telmisartan and hydrochlorothiazide 80 mg; 25 mg Tablet, 30-count — NDC 70756-317-30 (Billing 70756-0317-30)
This is a package of 30 tablets of telmisartan and hydrochlorothiazide 80 mg; 25 mg Tablet from Lifestar Pharma LLC, marketed since Dec 2025 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 057690
- GCN: 22866
- GPI-14 (Medi-Span): 36994002600345
- HICL (First Databank): 021873
- AHFS class code: 24:32.08.00
- RxCUI (RxNorm): 283316
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Thiazide Diuretic class.
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- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Great question. This combination is prescribed when one blood pressure drug alone isn't enough to reach your target. The two ingredients — telmisartan and hydrochlorothiazide — low...
- Why am I on two blood pressure drugs in one pill? Wouldn't one be simpler?
- You can take it either way — with or without food. Food does slightly reduce how much telmisartan your body absorbs, but not enough to matter clinically. Just try to take it at the...
- Can I take this pill with food, or does it have to be on an empty stomach?
Patient education
Supplement & herbal interactions
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- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.7873 | $23.62 / 30 tablets |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70756-0317-30 You're viewing this Main listing | 30 TABLET in 1 BOTTLE | 2025-12-25 | — | Active |
| 70756-0317-31 70756-317-31 | 3 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK | 2025-12-25 | — | Active |
| 70756-0317-99 70756-317-99 | 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK | 2025-12-25 | — | Active |
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 70756-0317-31?
What NDC number is used to bill for this package of telmisartan and hydrochlorothiazide 80 mg; 25 mg Tablet?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Telmisartan And Hydrochlorothiazide 80 mg/1; 25 mg 43547-0443-03 | Solco | 30 tablets | $0.338 | AB | Availability likely | — |
| Telmisartan and Hydrochlorothiazide 80 mg/1; 25 mg 65862-0978-03 | Aurobindo | 30 tablets | $0.338 | AB | Availability likely | — |
| Telmisartan and Hydrochlorothiazide 80 mg/1; 25 mg 68462-0842-13 | Glenmark | 30 tablets | $0.338 | AB | Availability likely | — |
| Micardis HCT 80 mg/1; 25 mg 00597-0042-37 | Boehringer | 30 tablets | $4.477 | AB | Availability likely | — |
| Telmisartan and Hydrochlorothiazide 80 mg/1; 25 mg 42291-0464-30 | AvKARE | 30 tablets | — | AB | FDA listed | — |
| Telmisartan and Hydrochlorothiazide 80 mg/1; 25 mg 46708-0211-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Telmisartan and Hydrochlorothiazide 80 mg/1; 25 mg 62332-0211-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| telmisartan and hydrochlorothiazide 80 mg/1; 25 mgthis 70756-0317-30 | Lifestar | 30 tablets | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
BOXED WARNING WARNING: FETAL TOXICITY When pregnancy is detected, discontinue telmisartan and hydrochlorothiazide as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning .
When pregnancy is detected, discontinue telmisartan and hydrochlorothiazide as soon as possible. (5.1, 8.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1, 8.1)
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Telmisartan and hydrochlorothiazide tablets are 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 the classes to which this drug principally belongs.
There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide tablets. 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 one 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 antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.
The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy [see Clinical Studies (14)]. Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)].
Telmisartan and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive agents. Telmisartan and hydrochlorothiazide tablets are combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
(1) Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy (1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Usual starting dose is 80 mg/12.5 mg once daily (2.1) Titrate up to 160 mg/25 mg as needed (2.1) Initiate patients with biliary obstructive disorders or hepatic insufficiency at 40 mg/12.5 mg (2.2)
2.1Dosing Information Initiate a patient whose blood pressure is not adequately controlled with telmisartan monotherapy 80 mg on telmisartan and hydrochlorothiazide tablets, 80 mg/12.5 mg orally once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary. Initiate a patient whose blood pressure is not adequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen on telmisartan and hydrochlorothiazide tablets 80 mg/12.5 mg once daily.
Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary. Patients titrated to the individual components (telmisartan and hydrochlorothiazide) may instead receive the corresponding dose of telmisartan and hydrochlorothiazide tablets. Telmisartan and hydrochlorothiazide tablets may be administered with other antihypertensive drugs.
2.2Dose Adjustment for Hepatic Impairment Initiate patients with biliary obstructive disorders or hepatic insufficiency under close medical supervision using the 40 mg/12.5 mg combination. Telmisartan and hydrochlorothiazide tablets are not recommended for patients with severe hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.3Important Administration Instructions Telmisartan and hydrochlorothiazide tablets should not be removed from blisters until immediately before administration.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Telmisartan and hydrochlorothiazide tablets, USP are available in three strengths as: 40 mg/12.5 mg, white to off white and light yellow to yellow colored, bilayered, oblong shaped, biconvex tablets, debossed with "LS" on one side and "315" on other side. The white to off white layer may contain yellow specks. 80 mg/12.5 mg, white to off white and light red to red colored, bilayered, oblong shaped, biconvex tablets, debossed with "LS" on one side and "316" on other side.
The white to off white layer may contain red specks. 80 mg/25 mg, white to off white and light yellow to yellow colored, bilayered, oblong shaped, biconvex tablets, debossed with "LS" on one side and "317" on other side. The white to off white layer may contain yellow specks.
Tablets: 40 mg/12.5 mg, 80 mg/12.5 mg, 80 mg/25 mg (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Telmisartan and hydrochlorothiazide tablets are contraindicated: In patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.5)]. In patients with anuria. For co-administration with aliskiren in patients with diabetes [see Drug Interactions (7.4)]. Hypersensitivity to telmisartan or any component (4) Anuria (4) Co-Administration with aliskiren in patients with diabetes (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Avoid fetal or neonatal exposure (5.1) Correct volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension (5.2) Monitor renal function and potassium in susceptible patients (5.3) Observe for clinical signs of fluid or electrolyte imbalance (5.4) Hypersensitivity Reaction (5.5) Acute Myopia and Secondary Angle-Closure Glaucoma (5.6)
5.1Fetal Toxicity Telmisartan 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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.
When pregnancy is detected, discontinue telmisartan and hydrochlorothiazide as soon as possible. Hydrochlorothiazide Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia [see Use in Specific Populations (8.1)].
5.2Hypotension in Volume- or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initialization of treatment with telmisartan and hydrochlorothiazide. Correct volume or salt depletion prior to administration of telmisartan and hydrochlorothiazide.
5.3Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin -angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing oliguria, progressive azotemia, or acute renal failure on telmisartan and hydrochlorothiazide.
Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on telmisartan and hydrochlorothiazide.
5.4Electrolytes and Metabolic Disorders Drugs, including telmisartan, that inhibit the renin-angiotensin system can cause hyperkalemia, particularly in patients with renal insufficiency, diabetes, or combination use with other angiotensin receptor blockers or ACE inhibitors and the concomitant use of other drugs that raise serum potassium levels [see Drug Interactions (7.1, 7.4)] . Hydrochlorothiazide can cause hypokalemia and hyponatremia. Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.
Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. Monitor serum electrolytes periodically. In controlled trials using the telmisartan/hydrochlorothiazide combination treatment, no patient administered 40 mg/12.5 mg, 80 mg/12.5 mg, or 80 mg/25 mg experienced a decrease in potassium ≥1.4 mEq/L, and no patient experienced hyperkalemia.
Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Because telmisartan decreases uric acid, telmisartan in combination with hydrochlorothiazide attenuates the diuretic-induced hyperuricemia.
5.5Hypersensitivity Reaction Hydrochlorothiazide Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history [see Contraindications (4)].
