TOLVAPTAN
TOLVAPTAN · KIT · Lupin Pharmaceuticals, Inc.
TOLVAPTAN is a kit containing tolvaptan. Manufactured by Lupin Pharmaceuticals, Inc..
Key Facts
- Brand Name
- TOLVAPTAN
- Generic Name
- TOLVAPTAN
- NDC Code (Product)
70748-242- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA216063
- Drug Class
- Vasopressin V2 Receptor Antagonist [EPC]
- Marketing Start
- 05/12/2025
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 are a selective vasopressin V 2 -receptor antagonist 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) ( 1 ) Limitations of Use: Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms shou…
Dosage & Administration
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 osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. The usual starting dose for tolvaptan tablets is 15 mg administered once daily without regard to meals. Increase the dose to 30 mg once daily, after at least 24 hours, to a maximum of 60 mg once daily, as needed to achieve the desired level of serum sodium. Do not administer tolvaptan tablets for more than 30 days to minimize the risk of liver injury [see Warnings and Precautions (5.2) ]. During initiation and titration, frequently monitor for changes in serum electrolytes and volume. Avoid fluid restriction during the first 24 hours of therapy. Patients …
Contraindications
4 CONTRAINDICATIONS Tolvaptan tablets are contraindicated in the following conditions: Patients with autosomal dominant polycystic kidney disease (ADPKD) outside of FDA-approved REMS [see Warnings and Precautions (5.2) ] Unable to sense or respond to thirst Hypovolemic hyponatremia Taking strong CYP3A inhibitors [see Warnings and Precautions (5.5) ] Anuria Hypersensitivity (e.g., anaphylactic shock, rash generalized) to tolvaptan or any components of the product [see Adverse Reactions (6) ] Use in patients with autosomal dominant polycystic kidney disease (ADPKD) outside of FDA approved REMS ( 4 ) Patients who are unable to respond appropriately to thirst ( 4 ) Hypovolemic hyponatremia ( 4 ) Concomitant use of strong CYP 3A inhibitors ( 4 ) Anuria ( 4 ) Hypersensitivity ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Avoid concomitant use with: Moderate CYP3A inhibitors ( 7.1 ) Strong CYP3A inducers ( 7.1 ) V 2 -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 ketoconazole [see Warnings and Precautions ( 5.5 ) and Clinical Pharmacology ( 12.3 )]. Larger doses of the strong CYP3A inhibitor would be expected to produce larger increases in tolvaptan exposure. Concomitant use of tolvaptan with strong CYP3A inhibitors is contraindicated [see Contraindications ( 4 )]. Moderate CYP3A Inhibitors A substantial increase in the exposure to tolvaptan would be expected when tolvaptan is co-administered with moderate CYP3A inhibitors. Avoid co-administration of tolvaptan with moderate CYP3A inhibitors [see Warnings and Precautions ( 5.5 )] . Patients should avoid grapefruit juice beverages while taking tolvaptan [see Clinical Pharmacology ( 12.3 )]. Strong CYP3A Inducers C…
Adverse Reactions
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 Endo at 1-800-828-9393 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 directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. In multiple-dose, placebo-controlled trials, 607 hyponatremic patients (serum sodium <135 mEq/L) were treated with tolvaptan. The mean age of these patients was 62 years; 70% of patients were male and 82% were Caucasian. One hundred eighty nine (189) tolvaptan-treated patients had a serum sodium <130 mEq/L, and 52 patients had a serum sodium <125 mEq/L. Hyponatremia was attributed to cirrhosis in 17% of patients, heart failure in 68%…
Frequently Asked Questions
What is TOLVAPTAN used for?
TOLVAPTAN contains TOLVAPTAN. It is a kit taken as directed. Consult your doctor for specific uses.
Is TOLVAPTAN a controlled substance?
TOLVAPTAN is not classified as a controlled substance by the DEA.
What is the generic name for TOLVAPTAN?
The generic name for TOLVAPTAN is TOLVAPTAN. There are 8 other brand versions of TOLVAPTAN.
What is the NDC code for TOLVAPTAN ?
The NDC (National Drug Code) for TOLVAPTAN is 70748-242, listed by Lupin Pharmaceuticals, Inc..