Keydrox

Uses

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 , .

Magaldrate is used to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux, hiatal hernia and flatulence. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary.

Keydrox is also used to associated treatment for these conditions: Acute 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 DigestionAcid indigestion, Aspiration, Bloating, Calcinosis, Dyspepsia, Gastroesophageal Reflux, Gastrointestinal Bleeding, Heartburn, Hyperacidity, Hyperparathyroidism, Kidney Stones, Peptic Ulcer, Stress Ulcers

How Keydrox works

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

Keydrox dosage

Tablet: 1-3 tablets, after meals and at bed time or as directed by the physician.

Syrup: 2 to 3 teaspoonful, 3 or 4 times daily, half to one hour after or before meal and at bedtime

Side Effects

Constipation and diarrhea may occur.

Toxicity

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

This drug is not believed to be absorbed when used in quantities from 1-30% .

Elimination Route

Aluminium oxide: absorbed Al ions are eliminated in the urine (0.1-0.5 mg of Al in aluminium-containing antacid is absorbed from standard daily doses of antacid) while insoluble or poorly absorbed Al salts in the intestines are excreted through the feces.

Magnesium oxide: absorbed Mg ions (up to 30%) are eliminated in the urine, unabsorbed is excreted in the feces.

Pregnancy & Breastfeeding use

Pregnant women: Magaldrate may be used in pregnancy if indicated however one should avoid excessive dosage.

Lactating mother: Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.

Contraindication

Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal function

Innovators Monograph

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