Maalox^® (Tablets, Suspension) Instructions for Use

ATC Code

A02AD01 (Simple combinations of salts)

Active Substances

Magnesium hydroxide (Ph.Eur.)

Algeldrate (Rec.INN)

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Acid-related disorder treatment agents, antacids; combination salts and complex compounds of aluminum, calcium, and magnesium

Pharmacological Action

Pharmacodynamics

Aluminum Hydroxide and Magnesium hydroxide neutralize free hydrochloric acid in gastric juice without causing its secondary hypersecretion.

Furthermore, the increase in gastric juice pH when taking Maalox^® leads to a decrease in the activity of pepsin in the gastric juice.

The drug also has adsorbent and enveloping effects, which reduce the impact of damaging factors on the mucous membrane of the esophagus and stomach.

Pharmacokinetics

Magnesium hydroxide and Aluminum Hydroxide are considered locally acting antacids. Due to low absorption, they do not exert systemic effects.

Indications

• Gastric and duodenal ulcer in the acute phase;
• Acute gastroduodenitis;
• Chronic gastroduodenitis with normal or increased secretory function in the acute phase;
• Hiatal hernia;
• Reflux esophagitis;
• Dyspeptic symptoms such as epigastric discomfort or pain, heartburn, acid regurgitation after dietary indiscretions, excessive consumption of alcohol, coffee, nicotine, etc.;
• Dyspeptic symptoms such as discomfort, epigastric pain, heartburn, acid regurgitation resulting from the use of certain medications (NSAIDs, corticosteroids, and others);
• Prevention of dyspeptic symptoms.

ICD codes

Dosage Regimen

Suspension

The drug is intended for oral administration only by persons over 15 years of age.

Before use, the suspension in the sachet should be homogenized by thoroughly kneading it between the fingers. The contents of the sachet are taken undissolved.

Maalox^® is taken as 1 sachet of suspension (15 ml) usually 1-2 hours after meals and at night, as well as when epigastric pain or heartburn occurs.

The daily dose should not exceed 6 sachets (90 ml of suspension per day).

For reflux esophagitis, the drug is taken 30-60 minutes after meals.

For gastric ulcer, the drug is taken 30 minutes before meals.

The course of treatment should not exceed 2-3 months.

For occasional use, for example, for discomfort after dietary indiscretions, take 15 ml once.

In patients with impaired renal function, the use of the drug in high doses and/or for a long time should be avoided (see section “Contraindications”, “With caution”).

Tablets

The tablets should be dissolved or chewed thoroughly.

Adults and adolescents over 15 years old – 1-2 tablets 3-4 times/day 1-2 hours after meals and at night.

For reflux esophagitis, the drug is taken a short time after meals.

The maximum number of drug intakes is 6 times/day. Do not take more than 12 tablets/day.

The course of treatment should not exceed 2-3 months.

For occasional use, for example, for discomfort after dietary indiscretions, take 1-2 tablets once.

Adverse Reactions

When the recommended dosage regimen is followed, side effects are rare.

Definition of adverse effect frequency (according to WHO classification): infrequent (≥0.1% and <1%); frequency unknown (cannot be estimated from the available data).

Immune system disorders: frequency unknown – hypersensitivity reactions such as pruritus, urticaria, angioedema and anaphylactic reactions.

Gastrointestinal disorders: infrequent – diarrhea, constipation.

Metabolism and nutrition disorders: frequency unknown – hypermagnesemia, hyperaluminemia, hypophosphatemia (with long-term treatment or high-dose intake, or with standard doses and low phosphate content in food), which may lead to increased bone resorption, hypercalciuria, osteomalacia.

Contraindications

• Severe renal failure;
• Hypersensitivity to the active substances and other components of the drug;

• Fructose intolerance (due to the presence of sorbitol in the drug composition);
• Childhood and adolescence under 15 years;
• Hypophosphatemia.

With caution

• Aluminum Hydroxide may cause constipation, overdose of magnesium salts may lead to weakened intestinal peristalsis; in patients at increased risk (patients with renal failure, elderly persons) taking high doses of the drug may cause or worsen intestinal obstruction and ileus.
• Aluminum Hydroxide is poorly absorbed in the gastrointestinal tract, so systemic effects rarely occur in patients with normal renal function. Long-term treatment, use of excessively high doses of the drug, or use of normal doses of the drug against a background of low dietary phosphate intake can lead to phosphate deficiency (due to aluminum binding with phosphate), which is accompanied by increased bone resorption and hypercalciuria with the risk of osteomalacia. Treatment of patients at risk of developing phosphate deficiency or long-term use of the drug should be carried out under medical supervision.
• In case of impaired renal function when taking Maalox^®, such patients may have increased plasma concentrations of magnesium and aluminum; and with long-term use of Maalox^® in high doses, including high therapeutic doses, the development of encephalopathy, dementia, microcytic anemia or worsening of dialysis-induced osteomalacia is possible).
• In patients with porphyria on hemodialysis.
• During pregnancy and breastfeeding (see section “Pregnancy and Lactation”).
• In Alzheimer’s disease.

