Tribenzor 40/5/25mg Tablets

Tribenzor combines three antihypertensive agents with complementary mechanisms to lower blood pressure. Olmesartan medoxomil is 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 sympathetic activity. Amlodipine besylate is a dihydropyridine calcium channel blocker (CCB) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and myocardial cells, primarily causing peripheral arterial vasodilation and reducing peripheral vascular resistance. Hydrochlorothiazide (HCTZ) is a thiazide diuretic that inhibits sodium and chloride reabsorption in the distal convoluted tubule, increasing the excretion of sodium, chloride, and water, and secondarily increasing potassium excretion.

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 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
Have your skin checked regularly as advised by your doctor
Contact your doctor immediately if you notice:
+ A change in color or size of a mole
+ Any new or changing skin lump or growth

Other Side Effects:

Most people do not experience significant side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical help if they bother you or do not go away:

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 breastfeeding is not recommended 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. This will help determine the safety of taking this medication in conjunction with your other 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 that you receive the best possible care.

To minimize the risk of accidents, avoid driving and other activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying down position, rise slowly to reduce the likelihood of dizziness or fainting. Be cautious when climbing stairs to prevent falls.

If you have diabetes (high blood sugar), this medication may cause your blood sugar levels to increase. Consult with your doctor about strategies to maintain control over your blood sugar levels. 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 on a low-salt or salt-free diet, consult with your doctor to ensure safe use of this medication.

Although rare, it is possible to experience new or worsening chest pain after starting 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, and certain natural products or aids, consult with your doctor. Also, discuss the use of alcohol, marijuana or other forms of cannabis, and prescription or OTC medications that may cause drowsiness with your doctor.

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 with 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 cause their condition to become active or worsen. If you experience new or worsening symptoms, inform 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 failure with olmesartan)
• Do not co-administer with ACE inhibitors in patients with diabetic nephropathy

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) or potassium supplements (increased risk of hyperkalemia with olmesartan)
• NSAIDs (including COX-2 inhibitors) (may reduce antihypertensive effect of olmesartan and HCTZ, and increase risk of renal impairment)
• Lithium (increased serum lithium levels and toxicity due to HCTZ)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) (may increase amlodipine exposure)
• CYP3A4 inducers (e.g., rifampin, St. John's Wort) (may decrease amlodipine exposure)
• Other antihypertensive agents (additive hypotensive effects)

• Corticosteroids (may antagonize the diuretic and antihypertensive effects of HCTZ)
• Bile acid sequestrants (e.g., cholestyramine, colestipol) (may reduce absorption of HCTZ)
• Digoxin (HCTZ-induced hypokalemia may potentiate digoxin toxicity)
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Metformin (risk of lactic acidosis with HCTZ in renal impairment)
• Skeletal muscle relaxants, non-depolarizing (prolonged effect with HCTZ)
• Alcohol, barbiturates, or narcotics (may potentiate orthostatic hypotension with HCTZ)

• Antidiabetic agents (HCTZ may increase blood glucose, requiring adjustment of antidiabetic therapy)
• Pressor amines (e.g., norepinephrine) (decreased arterial responsiveness to pressor amines with HCTZ)

• Dizziness or lightheadedness (especially upon standing)
• Fainting (syncope)
• Swelling of ankles, feet, or hands (edema)
• Unusual fatigue or weakness
• Muscle cramps or pain
• Irregular heartbeat
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing or swallowing)
• Persistent cough (less common with ARBs than ACEIs, but still possible)
• Yellowing of skin or eyes (jaundice)
• Severe skin reactions (rash, blistering)

Contraindicated in the 2nd and 3rd trimesters of pregnancy due to the risk of fetal injury and death associated with the olmesartan component. Discontinue as soon as pregnancy is detected. Use in the 1st trimester is generally not recommended due to potential risks.

Not recommended during breastfeeding. Olmesartan is not known to be excreted in human milk. Amlodipine is excreted in human milk, but risk to infant is considered low. Hydrochlorothiazide is excreted in human milk and may suppress lactation. Due to potential for serious adverse effects on the 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 have not been established in pediatric patients. Not recommended for use in children.

Use with caution, especially in patients 75 years or older. Start with lower doses of individual components if initiating therapy. Monitor renal function and electrolytes closely, as elderly patients may be more sensitive to the effects of the drug, particularly the diuretic component and potential for orthostatic hypotension.

• Tribenzor is a fixed-dose combination and is not indicated for initial therapy of hypertension. It is typically used when patients are not adequately controlled on dual therapy or are already on the individual components.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, as this is a rare but serious side effect of ARBs.
• Monitor for orthostatic hypotension, especially at the start of therapy, with dose increases, or in patients who are volume-depleted.
• Advise patients to avoid potassium supplements or salt substitutes containing potassium unless specifically instructed by their physician, due to the olmesartan component.
• Hydrochlorothiazide can cause photosensitivity reactions; advise patients to use sun protection.
• Regular monitoring of electrolytes (especially potassium and sodium) and renal function is crucial due to the diuretic and ARB components.

• Other ARB/CCB combinations (e.g., Azor, Exforge)
• Other ARB/diuretic combinations (e.g., Benicar HCT, Diovan HCT)
• Other CCB/diuretic combinations
• Individual monotherapy or dual therapy with different classes of antihypertensives (e.g., ACE inhibitors, beta-blockers, alpha-blockers)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. 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 details. 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.