Sella Boric Acid 3% Cutaneous Solution Bottle 500 ml

Therapeutic indications

Antiseptic for the disinfection of minor burns and irritated or chapped skin areas. The solution is also used in the form of local buffers with a decongestant action. Boric acid is indicated as an antibacterial for treating acne.

Dosage

External use: apply as needed on the affected area. Adults Boric acid can be applied directly once or twice a day to inflamed areas in case of chapped, irritated or dry skin, abrasions, mild sunburn, sunburn, windburn or insect bites. Children over the age of 3 Boric acid can be applied directly once or twice a day to inflamed areas associated with chapped, irritated or dry skin, diaper rash, mild sunburn, sunburn, wind burn or insect bites .

Overdose

The risk of acute cutaneous intoxication appears to be negligible given its low transcutaneous absorption index. Boric acid can be absorbed in toxic quantities through the gastrointestinal tract, by inhalation or through skin lesions. Symptoms Poisoning and death have occurred following the use of large quantities of boric acid on wounds or sores, especially in children. The mechanism of the toxic action is unknown and numerous organs and systems are affected, in particular the skin, kidney and digestive tract. The toxic effects also affect the CNS and lung with lesions, mainly hemorrhagic, of obscure origin. The main symptoms of boric acid poisoning are vomiting, diarrhea, visceral pain, skin rash followed by peeling, CNS stimulation followed by depression, restlessness, headache. Metabolic acidosis and severe water and salt imbalances are also frequent. Furthermore, boric acid in these situations can cause seizures, changes in body temperature and kidney damage which can be evidenced by oliguria. Death from circulatory collapse and untreated shock can occur within 3–5 days. Cyanosis, delirium, seizures and coma (HSDB) can also occur. Cases of severe intoxication have manifested themselves with gastrointestinal disorders (73%), central nervous system (67%) and skin lesions (76%). Symptoms of chronic poisoning include anorexia, confusion, debilitation, dermatitis, menstrual disorders, anemia, seizures and alopecia (see section 4.8). Treatment No treatment is needed if the dose taken is less than 50 mg / kg. For ingestion of higher doses, gastric lavage is performed with activated charcoal suspension and saline purgative. If the absorbed quantity exceeds 100 mg / kg, even if the patient is still asymptomatic, forced diuresis must be instituted immediately, in order to accelerate elimination and protect the kidney from toxic effects; at the first signs of renal insufficiency and water overdose, forced diuresis should be replaced with peritoneal dialysis or hemodialysis. The remaining therapy is symptomatic and resuscitation.

Contraindications

Boric acid is contraindicated in case of: - hypersensitivity to the active substance or to any of the excipients; - extensive skin lesions; - children under 3 years of age.

Side effects

Absorption of boric acid through intact skin is less than 0.5%; however it may increase if accidentally administered systemically or applied to wounds or lesions. The following are the undesirable effects of boric acid that occurred in case of accumulation toxicity, after prolonged exposure and following systemic absorption. These effects are organized according to the MedDRA System Organ Class. Insufficient data are available to establish the frequency of the individual effects listed. Skin and subcutaneous tissue disorders Dermatitis, rash, alopecia. Gastrointestinal disorders Gastro-intestinal disorders: nausea, vomiting, diarrhea. Metabolism and nutrition disorders Anorexia. Endocrine disorders Menstrual disorders. Blood and lymphatic system disorders Anemia. Musculoskeletal and connective tissue disorders Weakness. Psychiatric Disorders Confusion. Nervous system disorders Convulsions. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Pregnancy No clinical data on exposed pregnancies are available. Animal studies are insufficient to detect effects on embryonic / fetal development (see section 5.3). The potential risk for humans is unknown, however if the medicine is used in accordance with the directions for use, the absorption is low and, therefore, the risk of systemic effects is minimal. Breastfeeding There are no data on the use of the medicinal product during breastfeeding and it is not known whether this active ingredient passes into breast milk. However, as the absorption of the drug can be considered negligible, it is very unlikely that significant quantities reach the breast milk.

Special warnings

Excessive and prolonged application to large areas or broken skin can cause build-up toxicity. Keep out of reach of children, as deaths have occurred as a result of accidental ingestion. The medicinal product must not be used for ophthalmic use.

Expiry and Retention

Keep the container tightly closed to protect from light.

Active principles

100 ml of solution contain Active ingredient: boric acid 3 g Excipient with known effect: benzalkonium chloride For the full list of excipients, see section 6.1.

Excipients

Benzalkonium chloride Purified water