5.6Acute Myopia and Secondary Angle-Closure Glaucoma Hydrochlorothiaz… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in labeling: Hypotension [see Warnings and Precautions (5.2)] Renal Impairment [see Warnings and Precautions (5.3)] Electrolytes and Metabolic Disorders [see Warnings and Precautions (5.4)] The most common adverse reactions (≥2% of patients) were upper respiratory tract infection, dizziness, sinusitis, diarrhea, fatigue, influenza-like symptoms, and nausea (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995- 4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 practice. Telmisartan and hydrochlorothiazide has been evaluated for safety in more than 1700 patients, including 716 treated for hypertension for longer than 6 months and 420 for more than 1 year. Adverse reactions have been limited to those that have been previously reported with telmisartan and/or hydrochlorothiazide.
Adverse reactions occurring at an incidence of ≥2% in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo, are presented in Table 1 [see Clinical Studies (14)]. Table 1 Adverse Reactions Occurring at an Incidence of ≥2% in Patients Treated with Telmisartan/Hydrochlorothiazide and at a Greater Rate Than in Patients Treated with Placebo* Telmisartan/ Hydrochlorothiazide (n = 414) Placebo (n = 74) Telmisartan (n = 209) Hydrochlorothiazide (n = 121) Body as a whole Fatigue 3% 1% 3% 3% Influenza-like symptoms 2% 1% 2% 3% Central/Peripheral nervous system Dizziness 5% 1% 4% 6% Gastrointestinal system Diarrhea 3% 0% 5% 2% Nausea 2% 0% 1% 2% Respiratory system disorder Sinusitis 4% 3% 3% 6% Upper respiratory tract infection 8% 7% 7% 10% * includes all doses of telmisartan (20 to 160 mg), hydrochlorothiazide (6.25 to 25 mg), and combinations thereof Other adverse reactions observed for telmisartan/hydrochlorothiazide were: pain (including back and abdominal), dyspepsia, erythema, vomiting, bronchitis, and pharyngitis.
Adverse reactions occurred at approximately the same rates in men and women, older and younger patients, and black and non-black patients. Telmisartan Other adverse events that have been reported with telmisartan are listed below: Autonomic Nervous System: impotence, increased sweating, flushing Body as a Whole: allergy, fever, leg pain, chest pain Cardiovascular: palpitation, angina pectoris, abnormal ECG, hypertension, peripheral edema Central Nervous System: insomnia, somnolence, migraine, paresthesia, involuntary muscle contractions, hypoesthesia Gastrointestinal: flatulence, constipation, gastritis, dry mouth, hemorrhoids, gastroesophageal reflux, toothache Hepato-biliary: elevations of liver enzymes or serum bilirubin Metabolic: gout, hypercholesterolemia, diabetes mellitus Musculoskeletal: arthritis, arthralgia, leg cramps, myalgia Psychiatric: anxiety, depression, nervousness Resistance Mechanism: infection, abscess, otitis media Respiratory: asthma, rhinitis, dyspnea, epistaxis Skin: dermatitis, eczema, pruritus Urinary: micturition frequency, cystitis Vascular: cerebrovascular disorder Special Senses: abnormal vision, conjunctivitis, tinnitus, earache Hydrochlorothiazide Other adverse events that have been reported with hydrochlorothiazide are listed below: Body as a Whole: weakness Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic rea… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Lithium: Risk of lithium toxicity (7.2) Non-steroidal anti-inflammatory drugs (NSAIDs): Reduced diuretic, natriuretic, and antihypertensive effects; increased risk of renal impairment (7.3) Dual blockade of renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia (7.4) Antidiabetic drugs: Dosage adjustment may be required (7.6) Cholestyramine and colestipol: Reduced absorption of thiazides (7.7)
7.1Agents Increasing Serum Potassium Co-administration of telmisartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.
7.2Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of thiazide diuretics or angiotensin II receptor antagonists, including telmisartan. Monitor lithium levels in patients receiving telmisartan and hydrochlorothiazide and lithium.
