Tribenzor 40/10/25mg Tablets

Tribenzor combines three antihypertensive agents with complementary mechanisms of action: Olmesartan medoxomil, an angiotensin II receptor blocker (ARB), blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues. Amlodipine, a dihydropyridine calcium channel blocker (CCB), 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. Hydrochlorothiazide (HCTZ), a thiazide diuretic, inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule, increasing the excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium.

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 immediate 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 high blood sugar, including:
+ Confusion or feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing or fast breathing
+ Breath that smells like fruit
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of fluid and electrolyte problems, including:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling extremely tired or weak
+ Decreased appetite
+ Changes in urine output
+ Dry mouth or dry eyes
+ Severe stomach upset or vomiting
Pain while urinating
Joint pain or swelling
Shortness of breath, sudden weight gain, or swelling in the arms or legs
New or worsening chest pain
Significant weight loss
Muscle spasms
Restlessness

Eye Problems:

This medication can cause certain eye problems, which may lead to permanent vision loss if left untreated. If you experience any eye problems, symptoms such as changes in vision or eye pain typically occur within hours to weeks of starting this medication. Contact your doctor immediately if you notice any of these signs.

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 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 right away.

Other 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 symptoms that bother you or do not go away, contact your doctor or seek medical help:

Dizziness, tiredness, or weakness
Headache
Nose or throat irritation
Signs of a common cold
Upset stomach
* Diarrhea

Reporting 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 treatment with dofetilide.
Difficulty urinating or inability to pass urine.
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 other treatments and health issues. 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 any potential interactions with other treatments.

When starting this medication, be cautious when performing tasks that require alertness, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position and be careful when navigating stairs.

If you have diabetes, this medication may cause an increase in blood sugar levels. Consult your doctor about strategies to maintain control over your blood sugar levels. Additionally, monitor your blood pressure as directed and undergo regular blood tests and other laboratory evaluations as recommended by your doctor.

Be aware 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, discuss this with your doctor. Similarly, if you are following a low-salt or salt-free diet, consult your doctor for guidance.

Although rare, it is possible to experience new or worsening chest pain after initiating or increasing the dose of this medication, which may increase the risk of heart attack. This risk may be higher in individuals with severe heart blood vessel disease. 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.

Exercise caution when consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or OTC medications that may cause drowsiness. Discuss these substances with your doctor before use.

In hot weather or during physical activity, be mindful of the risk of fluid loss and dehydration. Drink plenty of fluids to stay hydrated, and inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, 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 in conjunction with this drug. Additionally, be aware of the potential for gout attacks.

Individuals with lupus should be aware that this medication may cause their condition to become active or worsen. If you experience any 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) - increased risk of hypotension, hyperkalemia, and renal impairment with olmesartan.

• Lithium - increased serum lithium concentrations and toxicity (due to HCTZ and olmesartan).
• NSAIDs (including COX-2 inhibitors) - reduced antihypertensive effect, increased risk of renal impairment (especially in elderly, volume-depleted, or renally impaired patients) with olmesartan and HCTZ.
• Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other agents that may increase serum potassium (e.g., heparin, trimethoprim) - increased risk of hyperkalemia with olmesartan.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - increased amlodipine exposure, leading to increased risk of hypotension.
• Strong CYP3A4 inducers (e.g., rifampin, St. John's Wort) - decreased amlodipine exposure, potentially reducing efficacy.
• Other antihypertensive agents - additive hypotensive effects.

• Antidiabetic agents (oral agents and insulin) - HCTZ may decrease glucose tolerance, requiring dosage adjustment of antidiabetic agents.
• Cholestyramine and colestipol resins - impaired absorption of HCTZ.
• Corticosteroids, ACTH - intensified electrolyte depletion, particularly hypokalemia, with HCTZ.
• Digitalis glycosides - hypokalemia/hypomagnesemia induced by HCTZ may predispose to digitalis toxicity.
• Muscle relaxants, non-depolarizing (e.g., tubocurarine) - HCTZ may potentiate their effect.
• Alcohol, barbiturates, or narcotics - orthostatic hypotension may be aggravated by HCTZ.
• Calcium supplements and Vitamin D - HCTZ may increase serum calcium levels due to decreased excretion.

• Not available (interactions are generally categorized as moderate or higher due to clinical significance)

• 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
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing or swallowing)

Contraindicated. Tribenzor can cause injury and death to the developing fetus when administered to pregnant women. If pregnancy is detected, discontinue Tribenzor as soon as possible.

Not recommended. Olmesartan is excreted in milk of lactating rats, and HCTZ is excreted in human milk and can suppress lactation. Amlodipine is present in human milk. Due to the potential for serious adverse reactions in breastfed infants, 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. Not recommended for use in children.

Use with caution. Elderly patients may be more sensitive to the effects of Tribenzor, particularly the hypotensive effects of amlodipine and the electrolyte disturbances of HCTZ. Consider lower starting doses of individual components if initiating therapy, and monitor renal function and electrolytes closely.

• Tribenzor is a fixed-dose combination and is not indicated for initial therapy of hypertension. It should be used in patients whose blood pressure is not adequately controlled on dual therapy or who are already on triple therapy with the individual components.
• Monitor serum electrolytes (especially potassium and sodium) and renal function (creatinine, eGFR) regularly, particularly after dose changes or in patients with impaired renal function.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately and discontinue the drug.
• Counsel patients on the importance of adherence to medication and lifestyle modifications (diet, exercise) for optimal blood pressure control.
• Avoid concomitant use with aliskiren in patients with diabetes or renal impairment due to increased risk of adverse events.

• Other classes of antihypertensives (e.g., ACE inhibitors, beta-blockers, alpha-blockers, direct vasodilators)
• Dual combination therapies (e.g., ARB/CCB, ARB/diuretic, CCB/diuretic)
• Monotherapy with individual components or other single agents

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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.