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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 a broad spectrum antibiotic used for the treatment of infections caused by tetracycline-sensitive organisms. Some tetracycline-resistant strains of Staphylococci are also sensitive. Minocycline is indicated for the treatment of the following infections: • Gonorrhoea • Non-gonococcal urethritis •…
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 6 weeks. If, after 6 months, there is no satisfactory response Minocycline should be discontinued and other therapies considered.
4).
Gonorrhoea:
In adult males: 200mg initially followed by 100mg every 12 hours for a minimum of 4 days with post-therapy cultures within 2-3 days. Adult females may require more prolonged therapy. Prophylaxis of asymptomatic meningococcal carriers: 100mg twice daily for 5 days, usually followed by a course of rifampicin.
Paediatric population Children over 12 years: 50mg every 12 hours.
Children under 12 years:
Not recommended. Elderly Minocycline may be used at the normal recommended dosage in elderly patients, 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.
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.
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) Infections and infestations: Very rare: Oral and anogenital candidiasis, vulvovaginitis Blood and lymphatic system disorders: Rare: Eosinophilia, leucopenia, neutropenia, thrombocytopenia Very rare: Haemolytic anaemia, pancytopenia Not known (cannot be estimated from the available data): Agranulocytosis Immune system disorders: Rare: Anaphylaxis/anaphylactoid reaction (including shock and fatalities) Not known (cannot be estimated from the available data): 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, hyperaesthesia, paraesthesia, intracranial hypertension, vertigo Treatment should be stopped if evidence of raised intracranial pressure develops.
Headache and visual disturbance can signify benign intracranial hypertension; treatment should cease if this develops.
Very rare:
Bulging fontanelle Not known (cannot be estimated from the available data): Convulsions, sedation Ataxia may also occur.
Ear and labyrinth disorders:
Rare: Impaired hearing, tinnitus Cardiac disorders: Rare: Myocarditis, pericarditis Respiratory, thoracic and mediastinal disorders: Rare: Cough, dyspnoea Very rare: Bronchospasm, exacerbation of asthma, pulmonary eosinophilia Not known (cannot be estimated from the available data): Pneumonitis Pulmonary infiltration has also been reported.
8) have been reported with Minocycline use. If patients develop breathing difficulties they should seek urgent medical advice and Minocycline should be discontinued. 3). Enamel hypoplasia has been reported.
Use in hepatic dysfunction:
Minocycline should be used with caution in patients with hepatic dysfunction and in conjunction with alcohol and other hepatotoxic drugs.
Auto –immune disorders:
Rare cases of auto-immune hepatotoxicity and isolated cases of systemic lupus erythematosus (SLE) and also exacerbation of pre-existing SLE have been reported. If patients develop signs or symptoms of SLE or hepatotoxicty, or suffer exacerbation of pre-existing SLE, Minocycline should be discontinued.
Renal impairment:
Clinical studies have shown that there is no significant drug accumulation in patients with renal impairment when they are treated with Minocycline in the recommended doses. In cases of severe renal insufficiency, reduction of dosage and monitoring of renal function may be required.
Cross-sensitivities:
Cross-resistance between tetracyclines may develop in micro-organisms and cross-sensitisation in patients. 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.
1 • 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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Gastrointestinal disturbances:
Rare: Diarrhoea, nausea, stomatitis, discolouration of teeth, vomiting Any diarrhoea must be differentiated from that due to bacterial overgrowth. Overgrowth with candida may also occur. 4). 4) Skin and subcutaneous tissue disorders: Rare: Alopecia, erythema multiforme, erythema nodosum, fixed drug eruption, hyperpigmentation of skin, photosensitivity, pruritus, rash, urticaria, vasculitis.
Very rare:
Angioedema, exfoliative dermatitis, hyperpigmentation of nails, Stevens-Johnson Syndrome, toxic epidermal necrolysis Not known: 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 (including conjunctiva and lacrimal) There are isolated cases of perspiration.
6). 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 drug reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
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.
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:
If photosensitivity occurs, patients should be warned to avoid direct exposure to natural or artificial light and to discontinue therapy at the first sign of discomfort.
Contraceptive failure:
Patients taking oral contraceptives should be warned that if diarrhoea or breakthrough bleeding occur there is a possibility of contraceptive failure.