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Tetracycline antibiotic Pregnancy: §4.6 of this SPC reads in full: 'See section 4.3.' §4.3 states that Vibramycin is contraindicated in pregnancy — 'It appears that the risks associated with the use of tetracyclines during pregnancy are predominantly due to effects on teeth and skeletal development' — and that tetracyclines are excreted into milk and are therefore contraindicated in nursing mothers. §4.4 adds that use of tetracyclines during tooth development (the last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent yellow-grey-brown discolouration of the teeth and that enamel hypoplasia has also been reported.

Doxycycline 100mg Capsules (Sinusitis — Penicillin Allergy)

Brand names: Vibramycin-D, Efracea (acne — different indication)

Used in: Pneumonia COPD Cellulitis & Skin Infection

Oral doxycycline, a tetracycline antibiotic, used here as an alternative agent for bacterial sinusitis in patients with penicillin allergy.

Adult dose

Dose: Acute bacterial sinusitis (adults and children aged 12 years to less than 18 years): 200 mg on the first day, given as a single dose or in divided doses, followed by a maintenance dose of 100 mg daily. In the management of more severe infections, 200 mg daily should be given throughout treatment.
Route: Oral. The fetched product is a dispersible tablet, administered by drinking a suspension of the tablet in a small amount of water, sitting or standing and well before retiring at night, to reduce the risk of oesophageal irritation and ulceration. If gastric irritation occurs it may be given with food or milk; §4.2 states that absorption is not notably influenced by simultaneous ingestion of food or milk.
Frequency: Day 1: 200 mg as a single dose or in divided doses. Thereafter 100 mg once daily (or 200 mg daily for more severe infections). §4.2 gives no course length specific to sinusitis; the only general duration rule it states is that 'Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided.' Take the course length from current national or local antimicrobial guidance.
Max: 200 mg daily for this indication — the highest daily dose §4.2 gives for the treatment of acute infection ('In the management of more severe infections, 200 mg daily should be given throughout treatment'). §4.2 also warns that 'Exceeding the recommended dosage may result in an increased incidence of side effects.' Higher daily doses appear in this SPC only under separately listed indications (for example 200 mg twice daily for primary or secondary syphilis) and must NOT be imported into sinusitis.
The therapeutic indications section of this SPC lists, under Respiratory tract infections, 'Treatment of chronic bronchitis, sinusitis.' Sinusitis is therefore an expressly licensed indication for this product, by the oral route, in the population this page addresses. || WHICH REGIMEN APPLIES. §4.2 gives indication-specific regimens for acne vulgaris, sexually transmitted diseases, acute epididymo-orchitis, primary and secondary syphilis, louse- and tick-borne relapsing fevers, chloroquine-resistant falciparum malaria, malaria prophylaxis, scrub typhus prevention, travellers' diarrhoea prevention, leptospirosis prevention and Rocky Mountain spotted fever. Sinusitis is not among those named regimens, so the dose published above is the SPC's own general regimen 'for the treatment of acute infections', which is the regimen that covers a licensed acute respiratory-tract infection such as sinusitis. No indication-specific figure has been borrowed. In particular the acne dose (50 mg daily with food or fluid for 6 to 12 weeks) belongs to a different indication and to the other brand named on this page (Efracea); it has deliberately not been used. || VERBATIM (§4.2): 'The usual dosage of Vibramycin for the treatment of acute infections in adults and children aged 12 years to less than 18 years is 200 mg on the first day (as a single dose or in divided doses) followed by a maintenance dose of 100 mg/day. In the management of more severe infections, 200 mg daily should be given throughout treatment.' || PENICILLIN ALLERGY. The SPC does not itself frame doxycycline as a penicillin alternative for sinusitis. The only penicillin-alternative wording in §4.2 concerns syphilis ('Non-pregnant penicillin-allergic patients who have primary or secondary syphilis can be treated with the following regimen: doxycycline 200 mg orally twice daily for two weeks, as an alternative to penicillin therapy') — a different indication at a different dose. The choice of doxycycline in penicillin-allergic sinusitis is a guideline decision, not an SPC statement. || CHILDREN — NO CALCULATOR IS ARMED ON THIS PAGE, DELIBERATELY. paedDose is null. §4.2 does give per-kilogram figures for children aged 8 years to less than 12 years, verbatim: 'For children 45 kg or less - Initial dose: 4.4 mg/kg (in single or 2 divided doses) with maintenance dose: 2.2 mg/kg (in single or 2 divided doses). In the management of more severe infections, up to 4.4 mg/kg should be given throughout treatment.' and 'For children over 45 kg - Dose administered for adults should be used.' RATE READING: the SPC writes these as 'mg/kg' without a stated interval, but each is qualified 'in single or 2 divided doses', which makes the figure a DAILY TOTAL that may be split, not a per-dose amount — the same structure as the adult regimen it parallels (200 mg on day one, then 100 mg/day). Anyone re-encoding these must therefore treat 4.4 and 2.2 as mg/kg/day; taking either as a per-dose value would double the intended daily amount. Those figures are recorded here as prose only. They are NOT exposed as paedDose.dosePerKg because the SPC gates them behind conditions no numeric field can carry: the band is restricted to ages 8 to less than 12 years, to weights of 45 kg or less, and to 'situations where other drugs are not available, are not likely to be effective or are contraindicated' — a bar that penicillin-allergic sinusitis, which has alternatives, does not meet. §4.2 also states that 'Doxycycline should not be used in children aged younger than 8 years due to the risk of teeth discolouration', and a weight-only calculator cannot enforce an age floor. Children aged 12 to less than 18 years are covered by the adult dose published above. || ELDERLY (§4.2): 'Vibramycin may be prescribed in the elderly in the usual dosages with no special precautions... The Vibramycin-D dispersible tablet may be preferred for the elderly since it is less likely to be associated with oesophageal irritation and ulceration.' || TRUNCATION: §4.4 was cut mid-sentence in the beta-haemolytic streptococci paragraph and §4.8 inside the adverse-reaction reporting text. §4.1 and §4.2 are complete.

