Nobac400 mg

Nobac is a broad-spectrum fluoroquinolone antibiotic. Because of a class-wide risk of serious, potentially irreversible adverse effects (see Precautions and Warnings), Nobac should be reserved for infections in which there is no other appropriate alternative antibacterial treatment.

Established/approved uses

• Urinary tract infections (uncomplicated and complicated) caused by susceptible organisms
• Lower respiratory tract infections, including exacerbations of chronic bronchitis, caused by susceptible organisms
• Skin and soft tissue infections caused by susceptible organisms
• Bone and joint infections (osteomyelitis, septic arthritis) caused by susceptible organisms
• Intra-abdominal and gastrointestinal infections caused by susceptible organisms
• Uncomplicated gonococcal urethritis/cervicitis (where local resistance patterns permit)

Guideline/adjunct or combination-therapy uses

• Bacterial meningitis and septicemia caused by susceptible organisms, generally as part of combination antibacterial therapy in severe or resistant infections
• Pelvic inflammatory disease, typically used together with an agent active against anaerobes

Nobac is not active against most Gram-positive anaerobes or against viral, fungal, or parasitic infections, and should not be used for these.

Each tablet of Pefloxacin typically contains Pefloxacin (as pefloxacin mesylate dihydrate) 400 mg as the active ingredient, along with standard pharmaceutical excipients such as microcrystalline cellulose, starch, povidone, and magnesium stearate. An injectable (intravenous) formulation is also available in some markets. Exact excipients vary by manufacturer; refer to the specific product label for full composition.

Nobac is a synthetic, second-generation fluoroquinolone antibacterial agent structurally related to norfloxacin. It is bactericidal against a broad range of Gram-negative and some Gram-positive organisms and achieves good tissue penetration, including into bone, prostate, and cerebrospinal fluid. Nobac is available as oral tablets and, in some markets, as an intravenous infusion.

Nobac belongs to the fluoroquinolone class of antibacterial agents.

Pefloxacin exerts its bactericidal effect by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes required for bacterial DNA replication, transcription, repair, and recombination. Inhibition of these enzymes causes breakage of bacterial DNA strands, leading to rapid bacterial cell death.

Pefloxacin is well absorbed orally with high bioavailability, undergoes hepatic metabolism (including formation of the active metabolite norfloxacin), and is eliminated mainly via the liver, with a relatively long elimination half-life that permits twice-daily dosing. It penetrates well into most body tissues and fluids.

Give Nobac tablets orally, ideally with or immediately after a meal, swallowed whole with water. Space dosing at least 2 hours apart from antacids, iron, zinc, calcium, or sucralfate to avoid reduced absorption. Maintain adequate fluid intake during treatment. Avoid excessive sun/UV exposure due to photosensitivity risk.

The following are well-documented, clinically significant interactions with Nobac:

• Antacids, sucralfate, and iron/zinc/calcium salts: Concurrent use markedly reduces absorption and efficacy of Nobac; separate administration by at least 2 hours.
• Theophylline: Nobac can increase theophylline plasma levels, raising the risk of theophylline toxicity (nausea, seizures, arrhythmia); dose adjustment and monitoring are recommended.
• Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use may increase the risk of central nervous system stimulation and seizures.
• Corticosteroids: Concurrent systemic corticosteroid use increases the risk of tendinitis and tendon rupture (see Precautions and Warnings).
• Drugs that prolong the QT interval (e.g., certain antiarrhythmics, some antipsychotics): Additive risk of QT prolongation and arrhythmia; avoid combination where possible.
• Oral anticoagulants (e.g., warfarin): May potentiate anticoagulant effect, increasing bleeding risk; monitor coagulation parameters.
• Probenecid and cimetidine: May increase Nobac plasma concentrations by reducing its elimination.

Most patients tolerate Nobac well. Reported adverse effects include:

• Common: Nausea, epigastric pain, diarrhea, vomiting, headache, dizziness, insomnia, photosensitivity/sunburn-like skin reaction
• Less common: Rash, pruritus, taste disturbance, elevated liver enzymes
• Serious (class-related, see boxed warning in Precautions and Warnings): Tendinitis and tendon rupture (especially Achilles tendon), peripheral neuropathy (which may be irreversible), central nervous system effects (confusion, hallucinations, seizures, increased intracranial pressure), QT interval prolongation and arrhythmia, hypersensitivity reactions including anaphylaxis, and Clostridioides difficile-associated diarrhea/colitis

Patients should seek prompt medical attention for tendon pain/swelling, unusual muscle weakness, numbness/tingling, palpitations, or signs of an allergic reaction.

