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Azithromycin Tablets 500mg (Generic)

Azithromycin Tablets 500mg (Generic)

Generic

Systemic antibiotic medicine
  • UK MHRA Licensed prescription Only medicine (multiple product licences for Azithromycin 500 mg Tablets; representative MA number example: PL 04416/0668).
  • Manufactured under EU/UK Good Manufacturing Practice (GMP) for medicinal products.
  • Distributed in the UK by DD Products and Services Ltd under MHRA Wholesale Distribution Authorisation UK WDA(H) 3912.
  • Supplied and stored under Good Distribution Practice (GDP) requirements for medicinal products.
  • Subject to MHRA Yellow Card pharmacovigilance monitoring for safety reporting.
Macrolide antibiotic \u2013 azithromycin 500 mg film-coated tablets

Description

Azithromycin Tablets 500mg (Generic) are prescription-only, film-coated oral tablets containing 500 mg azithromycin (as azithromycin dihydrate), a macrolide antibiotic. They are used in adults and adolescents (over 45 kg) for the treatment of a range of bacterial infections caused by azithromycin-susceptible organisms, including respiratory tract, ENT, skin and soft tissue infections, and uncomplicated genital infections due to Chlamydia trachomatis. The tablets are supplied by DD Group (Dental Directory) as a generic pack and are typically presented in blisters of 3 tablets for short-course therapy.

Bnefits

  • Broad-spectrum macrolide antibiotic active against a wide range of Gram-positive and Gram-negative bacteria.
  • Convenient short-course dosing: usually 500 mg once daily for 3 days for many indications.
  • Once-daily administration improves adherence compared with multiple daily doses.
  • Effective for common community-acquired respiratory tract infections such as bronchitis and pneumonia.
  • Used for ENT infections such as pharyngitis, tonsillitis and sinusitis when appropriate.
  • Indicated for certain skin and soft tissue infections and uncomplicated genital infections due to Chlamydia trachomatis.
  • Favourable tissue penetration and long half-life, allowing short treatment courses.

Indications

  • Acute bacterial sinusitis (adequately diagnosed).
  • Acute bacterial otitis media (adequately diagnosed).
  • Pharyngitis and tonsillitis.
  • Acute exacerbation of chronic bronchitis (adequately diagnosed).
  • Mild to moderately severe community-acquired pneumonia.
  • Skin and soft tissue infections (excluding infected burn wounds), when caused by azithromycin-susceptible organisms.
  • Uncomplicated urethritis and cervicitis caused by Chlamydia trachomatis.
  • Use should follow official/local antibiotic prescribing guidelines and susceptibility data.

Composition

  • Active ingredient: Azithromycin 500 mg (as azithromycin dihydrate) per film-coated tablet.
  • Excipient with known effect: Lactose monohydrate (approximately 6.16 mg per tablet).
  • Other core excipients: Microcrystalline cellulose, pregelatinised starch, sodium starch glycolate Type A, colloidal anhydrous silica, sodium laurilsulfate, magnesium stearate.
  • Film coating excipients: Hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 4000.

Formulation

  • Pharmaceutical form: Film-coated tablet for oral use.
  • Each film-coated tablet contains 500 mg azithromycin (as azithromycin dihydrate).
  • Appearance (representative generic): white to off-white oblong, biconvex film-coated tablet with score/break lines, divisible into equal doses.
  • Route of administration: Oral.

Packaging

  • PVC/PVDC/Aluminium blister packs in cardboard outer cartons.
  • Representative generic pack sizes: 2, 3, 6, 12, 24, 30, 50 or 100 film-coated tablets (not all pack sizes are marketed).
  • DD Group product code 700327 is supplied as Pack of 3 tablets, suitable for standard 3-day 500 mg once-daily regimens.
  • Patient Information Leaflet enclosed in each carton.

