STROMECTOL

What it is

STROMECTOL is a tablet containing 3 mg of ivermectin. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum antiparasitic agents isolated from fermentation broths of Streptomyces avermitilis. STROMECTOL is available as white, round, flat tablets with a bevelled edge, engraved with 'MSD' on one side and '32' on the other side.

Approved indications —

Onchocerciasis and intestinal strongyloidiasis (anguillulosis). — Crusted scabies in conjunction with topical therapy. — Human sarcoptic scabies when prior topical treatment has failed or is contraindicated. Treatment is only justified when the diagnosis of scabies has been established clinically and/or by parasitological examination.

Dosing overview

Treatment is administered as a single oral dose given with water, with the dose determined by the patient's weight. For classic/typical scabies, 2 doses are given: 1 dose on day 1 and another dose between day 8 and day 15. For crusted scabies in mild cases, 2 doses are given (1 dose on day 1 and another dose between day 8 and day 15), while moderate to severe cases may require more than 3 doses. For onchocerciasis, the suggested dose interval for most patients is 12 months, although at some sites it may be preferable to use a 6 month interval depending on density of skin microfilariae and/or prevalence.

Key safety warnings

Neurological toxicity, including depressed level of consciousness and coma, has been reported in patients with the use of ivermectin in the absence of Loa loa infection. These events have generally resolved with supportive care and the discontinuation of ivermectin. Rarely, patients with onchocerciasis who are also heavily infected with Loa Loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. Associated adverse experiences have included pain (including neck and back pain), red eye, conjunctival haemorrhage, dyspnoea, urinary and/or faecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, seizures or coma, although this syndrome has been seen very rarely following the use of ivermectin. Ivermectin has not been studied in patients with impaired hepatic function. As ivermectin is extensively metabolised by the liver, caution should be exercised if ivermectin is administered to patients with impaired hepatic function. Ivermectin should not be used in pregnancy as safety in pregnancy has not been established. Ivermectin is excreted in breast milk and safety in newborn infants has not been established. The drug should be given to nursing mothers only if the benefit to the mother outweighs the potential risk to the breast-fed infant, and the treatment of mothers who intend to breast-feed their infants should be delayed until at least one week after the birth of the child.

Contraindications

Hypersensitivity to any component of the product.

PBS listing

STROMECTOL 3 mg tablets are listed on the PBS under 2 items with streamlined restrictions at an ex-manufacturer price of A$16.35.

Regulatory history

STROMECTOL was first approved on 27 August 1999. ARTG registration 181338 for STROMECTOL ivermectin 3 mg tablet blister pack was first listed on 13 May 2011. The TGA approved STROMECTOL for extensions of indications on 15 July 2013, specifically to include the treatment of crusted scabies and human sarcoptic scabies. In November 2021, the PBAC recommended a change to extend listing and remove certain requirements for scabies.