Norper

Norper Uses, Dosage, Side Effects, Food Interaction and all others data.

Alginic acid, also referred to as algin or alginate, is a hydrophilic or anionic polysaccharide isolated from certain brown seaweed (Phacophycae) via alkaline extraction. It is present in cell walls of brown algae where it forms a viscous gel when binding with water. Alginic acid is a linear polymer consisted of L-glucuronic acid and D-mannuronic acid residues connected via 1,4-glycosidic linkages . Available in different types of salt, alginic acid has been used in a variety of uses in food, cosmetics and pharmaceu-tical products for over 100 years . Alginic acid is an FDA-approved food ingredient in soup and soup mixes as an emulsifier, thickener, and stabilizer . It is also available in oral dietary supplements and is found in antacids such as Gaviscon to inhibit gastroesophageal reflux by creating a physical barrier in presence of gastric acid . Alginate-based raft-forming formulations in the management of heartburn and gastric acid reflux have been used worldwide for over 30 years .

Alginic acid reduces reflux via its floating, foaming, and viscous properties . Alginic acid precipitates upon contact with gastric acid to create a mechanical barrier, or a "raft", that displaces the postprandial acid pocket . The formation of a raft is thought to occur rapidly, often within a few seconds of dosing . In clinical trials, alginic acid was effective in reducing the symptoms of gastroesophageal reflux disease (GERD) . In healthy volunteers, alginic acid in combination with an antacid was effective in decreasing postprandial reflux in the upright position . Alginic acid is able to bind to cations when ingested .

Magaldrate is a hydroxymagnesium aluminate complex that is converted rapidly in gastric acid to Mg(OH)2 and Al(OH)3, which are absorbed poorly and thus provide a sustained antacid effect

Simethicone is used as an antiflatulent to relieve symptoms commonly referred to gas including upper GI bloating, pressure, fullness or stuffed feeling. The clinical use of Simeticone is based on its antifoaming properties. Its antifoaming action relieves flatulence by dispersing and preventing the formation of mucous surrounded gas pockets in the GI tract. Simeticone acts in the stomach and intestines to change the surface tension of gas bubbles, enabling them to coalesce; thus gas is freed and eliminated more easily by belching or passing flatus. Simeticone aids in the elimination of gas from the GI tract and can be used to reduce postoperative gas pains. Simeticone can also be used prior to gastroscopy to enhance visualization and prior to radiography of the intestine to reduce gas shadows.

Simethicone decreases the surface tension of gas bubbles in the gastrointestinal tract, facilitating their expulsion. It has a short duration of action as it is generally given as needed, and a wide therapeutic index as it is not systemically absorbed.

Trade Name Norper
Generic Alginic Acid + Magaldrate + Simethicone
Type Tablet
Therapeutic Class
Manufacturer Dwd Pharmaceuticals Ltd
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Norper
Norper

Uses

Indicated for the management of gastric reflux, reflux oesophagitis, hiatus hernia, heartburn (including heartburn of pregnancy) and similar gastric distress .

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.

Flatulence, abdominal distention, fullness, gas and windy colic: Simethicone is an excellent and effective antiflatulent. It is used for relief of the painful symptoms of excess gas in the digestive tract. Such gas is frequently caused by excessive swallowing of air or by eating foods that disagree. Simethicone drop is especially used in infants, acts in the stomach and intestines. Thus Simethicone enables freeing and eliminating the gas more easily by belching or passing flatus.

Large bowel preparation: Addition of Simethicone to a polyethylene glycol bowel preparation produces symptomatic improvement prior to investigation in the management of accidental ingestion of foaming detergents.

Treatment of poisoning: Simethicone has an anecdotal use as an antifoaming agent in the management of accidental ingestion of foaming detergents.