Dose adjustments

Renal

§4.2 verbatim: 'No dosage adjustment is necessary in the presence of renal impairment' and 'Studies to date have indicated that administration of Vibramycin at the usual recommended doses does not lead to accumulation of the antibiotic in patients with renal impairment.' §4.4 adds that renal excretion of doxycycline is about 40%/72 hours with normal renal function and may fall to 1-5%/72 hours in severe renal insufficiency (creatinine clearance below 10 ml/min), that serum half-life is not significantly different between normal and severely impaired renal function, and that haemodialysis does not alter it.

Hepatic

§4.4 verbatim: 'Vibramycin should be administered with caution to patients with hepatic impairment or those receiving potentially hepatotoxic drugs. Abnormal hepatic function has been reported rarely and has been caused by both the oral and parenteral administration of tetracyclines, including doxycycline.' No numeric dose reduction is given.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to doxycycline or to any of the tetracyclines or to any of the excipients listed in section 6.1
  • Pregnancy — Vibramycin is contraindicated in pregnancy; the risks associated with tetracyclines in pregnancy are predominantly due to effects on teeth and skeletal development (§4.3)
  • Nursing mothers — tetracyclines are excreted into milk and are therefore contraindicated in nursing mothers (§4.3)
  • Children aged younger than 8 years — §4.2 states that 'Doxycycline should not be used in children aged younger than 8 years due to the risk of teeth discolouration'. This is not listed in §4.3; §4.4 permits use below 8 years only when the potential benefits outweigh the risks in severe or life-threatening conditions and there are no adequate alternative therapies
  • Concomitant isotretinoin or other systemic retinoids should be avoided, because isotretinoin is also known to cause benign intracranial hypertension (§4.4)

