Doxycycline 100mg Capsule POM x50

Doxycycline 100mg Capsule POM x50

Doxycycline (generic)

Prescription Medicine
  • UK Prescription Only Medicine (POM) in accordance with the Human Medicines Regulations.
  • Marketing Authorisation Holder: Sovereign Medical, PL 06464/3108 for Doxycycline 100mg Capsules.
  • Manufactured under EU–GMP by Waymade PLC, Sovereign House, Basildon, Essex, UK.
  • Listed on the electronic Medicines Compendium (emc) with SmPC and PIL last updated in 2024–2025.
  • Supplied in the UK by Williams Medical Supplies Ltd, operating under MHRA and GDP requirements for pharmaceutical wholesale.
Oral Antibiotic \u2013 Tetracycline Class

Description

Doxycycline 100mg Capsule POM x50 is a prescription-only broad-spectrum tetracycline antibiotic used to treat a wide range of bacterial infections and dermatological conditions such as acne vulgaris. Each hard gelatin capsule contains doxycycline hyclate equivalent to 100mg doxycycline. The capsules are unmarked with an opaque green cap and green body, printed \100mg\ in white ink in this presentation. Doxycycline acts primarily by inhibiting bacterial protein synthesis, providing bacteriostatic activity against many Gram-positive and Gram-negative organisms and certain atypical pathogens. Therapeutic indications include respiratory tract infections, urinary tract infections, sexually transmitted infections (including chlamydial infections and non-gonococcal urethritis), skin and soft tissue infections such as acne, ophthalmic infections, rickettsial diseases, and a range of other susceptible infections, as well as prophylaxis of conditions such as scrub typhus, travellers’ diarrhoea, leptospirosis and malaria in line with official guidance. This pack contains 50 capsules for oral use under medical supervision.

Bnefits

  • Broad-spectrum antibacterial activity against many Gram-positive and Gram-negative organisms and certain other micro-organisms.
  • Clinically proven effectiveness in common infections including respiratory, urinary, dermatological and sexually transmitted infections.
  • Indicated for inflammatory acne vulgaris when systemic antibiotic therapy is considered necessary, supporting dermatology and aesthetics practice.
  • Useful for a range of atypical and zoonotic infections such as rickettsial diseases, psittacosis and brucellosis (in combination with streptomycin).
  • Can be used for prophylaxis of scrub typhus, travellers’ diarrhoea, leptospirosis and malaria in accordance with current guidelines.
  • Once- or twice-daily dosing for most indications, supporting adherence and convenient treatment schedules.
  • High oral bioavailability and minimal impact of food or milk on absorption compared with some other tetracyclines.
  • Supplied as a POM pack of 50 capsules, suitable for full treatment courses and clinic stock.

Indications

  • Respiratory tract infections: pneumonia and other lower respiratory infections due to susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae and other organisms; Mycoplasma pneumoniae pneumonia; chronic bronchitis; sinusitis.
  • Urinary tract infections caused by susceptible strains of Klebsiella species, Enterobacter species, Escherichia coli, Streptococcus faecalis and other susceptible organisms.
  • Sexually transmitted diseases: infections due to Chlamydia trachomatis including uncomplicated urethral, endocervical or rectal infections; non-gonococcal urethritis caused by Ureaplasma urealyticum; chancroid; granuloma inguinale; lymphogranuloma venereum; alternative therapy for gonorrhoea and syphilis in selected patients according to guidelines.
  • Dermatological infections: acne vulgaris when antibiotic therapy is considered necessary; other skin infections caused by susceptible organisms.
  • Ophthalmic infections due to susceptible strains of gonococci, staphylococci and Haemophilus influenzae; trachoma (though the infectious agent may not always be eradicated); inclusion conjunctivitis alone or with topical therapy.
  • Rickettsial infections: Rocky Mountain spotted fever, typhus group, Q fever, Coxiella endocarditis and tick fevers.
  • Other infections: psittacosis, brucellosis (in combination with streptomycin), cholera, bubonic plague, louse- and tick-borne relapsing fever, tularaemia, glanders, melioidosis, acute intestinal amoebiasis (as adjunct to amoebicides), and chloroquine-resistant falciparum malaria (in combination with other antimalarials).
  • Alternative therapy in the treatment of leptospirosis, gas gangrene and tetanus where indicated.
  • Prophylaxis: scrub typhus, travellers’ diarrhoea (enterotoxigenic Escherichia coli), leptospirosis and malaria prophylaxis in accordance with current official guidance.

Composition

  • Active ingredient: Doxycycline hyclate equivalent to 100mg doxycycline per hard capsule.
  • Core excipients (fill): Hypromellose, Sodium lauryl sulphate, Microcrystalline cellulose, Magnesium stearate.
  • Capsule shell: Gelatin, Titanium dioxide (E171).
  • Colouring agents in 100mg capsules: Brilliant Blue (E133), Iron Oxide Yellow (E172).

Formulation

  • Pharmaceutical form: Capsule, hard.
  • Appearance: Unmarked hard gelatin capsule with opaque green cap and opaque green body, printed "100mg" in white ink for this WMS presentation; corresponding to a green hard capsule in the MA product.
  • Route of administration: Oral.