7.3Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors Telmisartan Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ARBs, including telmisartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
The antihypertensive effect of ARBs may be attenuated by NSAIDs. Therefore, monitor renal function and blood pressure periodically in patients receiving telmisartan and hydrochlorothiazide and NSAIDs. Hydrochlorothiazide Administration of a non-steroidal anti-inflammatory agent, including a selective COX-2 inhibitor, can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics.
Therefore, when telmisartan and hydrochlorothiazide and non-steroidal anti-inflammatory agents including selective COX-2 inhibitors are used concomitantly, observe closely to determine if the desired effect of the diuretic is obtained.
7.4Dual Blockade of the Renin-Angiotensin-Aldosterone System and Changes in Renal Function Dual blockade of the renin-angiotensin-aldosterone system (RAS) with angiotensin blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and renal impairment. The ONTARGET trial enrolled 25,620 patients ≥55 years old with atherosclerotic disease or diabetes with end-organ damage, randomizing them to telmisartan (ARB) only, ramipril (ACE inhibitor) only, or the combination, and followed them for a median of 56 months.
Patients who received the combination of ARB and ACE inhibitor did not obtain any additional benefit (no additional reduction of risk of cardiovascular death, myocardial infarction, stroke, or hospitalization from heart failure) compared to ARB monotherapy or ACE inhibitor monotherapy, but experienced an increased incidence of renal dysfunction (e.g., acute renal failure) compared with monotherapy groups. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on telmisartan and hydrochlorothiazide and other agents that affect the RAS.
Do not co-administer aliskiren with telmisartan and hydrochlorothiazide in patients with diabetes. Avoid concomitant use of aliskiren with telmisartan and hydrochlorothiazide in patients with renal impairment (GFR <60 mL/min/1.73 m 2 ).
7.5Digoxin When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Monitor digoxin levels in patients taking concomitant telmisartan and hydrochlorothiazide and digoxin.
7.6Antidiabetic Drugs (Oral Agents and Insulin) Dosage adjustment of antidiabetic drugs may be required when co-administered with hydrochlorothiazide.
7.7Cholestyramine and Colestip… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Do not breastfeed during treatment with telmisartan and hydrochlorothiazide (8.2) Severe Hepatic Impairment: Use not recommended (8.6) Severe Renal Impairment: Use not recommended (8.7)
8.1Pregnancy Risk Summary Telmisartan and 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 (see Clinical Considerations). Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.
Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses (see Data). When pregnancy is detected, discontinue telmisartan and hydrochlorothiazide as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage).
Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal adverse reactions Telmisartan Use of drugs that act on the RAS in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.
In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking telmisartan and hydrochlorothiazide during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation.
If oligohydramnios is observed, discontinue telmisartan and hydrochlorothiazide, unless it is considered lifesaving for the mother. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to telmisartan and hydrochlorothiazide for hypotension, oliguria, and hyperkalemia.
If oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function [see Use in Specific Populations (8.4)]. Hydrochlorothiazide Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possible other adverse reactions that have occurred in adults.
Data Animal Data Telmisartan and Hydrochlorothiazide A developmental toxicity study was performed in rats with telmisartan/hydrochlorothiazide doses of 3.2/1.0, 15/4.7, 50/15.6, and 0/15.6 mg/kg/day. Although the two higher dose combinations appeared to be more toxic (significant decrease in body weight gain) to the dams than either drug alone, there did not appear to be an increase in toxicity to the developing embryos. Telmisartan No teratogenic effects were observed when telmisartan was administered to pr… [Excerpted — this section continues on DailyMed.]
🆘 Overdosage ▾
10 OVERDOSAGE Telmisartan Limited data are available with regard to overdosage of telmisartan in humans. The most likely manifestations of overdosage with telmisartan are hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.
Telmisartan is not removed by hemofiltration and is not dialyzable. Hydrochlorothiazide The most common signs and symptoms observed in patients with a hydrochlorothiazide overdose are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD 50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Telmisartan and Hydrochlorothiazide Telmisartan and hydrochlorothiazide is a combination of two drugs with antihypertensive properties: a thiazide diuretic, hydrochlorothiazide, and an angiotensin II receptor blocker (ARB), telmisartan. Telmisartan Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.
Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis. There is also an AT 2 receptor found in many tissues, but AT 2 is not known to be associated with cardiovascular homeostasis.
Telmisartan has much greater affinity (>3,000-fold) for the AT 1 receptor than for the AT 2 receptor. Telmisartan does not inhibit ACE (kininase II) nor does it bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of telmisartan on blood pressure.
Hydrochlorothiazide Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium salt and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium.
The renin-aldosterone link is mediated by angiotensin II, so co-administration of an ARB tends to reverse the potassium loss associated with these diuretics. The mechanism of the antihypertensive effect of thiazides is not fully understood.
12.2Pharmacodynamics Telmisartan In normal volunteers, a dose of telmisartan 80 mg inhibited the pressor response to an intravenous infusion of angiotensin II by approximately 90% at peak plasma concentrations with approximately 40% inhibition persisting for 24 hours. Plasma concentration of angiotensin II and plasma renin activity increased in a dose-dependent manner after single administration of telmisartan to healthy subjects and repeated administration to hypertensive patients. The once-daily administration of up to 80 mg telmisartan to healthy subjects did not influence plasma aldosterone concentrations.
In multiple dose studies with hypertensive patients, there were no clinically significant changes in electrolytes (serum potassium or sodium) or in metabolic function (including serum levels of cholesterol, triglycerides, HDL, LDL, glucose, or uric acid). The antihypertensive effects of telmisartan have been studied in six placebo-controlled clinical trials including a total of 1773 patients with mild to moderate hypertension (diastolic blood pressure of 95 to 114 mmHg), 1031 of whom were treated with telmisartan. Following once-daily administration of telmisartan, the magnitude of blood pressure reduction from baseline after placebo subtraction was approximately (SBP/DBP) 6-8/6 mmHg for 20 mg, 9-13/6-8 mmHg for 40 mg, and 12-13/7-8 mmHg for 80 mg.
Larger doses (up to 160 mg) did not appear to cause a further decrease in blood pressure. The onset of antihypertensive activity occurs within 3 hours, with a maximal reduction by approximately 4 weeks. At doses of 20, 40, and 80 mg, the antihypertensive effect of once-daily… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Telmisartan and hydrochlorothiazide tablets, USP are available in three strengths as: 40 mg/12.5 mg tablet : white to off white and light yellow to yellow colored, bilayered, oblong shaped, biconvex tablets, debossed with "LS" on one side and "315" on other side. The white to off white layer may contain yellow specks. Bottles of 30 with child-resistant closure NDC 70756-315-30 Unit-dose child-resistant blister pack of 30 (3 x 10) tablets NDC 70756-315-31 Unit-dose child-resistant blister pack of 100 (10 x 10) tablets NDC 70756-315-99 80 mg/12.5 mg tablet : white to off white and light red to red colored, bilayered, oblong shaped, biconvex tablets, debossed with "LS" on one side and "316" on other side.
The white to off white layer may contain red specks. Bottles of 30 with child-resistant closure NDC 70756-316-30 Unit-dose child-resistant blister pack of 30 (3 x 10) tablets NDC 70756-316-31 Unit-dose child-resistant blister pack of 100 (10 x 10) tablets NDC 70756-316-99 80 mg/25 mg tablet: white to off white and light yellow to yellow colored, bilayered, oblong shaped, biconvex tablets, debossed with "LS" on one side and "317" on other side. The white to off white layer may contain yellow specks.
Bottles of 30 with child-resistant closure NDC 70756-317-30 Unit-dose child-resistant blister pack of 30 (3 x 10) tablets NDC 70756-317-31 Unit-dose child-resistant blister pack of 100 (10 x 10) tablets NDC 70756-317-99 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Tablets should not be removed from bottles or blisters until immediately before administration.
