Linezolid 600mg Tablets

Linezolid is an oxazolidinone antibacterial agent. It inhibits bacterial protein synthesis by binding to the 23S ribosomal RNA of the 50S ribosomal subunit, preventing the formation of a functional 70S initiation complex, which is essential for bacterial translation. This unique mechanism of action results in activity against Gram-positive bacteria, including multi-drug resistant strains.

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:

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.
Lactic Acidosis: Fast breathing, fast heartbeat, irregular heartbeat, severe upset stomach or vomiting, excessive sleepiness, shortness of breath, extreme fatigue or weakness, severe dizziness, feeling cold, or muscle pain or cramps.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Low Blood Sugar: Dizziness, headache, sleepiness, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating.
Low Sodium Levels: Headache, difficulty focusing, memory problems, confusion, weakness, seizures, or changes in balance.
Nerve Damage: Abnormal burning, numbness, or tingling sensations.
Vision Changes: Changes in eyesight.
Seizures: Convulsions or loss of consciousness.
Low Blood Cell Counts: Increased risk of bleeding, infection, or anemia, especially in patients with bone marrow, kidney, or liver problems, or those taking certain medications. If you experience signs of infection (fever, chills, sore throat), unexplained bruising or bleeding, or extreme fatigue or weakness, contact your doctor immediately.
C. diff-Associated Diarrhea (CDAD): Severe diarrhea, stomach pain, cramps, or loose, watery, or bloody stools. CDAD can occur during or after antibiotic treatment and may lead to life-threatening bowel problems. Contact your doctor immediately if you experience any of these symptoms.
Serotonin Syndrome: A potentially life-threatening condition that can occur when taking this medication with certain other drugs. Symptoms include agitation, changes in balance, confusion, hallucinations, fever, rapid or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, upset stomach, or vomiting, or severe headache. Seek medical help immediately if you experience any of these symptoms.
Rhabdomyolysis: A severe muscle problem that can cause muscle pain or tenderness, muscle weakness, or dark urine. Contact your doctor immediately if you experience any of these symptoms.

Other Side Effects

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

Headache
Diarrhea, upset stomach, or vomiting

Reporting Side Effects

If you have questions about side effects or experience any symptoms that concern you, 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, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ An adrenal gland tumor called pheochromocytoma
+ High blood pressure
+ An overactive thyroid gland
* If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining this medication with these drugs can lead to severely high blood pressure.

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all of your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify 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. Adhere to the prescribed duration of treatment, as prolonged use may increase the risk of a second infection.

Monitor your blood pressure regularly, as directed by your doctor, since this medication can cause high blood pressure. Before using any over-the-counter (OTC) products, consult your doctor, especially those that may raise blood pressure, such as:

Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs), including ibuprofen or naproxen
* Certain natural products or aids

Some foods and beverages, including cheese and red wine, can cause a sudden and severe increase in blood pressure, which can be life-threatening. Discuss your risk with your doctor and obtain a list of foods and drinks to avoid during and after treatment, as advised by your doctor.

Regularly undergo blood work and other laboratory tests as directed by your doctor. Be aware that prolonged use of this medication (beyond 28 days) may increase the risk of severe eye problems, including vision loss. Follow your doctor's recommendations for eye exams and discuss any concerns.

If you have diabetes, inform your doctor, as this medication may lower blood sugar levels, requiring adjustments to your diabetes treatment. Monitor your blood sugar levels as directed by your doctor.

This medication can cause low sodium levels and a condition called syndrome of inappropriate antidiuretic hormone (SIADH) secretion, which can be severe and lead to breathing problems or even death. If you have questions or concerns, consult your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Additionally, this medication may temporarily affect fertility in men, but this typically resolves after treatment is stopped. If you have questions, discuss them with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, isocarboxazid, selegiline, rasagiline) - due to risk of serotonin syndrome and hypertensive crisis.

• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, meperidine, dextromethorphan, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
• Adrenergic drugs (e.g., pseudoephedrine, phenylephrine, dopamine, epinephrine, norepinephrine, vasopressors) - increased risk of hypertensive crisis.
• Tyramine-rich foods and beverages (e.g., aged cheeses, cured meats, fermented products, red wine, tap beer) - risk of hypertensive crisis.

• Warfarin - potential for increased INR; monitor INR closely.
• Insulin and oral hypoglycemic agents - potential for hypoglycemia (rare, but reported).

• Fever
• Sore throat
• Easy bruising or bleeding (signs of myelosuppression)
• Numbness or tingling in hands or feet (peripheral neuropathy)
• Blurred vision, changes in color perception, or vision loss (optic neuropathy)
• Unexplained nausea, vomiting, abdominal pain, hyperventilation (lactic acidosis)
• Agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, loss of coordination, severe diarrhea (serotonin syndrome)
• Severe or persistent diarrhea (Clostridioides difficile-associated diarrhea)

Linezolid is classified as Pregnancy Category C. Animal studies have shown adverse effects on fetal development (e.g., reduced fetal weight, skeletal ossification delays, reduced survival) at doses similar to or below human therapeutic exposures. There are no adequate and well-controlled studies in pregnant women. Linezolid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Linezolid and its metabolites are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., myelosuppression, mitochondrial toxicity), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Linezolid is approved for pediatric use. Dosing varies by age and weight, typically 10 mg/kg every 8 hours for children under 12 years and 600 mg every 12 hours for adolescents (12 years and older). Safety and efficacy in neonates and infants are established. Monitor for adverse effects similar to adults.

No dose adjustment is required based on age. However, elderly patients may be more susceptible to adverse effects, particularly myelosuppression and neuropathy, and should be monitored closely.

• Linezolid is a valuable antibiotic for treating serious Gram-positive infections, including MRSA and VRE, especially in patients who cannot tolerate or fail other agents like vancomycin.
• The most common serious adverse effects are myelosuppression (especially thrombocytopenia), peripheral neuropathy, optic neuropathy, and lactic acidosis, particularly with prolonged use (>28 days).
• Strict dietary restrictions (avoiding tyramine-rich foods) and drug interaction precautions (especially with serotonergic and adrenergic agents) are crucial due to its weak MAOI activity.
• Monitor CBC weekly, especially platelet counts, during therapy. Discontinue if significant myelosuppression occurs.
• Educate patients on symptoms of serotonin syndrome, lactic acidosis, and neuropathy, and advise them to seek immediate medical attention if these occur.
• Linezolid has excellent oral bioavailability, allowing for IV-to-oral step-down therapy without dose adjustment.

• Vancomycin (for MRSA, VRE)
• Daptomycin (for MRSA, VRE)
• Tigecycline (for MRSA, VRE)
• Ceftaroline (for MRSA)
• Dalbavancin (for MRSA skin infections)
• Oritavancin (for MRSA skin infections)

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, including the amount taken and the time it happened.