Pedilid300 mg

Pedilid is a macrolide antibiotic indicated for the treatment of infections caused by susceptible organisms, including:

Established/Guideline-supported Uses

• Respiratory tract infections: acute bacterial bronchitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia of mild to moderate severity (including atypical pathogens such as Mycoplasma pneumoniae and Chlamydophila pneumoniae), sinusitis, pharyngitis, and tonsillitis
• Skin and soft-tissue infections: impetigo, erysipelas, folliculitis, and other susceptible skin infections
• Ear, nose and throat (ENT) infections: otitis media and other susceptible ENT infections
• Odontogenic (dental) infections caused by susceptible organisms
• Uncomplicated genital tract infections such as non-gonococcal urethritis/cervicitis due to Chlamydia trachomatis, used as an alternative agent where first-line options are unsuitable

Off-label / Adjunct Use

• Used off-label in some settings as part of combination regimens for eradication of Helicobacter pylori and in selected inflammatory skin conditions (e.g., rosacea); such use should be guided by a physician.

Pedilid should only be used for infections proven or strongly suspected to be caused by susceptible bacteria; it is not effective against viral infections such as the common cold or flu.

Each tablet contains Roxithromycin INN 150 mg or 300 mg. Roxithromycin is also available in some markets as a dispersible/soluble tablet formulation. Confirm the exact strength and formulation on the product label before use.

Pedilid is a semi-synthetic macrolide antibiotic derived from erythromycin. It is chemically and pharmacologically similar to erythromycin but has improved acid stability, better oral bioavailability, and a longer plasma half-life, which allows for less frequent dosing. Pedilid is widely marketed and used across Europe, Asia (including Bangladesh, India, China, and Japan), and Australia for the treatment of respiratory, skin, ENT, dental, and genital tract infections. It is not approved for marketing in the United States, so no FDA label or DailyMed entry exists for it; its profile here is based on WHO/EU and Asia-Pacific prescribing information together with established macrolide-class pharmacology.

Pedilid belongs to the macrolide antibiotic class (ATC code J01FA06), the same class as erythromycin, clarithromycin, and azithromycin.

Mechanism of Action

Roxithromycin inhibits bacterial protein synthesis by reversibly binding to the 50S ribosomal subunit, blocking the translocation step of peptide chain elongation. This action is primarily bacteriostatic, though it may be bactericidal against certain highly susceptible organisms at higher concentrations.

Spectrum of Activity

Roxithromycin is active against many Gram-positive organisms (e.g., Streptococcus pyogenes, Streptococcus pneumoniae, methicillin-susceptible Staphylococcus aureus), some Gram-negative organisms (e.g., Haemophilus influenzae, Bordetella pertussis), and atypical organisms (Mycoplasma pneumoniae, Chlamydia species, Legionella species).

Pharmacokinetics

Oral bioavailability is high (approximately 50-60%, reduced by food, so it should be taken before meals). Peak plasma concentrations occur about 1-2 hours after dosing. Protein binding is high (~90%, concentration-dependent). The elimination half-life is long (approximately 10-12 hours), permitting twice-daily or once-daily dosing. Elimination occurs mainly via hepatic metabolism with biliary/fecal excretion, with a smaller proportion excreted unchanged in urine.

Pedilid should be taken by mouth, swallowed whole with a full glass of water, preferably before meals (on an empty stomach) since food reduces its absorption. Doses should be spaced evenly, approximately 12 hours apart if taken twice daily. Do not crush or chew the tablet unless a dispersible formulation is specifically indicated for that purpose.

Pedilid has clinically significant interactions with the following:

• Ergot alkaloids (ergotamine, dihydroergotamine): concurrent use is contraindicated due to risk of ergotism (severe peripheral vasospasm and ischemia).
• QT-prolonging drugs (e.g., cisapride, terfenadine, astemizole, pimozide, disopyramide, certain antiarrhythmics): increased risk of QT prolongation and serious ventricular arrhythmias; concurrent use should be avoided.
• Theophylline: Pedilid may increase plasma theophylline concentrations, raising the risk of toxicity (nausea, tremor, seizures); monitoring of theophylline levels is advised when co-administered.
• Oral anticoagulants (e.g., warfarin): Pedilid may potentiate anticoagulant effect, increasing bleeding risk; more frequent monitoring of coagulation parameters (INR) is recommended.
• Ciclosporin and digoxin: possible increases in plasma levels with concurrent use; monitoring is advised.

