Telmisartan/hctz 80-12.5mg Tabs

Telmisartan selectively blocks the binding of angiotensin II to the AT1 receptor in many tissues, including vascular smooth muscle and the adrenal gland. This inhibits the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation and reduced sodium and water reabsorption. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium. This reduces plasma volume and peripheral vascular resistance.

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of pancreatitis (pancreas problems), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe nausea or vomiting
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of fluid and electrolyte problems, such as:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Abnormal heartbeat or palpitations
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Fatigue or weakness
+ Decreased appetite
+ Changes in urine output
+ Dry mouth or eyes
+ Severe nausea or vomiting
Chest pain
Severe dizziness or fainting
Difficulty passing urine
Pain while passing urine
Fever, chills, or sore throat
Unexplained bruising or bleeding
Fatigue or weakness
Abnormal sensations, such as burning, numbness, or tingling
Shortness of breath
Restlessness
Erectile dysfunction
Rarely, skin cancer has been reported in people taking hydrochlorothiazide. Protect your skin from the sun and follow your doctor's instructions for skin checks. If you notice any changes in the color or size of a mole, or any new or changing skin lump or growth, contact your doctor immediately.

Other Side Effects

Most people experience few or no side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor if they bother you or do not go away:

Signs of a common cold
Dizziness, fatigue, or weakness
Flu-like symptoms
Back pain
Diarrhea
* Nausea or upset stomach

This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
A known sulfa allergy.
Certain health conditions, including kidney disease or liver disease.
Dehydration or electrolyte imbalances.
Urinary retention, which means you are unable to pass urine.
Concurrent use of specific medications, such as:
+ Aliskiren
+ Benazepril
+ Captopril
+ Enalapril
+ Fosinopril
+ Lisinopril
+ Moexipril
+ Perindopril
+ Quinapril
+ Ramipril
+ Trandolapril
+ Dofetilide
* If you are breast-feeding, as you should not breast-feed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

If you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely. Be aware of signs of high blood sugar, which may include confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath. Notify your doctor if you experience any of these symptoms.

Regularly check your blood pressure as directed by your healthcare provider. Additionally, have your blood work checked as recommended by your doctor and discuss the results with them.

Please note that this medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.

If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult with your doctor. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor.

Before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products or aids, consult with your doctor.

Exercise caution when using alcohol, marijuana or other forms of cannabis, or prescription or OTC drugs that may impair your actions. Discuss their use with your doctor beforehand.

In hot weather or during physical activity, be mindful of fluid loss and drink plenty of fluids. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, notify your doctor, as these conditions may lead to low blood pressure.

This medication can cause eye problems, which, if left untreated, may result in permanent vision loss. Typically, signs of eye problems, such as changes in vision or eye pain, occur within hours to weeks of starting the medication. If you experience these symptoms, contact your doctor immediately.

Although rare, a severe reaction called angioedema has been associated with this medication, and in some cases, it has been fatal. Seek medical attention immediately if you experience symptoms such as swelling of the hands, face, lips, eyes, tongue, or throat, difficulty breathing or swallowing, or unusual hoarseness.

This medication may also cause elevated cholesterol and triglyceride levels. Discuss this with your doctor.

If you are taking cholestyramine or colestipol, consult with your pharmacist about how to take these medications in conjunction with this drug. Be aware of the potential for gout attacks.

For individuals with lupus, this medication may exacerbate the condition or trigger a flare-up. Notify your doctor promptly if you experience new or worsening symptoms.

Additionally, this medication may increase your susceptibility to sunburn. Exercise caution when exposed to the sun, and inform your doctor if you experience increased sensitivity to sunlight while taking this medication.

• Aliskiren in patients with diabetes or moderate to severe renal impairment (GFR < 60 mL/min/1.73 m²)

• Lithium (increased serum lithium concentrations and toxicity)
• NSAIDs (including selective COX-2 inhibitors - may attenuate antihypertensive effect, increase risk of renal impairment)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium (increased risk of hyperkalemia)
• Other antihypertensive agents (additive hypotensive effect)
• Digoxin (HCTZ may increase digoxin toxicity due to hypokalemia/hypomagnesemia)
• Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia)
• Pressor amines (e.g., norepinephrine - HCTZ may decrease arterial responsiveness)
• Non-depolarizing skeletal muscle relaxants (e.g., tubocurarine - HCTZ may potentiate effect)

• Alcohol, barbiturates, or narcotics (may potentiate orthostatic hypotension)
• Antidiabetic drugs (oral agents and insulin - HCTZ may require dose adjustment)
• Cholestyramine and colestipol resins (may impair HCTZ absorption)
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Amantadine (increased risk of adverse effects with HCTZ)
• Cytotoxic agents (e.g., cyclophosphamide, methotrexate - HCTZ may reduce renal excretion)
• Calcium salts (increased serum calcium levels due to HCTZ)

• Not available

• Dizziness
• Lightheadedness
• Fatigue
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Swelling of face, lips, tongue, or throat (angioedema - rare but serious)
• Persistent dry cough (less common with ARBs than ACEIs, but possible)
• Signs of dehydration (excessive thirst, dry mouth)
• Unusual bruising or bleeding (rare, due to HCTZ effect on platelets)

Contraindicated. Use of drugs acting 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. Discontinue as soon as pregnancy is detected.

Not recommended. Both telmisartan and hydrochlorothiazide are excreted in breast milk. Due to the potential for adverse effects on the nursing infant (e.g., hypotension, hyperkalemia, hypokalemia, dehydration), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.

No overall differences in effectiveness or safety were observed between elderly patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and titrate carefully, monitoring renal function and electrolytes closely due to increased susceptibility to volume depletion and electrolyte imbalances.

• This combination is typically used when monotherapy with Telmisartan or Hydrochlorothiazide is insufficient to control blood pressure.
• Administer once daily. Can be taken with or without food.
• Monitor for signs of hypotension, especially after the first dose or dose increases.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, or throat) immediately.
• Avoid concomitant use with potassium supplements or potassium-sparing diuretics unless serum potassium is closely monitored.
• Caution in patients with a history of gout due to the hydrochlorothiazide component increasing uric acid levels.
• Patients with severe renal impairment (CrCl < 30 mL/min) should not use this combination due to the hydrochlorothiazide component.
• Patients with severe hepatic impairment should not use this combination.

• ACE Inhibitors (e.g., Lisinopril, Ramipril)
• Calcium Channel Blockers (e.g., Amlodipine, Nifedipine)
• Beta-blockers (e.g., Metoprolol, Carvedilol)
• Loop Diuretics (e.g., Furosemide - for more potent diuresis)
• Alpha-blockers (e.g., Doxazosin, Terazosin)
• Direct Renin Inhibitors (e.g., Aliskiren - with caution)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.