Telmisartan/hctz 40-12.5mg Tabs

Telmisartan is an angiotensin II receptor blocker (ARB) that 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 vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, reduced peripheral resistance, and decreased blood pressure. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium and chloride 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, contributing to its antihypertensive effect.

Urgent 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 notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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 upset stomach or vomiting
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach 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 fast heart rate
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling extremely tired or weak
+ Decreased appetite
+ Changes in urine output
+ Dry mouth
+ Dry eyes
+ Severe upset stomach or vomiting
Chest pain
Severe dizziness or fainting
Difficulty passing urine
Pain while passing urine
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Abnormal sensations, such as burning, numbness, or tingling
Shortness of breath
Restlessness
Erectile dysfunction
Rarely, skin cancer has been reported in people taking hydrochlorothiazide. To minimize risk, protect your skin from the sun and follow your doctor's recommendations 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 Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Common cold symptoms
Dizziness, fatigue, or weakness
Flu-like symptoms
Back pain
Diarrhea
* Upset stomach

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
A known sulfa allergy.
Certain health conditions, including:
+ Kidney disease
+ Liver disease
Dehydration or electrolyte imbalances.
Inability to urinate.
Current medications, particularly:
+ Aliskiren
+ Benazepril
+ Captopril
+ Enalapril
+ Fosinopril
+ Lisinopril
+ Moexipril
+ Perindopril
+ Quinapril
+ Ramipril
+ Trandolapril
+ Dofetilide
* If you are breast-feeding. Note: 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.

Important Warnings and Cautions

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

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.

Managing Diabetes
If you have diabetes, closely monitor your blood sugar levels. Be aware of signs of high blood sugar, such as confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath. Report these symptoms to your doctor.

Monitoring Blood Pressure and Lab Tests
Check your blood pressure as directed by your healthcare provider. Additionally, have your blood work checked as scheduled, and discuss the results with your doctor. Note that this medication may affect certain lab tests, so inform all healthcare providers and lab personnel that you are taking this drug.

Interactions with Other Substances
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult with your doctor. Also, discuss your diet with your doctor if you are on a low-salt or salt-free diet. 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, consult with your doctor.

Caution with Other Medications and Substances
Before using alcohol, marijuana or other forms of cannabis, or prescription or OTC medications that may slow your reactions, discuss with your doctor.

Precautions in Hot Weather
In hot weather or during physical activity, drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions may lead to low blood pressure.

Eye Problems
This medication can cause certain eye problems, which, if left untreated, may result in permanent vision loss. If you experience eye problems, symptoms such as changes in vision or eye pain usually occur within hours to weeks of starting this medication. Seek medical attention immediately if you notice these symptoms.

Rare but Serious Reaction
In rare cases, a severe reaction called angioedema has occurred with this medication, which can be life-threatening. Seek medical help immediately if you experience symptoms such as swelling of the hands, face, lips, eyes, tongue, or throat, difficulty breathing or swallowing, or unusual hoarseness.

Cholesterol and Triglyceride Levels
This medication may increase cholesterol and triglyceride levels. Discuss this with your doctor. If you take cholestyramine or colestipol, consult with your pharmacist about how to take these medications with this drug. Be aware of the risk of gout attacks.

Lupus and Sun Sensitivity
If you have lupus, this medication may activate or worsen the condition. Inform your doctor immediately if you experience new or worsening symptoms. Additionally, this medication may increase your risk of sunburn. Take precautions when exposed to the sun, and inform your doctor if you experience increased sun sensitivity while taking this medication.

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

• Lithium (increased serum lithium concentrations and toxicity)
• NSAIDs (including COX-2 inhibitors - reduced antihypertensive effect, increased risk of renal impairment)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride - increased risk of hyperkalemia)
• Potassium supplements (increased risk of hyperkalemia)
• ACE inhibitors (increased risk of hypotension, hyperkalemia, and renal impairment when co-administered with ARBs)
• Digoxin (hydrochlorothiazide-induced hypokalemia can potentiate digoxin toxicity)
• Corticosteroids (increased risk of electrolyte depletion, particularly hypokalemia)
• Insulin and oral hypoglycemic agents (hydrochlorothiazide may decrease glucose tolerance, requiring dose adjustment of antidiabetic agents)

• Barbiturates, narcotics, or alcohol (additive hypotensive effect)
• Cholestyramine and colestipol resins (impaired absorption of hydrochlorothiazide)
• Pressor amines (e.g., norepinephrine - hydrochlorothiazide may decrease arterial responsiveness)
• Non-depolarizing skeletal muscle relaxants (e.g., tubocurarine - hydrochlorothiazide may potentiate effect)

• Allopurinol (increased risk of hypersensitivity reactions with hydrochlorothiazide)
• Calcium salts (increased serum calcium levels due to decreased excretion by hydrochlorothiazide)

• Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
• Fatigue or weakness
• Muscle cramps or weakness (signs of electrolyte imbalance, particularly hypokalemia)
• Dry mouth, thirst, nausea, vomiting (signs of dehydration or electrolyte imbalance)
• Swelling of face, lips, tongue, or throat (signs of angioedema, rare but serious)
• Difficulty breathing or swallowing (signs of angioedema)
• Changes in urination (e.g., decreased urine output, signs of renal dysfunction)
• Unusual bruising or bleeding (rare, but possible blood dyscrasias with HCTZ)
• Yellowing of skin or eyes (jaundice, rare, but possible hepatic issues)

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the first trimester is generally not recommended due to potential risks.

Not recommended during breastfeeding. Both telmisartan and hydrochlorothiazide are excreted in human milk. Due to the potential for serious adverse reactions in the breastfed infant (e.g., hypotension, hyperkalemia, effects on renal function from telmisartan; electrolyte disturbances, decreased milk production from hydrochlorothiazide), 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 have been observed between elderly 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, as elderly patients are more likely to have age-related renal impairment.

• This combination is often used when monotherapy with an ARB or a thiazide diuretic is insufficient to control blood pressure.
• Take consistently at the same time each day, preferably in the morning, to avoid nocturia (nighttime urination) due to the diuretic component.
• Monitor for signs of orthostatic hypotension, especially at the start of therapy or with dose increases.
• Educate patients on the importance of regular blood pressure monitoring at home.
• Caution patients about the risk of hyperkalemia with telmisartan (an ARB) and hypokalemia with hydrochlorothiazide (a diuretic); regular electrolyte monitoring is crucial to manage these opposing effects.
• Advise patients to report any signs of angioedema immediately, although rare with ARBs, it is a serious side effect.
• Hydrochlorothiazide can increase uric acid levels and may precipitate gout attacks in susceptible individuals.
• Hydrochlorothiazide can also cause photosensitivity; advise patients to use sun protection.

• Other classes of antihypertensives (e.g., ACE inhibitors, Calcium Channel Blockers, Beta-blockers, other diuretics)
• Monotherapy with Telmisartan or Hydrochlorothiazide if blood pressure is adequately controlled.

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 your 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.