Tribenzor 20/5/12.5mg Tablets

Tribenzor combines three antihypertensive agents with complementary mechanisms to lower blood pressure:
1. **Olmesartan medoxomil:** An angiotensin II receptor blocker (ARB) that selectively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle, leading to vasodilation, reduced aldosterone secretion, and decreased sodium and water reabsorption.
2. **Amlodipine besylate:** A dihydropyridine calcium channel blocker (CCB) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. This causes peripheral arterial vasodilation and a reduction in peripheral vascular resistance, leading to a decrease in blood pressure.
3. **Hydrochlorothiazide (HCTZ):** A thiazide diuretic that inhibits sodium and chloride reabsorption in the distal convoluted tubule of the nephron, 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.

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
+ 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 eye problems, symptoms may include changes in vision or eye pain, usually within hours to weeks of starting the 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 contact your doctor or seek medical help if you're bothered by any of the following:

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

This is not an exhaustive list of 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 use of dofetilide.
Inability to urinate.
Presence of 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. Note that 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 issues with your doctor and pharmacist. This will help determine the safety of taking this medication in conjunction with your other treatments and health conditions. 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 they are aware of any potential interactions or effects.

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 avoid falls.

If you have diabetes, this medication may cause an increase in blood sugar levels. Consult with your doctor about strategies to maintain control over your blood sugar levels. Regularly monitor your blood pressure as directed by your healthcare provider, and undergo blood work and other laboratory tests as scheduled.

This medication may interfere with certain laboratory tests, so it is crucial to inform all 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 with your doctor to ensure safe management.

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 to understand the potential risks and benefits.

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. Also, discuss the use of alcohol, marijuana or other forms of cannabis, or prescription and OTC medications that may cause drowsiness with your doctor.

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

If you are taking colesevelam, colestipol, or cholestyramine, consult with your pharmacist about the best way to take these medications in conjunction 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 exacerbate or reactivate 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)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (due to olmesartan and HCTZ effects on potassium)
• Lithium (due to increased lithium toxicity with HCTZ and ARBs)

• NSAIDs (including COX-2 inhibitors): May reduce antihypertensive effect of olmesartan and HCTZ, and increase risk of renal impairment.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): May increase amlodipine exposure, leading to increased risk of hypotension and edema.
• CYP3A4 inducers (e.g., rifampin, St. John's Wort): May decrease amlodipine exposure, leading to reduced efficacy.
• Colestipol and Cholestyramine: May impair absorption of HCTZ.
• Digoxin: Increased risk of digoxin toxicity with HCTZ (due to hypokalemia/hypomagnesemia).

• Other antihypertensives: Additive hypotensive effects.
• Alcohol: May potentiate orthostatic hypotension.
• Corticosteroids: May antagonize the diuretic and antihypertensive effects of HCTZ.
• Insulin and oral antidiabetics: HCTZ may decrease glucose tolerance, requiring adjustment of antidiabetic medication.
• Muscle relaxants (non-depolarizing): HCTZ may potentiate their effect.
• Pressor amines (e.g., norepinephrine): HCTZ may decrease arterial responsiveness.
• Allopurinol: Increased risk of hypersensitivity reactions to allopurinol with HCTZ.

• Not available

• Dizziness
• Lightheadedness
• Fatigue
• Swelling (edema)
• Muscle cramps or weakness
• Nausea
• Vomiting
• Excessive thirst
• Dry mouth
• Irregular heartbeat
• Signs of allergic reaction (rash, itching, swelling)

Tribenzor is contraindicated in the second and third trimesters of pregnancy due to the olmesartan component (an ARB), which can cause fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the first trimester is generally not recommended due to potential risks, though less severe than later trimesters.

Use with caution. It is not known if olmesartan is excreted in human milk. Amlodipine is present in human milk, but effects on the breastfed infant are unknown. HCTZ is excreted in human milk and can suppress lactation. Weigh the benefits of breastfeeding against the potential risks to the infant.

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

No overall differences in efficacy or safety were observed between elderly (≥65 years) and younger patients in clinical trials, but greater sensitivity of some older individuals cannot be ruled out. Start at the lower end of the dosing range and titrate carefully due to potential for increased sensitivity to hypotensive effects and age-related decline in renal/hepatic function.

• Tribenzor is a triple combination therapy, typically reserved for patients whose blood pressure is not adequately controlled on dual therapy or who require multiple agents.
• Due to the olmesartan component, Tribenzor carries a Black Box Warning for fetal toxicity; it is contraindicated in pregnancy.
• Monitor serum electrolytes (especially potassium) and renal function closely, particularly after initiation or dose changes, and in patients with pre-existing renal impairment.
• Advise patients to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately.
• Patients should be advised about the potential for orthostatic hypotension, especially at the start of therapy, with dose increases, or when standing up quickly.
• A rare but serious adverse effect of olmesartan is sprue-like enteropathy, presenting as severe, chronic diarrhea with substantial weight loss, sometimes months to years after initiation. Consider discontinuation if these symptoms develop and no other cause is found.

• Other classes of antihypertensives (e.g., ACE inhibitors, Beta-blockers, Alpha-blockers, direct vasodilators)
• Individual components (Olmesartan, Amlodipine, Hydrochlorothiazide) as separate tablets, allowing for more flexible titration.
• Dual combination therapies (e.g., ARB + CCB, ARB + Diuretic, CCB + Diuretic)

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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.