Lisinopril-HCTZ 20/12.5mg Tablets

Manufacturer LUPIN PHARMACEUTICALS Active Ingredient Lisinopril and Hydrochlorothiazide(lyse IN oh pril & hye droe klor oh THYE a zide) Pronunciation lyse IN oh pril & hye droe klor oh THYE a zide
WARNING: Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away. @ COMMON USES: It is used to treat high blood pressure.
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Drug Class
Antihypertensive
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Pharmacologic Class
Angiotensin-Converting Enzyme (ACE) Inhibitor / Thiazide Diuretic
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Pregnancy Category
D
FDA Approved
Aug 1989
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lisinopril-HCTZ is a combination medicine that helps lower high blood pressure. Lisinopril relaxes blood vessels, and hydrochlorothiazide helps your body get rid of extra salt and water. Together, they help reduce the strain on your heart and blood vessels.
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How to Use This Medicine

Taking Your Medication

To get the most benefit from your medication, follow these guidelines:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.

Note: This medication may increase the frequency of urination. To minimize sleep disturbances, try to avoid taking it too close to bedtime.

Drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.

Storing and Disposing of Your Medication

To ensure the safety and effectiveness of your medication:

Store it at room temperature, away from light and moisture.
Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom.
Keep all medications out of the reach of children and pets.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication, or look into local drug take-back programs.

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take medication exactly as prescribed, usually once daily.
  • Do not stop taking the medication without consulting your doctor, even if you feel well.
  • Limit sodium (salt) intake in your diet.
  • Maintain a healthy weight through diet and regular exercise.
  • Limit alcohol consumption.
  • Avoid potassium supplements or salt substitutes containing potassium unless advised by your doctor.
  • Inform your doctor or dentist that you are taking this medication before any surgery or dental procedures.

Dosing & Administration

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Adult Dosing

Standard Dose: One 20/12.5 mg tablet orally once daily.
Dose Range: 10 - 40 mg

Condition-Specific Dosing:

initial_therapy: Typically initiated with lower doses (e.g., 10/12.5 mg) and titrated based on blood pressure response. 20/12.5 mg is a common maintenance dose.
maximum_dose: Lisinopril 40 mg / HCTZ 25 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: CrCl > 30 mL/min: No initial dose adjustment for the combination, but monitor renal function closely. If CrCl is 30-80 mL/min, consider starting with lower doses of individual components if not already on them.
Moderate: CrCl 30-80 mL/min: Use with caution. Monitor renal function and electrolytes closely. Lower doses of individual components may be preferred for initiation.
Severe: CrCl < 30 mL/min: Contraindicated due to the hydrochlorothiazide component.
Dialysis: Contraindicated. Lisinopril is dialyzable, but HCTZ is not effectively removed by dialysis. Risk of severe hypotension and renal dysfunction.

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: Use with caution. Thiazides may precipitate hepatic coma in patients with severe liver impairment. Lisinopril is not extensively metabolized by the liver.
Severe: Use with caution and monitor closely. Thiazides may precipitate hepatic coma.

Pharmacology

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Mechanism of Action

Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor. It prevents the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. This leads to decreased vasoconstriction, reduced aldosterone secretion (resulting in decreased sodium and water retention), and increased bradykinin levels (contributing to vasodilation). Hydrochlorothiazide is a thiazide diuretic. It acts on the distal convoluted tubule of the kidney to inhibit sodium chloride reabsorption, thereby increasing the excretion of sodium, chloride, and water. It also increases potassium and magnesium excretion and decreases calcium excretion.
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Pharmacokinetics

Absorption:

Bioavailability: Lisinopril: Approximately 25-30% (variable); Hydrochlorothiazide: Approximately 65-75%
Tmax: Lisinopril: 6-8 hours; Hydrochlorothiazide: 1-2.5 hours
FoodEffect: Lisinopril: Absorption is not affected by food; Hydrochlorothiazide: Absorption is not significantly affected by food, but may be slightly reduced.

