Linosept

Description

Linosept Tablet: Uses, Dosing, and Important Information

Linosept Tablet contains linezolid, an antibiotic used to treat serious bacterial infections, especially those caused by resistant bacteria.

What Is Linosept Used For?

Linosept Tablet is used to treat:

• Pneumonia:
  • Community-acquired pneumonia
  • Nosocomial pneumonia (hospital-acquired pneumonia)
• Skin and Skin Structure Infections:
  • Uncomplicated skin and skin structure infections
  • Complicated skin and skin structure infections
• Specific Resistant Bacterial Infections:
  • Vancomycin-resistant Enterococcus faecium (VRE) infections
  • Methicillin-resistant Staphylococcus aureus (MRSA) infections

Dosing Information

Always follow your doctor’s instructions for dosage and administration.

Adult Dosing (including elderly patients)

• Uncomplicated Skin and Skin Structure Infections: 400 mg every 12 hours for 10-14 days.
• Vancomycin-resistant Enterococcus faecium Infections: 600 mg every 12 hours for 14-28 days.
• Methicillin-resistant Staphylococcus aureus (MRSA) Infections: 600 mg twice daily for 7-21 days.
• Community-acquired pneumonia, Nosocomial pneumonia, Complicated skin and skin structure infections: 600 mg every 12 hours for 10-14 days.
• Elderly patients: No dosage adjustment is typically needed.
• Mild to Moderate Hepatic (Liver) Impairment: No dosage adjustment is typically needed.

Child Dosing (Oral)

• Pneumonia, Complicated Skin Infections, Vancomycin-Resistant Enterococci:
  • Birth – 11 years: 30 mg/kg/day, given every 8 hours.
  • Over 11 years: 1,200 mg/day, given every 12 hours.
• Uncomplicated Skin Infections:
  • Birth – 5 years: 30 mg/kg/day, given every 8 hours.
  • 5 – 11 years: 20 mg/kg/day, given every 12 hours.
  • Over 11 – 18 years: 1,200 mg/day, given every 12 hours.

Renal Dosing (Kidney Impairment)

• No dosage adjustment is typically needed for patients with kidney impairment.
• For patients on hemodialysis, it should be given after the hemodialysis session. It is not known if linezolid or its metabolites are removed during peritoneal dialysis.

Administration

• Linosept Tablet may be taken with or without food.

Important Warnings and Precautions

Do Not Use Linosept If:

• You have a known hypersensitivity (allergy) to linezolid or any of its ingredients.
• You are currently taking or have taken any monoamine oxidase inhibitors (MAOIs) (e.g., phenelzine, isocarboxazid) within the last two weeks.
• You have uncontrolled high blood pressure (hypertension), pheochromocytoma (a tumor of the adrenal gland), thyrotoxicosis (overactive thyroid), carcinoid syndrome.
• You are taking certain medications that affect blood pressure or serotonin levels, such as:
  • Directly and indirectly acting sympathomimetic agents (e.g., pseudoephedrine)
  • Vasopressive agents (e.g., epinephrine, norepinephrine)
  • Dopaminergic agents (e.g., dopamine, dobutamine)
  • Serotonin re-uptake inhibitors (SSRIs)
  • Tricyclic antidepressants (TCAs)
  • Serotonin 5-HT1 receptor agonists (triptans, used for migraines)
  • Meperidine (a pain medication) or buspirone (an anxiety medication)

Special Considerations:

• Blood Counts: Use with caution if you have pre-existing myelosuppression (reduced bone marrow activity, affecting blood cell production). Your doctor will monitor your complete blood counts weekly, especially if treatment lasts longer than 10-14 days.
• Kidney Impairment: Use with caution in severe kidney impairment (CrCl < 30 mL/min).
• Other Conditions: Use with caution if you have chronic infections, a history of seizures, bipolar depression, schizophrenia, acute confusional states, or untreated hyperthyroidism.
• Sunlight Exposure: Avoid unnecessary exposure to sunlight or artificial UV light.
• QT Interval: Use with caution if you have a history of prolonged QT interval (a heart rhythm abnormality) or uncorrected electrolyte disturbances.
• Diabetes Mellitus (DM): Carefully monitor blood glucose levels.
• Driving/Operating Machinery: This medication may impair your ability to drive or operate machinery.

