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MINOCYCLINE is a brand name for Minocycline. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Minocycline is indicated for the treatment of the following infections: 1) Gonorrhoea. 2) Non-gonococcal urethritis. 3) Prostatitis. 4) Moderate to severe acne; use in moderate acne only if topical treatment is ineffective, if acne is extensive or hard to reach and if there is a high risk of scarring. 5) Acute and…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults:
Routine antibiotic use: 200mg daily in divided doses. Acne: 50mg twice daily. Treatment should continue for a minimum of six weeks.
Gonorrhoea:
Males: 200mg initially followed by 100mg every 12 hours for a minimum of 4 days with post-therapy cultures within 2-3 days. Females may require more prolonged therapy. Prophylaxis of asymptomatic meningococcal carriers: 100mg twice daily for five days, usually followed by a course of rifampicin.
If, after six months, there is no satisfactory response minocycline should be discontinued and other therapies considered. 4).
Special populations Renal impairment:
Minocycline may be used at the normal recommended dosage in mild to moderate renal impairment, however caution is advised in patients with severe renal impairment.
Hepatic impairment:
Minocycline should be used with caution in patients with hepatic impairment.
Elderly:
Care is required if Minocycline is given to the elderly. Dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Paediatric population:
Children over 12 years: 50mg every 12 hours.
Children under 12 years:
Not recommended. Method of Administration For oral administration. To reduce the risk of oesophageal irritation and ulceration, the tablets should be swallowed whole with plenty of fluid, while sitting or standing. Unlike earlier tetracyclines, absorption of minocycline is not significantly impaired by food or moderate amounts of milk.
Adverse reactions are listed in the Table in CIOMS frequency categories under MedDRA system/organ classes.
The frequency of adverse reactions is defined using the following convention:
Common: (≥1/100 to <1/10) Uncommon: (≥1/1,000 to <1/100) Rare: (≥1/10,000 to <1/1,000) Very Rare: (<1/10,000) Not known (cannot be estimated from the available data) MedDRA system organ class Adverse Drug Reaction Infections and infestations Very rare Oral and anogenital candidiasis, vulvovaginitis.
Blood and lymphatic system disorders Rare Eosinophilia, leucopenia, neutropenia, thrombocytopenia Very rare Not known Haemolytic anaemia, pancytopenia. Agranulocytosis Immune system disorders Rare Anaphylaxis/anaphylactoid reaction (including shock and fatalities).
Not known Hypersensitivity, pulmonary infiltrates, anaphylactoid purpura, polyarteritis nodosa. Endocrine disorders Very rare Abnormal thyroid function, brown-black discolouration of the thyroid. Metabolism and nutrition disorders Rare Anorexia.
Nervous system disorders Common Dizziness (lightheadedness). Rare Headache, hypaesthesia, paraesthesia, intracranial hypertension, vertigo. Very rare Not known Bulging fontanelle. Convulsions, sedation. Ear and labyrinth disorders Rare Impaired hearing, tinnitus.
Cardiac disorders Rare Myocarditis, pericarditis. Respiratory, thoracic and mediastinal disorders Rare Cough, dyspnoea. Very rare Not known Bronchospasm, exacerbation of asthma, pulmonary eosinophilia. Pneumonitis. Gastrointestinal disorders Rare Diarrhoea, nausea, stomatitis, discolouration of teeth, vomiting.
Very rare Dyspepsia, dysphagia, enamel hypoplasia, enterocolitis, oesophagitis, oesophageal ulceration, glossitis, pancreatitis, pseudomembranous colitis. 4). Very rare Not known Hepatic cholestatis, hepatic failure (including fatalities), hyperbilirubinaemia, jaundice.
8) have been reported with minocycline use. If patients develop breathing difficulties they should seek urgent medical advice and minocycline should be discontinued. Paediatric population All tetracyclines form a stable calcium complex in any bone forming tissue.
