{"id":9368,"date":"2026-08-10T10:13:23","date_gmt":"2026-08-10T10:13:23","guid":{"rendered":"https:\/\/majistraleczacilari.org.tr\/?post_type=docs&p=1952"},"modified":"2026-08-21T11:48:15","modified_gmt":"2026-08-21T11:48:15","password":"","slug":"topical-drug-use-in-neonates-2","status":"publish","type":"docs","link":"https:\/\/majistraleczacilari.org.tr\/en\/dokumanlar\/general-articles\/topical-drug-use-in-neonates-2\/","title":{"rendered":"Topical Drug Use in Neonates – 2"},"content":{"rendered":"
\"\"<\/div>\n
<\/div>\n
\n

Skin Surface pH Value;<\/strong>At birth, the neonatal skin surface has a neutral or alkaline pH (pH: 6.2-7.5). In both term and preterm infants, skin pH drops rapidly within the first week after birth, followed by a slower decline over a period of 3 weeks. By the end of the first month, an acidic surface pH value (pH: 5.0-5.5) very close to adult and older children levels is achieved. As the skin pH shifts toward acidity, it contributes to skin integrity through actions on enzymes involved in stratum corneum formation, supports the epidermal innate immune response, narrows the skin flora, and reduces the number of pathogenic bacterial colonies. The acid mantle also reduces the activity of fecal enzymes.Based on these data, the production of diapers buffered with a pH 5.5 buffer solution has come to the agenda.<\/strong><\/p>\n

Dermis;<\/strong>In an adult individual, the dermis provides the production of nutrients for the epidermis in addition to sweat and sebum. Dermal blood vessels play a primary role in thermoregulation. With its mesh-like structure composed of collagen and elastic fibers, the dermis keeps the epidermis and subcutaneous adipose tissue interconnected and anchored, providing resistance against trauma.Wound Healing;<\/strong>While tissue damage involving the dermis and basal layer heals with a scar in adult skin, fetal skin exhibits scarless healing.Topical Drug Use in Neonates;<\/strong>The neonatal period is a phase in which medications and medical supplies applied topically to the skin can lead to severe local or systemic toxicity. There are not enough controlled studies investigating which topical products are safer in neonates.The safety of products stated to be manufactured for infants and labeled with expressions such as “Dermatologically tested”, “pH balanced”, “contains natural\/organic substances”, etc. is also debatable.<\/strong>Therefore, as a general approach during this period, topical applications should be restricted to the short-term use of pure, reliable agents only when necessary. In common, benign, transient dermatoses of the newborn (sebaceous hyperplasia, erythema toxicum neonatorum, transient neonatal pustular melanosis, etc.), the condition should be explained to the baby’s parents, and keeping the infant under observation without treatment should be preferred. In this section, topical medications and applications frequently used in newborn infants will be briefly summarized under headings:Baby Bath – Hair and Scalp Cleansing;<\/strong>Due in part to cultural differences, widely varying practices exist regarding the first bath of a newborn. In term newborns, the skin is covered with vernix caseosa at birth, and contamination with maternal blood, cellular debris, and meconium is present. Therefore, especially in infants carrying a risk of maternal infection transmission, washing is preferred over merely wiping off the vernix caseosa after birth. To minimize the risk of hypothermia, the first bath should be administered between 2 to 4 hours postpartum following the stabilization of the infant’s vital signs and body temperature, and the ambient temperature should be kept under control after the bath. Particularly in infants under 36 weeks, bathing should be delayed until after 24 hours. Daily bathing is not indicated. Washing is recommended twice a week in term infants and every 4 days in preterm infants. Opinions vary regarding the ideal bath water temperature: it is recommended to be close to body temperature (37\u201337.5\u00b0C) or at a lower temperature (34\u201336\u00b0C). The bath duration should be kept short (<5 minutes). For skin cleansing, non-alkaline, mildly formulated, neutral or slightly acidic, fragrance-free, liquid syndets should be preferred. Soaps with glycerin additives should not be used in newborns, as their humectant properties lead to dryness and irritation. Rubbing should not be performed. Skin folds should be carefully dried after the bath. In premature infants without infection risk, cleansing with warm, sterile water 2\u20133 times a week is recommended during the first few weeks of life. There is no standardized pediatric formulation for baby shampoos. In newborns with short, fine, and fragile hair, the use of shampoos containing amphoteric and non-ionic agents is not strictly necessary. Mildly formulated shampoos with a pH close to that of tears (tear-free) should be preferred. Leading the substances that must be avoided in