Gaviscon Forte suspension for intravenous application pack 10ml No. 12 during pregnancy


Gaviscon Forte suspension for intravenous application pack 10ml No. 12 during pregnancy

Compound

Active ingredients: sodium alginate 1000 mg, potassium bicarbonate 200 mg.
Excipients: calcium carbonate - 200 mg, carbomer - 40 mg, methyl parahydroxybenzoate - 40 mg, propyl parahydroxybenzoate - 6 mg, sodium hydroxide - 14.44 mg, sodium saccharinate - 10 mg, mint flavor - 6 mg, purified water - up to 10 ml.

Pharmacokinetics

The mechanism of action of Gaviscon® forte does not depend on absorption into the systemic circulation.

Indications for use

Symptomatic treatment of dyspepsia associated with increased acidity of gastric juice and gastroesophageal reflux (heartburn, sour belching), a feeling of heaviness in the stomach after eating, incl. during pregnancy.

Contraindications

  • Children under 12 years of age;
  • hypersensitivity to the components of the drug.

Carefully

If the following diseases or conditions are present, the patient should consult a doctor before using the drug: hypercalcemia, nephrocalcinosis, urolithiasis with the formation of calcium oxalate stones (see section “Special Instructions”), congestive heart failure (see section “Special Instructions”), hypophosphatemia, mild renal failure (see section "Special instructions").

Directions for use and doses

The drug is taken orally.

Adults and children over 12 years of age are prescribed 5-10 ml of suspension after meals and before bedtime. The maximum daily dose is 40 ml.

The drug should not be used for a long time. If symptoms persist after 7 days of taking the drug, the patient should consult a doctor to review therapy.

For elderly patients, no dose adjustment is required.

Patients with impaired liver function do not require dose changes.

Patients with renal failure who need to follow a low-salt diet should take the drug with caution.

Storage conditions

The drug should be stored out of the reach of children at a temperature of 15° to 30°C.

Best before date

2 years. Do not use after expiration date.

special instructions

10 ml of suspension contains 106 mg (4.6 mmol) sodium, which should be taken into account when it is necessary to follow a diet with limited salt content (for example, with congestive heart failure and mild renal failure).

10 ml of suspension contains 78 mg (2 mmol) of potassium, so caution should be exercised when treating patients with mild renal failure, the need to follow a diet with limited potassium content and the use of drugs that may increase the concentration of potassium in the blood plasma.

It should be taken into account that 10 ml of suspension contains 200 mg (2 mmol) of calcium carbonate. Therefore, caution should be exercised in prescribing the drug for hypercalcemia, nephrocalcinosis and urolithiasis with the formation of calcium oxalate stones.

The drug contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, and therefore may cause allergic reactions (including delayed ones).

Description

Antacid drug.

Use in children

The use of the drug is contraindicated in children under 12 years of age.

Pharmacodynamics

After ingestion, the active ingredients of the drug quickly interact with the acidic contents of the stomach. In this case, an alginate gel is formed with a pH value close to neutral. The gel forms a protective shell on the surface of the stomach contents, preventing the occurrence of gastroesophageal reflux for a period of up to 4 hours.

In severe cases (with regurgitation), the gel enters the esophagus faster than the rest of the gastric contents, where it reduces irritation of the mucous membrane.

A decrease in irritation is felt 3-4 minutes after taking the drug.

Side effects

The incidence of adverse reactions was assessed based on the following criteria: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1 /10000, <1/1000), very rare (<1/10000), frequency unknown (frequency cannot be calculated from available data).

From the immune system: frequency unknown - anaphylactic and anaphylactoid reactions, hypersensitivity reactions (urticaria).

From the respiratory system: frequency unknown - respiratory effects (bronchospasm).

If any of the side effects indicated in the instructions are aggravated or other side effects not listed in the instructions are noted, the patient should inform the doctor.

Use during pregnancy and breastfeeding

Clinical studies involving more than 500 pregnant women and the amount of data obtained during the post-registration period did not show feto- and neonatal toxicity of the active substances. Gaviscon® forte can be used during pregnancy if clinically necessary.

The effect of the active ingredients of the drug on newborns and infants has not been demonstrated. Gaviscon® forte can be used during breastfeeding.

Interaction

The drug contains calcium carbonate, which exhibits antacid activity, therefore, at least 2 hours should pass between taking Gaviscon® forte and other drugs, especially when used simultaneously with histamine H2 receptor blockers, antibiotics from the tetracycline group, digoxin, fluoroquinolones, salts iron, ketoconazole, antipsychotics, thyroid hormones, levothyroxine sodium, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), corticosteroids, chloroquine, bisphosphonates and estramustine.

Overdose

Symptoms: Abdominal bloating may occur.

Treatment: symptomatic therapy.