An increase in the fibula growth rate has been observed in premature babies administered oral tetracyclines. Tetracyclines are known to cause a yellow to brown discoloration of the teeth and enamel hypoplasia in the developing child or foetus.
Hepatic impairment Minocycline should be used with caution in patients with hepatic dysfunction or in conjunction with potentially hepatotoxic drugs, including alcohol. Auto–immune disorders Rare cases of auto-immune hepatotoxicity and isolated cases of systemic lupus erythematosus (SLE) and also exacerbation or pre-existing SLE have been reported.
If patients develop signs or symptoms of SLE or hepatotoxicity, or suffer exacerbation or pre-existing SLE, minocycline should be discontinued. Renal impairment Studies indicate there is no significant drug accumulation in patients with mild to moderate renal impairment when treated with the recommended dosages of minocycline.
In cases of severe renal impairment a reduction of dosage and monitoring of renal function may be required. Cross-sensitivities Micro-organisms can develop cross resistance to tetracyclines and patients can develop cross sensitivity.
g. glossitis, stomatitis, vaginitis, pruritus ani or staphylococcal enteritis. Myasthenia Gravis Tetracyclines can cause weak neuromuscular blockade - use with caution in Myasthenia Gravis. Intracranial hypertension As with other tetracyclines, bulging fontanelles in infants and benign intracranial hypertension in juveniles and adults have been reported.
Presenting features were headache and visual disturbances including blurring of vision, scotoma and diplopia. Permanent vision loss has been reported. Treatment should cease if evidence of raised intracranial pressure develops. 8). Hyperpigmentation may present regardless of dose or duration of therapy but develops more commonly during long term treatment.
1 • Systemic Lupus Erythematosus • Pregnancy and lactation • Children under 12 years • Complete renal failure.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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*Autoimmune hepatitis Skin and subcutaneous tissue disorders Rare Alopecia, erythema multiforme, erythema nodosum, fixed drug eruption, hyperpigmentation of skin, photosensitivity, pruritis, rash, urticaria, vasculitis. Very rare Not known Angioedema, exfoliative dermatitis, hyperpigmentation of nails, Stevens-Johnson Syndrome, toxic epidermal necrolysis.
Drug rash with eosinophilia and systemic symptoms (DRESS) Musculoskeletal and connective tissue disorders Rare Arthralgia, lupus-like syndrome, myalgia. 4), joint stiffness, joint swelling. Renal and urinary disorders Rare Increased serum urea, acute renal failure, interstitial nephritis.
Reproductive system and breast disorders Very rare Balanitis. General disorders and administration site conditions Uncommon Fever Very rare Discolouration of secretions. 4. The following syndromes have been reported. In some cases involving these syndromes, death has been reported.
As with other serious adverse reactions, if any of these syndromes are recognised, the drug should be discontinued immediately: • Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, pericarditis.
Fever and lymphadenopathy may be present. • Lupus-like syndrome consisting of positive antinuclear antibody, arthralgia, arthritis, joint stiffness or joint swelling, and one or more of the following: fever, myalgia, hepatitis, rash, vasculitis.
• Serum sickness-like syndrome consisting of fever, urticaria or rash, and arthralgia, arthritis, joint stiffness or joint swelling. Eosinophilia may be present. Hyperpigmentation of various body sites including the skin, nails, teeth, oral mucosa, bones, thyroid, eyes (including sclera and conjunctiva), breast milk, lacrimal secretions and perspiration has been reported.
This blue/black/grey or muddy-brown discolouration may be localised or diffuse. The most frequently reported site is in the skin. Pigmentation is often reversible on discontinuation of the drug, although it may take several months or may persist in some cases.
The generalised muddy-brown skin pigmentation may persist, particularly in areas exposed to the sun. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Patients should be advised to report any unusual pigmentation without delay and minocycline should be discontinued. This is generally reversible on cessation of therapy. Photosensitivity Tetracyclines are known to cause photosensitivity reactions.
Such patients should be warned to avoid direct exposure to natural or artificial light and to discontinue therapy at the first sign of discomfort. Excipients Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.