📋 Description ▾
11 DESCRIPTION Telmisartan and hydrochlorothiazide tablets, USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT 1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, USP a non-peptide molecule, is chemically described as 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its molecular formula is C 33 H 30 N4O 2 , its molecular weight is 514.62, and its structural formula is: Telmisartan, USP is a white to slightly yellowish crystalline powder.
It is sparingly soluble in methylene chloride, slightly soluble in methanol, and practically insoluble in water. It dissolves in 1M sodium hydroxide. Hydrochlorothiazide, USP is a white or practically white crystalline powder with a molecular weight of 297.74.
It is freely soluble in sodium hydroxide solution, in n -butyl amine and in dimethyl formamide. It is also very slightly soluble in water, sparingly soluble in methanol, and insoluble in ether, in chloroform and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.
Its molecular formula is C 7 H 8 ClN 3 O 4 S 2 , and its structural formula is: Telmisartan and hydrochlorothiazide tablets, USP are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, mannitol, meglumine, povidone K 30, sodium hydroxide, sodium stearyl fumarate. As coloring agents, the 80 mg/12.5 mg tablets contain ferric oxide red, and the 40 mg/12.5 mg and 80 mg/25 mg tablets contain ferric oxide yellow.
Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture. FDA approved dissolution test specifications differ from USP. structure1 struct2
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION 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 telmisartan and hydrochlorothiazide during pregnancy. Discuss treatment options with women planning to become pregnant.
Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Lactation Advise nursing women not to breastfeed during treatment with telmisartan and hydrochlorothiazide [see Use in Specific Populations (8.2)]. Symptomatic Hypotension and Syncope Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report it to their healthcare provider.
Inform patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope. Advise patients to contact their healthcare provider if syncope occurs [see Warnings and Precautions (5.2)]. Potassium Supplements Advise patients not to use potassium supplements or salt substitutes that contain potassium without consulting the prescribing healthcare provider [see Warnings and Precautions (5.4) and Drug Interactions (7.1)].
Acute Myopia and Secondary Angle-Closure Glaucoma Advise patients to discontinue telmisartan and hydrochlorothiazide and seek immediate medical attention if they experience symptoms of Acute Myopia or Secondary Angle-Closure Glaucoma [see Warnings and Precautions (5.6)]. Non-melanoma Skin Cancer Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd.
Mahwah, NJ 07430 USA Made in India Revised: July 2024, V-03 The other brands listed are trademarks of their owners.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Telmisartan and Hydrochlorothiazide In controlled clinical trials with more than 2500 hypertensive patients, 1017 patients were exposed to telmisartan (20 mg to 160 mg) and concomitant hydrochlorothiazide (6.25 mg to 25 mg). These trials included one factorial trial (Study 1) with combinations of telmisartan (20 mg, 40 mg, 80 mg, 160 mg, or placebo) and hydrochlorothiazide (6.25 mg, 12.5 mg, 25 mg, and placebo). The factorial trial randomized 818 patients, including 493 (60%) males; 596 (73%) Non-Black and 222 (27%) Blacks; and 143 (18%) ≥65 years of age (median age was 53 years old).
The mean supine blood pressure at baseline for the total population was 154/101 mmHg. The combination of telmisartan and hydrochlorothiazide resulted in additive placebo-adjusted decreases in systolic and diastolic blood pressures at trough of 16-21/9-11 mmHg for doses between 40 mg/12.5 mg and 80 mg/25 mg, compared with 9-13/7-8 mmHg for telmisartan 40 mg to 80 mg monotherapy and 4/4 mmHg for hydrochlorothiazide 12.5 mg monotherapy. The antihypertensive effect was independent of age or gender.