Distribution:

Vd: Lisinopril: Approximately 1.24 L/kg; Hydrochlorothiazide: Approximately 0.8-1.7 L/kg
ProteinBinding: Lisinopril: Minimal (<1%); Hydrochlorothiazide: 40-68%
CnssPenetration: Limited

Elimination:

HalfLife: Lisinopril: Effective half-life ~12 hours (terminal half-life ~30 hours); Hydrochlorothiazide: 5.6-14.8 hours
Clearance: Lisinopril: Primarily renal clearance; Hydrochlorothiazide: Primarily renal clearance
ExcretionRoute: Renal (urine)
Unchanged: Lisinopril: 100%; Hydrochlorothiazide: >95%
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Pharmacodynamics

OnsetOfAction: Lisinopril: ~1 hour; Hydrochlorothiazide: ~2 hours
PeakEffect: Lisinopril: 6-8 hours; Hydrochlorothiazide: ~4 hours
DurationOfAction: Lisinopril: ~24 hours; Hydrochlorothiazide: 6-12 hours

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue Lisinopril-HCTZ as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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Side 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 immediately or seek medical attention:

Allergic Reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
High Blood Sugar: Confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, fast breathing, or fruity-smelling breath.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Fluid and Electrolyte Imbalance: Mood changes, confusion, muscle pain or weakness, irregular heartbeat, severe dizziness or fainting, increased thirst, seizures, fatigue, weakness, decreased appetite, changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Chest Pain or Persistent Cough: Seek medical attention if you experience chest pain or a cough that does not subside.
Severe Stomach Pain: Contact your doctor if you experience severe stomach pain.
Eye Problems: This medication can cause eye problems that may lead to permanent vision loss if left untreated. If you notice changes in vision or eye pain, typically within hours to weeks of starting the medication, contact your doctor immediately.
Liver Problems: In rare cases, liver problems have occurred with similar medications, sometimes leading to fatal outcomes. Seek medical attention if you experience dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellowing of the skin and eyes.
Skin Cancer: Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. Protect your skin from the sun and follow your doctor's recommendations for skin checks. Contact your doctor if you notice any changes in mole color or size, or new or changing skin growths.
Low White Blood Cell Count: This medication can increase the risk of infection, particularly in people with kidney problems or other underlying health conditions. Seek medical attention if you experience fever, chills, or sore throat.

Other Side Effects

Most people do not experience significant side effects or only have minor ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Dizziness, fatigue, or weakness
Headache
* Cough

This is not an exhaustive list of possible side effects. If you have 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.
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Seek Immediate Medical Attention If You Experience:

  • Swelling of the face, lips, tongue, or throat (angioedema) - seek immediate medical attention.
  • Severe dizziness or fainting, especially when standing up.
  • Signs of electrolyte imbalance: unusual tiredness, muscle weakness, muscle cramps, nausea, vomiting, irregular heartbeats.
  • Persistent dry cough that does not go away.
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems).
  • Signs of infection (fever, sore throat) as ACE inhibitors can rarely cause a decrease in white blood cells.
  • Sudden, severe joint pain (signs of gout).
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A known sulfa allergy.
A history of angioedema, a severe and potentially life-threatening reaction characterized by symptoms such as swelling of the hands, face, lips, eyes, tongue, or throat, difficulty breathing, swallowing problems, or unusual hoarseness.
Kidney disease or any kidney problems.
Inability to urinate.
Current or recent use of specific medications, including:
+ Dofetilide.
+ Lithium.
+ Aliskiren-containing drugs, particularly if you have diabetes or kidney problems.
+ Sacubitril-containing drugs, if taken within the last 36 hours.

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health issues, to your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

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 activities that require you to be alert. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and be cautious when climbing stairs.

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

Monitoring and Laboratory Tests
If you have diabetes, closely monitor your blood sugar levels. Regularly undergo blood work, blood pressure checks, and other laboratory tests as advised by your doctor. Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.

Potassium and Salt Interactions
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, discuss this with your doctor. Additionally, if you are on a low-salt or salt-free diet, consult with your doctor before taking this medication.

