Vitapep Forte

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 , .

Children:

• Reduced or absence of pancreatic exocrine secretion
• Cystic fbrosis

Adults:

In the conditions with defcient pancreatic exocrine function such as-

• Following pancreatectomy
• Following total gastrectomy
• Chronic pancreatitis
• Steatorrhea
• Somatostatinoma
• Celiac disease

Vitapep Forte 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 DigestionAerophagy, Deficiency Digestive enzymes, Diarrhoea, Dyspepsia, Exocrine Pancreatic Insufficiency, Flatulence, Gastrointestinal Discomfort, Pancreatic Insufficiency, Post Operative Gas, Pre-operative Gas, Fat malabsorption, Meteorism, Bile Duct Disorders, Carbohydrate Digestion, Digestive Aid, Fat Digestion, Liver Metabolism, Protein Digestion

How Vitapep Forte 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 .

Pancrelipase is used to replace the deficiency of pancreatic enzymes. As abovementioned, pancrelipase is formed by a mixture of lipase, protease, and amylase which are able to break down fat, protein, and starches, respectively, in the small intestine. For a more specific description of each mechanism of action, please visit Pancrelipase amylase, Pancrelipase protease and Pancrelipase lipase.

Dosage

Vitapep Forte dosage

1-3 tablets daily with meal or as per direction of the physician.

Side Effects

Pancreatin may cause buccal and perianal soreness, particularly in infants. Hypersensitivity reactions have been reported; these may be sneezing, lacrimation or skin rashes.

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 .

The studies of the toxicology of pancrelipase are not needed as this drug has been used clinically for a long time. Clinical overdose studies proved no effect on lungs, pancreas, liver and kidneys but it can produce symptoms such as diarrhea or stomach upset. Carcinogenicity studies have not shown any increased incidence with the use of pancrelipase. As pancrelipase is not absorbed, the effect on fetal development or reproduction is not expected.

Precaution

A proper balance between fat, protein and starch intake must be maintained to avoid temporary indigestion.

Interaction

Alkaline media will rupture the enteric coating. As such to prevent bursting out of the content in the stomach Pancreatin should not be used concurrently with antacid.

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 .

Pancrelipase acts locally in the GI tract and it is not absorbed in any significant amount thus, the volume of distribution is not relevant.

Elimination Route

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

Pancrelipase acts locally in the GI tract and it is not absorbed in any significant amount.

Half Life

Pancrelipase acts locally in the GI tract and it is not absorbed in any significant amount thus, the elimination half-life is not relevant.

Clearance

Pancrelipase acts locally in the GI tract and it is not absorbed in any significant amount thus, the clearance rate is not relevant.

Elimination Route

Pancrelipase is entirely eliminated in the feces.

Pregnancy & Breastfeeding use

Pregnancy category C. Not known whether Pancreatin is distributed into milk. Caution advised if Pancreatin is used.

Acute Overdose

Excessive dosage may produce a laxative efect. Systemic toxicity does not occur. Very high dosage may cause hyperuricemia and hyperuricos-uria.

Storage Condition

Store in a cool and dry place. Keep out of the reach of children.

Innovators Monograph

You find simplified version here Vitapep Forte