Pregnancy and Lactation:

• Pregnancy: Consult your doctor.
• Lactation (Breastfeeding): It is unknown if linezolid is excreted in breast milk; use caution or discuss alternatives with your doctor. Not generally recommended.

Possible Drug Interactions

Tell your doctor about all medications you are taking, including over-the-counter drugs and herbal supplements, as Linosept can interact with them.

• Rifampicin and Phenytoin: May reduce the blood levels of linezolid.
• Insulin or Oral Antidiabetics: May cause low blood sugar (hypoglycemia).
• Tramadol: May increase the risk of seizures.

Potentially Fatal Interactions:

• Serotonin Syndrome: Increased risk of a serious condition called serotonin syndrome when taken with MAOIs, TCAs, SNRIs, or other serotonergic drugs (e.g., bupropion, vilazodone, mirtazapine, amoxapine, buspirone, maprotiline, meperidine, trazodone, nefazodone). Symptoms can include agitation, hallucinations, rapid heartbeat, fever, sweating, muscle stiffness, twitching, and confusion.
• Increased Blood Pressure: Significant increase in blood pressure when taken with vasopressive agents (e.g., epinephrine, norepinephrine), sympathomimetic agents (e.g., pseudoephedrine), and dopaminergic agents (e.g., dopamine, dobutamine).

Possible Side Effects

Like all medicines, Linosept can cause side effects. Some are common and mild, while others can be serious. If you experience any severe or concerning side effects, contact your doctor immediately.

• Very Common (>10%):
  • In children: Diarrhea (7.8-10.8%)
• Common (1-10%):
  • Headache (5.7-8.8%), Diarrhea (8.2-8.3%), Nausea (5.1-6.6%), Vomiting (2-4.3%), Dizziness (1.8-2.6%), Rash (1.1-2.3%), Vaginal yeast infection (moniliasis) (1.1-1.8%), Taste alteration (1-1.8%), Oral yeast infection (moniliasis) (0.5-1.7%), Abnormal liver function tests (0.4-1.6%), Fungal infection (0.3-1.5%), Localized abdominal pain (1.2-1.3%), Tongue discoloration (0.3-1.3%), Generalized abdominal pain (0.9-1.2%).
  • In children (additional or more common): Vomiting (2.9-9.4%), Headache (0.9-6.5%), Anemia (5.6%), Thrombocytopenia (4.7%), Nausea (1.9-3.7%), Generalized abdominal pain (0.9-2.4%), Localized abdominal pain (0.5-2.4%), Loose stools (1.6-2.3%), Eosinophilia (0.4-1.9%), Itching (pruritus, other than application site) (0.8-1.4%), Vertigo (1.2%).
• Less Common (<1%):
  • Lactic acidosis, Myelosuppression (bone marrow suppression), Peripheral neuropathy (nerve damage in extremities), Optic nerve disorder (vision problems), Serotonin syndrome.

Potentially Fatal Side Effects:

• Reversible Myelosuppression: Including anemia, leukopenia (low white blood cells), pancytopenia (low levels of all blood cells), and thrombocytopenia (low platelets), especially with prolonged use (>10-14 days).
• Transient ischemic attacks (mini-strokes), renal failure (kidney failure), Stevens-Johnson syndrome (severe skin reaction).

How Linosept Works

Linezolid is a bacteriostatic oxazolidinone. This means it stops bacteria from growing rather than directly killing them. It works by inhibiting the third and last step of bacterial protein synthesis, specifically by binding to bacterial ribosomes. It is effective against gram-positive bacteria, including resistant strains like vancomycin-resistant enterococci (VRE) and MRSA. It has limited activity against gram-negative bacteria.

Note: This information about Linosept 600mg Tablet, manufactured by Micro Labs Ltd. (generic name: Linezolid), is available in Nepal. This drug index information is for general knowledge only and is not intended for diagnosis, medical advice, or treatment. It should never replace the professional judgment of a healthcare provider. Always consult your doctor or pharmacist for medical advice specific to your condition.