1. Name Of The Medicinal Product
Aknemin
2. Qualitative And Quantitative Composition
Minocycline base 100 mg (as the hydrochloride Ph Eur) per capsule.
3. Pharmaceutical Form
Capsule.
4. Clinical Particulars
4.1 Therapeutic Indications
Minocycline is an antibiotic with a spectrum of activity similar to other tetracyclines but more active against Staphylococcus aureus and Nocardia spp.
It is indicated for the treatment of organisms sensitive to tetracyclines such as acne, respiratory infections, gonorrhoea, nocardiosis, staphylococcal infections; the chemoprophylaxis of meningococcal infections.
4.2 Posology And Method Of Administration
For oral administration.
Adults:
1) Routine antibiotic use: 200 mg daily in divided doses.
2) Acne: 50 mg twice daily or 100 mg once daily.
3) Gonorrhoea: In adult males, 200 mg initially followed by 100 mg every 12 hours for a minimum of 4 days with post-therapy cultures within 2-3 days. Adult females may require more prolonged therapy.
4) Prophylaxis of meningococcal infections: 100 mg twice daily for five days, usually followed by a course of rifampicin.
Children:
Aknemin is not recommended for children under 12 years old. For children above 12 years old the recommended dose is 50 mg every 12 hours or 100 mg once daily.
The Elderly:
Aknemin may be used at the normal recommended dosage in elderly patients but caution is advised in patients with renal impairment.
Unlike earlier tetracyclines, absorption of Aknemin is not impaired significantly by the intake of food or moderate amounts of milk.
The treatment of acne should be continued for a minimum of 6 weeks. If after 6 months there is no satisfactory response, Aknemin should be discontinued and other therapies considered. If Aknemin is to be continued for more than 6 months, patients should be monitored at least 3 monthly thereafter for signs and symptoms of hepatitis or SLE (See 4.4).
4.3 Contraindications
Hypersensitivity to tetracyclines, systemic lupus erythematosus, renal failure, children under 12 years old, pregnancy, lactation.
4.4 Special Warnings And Precautions For Use
Aknemin should be used with caution in patients with hepatic dysfunction and in conjunction with alcohol and other hepatotoxic drugs.
Cross-resistance between tetracyclines may develop in micro-organisms and cross-sensitisation in patients. Aknemin should be discontinued if there are signs or symptoms of overgrowth of resistant organisms, eg enteritis, glossitis, stomatitis, vaginitis, pruritus ani or staphylococcal enteritis.
Patients taking oral contraceptives should be warned that if diarrhoea or breakthrough bleeding occurs there is a possibility of contraceptive failure.
Rare cases of autoimmune hepatotoxicity and isolated cases of systemic lupus erythematosus (SLE) and also exacerbations of pre-existing SLE have been reported. If patients develop signs or symptoms of SLE or hepatotoxicity, or suffer exacerbation of existing SLE, minocycline should be discontinued.
Caution should be exercised in patients with Myasthenia Gravis as tetracyclines can cause weak neuromuscular blockade.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Tetracyclines decrease plasma prothrombin activity; reduced doses of concomitant anticoagulants may therefore be required. Aknemin should not be used with penicillins. The absorption of Aknemin is impaired by concomitant administration of antacids and preparations containing iron, calcium, aluminium, magnesium, bismuth or zinc salts. Diuretics may aggravate nephrotoxicity by volume depletion.
4.6 Pregnancy And Lactation
Aknemin should not be used in pregnancy unless essential. Animal studies have indicated that tetracyclines cross the placenta, are found in foetal tissues, and can cause toxicity in the foetus usually related to a retardation of skeletal development. Yellow-brown discolouration of the teeth and enamel hypoplasia can occur when drugs of the tetracycline group are administered after the first trimester of pregnancy.
Aknemin should not be given to lactating women.
4.7 Effects On Ability To Drive And Use Machines
Patients should be warned of the hazards of driving or operating machinery until the effect of treatment is known (See 4.8).
