Footsave
Footsave Uses, Dosage, Side Effects, Food Interaction and all others data.
Allantoin is a substance that is endogenous to the human body and also found as a normal component of human diets . In healthy human volunteers, the mean plasma concentration of allantoin is about 2-3 mg/l. During exercise, the plasma allantoin concentration rapidly increases about two fold and remains elevated . In human muscle, urate is oxidized to allantoin during such exercise . The concentration of allantoin in muscles increases from a resting value of about 5000 ug/kg to about 16000 ug/kg immediately after short-term exhaustive cycling exercise .
More specifically, allantoin is a diureide of glyoxylic acid that is produced from uric acid. It is a major metabolic intermediate in most organisms. Allantoin is found in OTC cosmetic products and other commercial products such as oral hygiene products, in shampoos, lipsticks, anti-acne products, sun care products, and clarifying lotions . Allantoin has also demonstrated to ameliorate the wound healing process in some studies .
There is no well controlled and appropriate data that can formally substantiate the pharmacodynamic properties of allantoin . Nevertheless, ongoing studies suggest that allantoin possesses moisturizing and keratolytic effects, as well as abilities to increase the water content of the extracellular matrix and enhance the desquamation of upper layers of dead skin cells, all of which are activities that can promote cell proliferation and facilitate wound healing .
Dimethicone is a silicone oil that is also known as polydimethylsiloxane (PDMS). It has viscoelastic properties. Dimethicone is used as a surfactant, antifoaming agent, carminative in various products such as medical devices, food products, and lubricants. It is used in a number of health and beauty products including hair care products such as shampoo, conditioner, leave-in conditioner, and de-tangling products. On skin, it is also observed to have moisturizing actions .
A study found that that the 100 % dimethicone product is a safe and highly effective head lice treatment for children and may serve as less toxic and less resistance-prone alternative to pesticide-containing products .
This drug acts as a skin protectant by helping to treat and prevent minor skin irritation due to diaper rash and seals out moisture from the diaper area. This drug temporarily protects and helps prevent chafed, chapped, cracked or windburned skin. .
Urea is an osmotic diuretic similar to mannitol but more irritant. It induces diuresis by increasing osmotic pressure of the glomerular filtrate and increasing excretion of sodium, potassium and chloride ions. Its osmotic effect also draws water from cells e.g. brain, CSF and anterior chamber of the eye, thereby decreasing intracranial or intraocular pressure. Unlike mannitol, urea penetrates the eye and causes a rebound increase in intraocular pressure if the plasma concentration of the drug is less than that in the vitreous humour. Applied topically, urea promotes hydration of keratin and mild keratolysis in dry skin. It increases water uptake by the stratum corneum and has an antipruritic effect.
As a humectant, urea draws water into the striatum corneum.
| Trade Name | Footsave |
| Generic | Allantoin + Dimethicone + Urea |
| Type | Cream |
| Therapeutic Class | |
| Manufacturer | Anthem Biopharma Pvt Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Allantoin is an ingredient used in skin care products to relieve irritation and protect minor cuts, scrapes, and burns.
Allantoin is commonly applied in a variety of topical vehicles or applications such as cosmetic creams, toothpastes, mouthwashes, shampoos, lipsticks, anti-acne products, and lotions for the purpose of moisturizing skin, enhancing the smoothness of skin, stimulating the healing of wounds, and soothing irritated skin .
Dimethicone is an ingredient used to treat dry and irritated eyes.
Dimethicone is a colorless liquid with both cosmetic and therapeutic uses. It is used in topical creams and ointments to help distribute the active ingredients. Dimethicone is used as an anti-foaming agent, a hair and skin conditioner, and in the treatment of head lice and, as an anti-bloating/anti-flatulence agent , .
Urea 25% cream is used for the treatment of dry, cracked skin and hyperkeratosis on the soles of the feet including the heels. Suitable for general and diabetic foot care.
Footsave is also used to associated treatment for these conditions: Scarring, Dental cleaning, Skin Lightening, Skin protectionAcute Diarrhoea, Aerophagy, Dry Skin, Duodenal Ulcer, Dyspepsia, Flatulence, Gastric Ulcer, Gastritis, Gastro-esophageal Reflux Disease (GERD), Hiatus Hernia, Pancreatic Insufficiency, Post Operative Gas, Pre-operative Gas, Stress Ulcers, Bowel preparation therapy, Carbohydrate Digestion, Digestive Aid, Fat Digestion, Protein DigestionDermatitis, Dermatitis, Contact, Dermatitis, Eczematous, Dry Eyes, Dry Skin, Dry Skin; Eczema, Eczema, Dyshidrotic, Eye pruritus, Helicobacter Pylori Infection, Insect Bites, Lichen Planus (LP), Neurodermatitis, Nummular Dermatitis, Psoriasis, Seborrheic Dermatitis, Sunburn, Allergic skin manifestations, Anal eczema, Calluses, Moisturizing
How Footsave works
There is no well controlled data that can formally substantiate the method of action . However, ongoing studies suggest that there may exist a histological wound healing profile induced by allantoin in rats that leads to the amelioration and fastening of the reestablishment of normal skin . This facilitation of wound healing is supported by observations that wounds inflicted to rat subjects to which topical allantoin preparations were applied histologically demonstrated increased vasodilation, presence of inflammatory exudates, number of inflammatory cells, angiogenesis, fibroblast proliferation, and increased collagen deposition when compared to rat subjects with wounds that did not receive any allantoin administration .
