Olmesartan Medox/hctz 20-12.5mg Tab

Olmesartan medoxomil is a prodrug that is rapidly converted to olmesartan, a selective angiotensin II receptor blocker (ARB). It selectively blocks the binding of angiotensin II to the AT1 receptor in many tissues, including vascular smooth muscle and the adrenal gland. This blockade inhibits the vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, reduced peripheral vascular resistance, and decreased blood pressure. Hydrochlorothiazide (HCTZ) is a thiazide diuretic that inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule of the nephron. This increases the excretion of sodium, chloride, and water, leading to a reduction in plasma volume and blood pressure. The combination provides additive antihypertensive effects.

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 medical attention immediately:

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 kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of fluid and electrolyte problems, such as:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Abnormal heartbeat
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling extremely tired or weak
+ Decreased appetite
+ Changes in urine output
+ Dry mouth
+ Dry eyes
+ Severe nausea or vomiting
Signs of pancreatitis (pancreas problems), including:
+ Severe stomach pain
+ Severe back pain
+ Severe nausea or vomiting
Chest pain
Swelling in the arms or legs
Persistent diarrhea
Severe diarrhea
Significant weight loss
Dark urine or yellow skin and eyes
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
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 usually 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 this 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. 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:

Dizziness
Signs of a common cold
* Upset stomach

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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
A known sulfa allergy.
Current use of dofetilide.
Inability to urinate.
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.

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. They will help determine the safety of taking this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.

Monitoring Your Condition
If you have diabetes (high blood sugar), closely monitor your blood sugar levels. Be aware of signs of high blood sugar, such as confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath. Report these symptoms to your doctor.

Regular Health Checks
Check your blood pressure as directed by your doctor. Also, have your blood work and other lab tests done as scheduled. Inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab tests.

Interactions with Other Substances
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor. Additionally, discuss your low-salt or salt-free diet 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.

Caution with Other Medications and Substances
Before using alcohol, marijuana, or other forms of cannabis, or prescription or OTC medications that may slow your reactions, consult your doctor. If you take colesevelam, take it at least 4 hours after taking this medication. If you take cholestyramine or colestipol, consult your pharmacist about the best way to take them with this medication.

Precautions in Hot Weather and with Physical Activity
Be cautious in hot weather or during physical activity, and drink plenty of fluids to avoid dehydration. Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these may lead to low blood pressure.

Sun Sensitivity
This medication may increase your risk of sunburn. Take precautions when exposed to the sun, and report any increased sun sensitivity to your doctor.

Gout and Lupus
Be aware of the risk of gout attacks. If you have lupus, this medication may worsen your condition or trigger a flare-up. Report any new or worsening symptoms to your doctor promptly.

Breastfeeding
If you are breastfeeding, discuss the potential risks to your baby with your doctor.

• Aliskiren (in patients with diabetes or moderate to severe renal impairment (GFR < 60 mL/min/1.73 m²))

• Lithium (increased serum lithium concentrations and toxicity)
• NSAIDs (including selective COX-2 inhibitors - may reduce antihypertensive effect and increase risk of renal impairment)
• Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium (increased risk of hyperkalemia)
• Other antihypertensive agents (additive hypotensive effect)
• Digitalis glycosides (increased risk of digitalis toxicity with HCTZ-induced hypokalemia/hypomagnesemia)

• Alcohol, barbiturates, narcotics (may potentiate orthostatic hypotension)
• Corticosteroids, ACTH, amphotericin B, carbenoxolone, laxatives (may intensify electrolyte depletion, particularly hypokalemia)
• Antidiabetic agents (oral agents and insulin - HCTZ may decrease glucose tolerance, requiring dose adjustment)
• Cholestyramine and colestipol resins (may impair absorption of HCTZ)
• Non-depolarizing skeletal muscle relaxants (e.g., tubocurarine - HCTZ may potentiate their effect)
• Pressor amines (e.g., norepinephrine - HCTZ may decrease arterial responsiveness)

• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Calcium salts (increased serum calcium levels due to decreased excretion by HCTZ)
• Immunosuppressive drugs (e.g., cyclosporine - increased risk of hyperuricemia and gout with HCTZ)

• Dizziness or lightheadedness (especially upon standing)
• Fatigue or weakness
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Swelling in ankles, feet, or hands (edema)
• Persistent dry cough (less common with ARBs than ACEIs, but still possible)
• Signs of allergic reaction (rash, itching, swelling of face/lips/tongue)
• Symptoms of hyperkalemia (e.g., palpitations, muscle weakness, paresthesias)
• Symptoms of hypokalemia (e.g., muscle cramps, weakness, irregular heart beat)
• Symptoms of hyponatremia (e.g., headache, confusion, nausea, seizures)

Contraindicated during the second and third trimesters of pregnancy. Discontinue as soon as pregnancy is detected. Exposure during these trimesters can cause fetal injury or death (e.g., fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, and skull hypoplasia). First trimester exposure risk is less clear but generally avoided.

Not recommended during breastfeeding. Both olmesartan and hydrochlorothiazide are excreted in human milk. Due to the potential for serious adverse effects in the breastfed infant (e.g., hypotension, hyperkalemia from olmesartan; electrolyte disturbances, jaundice, thrombocytopenia from HCTZ), 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. Use is not recommended.

No overall differences in efficacy or safety have been observed between elderly patients (≥65 years) and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and titrate carefully, monitoring renal function and electrolytes closely, as elderly patients are more likely to have age-related decreases in renal function.

• This fixed-dose combination is not for initial therapy; it's intended for patients whose blood pressure is not adequately controlled on monotherapy or for replacement therapy.
• Monitor serum potassium levels closely, as olmesartan can cause hyperkalemia and hydrochlorothiazide can cause hypokalemia, potentially balancing each other out or leading to unpredictable shifts.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, although it is less common with ARBs than ACE inhibitors.
• Hydrochlorothiazide can increase serum uric acid and glucose levels; monitor these parameters, especially in patients with a history of gout or diabetes.
• Avoid concomitant use with aliskiren in patients with diabetes or moderate to severe renal impairment due to increased risk of adverse events (hypotension, hyperkalemia, renal impairment).
• Educate patients on the importance of consistent daily dosing and not abruptly discontinuing the medication.

• Other classes of antihypertensives (e.g., ACE inhibitors, Beta-blockers, Calcium Channel Blockers, other diuretics)
• Monotherapy with an ARB (e.g., Olmesartan)
• Monotherapy with a thiazide diuretic (e.g., Hydrochlorothiazide, Chlorthalidone)
• Other combination antihypertensive therapies (e.g., ACEI/CCB, ARB/CCB)

If your symptoms or health issues persist or worsen, it is 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 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 substance taken, the amount, and the time it occurred.