Digel Orange
Digel Orange Uses, Dosage, Side Effects, Food Interaction and all others data.
Alumunium hydroxide acts on the HCI in the stomach by neutralization, forming aluminium chloride salt and water.
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.
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 | Digel Orange |
| Generic | Aluminium Hydroxide + Magnesium Hydroxide + Simethicone + Sodium Carboxymethylcellulose |
| Type | Syrup |
| Therapeutic Class | |
| Manufacturer | Laborate Pharmaceuticals India Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Aluminium Hydroxide is used for Duodenal ulcer, Dyspepsia, Flatulence, Gastric Hyperacidity, Gastric ulcer, Gastritis, Gastroesophageal reflux disease (GERD), Gastrointestinal hyperacidity, Heartburn, Heartburn & gastritis, Hyperacidity, Indigestion, Oesophagitis, Peptic ulcer disease, Stomach distension, Upper Gl bloating.
Acid regurgitation, Constipation, Gastric ulcer, Gastrointestinal hyperacidity, Heartburn, Indigestion, Non ulcer dyspepsia, Osmotic laxative
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.
Digel Orange is also used to associated treatment for these conditions: Acid indigestion, Colic, Constipation, Dyspepsia, Flatulence, Gastric Ulcer, Heartburn, Upset stomach, Antacid therapy, Gastric Acid SuppressionAbdominal 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 Digel Orange works
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.
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
Digel Orange dosage
Usual Adult Dose: Up to 1 g daily.
Dyspepsia: 500 to 600 mg orally 4 to 6 times a day as needed, between meals and at bedtime.
Duodenal Ulcer: 500 to 1500 mg orally 4 to 6 times a day as needed, between meals and at bedtime.
Erosive Esophagitis: 500 to 1500 mg orally 4 to 6 times a day as needed, between meals and at bedtime.
Gastric Ulcer: 500 to 1500 mg orally 4 to 6 times a day as needed, between meals and at bedtime.
Gastroesophageal Reflux Disease: 500 to 1500 mg orally 4 to 6 times a day as needed, between meals and at bedtime.
Zollinger-Ellison Syndrome: 500 to 3600 mg orally 4 to 6 times a day as needed, between meals and at bedtime.
Hyperphosphatemia: 500 to 1000 mg orally 4 times a day, with meals and at bedtime. The dosage should be titrated to the serum phosphate level. Max Dosage: 10 g daily in divided doses may be taken with or without food.
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
Constipation; intestinal obstruction (with large doses); phosphate depletion may occur with prolonged admin or large doses.
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
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.
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
Chronic renal impairment; CHF; oedema; cirrhosis and low Na diets; patients with recent Gl haemorrhage. Administer 2-3 hrs before/after another medication to minimise drug interactions. Pregnancy and lactation
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
Enhanced absorption with citrates or ascorbic acid. Decreases absorption of allopurinol, tetracyclines, quinolones, cephalosporins, biphosphonate derivatives, corticosteroids, cyclosporin, delavirdine, Fe salts, imidazole antifungals, isoniazid, mycophenolate, penicillamine, phosphate supplements, phenytoin, phenothiazines, trientine.
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
The peak action and distribution of magnesium hydroxide are variable.
Simethicone is not systemically absorbed and so these data are not readily available.
Elimination Route
About 15%-50% of magnesium hydroxide is absorbed very slowly through the small intestine.
Simethicone is not systemically absorbed and so these data are not readily available.
Half Life
N/A
Simethicone is not systemically absorbed and so these data are not readily available.
Clearance
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.
Simethicone is not systemically absorbed and so these data are not readily available.
Elimination Route
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.
Simethicone is eliminated in the feces.
Pregnancy & Breastfeeding use
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
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
Hypersensitivity to aluminium salts.
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
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