Linezolid 100mg/5ml Oral Susp 150ml

Linezolid is an antibacterial agent that inhibits bacterial protein synthesis. It binds 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 bacteriostatic activity against enterococci and staphylococci, and bactericidal activity against most streptococci.

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, abnormal heartbeat, severe upset stomach or vomiting, excessive sleepiness, shortness of breath, feeling extremely tired or weak, 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, feeling sleepy, 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 fits.
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 other 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, which can lead to a life-threatening bowel condition. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately.
Serotonin Syndrome: A potentially life-threatening condition that can occur when taking this medication with certain other drugs. If you experience 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, contact your doctor immediately.
Rhabdomyolysis: A severe muscle problem that can cause muscle pain or tenderness, weakness, or dark urine. If you experience any of these symptoms, contact your doctor immediately.

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 if they bother you or do not go away:

Headache
Diarrhea, upset stomach, or vomiting

This is not an exhaustive list of possible 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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ 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, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications with this drug can lead to severely high blood pressure.

Please note that this is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

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.

If you have phenylketonuria (PKU), consult your doctor before taking this medication, as some products contain phenylalanine.

This medication may cause high blood pressure. Regularly monitor your blood pressure as advised by your doctor. Additionally, discuss with your doctor the use of over-the-counter (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
* Certain natural products or aids

Certain foods and beverages, including cheese and red wine, may trigger sudden and severe high blood pressure when taking this medication, which can be life-threatening. Consult your doctor to assess your risk and obtain a list of foods and drinks to avoid. Refrain from consuming these items for the duration specified by your doctor, even after stopping the medication.

Prolonged use of this medication (beyond 28 days) may lead to severe eye problems, including vision loss. Follow your doctor's recommendations for regular eyesight checks and discuss any concerns.

If you have diabetes (high blood sugar), inform your doctor, as this medication may lower blood sugar levels. Your diabetes medication may need to be adjusted. Monitor your blood sugar levels as directed by your doctor.

This medication may cause low sodium levels and a condition called syndrome of inappropriate antidiuretic hormone (SIADH) secretion, which can be severe and potentially life-threatening, leading to breathing difficulties. If you have questions or concerns, consult your doctor.

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

This medication may temporarily affect fertility in males, but this typically resolves after stopping the medication. If you have concerns, 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) - due to MAOI activity of linezolid, risk of hypertensive crisis or serotonin syndrome.
• Vasopressors (e.g., dopamine, epinephrine, norepinephrine) - use with caution, monitor blood pressure, consider lower initial doses of vasopressors.

• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, buspirone, meperidine, tramadol, dextromethorphan, St. John's Wort) - risk of serotonin syndrome.
• Adrenergic drugs (e.g., pseudoephedrine, phenylephrine, phenylpropanolamine) - risk of hypertensive crisis.
• Tyramine-rich foods/beverages (e.g., aged cheeses, cured meats, fermented products, red wine, tap beer) - risk of hypertensive crisis.
• Myelosuppressive agents (e.g., methotrexate, azathioprine) - increased risk of myelosuppression.

• Anticoagulants (e.g., warfarin) - potential for increased bleeding risk (monitor INR).
• Insulin sensitizers (e.g., metformin) - potential for lactic acidosis (linezolid can cause lactic acidosis).

• Not available

• Vision changes (blurred vision, visual field defects, optic neuropathy)
• Numbness, tingling, or weakness in hands or feet (peripheral neuropathy)
• Severe diarrhea (Clostridioides difficile-associated diarrhea)
• Signs of serotonin syndrome (agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
• Signs of lactic acidosis (unexplained nausea, vomiting, abdominal pain, hyperventilation, fatigue)
• Signs of myelosuppression (unusual bleeding/bruising, fever, sore throat, fatigue)

Linezolid is classified as Pregnancy Category C. Animal studies have shown adverse effects on fetal development (e.g., reduced fetal body weights, skeletal ossification delays, reduced survival) at clinically relevant exposures. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Linezolid and its metabolites are excreted into human milk. The amount of linezolid ingested by a breastfed infant is estimated to be low. However, due to the potential for serious adverse reactions in the breastfed infant (e.g., myelosuppression, mitochondrial toxicity, MAOI effects), 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 use in pediatric patients from birth. Dosing varies by age and weight. Neonates and infants may require more frequent dosing (every 8 hours) due to faster clearance. Safety and efficacy in pediatric patients treated for longer than 28 days have not been evaluated.

No dose adjustment is required based on age. However, elderly patients may be more susceptible to drug-related adverse effects, particularly myelosuppression and neuropathy. Monitor closely for these effects.

• Linezolid is a unique antibiotic effective against multi-drug resistant Gram-positive bacteria, including MRSA and VRE.
• It possesses weak, reversible, non-selective monoamine oxidase (MAO) inhibitory activity, leading to significant drug-food and drug-drug interactions (e.g., serotonin syndrome, hypertensive crisis).
• Myelosuppression (especially thrombocytopenia) is a common and dose-limiting adverse effect, particularly with prolonged therapy (>10-14 days). Weekly CBC monitoring is crucial.
• Peripheral and optic neuropathy can occur, especially with prolonged use (>28 days). Patients should be advised to report any visual changes or sensory symptoms.
• Lactic acidosis is a rare but serious adverse effect, likely due to mitochondrial toxicity. Patients presenting with unexplained nausea, vomiting, abdominal pain, or hyperventilation should be evaluated for lactic acidosis.
• Oral and IV formulations are 100% bioequivalent, allowing for seamless IV to oral step-down therapy.
• Linezolid is not significantly cleared by the kidneys or liver, so dose adjustments are generally not needed for renal or hepatic impairment, but monitoring for metabolite accumulation and adverse effects is important in severe impairment.

• Vancomycin (for MRSA, VRE)
• Daptomycin (for MRSA, VRE)
• Tigecycline (for MRSA, VRE, complicated skin and skin structure infections)
• Ceftaroline (for MRSA, CAP, cSSSI)
• Tedizolid (another oxazolidinone, for acute bacterial skin and skin structure infections)
• Quinupristin/dalfopristin (for VRE faecium)

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 your 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.