Telmisartan/hctz 80-25mg Tabs
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
It's essential to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. Be aware that this medication may increase your urine production, so try to avoid taking it too close to bedtime to minimize sleep disruptions. Establish a routine by taking your medication at the same time every day.
Special Handling Instructions
Some brands of this medication come in a blister pack. If your medication is packaged in a blister pack, remove the tablet from the pack immediately before taking it. To do this, peel back the foil on the blister pack, but avoid pushing the tablet through the foil, as this may cause it to break.
Storing and Disposing of Your Medication
Store your medication in its original container at room temperature, in a dry location, and away from the bathroom. Keep all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take this medication exactly as prescribed, usually once daily with or without food.
- Do not stop taking this medication without consulting your doctor, even if you feel well.
- Limit your intake of sodium (salt) as directed by your doctor or dietitian.
- Engage in regular physical activity as recommended by your doctor.
- Limit alcohol consumption.
- Avoid smoking.
- Stay well-hydrated, especially in hot weather or during exercise, but avoid excessive fluid intake unless advised by your doctor.
- Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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 immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble 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
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling extremely tired or weak
+ Decreased appetite
+ Inability to pass urine or changes in urine output
+ Dry mouth
+ Dry eyes
+ Severe upset stomach or vomiting
Chest pain
Severe dizziness or fainting
Trouble 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 or any other unusual symptoms, contact your doctor or seek medical help:
Common cold symptoms
Dizziness
Fatigue
Weakness
Flu-like symptoms
Back pain
Diarrhea
* Upset stomach
This is not an exhaustive list of possible side effects. 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.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting (signs of very low blood pressure)
- Swelling of the face, lips, tongue, or throat (signs of angioedema, a serious allergic reaction)
- Difficulty breathing or swallowing
- Severe muscle weakness, cramps, or irregular heartbeat (signs of electrolyte imbalance)
- Unusual tiredness or weakness
- Yellowing of the skin or eyes (jaundice)
- Decreased urination or swelling in the feet/ankles (signs of kidney problems)
- Persistent nausea or vomiting
Before Using This Medicine
It is essential to inform your doctor about the following conditions and situations 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 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 you determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. 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. Also, have blood work done 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 your doctor. Additionally, 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, consult your doctor.
Caution with Other Medications and Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or using prescription or OTC medications that may slow your reactions, discuss this with your doctor.
Precautions in Hot Weather
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms may lead to low blood pressure.
Eye Problems
This medication can cause 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 typically occur within hours to weeks of starting the medication. Seek medical attention immediately if you notice these symptoms.
Rare but Serious Reaction
In rare cases, this medication can cause a severe reaction called angioedema, 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 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 worsen your 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.
Overdose Information
Overdose Symptoms:
- Profound hypotension (very low blood pressure)
- Tachycardia (rapid heart rate)
- Bradycardia (slow heart rate)
- Dizziness
- Lightheadedness
- Syncope (fainting)
- Electrolyte depletion (e.g., hypokalemia, hyponatremia)
- Dehydration
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is symptomatic and supportive. If ingestion is recent, gastric lavage may be considered. Administer intravenous fluids to correct hypotension and electrolyte imbalances. Monitor vital signs and laboratory parameters closely.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or renal impairment)
- Lithium (due to increased lithium levels and toxicity from HCTZ)
Major Interactions
- NSAIDs (including COX-2 inhibitors) - may reduce antihypertensive effect and increase risk of renal impairment, especially in dehydrated or elderly patients.
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) or potassium supplements - increased risk of hyperkalemia due to telmisartan.
- Digoxin - HCTZ-induced hypokalemia or hypomagnesemia can increase digoxin toxicity.
- Other antihypertensive agents - additive hypotensive effects.
Moderate Interactions
- Corticosteroids - may antagonize the diuretic and antihypertensive effects of HCTZ.
- Bile acid sequestrants (e.g., cholestyramine, colestipol) - may reduce absorption of HCTZ.
- Alcohol, barbiturates, or narcotics - may potentiate orthostatic hypotension.
