Soolantra

/ Rafa

One application a day for up to 4 months. This medicinal product should be applied daily over the treatment course. The treatment course may be repeated.
In case of no improvement after 3 months, the treatment should be discontinued.

Topical treatment of inflammatory (papulopustular) lesions caused by rosacea in adults.

Hypersensitivity to the active substance or to any of the excipients.

Patients may experience transient aggravation of rosacea, which usually resolves within 1 week under continuation of the treatment as might be expected due to a reaction to the dying Demodex mites.
In case of severe worsening with a strong dermal reaction, the treatment should be discontinued.
This drug  has not been studied in patients with renal or hepatic impairment.
The medicinal product contains:
– cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis),
– methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed),
– and propylene glycol which may cause skin irritation.

Common: Skin burning sensation.
See prescribing information for full details.

No interaction studies have been performed.
Concomitant use with other topical or systemic medicinal products for the treatment of rosacea has not been investigated.
In vitro studies have shown that ivermectin is primarily metabolised by CYP3A4. Consequently, caution is advised when ivermectin is administered concomitantly with potent CYP3A4 inhibitors as the plasma exposure may be significantly increased.

Pregnancy:
There are no or a limited amount of data from the topical use of ivermectin in pregnant women. Oral reproductive toxicity studies have shown that ivermectin is teratogenic in rats and rabbits, however due to the low systemic exposure following topical administration of the product at the proposed posology, there is a low safety concern for a human foetus. This medicinal product is not recommended during pregnancy.
Breast-feeding:
Following oral administration, ivermectin is excreted in human milk in low concentrations. Excretion in human milk following topical administration has not been evaluated. Available pharmacokinetic/ toxicological data in animals have also shown excretion of ivermectin in milk. A risk to a suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Soolantra therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

There are no reports of overdosage with this drug.
In accidental or significant exposure to unknown quantities of veterinary formulations of ivermectin in humans, either by ingestion, inhalation, injection, or exposure to body surfaces, the following adverse effects have been reported most frequently: rash, oedema, headache, dizziness, asthenia, nausea, vomiting, and diarrhoea. Other adverse effects that have been reported include: seizure, ataxia, dyspnea, abdominal pain, paresthesia, urticaria, and contact dermatitis.
In case of accidental ingestion, supportive therapy, if indicated, should include parenteral fluids and electrolytes, respiratory support (oxygen and mechanical ventilation if necessary) and pressor agents if clinically significant hypotension is present. Induction of emesis and/or gastric lavage as soon as possible, followed by purgatives and other routine anti-poison measures, may be indicated if needed to prevent absorption of ingested material.

After first opening: use within 6 months.
Store below 30°C.