Usage

  • For oral use in adults and adolescents weighing more than 45 kg; always follow the prescribing clinician’s instructions and the patient information leaflet.
  • General dosing for most infections: 1,500 mg total, given as 500 mg once daily for 3 days, OR 1,500 mg over 5 days (500 mg on day 1, then 250 mg once daily on days 2–5).
  • Uncomplicated Chlamydia trachomatis urethritis and cervicitis: a single 1,000 mg oral dose (usually as two 500 mg tablets taken together).
  • The tablets are taken once daily and may be taken with food.
  • Swallow tablets whole with a glass of water; do not crush or chew unless advised.
  • Use in children under 45 kg generally requires other pharmaceutical forms (e.g. oral suspension) rather than 500 mg tablets.
  • No dose adjustment is usually needed in mild to moderate renal impairment (GFR 10–80 ml/min) or in mild to moderate hepatic impairment; special care is required in more severe impairment.
  • Continue the full prescribed course even if symptoms improve earlier, to reduce the risk of relapse and resistance.
  • If a dose is missed, take it as soon as remembered unless it is almost time for the next dose; do not double the dose.
  • Avoid taking antacids at the exact same time as azithromycin; if needed, separate doses by about 2 hours.

Contraindications

  • Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic.
  • Hypersensitivity to lactose or any of the excipients (including lactose monohydrate) in the formulation.
  • History of severe allergic reactions (e.g. anaphylaxis) to macrolide antibiotics.
  • Use is generally contraindicated or not recommended in patients with known congenital or documented QT prolongation or with ongoing proarrhythmic conditions.
  • Concomitant use with certain drugs that prolong the QT interval (e.g. some class IA and III antiarrhythmics, certain antipsychotics, some fluoroquinolones) is generally contraindicated or requires extreme caution per SmPC.
  • Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine because of the lactose content.

Adverse Effects

  • Very common and common adverse effects: gastrointestinal symptoms such as diarrhoea, loose stools, abdominal pain, nausea and vomiting; headache; taste disturbance; loss of appetite.
  • Uncommon effects: dizziness, somnolence, paraesthesia, dyspepsia, flatulence, constipation, gastritis, dry mouth, rash, pruritus, arthralgia, fatigue, chest pain, fever, peripheral oedema.
  • Liver-related effects: abnormal liver function tests, hepatitis, cholestatic jaundice; rare cases of severe hepatotoxicity including fulminant hepatitis and liver failure (some fatal).
  • Hypersensitivity reactions: angioedema, anaphylaxis (rarely fatal), drug rash, urticaria, photosensitivity, and serious cutaneous adverse reactions such as Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis (AGEP), and DRESS.
  • Cardiovascular: prolonged QT interval and risk of ventricular arrhythmias including torsades de pointes, especially in patients with risk factors (e.g. existing QT prolongation, electrolyte disturbances, concurrent QT-prolonging drugs).
  • Haematologic and immune: eosinophilia, leukopenia, neutropenia (including when combined with other agents such as rifabutin), thrombocytopenia (rare); hypersensitivity and immune reactions as noted above.
  • Nervous system/psychiatric: insomnia, nervousness, agitation; rarely serious neuropsychiatric events have been reported.
  • Infections: as with other antibiotics, Clostridioides difficile-associated diarrhoea and colitis may occur and can be serious or life-threatening; risk of superinfection with non-susceptible organisms, including fungi.
  • Worsening of myasthenia gravis or new onset myasthenic syndrome has been reported.
  • The overall safety profile is consistent with the macrolide class and full details are provided in the SmPC and patient information leaflet.

Storage Conditions

  • This medicinal product does not require any special storage conditions under the representative UK SmPC.
  • Store in the original package (blister and carton) to protect from moisture and physical damage.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date stated on the blister and carton.
  • Dispose of any unused medicine in accordance with local requirements; do not throw away via wastewater or household waste.

Duration

Typically short course therapy: for most respiratory, ENT, and skin/soft tissue infections, total dose 1,500 mg is given over 3 days (500 mg once daily) or 5 days (500 mg on day 1, then 250 mg once daily on days 2\u20135). For uncomplicated genital Chlamydia trachomatis infection, a single 1,000 mg dose is used. Actual duration and dose must follow the SmPC and prescriber\u2019s instructions based on infection type and patient factors.

Onset

Bacteriological activity begins soon after adequate serum and tissue levels are achieved; clinical improvement in symptoms is often observed within 2\u20133 days of starting treatment, although this varies with site and severity of infection and susceptibility of the pathogen.

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