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Amlod-Valsa-Hctz 10-320-25 Mg Tab 30

  • Manufacturer Name : STRIDES PHARMA, INC
  • MFG # : 64380020101
  • NDC : 64380020101
  • Distributor Name : AmeriSource Bergen
PID UOM Price Qty
325211 UN
$523.05
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amlodipine/valsartan/hcthiazid ORAL TABL

Product Properties:

Description N
Description -
DESI Drug Ind -
DESI Drug Ind -; -
DESI2 Drug Ind -
Drug Category N
Drug Category USES: This product is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 3 medications: amlodipine, valsartan, and hydrochlorothiazide. Amlodipine is a calcium channel blocker, and valsartan is an angiotensin receptor blocker (ARB). They both work by relaxing blood vessels so blood can flow more easily. Hydrochlorothiazide is called a "water pill" (diuretic) and causes your body to get rid of extra salt and water by making more urine.
Drug Type Code COMMON BRAND NAME(S): Exforge HCT
Drug Type Code 1
FDA Approval Date 06/01/2015
FDA Therap Equiv AB
HCPCS -
HCPCS 1
Market Entry Date 06/01/2015
Medical Coverage -
Medical Coverage -
Termination Date -
Termination Date (am-LOE-di-peen/val-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide)
Unit TAB
Units Per Pkg 30
Active Ingredients 2294 hydrochlorothiazide 58935; 3673 amlodipine besylate 111470996; 6279 valsartan 137862534
Active Ingredients 2294 hydrochlorothiazide 58935; 3673 amlodipine besylate 111470996; 6279 valsartan 137862534
AHFS Class 24280800 DIHYDROPYRIDINES; 24081208 DIHYDROPYRIDINES (ANTIHYPERTENSIVE); 24280000 CALCIUM-CHANNEL BLOCKING AGENTS; 24320800 ANGIOTENSIN II RECEPTOR ANTAGONISTS; 24084408 ANGIOTENSIN II RECEPTOR ANTAGON.(HYPOTN); 40282000 THIAZIDE DIURETICS; 24082420 THIAZIDE DIURETICS(HYPOTENSIVE AGENTS)
AHFS Class 24280800 DIHYDROPYRIDINES; 24081208 DIHYDROPYRIDINES (ANTIHYPERTENSIVE); 24280000 CALCIUM-CHANNEL BLOCKING AGENTS; 24320800 ANGIOTENSIN II RECEPTOR ANTAGONISTS; 24084408 ANGIOTENSIN II RECEPTOR ANTAGON.(HYPOTN); 40282000 THIAZIDE DIURETICS; 24082420 THIAZIDE DIURETICS(HYPOTENSIVE AGENTS)
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 65152 amlodipine/valsartan/hcthiazid ORAL TABLET 10-320-25
Gen Code and Des 65152 amlodipine/valsartan/hcthiazid ORAL TABLET 10-320-25
Inactive Ingredients 2432 lactose 64044515; 2537 povidone 9003398; 8923 FD and C no.5 (tartrazine)
Inactive Ingredients 2432 lactose 64044515; 2537 povidone 9003398; 8923 FD and C no.5 (tartrazine)
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength -
Strength -
Common Brand Name COMMON BRAND NAME(S): Exforge HCT
Common Brand Name -
Drug Interaction -
Drug Interaction DRUG INTERACTIONS: See also How to Use and Precautions sections. 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: aliskiren, dofetilide, lithium, drugs that may increase the level of potassium in the blood (such as sparsentan, ACE inhibitors including benazepril/lisinopril, birth control pills containing drospirenone). Some products have ingredients that could raise your blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen). This product may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
Allocation Period -
Allocation Period -
Case Quantity 24
Case Quantity 24
Drug Form Pack Size 30
Drug Form Pack Size 30
Form TABLET
Form TABLET
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 30
Unit Size 30
How to Use -
How to Use HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. If you take this drug too close to bedtime, you may need to wake up to urinate. It is best to take this medication at least 4 hours before your bedtime. The dosage is based on your medical condition and response to treatment. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It may take up to 2 weeks before you get the full benefit of this product. Keep taking this product even if you feel well. Most people with high blood pressure do not feel sick. If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine, colestipol), take amlodipine/valsartan/hydrochlorothiazide at least 4 hours before or at least 4 to 6 hours after these medications. Tell your doctor if you do not get better or if you get worse (your blood pressure readings remain high or increase).
Missed Dose 30
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. Lifestyle changes that may help this medication work better include exercising, stopping smoking, and eating a low-cholesterol/low-fat diet. Consult your doctor for more details. Lab and/or medical tests (such as kidney function tests, potassium levels, skin exams) should be done while you are taking this product. Keep all medical and lab appointments. Have your blood pressure checked regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.
Notes TAB
Overdose AB
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. Symptoms of overdose may include: severe dizziness, fainting.
Phonetic Pronunciation -
Phonetic Pronunciation (am-LOE-di-peen/val-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide)
Precautions -
Precautions PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to amlodipine, valsartan, or hydrochlorothiazide; 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, dehydration, untreated electrolytes imbalance (such as high/low potassium, low magnesium, high calcium), gout, lupus, certain heart valve conditions (aortic or mitral stenosis), skin cancer. 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). Severe sweating, diarrhea, or vomiting can increase the risk for lightheadedness or dehydration. Report prolonged diarrhea or vomiting to your doctor. To prevent dehydration, drink plenty of fluids unless your doctor directs you otherwise. If you have diabetes, this product may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet. This product may affect your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist. This medication may make you more sensitive to the sun. It may also increase your risk for skin cancer, especially if you take it for a long time. 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, have skin blisters/redness, or notice new or changed moles/skin lesions. 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 more sensitive to the side effects of this drug, especially dizziness and change in the amount of urine (kidney problems). Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using this medication. Valsartan may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. See also Warning section. It is unknown if valsartan passes into breast milk. Hydrochlorothiazide and amlodipine pass into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Dizziness, lightheadedness, or headache may occur as your body adjusts to the medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. 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 product may cause dehydration and electrolyte imbalance. Tell your doctor right away if you have any symptoms of dehydration or electrolyte imbalance, including: extreme thirst, very dry mouth, muscle cramps/weakness, fast/slow/irregular heartbeat, confusion. Tell your doctor right away if you have any serious side effects, including: fainting, severe tiredness, big toe/joint pain, swelling hands/ankles/feet, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), signs of infection (such as sore throat that doesn't go away, fever, chills), signs of kidney problems (such as change in the amount of urine). Get medical help right away if you have any very serious side effects, including: decrease in vision, eye pain. Some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating). 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 06/01/2015
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 USES: This product is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 3 medications: amlodipine, valsartan, and hydrochlorothiazide. Amlodipine is a calcium channel blocker, and valsartan is an angiotensin receptor blocker (ARB). They both work by relaxing blood vessels so blood can flow more easily. Hydrochlorothiazide is called a "water pill" (diuretic) and causes your body to get rid of extra salt and water by making more urine.

Frequently Asked Questions(FAQs)

The cost of AMLOD-VALSA-HCTZ 10-320-25 MG TAB 30 is $ 523.05.
AMLOD-VALSA-HCTZ 10-320-25 MG TAB 30 is manufactured by STRIDES PHARMA, INC.
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