AKAMIN

What it is

AKAMIN is minocycline hydrochloride dihydrate available as a 50 mg tablet. Minocycline hydrochloride dihydrate is a semisynthetic derivative of the broad spectrum antibiotic, tetracycline. Minocycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by protein synthesis inhibition.

Approved indications

— Infections due to Escherichia coli, Enterobacter aerogenes, Haemophilus influenzae, Klebsiella and Proteus, provided that they have been shown by bacteriological testing to be susceptible to minocycline. — Infections due to Streptococcus pyogenes (group A haemolytic) and Streptococcus faecalis, however minocycline should be used only if the organisms have definitely been shown to be sensitive. — Staphylococcal infections only if other suitable agents are not available and the organism has been shown to be sensitive to minocycline, and tetracycline resistant acne.

Dosing overview

The usual dosage for adults in infections is 200 mg initially followed by 100 mg every twelve hours. Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided. In tetracycline resistant acne the dosage is 100 mg daily, given preferably as 50 mg twice daily. Most cases are likely to resolve within 3 months.

Key safety warnings

The use of tetracyclines during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discolouration of the teeth (yellow–grey–brown), which is more common during long-term use but has been observed following repeated short-term courses. Minocycline use has been associated with blue–black cutaneous hyperpigmentation affecting most areas of the body including the face, and also reported in nails, mucous membranes, hard palate and bone, with incidence appearing more likely in patients with certain immunological conditions, acne vulgaris and with prolonged use and/or higher doses. In many cases the cutaneous pigmentation is reversible or partially reversible on discontinuation of minocycline, though complete resolution may take several months or years. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, and patients should be advised to avoid direct sunlight or ultraviolet light exposure if possible. Antibiotic associated pseudomembranous colitis has been reported with minocycline, with a toxin produced by Clostridium difficile appearing to be the primary cause, and severity may range from mild to life threatening. Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with minocycline therapy, and patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery.

Contraindications

Hypersensitivity to any of the tetracyclines. Severe renal insufficiency. Systemic lupus erythematosus. Concomitant treatment of tetracyclines with vitamin A or retinoids such as isotretinoin or etretinate is contraindicated due to rare cases of benign intracranial hypertension reported after use of these combinations.

PBS listing

AKAMIN 50 mg tablets are listed on the PBS as 2 items with restricted authority required status, at an ex-manufacturer price of A$11.90.

Regulatory history

AKAMIN 50 mg tablets were first listed on the ARTG on 1 September 1999. The product was first approved on 18 August 2005.