topical applications for newborns is sodium lauryl sulfate (SLS), found in shampoos. SLS damages the lipid barrier and causes irritation by inducing separation between skin layers. When applied together with triclosan, SLS remains bound to the skin for days. Sodium and ammonium laureth sulfate are added to various cleansing care products to create a foaming effect. Since they induce an irritant effect through protein damage, newborn products should not contain these agents. Methylisothiazolinone is found in hair care products and has been reported to be absorbed and potentially cause neurological disorders.Parabens (methylparaben, propylparaben, ethylparaben, butylparaben); found in baby shampoos, lotions, and wet wipes, it should be kept in mind that they can cause contact dermatitis, and antiseptic soaps, lotions, and wet wipes should not be used in newborns.<\/strong><\/p>\n

Use of Emollients \u2013 Moisturizing;<\/strong>The necessity of routine emollient application to the skin to accelerate the maturation of the epidermal barrier in preterm neonates remains controversial. It is a fact that these products prevent skin dryness and fissures, contribute to skin integrity by smoothing the skin, and reduce TEWL. Petrolatum (vaseline) is the most commonly used agent for this purpose, and routine emollient use in neonates has been shown to increase the risk of coagulase-negative staphylococcal and nosocomial infections. In one study, it was concluded that sunflower oil did not pose a risk for the aforementioned infections in neonates but instead demonstrated a protective effect, and also had superior efficacy compared to olive oil, soybean oil, and mustard oil. However, there are also researchers who report finding no difference in infection risk between infants with and without regular emollient use. It is suggested that occlusion significantly contributes to the development of infection and that dense applications exceeding 0.5-2.0 g\/cm2 create pronounced occlusion. In a Cochrane review, the use of petrolatum-based, occlusive products is not recommended in premature infants. As a general approach, moisturizing products that are free of perfume, dyes, and additives, have a physiological epidermal lipid balance (cholesterol, ceramide, linoleate, and palmitate), or contain sunflower oil should be preferred in neonates. Propylene glycol, a hydrophilic base found in the composition of many emollients, causes skin irritation and a burning sensation when its concentration exceeds 5%. Because its percutaneous absorption can cause hyperosmolality and seizures, it should not be present in neonatal products. Emollients: especially in hot and humid climatic conditions, should not be applied to intertriginous areas; during use acne, folliculitis, miliaria, or itching colonization site; it easily progresses to omphalitis and sepsis; it is a major source of morbidity and mortality, especially in developing countries. In 1998, the WHO recommended the application of chlorhexidine, povidone-iodine, triple dye (“triple dye”: a mixture of gentian violet, brilliant green, and proflavine sulfate), silver sulfadiazine, or isopropyl alcohol (70%) for umbilical cord care aimed at reducing pathogenic bacterial colonization. These antimicrobial applications have been shown to significantly reduce morbidity compared to leaving the umbilical cord dry and untreated; however, adverse side effects associated with these topical agents have been reported. Both in the past and today, there appears to be no consensus among neonatal intensive care units regarding umbilical cord care (dry care with sterile gauze dressing, topical agents such as alcohol, triple dye, neomycin-bacitracin mixture, colloidal silver-benzoyl peroxide, basic fuchsin, chlorhexidine powder, salicylic acid-containing sugar powder). Although the level of evidence is low, a Cochrane review (n=8959) compared antiseptic application to the umbilical cord with dry care and placebo in infants of high-income families and found no significant difference between them. Topical antibiotics were found to be more successful than antiseptics in reducing bacterial colonization. It was concluded that antiseptics prolonged the cord detachment time. A recent study revealed that a single topical application of triple dye to neonates prior to hospital discharge was an adequate care method on its own. In recent years, it has been emphasized that gentian violet, contained within the triple dye, is an effective agent in wound care and against many resistant nosocomial infections, including MRSA. In summary; umbilical cord care should be determined according to the infant’s infection risk and hygienic conditions. In the treatment of umbilical granuloma, which develops in the umbilicus following cord separation as a pink-red, easily bleeding nodule, the first-choice method due to its practicality\u2014alongside cryotherapy, ligation, and excision\u2014is chemical cauterization applied onto the granuloma using a