Rosil Antacid
Rosil Antacid 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 .
Magnesium hydroxide increases peristaltic activity causing osmotic retention of fluids, thus resulting in bowel evacuation. It also reduces stomach acid by reacting with hydrochloric acid to form Mg chloride.
As an antacid, magnesium hydroxide suspension neutralizes gastric acid by reacting with hydrochloric acid in the stomach to form magnesium chloride and water. It is practically insoluble in water and does not have any effect until it reacts with the hydrochloric acid in the stomach. There, it decreases the direct acid irritant effect and increases the pH in the stomach leading to inactivation of pepsin. Magnesium hydroxide enhances the integrity of the mucosal barrier of the stomach as well as improving the tone of both the gastric and esophageal sphincters.
As a laxative, the magnesium hydroxide works by increasing the osmotic effect in the intestinal tract and drawing water in. This creates distension of the colon which results in an increase in peristaltic movement and bowel evacuation.
Magnesium trisilicate is an inorganic compound that is used as an antacid in the treatment of peptic ulcers.
Magnesium trisilicate works by increasing the pH of gastric juice via a neutralisation reaction. It also precipitates colloidal silica, which can coat gastrointestinal mucosa conferring further protection.
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 | Rosil Antacid |
Generic | Alginic Acid + Magnesium Hydroxide + Dried Aluminium Hydroxide + Magnesium Trisilicate + Simethicone + Syrup Base |
Weight | 200mg, 250mg,250mg, 250mg, 120mg |
Type | Suspension |
Therapeutic Class | |
Manufacturer | Richy Gold International Ltd |
Available Country | Nigeria |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Indicated for the management of gastric reflux, reflux oesophagitis, hiatus hernia, heartburn (including heartburn of pregnancy) and similar gastric distress .
Acid regurgitation, Constipation, Gastric ulcer, Gastrointestinal hyperacidity, Heartburn, Indigestion, Non ulcer dyspepsia, Osmotic laxative
Magnesium trisilicate is an antacid used for the symptomatic treatment of peptic ulcers.
For the treatment of peptic ulcers. Relieving indigestion and heartburn.
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.
Rosil Antacid is also used to associated treatment for these conditions: Acid Reflux, Dyspepsia, Flatulence, Gastroesophageal Reflux, Heartburn, Oesophageal Reflux, Reflux Esophagitis (RE), RegurgitationAcid indigestion, Colic, Constipation, Dyspepsia, Flatulence, Gastric Ulcer, Heartburn, Upset stomach, Antacid therapy, Gastric Acid SuppressionAcid Reflux, Acid indigestion, Bloating, Colic, Flatulence, Gastric Ulcer, Heartburn, Upset stomachAbdominal 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 Rosil Antacid 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 .
The suspension of magnesium hydroxide is ingested and enters the stomach. According to the amount ingested, the magnesium hydroxide will either act as an antacid or a laxative.
Through the ingestion of 0.5-1.5 grams (in adults) the magnesium hydroxide will act by simple acid neutralization in the stomach. The hydroxide ions from the magnesium hydroxide suspension will combine with the acidic H+ ions of the hydrochloric acid made by the stomachs parietal cells. This neutralization reaction will result in the formation of magnesium chloride and water.
Through the ingestion of 2-5 grams (in adults) the magnesium hydroxide acts as a laxative in the colon. The majority of the suspension is not absorbed in the intestinal tract and will create an osmotic effect to draw water into the gut from surrounding tissues. With this increase of water in the intestines, the feces will soften and the intraluminal volume of the feces will increase. These effects still stimulate intestinal motility and induce the urge to defecate. Magnesium hydroxide will also release cholecystokinin (CKK) in the intestines which will accumulate water and electrolytes in the lumen and furthermore increase intestinal motility.
The gelatinous silicon dioxide, formed by the reaction of magnesium trisilicate with gastric contents is said to protect ulcerated mucosal surfaces and favor healing.
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
Rosil Antacid dosage
Gastrointestinal hyperacidity:
- Adult: Up to 1 g daily, usually given in conjunction with an aluminium-containing antacid eg, aluminium hydroxide.