- Antidiabetic agents (oral agents and insulin) - HCTZ may decrease glucose tolerance, requiring dose adjustment of antidiabetic agents.
Minor Interactions
- Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine) - HCTZ may potentiate their effect.
Monitoring
Baseline Monitoring
Rationale: To establish baseline control and guide therapy.
Timing: Prior to initiation
Rationale: To assess baseline electrolyte status, as HCTZ can cause imbalances and telmisartan can cause hyperkalemia.
Timing: Prior to initiation
Rationale: To assess baseline kidney function, as both components can affect renal function and dose adjustments may be needed.
Timing: Prior to initiation
Rationale: To assess baseline liver function, as telmisartan is primarily eliminated via bile and hepatic impairment requires caution.
Timing: Prior to initiation
Rationale: HCTZ can increase uric acid levels.
Timing: Prior to initiation
Rationale: HCTZ can affect glucose metabolism.
Timing: Prior to initiation
Routine Monitoring
Frequency: Regularly (e.g., daily at home, at each clinic visit)
Target: <130/80 mmHg or individualized target
Action Threshold: Persistently elevated BP despite adherence, or symptomatic hypotension
Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months, or as clinically indicated)
Target: Potassium: 3.5-5.0 mEq/L; Sodium: 135-145 mEq/L
Action Threshold: Potassium <3.0 or >5.5 mEq/L; Sodium <130 or >150 mEq/L, or symptomatic changes
Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months, or as clinically indicated)
Target: Stable creatinine, eGFR >60 mL/min/1.73m2
Action Threshold: Significant increase in creatinine (>30% from baseline) or decrease in eGFR
Frequency: Periodically, especially in diabetic patients or those at risk for diabetes
Target: Individualized based on diabetes management guidelines
Action Threshold: Persistent hyperglycemia
Frequency: Periodically, especially in patients with history of gout or hyperuricemia
Target: Individualized, typically <7 mg/dL
Action Threshold: Significant increase or symptoms of gout
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fainting (syncope)
- Excessive fatigue or weakness
- Muscle cramps or pain
- Dry mouth
- Increased thirst
- Nausea
- Vomiting
- Irregular heartbeat
- Swelling of face, lips, tongue, or throat (angioedema)
- Difficulty breathing or swallowing
- Yellowing of skin or eyes (jaundice)
- Signs of infection (fever, sore throat) - rare, but HCTZ can cause blood dyscrasias
Special Patient Groups
Pregnancy
Contraindicated during the second and third trimesters of pregnancy due to risk of fetal injury and death. Avoid use in the first trimester as well. If pregnancy is detected, discontinue as soon as possible.
Trimester-Specific Risks:
Lactation
Not recommended during breastfeeding. Hydrochlorothiazide is excreted in human milk and can suppress lactation. It is unknown if telmisartan is excreted in human milk. Due to the potential for serious adverse effects on the breastfed infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.
Geriatric Use
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. Monitor renal function and electrolytes closely, as elderly patients are more likely to have age-related decreases in renal function and be on concomitant medications.
Clinical Information
Clinical Pearls
- This combination is typically used when monotherapy with telmisartan or HCTZ is insufficient to control blood pressure.
- Take consistently at the same time each day to maintain steady blood pressure control.
- Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, or throat) immediately.
- Monitor for signs of electrolyte imbalance, especially hypokalemia (due to HCTZ) and hyperkalemia (less common, but possible with telmisartan, especially with renal impairment or potassium-sparing diuretics).
- Educate patients about orthostatic hypotension (dizziness upon standing) and advise them to rise slowly.
- Avoid concomitant use with NSAIDs, especially in patients with dehydration or renal impairment, due to increased risk of acute renal failure and reduced antihypertensive effect.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs) monotherapy (e.g., telmisartan, valsartan)
- ACE Inhibitors (e.g., lisinopril, enalapril)
- Calcium Channel Blockers (e.g., amlodipine, nifedipine)
- Beta-blockers (e.g., metoprolol, carvedilol)
- Other Diuretics (e.g., loop diuretics, potassium-sparing diuretics)
- Direct Renin Inhibitors (e.g., aliskiren - generally not first-line)