Decubal
Decubal Uses, Dosage, Side Effects, Food Interaction and all others data.
Cetyl alcohol, also known as 1-hexadecanol or n-hexadecyl alcohol, is a 16-C fatty alcohol with the chemical formula CH3(CH2)15OH. It can be produced from the reduction of palmitic acid. Cetyl alcohol is present in a waxy white powder or flake form at room temperature, and is insoluble in water and soluble in alcohols and oils . Discovered by Chevrenl in 1913, cetyl alcohol is one of the oldest known long-chain alcohol . It may be contained in cosmetic and personal care products such as shampoos, creams and lotions. Mainly it is used as an opacifier, emulsifier, and thickening agent that alter the thickness of the liquid, and increase and stabilize the foaming capacity. Due to its water-binding property, cetyl alcohol is commonly used as an emollient that prevents drying and chapping of the skin . According to the FDA Code of Federal Regulations, cetyl alcohol is a safe synthetic fatty acid in food and in the synthesis of food components under the condition that it contain not less than 98 percent of total alcohols and not less than 94 percent of straight chain alcohols . Cetyl alcohol is also listed in the OTC ingredient list as a skin protectant for skin irritations caused by poison ivy, oak, sumac, and insect bites or stings . Cetyl alcohol is reported to be a mild skin or eye irritant.
Cetyl alcohol exhibits skin protect properties against skin irritations caused by bites, rashes and stings. The inhibitory action of cetyl alcohol against the growth of Mycoplasma gallisepticum and Mycopiasma pneumoniae has been reported .
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. .
Glycerol is a simple polyol compound. It is a colorless, odorless, viscous liquid that is sweet-tasting and non-toxic. Glycerol is used in medical, pharmaceutical and personal care preparations, mainly as a means of improving smoothness, providing lubrication, and as humectants.
Isopropyl myristate is a moisturizer with polar characteristics used in cosmetics and topical medical preparations to ameliorate the skin absorption. Isopropyl myristate has been largely studied and impulsed as a skin penetration enhancer.
At the moment the primary usage for which isopropyl myristate is formally indicated is as the active ingredient in a non-prescription pediculicide rinse .
Isopropyl myristate is an emollient vehicle that is effective at enhancing the penetration of other medical agents that may be incorporated into the vehicle as active agents . In one study, a 50:50 isopropanol-isopropyl myristate binary enhancer synergistically increased the transport of estradiol across a two-layer human epidermis in vitro .
Trade Name | Decubal |
Generic | Anhydrous Lanolin + Isopropyl Myristate + Cetyl Alcohol + Sorbitan Monostearate + Polysorbate + Glycerol + Dimethicone + Sorbic Acid |
Type | Cream |
Therapeutic Class | |
Manufacturer | LF Beauty Manufacturing Indonesia, Actavis Indonesia |
Available Country | Indonesia |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
No therapeutic indications in medicinal products. Indicated to be used as an indirect additive in food contact substances, or an ingredient in commercial or cosmetic products.
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 , .
Glycerol helps lubricating in sexual intercourse specially for post menopausal women to reduce irritation, for lubrication during vaginal examinations, endoscopy, catheterization for gloves and instruments. It is also used to treat or prevent dry skin.
Isopropyl myristate is a polar skin moisturizer that is used to enhance skin penetration of drugs.
The primary medical indication for which isopropyl myristate is formally used as an active ingredient in a patient care product is as a non-prescription pediculicide rinse .
Decubal is also used to associated treatment for these conditions: Dry, itchy skinAcute 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 DigestionHead Lice Infestation
How Decubal works
Cetyl alcohol has hydrating properties that makes it a suitable emulsifier and stabilizer in pharmaceutical formulations. It is also present in washable ointment base due to its dispersant abilities and stabilizing properties . Potential antimicrobial activity of cetyl alcohol may be due to a change in cell membrane permeability that either blocks absorption of essential nutrients and induction of outward diffusion vital cellular components . This proposed mechanism of action is thought to be similar for other long-chain aliphatic alcohols with same antimicrobial activity, such as myristyl alcohol and behenyl alcohol .