silver nitrate solution or stick.Use of Antiseptic Products;<\/strong>procedures such as central venous catheterization, in particular, cause rapid microbial colonization on the skin and serious infections progressing to sepsis. In such interventions, preventing infection depends not only on appropriate routine handwashing and hygienic practices of the caregiving team, but also on the antisepsis of the application site. The physiological characteristics of neonatal (especially preterm) skin and experienced adverse reactions limit the use of antiseptics in neonatology. Controlled studies on the use of antiseptics in neonates and consequently data regarding safety are insufficient. The characteristics of topical antiseptics used in neonates can be summarized as follows:Chlorhexidine: <\/em><\/strong>It is an agent with high antibacterial efficacy and low toxicity. It is stated that 0.5% chlorhexidine is at least as effective as povidone-iodine. Chlorhexidine is preferred as the most reliable antiseptic agent, especially before surgical procedures. It is applied topically after cleaning the procedure site with soap and rinsing with sterile water. In preterms, following topical application, chlorhexidine should be allowed to dry for 30 seconds and then removed with sterile water. It causes irritation on mucous membranes at concentrations above 0.02%, and since it causes neurotoxicity upon contact with neural tissues, contact with brain tissue and meninges must be avoided (aplasia cutis congenita, tympanic membrane perforation, etc.). Systemic toxic effects may occur when applied over large surfaces, under occlusion, or with repeated applications. It is an advantage that the product in alcoholic solution form can be used for months after opening the bottle.Povidone-iodine: <\/em><\/strong>It is the most effective antiseptic with the broadest antimicrobial spectrum; however, because percutaneous absorption in neonates causes transient, severe hypothyroidism due to iodine overload, its use should be avoided, especially in preterm infants. However, if contact with povidone-iodine has occurred, particularly in premature infants, the povidone-iodine should be wiped off with sterile water, and thyroid hormone levels should be monitored.Dakin’s solution: <\/em><\/strong>It is an antiseptic mixture containing sodium hypochlorite. It is not preferred due to its rapid inactivation in the presence of organic material, but it can be applied after debridement. Following topical application for umbilical cord cleaning, especially in preterm infants, it should be removed from the skin with sterile saline solution after completing a 30-second contact time.Alcohol: <\/em><\/strong>They are broad-spectrum and fast-acting antiseptic agents, but their use has been abandoned because they can cause hemorrhagic cutaneous necrosis in preterm infants and alcohol toxicity in low birth weight infants.Hexamidine: <\/em><\/strong>Despite its widespread use, its slow onset of action and narrow spectrum make its use before invasive procedures unsuitable.Eosin: <\/em><\/strong>It is an aqueous dye. Although widely used in umbilical cord care, it should not be preferred. It becomes contaminated shortly after opening the product container and is therefore held responsible for many serious neonatal infections. Octenidine is an alternative to antiseptics that can be used in the neonatal period, but there is not yet sufficient experience regarding its efficacy and side effects. The use of mercury derivatives is contraindicated in the neonatal period due to their toxic effects.Use of Medical Tapes and Dressings;<\/strong>Epidermal stripping may occur, especially during the removal of medical tapes applied to infants younger than 27 weeks of gestation. To prevent this, adhesive tapes should not be used in preterm infants, and tubular mesh dressings that do not impede perfusion as well as gel electrodes should be preferred. Additionally, pectin-based skin barriers can be applied between the skin and the adhesive tape when securing catheters and similar materials to the skin. If medical tape has been applied, it should be moistened with emollients or warm water prior to removal, and a horizontal rather than vertical pulling force should be applied for the detachment procedure. In cases with a potential to develop decubitus ulcers, transparent dressings (hydrocolloid, hydrogel, etc.) should be preferred.Use of Topical Anesthetic Agents in Neonates;<\/strong>Infants monitored especially in neonatal intensive care units are exposed to many painful and stressful interventions for diagnostic and therapeutic purposes. The sensation of pain disrupts clinical stability, leading to adverse outcomes, particularly in preterm infants. Topical analgesics used for this purpose can only be applied to intact skin surfaces. Two topical anesthetic agents can be used in neonates: EMLA cream (“Eutectic mixture of local anesthetics” – prilocaine-lidocaine eutectic mixture) and 4% tetracaine