Packaging

  • Nature and contents of container: Blister packs composed of 200 micron rigid, opaque white PVC and 20 micron aluminium foil.
  • Pack size: 50 capsules (POM x50) as marketed by Williams Medical Supplies.
  • Blisters contained within an outer carton labelled with product name, strength, batch number and expiry date in accordance with UK medicines regulations.

Usage

  • Use only as prescribed by a suitably qualified healthcare professional.
  • Adults and children ≥12 years: usual dose for acute infections is 200mg on the first day (as a single dose or divided), followed by 100mg once daily; in more severe infections, 200mg daily may be continued throughout treatment.
  • Acne vulgaris: typical regimen is 50mg daily for 6–12 weeks; some local practice also uses 100mg daily according to clinical judgement.
  • Sexually transmitted infections, rickettsial infections, malaria treatment/prophylaxis and other specific uses should follow the dosing schedules outlined in the SmPC and current clinical guidelines.
  • Swallow capsules whole with plenty of water in the sitting or standing position.
  • Do not lie down for at least 30 minutes after taking a dose to reduce the risk of oesophageal irritation and ulceration.
  • May be taken with or without food; if gastric irritation occurs, taking with food or milk is recommended (absorption is not notably affected).
  • Avoid taking at the same time as antacids, iron, zinc, calcium, magnesium or bismuth-containing products; if needed, separate by several hours to minimise reduced absorption.
  • Avoid excessive sunlight or UV exposure and use adequate sun protection because doxycycline can cause photosensitivity; discontinue and seek medical advice if skin erythema or severe sunburn occurs.
  • Complete the full course as prescribed, even if symptoms improve earlier, to ensure eradication of infection and reduce the risk of 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.

Contraindications

  • Hypersensitivity to doxycycline, any other tetracycline-class antibiotic, or any of the excipients.
  • Pregnancy: contraindicated due to risk of effects on foetal bone and tooth development.
  • Breastfeeding: contraindicated because tetracyclines are excreted in breast milk and may affect infant bones and teeth.
  • Children under 8 years of age, except in life-threatening conditions where benefits outweigh risks, because of risk of permanent tooth discolouration and enamel hypoplasia.
  • Patients with a history of severe photosensitivity reactions to tetracyclines.
  • Concomitant use with systemic retinoids such as isotretinoin is generally contraindicated/should be avoided due to risk of benign intracranial hypertension.
  • Known severe intolerance or previous serious adverse reaction to doxycycline or tetracyclines, such as severe cutaneous adverse reactions or severe hepatic toxicity.

Adverse Effects

  • Gastrointestinal: nausea, vomiting, dyspepsia/heartburn, abdominal pain, diarrhoea, glossitis, stomatitis; oesophagitis and oesophageal ulceration, particularly if taken without adequate water or before lying down.
  • Photosensitivity: exaggerated sunburn reaction, rash, pruritus, photoonycholysis; hyperpigmentation of skin with chronic use.
  • Infections: vaginal candidiasis and other Candida superinfections; Clostridioides difficile-associated diarrhoea and pseudomembranous colitis.
  • Blood and lymphatic system: haemolytic anaemia, neutropenia, thrombocytopenia, eosinophilia.
  • Immune system and hypersensitivity: allergic reactions including rash, urticaria, angioedema, anaphylactic/anaphylactoid reactions, serum sickness-like reactions, Henoch–Schönlein purpura, exacerbation of systemic lupus erythematosus, DRESS syndrome.
  • Nervous system: headache (common), benign intracranial hypertension (pseudotumour cerebri) with symptoms such as severe headache and visual disturbance, fontanelle bulging in infants, anxiety.
  • Eye and ear: visual disturbances (e.g., blurred vision, scotoma, diplopia), tinnitus.
  • Hepatobiliary: hepatitis, hepatotoxicity, jaundice, abnormal liver function tests, rare hepatic failure.
  • Musculoskeletal: arthralgia, myalgia.
  • Renal: increased blood urea levels.
  • Dental and bone: tooth discolouration and enamel hypoplasia when used during tooth development; reversible superficial discolouration of permanent teeth has been reported.
  • Other: Jarisch–Herxheimer reaction in spirochaetal infections, low blood pressure, increased heart rate, darker patches on skin, nail changes including loosening of nails after sun exposure.

Storage Conditions

  • Do not store above 25°C.
  • Store in the original blister pack and outer carton to protect from moisture and light.
  • Keep in a dry place.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date stated on the carton and blister strip.
  • Do not use capsules that are discoloured or show signs of deterioration; consult a pharmacist for advice.
  • Dispose of unused or expired medicines via a pharmacy; do not dispose via wastewater or household waste.

Duration

The duration of treatment depends on the indication and clinical response. Acute bacterial infections are generally treated for a minimum of 5\u20137 days and at least 24\u201348 hours after symptoms and fever resolve. Streptococcal infections should be treated for at least 10 days. Acne therapy typically continues for 6\u201312 weeks. Prophylactic regimens (e.g., malaria, leptospirosis, travellers\u2019 diarrhoea) follow defined schedules and should not usually exceed 21 days for some prophylaxis indications without specialist review.

Onset

For most acute infections, clinical improvement is usually seen within a few days of starting therapy if the pathogen is susceptible. For acne vulgaris, noticeable improvement may take several weeks, with optimal benefit often after 6\u201312 weeks of continuous treatment. Individual response may vary and therapy should be periodically reviewed by the prescriber.

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