Impact on the ability to drive vehicles and operate machinery

The drug does not affect the ability to drive vehicles and machinery, as well as to engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Gaviscon Double action mint suspension, 300 ml

Manufacturer

Reckitt Benckiser, UK

Briefly about the product

Compound

10 ml of suspension contains: active ingredients: sodium alginate 500 mg, sodium bicarbonate 213 mg, calcium carbonate 325 mg; excipients: carbomer (974P) 65 mg, methyl parahydroxybenzoate 40 mg, propyl parahydroxybenzoate 6 mg, sodium hydroxide 26.67 mg, sodium saccharinate 10 mg, mint flavor 6 mg, purified water up to 10 ml.

pharmachologic effect

This drug is a combination of alginate and antacids (calcium carbonate and sodium bicarbonate). Pharmacodynamics
When taken orally, the active ingredients of Gaviscon® Double Action quickly react with the acidic contents of the stomach.
In this case, an alginate gel is formed with a pH value close to neutral. Within three minutes, the gel forms a protective barrier on the surface of the stomach contents, preventing the occurrence of gastroesophageal reflux (return of stomach contents into the esophagus) for a period of up to four hours. In severe cases of reflux (regurgitation), the gel enters the esophagus, ahead of the rest of the gastric contents, where it reduces irritation of the esophageal mucosa. Calcium carbonate quickly neutralizes the hydrochloric acid of gastric juice, relieving the feeling of heartburn. This effect is enhanced by the presence of sodium bicarbonate in the drug, which also has a neutralizing effect. The total acid neutralizing activity of the drug in a minimum dose of 10 ml is approximately 10 mEq. Pharmacokinetics
The mechanism of action of the drug Gaviscon® Double Action is physical and does not depend on absorption into the systemic circulation.

Indications

Symptomatic treatment of diseases associated with digestive disorders, increased acidity of gastric juice and gastroesophageal reflux (heartburn, sour belching), a feeling of heaviness in the stomach after eating, including during pregnancy.

Use during pregnancy and breastfeeding

Pregnancy Clinical studies involving more than 500 pregnant women and the volume of data obtained during the post-registration period did not show congenital, feto- and neonatal toxicity of the active substances. Gaviscon® Double Action can be used during pregnancy if clinically necessary. Taking into account the presence of calcium carbonate in the composition, it is recommended to reduce the duration of use of the drug. Breastfeeding period The effect of the active ingredients of the drug on newborns, infants, and lactating women has not been demonstrated. Gaviscon® Double Action can be used during breastfeeding.

Contraindications

  • Hypersensitivity to any of the components of the drug;
  • moderate to severe renal failure;
  • children's age up to 12 years.

With caution:
If you have the following diseases or conditions, you should consult your doctor before using the drug: hypercalcemia, nephrocalcinosis, urolithiasis with the formation of calcium oxalate stones, congestive heart failure, hypophosphatemia, mild renal failure).

Side effects

The incidence of adverse reactions was assessed based on the following criteria: very often (≥ 1/10), often (≥ 1/100, < 1/10), infrequently (≥ 1/1000, < 1/100), rarely (≥ 1 /10000, <1/1000), very rare (<1/10000) and unknown frequency (frequency cannot be calculated from available data).

Immune system disorders: unknown frequency - anaphylactic and anaphylactoid reactions, hypersensitivity reactions (urticaria).

Disorders of the respiratory system, chest and mediastinal organs: unknown frequency - respiratory effects (bronchospasm).

Ingestion of large amounts of calcium carbonate can cause alkalosis, hypercalcemia, acid rebound, milk-base syndrome, and constipation. These conditions usually occur with an overdose.

If any of the side effects indicated in the instructions get worse, or you notice other side effects not listed in the instructions, tell your doctor.

Interaction

Since calcium carbonate, which is part of the drug, exhibits antacid activity, at least 2 hours should pass between taking Gaviscon® Double Action and other drugs, especially when taken simultaneously with H2-histamine receptor blockers, antibiotics from the tetracycline group, digoxin, fluoroquinolone, iron salts, ketoconazole, antipsychotics, thyroid hormones, levothyroxine sodium, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticosteroids, chloroquine, bisphosphonates and estramustine.

How to take, course of administration and dosage

Inside.

Adults and children over 12 years of age: 10–20 ml after meals and before bed (up to 4 times a day).

The maximum daily dose is 80 ml.

For elderly patients, no dose change is required.

The drug should not be used for a long time; if symptoms persist after 7 days of taking the drug, you should consult a doctor to review therapy.

Overdose

Symptoms: Abdominal bloating may occur.

Treatment: symptomatic.

Special instructions

In 10 ml of suspension the sodium content is 127.25 mg (5.53 mmol). This should be taken into account when a salt-restricted diet is required, for example in congestive heart failure and mild renal failure. 10 ml of suspension contains 130 mg (3.25 mmol) of calcium. Therefore, caution should be exercised when treating patients with hypercalcemia, nephrocalcinosis and urolithiasis with the formation of calcium oxalate stones. Gaviscon® Double Action contains antacids, which can mask the symptoms of serious gastrointestinal diseases. The effectiveness of the drug may be reduced in patients with low acidity of gastric juice. Children with gastroenteritis or suspected renal failure are at increased risk of hypernatremia. The drug contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, and therefore may cause allergic reactions (including delayed ones). Effect on the ability to drive vehicles and machinery The drug does not affect the ability to drive vehicles and machinery, as well as engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form

Oral suspension [mint]. 150 ml, 200 ml, 300 ml or 600 ml in dark glass bottles, wrapped in shrink film, with a polypropylene cap that provides first-opening control. Instructions for use are located under the label. 10 ml of suspension in multilayer bags (polyester, aluminum, polyethylene). 4, 6, 8, 10, 12, 16, 20 or 24 sachets along with instructions for use in a cardboard box.

Storage conditions

At a temperature not exceeding 30 °C. Keep out of the reach of children.

Best before date

2 years.

Active substance

Sodium alginate, Sodium bicarbonate, Calcium carbonate

Dosage form

suspension for oral administration

Barcode and weight

Barcode: 4640018991592, 5000158071773 Weight: 0.546 kg

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