The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. Although the incidence of adverse effects with Lidocaine Hydrochloride Jelly USP, 2% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.
The studies cited above used a variety of methods for extemporaneous compounding of TXA ranging from % to 10% solutions. Two methods have been suggested depending on the formulation used. ( 21275495 ) If the 100 mg/mL or 10% solution for injection is used, a 5% oral solution can be prepared by diluting 5 mL of tranexamic acid with 5 mL of sterile water. If the 500 mg tablets are available, one tablet can be placed into 20 mL of water, and stirred until the tablets are completely disintegrated to form a fine particular suspension. It is suggested that a maximum expiration date of five days should be employed if refrigerated, and the solution should be protected from light. 3 In the place of a 500 mg tablet, it seems that use of a 650 mg tablet dissolved in 20 mL could be safely used as well. This is supported by evidence in which a 500 mg tablet was dissolved in 10 mL of water with no reports of adverse events. ( 24808695 ) There is evidence to support that an even lower concentration may be effective, as a % solution was utilized by Kaewpradub and colleagues, although higher concentrations have safely been used.
ALTABAX was evaluated in a placebo-controlled trial that enrolled adult and pediatric subjects aged 9 months and older for treatment of impetigo up to 100 cm² in total area (up to 10 lesions) or a total body surface area not exceeding 2%. The majority of subjects enrolled (164/210, 78%) were under the age of 13. The trial was a double-blind, randomized, multi-center, parallel-group comparison of the safety of ALTABAX and placebo ointment, both applied twice daily for 5 days. Subjects were randomized to ALTABAX or placebo (2:1). Subjects with underlying skin disease (., pre-existing eczematous dermatitis ) or skin trauma , with clinical evidence of secondary infection, were excluded from these trials. In addition, subjects with any systemic signs and symptoms of infection (such as fever) were excluded from the trial. Clinical success was defined as the absence of treated lesions, or treated lesions had become dry without crusts with or without erythema compared with baseline, or had improved (defined as a decline in the size of the affected area, number of lesions or both) such that no further antimicrobial therapy was required. The intent-to-treat clinical (ITTC) population consisted of all randomized subjects who took at least 1 dose of trial medication. The clinical per protocol (PPC) population included all ITTC subjects who satisfied the inclusion/exclusion criteria and subsequently adhered to the protocol. The intent-to-treat bacteriological (ITTB) population consisted of all randomized subjects who took at least 1 dose of trial medication and had a pathogen identified at trial entry. The bacteriological per protocol (PPB) population included all ITTB subjects who satisfied the inclusion/exclusion criteria and subsequently adhered to the protocol.