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 .
As a pediculicide, isopropyl myristate is capable of physically coating the exoskeleton bodies of lice . This physical coating subsequently immobilizes the lice and works to dissolve the wax covering on the insect exoskeleton and blocks the insects' airways, leading to death by dehydration . Although this physical action of isopropyl myristate results in little lice resistance (given the lack of immunologic or chemical activity in this mechanism of action), the substance is also not ovicidal, which means any eggs that may have been laid by lice would not be affected . Moreover, isopropyl myristate is capable of eliciting its pediculicide action in a contact time of only 10 minutes per each necessary administration .
Dosage
Decubal dosage
Apply as needed.
Toxicity
Acute oral LD50 in mouse is 3200 mg/kg and acute dermal LD50 is >2600 mg/kg in rabbit . It is considered to be slightly toxic in humans in case of oral ingestion at doses of 5 g/kg and greater . In a rat study, the effects of toxicity were mainly in the central nervous system (CNS) leading to CNS depression and difficulty in respiration after 7-14 days post-administration via stomach tube . In a subchronic dermal toxicity study of rabbits, topical application of 11.5 % cetyl alcohol was associated with histological findings of keratosis, hyperkeratosis, and papillary projections of the epidermis, all of which are features of exfoliative dermatitis . However it is concluded that there is no evidence of major skin irritation and systemic toxicity of cetyl alcohol. Inhalation of 26 ppm cetyl alcohol vapors in animals caused slight irritation of the mucous membranes of the eyes, nose, throat, and respiratory passages . Cetyl Alcohol was not mutagenic in Salmonella typhimurium LT2 mutant strains in the spot test .
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 .
Readily available information regarding the pharmacokinetics of isopropyl myristate is not available .
Precaution
Glycerol is for external use only. When using this product do not get into eyes. Do not use on deep or puncture wounds, animal bites & serious burns.
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 .
Readily available information regarding the pharmacokinetics of isopropyl myristate is not available .
Elimination Route
Following ingestion at a dose level of 2.0 g/kg in rats, cetyl alcohol was partly absorbed . Administration of 0.2 mg cetyl alcohol in rat by stomach tube indicated good absorption as 63-96 % of radiolabeled cetyl alcohol was detected in the lymph . About 15% of total cetyl alcohol was unchanged during its passage through the mucosal cells of the small intestine but mostly underwent oxidation to palmitic acid . The extent of absorption was reported to be 26% in poultry .
This drug is not believed to be absorbed when used in quantities from 1-30% .
Dermal absorption of isopropyl myristate is predicated to be 0.00020 mg/cm2/event, which is considered a very low absorption rate . In a study, topically applied isopropyl myristate was largely retained in the stratum corneum . It was not detected in the receptor fluid of flow-through diffusion cells in in-vitro skin permeation experiments using human epidermis (stratum corneum and viable epidermis) and dermis of varying thickness .
Half Life
Readily available information regarding the pharmacokinetics of isopropyl myristate is not available .
Clearance
Readily available information regarding the pharmacokinetics of isopropyl myristate is not available .
Elimination Route
Following ingestion at a dose level of 2.0 g/kg in rats, about 20% of the dose was recovered as unchanged molecule in the feces . This may be due to the interconvertibility of fatty acids and alcohols, resulting in the conversion of palmitic acid to cetyl alcohol during its passage through the intestinal mucosal cells into the intestinal lumen . In rats, cetyl Alcohol was also excreted in the urine as conjugated glucuronic acid and as expired carbon dioxide .
Readily available information regarding the pharmacokinetics of isopropyl myristate is not available .
Contraindication
Usually well tolerated. People with prior history of sensitivity or allergic reaction to this product or any of its ingredients should not use it.
Storage Condition
Store in a cool & dry place, protected from light. Keep out of reach of children.
Innovators Monograph
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