Use in Pregnancy and Lactation

Pregnancy

Animal studies have not provided clear evidence of a teratogenic effect of aluminum hydroxide and magnesium hydroxide.

To date, no specific teratogenic effects have been identified with the use of Maalox^® during pregnancy, however, due to insufficient clinical experience of its use during pregnancy, prescription is possible only if the potential benefit of therapy for the mother justifies the potential risk to the fetus.

Breastfeeding period

When used according to recommendations, the absorption of aluminum hydroxide and magnesium salt combinations in the mother is limited, therefore Maalox^® is recognized as compatible with breastfeeding.

Use in Renal Impairment

The drug should be used with caution in patients with renal failure.

Contraindicated in severe renal failure.

Pediatric Use

Use in children and adolescents under 15 years of age is contraindicated.

Geriatric Use

In elderly patients, use of the drug in high doses may cause or worsen intestinal obstruction and ileus.

Special Precautions

If gastrointestinal symptoms persist for more than 10 days during treatment or if the condition worsens, the diagnosis should be clarified and treatment measures adjusted.

A 2-hour interval should be observed between the use of Maalox^® and other drugs and a 4-hour interval between taking Maalox^® and fluoroquinolones (see section “Drug Interactions”).

Although the drug is available without a prescription, it is recommended to consult a doctor before using the drug during pregnancy and lactation (breastfeeding), as well as in adolescents and patients with mild to moderate renal failure.

Long-term prescription of Maalox^® should be avoided in cases of impaired renal function. When prescribing Maalox^® to patients with mild to moderate renal failure, plasma concentrations of aluminum and magnesium should be carefully monitored, and if they increase, the use of the drug should be discontinued immediately.

Algeldrat, with low phosphate content in food, can lead to the development of phosphorus deficiency in the body. Therefore, during its use, especially long-term, sufficient intake of phosphates with food should be ensured.

Effect on ability to drive vehicles and operate machinery

The drug does not affect the ability to drive vehicles and operate machinery.

Overdose

Symptoms of acute overdose with the combination of aluminum hydroxide and magnesium salts include diarrhea, abdominal pain and vomiting. In at-risk patients, taking the drug in high doses may cause or worsen intestinal obstruction or ileus (see section “With caution”).

Treatment: aluminum and magnesium are excreted in the urine. In case of acute overdose, fluid loss replacement and forced diuresis are performed. Patients with renal failure require hemodialysis or peritoneal dialysis.

Drug Interactions

With quinidine

When used concomitantly with quinidine, an increase in serum quinidine concentrations and the development of quinidine overdose are possible.

With histamine H₂-receptor blockers, atenolol, bisphosphonates, cefdinir, cefpodoxime, chloroquine, cyclines, dasatinib monohydrate, diflunisal, digoxin, eltrombopag olamine, ethambutol, fluoroquinolones, gabapentin, glucocorticoids, indomethacin, iron salts, isoniazid, ketoconazole, levothyroxine, lincosamides, metoprolol, mycophenolate mofetil, phenothiazine neuroleptics, penicillamine, phenytoin, propranolol, raltegravir potassium, riociguat, rosuvastatin, sodium fluoride, tacrolimus, and antiviral drugs (combination of tenofovir alafenamide fumarate / emtricitabine / bictegravir sodium)

When taken concomitantly with Maalox^®, the absorption of the above-listed drugs in the gastrointestinal tract is reduced. In case of a 2-hour interval between taking these drugs and Maalox^® and a 4-hour interval between taking fluoroquinolones and Maalox^®, this undesirable interaction can be avoided in most cases.

With polystyrene sulfonate (kayexalate)

Caution should be exercised when using Maalox^® concomitantly with polystyrene sulfonate (kayexalate) due to the possible risk of reduced potassium binding efficacy of the resin and the development of metabolic alkalosis in patients with renal failure (for aluminum hydroxide and magnesium hydroxide) and intestinal obstruction (for aluminum hydroxide).

With citrates

When combining aluminum hydroxide with citrates, an increase in plasma aluminum concentrations is possible, especially in patients with renal failure.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.