kidney problems or high blood pressure while using this drug. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby or cause other problems with the baby such as being born too early (premature) or having low birth weight. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before taking cyclosporine, 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, liver disease, high blood pressure, cancer, skin lesions of unknown cause, radiation treatment (including light treatment with PUVA or UVB), mineral imbalance (such as low level of magnesium or high level of potassium), recent/current infections, high cholesterol/triglycerides levels. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). This medication may contain alcohol. Caution is advised if you are pregnant or breastfeeding or have liver disease, alcohol dependence, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor or pharmacist about using this product safely. Cyclosporine can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details. Tell your health care professional that you are using cyclosporine before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). This medication may increase your risk of developing skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Your doctor may direct you to avoid phototherapy while you use this product. Ask your doctor for details. This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist. 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 at greater risk for kidney problems or high blood pressure while using this drug. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby or cause other problems with the baby such as being born too early (premature) or having low birth weight. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also Warning section. Shaking, headache, dizziness, unusual growth of body hair, nausea/vomiting, diarrhea, stomach upset, or flushing may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Unusual growth and swelling of the gums may occur. Brush your teeth and floss daily to reduce this problem. See your dentist regularly. 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. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication. Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as a change in the amount of urine), signs of liver disease (such as nausea/vomiting that doesn't stop, dark urine, yellowing eyes/skin, stomach/abdominal pain), easy bruising/bleeding, unusual tiredness, muscle weakness/spasms, slow/irregular heartbeat, numb/tingling skin, severe leg pain. Get medical help right away if you have any very serious side effects, including: mental/mood changes (such as confusion, difficulty concentrating), vision changes, problems with speech, clumsiness, loss of coordination, weakness on one side of the body, seizures, chest pain. 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.
Side Effects SIDE EFFECTS: See also Warning section. Shaking, headache, dizziness, unusual growth of body hair, nausea/vomiting, diarrhea, stomach upset, or flushing may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Unusual growth and swelling of the gums may occur. Brush your teeth and floss daily to reduce this problem. See your dentist regularly. 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. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication. Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as a change in the amount of urine), signs of liver disease (such as nausea/vomiting that doesn't stop, dark urine, yellowing eyes/skin, stomach/abdominal pain), easy bruising/bleeding, unusual tiredness, muscle weakness/spasms, slow/irregular heartbeat, numb/tingling skin, severe leg pain. Get medical help right away if you have any very serious side effects, including: mental/mood changes (such as confusion, difficulty concentrating), vision changes, problems with speech, clumsiness, loss of coordination, weakness on one side of the body, seizures, chest pain. 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 in the original blister pack at room temperature away from heat 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 STORAGE: Store in the original blister pack at room temperature away from heat 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 is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually taken along with other medications to allow your new organ to function normally. Cyclosporine is also used to treat severe cases of rheumatoid arthritis and plaque psoriasis. In these conditions, the body's defense system (immune system) attacks healthy tissues. Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by weakening the immune system to help your body accept the new organ as if it were your own (in the case of an organ transplant) and to prevent further damage to your joints (in the case of rheumatoid arthritis) or skin (in the case of psoriasis).
Uses USES: Cyclosporine is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually taken along with other medications to allow your new organ to function normally. Cyclosporine is also used to treat severe cases of rheumatoid arthritis and plaque psoriasis. In these conditions, the body's defense system (immune system) attacks healthy tissues. Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by weakening the immune system to help your body accept the new organ as if it were your own (in the case of an organ transplant) and to prevent further damage to your joints (in the case of rheumatoid arthritis) or skin (in the case of psoriasis).

Frequently Asked Questions(FAQs)

The cost of Cyclosporine Mod 25 Mg Sgc 30 Ud is available for registerd members only .
Cyclosporine Mod 25 Mg Sgc 30 Ud is manufactured by TEVA USA.
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