gel. To achieve clinical efficacy with EMLA, 0.5\u20132 g (dose determined according to prematurity and age) is applied to the skin under occlusion 1\u20132 hours before the procedure, providing anesthesia with a penetration depth of 2\u20133 mm. The application of EMLA, provided it is applied topically at 0.5 g once daily, has been found safe for infants older than 30 weeks of gestation. Prilocaine should be used with caution, as percutaneous absorption in cases of overdose may cause methemoglobinemia. It can be used up to a maximum of 25 mg and over an area no larger than 10 cm2. Tetracaine gel has a faster and longer duration of action (a 4-hour effect starting within 30\u201340 minutes); although it is not a cause of methemoglobinemia, it may cause contact dermatitis in premature infants.Camphor is not used in neonates.<\/strong><\/p>\n

Diaper Area Care – Diaper Dermatitis Treatment;<\/strong>The development of skin damage in the diaper area is the result of environmental factors. These factors are: increased skin hydration under occlusion, exposure to skin irritants (urine, feces, digestive enzymes, bile salts, dietary factors, fecal composition, etc.), mechanical friction (skin-to-skin, skin-to-diaper), high pH, diarrhea, antibiotic use, and the level of skin barrier maturation depending on gestational age. Overhydration allows exogenous substances to be easily transported into the skin through swelling of corneocytes and increased permeability resulting from lipid liquefaction. To prevent this, the use of superabsorbent diapers should be preferred, and diapers should be changed frequently. To protect the skin from irritants: semi-permeable film- or layer-forming barrier creams should be used; water and cotton for cleaning urine; mild-formulation cleansers for cleaning stool; and moisture should be prevented by leaving the area exposed after cleaning. Active ingredients in product formulations approved for use in the diaper area under the category of skin protectant agents by the US Food and Drug Administration (FDA) are presented in Table 3. There is no consensus on whether these products should be used routinely or only when skin damage occurs. Care products to be applied to the diaper area, especially petrolatum-containing agents, should not be applied thickly, and the diaper should not be fastened before they are fully absorbed by the skin. Otherwise, these agents will coat the inner surface of the diaper, impair absorbency, and facilitate maceration of the diaper area. Since superinfections can easily develop on diaper dermatitis, antifungal and antibacterial medications should be added to the treatment when necessary, and the use of topical corticosteroids should be avoided. When diaper dermatitis is determined to develop as a result of excessive bile and gastric secretions, the use of protective creams containing cholestyramine and sucralfate is reported to be beneficial. Baby powders are currently not recommended due to pulmonary complications (pneumonia, pulmonary granuloma\/fibrosis, etc.) that may occur in case of inhalation.\"\"<\/p>\n

Use of Topical Antibiotics in Neonates;<\/strong>Staphylococcal bullous impetigo and other pyodermas frequently encountered in neonates are generally infections with a favorable prognosis when treated early. In neonates with localized lesions, topical treatment with mupirocin, bacitracin, fusidic acid, or bacitracin-polymyxin B can be administered. It is recommended that topical mupirocin and fusidic acid, which are the most commonly used agents, be used for a short duration and\/or in combination with an antiseptic due to their potential for resistance development. Careful follow-up and, if necessary, systemic antibiotics may be required, particularly in bullous impetigo localized around the umbilicus, as the risk of bacterial omphalitis and sepsis may be high3. Other topical antibiotics indicated for use during this period include erythromycin and clindamycin, although topical clindamycin administration also carries a rare risk of developing pseudomembranous enterocolitis. The use of topical sulfonamides during the neonatal period is contraindicated due to severe adverse effects such as kernicterus.Use of Antifungal Agents in Neonates;<\/strong>In the neonatal period, the use of topical antifungals becomes necessary in the treatment of dermatoses such as localized cutaneous candida infections\u2014frequently encountered particularly in the diaper area\u2014as well as seborrheic dermatitis, in which P. ovale plays an etiological role, and neonatal cephalic pustulosis, for which Malassezia species (M. furfur, M. sympodialis) are held responsible. Foremost among the topical antifungal agents that can be used in the neonatal period is nystatin, a derivative of Streptomyces noursei, which has anticandidal activity despite being ineffective against dermatophytes. Among the antifungals recommended for twice-daily topical use, nystatin formulated in an ointment base has