Cortef 10mg Tablets

Manufacturer PFIZER Active Ingredient Hydrocortisone Tablets(hye droe KOR ti sone) Pronunciation hye droe KOR ti sone
It is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that this drug may be used for. Talk with the doctor.
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Drug Class
Adrenocortical steroid, anti-inflammatory, immunosuppressant
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Jan 1952
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Hydrocortisone is a type of steroid medicine that is very similar to a natural hormone your body makes. It's used to replace that hormone when your body doesn't make enough (like in adrenal insufficiency), or to reduce inflammation and calm down an overactive immune system in conditions like allergies, asthma, or arthritis.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. It's recommended to take your tablet with food to help your body absorb the medication properly. Continue taking your medication as instructed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to inquire about drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing 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 with food or milk to reduce stomach upset.
  • Do not stop taking this medication suddenly, especially if you've been on it for a long time or at high doses. Your doctor will tell you how to slowly reduce the dose to prevent withdrawal symptoms.
  • Avoid exposure to people with infections (especially chickenpox or measles) as your immune system may be weakened.
  • Report any signs of infection (fever, sore throat, body aches) to your doctor immediately.
  • Carry a medical alert card or wear a bracelet if you are taking hydrocortisone for adrenal insufficiency, especially if you are on long-term therapy.
  • Limit sodium intake and ensure adequate potassium intake as advised by your doctor.
  • Regular exercise and calcium/vitamin D supplementation may be recommended for long-term use to protect bone health.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Adrenal insufficiency: 20-30 mg daily in divided doses (e.g., 2/3 in morning, 1/3 in afternoon). Anti-inflammatory/Immunosuppressive: Highly variable, typically 20-240 mg daily in divided doses.
Dose Range: 20 - 240 mg

Condition-Specific Dosing:

adrenal_insufficiency: 20-30 mg daily, divided (e.g., 2/3 AM, 1/3 PM)
anti_inflammatory_immunosuppressive: 20-240 mg daily, divided, depending on condition severity and patient response. Tapering required for long-term use.
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Pediatric Dosing

Neonatal: Adrenal insufficiency: 0.5-0.75 mg/kg/day orally in 3 divided doses. Anti-inflammatory: Not established for routine use, highly individualized.
Infant: Adrenal insufficiency: 0.5-0.75 mg/kg/day orally in 3 divided doses. Anti-inflammatory: Highly individualized, typically 0.5-4 mg/kg/day in 3-4 divided doses.
Child: Adrenal insufficiency: 0.5-0.75 mg/kg/day orally in 3 divided doses. Anti-inflammatory: Highly individualized, typically 0.5-4 mg/kg/day in 3-4 divided doses (max 240 mg/day).
Adolescent: Adrenal insufficiency: 20-30 mg daily in divided doses. Anti-inflammatory: Similar to adult dosing, highly individualized.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required, but monitor for fluid and electrolyte imbalances.
Dialysis: Hydrocortisone is not significantly removed by dialysis. No specific dose adjustment required.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required, but monitor for increased systemic effects due to reduced metabolism.
Severe: No specific dose adjustment required, but monitor for increased systemic effects due to reduced metabolism.

Pharmacology

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Mechanism of Action

Hydrocortisone is a naturally occurring glucocorticoid. It binds to specific intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus. This complex then interacts with DNA (glucocorticoid response elements) to regulate gene transcription, leading to altered protein synthesis. This results in diverse physiological effects, including potent anti-inflammatory and immunosuppressive actions (e.g., inhibition of prostaglandin and leukotriene synthesis, reduction of leukocyte migration, stabilization of lysosomal membranes), metabolic effects (e.g., gluconeogenesis, protein catabolism, fat redistribution), and mineralocorticoid effects (e.g., sodium retention, potassium excretion).
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90%
Tmax: 1-2 hours
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Approximately 0.2-0.6 L/kg
ProteinBinding: Approximately 90% (primarily to corticosteroid-binding globulin [transcortin] and albumin)
CnssPenetration: Limited (readily crosses blood-brain barrier, but active efflux mechanisms limit accumulation)

Elimination:

