Hyzaar 100/12.5 Tablets

Losartan is an 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 inhibits the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased peripheral resistance, and reduced sodium and water retention. Hydrochlorothiazide is a thiazide diuretic. It acts on the distal convoluted tubule of the kidney to inhibit the reabsorption of sodium and chloride ions. This increases the excretion of sodium, chloride, and water, leading to a reduction in plasma volume and blood pressure. It also increases potassium and magnesium excretion and decreases calcium 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 immediately or seek 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
+ Difficulty 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
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of fluid and electrolyte problems, including:
+ 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), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe nausea or vomiting
Severe dizziness or fainting
Swelling in the arms or legs
Yellowing of the skin or eyes
Difficulty getting or maintaining an erection

This medication can also cause eye problems, which may lead to permanent vision loss if left untreated. If you experience any of the following symptoms, contact your doctor immediately:
Changes in vision
Eye pain

These symptoms usually occur within hours to weeks of starting the medication.

Rare but Serious Side Effects

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 recommendations for skin checks
Contact your doctor immediately if you notice:
+ Changes in the color or size of a mole
+ New or changing skin lumps or growths

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people experience no side effects or only mild ones, some may be more bothersome. If you experience any of the following, contact your doctor:
Dizziness
Signs of a common cold
* Back pain

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
Dehydration - discuss this condition with your doctor.
Use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.

This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine the safety of taking this medication with your other drugs 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.

To minimize the risk of dizziness or fainting, it is crucial to rise slowly from a sitting or lying down position. Additionally, be cautious when climbing stairs. If you experience dizziness or lightheadedness, avoid driving or engaging in activities that require your full attention until you understand how this medication affects you.

If you have diabetes, it is vital to monitor your blood sugar levels closely while taking this medication. Regularly check your blood pressure as directed by your healthcare provider. Your doctor may also recommend regular blood tests to monitor your condition; be sure to follow their instructions and discuss any concerns with them.

This medication may interfere with certain laboratory tests. Therefore, it is essential to 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, consult your doctor to discuss potential interactions. Similarly, if you are on a low-salt or salt-free diet, talk to your doctor to determine the best course of action.

Before taking any over-the-counter (OTC) products, including cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products, consult your doctor to avoid potential interactions that may increase your blood pressure.

When using alcohol, marijuana, or other forms of cannabis, or prescription and OTC medications that may cause drowsiness, exercise caution and discuss potential risks with your doctor.

In hot weather or during physical activity, it is crucial to stay hydrated by drinking 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 cholestyramine or colestipol, consult your pharmacist for guidance on how to take these medications with this drug. Additionally, be aware of the potential for gout attacks.

This medication may cause increased cholesterol and triglyceride levels. Discuss this potential risk with your doctor. If you have lupus, this medication may exacerbate your condition or trigger a flare-up; promptly report any new or worsening symptoms to your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Breastfeeding mothers should consult their doctor to discuss potential risks to their baby.

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

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements
• Salt substitutes containing potassium
• Lithium (increased serum lithium levels and toxicity)
• NSAIDs (including selective COX-2 inhibitors) (reduced antihypertensive effect, increased risk of renal impairment)
• Other antihypertensive agents (additive hypotensive effects)
• Corticosteroids (antagonism of diuretic effect)
• Digitalis glycosides (increased risk of digitalis toxicity due to hypokalemia/hypomagnesemia)
• Non-depolarizing skeletal muscle relaxants (prolonged effect)

• Barbiturates, narcotics, alcohol (orthostatic hypotension)
• Antidiabetic drugs (oral agents and insulin) (may require dosage adjustment)
• Cholestyramine and colestipol resins (reduced absorption of HCTZ)
• Pressor amines (e.g., norepinephrine) (possible decreased response)
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Amantadine (increased risk of adverse effects with HCTZ)
• Cytotoxic agents (e.g., cyclophosphamide, methotrexate) (increased myelosuppression with HCTZ)
• Carbamazepine (risk of symptomatic hyponatremia)
• Calcium salts (increased serum calcium levels)

• Not available

• Dizziness
• Lightheadedness
• Fatigue
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Excessive thirst
• Dry mouth
• Nausea
• Vomiting
• Irregular heartbeat
• Swelling of face, lips, tongue, or throat (angioedema - rare but serious)
• Signs of kidney problems (e.g., decreased urination)
• Signs of liver problems (e.g., yellowing of skin/eyes, dark urine)

Contraindicated in the second and third trimesters of pregnancy due to risk of fetal injury and death. Discontinue as soon as pregnancy is detected.

Not recommended during breastfeeding. Both Losartan and Hydrochlorothiazide are excreted in human milk.

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.

No overall differences in effectiveness or safety have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Initiate therapy with caution, often with lower doses, due to potential for decreased renal function and increased sensitivity to hypotensive effects.

• Hyzaar is a fixed-dose combination and should not be used for initial therapy in patients requiring individualized dose titration of Losartan or Hydrochlorothiazide.
• Monitor for signs of angioedema, a rare but serious side effect, especially in patients with a history of angioedema with ACE inhibitors.
• Patients should be advised to report any symptoms of electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeat).
• Hydrochlorothiazide can cause photosensitivity; advise patients to use sun protection.
• Thiazide diuretics can exacerbate or activate systemic lupus erythematosus.
• Thiazide diuretics can increase serum uric acid and glucose levels, requiring monitoring in susceptible patients.
• Avoid concomitant use with potassium supplements or potassium-sparing diuretics unless serum potassium is closely monitored due to the risk of hyperkalemia with Losartan.

• ACE inhibitors (e.g., Lisinopril, Enalapril)
• Calcium Channel Blockers (e.g., Amlodipine, Nifedipine)
• Beta-blockers (e.g., Metoprolol, Atenolol)
• Other diuretics (e.g., Loop diuretics, Potassium-sparing diuretics)
• Direct Renin Inhibitors (e.g., Aliskiren - with caution)

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