Amlodipine 5 mg, Valsartan 160 mg, Hydrochlorothiazide 25 mg Tablet## (active ingredient spelling)

Amlodipine/valsartan/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 ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine/valsartan/hydrochlorothiazide. …

• Dose once-daily
• Titrate up to a maximum dose of 10/320/25 mg
• Amlodipine/valsartan/hydrochlorothiazide 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
• Amlodipine/valsartan/hydrochlorothiazide may be substituted for its individually titrated components
• 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 amlodipine/valsartan/hydrochlorothiazide
• The maximum recommended dose of amlodipine/valsartan/hydrochlorothiazide is 10/320/25 mg
• Add-on/Switch Therapy Amlodipine/valsartan/hydrochlorothiazide 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 amlodipine/valsartan/hydrochlorothiazide may be switched to amlodipine/valsartan/hydrochlorothiazide containing a lower dose of that component to achieve similar blood pressure reductions
• Replacement Therapy Amlodipine/valsartan/hydrochlorothiazide may be substituted for the individually titrated components
• Use With Other Antihypertensive Drugs Amlodipine/valsartan/hydrochlorothiazide may be administered with other antihypertensive agents

Amlodipine/valsartan/hydrochlorothiazide tablets are available as follows: 5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets – White to off-white, film coated, oval shaped biconvex tablets, debossed with "P" on one side of the tablet and "172" on the other. …

• The safety and effectiveness of amlodipine/valsartan/hydrochlorothiazide
• Pediatric patients have not been established

Amlodipine Clinical studies of amlodipine besylate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Pregnancy: Advise female patients of childbearing age about the consequences of exposure to amlodipine/valsartan/ hydrochlorothiazide during pregnancy
• Discuss treatment options with women planning to become pregnant
• Ask patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions and Use in Specific Populations ] Lactation: Advise women not to breastfeed during treatment with amlodipine/valsartan/hydrochlorothiazide [see Use in Specific Populations ]. …

• 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 amlodipine/valsartan/hydrochlorothiazide in patients with diabetes [see Drug Interactions ]
• Anuria Hypersensitivity to sulfonamide-derived drugs Known hypersensitivity to any component Do not coadminister aliskiren with amlodipine/valsartan/hydrochlorothiazide in patients with diabetes

No drug interaction studies have been conducted with amlodipine/valsartan/hydrochlorothiazide 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, amlodipine/valsartan/hydrochlorothiazide, 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. …

Hypotension: Correct volume depletion prior to initiation (5.2) Increased angina and/or myocardial infarction (5.3) Monitor renal function and potassium in susceptible patients (5.4, 5.5) Exacerbation or activation of systemic lupus erythematosus (5.7) Observe for signs of fluid or electrolyte imbalance (5.9) Acute angle-closure glaucoma (5.10) 5.1 Fetal Toxicity Valsartan Amlodipine/valsartan/hydrochlorothiazide can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. …

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 Strides Pharma Inc at 1-877-244-9825 and/or www.strides.com 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. …

8.1 Pregnancy Risk Summary Amlodipine/valsartan/hydrochlorothiazide can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. …

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, institute supportive treatment. Amlodipine Single oral doses of amlodipine maleate equivalent to 40 mg/kg and 100 mg/kg amlodipine in mice and rats, respectively, caused deaths. Single oral doses equivalent to 4 or more mg/kg amlodipine in dogs (11 or more times the MRHD on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.