been stated to have the least irritating effect on the skin. Other topical antifungals recommended in the neonatal period are imidazoles (e.g., miconazole, clotrimazole, ketoconazole) and ciclopirox olamine, with a 1\u20132 week course of treatment applied twice daily being recommended. In the neonatal period, topical antifungal therapy should generally be preferred only in healthy newborns and for the specified limited indications. It must be taken into account that adequate efficacy often cannot be achieved in low-birth-weight, preterm infants, or those with secondary health problems, or infants who have undergone catheterization and immunosuppressive therapy.Use of Topical Corticosteroids in Neonates;<\/strong>In cases where the use of topical corticosteroids is necessary, the lowest potency topical corticosteroid (Class I) may be applied once daily to a limited skin area for a short duration (maximum 5 days). In infants, the use of 1% hydrocortisone is generally sufficient. It should be kept in mind that the need for corticosteroids will decrease if a moisturizing product is used concomitantly. It should be anticipated that the absorption and side effects of topical corticosteroids may occur more severely in intertriginous areas, and the amount and duration of medication should be restricted when applying to these regions. Occlusion (such as closing the diaper, etc.) should not be applied to the application area for 1 hour following topical application.Other Topical Applications;<\/strong>In the treatment of scabies and pediculosis capitis during the neonatal period, while lindane, gamma-benzene hexachloride, and benzyl benzoate have fallen out of use today due to their neurotoxic potential, permethrin lotion (5%) and crotamiton (10%) are stated as safe options. Due to immature melanosomes during the neonatal period, the general principle is to ensure infants avoid sun exposure. For infants diagnosed with neonatal lupus erythematosus, xeroderma pigmentosum, porphyria, etc., sun protection must be maintained within a stricter framework.However, the use of topical sunscreen agents during the neonatal period is generally not recommended.<\/strong> Calcipotriol, dithranol, lactic acid, salicylic acid, alcohol, hexachlorophene, neomycin, urea-containing preparations, clioquinol, boric acid, and resorcinol are contraindicated in the neonatal period.<\/strong>Wishing you a good week\u2026<\/p>\n

Source: Ay\u015fe An\u0131l Karabulut<\/p>\n

K\u0131r\u0131kkale University Faculty of Medicine, Department of Dermatology and Venereal Diseases, K\u0131r\u0131kkale, Turkey<\/p>\n

Exp. Pharm. Ahmet Nezihi Pekcan
\nPekcan Pharmacy – Konya
\npekcanecz@gmail.com
\nTel: (332) 3520657http:\/\/www.majistralformul.com\/<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Skin Surface pH Value;At birth, the neonatal skin surface has a neutral or alkaline pH (pH: 6.2-7.5). In both term and preterm infants, skin pH drops rapidly within the first […]<\/p>\n","protected":false},"author":1,"featured_media":1953,"comment_status":"open","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"doc_category":[159],"doc_tag":[],"class_list":["post-9368","docs","type-docs","status-publish","has-post-thumbnail","hentry","doc_category-general-articles"],"acf":[],"year_month":"2026-08","word_count":3191,"total_views":"1","reactions":{"happy":"0","normal":"0","sad":"0"},"author_info":{"name":"m921a","author_nicename":"m921a","author_url":"https:\/\/majistraleczacilari.org.tr\/en\/author\/m921a\/"},"doc_category_info":[{"term_name":"General Articles","term_url":"https:\/\/majistraleczacilari.org.tr\/en\/dokuman-kategori\/general-articles\/"}],"doc_tag_info":[],"knowledge_base_info":[],"knowledge_base_slug":[],"_links":{"self":[{"href":"https:\/\/majistraleczacilari.org.tr\/en\/wp-json\/wp\/v2\/docs\/9368","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/majistraleczacilari.org.tr\/en\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/majistraleczacilari.org.tr\/en\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/majistraleczacilari.org.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/majistraleczacilari.org.tr\/en\/wp-json\/wp\/v2\/comments?post=9368"}],"version-history":[{"count":1,"href":"https:\/\/majistraleczacilari.org.tr\/en\/wp-json\/wp\/v2\/docs\/9368\/revisions"}],"predecessor-version":[{"id":9370,"href":"https:\/\/majistraleczacilari.org.tr\/en\/wp-json\/wp\/v2\/docs\/9368\/revisions\/9370"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/majistraleczacilari.org.tr\/en\/wp-json\/wp\/v2\/media\/1953"}],"wp:attachment":[{"href":"https:\/\/majistraleczacilari.org.tr\/en\/wp-json\/wp\/v2\/media?parent=9368"}],"wp:term":[{"taxonomy":"doc_category","embeddable":true,"href":"https:\/\/majistraleczacilari.org.tr\/en\/wp-json\/wp\/v2\/doc_category?post=9368"},{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/majistraleczacilari.org.tr\/en\/wp-json\/wp\/v2\/doc_tag?post=9368"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}