Tribenzor 40/10/12.5mg Tablets

Tribenzor combines three antihypertensive agents with complementary mechanisms of action: Olmesartan medoxomil, an angiotensin II receptor blocker (ARB); Amlodipine besylate, a dihydropyridine calcium channel blocker (CCB); and Hydrochlorothiazide (HCTZ), a thiazide diuretic. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor. Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, leading to peripheral arterial vasodilation and reduction in peripheral vascular resistance. HCTZ inhibits the reabsorption of sodium and chloride in the distal convoluted tubule, increasing the excretion of sodium, chloride, and water, thereby reducing plasma volume.

Serious Side Effects: Seek Medical Attention Immediately

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 help right away:

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 high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of kidney problems, such as:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ Significant weight gain
Signs of fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or change in the amount of urine produced
+ Dry mouth
+ Dry eyes
+ Severe upset stomach or vomiting
Pain when passing urine
Joint pain or swelling
Shortness of breath, significant weight gain, or swelling in the arms or legs
Chest pain that is new or worsening
Significant weight loss
Muscle spasm
Restlessness

Eye Problems

This medication can cause certain eye problems, which can lead to permanent vision loss if left untreated. If you experience any of the following symptoms, contact your doctor right away:

Change in vision
Eye pain

These symptoms usually occur within hours to weeks of starting this medication.

Skin Cancer Risk

Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. To minimize your risk, 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 right away.

Other Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor or seek medical help:

Feeling dizzy, tired, or weak
Headache
Nose or throat irritation
Signs of a common cold
Upset stomach
* Diarrhea

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. Describe the allergic reaction you experienced, including the symptoms that occurred.
A known sulfa allergy.
Current or planned use of dofetilide.
Difficulty urinating or inability to pass urine.
Pre-existing kidney disease.
Use of another medication with similar properties. If you are unsure, consult your doctor or pharmacist for clarification.
Concurrent use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.
Breastfeeding status, as you should not breastfeed 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 conditions with your doctor and pharmacist. They will help determine the safety of taking this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.

To minimize the risk of accidents, 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 reduce the likelihood of dizziness or fainting. Be cautious when navigating stairs to prevent falls.

If you have diabetes, this medication may occasionally increase your blood sugar levels. Consult your doctor about strategies to maintain control over your blood sugar. Monitor your blood pressure as directed by your healthcare provider, and undergo regular blood tests and other laboratory evaluations as recommended.

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, discuss this with your doctor. Additionally, if you are following a low-sodium or sodium-free diet, consult your doctor for guidance.

Although rare, it is possible to experience new or worsening chest pain after starting this medication or increasing the dose. In some cases, this may lead to a heart attack, particularly in individuals with severe heart blood vessel disease. Discuss this risk 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. Also, discuss the use of alcohol, marijuana, or other cannabis products, as well as prescription or OTC medications that may cause drowsiness, with your doctor before consumption.

In hot weather or during physical activity, be cautious 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.

If you are taking colesevelam, colestipol, or cholestyramine, consult your pharmacist about the best way to take these medications with this drug. Be aware of the potential for gout attacks, and monitor your condition accordingly.

Individuals with lupus should be aware that this medication may reactivate or worsen the condition. If you experience new or worsening symptoms, notify your doctor promptly. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

• Aliskiren (in patients with diabetes or renal impairment due to increased risk of hyperkalemia, hypotension, and renal impairment with olmesartan)

• Lithium (increased serum lithium concentrations and toxicity)
• NSAIDs (including COX-2 inhibitors - may attenuate antihypertensive effect and increase risk of renal impairment with olmesartan and HCTZ)
• Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium (increased risk of hyperkalemia with olmesartan)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, diltiazem, verapamil - increased amlodipine exposure)
• CYP3A4 inducers (e.g., rifampin, St. John's Wort - decreased amlodipine exposure)
• Digoxin (increased digoxin levels with amlodipine)
• Cyclosporine (increased cyclosporine levels with amlodipine)
• Colestipol and Cholestyramine resins (may impair absorption of HCTZ)
• Barbiturates, narcotics, alcohol (may potentiate orthostatic hypotension with HCTZ)
• Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia with HCTZ)
• Pressor amines (e.g., norepinephrine - possible decreased response to pressor amines with HCTZ)
• Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine - possible increased responsiveness to muscle relaxants with HCTZ)
• Antidiabetic drugs (oral agents and insulin - dosage adjustment may be required with HCTZ due to hyperglycemia risk)

• Other antihypertensive agents (additive hypotensive effect)
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Amantadine (increased risk of adverse effects with HCTZ)
• Calcium salts (increased serum calcium levels with HCTZ)
• Diazoxide (enhanced hyperglycemic and hyperuricemic effects with HCTZ)
• Loop diuretics (additive diuretic and hypotensive effects)
• Metformin (risk of lactic acidosis due to HCTZ-induced renal impairment)
• Non-depolarizing muscle relaxants (prolonged effect with HCTZ)
• Pre-anesthetic and anesthetic agents (may potentiate hypotension with amlodipine)
• Simvastatin (limit simvastatin dose to 20 mg daily with amlodipine)

• Not available (specific minor interactions for this combination are less clinically significant than major/moderate)

• Dizziness or lightheadedness (especially upon standing)
• Fatigue or weakness
• Swelling of ankles, feet, or hands (edema)
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Unusual thirst or dry mouth
• Nausea or vomiting
• Changes in urination (frequency, volume)
• Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death associated with the olmesartan component. Discontinue as soon as pregnancy is detected. First trimester exposure may also carry risk.

Not recommended during breastfeeding. Olmesartan, amlodipine, and hydrochlorothiazide are 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.

Safety and effectiveness in pediatric patients have not been established. Use is not recommended.

No overall differences in effectiveness or safety were observed between elderly patients (65 years and over) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution, generally starting at the lower end of the dosing range, and monitor renal function closely due to potential age-related decreases in renal function.

• Tribenzor is a triple combination therapy indicated for patients whose blood pressure is not adequately controlled on dual therapy or who are already on the individual components.
• Due to the HCTZ component, monitor for electrolyte imbalances (especially hypokalemia, hyponatremia, hypomagnesemia, hypercalcemia) and hyperuricemia.
• Due to the olmesartan component, monitor for hyperkalemia, especially in patients with renal impairment or those taking potassium-sparing diuretics or supplements.
• Amlodipine can cause peripheral edema, which may be dose-dependent.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, although this is rare with ARBs compared to ACE inhibitors.
• Avoid concomitant use with NSAIDs, as they can reduce the antihypertensive effect and increase the risk of renal impairment.
• Educate patients on the importance of adherence and lifestyle modifications for optimal blood pressure control.

• Individual components (Olmesartan, Amlodipine, Hydrochlorothiazide)
• Dual combination therapies (e.g., Olmesartan/Amlodipine, Olmesartan/HCTZ, Amlodipine/HCTZ)
• Other classes of antihypertensives (e.g., ACE inhibitors, Beta-blockers, other diuretics, other CCBs)

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.