There was essentially no change in heart rate in patients treated with the combination of telmisartan and hydrochlorothiazide in the placebo-controlled trial. Four other studies of hypertensive patients of at least six months' duration allowed add-on of hydrochlorothiazide for patients who either were not adequately controlled on the randomized telmisartan monotherapy dose or had not achieved adequate blood pressure response after completing the up-titration of telmisartan. In active-controlled studies, the addition of 12.5 mg hydrochlorothiazide to titrated doses of telmisartan in patients who did not achieve or maintain adequate response with telmisartan monotherapy further reduced systolic and diastolic blood pressures.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Telmisartan and Hydrochlorothiazide No carcinogenicity, mutagenicity, or fertility studies have been conducted with the combination of telmisartan and hydrochlorothiazide. Telmisartan There was no evidence of carcinogenicity when telmisartan was administered in the diet to mice and rats for up to 2 years. The highest doses administered to mice (1000 mg/kg/day) and rats (100 mg/kg/day) are, on a mg/m 2 basis, about 59 and 13 times, respectively, the maximum recommended human dose (MRHD) of telmisartan.
These same doses have been shown to provide average systemic exposures to telmisartan >100 times and >25 times, respectively, the systemic exposure in humans receiving the MRHD of telmisartan (80 mg/day). Genotoxicity assays did not reveal any telmisartan-related effects at either the gene or chromosome level. These assays included bacterial mutagenicity tests with Salmonella and E. coli (Ames), a gene mutation test with Chinese hamster V79 cells, a cytogenetic test with human lymphocytes, and a mouse micronucleus test.
No drug-related effects on the reproductive performance of male and female rats were noted at 100 mg/kg/day (the highest dose administered), about 13 times, on a mg/m 2 basis, the MRHD of telmisartan. This dose in the rat resulted in an average systemic exposure (telmisartan AUC as determined on day 6 of pregnancy) at least 50 times the average systemic exposure in humans at the MRHD (80 mg/day). Hydrochlorothiazide Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of up to approximately 100 mg/kg/day).
The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in vivo in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Positive test results were obtained in the in vitro CHO Sister Chromatid Exchange (clastogenicity) assay, in the Mouse Lymphoma Cell (mutagenicity) assay, and in the Aspergillus nidulans non-disjunction assay.
Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to mating and throughout gestation.
📄 Patient Package Insert ▾
Patient Information Telmisartan and Hydrochlorothiazide Tablets, USP (tel"mi sar' tan and hye" droe klor" oh thye' a zide) Read this Patient Information before you start taking telmisartan and hydrochlorothiazide tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is the most important information I should know about telmisartan and hydrochlorothiazide tablets? Telmisartan and hydrochlorothiazide tablets can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
If you get pregnant while taking telmisartan and hydrochlorothiazide tablets, tell your doctor right away. What are telmisartan and hydrochlorothiazide tablets ? Telmisartan and hydrochlorothiazide tablets are prescription medicine used to treat high blood pressure (hypertension).
Telmisartan and hydrochlorothiazide tablets contains: telmisartan, an angiotensin receptor blocker (ARB) hydrochlorothiazide, a water pill or diuretic Your doctor may prescribe other medicines for you to take along with telmisartan and hydrochlorothiazide tablets to treat your high blood pressure. It is not known if telmisartan and hydrochlorothiazide tablets are safe and effective in children. Do not take telmisartan and hydrochlorothiazide tablets if you: have low or no urine output are allergic (hypersensitive) to the active ingredients (telmisartan or hydrochlorothiazide) or any of the other ingredients listed at the end of this leaflet What should I tell my doctor before using telmisartan and hydrochlorothiazide tablets?
Before you take telmisartan and hydrochlorothiazide tablets, tell your doctor if you: are pregnant or are planning to become pregnant. See "What is the most important information I should know about telmisartan and hydrochlorothiazide tablets?" are breast-feeding or plan to breast-feed. Telmisartan and hydrochlorothiazide can pass into your breast milk and may harm your baby.
