Novagel D

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

Domperidone is dopamine receptor (D2) antagonist which selectively inhibits dopamine at the D2 receptor. It acts principally at receptors in the chemoreceptor trigger zone (CTZ) and also at receptors in the stomach.

Domperidone is a specific blocker of dopamine receptors. It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms.

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.

Novagel D
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Novagel D
Generic	Domperidone + Magaldrate + Simethicone
Type	Suspension
Therapeutic Class
Manufacturer	Osper Pharmaceuticls Pvt Ltd
Available Country	India
Last Updated:	September 19, 2023 at 7:00 am

Uses

Stimulation of gut motility in-

Non-ulcer dyspepsia
Oesophageal reflux, reflux oesophagitis and gastritis
Diabetic gastroparesis
Functional dyspepsia
Speeding barium transit in follow through radiological studies

Prevention and symptomatic relief of acute nausea and vomiting from any cause including cytotoxic therapy, radiotherapy and antiparkinsonism therapy.

In the prophylactic treatment of migraine.

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.

Novagel D is also used to associated treatment for these conditions: Diabetic Gastroparesis, Dyspepsia, Erosive Esophagitis, Gastrointestinal Symptoms, Non-erosive Reflux Esophagitis Disease (NERD), Upper gastrointestinal motility disordersAcid 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 Novagel D works

Domperidone acts as a gastrointestinal emptying (delayed) adjunct and peristaltic stimulant. The gastroprokinetic properties of domperidone are related to its peripheral dopamine receptor blocking properties. Domperidone facilitates gastric emptying and decreases small bowel transit time by increasing esophageal and gastric peristalsis and by lowering esophageal sphincter pressure. Antiemetic: The antiemetic properties of domperidone are related to its dopamine receptor blocking activity at both the chemoreceptor trigger zone and at the gastric level. It has strong affinities for the D2 and D3 dopamine receptors, which are found in the chemoreceptor trigger zone, located just outside the blood brain barrier, which - among others - regulates nausea and vomiting

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

Novagel D dosage

Adults: 10 - 20 mg every 4 - 8 hours daily

Children: 0.2 - 0.4 mg/kg every 4 - 8 hours daily.

Domperidone tablet and suspension should be taken 15 - 30 minutes before a meal. For acute nausea and vomiting, maximum period of treatment is 12 weeks.

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

Domperidone may produce hyperprolactinemia which may cause galactorrhea & breast enlargement, soreness and reduced libido. It may rarely cause dry mouth, thirst, headache, nervousness, drowsiness, diarrhea, skin rash and itching.

Constipation and diarrhea may occur.

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

Toxicity

Side effects include galactorrhea, gynecomastia, or menstrual irregularities.

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

Domperidone should be used with absolute caution in case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood brain barrier.

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

Interaction

Domperidone may reduce the hypoprolactinaemic effect of bromocriptine. Anti-muscarinics and opioid analgesics may antagonize the action of Domperidone on gastrointestinal function.

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

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

Elimination Route

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

Half Life

7 hours

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

Clearance

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

Elimination Route

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

Use in pregnancy: The safety of this drug has not been established for pregnant women. So it is not recommended during pregnancy.

Use in lactation: Domperidone may precipitate galactorrhea and improve postnatal lactation, which is secreted in breast milk but in very small quantities insufficient to be considered harmful.

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

Domperidone is contraindicated to the patients who have hypersensitivity to this drug and in case of neonates.

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

Acute Overdose

Overdose has been reported primarily in infants and children. Symptoms of overdosage may include disorientation, somnolence and extrapyramidal reactions. There is no specific antidote to domperidone, but in the event of overdose, the administration of activated charcoal may be useful. Anticholinergics, antiparkinson drugs may be useful in controlling extrapyramidal reactions. The patient should be observed closely and supportive measures employed.