HalfLife: Biological half-life: 8-12 hours; Plasma half-life: 1.5-2 hours
Clearance: Approximately 0.5-1 L/hr/kg
ExcretionRoute: Renal (as inactive metabolites)
Unchanged: <1% (renal)
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Pharmacodynamics

OnsetOfAction: Within hours (oral)
PeakEffect: Variable, depends on condition and dose; anti-inflammatory effects may take days to fully manifest.
DurationOfAction: 8-12 hours (physiological effects, though plasma half-life is shorter)
Confidence: Medium

Safety & Warnings

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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 emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased sputum production or a change in sputum color
+ Painful urination or mouth sores
+ A wound that will not heal
Signs of high blood sugar, such as:
+ Confusion or drowsiness
+ Excessive thirst or hunger
+ Frequent urination or flushing
+ Rapid breathing or fruity-smelling breath
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps or an irregular heartbeat
Signs of pancreatitis (pancreas problems), such as:
+ Severe stomach or back pain
+ Severe nausea or vomiting
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or abdomen
+ Moon face or severe headache
+ Slow wound healing
Signs of a weak adrenal gland, including:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness or fatigue
+ Mood changes, decreased appetite, or weight loss
Other severe symptoms, such as:
+ Shortness of breath
+ Sudden weight gain or swelling in the arms or legs
+ Skin changes (acne, stretch marks, slow healing, or excessive hair growth)
+ Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth
+ Bone or joint pain
+ Menstrual changes
+ Chest pain or pressure
+ Changes in vision, eye pain, or severe eye irritation
+ Changes in behavior or mood
+ Hallucinations (seeing or hearing things that are not there)
+ Seizures
+ Unexplained bruising or bleeding
+ Severe stomach pain
+ Black, tarry, or bloody stools
+ Vomiting blood or coffee ground-like material

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects. If you notice any of these symptoms or if they bother you or persist, contact your doctor:

Upset stomach or vomiting
Difficulty sleeping
Restlessness
Excessive sweating
Increased appetite
* Weight gain

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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:

  • Severe stomach pain, black/tarry stools, or vomiting blood (signs of GI bleeding)
  • Signs of infection (fever, chills, severe sore throat, painful urination, unexplained wounds)
  • Swelling in your hands, ankles, or feet; rapid weight gain (fluid retention)
  • Unusual mood changes (severe depression, euphoria, confusion, insomnia)
  • Muscle weakness or severe fatigue
  • Blurred vision or eye pain
  • Increased thirst or urination (signs of high blood sugar)
  • Easy bruising or thinning skin
  • Any signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have an active infection, including bacterial, viral, or fungal infections, as well as conditions like amoeba infection (e.g., traveler's diarrhea), herpes infection of the eye, cerebral malaria, threadworm infestation, or any other type of infection.
* If you have nerve problems affecting your eyes.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription and over-the-counter), natural products, vitamins, and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication in combination with your other medications and health conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor will likely recommend regular blood tests to monitor your condition. If you are taking this medication long-term, you may also need to have your eye pressure and bone density checked.

This medication may interfere with allergy skin tests, so be sure to notify your doctor and laboratory personnel that you are taking it. Long-term use of this medication may increase the risk of developing cataracts or glaucoma, so it is crucial to discuss this with your doctor.

Prolonged use of this medication can also lead to weak bones (osteoporosis). Your doctor can help determine if you are at higher risk of developing osteoporosis and answer any questions you may have. You may need to reduce your salt intake and take potassium supplements, so consult with your doctor about this.

If you have diabetes, it is vital to closely monitor your blood sugar levels while taking this medication. Before consuming alcohol, discuss the potential risks with your doctor. Additionally, if you regularly drink grapefruit juice or eat grapefruit, talk to your doctor about potential interactions.

Do not exceed the prescribed dose of this medication, as taking more than recommended can increase the risk of severe side effects. Before receiving any vaccines, consult with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

If you have not had chickenpox or measles before, avoid close contact with anyone who has these conditions, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, inform your doctor immediately.

Steroid medications, including this one, can increase the risk of infection, which can be mild or severe. They can also make it more challenging to recognize the signs of infection. To minimize the risk of infection, wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and notify your doctor if you experience any symptoms of infection.