Nobac should generally be avoided during pregnancy because fluoroquinolones have been associated with cartilage/joint abnormalities in juvenile animal studies, and adequate, well-controlled studies in pregnant women are lacking. Nobac should be used in pregnancy only if clearly needed and the potential benefit to the mother justifies the potential risk to the fetus, and only after consulting a physician.

Nobac is excreted into breast milk. Because of the potential for joint/cartilage effects and other adverse reactions in the nursing infant, breastfeeding is generally not recommended during treatment with Nobac; a physician should be consulted to weigh the benefits of breastfeeding against the potential infant risk, or an alternative antibiotic considered.

Boxed warning (class effect)

Fluoroquinolone antibacterial drugs, including Nobac, are associated with an increased risk of tendinitis and tendon rupture (occurring in all ages but more frequent in the elderly, in patients on concurrent corticosteroids, and in organ transplant recipients), peripheral neuropathy that may be irreversible, and central nervous system effects including seizures, increased intracranial pressure, and confusion, as well as exacerbation of myasthenia gravis. Because of this risk profile, Nobac should be reserved for patients who have no alternative treatment option.

Other precautions

• Photosensitivity: Nobac can cause exaggerated sunburn-type reactions; avoid prolonged sun/UV exposure and use sun protection during treatment.
• QT prolongation: Use with caution in patients with a history of QT prolongation, uncorrected electrolyte imbalance, or concomitant use of other QT-prolonging drugs.
• Hepatic impairment: Use with caution and adjust dosing interval as Nobac is largely hepatically eliminated.
• Seizure disorders: Use with caution in patients with a history of seizures or other CNS conditions that may lower seizure threshold.
• Clostridioides difficile-associated diarrhea: May occur during or after treatment; evaluate if persistent diarrhea develops.

Antibiotic stewardship: Take Nobac exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice.

Overdose of Nobac may cause exaggerated side effects such as nausea, vomiting, dizziness, confusion, seizures, or cardiac rhythm disturbances. There is no specific antidote. In case of suspected overdose, seek immediate medical attention or contact a poison control center; treatment is supportive, and general measures (such as gastric decontamination if presenting soon after ingestion, and cardiac monitoring) should be provided under medical supervision. Adequate hydration should be maintained to prevent crystalluria.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

• Pediatric patients: Nobac is generally not recommended in children and adolescents under 18 years because of the risk of arthropathy (joint/cartilage damage) seen in juvenile animal studies. It may be considered only when no alternative antibacterial therapy is suitable and the potential benefit outweighs the risk, under specialist supervision.
• Elderly patients: Elderly patients are at higher risk of tendon rupture, especially if also taking corticosteroids; use with caution and monitor for musculoskeletal symptoms.
• Renal impairment: No dose adjustment generally required, as elimination is mainly hepatic; use with caution in severe renal failure.
• Hepatic impairment: Dosing interval should be extended; use with caution and monitor liver function.
• Pregnancy and lactation: See Pregnancy and Lactation section.
• Myasthenia gravis: Contraindicated (see Contraindications) due to risk of worsening muscle weakness.

Duration of Nobac therapy depends on the site and severity of infection: typically 5–10 days for uncomplicated urinary tract infections, 7–14 days for respiratory, skin/soft tissue, or complicated infections, longer courses (several weeks) for bone/joint infections, and a single dose for uncomplicated gonococcal infection. The prescribed course should always be completed even if symptoms improve earlier, unless a physician advises otherwise.

Pefloxacin is a member of the fluoroquinolone class of synthetic antibacterial agents.

Pefloxacin inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for bacterial DNA replication and repair, resulting in rapid bactericidal activity.

C

Safety and efficacy of Nobac in children and adolescents under 18 years have not been well established, and use is generally avoided in this age group because fluoroquinolones have been shown to cause arthropathy (cartilage/joint damage) in juvenile animals. Nobac should be used in pediatric patients only when no other suitable antibacterial agent is available and a physician determines the potential benefit outweighs the risk, with close monitoring for musculoskeletal symptoms.