Tribenzor 40/5/12.5mg Tablets

Tribenzor combines three antihypertensive agents with complementary mechanisms to lower blood pressure: Olmesartan medoxomil, an angiotensin II receptor blocker (ARB); Amlodipine besylate, a dihydropyridine calcium channel blocker (CCB); and Hydrochlorothiazide (HCTZ), a thiazide diuretic. Olmesartan 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. Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and myocardial cells, resulting in peripheral arterial vasodilation and reduction in peripheral vascular resistance. Hydrochlorothiazide inhibits sodium reabsorption 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
+ 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
+ Sudden 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, sudden weight gain, or swelling in the arms or legs
Chest pain that is new or worsening
Sudden 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 the 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
Follow your doctor's instructions for skin checks
Contact your doctor immediately if you notice:
+ A change in the color or size of a mole
+ Any new or changing skin lump or growth

Other Side Effects:

Like all medications, this drug can cause side effects. While many people experience no side effects or only mild 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 help if they bother you or persist:

Feeling dizzy, tired, or weak
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 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 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 occasionally increase your blood sugar levels. Consult your doctor about strategies to maintain control over your blood sugar. Additionally, 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, so it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this drug. 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 on 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 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 forms of cannabis, as well as prescription or OTC drugs that may cause drowsiness, with your doctor before consumption.

In hot weather or during physical activity, be mindful of your fluid intake 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. Additionally, be aware of the potential for gout attacks.

Individuals with lupus should be cautious, as 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)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia with olmesartan)
• Lithium (increased lithium toxicity with HCTZ and olmesartan)

• NSAIDs (including COX-2 inhibitors) - may reduce antihypertensive effect of all components and increase risk of renal impairment (especially in elderly, volume-depleted, or renally impaired patients)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - increased amlodipine exposure
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) - decreased amlodipine exposure
• Simvastatin (amlodipine may increase simvastatin exposure; limit simvastatin to 20 mg/day)
• Digoxin (hypokalemia/hypomagnesemia from HCTZ can increase digoxin toxicity)
• Corticosteroids (increased risk of hypokalemia with HCTZ)
• Antidiabetic agents (HCTZ may decrease glucose tolerance, requiring adjustment of antidiabetic dose)

• Bile acid sequestrants (e.g., cholestyramine, colestipol) - may reduce absorption of HCTZ
• Other antihypertensive agents (additive hypotensive effects)
• Alcohol (additive hypotensive effects)
• Barbiturates, narcotics (additive hypotensive effects)
• Pressor amines (e.g., norepinephrine) - HCTZ may decrease arterial responsiveness
• Non-depolarizing skeletal muscle relaxants (HCTZ may potentiate effect)

• Not available

• Dizziness
• Lightheadedness
• Fainting (orthostatic hypotension)
• Peripheral edema (swelling of ankles/feet)
• Muscle cramps or weakness (electrolyte imbalance)
• Excessive fatigue
• Signs of angioedema (swelling of face, lips, tongue, throat)
• Signs of jaundice or liver dysfunction (yellowing of skin/eyes, dark urine)
• Signs of acute myopia or secondary angle-closure glaucoma (sudden decrease in visual acuity, ocular pain)

Contraindicated during the second and third trimesters of pregnancy due to the olmesartan component, which can cause fetal injury or death. Discontinue as soon as pregnancy is detected. First trimester exposure to ARBs is also associated with potential risks. Amlodipine is Category C, and HCTZ is Category B (first trimester) / D (second/third trimester).

Not recommended during breastfeeding. Olmesartan is excreted in rat milk, and it is unknown if it is excreted in human milk. Amlodipine is present in human milk, and HCTZ is excreted in human milk. Due to the potential for serious adverse effects on the breastfed infant (e.g., hypotension, electrolyte disturbances), 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 efficacy or safety were observed between elderly (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be more susceptible to the hypotensive effects and electrolyte imbalances (especially hypokalemia) due to HCTZ. Initiate with caution and monitor renal function and electrolytes closely.

• Tribenzor is a convenient once-daily combination therapy for patients whose blood pressure is not adequately controlled on dual therapy or who require multiple agents.
• Monitor for orthostatic hypotension, especially at initiation or dose titration, and advise patients to rise slowly.
• Peripheral edema is a common side effect of amlodipine; the diuretic component (HCTZ) may help mitigate this in some patients.
• Educate patients on the importance of avoiding potassium supplements or salt substitutes unless specifically advised by their doctor due to the ARB component.
• Regular monitoring of electrolytes (especially potassium, sodium) and renal function is crucial due to the combined effects of the ARB and diuretic.
• Patients should be advised to report any signs of angioedema immediately, although rare with ARBs, it is a serious adverse event.

• Other ARB/CCB/diuretic combinations
• Individual components (Olmesartan, Amlodipine, HCTZ) taken separately
• Other classes of antihypertensives (e.g., ACE inhibitors, beta-blockers, alpha-blockers, direct vasodilators) depending on patient profile and comorbidities.

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 information about the medication taken, the amount, and the time it happened.