Generic equivalent of Tolvaptan
1 SKUs available · Available to order · NABP accredited · DSCSA compliant
Tolvaptan is the generic equivalent of the brand-name drug Tolvaptan. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Tolvaptan through Premier Pharma with same-day fulfillment on in-stock SKUs.
1 INDICATIONS AND USAGE Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Limitations of Use Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets. It has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients. Tolvaptan tablets is a selective v…
6 ADVERSE REACTIONS Most common adverse reactions (≥5% placebo) are thirst, dry mouth, asthenia, constipation, pollakiuria or polyuria, and hyperglycemia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ). 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be dire…
7 DRUG INTERACTIONS Avoid concomitant use with: • Moderate CYP3A inhibitors ( 7.1 ) • Strong CYP3A inducers ( 7.1 ) • V2-receptor antagonists ( 7.3 ) Monitor serum potassium during concomitant therapy with ( 7.2 ): • Angiotensin receptor blockers • Angiotensin converting enzyme inhibitors • Potassium sparing diuretics 7.1 CYP3A Inhibitors and Inducers Strong CYP3A Inhibitors Tolvaptan's AUC was 5.4 times as large and C max was 3.5 times as large after co-administration of tolvaptan and 200 mg ke…
2 DOSAGE AND ADMINISTRATION Tolvaptan tablets should be initiated and re-initiated in a hospital ( 2.1 ) The recommended starting dose is 15 mg once daily. Dosage may be increased at intervals ≥24 hr to 30 mg once daily, and to a maximum of 60 mg once daily as needed to raise serum sodium. ( 2.1 ) 2.1 Recommended Dosage Patients should be in a hospital for initiation and re-initiation of therapy to evaluate the therapeutic response and because too rapid correction of hyponatremia can cause osmot…
17 PATIENT COUNSELING INFORMATION As a part of patient counseling, healthcare providers must review the tolvaptan tablets Medication Guide with every patient [see FDA-Approved Medication Guide]. Pregnancy Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1)]. Lactation Advise patients not to breastfeed an infant if they are taking tolvaptan tablets [see Use in Specific Populations (8.2)]. Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by:…
Source: FDA. For professional use only. Not a substitute for prescribing information.
Premier Pharma stocks 1 Tolvaptan SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Tolvaptan is the generic equivalent of Tolvaptan. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Tolvaptan in 30 mg/1 and TABLET.
Create a free Premier Pharma account to unlock live wholesale pricing, place orders, and track shipments — approval typically takes minutes for licensed pharmacies, clinics, doctor's offices, and veterinary practices.