OTC Medications and Blood Pressure
Before using 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 with your doctor.

Interactions with Other Medications
If you are taking cholestyramine or colestipol, consult with your pharmacist about the proper administration of these medications with this drug. Be aware of the potential for gout attacks.

Lupus and Other Conditions
If you have lupus, this medication may exacerbate or reactivate the condition. Immediately inform your doctor if you experience any new or worsening symptoms. 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, which may lead to low blood pressure, inform your doctor.

High Cholesterol and Triglycerides
This medication may cause increased cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor.

Angioedema and Other Serious Reactions
A severe and potentially life-threatening reaction called angioedema has been associated with this medication, with a higher risk in Black patients.

Special Considerations
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, consult with your doctor to discuss potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (low blood pressure) with dizziness, lightheadedness, or fainting
  • Electrolyte imbalances (e.g., hypokalemia, hyponatremia, hyperkalemia)
  • Dehydration
  • Renal failure

What to Do:

Call 911 or Poison Control (1-800-222-1222) immediately. Treatment is supportive and symptomatic, including intravenous fluids for hypotension and electrolyte correction. Hemodialysis may be considered for severe lisinopril overdose.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment (GFR < 60 mL/min/1.73 m²))
  • Sacubitril/valsartan (Entresto) - concomitant use or within 36 hours of switching due to increased risk of angioedema
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Major Interactions

  • Potassium supplements, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), or other agents that may increase serum potassium (e.g., trimethoprim, cyclosporine, heparin): Increased risk of hyperkalemia.
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including COX-2 inhibitors: May reduce the antihypertensive effect of lisinopril and hydrochlorothiazide, and may worsen renal function, especially in patients with pre-existing renal impairment.
  • Lithium: Increased serum lithium concentrations and symptoms of lithium toxicity due to reduced renal clearance by both components.
  • Other antihypertensive agents: Additive hypotensive effects.
  • Gold injections (sodium aurothiomalate): Nitritoid reactions (flushing, nausea, vomiting, hypotension) have been reported rarely in patients receiving concomitant gold and ACE inhibitor therapy.
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Moderate Interactions

  • Antidiabetic agents (oral agents and insulin): Thiazides may decrease glucose tolerance, requiring adjustment of antidiabetic dosage. Lisinopril may enhance the glucose-lowering effect.
  • Cholestyramine and colestipol resins: May impair the absorption of hydrochlorothiazide.
  • Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia.
  • Digitalis glycosides: Hypokalemia or hypomagnesemia induced by thiazides may predispose to digitalis toxicity.
  • Allopurinol: Increased risk of hypersensitivity reactions to allopurinol.
  • Pressor amines (e.g., norepinephrine): Possible decreased response to pressor amines.
  • Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine): Possible increased responsiveness to the muscle relaxant.
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Minor Interactions

  • Alcohol, barbiturates, or narcotics: May potentiate orthostatic hypotension.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide therapy.

Timing: Prior to initiation

Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)

Rationale: To assess baseline electrolyte status and identify pre-existing imbalances. Lisinopril can cause hyperkalemia, HCTZ can cause hypokalemia, hyponatremia, hypomagnesemia, and hypercalcemia.

Timing: Prior to initiation

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess baseline kidney function, as dose adjustments are required in renal impairment and the drug is contraindicated in severe impairment.

Timing: Prior to initiation

Uric Acid

Rationale: HCTZ can increase serum uric acid levels.

Timing: Prior to initiation

Blood Glucose

Rationale: HCTZ can cause hyperglycemia.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, as clinically indicated (e.g., weekly after initiation/dose change, then monthly/quarterly)

Target: <130/80 mmHg or individualized target

Action Threshold: If BP remains uncontrolled, consider dose titration or additional therapy. If BP is too low, consider dose reduction.

Serum Electrolytes (Potassium, Sodium)

Frequency: Within 1-2 weeks of initiation or dose change, then periodically (e.g., every 3-6 months) or as clinically indicated.