When applied topically, dimethicone forms a layer to delay the evaporation of water . In the treatment of head lice dimethicone 100, the respiratory systems of head lice are targeted. NYDA works by suffocating the lice, nymphs and the embryos. The physical properties of this drug, including the viscosity and spreading property of the solution allow it to easily flow into the respiratory system of all developmental stages of the insect, causing suffocation and death of the organisms. It diffuses through the stigmata (spiracles) of the lice, into the tracheae of the head lice as well as through the aeropyles of the egg operculum. The solution then displaces oxygen. The low viscosity, volatile dimethicone enables the NYDA head lice solution to penetrate into the breathing system. Its evaporation causes the thickening of the NYDA solution. The remaining high viscosity dimethicone ultimately encloses the respiratory system and thus leading to suffocation of all stages of head lice (adult lice, larvae and eggs). This mode of action prevents the development of lice resistance by preventing the formation of new progency .
Studies performed using house crickets and lice suggest a close correlation between the death of the lice and the influx of the solution into the insect head tracheae. These data strongly suggest that the total filling of the head tracheae immediately blocks the oxygen supply to the insect central nervous system. Death, following numerous stages of disability after the entrance of dimethicones into the abdominal tracheal system, demonstrates the sequence of oxygen deprivation. NYDA was applied directly to the head and mouth of the organism, and was found to have no effect when applied solely to the outside of the head/mouth .
Dosage
Footsave dosage
Apply a small amount twice daily to the skin after washing or bathing.
In extreme cases, before bed you may choose to cover the feet with plastic wrap and then put socks over the plastic wrap to increase the hydration rate.
Recommended for use on adults and children over 12 years.
After use, wear sandals or slippers to avoid staining carpets.
Side Effects
May irritate inflamed skin or exudative lesions. Transient stinging may occur in deep cracks. Discontinue use if local irritation or rash occurs during use.
Toxicity
No studies on repeated dose toxicity and reproductive toxicity have been submitted. Moreover, studies show that the tumor incidence in allantoin treated animals did not differ largely from that found in untreated controls. As a result, further or additional toxicity, mutagenicity, or carcinogenicity tests are not required in view of the endogenous nature of allantoin and the general lack of overall toxicity .
Finally, as allantoin is a normal component of the diet in humans and is a substance of endogenous origin present in the body of humans, it is generally recognized as being a safe substance for humans .
The minimum lethal oral dose of dimethicone 200 (50 cs), dimethicone 550 (75 cs), dimethicone in rats .
A 76-week dietary toxicity study of a silicone antifoam compound (94% polydimethylsiloxane silicone oil and 6% silicone dioxide) was performed in mice. Three groups were given diet containing 0, 0.25%, or 2.5% of the test article. The dose levels in the treatment groups were estimated to be 580 and 5800 mg/kg/day. Mortality was increased in the 5800 mg/kg/day females. No target organs of toxicity were observed. The no-effect dose was 580 mg/kg/day. This study is of limited usefulness for assessing the toxicity of dimethicones, due to the small number of organs/tissues that were examined .
In one clinical study, 145 subjects were treated with either NYDA (dimethicone )or with a permethrin-based lice product. The number of subjects experiencing any adverse events was similar in both groups. In the NYDA group, 29 adverse events were reported in 25 subjects. All except two adverse events were categorized as being unrelated to the lice treatment (e.g., superficial wound after a fall, otitis externa following swimming in a pool). Two patients in the NYDA group experienced ocular irritation after treatment when the product entered the eyes. The irritation resolved spontaneously in both cases after rinsing the eyes with clean water .
Volume of Distribution
Following injection of [14C]dimethicone fluid in the hind limb of rats, the radioactivity was distributed primarily in the gastrointestinal tract, and no evidence of metabolism was observed. When [14C]dimethicone was administered through i.p. injection in rats, the following distribution of radioactivity was observed at 25 days after dosing: 51% in adipose tissue, 27% in gastrointestinal tissues, and 15% in liver .
Elimination Route
In studies on human subjects, a recovery of 19% and 34% of allantoin in the urine was observed but only in two individuals and only after the administration of massive doses of allantoin . After intravenous administration, recovery in the urine was practically quantitative with doses of 75 to 600 mgm in the human model . After 240 mgm, excretion continued for 72 hours in human subjects and the results were similar in regards to subcutaneous injection .
This drug is not believed to be absorbed when used in quantities from 1-30% .
Half Life
When studied in cattle, sheep, and horses, the half-life of allantoin is in the range of 1 to 2.5 hours .
Clearance
Some studies suggest that the average renal clearance of allantoin in normal, healthy human subjects is approximately 123 cc per minute . It is generally agreed upon that exogenously administered allantoin is rapidly excreted .
Elimination Route
Urinary clearance is the predominant excretion route .
Pregnancy & Breastfeeding use
Urea cream can be used during pregnancy and lactation.
Contraindication
For use only on the soles of the feet and heels unless otherwise directed by the prescriber. Pregnant women should consult their Healthcare Professional before use. For External Use Only. Avoid contact with eyes. Keep out of reach of children. Always replace cap after use. Do not use if tube seal is broken or appears tampered with.
Storage Condition
Store between 10° – 30° C in a dry place. Keep lid tightly closed.
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