Olmesartan Medox/hctz 40-25mg 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 aldosterone secretion, and decreased sodium and water reabsorption. 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. It also increases potassium and magnesium excretion and decreases calcium excretion.

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 very tired or weak
+ Decreased appetite
+ Changes in urine output
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting
Signs of pancreatitis (pancreas problems), including:
+ Severe stomach pain
+ Severe back pain
+ Severe stomach upset 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 very 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:

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

Dizziness
Signs of a common cold
* Stomach upset

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 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.

Managing High Blood Sugar (Diabetes)
If you have diabetes, 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.

Monitoring Your Condition
Regularly check your blood pressure as directed by your doctor. Also, have your blood work and other laboratory tests done as scheduled. Note that this medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug.

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.

Using Other Medications and Substances Safely
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or OTC medications that may slow your reactions, discuss the risks with your doctor.

Taking Other Medications
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.

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

Sun Protection
This medication may increase your risk of sunburn. Take precautions when spending time in the sun, and report any increased sensitivity to your doctor.

Watching for Gout Attacks
Be aware of the signs of gout attacks, and seek medical attention if you experience any symptoms.

Lupus Considerations
If you have lupus, this medication can cause your condition to become active or worsen. Immediately report any new or worsening symptoms to your doctor.

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

• Aliskiren (in patients with diabetes or renal impairment [CrCl < 60 mL/min])

• Lithium (increased serum lithium levels and toxicity)
• Non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors (reduced antihypertensive effect, increased risk of renal impairment)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia)
• Other antihypertensive agents (additive hypotensive effect)

• Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia)
• Antidiabetic drugs (oral agents and insulin) (may require dose adjustment of antidiabetic drug due to HCTZ-induced hyperglycemia)
• Cholestyramine and colestipol resins (impaired absorption of hydrochlorothiazide)
• Alcohol, barbiturates, or narcotics (potentiate orthostatic hypotension)
• Digitalis glycosides (hypokalemia/hypomagnesemia may predispose to digitalis toxicity)
• Muscle relaxants, non-depolarizing (e.g., tubocurarine) (potentiated effect of muscle relaxant)
• Pressor amines (e.g., norepinephrine) (possible decreased response to pressor amines)
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Calcium salts (increased serum calcium levels due to decreased excretion by HCTZ)

• Not available

• Dizziness or lightheadedness (especially upon standing)
• Excessive fatigue or weakness
• Signs of electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeat, excessive thirst, dry mouth)
• Swelling of face, lips, tongue, or throat (angioedema - rare but serious)
• Persistent, severe diarrhea with substantial weight loss (sprue-like enteropathy - rare)
• Unusual bruising or bleeding (rare, due to thrombocytopenia)
• Yellowing of skin or eyes (jaundice)

Contraindicated during 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. Both olmesartan and hydrochlorothiazide are excreted in breast milk. Due to the potential for 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 efficacy or safety were observed between elderly patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution, especially regarding renal function, as elderly patients are more likely to have impaired renal function.

• This combination is not indicated for initial therapy of hypertension. It should be used after a patient has been titrated on the individual components or if blood pressure is not adequately controlled on monotherapy.
• Monitor serum electrolytes (especially potassium, sodium) and renal function closely, particularly during initiation and dose adjustments, and in patients with pre-existing renal impairment or those on concomitant medications that affect electrolytes.
• Rarely, olmesartan has been associated with severe, chronic diarrhea with substantial weight loss, sometimes months to years after initiation, consistent with sprue-like enteropathy. If this occurs, discontinue the drug and consider alternative antihypertensive therapy.
• Hydrochlorothiazide can increase serum uric acid levels and may precipitate gout attacks in susceptible individuals.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, or throat) immediately, as this is a serious but rare side effect.

• Other classes of antihypertensives (e.g., ACE inhibitors, calcium channel blockers, beta-blockers, other diuretics)
• Monotherapy with an ARB or a thiazide diuretic, if blood pressure is adequately controlled.

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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 details about the overdose, including the medication taken, the amount, and the time it occurred.