Norper is also used to associated treatment for these conditions: Acid Reflux, Dyspepsia, Flatulence, Gastroesophageal Reflux, Heartburn, Oesophageal Reflux, Reflux Esophagitis (RE), RegurgitationAcid indigestion, Aspiration, Bloating, Calcinosis, Dyspepsia, Gastroesophageal Reflux, Gastrointestinal Bleeding, Heartburn, Hyperacidity, Hyperparathyroidism, Kidney Stones, Peptic Ulcer, Stress UlcersAbdominal Cramping, Abdominal Pain, Abdominal distension, Acid Reflux, Bloating, Colic, Diarrhoea, Distention, Dyspepsia, Flatulence, Gastric Ulcer, Gastritis, Heartburn, Hiatus Hernia, Hyperacidity, Pain, Pancreatic Insufficiency, Peptic Esophagitis, Peptic Ulcer, Stomach ache, Gastrointestinal cramps, Gastrointestinal cramps caused by Gas, Gastrointestinal spasms, Stomach cramps, Antacid therapy, Bowel preparation therapy

How Norper works

Once orally administered, alginic acid reacts with gastric acid to form a floating "raft" of alginic acid gel on the gastric acid pool. Alginate-based raft-forming formulations commonly contain sodium or bicarbonate; bicarbonate ions are converted to carbon dioxide in presence of gastric acid and get entrapped within the gel precipitate, converting it into a foam which floats on the surface of the gastric contents, much like a raft on water . The "raft" has a near neutral pH due to carbon dioxide and floats on the stomach contents and potentially functions as a barrier to impede gastroesophageal reflux . In severe cases, the raft itself may be refluxed into the oesophagus in preference to the stomach contents and exert a demulcent effect .

Simethicone is a surfactant that decreases the surface tension of gas bubbles in the gastrointestinal tract, more easily allowing gas to exit the body.

Dosage

Norper 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

Take after meals and at bedtime. Can be given with infant’s feeds. Shake the bottle well before each use.

  • Children less than 2 years of age: 20 mg (0.3 ml Simethicone Paediatric Drops) 4 times daily up to 240 mg/day (3.6 ml Simethicone Paediatric Drops).
  • Children 2-12 years of age: 40 mg (0.6 ml Simethicone Paediatric Drops) 4 times daily.
  • Adults: 40-125 mg or 1-3 Simethicone chewable tablets; 4 times daily, up to 500 mg/day (12 Simethicone chewable tablets).

Side Effects

Constipation and diarrhea may occur.

Simethicone is physiologically inert and no adverse effect has been noted after oral ingestion.

Toxicity

Probable oral lethal dose reported in humans is above 15 g/kg . Ingestion of large quantities may result in abdominal distension, intestinal obstruction, nausea, vomiting, and difficulty swallowing. Aspiration or inhalation may lead to pneumonitis . In the event of overdosage symptomatic treatment should be given .

Data regarding overdoses with simethicone are rare due to the fact that it is not systemically absorbed.. In the case of an overdose stop the drug and initiate symptomatic and supportive care.

Precaution

Do not exceed 12 doses per day except under the advice and supervision of a physician.

Interaction

There is no evidence that Simethicone modifies the effect of other drugs. The defoaming effect of Simethicone is reduced by antacids such as Aluminium Hydroxide and Magnesium Carbonate, which absorb the Silicone.

Volume of Distribution

This pharmacokinetic parameter is unlikely to apply for alginic acid.

Simethicone is not systemically absorbed and so these data are not readily available.

Elimination Route

The absorption into the systemic circulation from oral formulations of alginic acid is reported to be minimal, as the mode of action of alginic acid is physical .

Simethicone is not systemically absorbed and so these data are not readily available.

Half Life

This pharmacokinetic parameter is unlikely to apply for alginic acid.

Simethicone is not systemically absorbed and so these data are not readily available.

Clearance

This pharmacokinetic parameter is unlikely to apply for alginic acid.

Simethicone is not systemically absorbed and so these data are not readily available.

Elimination Route

This pharmacokinetic parameter is unlikely to apply for alginic acid.

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.

Simethicone is eliminated 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.

Pregnant women: No data are available to suggest any harmful effects.

Lactating mother: Excretion of simethicone in breast milk has not been established, and would be most unlikely.

Contraindication

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

Storage Condition

Should be stored in cool and dry place, protected from light. Keep the medicine out of the reach of children.

Innovators Monograph

You find simplified version here Norper


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