Exforge HCT 10 mg/1
amlodipine valsartan and hydrochlorothiazide · TABLET, FILM COATED · Novartis Pharmaceuticals Corporation
Exforge HCT is a prescription tablet that combines three blood pressure-lowering medications: amlodipine (a calcium channel blocker), valsartan (an angiotensin II receptor blocker), and hydrochlorothiazide (a diuretic). It is used to treat high blood pressure in patients who need multiple medications to control their condition.
Key Facts
- Brand Name
- Exforge HCT
- Generic Name
- amlodipine valsartan and hydrochlorothiazide
- NDC Code (Product)
0078-0563- Manufacturer
- Novartis Pharmaceuticals Corporation
- Strength
- 10 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA022314
- Drug Class
- Thiazide Diuretic [EPC]; Angiotensin 2 Receptor Blocker [EPC]
- Marketing Start
- 04/04/2009
Recall History
Novartis Pharmaceuticals Corp.
Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Novartis Pharmaceuticals Corp.
Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Novartis Pharmaceuticals Corp.
Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
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 Exforge HCT (amlodipine, valsartan, and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Exforge HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous an…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dose once-daily. Titrate up to a maximum dose of 10/320/25 mg. ( 2.1 ) Exforge HCT may be used as add-on/switch therapy for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics. ( 2.2 ) Exforge HCT may be substituted for its individually titrated components. ( 2.3 ) 2.1 General Considerations Dose once-daily. The dosage may be increased after 2 weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Exforge HCT. The maximum recommended dose of Exforge HCT is 10/320/25 mg. 2.2 Add-on/Switch Therapy Exforge HCT may be used for patients not adequately controlled on any 2 of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics. A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Exforge HCT may be switched to Exforge HCT containing a lower dose of that component to achieve similar blood pressure reductions. 2.3 Replacement Therapy Exforge HCT may be substit…
Contraindications
4 CONTRAINDICATIONS Do not use in patients with anuria, hypersensitivity to other sulfonamide-derived drugs, or hypersensitivity to any component of this product. Do not coadminister aliskiren with Exforge HCT in patients with diabetes [see Drug Interactions (7)] . Anuria ( 4 ) Hypersensitivity to sulfonamide-derived drugs ( 4 ) Known hypersensitivity to any component ( 4 ) Do not coadminister aliskiren with Exforge HCT in patients with diabetes ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No drug interaction studies have been conducted with Exforge HCT and other drugs, although studies have been conducted with the individual components. A pharmacokinetic drug-drug interaction study has been conducted to address the potential for pharmacokinetic interaction between the triple combination, Exforge HCT, and the corresponding 3 double combinations. No clinically relevant interaction was observed. Amlodipine Impact of Other Drugs on Amlodipine CYP3A Inhibitors Coadministration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors to determine the need for dose adjustment [see Clinical Pharmacology (12.3)] . CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is coadministered with CYP3A inducers (e.g., rifampicin, St. John’s Wort). Sildenafil Monitor for hypotension when sildenafil is coadministered with amlodipine [see Clinical Pharmacology (12.2)]. Impact of Amlodipi…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse events (≥ 2% incidence) are dizziness, peripheral edema, headache, dyspepsia, fatigue, muscle spasms, back pain, nausea, and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. In the controlled trial of Exforge HCT, where only the maximum dose (10/320/25 mg) was evaluated, safety data were obtained in 582 patients with hypertension. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall frequency of adverse reactions was similar between men and women, younger (< 65 years) and older ( > 65 years) patients, and black and white patients. In the active controlled clinical trial, discontinuation because of adverse events occurred in 4.…
Frequently Asked Questions
What is Exforge HCT used for?
Exforge HCT is a prescription tablet that combines three blood pressure-lowering medications: amlodipine (a calcium channel blocker), valsartan (an angiotensin II receptor blocker), and hydrochlorothiazide (a diuretic). It is used to treat high blood pressure in patients who need multiple medications to control their condition.
Is Exforge HCT a controlled substance?
Exforge HCT is not classified as a controlled substance by the DEA.
What is the generic name for Exforge HCT?
The generic name for Exforge HCT is amlodipine valsartan and hydrochlorothiazide. There are no other listed brand versions of amlodipine valsartan and hydrochlorothiazide.
What is the NDC code for Exforge HCT 10 mg/1?
The NDC (National Drug Code) for Exforge HCT 10 mg/1 is 0078-0563, listed by Novartis Pharmaceuticals Corporation.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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