Product Details
CALCIPOTR-BETAMETH 0.005-0.064% SUS 60GM
Manufacturer: TARO PHARMACEUTICAL INDUSTRIES LTD
MFG#: 51672-1402-04
NDC: 51672-1402-04
PID: 278192
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Product Properties:
| Description | - |
|---|---|
| Description | N |
| DESI Drug Ind | -; - |
| DESI Drug Ind | - |
| DESI2 Drug Ind | AB |
| Drug Category | - |
| Drug Category | USES: This product contains 2 drugs (betamethasone and calcipotriene) and is used to treat psoriasis of the scalp. Some brands of this medication are also used to treat psoriasis on the body. Betamethasone is a very strong corticosteroid drug that helps decrease the swelling, redness, and itching of the skin that occurs with this condition. Calcipotriene, which is also known as calcipotriol in other countries, is a form of vitamin D. It works by slowing down the growth of skin cells so that they do not build up into thickened, scaly skin patches. This medication should not be used if you have certain types of psoriasis (skin patches with pus-filled blisters, psoriasis with intense redness/shedding/oozing). Consult your doctor for more information. This product is not recommended for use in children because they may be at an increased risk for side effects. See also Side Effects and Precautions sections. |
| Drug Type Code | COMMON BRAND NAME(S): Taclonex Scalp |
| Drug Type Code | N |
| FDA Approval Date | 10/08/2020 |
| FDA Therap Equiv | GM |
| HCPCS | - |
| HCPCS | 1 |
| Market Entry Date | - |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | (BAY-ta-METH-a-sone/KAL-si-poe-TRYE-een/KAL-si-poe-TRYE-ol) |
| Termination Date | 1 |
| Unit | 60 |
| Units Per Pkg | 09/02/2020 |
| Active Ingredients | 2171 betamethasone dipropionate 5593204; 3941 calcipotriene 112965216 |
| Active Ingredients | 2171 betamethasone dipropionate 5593204; 3941 calcipotriene 112965216 |
| AHFS Class | 84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.; 84060800 CORTICOSTEROIDS (SKIN, MUCOUS MEMBRANE) |
| AHFS Class | 84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.; 84060800 CORTICOSTEROIDS (SKIN, MUCOUS MEMBRANE) |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | SUSPENSION, TOPICAL (GRAM) |
| Dose Form | SUSPENSION, TOPICAL (GRAM) |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 63988 calcipotriene/betamethasone TOPICAL SUSPENSION 0.005-.064 |
| Gen Code and Des | 63988 calcipotriene/betamethasone TOPICAL SUSPENSION 0.005-.064 |
| Inactive Ingredients | 2468 propylene glycol 57556; 9290 cremophor el (polyethoxlated castor oil) |
| Inactive Ingredients | 2468 propylene glycol 57556; 9290 cremophor el (polyethoxlated castor oil) |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | - |
| Strength | - |
| Common Brand Name | COMMON BRAND NAME(S): Taclonex Scalp |
| Common Brand Name | - |
| Drug Interaction | - |
| 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 | - |
| Allocation Period | - |
| Case Quantity | 48 |
| Case Quantity | 48 |
| Drug Form Pack Size | 60 |
| Drug Form Pack Size | 60 |
| Form | SUSPENSION |
| Form | SUSPENSION |
| Hazard Code | - |
| Hazard Code | - |
| Listed Chemical | - |
| Listed Chemical | - |
| NIOSH Code | - |
| NIOSH Code | - |
| 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 | 60 |
| Unit Size | 60 |
| How to Use | HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is for use on the scalp. Do not apply this product 12 hours before or after any chemical treatments to your hair. Shake the bottle well before use. Part your hair, apply the product only to the affected area(s) of the scalp, and gently rub in as directed by your doctor, usually once daily. Wash your hands after using, but do not wash your hair right after applying this product. Avoid getting any medication in the eyes or ears. If this occurs, immediately rinse with plenty of water. Do not apply this product to the face, underarms, or groin area. If your doctor has directed you to use this product on your body, follow your doctor's directions for how much to use and where to use it. Apply to affected areas and gently rub in. Wash your hands after using. Do not use this medication more often or for longer than directed. Do not use more than 100 grams of this product a week unless directed and closely monitored by your doctor. Do not bandage, wrap, or cover the treated area unless your doctor instructs you to do so. Do not use this product on large areas of damaged skin. Following these instructions helps to reduce your risk of side effects. Tell your doctor if your condition does not improve or if it worsens. It may take up to 2 weeks to see any improvement. |
| How to Use | - |
| Missed Dose | 60 |
| 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. Lab and/or medical tests (such as adrenal gland function) may be done while you are using this medication, especially if you use this drug for an extended period of time or apply it over large areas of the body. Keep all medical and lab appointments. Consult your doctor for more details. Try to identify and reduce the triggers that may worsen your psoriasis (such as stress, skin injury, smoking). Discuss with your doctor additional ways to control symptoms. |
| Notes | GM |
| Overdose | AB |
| 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 | - |
| Phonetic Pronunciation | (BAY-ta-METH-a-sone/KAL-si-poe-TRYE-een/KAL-si-poe-TRYE-ol) |
| Precautions | - |
| Precautions | PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to betamethasone or calcipotriene; 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 your medical history, especially of: a certain mineral imbalance (high calcium levels in the blood or urine), thin skin in the area to be treated, liver disease. If you have a skin infection (such as chickenpox, herpes simplex) or a skin problem other than psoriasis, it should be treated before you start this medication. Betamethasone and other corticosteroid drugs can slow down your body's response to antibiotic drugs and make it more difficult to clear an infection. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Your doctor may direct you to limit or avoid phototherapy while you use this product. Ask your doctor for details. Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked. 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: Itching, burning, redness, or irritation of the skin 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: skin thinning/discoloration/"stretch marks", small red bumps on the skin (folliculitis), worsening of psoriasis. This medication may rarely cause an increase in the level of calcium in your blood or urine. Tell your doctor right away if you notice any of the following unlikely but serious side effects: mental/mood changes, unexplained constipation, pink/bloody urine, painful urination. Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems. 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 | - |
| Storage | 09/02/2020 |
| Storage | STORAGE: Store at room temperature and do not refrigerate. Keep the bottle in the outer carton when not in use. Discard any unused product 6 months after the bottle has been opened. 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 | USES: This product contains 2 drugs (betamethasone and calcipotriene) and is used to treat psoriasis of the scalp. Some brands of this medication are also used to treat psoriasis on the body. Betamethasone is a very strong corticosteroid drug that helps decrease the swelling, redness, and itching of the skin that occurs with this condition. Calcipotriene, which is also known as calcipotriol in other countries, is a form of vitamin D. It works by slowing down the growth of skin cells so that they do not build up into thickened, scaly skin patches. This medication should not be used if you have certain types of psoriasis (skin patches with pus-filled blisters, psoriasis with intense redness/shedding/oozing). Consult your doctor for more information. This product is not recommended for use in children because they may be at an increased risk for side effects. See also Side Effects and Precautions sections. |
Frequently Asked Questions (FAQs)
The cost of CALCIPOTR-BETAMETH 0.005-0.064% SUS 60GM is $available for registerd members only
CALCIPOTR-BETAMETH 0.005-0.064% SUS 60GM is manufactured by TARO PHARMACEUTICAL INDUSTRIES LTD.
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