Latest news with #Amlodipine
Medscape
29-05-2025
- General
- Medscape
Rapid Rx Quiz: Calcium-Channel Blockers
Calcium-channel blockers (CCBs) play a central role in the treatment of hypertension, angina, and certain cardiac arrhythmias and are among the most commonly prescribed drugs in the United States. Beyond their US Food and Drug Administration–approved uses, CCBs have found a place in treating several off-label conditions. With their widespread use, however, comes the responsibility of understanding their pharmacodynamics, drug-drug interactions, and potential toxicities. How much do you know about CCBs? Test yourself with this short quiz. Off-label uses for CCBs include Raynaud phenomenon, migraines, and subarachnoid hemorrhage. CCBs do not treat depression; in fact, their use has been associated with depression. Verapamil might reduce diastolic dysfunction, but this is not a mainstream use. The most common CCBs are relatively weight neutral. Learn more about Raynaud phenomenon. Including lightheadedness, specific adverse and serious adverse events from CCB use are bradycardia, constipation, headaches, flushing, worsening cardiac output, and peripheral edema, possibly from fluid redistributing from the intravascular space. Learn more about dizziness and vertigo. A recent study found that amlodipine was involved in the majority of overdose cases, accounting for 62% of all CCB overdoses. This far surpasses other agents such as lercanidipine (12%), diltiazem (11%), verapamil (10%), and felodipine (5%). The lower incidence of overdoses involving lercanidipine, diltiazem, verapamil, and felodipine corresponds with their declining presence in current hypertension treatment guidelines. Although amlodipine is involved in more overdose cases overall, the study underscores that the severity of overdose varies significantly by CCB class. Nondihydropyridines, such as diltiazem and verapamil, were associated with markedly higher rates of life-threatening complications, including dysrhythmias (33-35% of cases) and intensive care unit (ICU) admissions (52% and 30%, respectively). In contrast, amlodipine showed much lower rates of dysrhythmias (1%) and ICU admissions (18%). Learn more about CCB toxicity. Many of the signs and symptoms of CCB toxicity are similar to normal CCB adverse events, making diagnosis challenging. A blood test can aid in diagnosis; abnormal findings that suggest CCB toxicity include acidosis, hyperglycemia, and hypokalemia. Neutrophilia has no established connection. Learn more about CCB toxicity. Combining diltiazem or verapamil with direct oral anticoagulants might increase risk for bleeding or clotting complications, though previous research has shown mixed results. A recent study found no evidence of increased risk when direct oral anticoagulants were used alongside diltiazem or verapamil. However, patients who began direct oral anticoagulant therapy while already taking diltiazem had higher rates of overall mortality and cardiovascular-related death within 30 days, compared with those taking anticoagulants alone. Learn more about diltiazem.
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Business Standard
23-05-2025
- Business
- Business Standard
Alembic Pharma receives USFDA approval for generic hypertension drug
Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for its generic version of amlodipine and atorvastatin tablets, used to treat high blood pressure. The final approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amlodipine and Atorvastatin tablets of strengths 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, the company said in a statement. These are therapeutically equivalent to the reference-listed drug product, Caduet tablets of corresponding strengths of Pharmacia and Upjohn Co LLC, it added. Alembic said it has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from the USFDA. (Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Business Standard
23-05-2025
- Business
- Business Standard
Alembic Pharma receives USFDA nod for Amlodipine and Atorvastatin Tablets
Alembic Pharmaceuticals announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Amlodipine and Atorvastatin Tablets USP. Amlodipine and Atorvastatin tablets are a combination medication used to treat high blood pressure (hypertension) and high cholesterol (hyperlipidemia). The approved product is therapeutically equivalent to the reference listed drug, Caduet Tablets, marketed by Pharmacia and Upjohn Co. LLC. The company now has a cumulative total of 223 ANDA approvals from the USFDA, including 199 final approvals and 24 tentative approvals. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24. The counter shed 0.13% to Rs 971.25 on the BSE.
Time of India
23-05-2025
- Business
- Time of India
Alembic Pharma gets USFDA nod for generic high blood pressure treatment drug
Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for its generic version of amlodipine and atorvastatin tablets, used to treat high blood pressure. The final approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amlodipine and Atorvastatin tablets of strengths 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, the company said in a statement. These are therapeutically equivalent to the reference-listed drug product, Caduet tablets of corresponding strengths of Pharmacia and Upjohn Co LLC, it added. Alembic said it has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from the USFDA.
Business Upturn
23-05-2025
- Business
- Business Upturn
Alembic Pharmaceuticals gets USFDA final approval for Amlodipine and Atorvastatin Tablets
By Aman Shukla Published on May 23, 2025, 12:01 IST Alembic Pharmaceuticals Limited has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amlodipine and Atorvastatin Tablets USP. The approved product includes a range of dosage combinations: 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg. These formulations are therapeutically equivalent to Caduet Tablets, the reference listed drug (RLD) marketed by Pharmacia and Upjohn Co. LLC. Amlodipine and Atorvastatin Tablets are prescribed for patients who require treatment with both medications. The drug combines a calcium channel blocker and a statin to manage conditions such as high blood pressure and high cholesterol. The approval by the USFDA allows Alembic to market these tablets in the United States. With this approval, Alembic now has a total of 223 ANDA approvals from the USFDA, including 199 final approvals and 24 tentative approvals. About Alembic Pharmaceuticals Limited Alembic Pharmaceuticals Limited is an India-based pharmaceutical company involved in the development, manufacture, and marketing of generic pharmaceutical products. Established in 1907, the company is headquartered in Vadodara, Gujarat. Alembic operates research and manufacturing facilities that are approved by regulatory agencies including the USFDA and markets its products globally. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
