LINCOCIN

What it is

LINCOCIN is a solution for injection containing lincomycin hydrochloride monohydrate, with each 2 mL injection containing 680.4 mg lincomycin hydrochloride monohydrate equivalent to 600.0 mg lincomycin. It is a clear, colourless to slightly yellow solution, essentially free from visible particulate matter.

Approved indications

LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of gram-positive aerobes such as streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate. — Upper respiratory infections including tonsillitis, pharyngitis, otitis media, sinusitis, scarlet fever and as adjuvant therapy for diphtheria. — Lower respiratory infections including acute and chronic bronchitis and pneumonia. — Skin and skin structure infections including cellulitis, furuncles, abscesses, impetigo, acne and wound infections. — Bone and joint infections including osteomyelitis and septic arthritis. — Septicaemia and endocarditis. — Bacillary Dysentery.

Dosing overview

**Intramuscular administration:** For adults with serious infections, 600 mg intramuscularly every 24 hours, or for more serious infections, 600 mg intramuscularly every 12 hours or more often as determined by the severity of the infection. For children over 1 month of age with serious infections, one intramuscular injection of 10 mg/kg/day, or for more serious infections, one intramuscular injection of 10 mg/kg every 12 hours or more often. **Intravenous administration:** Intravenous doses are given on the basis of 1 g LINCOCIN diluted in not less than 100 mL of appropriate solution and infused over a period of not less than one hour. For adults with serious infections, 600 mg to 1 g is given every 8–12 hours, with the above doses increased for more severe infections. For patients with severe impairment of renal function, an appropriate dose is 25 to 30 per cent of that recommended for patients with normal renal function.

Key safety warnings

**Risk of colitis:** The use of lincomycin can lead to the development of severe colitis, with fatalities reported. A toxin produced by Clostridium difficile appears to be the primary cause, with severity of colitis ranging from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with the use of antibiotics, including parenteral lincomycin, with symptoms possibly occurring up to several weeks after cessation of antibiotic therapy. **Hypersensitivity and allergic reactions:** Hypersensitivity reactions such as anaphylactic reaction, angioedema and serum sickness have been reported, some in patients known to be sensitive to penicillin. Severe hypersensitivity reactions, including anaphylactic reactions and severe cutaneous adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis, and erythema multiforme have been reported in patients receiving lincomycin therapy. **Intravenous administration:** Severe cardiopulmonary reactions have occurred when this drug has been given at greater than the recommended concentration and rate.

Contraindications

LINCOCIN is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin. Lincomycin is not indicated in the newborn.

PBS listing

LINCOCIN injection 600 mg (as hydrochloride monohydrate) in 2 mL is listed on the PBS with 2 items, unrestricted restriction, and an ex-manufacturer price of A$44.01.

Regulatory history

LINCOCIN was first listed on the Australian Register of Therapeutic Goods on 2 August 1991 under ARTG registration 12281.