Olmesartan Medox/hctz 40-12.5mg Tab

Olmesartan medoxomil is a prodrug that is rapidly converted to olmesartan, an angiotensin II receptor blocker (ARB). Olmesartan selectively blocks the binding of angiotensin II to the AT1 receptor in many tissues, including vascular smooth muscle and the adrenal gland. This inhibits the vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, reduced peripheral resistance, and decreased blood pressure. Hydrochlorothiazide is a thiazide diuretic that inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, as well as potassium and magnesium. This reduces plasma volume and peripheral resistance, contributing to its antihypertensive effect.

Serious Side Effects: Seek Medical Attention Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

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
+ Fast or 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 can 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 experience these symptoms.

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. Contact your doctor immediately if you notice any changes in the color or size of a mole, or any new or changing skin lump or growth.

Other Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, 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
Signs of a common cold
* Upset stomach

Reporting Side Effects

This is not a comprehensive list of all 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
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 with your existing regimen. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.

Important Warnings and Precautions

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 activities 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 any of these symptoms to your doctor.

Regular Check-Ups
Check your blood pressure as directed by your doctor. Additionally, have your blood work and other laboratory tests done as scheduled by your doctor. Note that this medication may affect certain lab tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication.

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

Caution with Other Medications and Substances
Before using alcohol, marijuana or other forms of cannabis, or prescription or OTC medications that may cause drowsiness, discuss this with 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 these medications with this drug.

Precautions in Hot Weather
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, which may lead to low blood pressure, inform your doctor.

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 potential for gout attacks. If you have lupus, this medication may cause your condition to become active or worsen. Report any new or worsening symptoms to your doctor immediately.

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

• Aliskiren (in patients with diabetes or renal impairment)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements
• Lithium (due to increased lithium toxicity risk)

• NSAIDs (including COX-2 inhibitors) - may reduce antihypertensive effect and worsen renal function, especially in elderly or volume-depleted patients.
• Other antihypertensives (e.g., ACE inhibitors, beta-blockers) - additive hypotensive effects.
• Corticosteroids - may antagonize diuretic effect.
• Cholestyramine, Colestipol - may reduce HCTZ absorption.
• Digitalis glycosides - increased risk of digitalis toxicity with hypokalemia/hypomagnesemia from HCTZ.
• Non-depolarizing skeletal muscle relaxants (e.g., tubocurarine) - enhanced effect due to HCTZ.

• Antidiabetic agents (insulin, oral hypoglycemics) - HCTZ may increase blood glucose, requiring dose adjustment.
• Alcohol, barbiturates, narcotics - additive orthostatic hypotension.
• Pressor amines (e.g., norepinephrine) - decreased arterial responsiveness to pressor amines.
• Allopurinol - increased risk of hypersensitivity reactions to allopurinol.
• Calcium salts - increased serum calcium levels due to decreased excretion by HCTZ.
• Diazoxide - enhanced hyperglycemic and hypotensive effects.

• Certain antineoplastics (e.g., cyclophosphamide, methotrexate) - HCTZ may reduce renal excretion of these drugs, increasing myelosuppressive effects.

• Dizziness
• Lightheadedness
• Fatigue
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Swelling (edema)
• Shortness of breath
• Unusual thirst or dry mouth
• Changes in urination (frequency, volume)
• Signs of allergic reaction (rash, itching, swelling)

Contraindicated in pregnancy. Use of drugs acting on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Discontinue as soon as pregnancy is detected.

Not recommended during breastfeeding. Both olmesartan and hydrochlorothiazide are excreted in breast milk. Hydrochlorothiazide can suppress lactation. Due to the potential for serious adverse effects on the nursing 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.

No overall differences in effectiveness or safety were observed between elderly patients (65 years and older) and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Monitor renal function and electrolytes closely.

• This combination is often used when monotherapy with an ARB or a thiazide diuretic is insufficient to control blood pressure.
• The full antihypertensive effect may take 2-4 weeks to develop, so dose adjustments should not be made more frequently than every 2-4 weeks.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, although this is rare with ARBs compared to ACE inhibitors.
• Monitor for orthostatic hypotension, especially at the start of therapy, with dose increases, or in volume-depleted patients.
• Hydrochlorothiazide can cause photosensitivity; advise patients to use sun protection.
• Patients with a history of gout may experience flares due to HCTZ-induced hyperuricemia.
• This medication is not for initial therapy in patients with severe hypertension where rapid titration is needed.

• Other classes of antihypertensives (e.g., ACE inhibitors, calcium channel blockers, beta-blockers, other diuretics)
• Monotherapy with an ARB (e.g., Olmesartan) if HCTZ is not needed or tolerated.
• Monotherapy with a thiazide diuretic (e.g., Hydrochlorothiazide, Chlorthalidone) if ARB is not needed or tolerated.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.