Target: Potassium: 3.5-5.0 mEq/L; Sodium: 135-145 mEq/L

Action Threshold: Potassium <3.0 or >5.5 mEq/L, Sodium <130 mEq/L: Investigate cause, consider dose adjustment or discontinuation, and manage imbalance.

Renal Function (BUN, Serum Creatinine, eGFR)

Frequency: Within 1-2 weeks of initiation or dose change, then periodically (e.g., every 3-6 months) or as clinically indicated.

Target: Stable within patient's baseline range

Action Threshold: Significant increase in creatinine (>30% from baseline) or decrease in eGFR: Investigate cause, consider dose reduction or discontinuation.

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Symptom Monitoring

  • Signs of angioedema (swelling of face, lips, tongue, glottis, larynx, extremities)
  • Symptoms of hypotension (dizziness, lightheadedness, fainting, especially upon standing)
  • Persistent dry cough (common ACE inhibitor side effect)
  • Symptoms of electrolyte imbalance (muscle cramps, weakness, fatigue, irregular heartbeats, nausea, vomiting)
  • Signs of liver problems (yellowing of skin/eyes, dark urine, persistent nausea/vomiting)
  • Symptoms of gout (sudden, severe joint pain, redness, swelling)
  • Signs of dehydration (excessive thirst, dry mouth, decreased urination)

Special Patient Groups

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Pregnancy

Contraindicated during pregnancy. Use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal injury and death. Exposure during the first trimester may also carry risks.

Trimester-Specific Risks:

First Trimester: Potential for major congenital malformations (cardiovascular, CNS, craniofacial) has been suggested by some studies, though data are conflicting. Discontinue as soon as pregnancy is detected.
Second Trimester: Fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, and fetal death.
Third Trimester: Fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, and fetal death.
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Lactation

Not recommended during breastfeeding. Both lisinopril and hydrochlorothiazide are excreted in human milk. Hydrochlorothiazide can reduce milk production. Potential for serious adverse effects in the breastfed infant.

Infant Risk: Lisinopril: Low risk, but potential for hypotension. Hydrochlorothiazide: Potential for electrolyte disturbances, dehydration, and reduced milk supply. Overall, the combination is generally not recommended.
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Pediatric Use

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

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Geriatric Use

Use with caution. Elderly patients may be more sensitive to the hypotensive and electrolyte-altering effects (e.g., hypokalemia, hyponatremia) and may have age-related decreases in renal function, requiring closer monitoring of renal function and electrolytes. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • First-dose hypotension can occur, especially in patients who are volume-depleted (e.g., on high-dose diuretics, dialysis, or with severe heart failure). Consider discontinuing diuretics 2-3 days prior to initiation if possible, or starting with a very low dose.
  • Angioedema is a rare but potentially life-threatening side effect of ACE inhibitors. Patients should be educated on symptoms and instructed to seek immediate medical attention if it occurs.
  • A persistent, non-productive dry cough is a common side effect of ACE inhibitors, occurring in up to 20% of patients. It typically resolves within days to weeks after discontinuation.
  • Monitor potassium levels carefully. While lisinopril tends to increase potassium and HCTZ tends to decrease it, individual responses vary, and both hyperkalemia and hypokalemia can occur.
  • Hydrochlorothiazide can increase serum uric acid levels and may precipitate gout attacks in susceptible individuals.
  • Thiazide diuretics can cause photosensitivity reactions; advise patients to use sun protection.
  • This combination is a good option for patients who require both an ACE inhibitor and a diuretic for blood pressure control, simplifying the regimen and potentially improving adherence.
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Alternative Therapies

  • Angiotensin Receptor Blocker (ARB) / Diuretic combinations (e.g., Valsartan/HCTZ, Losartan/HCTZ)
  • Calcium Channel Blockers (CCBs)
  • Beta-blockers
  • Other classes of diuretics (e.g., loop diuretics, potassium-sparing diuretics)
  • Direct Renin Inhibitors (e.g., Aliskiren)
  • Alpha-blockers
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

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 be sure to check with your pharmacist for more information. 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.