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Clarithromycin 500mg (14)

Clarithromycin 500mg (14)

Generic

Pharmaceutical Product
  • Generic clarithromycin 500 mg film Coated tablets supplied in the UK hold MHRA marketing authorisations as prescription Only medicinal products.
  • Manufactured by MHRA or EMA Approved manufacturers in accordance with EU/UK Good Manufacturing Practice (GMP) standards.
  • Teleta Pharma Ltd is described as MHRA accredited, WDA certified and GDP compliant, operating as an internet Based pharmacy and pharmaceutical supplier.
  • Dispensing and supply of clarithromycin 500 mg tablets follow UK medicines legislation and professional standards for prescription Only medicines.
Oral macrolide antibiotic tablets

Description

Clarithromycin 500mg (14) is a prescription-only (POM) macrolide antibacterial medicine supplied as a pack of 14 oral film-coated tablets. Each tablet contains 500 mg of clarithromycin and is used for the treatment of a range of susceptible bacterial infections in adults and, for specific indications, in adolescents and children, when use of a macrolide antibiotic is considered appropriate according to official guidance and the Summary of Product Characteristics for the dispensed generic brand. The product offered by Teleta Pharma is a generic clarithromycin 500 mg tablet pack sourced from UK-licensed manufacturers and is dispensed against a valid prescription.

Bnefits

  • Broad-spectrum macrolide antibiotic active against many common Gram-positive and Gram-negative organisms, including respiratory and some skin and soft tissue pathogens.
  • Useful alternative for patients with penicillin allergy where a macrolide is indicated and local resistance patterns allow.
  • Oral tablet formulation enables outpatient treatment and step-down from intravenous therapy where clinically appropriate.
  • 500 mg strength and 14-tablet pack size are suitable for typical adult treatment courses of 7–14 days for many indications when prescribed twice daily.
  • Well-established clinical experience and detailed prescribing information via UK and international Summaries of Product Characteristics.

Indications

  • This is a generic clarithromycin 500 mg tablet pack; licensed indications may vary slightly between manufacturers. In UK SmPCs for clarithromycin 500 mg film-coated tablets, typical adult indications include treatment of infections caused by clarithromycin-susceptible organisms, such as:
  • • Lower respiratory tract infections (e.g. acute bacterial exacerbation of chronic bronchitis; community-acquired pneumonia) when caused by susceptible organisms.
  • • Upper respiratory tract infections (e.g. bacterial pharyngitis, tonsillitis, sinusitis) where appropriate.
  • • Skin and soft tissue infections of mild to moderate severity (e.g. folliculitis, cellulitis, erysipelas) caused by susceptible organisms.
  • • Disseminated or localised Mycobacterium avium complex (MAC) infections in appropriate patients, as part of combination therapy, according to specialist guidance.
  • • Eradication of Helicobacter pylori in combination with other appropriate medicines as part of triple therapy regimens for peptic ulcer disease, according to relevant guidelines and SmPCs.
  • Use and dosing must follow the SmPC for the specific manufacturer’s product dispensed and current official guidelines on appropriate antibiotic use.

Composition

  • Active ingredient: Clarithromycin 500 mg per film-coated tablet.
  • Excipients: The exact excipient profile varies by manufacturer, but typical generic clarithromycin 500 mg film-coated tablets may contain excipients such as microcrystalline cellulose, croscarmellose sodium, pregelatinised starch, povidone, magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E171), polyethylene glycol, and colourants (e.g. iron oxides) in the film coating. The precise qualitative and quantitative excipient list is stated in the SmPC and patient leaflet for the dispensed brand.

Formulation

  • Pharmaceutical form: Film-coated tablet for oral use.
  • Strength: 500 mg clarithromycin per tablet.
  • Typical appearance in UK SmPCs: light yellow, oval, biconvex film-coated tablets with embossed or debossed markings that vary by manufacturer (e.g. certain brands are embossed with specific letters or numbers and may have breaklines).
  • Legal classification (UK): Prescription-only medicine (POM).

Packaging

  • Pack size: 14 tablets (commonly presented as 2 blister strips of 7 tablets each, though configuration may vary by manufacturer).
  • Primary packaging: PVC/PVdC or similar blister strips with aluminium foil backing (or equivalent) containing clarithromycin 500 mg film-coated tablets.
  • Secondary packaging: Outer carton bearing product name, strength, pack size, legal classification, batch number, expiry date, storage instructions and manufacturer details.
  • Teleta listing: product sold as “Clarithromycin 500mg (14)” within the Consumables / POM category for dispensing against prescription.

