Linezolid 100mg/5ml Oralsusp 150ml

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 no cross-resistance with other antibiotic classes.

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 nausea 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 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 may be bloody or watery, stomach pain, or cramps. CDAD can occur during or after antibiotic treatment and may lead to life-threatening bowel problems. Contact your doctor if you experience any of these symptoms.
Serotonin Syndrome: A potentially life-threatening condition that may 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, nausea, or vomiting, or severe headache. Seek medical help immediately if you experience any of these symptoms.
Rhabdomyolysis: A severe muscle problem that may cause muscle pain or tenderness, muscle weakness, or dark urine. Contact your doctor right away if you experience any of these symptoms.

Other Side Effects

Most people do not experience significant 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 may lead to very high blood pressure.

This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history

To ensure your safety, always check with your doctor before:
Starting any new medication
Stopping or changing the dose of any medication
* Adding or removing any health supplements or vitamins to your regimen.

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, be cautious when using 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

Some 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. Discuss your risk with your doctor and obtain a list of foods and drinks to avoid. Continue to avoid these items for the duration recommended by your doctor after stopping the medication.

Regular blood work and laboratory tests are crucial, as prescribed by your doctor.

Prolonged use of this medication (beyond 28 days) may increase the risk of severe eye problems, including vision loss. Follow your doctor's instructions for regular eyesight checks and consult with them if you have 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, discuss them with 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 returns to normal after stopping the medication. If you have concerns, consult 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.

• Patients taking any monoamine oxidase inhibitors (MAOIs) or within 2 weeks of taking MAOIs (e.g., phenelzine, isocarboxazid, selegiline, tranylcypromine) due to risk of hypertensive crisis or serotonin syndrome.
• Patients with uncontrolled hypertension, pheochromocytoma, carcinoid syndrome, or thyrotoxicosis if not closely monitored.

• Serotonergic agents (e.g., SSRIs, SNRIs, TCAs, triptans, buspirone, meperidine, tramadol, dextromethorphan, St. John's Wort): Risk of serotonin syndrome.
• Adrenergic agents (e.g., pseudoephedrine, phenylephrine, dopamine, epinephrine, norepinephrine, dobutamine): 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, chloramphenicol): Increased risk of myelosuppression (especially thrombocytopenia).

• Insulin sensitizers (e.g., metformin): Potential for lactic acidosis (rare, but reported).
• Warfarin: Potential for increased INR/bleeding (monitor INR closely).

• Not available

• Fever
• Sore throat
• Unusual bleeding or bruising
• Fatigue
• Pale skin
• Numbness or tingling in hands or feet
• Blurred vision
• Changes in color vision
• Headache
• Dizziness
• Sweating
• Agitation
• Confusion
• Tremor
• Muscle rigidity
• Diarrhea (especially severe or persistent)
• Abdominal pain
• Rash
• Itching

Linezolid is classified as Pregnancy Category C. Animal studies have shown adverse effects on fetal development at doses similar to or higher than human therapeutic doses. It 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, gastrointestinal disturbances), 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 is weight-based and varies by age group (neonates, infants, children, adolescents). Close monitoring for adverse effects, particularly myelosuppression, is crucial, especially in neonates and infants.

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

• Linezolid is a valuable antibiotic for treating serious Gram-positive infections, including those caused by MRSA and VRE, where other agents may be ineffective or contraindicated.
• The risk of myelosuppression (especially thrombocytopenia) increases with duration of therapy, particularly beyond 10-14 days. Weekly CBC monitoring is essential for prolonged courses.
• Counsel patients extensively on the risk of serotonin syndrome when co-administered with serotonergic drugs and the risk of hypertensive crisis with tyramine-rich foods or adrenergic agents.
• Peripheral and optic neuropathy are rare but serious adverse effects, typically associated with prolonged therapy (>28 days). Patients should be advised to report any visual changes or new onset numbness/tingling.
• Oral bioavailability is 100%, allowing for convenient IV-to-oral step-down therapy without dose adjustment.

• Vancomycin (for MRSA, but not VRE)
• Daptomycin (for MRSA, VRE, but not pneumonia)
• Tigecycline (for MRSA, VRE, but not bacteremia)
• Ceftaroline (for MRSA, but not VRE)
• Quinupristin/dalfopristin (for VRE, but limited use due to adverse effects)
• Dalbavancin (for cSSSI, MRSA)
• Oritavancin (for cSSSI, MRSA)

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 information about the medication taken, the amount, and the time it happened.