In some cases, this medication can reactivate latent infections, such as tuberculosis or hepatitis B. If you have a history of these infections, inform your doctor. This medication can also lower the levels of natural steroids in your body. If you experience a fever, infection, surgery, or injury, consult with your doctor, as you may require additional oral steroid doses to help your body cope with these stresses. Carry a warning card indicating that you may need extra steroids in certain situations.

If you have been taking this medication for an extended period, do not stop taking it without consulting your doctor, as this can lead to withdrawal symptoms. If you miss a dose or recently stopped taking this medication and experience fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform your doctor promptly.

Long-term use of this medication has been associated with an increased risk of developing Kaposi's sarcoma, a type of cancer. Discuss this risk with your doctor. If you have or may have pheochromocytoma, a rare condition, inform your doctor, as this medication can have severe and potentially life-threatening effects in people with this condition.

Patients with cancer may be at higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition. Discuss this risk with your doctor. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

This medication can affect growth in children and adolescents, so regular growth checks may be necessary. If you are a premature infant, inform your doctor, as this medication can increase the risk of a specific heart problem.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. If you took this medication during pregnancy, inform your baby's doctor. For individuals with poor adrenal function, stopping this medication, taking too low of a dose, or switching between dose forms can lead to severe and potentially life-threatening adrenal gland problems. If you have questions or concerns, consult with your doctor.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare but may include: fluid retention, hypertension, hypokalemia, hyperglycemia, and Cushingoid features (moon face, buffalo hump) with chronic overdose.

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic. Chronic overdose requires gradual withdrawal of the drug under medical supervision.

Drug Interactions

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Contraindicated Interactions

  • Live or live attenuated vaccines (in patients receiving immunosuppressive doses of corticosteroids)
  • Systemic fungal infections (unless used as replacement therapy)
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Major Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, grapefruit juice) - may increase hydrocortisone levels and effects.
  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, barbiturates) - may decrease hydrocortisone levels and effects.
  • NSAIDs (e.g., ibuprofen, naproxen) - increased risk of gastrointestinal ulceration and bleeding.
  • Anticoagulants (e.g., warfarin) - corticosteroids may alter anticoagulant effects (either increase or decrease).
  • Diuretics (e.g., thiazides, loop diuretics) - increased risk of hypokalemia.
  • Digitalis glycosides (e.g., digoxin) - increased risk of digitalis toxicity due to hypokalemia.
  • Antidiabetic agents (e.g., insulin, oral hypoglycemics) - corticosteroids may increase blood glucose, requiring dose adjustments of antidiabetics.
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Moderate Interactions

  • Cholestyramine, colestipol - may decrease absorption of hydrocortisone.
  • Oral contraceptives/estrogens - may increase hydrocortisone levels by increasing transcortin.
  • Immunosuppressants (e.g., cyclosporine) - increased risk of seizures with concomitant use; increased levels of both drugs.
  • Vaccines (other than live) - diminished antibody response.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Electrolytes (Na, K)

Rationale: To establish baseline and monitor for mineralocorticoid effects (sodium retention, potassium excretion).

Timing: Prior to initiation of therapy.

Blood Glucose

Rationale: To establish baseline and monitor for glucocorticoid-induced hyperglycemia.

Timing: Prior to initiation of therapy.

Blood Pressure

Rationale: To establish baseline and monitor for hypertension.

Timing: Prior to initiation of therapy.

Weight

Rationale: To establish baseline and monitor for fluid retention.

Timing: Prior to initiation of therapy.

Adrenal Function (e.g., morning cortisol, ACTH stimulation test)

Rationale: If used for adrenal insufficiency, to confirm diagnosis. If used for other conditions, to assess baseline adrenal axis function if prolonged therapy is anticipated.

Timing: Prior to initiation of therapy (especially for adrenal insufficiency).

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Routine Monitoring

Electrolytes (Na, K)

Frequency: Periodically, especially during initiation or dose changes, or with concomitant diuretics.

Target: Within normal limits (Na: 135-145 mEq/L, K: 3.5-5.0 mEq/L)

Action Threshold: Significant deviations (e.g., K < 3.0 mEq/L or Na > 145 mEq/L) warrant intervention.