Usage

  • For oral use only.
  • The exact dose, dosing frequency and duration of treatment must be determined by the prescriber based on the type and severity of infection, susceptibility of the pathogen, age, body weight (for children), renal and hepatic function, and relevant clinical guidelines.
  • In adults, typical oral doses for many infections are 250–500 mg twice daily for 7–14 days; severe infections may require 500 mg twice daily, always according to the specific product SmPC and prescriber’s judgement.
  • Tablets should be swallowed whole with water and can usually be taken with or without food; some SmPCs suggest administration with food to improve tolerability.
  • Patients should be advised to take doses at evenly spaced intervals (e.g. every 12 hours when prescribed twice daily) and to complete the full prescribed course, even if they feel better earlier, unless the prescriber advises otherwise.
  • Dosage adjustments are usually required in patients with significant renal impairment and/or when co-administered with certain interacting medicines; this must follow the relevant SmPC and prescriber’s instructions.
  • Patients should be reminded to read the patient information leaflet supplied with the specific clarithromycin 500 mg tablets they receive and to follow the instructions provided by their healthcare professional.

Contraindications

  • Hypersensitivity to clarithromycin, other macrolide antibiotics, or any excipient in the specific product.
  • Concomitant use with astemizole, cisapride, pimozide, terfenadine or similar drugs known to prolong the QT interval and metabolised by CYP3A4, due to risk of serious cardiac arrhythmias.
  • Concomitant use with ergotamine or dihydroergotamine (risk of ergot toxicity).
  • History of cholestatic jaundice/hepatic dysfunction associated with prior clarithromycin use.
  • Concomitant administration with certain HMG-CoA reductase inhibitors (statins) that are extensively metabolised by CYP3A4 (e.g. simvastatin, lovastatin) is contraindicated in many SmPCs due to increased risk of myopathy/rhabdomyolysis; guidance for other statins must follow the relevant SmPC.
  • History of congenital or documented acquired QT prolongation or ventricular cardiac arrhythmia, including torsades de pointes, and in patients with electrolyte disturbances predisposing to QT prolongation (e.g. uncorrected hypokalaemia).
  • Use with caution or according to SmPC restrictions in patients with severe hepatic impairment and significant renal impairment, and in those with myasthenia gravis or other neuromuscular disorders.

Adverse Effects

  • Very common and common adverse reactions reported in clarithromycin SmPCs include gastrointestinal disturbances such as nausea, vomiting, abdominal pain and diarrhoea, as well as taste disturbance and dyspepsia.
  • Headache, insomnia, dysgeusia (abnormal taste), oral or vaginal candidiasis, and mild elevations in liver enzymes may occur.
  • Less common or rare reactions include cholestatic hepatitis, jaundice, severe hepatic dysfunction (including rarely fatal hepatic failure), pancreatitis, and severe cutaneous adverse reactions (e.g. Stevens–Johnson syndrome, toxic epidermal necrolysis, DRESS).
  • Allergic reactions such as rash, urticaria, pruritus and, rarely, anaphylaxis and angioedema have been reported.
  • As with other macrolides, clarithromycin can prolong the QT interval and has been associated with ventricular arrhythmias including torsades de pointes, particularly in patients with risk factors or concurrent use of interacting drugs.
  • Reversible hearing loss has been reported, especially at higher doses or in older patients.
  • Psychiatric and CNS effects such as anxiety, confusion, insomnia, nightmares, psychotic disorders and, rarely, seizures may occur.
  • Pseudo-membranous colitis/Clostridioides difficile-associated diarrhoea can occur during or after antibiotic treatment and may be severe or life-threatening.
  • Haematological reactions (e.g. leukopenia, thrombocytopenia) and renal impairment (e.g. interstitial nephritis) have been reported rarely.
  • Patients should refer to the patient information leaflet for the specific product supplied and report any severe or unusual symptoms to a healthcare professional promptly.

Storage Conditions

  • Do not store above 25°C (or as stated on the specific product packaging).
  • Store in the original package to protect from moisture and light.
  • Keep blister strips and cartons tightly closed and intact until use.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date shown on the carton and blister packaging.
  • Unused or expired tablets should be disposed of in accordance with local requirements and not via wastewater or household waste.

Duration

Treatment duration is determined by the prescriber according to the type and severity of infection and the patient\u2019s clinical response. Typical adult courses for many infections are 6\u201314 days, with triple therapy regimens for Helicobacter pylori usually given for 7\u201314 days. Therapy should follow the specific SmPC for the dispensed product and current official guidelines.

Onset

As with other systemic antibiotics, bacteriostatic/bactericidal activity begins once adequate serum and tissue levels are achieved. Symptomatic improvement is often seen within a few days of starting appropriate therapy, but treatment should be continued for the full course as prescribed to reduce the risk of relapse and resistance.

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