Product Details
RAYALDEE 30 MCG ER CAP 30
Manufacturer: OPKO PHARMACEUT
MFG#: 70301-1001-01
NDC: 70301-1001-01
PID: 223084
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Product Properties:
| Description | - |
|---|---|
| Description | - |
| DESI Drug Ind | - |
| DESI Drug Ind | - |
| DESI2 Drug Ind | NR |
| DESI2 Drug Ind | NR |
| Drug Category | - |
| Drug Category | - |
| Drug Type Code | S |
| Drug Type Code | S |
| FDA Approval Date | 11/29/2016 |
| FDA Approval Date | 11/29/2016 |
| FDA Therap Equiv | CAP |
| FDA Therap Equiv | CAP |
| HCPCS | - |
| HCPCS | - |
| Market Entry Date | - |
| Market Entry Date | - |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | 1 |
| Termination Date | 1 |
| Unit | 30 |
| Unit | 30 |
| Units Per Pkg | 06/17/2016 |
| Units Per Pkg | 06/17/2016 |
| Active Ingredients | 1016 calcifediol 19356173 |
| Active Ingredients | 1016 calcifediol 19356173 |
| AHFS Class | 88160000 VITAMIN D |
| AHFS Class | 88160000 VITAMIN D |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | CAPSULE, EXTENDED RELEASE 24HR |
| Dose Form | CAPSULE, EXTENDED RELEASE 24HR |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 76295 calcifediol ORAL CAP SA 24H 30 MCG |
| Gen Code and Des | 76295 calcifediol ORAL CAP SA 24H 30 MCG |
| Inactive Ingredients | 10138 blue dye; 16176 coconut; 2599 sorbitol 50704; 7543 sorbitan esters |
| Inactive Ingredients | 10138 blue dye; 16176 coconut; 2599 sorbitol 50704; 7543 sorbitan esters |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 30MCG ER |
| Strength | 30MCG ER |
| Common Brand Name | COMMON BRAND NAME(S): Rayaldee |
| Common Brand Name | COMMON BRAND NAME(S): Rayaldee |
| 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: burosumab. Calcifediol is very similar to other forms of vitamin D. Do not use medications containing other forms of vitamin D while using calcifediol. |
| 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: burosumab. Calcifediol is very similar to other forms of vitamin D. Do not use medications containing other forms of vitamin D while using calcifediol. |
| Allocation Period | - |
| Allocation Period | - |
| Case Quantity | 72 |
| Case Quantity | 72 |
| Drug Form Pack Size | 30 |
| Drug Form Pack Size | 30 |
| Form | CAPSULES |
| Form | CAPSULES |
| Hazard Code | - |
| Hazard Code | - |
| Listed Chemical | - |
| Listed Chemical | - |
| 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. |
| 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 once daily at bedtime. Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects. 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. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. If your doctor has told you to follow a special diet (such as a diet high in calcium), it is very important to follow the diet to get the most benefit from this medication and to prevent serious side effects. Do not take other vitamins/supplements unless directed by your doctor. |
| How to Use | HOW TO USE: Take this medication by mouth as directed by your doctor, usually once daily at bedtime. Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects. 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. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. If your doctor has told you to follow a special diet (such as a diet high in calcium), it is very important to follow the diet to get the most benefit from this medication and to prevent serious side effects. Do not take other vitamins/supplements unless directed by your doctor. |
| 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 PTH, calcium/phosphorus, vitamin D levels) should be done while you are taking this medication. Keep all medical and lab appointments. |
| Notes | NOTES: Do not share this medication with others. Lab and/or medical tests (such as PTH, calcium/phosphorus, vitamin D levels) should be done while you are taking this medication. Keep all medical and lab appointments. |
| 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 | (KAL-sif-e-DYE-ol) |
| Phonetic Pronunciation | (KAL-sif-e-DYE-ol) |
| Precautions | PRECAUTIONS: Before taking calcifediol, tell your doctor or pharmacist if you are allergic to it; or to other vitamin D products (such as calcitriol); 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. 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. |
| Precautions | PRECAUTIONS: Before taking calcifediol, tell your doctor or pharmacist if you are allergic to it; or to other vitamin D products (such as calcitriol); 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. 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: Calcifediol usually has very few side effects. If you have any unusual side effects, contact 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: bone/joint/muscle pain, loss of appetite, nausea/vomiting, constipation, increased thirst, increased urination, fast/slow/irregular heartbeat, mental/mood changes (such as difficulty thinking clearly), weakness. 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: Calcifediol usually has very few side effects. If you have any unusual side effects, contact 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: bone/joint/muscle pain, loss of appetite, nausea/vomiting, constipation, increased thirst, increased urination, fast/slow/irregular heartbeat, mental/mood changes (such as difficulty thinking clearly), weakness. 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. |
| 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 people with serious kidney disease whose bodies make too much of a certain natural substance (parathyroid hormone-PTH). High amounts of PTH can affect other minerals in the body (such as calcium, phosphorus) that are needed for strong bones. Calcifediol belongs to a class of drugs known as vitamin D analogs. It works by decreasing PTH and increasing calcium and phosphorus in the body. |
| Uses | USES: This medication is used to treat people with serious kidney disease whose bodies make too much of a certain natural substance (parathyroid hormone-PTH). High amounts of PTH can affect other minerals in the body (such as calcium, phosphorus) that are needed for strong bones. Calcifediol belongs to a class of drugs known as vitamin D analogs. It works by decreasing PTH and increasing calcium and phosphorus in the body. |
Frequently Asked Questions (FAQs)
The cost of RAYALDEE 30 MCG ER CAP 30 is $available for registerd members only
RAYALDEE 30 MCG ER CAP 30 is manufactured by OPKO PHARMACEUT.
You can purchase RAYALDEE 30 MCG ER CAP 30 on our website at https://supplies.pipelinemedical.com/product/detail/rayaldee-30-mcg-er-cap-30-223084