Blood Glucose

Frequency: Periodically, more frequently in diabetic patients or those at risk.

Target: Fasting: <100 mg/dL; Postprandial: <140 mg/dL

Action Threshold: Persistent hyperglycemia (>126 mg/dL fasting) warrants intervention (e.g., diet, antidiabetic medication).

Blood Pressure

Frequency: Regularly, especially during initiation or dose changes.

Target: <120/80 mmHg

Action Threshold: Sustained hypertension (>140/90 mmHg) warrants intervention.

Weight

Frequency: Regularly.

Target: Stable

Action Threshold: Significant weight gain (>2 kg/week) may indicate fluid retention.

Growth (in pediatric patients)

Frequency: Regularly (e.g., every 3-6 months) for long-term therapy.

Target: Normal growth velocity for age.

Action Threshold: Growth suppression warrants re-evaluation of therapy.

Bone Mineral Density (BMD)

Frequency: Baseline and periodically (e.g., every 1-2 years) for long-term therapy (>3 months).

Target: Stable or improving BMD.

Action Threshold: Significant bone loss warrants intervention (e.g., calcium, vitamin D, bisphosphonates).

Ophthalmic Exam (intraocular pressure, cataracts)

Frequency: Annually for long-term therapy.

Target: Normal intraocular pressure, absence of posterior subcapsular cataracts.

Action Threshold: Elevated IOP or cataract formation warrants ophthalmology referral.

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Symptom Monitoring

  • Signs of infection (fever, sore throat, malaise, localized pain/redness)
  • Gastrointestinal symptoms (abdominal pain, black/tarry stools, vomiting blood)
  • Mood changes (depression, euphoria, insomnia, irritability)
  • Muscle weakness or pain
  • Swelling of ankles/feet
  • Unusual bruising or skin thinning
  • Vision changes
  • Increased thirst or urination
  • Signs of adrenal insufficiency upon withdrawal (fatigue, weakness, nausea, vomiting, dizziness, hypotension)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Hydrocortisone crosses the placenta. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of oral clefts, though data are conflicting and overall risk appears low.
Second Trimester: Generally considered safer than first trimester, but continued monitoring for fetal growth and adrenal suppression is warranted.
Third Trimester: Risk of fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism.
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Lactation

Hydrocortisone is excreted in breast milk in small amounts. Generally considered compatible with breastfeeding, especially at typical replacement doses. Monitor infant for signs of adrenal suppression (e.g., poor weight gain, irritability) or other adverse effects.

Infant Risk: Low risk at typical doses. Higher doses or prolonged use may theoretically lead to infant adrenal suppression, though unlikely to be clinically significant.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Growth should be carefully monitored. Long-term use can also lead to adrenal suppression, osteoporosis, and cataracts. Use the lowest effective dose for the shortest possible duration.

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Geriatric Use

Elderly patients may be at increased risk of adverse effects, including osteoporosis, fluid retention, hypertension, and diabetes. Use with caution and monitor closely.

Clinical Information

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Clinical Pearls

  • Hydrocortisone is the physiological glucocorticoid, making it the preferred agent for adrenal insufficiency replacement therapy.
  • For replacement therapy, mimic the body's natural diurnal rhythm by giving a larger dose in the morning and a smaller dose in the afternoon/evening.
  • Patients on long-term systemic corticosteroids should never stop the medication abruptly due to the risk of acute adrenal crisis.
  • Stress dosing (increasing the dose during illness, surgery, or severe stress) is crucial for patients on chronic hydrocortisone therapy for adrenal insufficiency.
  • Monitor for signs of infection, as corticosteroids can mask symptoms and increase susceptibility.
  • Consider bone protection strategies (calcium, vitamin D, bisphosphonates) for patients on long-term corticosteroid therapy.
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Alternative Therapies

  • Prednisone (longer-acting glucocorticoid)
  • Methylprednisolone (longer-acting glucocorticoid)
  • Dexamethasone (very long-acting, potent glucocorticoid)
  • Budesonide (topical or locally acting glucocorticoid with high first-pass metabolism, less systemic effects)
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Cost & Coverage

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

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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.