4.8 Undesirable Effects
Blood and lymphatic system disorders: Haemolytic anaemia, thrombocytopenia, neutropenia and eosinophilia have been reported with tetracyclines.
Hypersensitivity reactions: Urticaria, fever, arthralgia, angioneurotic oedema, anaphylaxis and anaphylactoid purpura.
Nervous system disorders: Hyperaesthesia, paraesthesia have rarely been reported.
Headache, dizziness, vertigo and ataxia may occur. These disturbances are reversible within 3-48 hours of discontinuing therapy and occur less frequently when a low dose is given.
As with other tetracyclines, bulging fontanelles in infants and benign intracranial hypertension in adults have been reported. Treatment should be stopped if evidence of raised intracranial pressure develops.
Eye disorders: There are isolated cases of discolouration of the conjunctiva and lacrimal secretions. (See 4.6).
Ear and labyrinth disorders: Impaired hearing has rarely been reported. Tinnitus may occur.
Cardiac disorders: Rarely pericarditis has been reported.
Respiratory, thoracic and mediastinal disorders: Rarely pulmonary infiltration has been reported.
Gastrointestinal disorders: Disturbances like anorexia, nausea, vomiting, diarrhoea, dyspepsia, dysphagia, antibiotic-associated colitis may occur. There have been isolated incidences of pancreatitis. A few cases of oesophagitis and oesophageal ulceration have been reported. To reduce the risk of oesophageal irritation and ulceration the capsules should be administered with adequate amount of fluids and probably not be given at bedtime or to patients with oesophageal obstruction or compression
Hepato-biliary disorders: In common with other tetracyclines transient increases in liver function test values and, rarely, hepatitis have been reported. Some hepatic reactions have an autoimmune basis, and may occur after several months of minocycline treatment (See 4.2).
Skin and subcutaneous tissue disorders: Dermatological reactions are rare but erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, photosensitivity and alopecia have been reported.
Hyperpigmentation of skin have been reported occasionally.
Renal and urinary disorders: Rarely acute renal failure has been reported.
Other: When given over long periods, tetracyclines have been reported to produce brownish-black microscopic discolouration of thyroid tissue; no abnormalities of function are known to occur.
Discolouration of teeth and buccal mucosa have been reported occasionally. These are generally reversible on cessation of therapy. There are isolated cases of breast secretions and perspiration. (See 4.6).
4.9 Overdose
There is no specific antidote. Treatment is gastric lavage with appropriate supportive treatment.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Minocycline is an antibiotic with a spectrum of activity similar to other tetracyclines but is more active against Staphylococcus aureus and Nocardia spp.
5.2 Pharmacokinetic Properties
Minocycline is almost completely absorbed after oral administration.
Absorption is not significantly affected by the presence of food or milk. Doses of 200 mg followed by 100 mg every 12 hours produce plasma concentrations of 1 to 4 mg per ml.
Plasma half life is 12-16 hours in patients with normal renal function but increased in renal impairment.
Minocycline is widely distributed in body fluids and tissue. It crosses the placenta and is excreted in breast milk.
5.3 Preclinical Safety Data
No relevant preclinical safety data have been generated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Polyethylene glycol
Erythrosine (E127)
Red iron oxide (E172)
Yellow iron oxide (E172)
Titanium dioxide (E171)
Gelatin
6.2 Incompatibilities
None stated.
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Store below 25°C
6.5 Nature And Contents Of Container
Aluminium/PVC strip of 14 in a cardboard outer carton containing 28 or 56 capsules.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
Almirall Hermal GmbH,
Scholtzstrasse 3,
D-21465,
Reinbek,
Germany.
8. Marketing Authorisation Number(S)
PL 33016/0006
9. Date Of First Authorisation/Renewal Of The Authorisation
30th January 2009
10. Date Of Revision Of The Text
5th August 2010
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