Always inform your physician or pharmacist of all medicines, supplements, and herbal products you are taking before starting Pedilid.

Most side effects of Pedilid are mild and gastrointestinal in nature.

Common

• Nausea, vomiting
• Diarrhea, abdominal pain or discomfort
• Dyspepsia
• Altered or metallic taste (dysgeusia)

Less Common

• Headache, dizziness
• Skin rash, urticaria (hives)

Rare but Serious

• Hepatotoxicity (elevated liver enzymes, cholestatic jaundice)
• QT interval prolongation and, rarely, serious ventricular arrhythmias
• Clostridioides difficile-associated diarrhea/pseudomembranous colitis
• Severe hypersensitivity reactions including angioedema and, very rarely, Stevens-Johnson syndrome

Seek prompt medical attention for severe rash, yellowing of the skin/eyes, palpitations, fainting, or persistent severe diarrhea while taking Pedilid.

Pregnancy

Pedilid has not been extensively studied in pregnant women, and no formal FDA pregnancy category exists as it is not FDA-approved. Animal reproduction studies have not shown clear evidence of harm, but human data remain limited. Pedilid should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus; use should be under medical supervision.

Lactation

Pedilid is excreted into breast milk in small amounts. As with other macrolides, caution is advised; a physician should weigh the benefits of treatment against the possibility of adverse effects (such as diarrhea or thrush) in the breastfed infant before Pedilid is prescribed to a nursing mother.

Use Pedilid with caution in the following situations:

• Hepatic impairment: monitor liver function; avoid in severe impairment (see Contraindications).
• Cardiac risk factors: use caution in patients with a history of QT prolongation, uncorrected electrolyte disturbances (hypokalemia/hypomagnesemia), or significant bradycardia, given the class-associated risk of QT prolongation.
• Myasthenia gravis: macrolides, including Pedilid, may exacerbate muscle weakness in myasthenia gravis.
• Superinfection: prolonged use may result in overgrowth of non-susceptible organisms, including Clostridioides difficile.

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

Reported overdose experience with Pedilid is limited; symptoms would be expected to be an exaggeration of known side effects, primarily gastrointestinal upset (nausea, vomiting, diarrhea). There is no specific antidote. In case of suspected overdose, seek immediate medical attention or contact a poison control center; treatment is supportive and symptomatic, and may include gastric decontamination if performed soon after ingestion under medical supervision. Do not attempt to manage an overdose at home.

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

Elderly

No specific dose adjustment is generally required in elderly patients with normal hepatic and renal function, though age-related decline in organ function should be considered, and caution regarding QT prolongation risk is advised (see Precautions).

Renal Impairment

No significant dose adjustment is typically needed in mild-to-moderate renal impairment, since Pedilid is eliminated mainly by hepatic pathways; caution is advised in severe renal impairment.

Hepatic Impairment

Pedilid is contraindicated in severe hepatic impairment; dose reduction and liver function monitoring are advised in milder impairment (see Contraindications).

Pediatric Population

See Pediatric Uses section.

Treatment duration with Pedilid is typically 5 to 10 days for most respiratory, skin, and ENT infections, depending on severity and clinical response. Genital tract infections such as uncomplicated chlamydial infection may require a longer course (up to 10-14 days) as directed by a physician. The full prescribed course should always be completed even if symptoms resolve earlier, to reduce the risk of relapse and antibiotic resistance.

Macrolide antibiotic (erythromycin derivative)

Roxithromycin binds reversibly to the 50S subunit of the bacterial ribosome, inhibiting the translocation step of protein synthesis. This interrupts bacterial growth and replication, producing a primarily bacteriostatic effect against susceptible organisms.

Pedilid may be used in children for susceptible respiratory, skin/soft-tissue, and ENT infections at a weight-based dose of approximately 5-8 mg/kg/day given in two divided doses, not exceeding the usual adult dose. As Pedilid is not FDA-approved, formally established pediatric labeling (including safety and efficacy in neonates and infants) is limited; use in young children should be individualized and supervised by a physician, based on local pediatric prescribing guidance (e.g., as reflected in Bangladesh/Asia-Pacific and European prescribing practice).