Osmotic laxative:
- Adult: 2.4-4.8 g daily as a single dose or in divided doses.
- Child: 6-11 yr: 1.2-2.4 g daily; 2-5 yr: 0.4-1.2 g daily. Doses may be given as a single dose or in divided doses.
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
GI irritation, diarrhoea, abdominal cramps; hypermagnesaemia (in patients with renal impairment). Paralytic ileus.
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 .
LD50=8500 mg/kg (rat, oral)
Common side effects include drowsiness or flushing (warmth, redness or tingly feeling).
Daily use of magnesium hydroxide can result in fluid and electrolyte disturbances.
Excessive use of the laxative effects of magnesium hydroxide may result in abdominal cramping, nausea and/or diarrhea.
In overdose, symptoms of gastrointestinal irritation and/or watery diarrhea may occur.
Magnesium hydroxide poisoning can result in hypermagnesemia which includes symptoms of: nausea, vomiting, flushing, thirst, hypotension, drowsiness, confusion, loss of tendon reflexes, muscle weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest.
Not to be used in individuals with any form of kidney disease or renal failure, a magnesium restricted diet or with any sudden changes in bowel movement lasting over two weeks. Also not to be used in those individuals with abdominal pain, nausea, vomiting, symptoms of appendicitis or myocardial damage, heart block, fecal impaction, rectal fissures, intestinal obstruction or perforation or renal disease. Not to be used in women who are about to deliver as magnesium crosses the placenta and is excreted in small amounts in breast milk.
Using magnesium hydroxide with aluminum hydroxide can decrease the absorption rate of these drugs.
Magnesium hydroxide can react with digoxin, dicoumerol and cimetidine.
Use of ibuprofen with magnesium hydroxide can increase the absorption of the ibuprofen.
Use of magnesium hydroxide with penicallamine, bisphosphates, ketoconazole, quinolones or tetracycline can decrease the absorption of these drugs.
Enteric-coated tablets can be prematurely released when taken with magnesium hydroxide.
It is important to routinely monitor levels of serum magnesium and potassium in patients using magnesium hydroxide. Serum magnesium levels are necessary to determine how much magnesium is being absorbed and how much is being excreted by the kidneys. Excessive diarrhea can occur from use of magnesium hydroxide and thus it is important to also monitor serum potassium levels to ensure hypokalemia does not occur.
Adequate doses of magnesium trisilicate may cause diarrhea due to the action of soluble magnesium salts in the enteric tract. Approx 5% of the magnesium is absorbed.
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
Colostomy, ileostomy; electrolyte imbalance. Monitor for toxicity in patients with impaired renal function. Pregnancy.
Do not exceed 12 doses per day except under the advice and supervision of a physician.
Interaction
Decreases absorption of tetracyclines and biphosphonates. Separate administration of these and other drugs by around 2 hr.
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.
The peak action and distribution of magnesium hydroxide are variable.
The hydrated silicon dioxide formed in the stomach and passes into the intestinal track.
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 .
About 15%-50% of magnesium hydroxide is absorbed very slowly through the small intestine.
The hydrated silicon dioxide formed in the stomach and passes into the intestinal track where, silica can be partly absorbed.
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.
N/A
16-20 hours
Simethicone is not systemically absorbed and so these data are not readily available.
Clearance
This pharmacokinetic parameter is unlikely to apply for alginic acid.
Magnesium hydroxide is mainly excreted in the urine by the kidneys. Since the kidneys play a major role in its clearance, individuals with renal failure are at risk of hypermagnesemia with long term consumption as the appropriate amounts of magnesium may not be excreted.
Maximum magnesium clearance is directly proportional to creatinine clearance.
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.
After oral administration, up to 50% of the magnesium hydroxide suspension may be absorbed as magnesium ions through the small intestines and then rapidly excreted in the urine through the kidneys. The unabsorbed drug is mainly excreted in the feces and saliva.
Excreted in the urine.
Simethicone is eliminated in the feces.
Pregnancy & Breastfeeding use
Pregnancy category- A.
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
Intestinal obstruction, faecal impaction; renal failure; appendicitis.
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 Rosil Antacid