Side effects

  • Common — nausea/vomiting; vaginal infection
  • Uncommon — candida infection; headache; dyspepsia (heartburn/gastritis); photosensitivity reaction; rash including maculopapular and erythematous rashes
  • Serious skin reactions — exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS); §4.4 directs that doxycycline be discontinued immediately and appropriate therapy instituted if these occur
  • Hypersensitivity including anaphylactic shock, anaphylactic reaction, anaphylactoid reaction, angioedema, exacerbation of systemic lupus erythematosus, pericarditis, serum sickness, Henoch-Schonlein purpura, hypotension, dyspnoea, tachycardia, peripheral oedema and urticaria
  • Benign intracranial hypertension (pseudotumor cerebri), with headache, vomiting and visual disturbance including blurred vision, scotoma, diplopia or permanent loss of vision; fontanelle bulging in infants. Administration should be discontinued if raised intracranial pressure is suspected
  • Gastrointestinal — pancreatitis, pseudomembranous colitis, Clostridium difficile colitis, oesophageal ulcer, oesophagitis, enterocolitis, dysphagia, abdominal pain, diarrhoea, glossitis, stomatitis, and inflammatory lesions with monilial overgrowth in the anogenital region
  • Hepatobiliary — hepatic failure, hepatitis, hepatotoxicity, jaundice, abnormal hepatic function
  • Haematological — haemolytic anaemia, neutropenia, thrombocytopenia, eosinophilia
  • Tooth discolouration — reversible and superficial discolouration of permanent teeth has been reported; skin hyperpigmentation with chronic use; photoonycholysis; blood urea increased
  • Other — anxiety, tinnitus, flushing, arthralgia, myalgia, porphyria, decreased appetite, brown-black microscopic discolouration of thyroid glands; Jarisch-Herxheimer reaction in the setting of spirochete infections treated with doxycycline
  • This side-effect list may be incomplete — check the full SPC.

Monitoring

  • Discontinue doxycycline immediately and institute appropriate therapy if a serious skin reaction occurs — exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS (§4.4)
  • Warn patients likely to be exposed to direct sunlight or ultraviolet light about an exaggerated sunburn reaction, and discontinue treatment at the first evidence of skin erythema (§4.4)
  • If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted; discontinue if raised intracranial pressure is suspected, and monitor until stable, since intracranial pressure can remain elevated for weeks after the drug is stopped (§4.4)
  • Consider Clostridium difficile-associated diarrhoea and pseudomembranous colitis in any patient who presents with diarrhoea after antibacterial use — §4.4 notes it has been reported to occur over two months after administration
  • Take with adequate fluid, sitting or standing, and well before lying down, to reduce oesophageal irritation and ulceration (§4.2, §4.4)
  • Continue therapy for at least 24 to 48 hours after symptoms and fever have subsided (§4.2)
  • If a resistant organism appears (including Candida overgrowth), discontinue the antibiotic and institute appropriate therapy (§4.4)

Clinical monograph

How it works

It is a bacteriostatic tetracycline that binds the bacterial 30S ribosomal subunit and inhibits protein synthesis, covering common respiratory pathogens implicated in sinusitis.

Prescribing in practice

  • Contraindicated in pregnancy, breastfeeding and in children because tetracyclines deposit in growing bone and teeth, causing permanent discolouration and enamel defects.
  • It can cause photosensitivity and oesophageal irritation or ulceration, so it should be taken with plenty of fluid and the patient kept upright after dosing.
  • Absorption is reduced by calcium, iron, magnesium and antacids, which should be separated in time from the dose.

Monitoring

Routine laboratory monitoring is not generally required for a short sinusitis course; review clinically if symptoms fail to improve.

Counselling the patient

  • Swallow with a full glass of water while sitting or standing and do not lie down straight afterwards.
  • Avoid taking it at the same time as indigestion remedies, iron or calcium supplements, or dairy.
  • Use sun protection as your skin may burn more easily.

Evidence & guidelines

NICE guidance on acute sinusitis supports a tetracycline such as doxycycline as an antibiotic option when treatment is indicated in penicillin-allergic adults.

Reference: NICE NG120 Sinusitis; PHE Antibiotic Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.