Chemical formula: C₃₀H₅₀O₂ Molecular mass: 442.381 g/mol
Betulin interacts in the following cases:
Wound infection is an important and serious complication that can occur during wound healing. In the case of infection, it is recommended to discontinue treatment with betulin. Additional standard treatment may be required.
No studies in pregnant women have been conducted.
No effects during pregnancy are anticipated, since systemic exposure to betulin is negligible. Betulin can be used during pregnancy.
No data are available to evaluate whether betulin is excreted into human milk.
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to betulin is negligible. Betulin can be used during breast-feeding, unless the chest area is subject to treatment.
Fertility studies have not been conducted. No effects on human fertility are anticipated, since the systemic exposure is negligible.
Betulin has no or negligible influence on the ability to drive and use machines.
The most frequently observed adverse reactions were wound complication (in 2.9% of patients), pain of skin (2.5%) and pruritus (1.3%). Adverse reactions were administration site reactions only. Wound complication adverse reactions such as wound infection and wound necrosis are complications of healing of partial thickness skin wounds and can be serious.
In the following table, adverse reactions are listed by MedDRA system organ class and preferred term. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Adverse reactions reported in clinical trials:
| System organ class | Common | Uncommon |
|---|---|---|
| Infections and infestations | Wound infection | |
| Immune system disorders | Hypersensitivity | |
| Skin and subcutaneous tissue disorders | Pain of skin Pruritus | Dermatitis Rash pruritic Purpura |
| General disorders and administration site conditions | Pain | |
| Injury, poisoning and procedural complications | Wound complication* |
* Wound complication comprises different kinds of local complications such as post-procedural complications, wound necrosis, wound secretion, impaired healing, or inflammation of wound.
In addition, there is one case report of contact dermatitis reported from a literature in a patient after prolonged use of a topical birch bark extract containing cosmetic product.
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