Nugel/Nugel-O Suspension Composition, Dose, Use, Side Effect

Nugel is an antacid suspension. One of the major differences between this antacid and others is that it has an ingredient with double action. However, Nugel-O is an advanced formulation. It has extra ingredients making it superior. It is manufactured in India by Sai Mirra Innopharm Pvt. Ltd.

Nugel-O

Composition Of Nugel

Each 5 mL Contains:

Alginic Acid BP 70 mg

Dried Aluminum Hydroxide BP 85 mg

Magnesium Hydroxide BP 85 mg

Magnesium Trisilicate BP 85 mg

Simethicone BP 50 mg

Excipients Nugel Suspension: Sorbitol Solution 70%, Propylene Glycol, Methyl Paraben, PropylParaben, Sodium Saccharin, Disodium Edetate, Sodium Citrate, Xanthan Gum, Mentholyptus flavor & Erythrosine supra color.

Composition Of Nugel-O

Each 5 mL Contains:

Alginic Acid BP 70 mg

Dried Aluminum Hydroxide BP 85 mg

Magnesium Hydroxide BP 85 mg

Magnesium Trisilicate BP 85 mg

Simethicone BP 50 mg

Oxetacaine BP 10 mg

Excipients Nugel-O Suspension: Sorbitol Solution 70%, Propylene Glycol, Methyl Paraben, PropylParaben, Sodium Saccharin, Disodium edetate, Sodium Citrate, Xanthan Gum, Mentholyptus flavor and Erythrosine supra color.

Actions And Pharmacology

Nugel is a balanced mixture of two antacids; aluminum hydroxide is a slow-acting antacid and magnesium hydroxide is a quick-acting one. The two are frequently combined in antacid mixtures.

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Aluminum hydroxide on its own is an astringent and may cause constipation. This effect is balanced by the effect of magnesium hydroxide, which, in common with other magnesium salts, may cause diarrhea. Gastro-intestinal side effects are thus rare with NUGEL and this makes it especially suitable when long term therapy is necessary.

Simeticone either alone or with an antacid mixture act as an antifoaming agent to reduce flatulence. It is a silicon polymer that lowers surface tension and allows the small bubbles of froth to coalesce into large bubbles that can be more easily passed up from the stomach or down from the colon. Antacid Simeticone combination may also be useful for the relief of hiccups in palliative care.

Alginic Acid is combined with antacids to encourage adherence of the mixture to the mucosa. Alginate as a mucosal protectant is useful in reflux esophagitis. As the ingredients used in this drug are well established, tolerated and accepted all over the world and hence confirming its physiological availability, pharmacological effects studies are not conducted.

Oxetacaine in Nugel-O is added to the formulation to act as a local anesthetic. This will further assist in the relief of symptoms associated with Ulcer, Gastritis, Reflux Esophagitis, etc.

Pharmacokinetics

The absorption of aluminum and magnesium from antacids is small. Aluminum hydroxide is slowly converted to aluminum chloride in the stomach.

Some absorption of soluble aluminum salts occurs in the gastro-intestinal tract with urinary excretion. Any absorbed magnesium is likewise excreted in the urine.

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Indications Of Nugel

Nugel acts as an antacid in dyspepsia and is used for the symptomatic relief of gastritis, hyperacidity associated with peptic ulceration.

Indications Of Nugel-O

Nugel-O acts as an antacid in non-ulcer dyspepsia and is used for the symptomatic relief of gastritis, hyperacidity associated with peptic ulceration, relief from ulcer, reflux esophagitis, heartburn and flatulence.

Dosage And Administration Of Nugel

One tablespoonful (15mL) twice daily for adults and 5 mL, (One teaspoonful) twice daily for children or as directed by the physician

Dosage And Administration Of Nugel-O

15mL (One tablespoonful) twice daily for adults or as directed by the Physician. Not to be used in Children.

Side Effects Of Nugel

Some patients may experience dizziness, faintness or drowsiness. Sensitivity reactions including skin eruptions (dermatitis, urticaria), pruritus, glossitis, have been reported. Magnesium-containing antacids may cause diarrhea. Aluminum-containing antacids may cause constipation.

Cautions

The use of magnesium-containing antacids in patients with mild to moderate renal impairment should be carefully monitored due to a possible increased danger of hypomagnesaemia. In patients with chronic renal failure, hypoalbuminemia may occur. Encephalopathy and dementia may occur in patients with poor renal function or patients on dialysis, due to an increase in plasma concentration of aluminum.

Hypophosphatemia may occur with prolonged administration or large doses of aluminum-containing antacids (except aluminum phosphate) especially in patients with an inadequate dietary intake of phosphorus. Laboratory Tests Serum phosphate levels should be monitored at monthly or bi-monthly intervals in patients on maintenance hemodialysis who are receiving chronic antacid therapy.

Drug Interactions

The rate and/or extent of absorption of many medicines may be increased or decreased. Therefore, medication should not be taken within one to two hours of Nugel. An incomplete list of substances for which the above statement has been shown to apply includes: tetracycline, iron salts, isoniazid, ethambutol, some antimuscarinic drugs, benzodiazepines, phenothiazines ranitidine, indomethacin, phenytoin, nitrofurantoin, Vitamin A, fluoride and phosphate. An increase in the plasma level of quinidine and possible. Toxicity may result in alkalization of the urine following antacid therapy.

Contraindications

Do not use this formulation if you are presently taking a prescription antibiotic drug containing any form of tetracycline. This medicine should not be given to any patient who has demonstrated a sensitivity to it. The use of aluminum- or magnesium- containing antacids is contra-indicated in patients with symptoms of appendicitis, since these medicines may increase the danger of perforation or rupture due to their constipating or laxative effects.

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The use of aluminum- containing antacids (except those containing aluminum phosphate) is contra-indicated in patients with hypophosphatemia due to the phosphate binding properties of aluminum salts. The use of magnesium-containing antacids is contra-indicated in patients with properties of aluminum salts. The use of magnesium- containing antacids is contra-indicated in patients with severe renal function impairment due to increased danger of occurrence of hypomagnesaemia. Pregnant and lactating women can take it after consulting the Physician.

Interaction With Other Medicinal Products And Other Forms Of Interaction

Antacids may interfere with drugs by;

-Increasing the gastric pH, altering disintegration, dissolution, solubility, ionization and gastric emptying time.

-Absorbing or binding drugs to their surface resulting in decreased bioavailability such as tetracycline.

-Increasing urinary pH affecting the rate of drug elimination.

-Urinary excretion of certain drugs may also be affected.

-Antacids reduce the absorption of ACE Inhibitors Beta blockers.

-Antacids containing Magnesium salt may increase absorption of Sulphonylureas and thereby increases the hypoglycemic effect.

Overdose

Treatment is symptomatic and supportive.

Warning And Precautions

No clinical data on exposed pregnancies is available. Use of antacids should be avoided in the first trimester of pregnancy. Caution should be exercised when prescribing to pregnant and lactating women. Adequate diagnostic studies are recommended.

The possibility of gastrointestinal carcinoma should be considered in patients with protracted or recurrent indigestion.