Metoprolol HCT 100/50mg Tablets

Metoprolol is a cardioselective beta-1 adrenergic receptor blocker that decreases heart rate, cardiac output, and blood pressure. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium and chloride reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium.

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 fluid and electrolyte problems, such as:
+ 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
Signs of kidney problems, including:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ Significant weight gain
New or worsening chest pain
Slow heartbeat
Depression
Feeling confused
Memory problems or loss
Shortness of breath
Significant weight gain
Swelling in the arms or legs
Difficulty getting or maintaining an erection

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:

Changes in vision
Eye pain (usually occurring within hours to weeks of starting the medication)

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 immediately.

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 attention if they bother you or do not go away:

Feeling dizzy, sleepy, tired, or weak
Headache
Diarrhea
* Flu-like symptoms

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:

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.
If you have a sulfa allergy.
Certain health conditions, including:
+ Abnormal heart rhythms, such as heart block or sick-sinus syndrome
+ Heart failure (a weakened heart)
+ Low blood pressure
+ Poor blood circulation to the arms or legs
+ Shock caused by heart problems
+ A slow heartbeat
Respiratory conditions, such as:
+ Asthma
+ Chronic obstructive pulmonary disease (COPD) or other breathing problems
If you have difficulty urinating or are unable to pass urine.
If you are taking dofetilide or any other medications that may interact with this drug.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
* Any health problems you have

This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

Important Warnings and Cautions

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

To ensure your safety, 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 minimize the risk of dizziness or fainting. Be cautious when using stairs.

Regularly monitor your blood pressure and heart rate as directed by your doctor. Additionally, have your blood work checked as instructed by your doctor, and discuss the results with them.

Be aware that this medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.

Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.

Do not abruptly stop taking this medication, as this may lead to worsening chest pain or even a heart attack, particularly if you have certain types of heart disease. To avoid side effects, your doctor will guide you on how to gradually stop taking this medication. If you experience new or worsening chest pain or other heart problems, contact your doctor immediately.

This medication may mask symptoms of low blood sugar, such as a rapid heartbeat, which can increase the risk of severe or prolonged low blood sugar, especially in individuals with diabetes, children, and those who are fasting or undergoing surgery. If you have questions or concerns, discuss them with your doctor.

If you have diabetes, it is essential to closely monitor your blood sugar levels.

High cholesterol and triglyceride levels have been associated with this medication. If you have high cholesterol or triglycerides, consult 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.

Be aware of the risk of gout attacks, and if you have lupus, this medication may exacerbate your condition. Inform your doctor immediately if you experience any new or worsening symptoms.

This medication may make it more challenging to recognize symptoms of an overactive thyroid, such as a rapid heartbeat. If you have an overactive thyroid and stop taking this medication abruptly, your condition may worsen and become life-threatening. Discuss this with your doctor.

If you have a history of severe allergic reactions, consult with your doctor, as you may be at risk of an even more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, inform your doctor, as this medication may reduce the effectiveness of epinephrine.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• Anuria (Hydrochlorothiazide)
• Cardiogenic shock (Metoprolol)
• Second- or third-degree atrioventricular block (Metoprolol)
• Sick sinus syndrome (without a pacemaker) (Metoprolol)
• Overt cardiac failure (Metoprolol)
• Severe bradycardia (Metoprolol)

• Lithium (increased lithium toxicity due to HCTZ)
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (reduced antihypertensive effect of both components)
• Other antihypertensives (additive hypotensive effects)
• Digoxin (increased risk of digoxin toxicity due to HCTZ-induced hypokalemia)
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, propafenone) (increased metoprolol levels)
• Antiarrhythmics (e.g., amiodarone, disopyramide) (additive negative inotropic/chronotropic effects with metoprolol)
• Barbiturates, narcotics, alcohol (potentiation of orthostatic hypotension with HCTZ)
• Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia with HCTZ)

• Antidiabetic agents (insulin, oral hypoglycemics) (HCTZ may increase blood glucose, requiring dose adjustment)
• Skeletal muscle relaxants, non-depolarizing (prolonged effect with HCTZ)
• Cholestyramine, colestipol resins (reduced absorption of HCTZ)
• Pressor amines (e.g., norepinephrine) (possible decreased response to pressor amines with metoprolol)
• Alpha-blockers (e.g., prazosin) (increased risk of first-dose hypotension with metoprolol)

• Not available

• Dizziness
• Lightheadedness
• Fainting (orthostatic hypotension)
• Unusual fatigue or weakness
• Shortness of breath
• Swelling of ankles or feet (edema)
• Muscle cramps or weakness (electrolyte imbalance)
• Nausea or vomiting
• Slow or irregular heartbeat
• Cold hands or feet
• Symptoms of gout (joint pain, swelling)

Category D. Should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Both components carry risks.

Both metoprolol and hydrochlorothiazide are excreted into breast milk. Use with caution. Monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, lethargy, poor feeding) and diuretic effects (e.g., dehydration, electrolyte imbalance).

Safety and effectiveness have not been established in pediatric patients. Fixed-dose combination products are generally not recommended for initial therapy in children.

Elderly patients may be more sensitive to the effects of metoprolol and hydrochlorothiazide, particularly regarding hypotension, bradycardia, and electrolyte disturbances. Start with lower doses and monitor closely. Renal function often declines with age, which can affect hydrochlorothiazide clearance.

• Do not discontinue abruptly due to the risk of rebound hypertension, angina, or myocardial infarction associated with the metoprolol component.
• Monitor serum electrolytes, especially potassium, regularly due to the hydrochlorothiazide component, which can cause hypokalemia.
• May mask symptoms of hypoglycemia (e.g., tachycardia) in diabetic patients.
• May exacerbate or precipitate gout due to increased uric acid levels caused by hydrochlorothiazide.
• Take with or immediately after food to enhance metoprolol absorption and reduce gastrointestinal upset.
• Educate patients on symptoms of orthostatic hypotension and advise them to rise slowly.

• ACE inhibitors (e.g., Lisinopril)
• Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan)
• Calcium Channel Blockers (e.g., Amlodipine)
• Other diuretics (e.g., Loop diuretics, Potassium-sparing diuretics)
• Other beta-blockers (e.g., Carvedilol, Nebivolol)

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. If you have any questions or concerns about this medication, consult 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.