You and your doctor should decide if you will take telmisartan and hydrochlorothiazide tablets or breast-feed. You should not do both. Talk with your doctor about the best way to feed your baby if you take telmisartan and hydrochlorothiazide tablets. have been told that you have abnormal body salt (electrolytes) levels in your blood have liver problems have asthma or history of asthma have lupus have diabetes have kidney problems have any other medical conditions Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Also, tell your doctor if you drink alcohol. Telmisartan and hydrochlorothiazide tablets may affect the way other medicines work, and other medicines may affect how telmisartan and hydrochlorothiazide tablets works. Especially tell your doctor if you take: aliskiren digoxin (Lanoxin ® ) lithium (Lithobid ® , lithium carbonate, lithium citrate) other medicines used to treat your high blood pressure or a heart problem water pills (diuretic) aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) potassium supplements or a salt substitute containing potassium medicine used to treat diabetes, including insulin narcotic pain medicines sleeping pills steroid medicine or Adrenocorticotrophic Hormone (ACTH) barbiturates certain cholesterol lowering medicines (resins that are used for cholesterol reduction, e.g., cholestyramine and colestipol resins) Ask your doctor if you are not sure if you are taking one of the medicines listed above.
Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine. How should I take telmisartan and hydrochlorothiazide tablets?
Take telmisartan and hydrochlorothiazide tablets exactly as your doctor tells you to take it. Your doctor will tell you how much telmisartan and hydrochlorothiazide tablets to… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70756-315-30 Telmisartan and Hydrochlorothiazide Tablets, USP 40 mg/12.5 mg Important: Moisture sensitive tablets - do not remove from bottle until immediately before administration. 30 Tablets Rx only NDC 70756-316-30 Telmisartan and Hydrochlorothiazide Tablets, USP 80 mg/12.5 mg Important: Moisture sensitive tablets - do not remove from bottle until immediately before administration. 30 Tablets Rx only NDC 70756-317-30 Telmisartan and Hydrochlorothiazide Tablets, USP 80 mg/25 mg Important: Moisture sensitive tablets - do not remove from bottle until immediately before administration.
30 Tablets Rx only NDC 70756-315-31 Telmisartan and Hydrochlorothiazide Tablets, USP 40 mg/12.5 mg Important: Moisture sensitive tablets - do not remove from blister until immediately before administration. 30 Tablets (3 x 10 unit-dose) Rx only NDC 70756-316-31 Telmisartan and Hydrochlorothiazide Tablets, USP 80 mg/12.5 mg Important: Moisture sensitive tablets - do not remove from blister until immediately before administration. 30 Tablets (3 x 10 unit-dose) Rx only NDC 70756-317-31 Telmisartan and Hydrochlorothiazide Tablets, USP 80 mg/25 mg Important: Moisture sensitive tablets - do not remove from blister until immediately before administration.
30 Tablets (3 x 10 unit-dose) Rx only NDC 70756-315-99 Telmisartan and Hydrochlorothiazide Tablets, USP 40 mg/12.5 mg Important: Moisture sensitive tablets - do not remove from blister until immediately before administration. 100 Tablets (10 x10 unit-dose) Rx only NDC 70756-316-99 Telmisartan and Hydrochlorothiazide Tablets, USP 80 mg/12.5 mg Important: Moisture sensitive tablets - do not remove from blister until immediately before administration. 100 Tablets (10 x10 unit-dose) Rx only NDC 70756-317-99 Telmisartan and Hydrochlorothiazide Tablets, USP 80 mg/25 mg Important: Moisture sensitive tablets - do not remove from blister until immediately before administration.
100 Tablets (10 x10 unit-dose) Rx only 40 mg/12.5 mg, 10's Blister Card : 80 mg/12.5 mg, 10's Blister Card : 80 mg/25 mg, 10's Blister Card : 40-12.5 mg bottle 80-12.5mg bottle 80-25mgbottle 40-12.5mg 30 carton 80-12.5mg 30 carton 80-25mg 30 carton 40-12.5 mg 100 carton 80-12.5 mg 100 carton 80-25mg 100 carton 40-12.5mg foil 80-12.5 mg foil 80-25 mg foil
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