Composition, form of production and packaging
? Suspension for ingestion in the form of a liquid white or almost white, resembling milk, with the smell of mint.
1 pack. (15 ml)
aluminum hydroxide (as a gel) 525 mg
magnesium hydroxide (as a gel) 600 mg
Auxiliary substances: hydrochloric acid, concentrated - 21.3 mg, citric acid monohydrate 9.83 mg, peppermint leaf oil 1.89 mg, mannitol 37.5 mg, methyl parahydroxybenzoate 15 mg, propyl parahydroxybenzoate 7.5 mg, sodium saccharinate 4.21 mg, sorbitol 70% 214.29 mg, hydrogen peroxide 30% - 9.75 mg, purified water 4746.59 mg.
15 ml - bags (sachets) (30) - packs of cardboard.
? Suspension for ingestion of white color, homogeneous after shaking.
100 ml
aluminum hydroxide (as a gel) 3.5 g,
which corresponds to the content of aluminum oxide 2.3 g
magnesium hydroxide (as a gel) 4 g
Auxiliary substances: hydrochloric acid 10% - 0.52815 g, citric acid monohydrate 0.0655 g, peppermint leaf oil 0.0126 g, mannitol 0.25 g, domiphenum bromide 0.00422 g, sodium saccharinate 0.028 g, sorbitol 70% 1.429 g, hydrogen peroxide 30% - 0.065 g, purified water - up to 100 ml.
250 ml - bottles of polyethylene terephthalate (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Antacid preparation. Aluminum hydroxide and magnesium hydroxide neutralize the free hydrochloric acid of gastric juice without causing its secondary hypersecretion. In addition, an increase in the pH of gastric juice with the administration of Maalox В® leads to a decrease in the activity of pepsin in gastric juice. The drug also has an adsorbent and enveloping action, due to which the effect of damaging factors on the mucous membrane of the esophagus and stomach decreases.
PHARMACOKINETICS
Magnesium hydroxide and aluminum hydroxide are considered local action antacids. Because of low absorption, no systemic effect is provided.
INDICATIONS
- Stomach ulcer and duodenal ulcer in the phase of exacerbation;
- Acute gastroduodenitis, chronic gastroduodenitis with normal or increased secretory function in the exacerbation phase;
- hernia of the esophageal opening of the diaphragm, reflux esophagitis;
- dyspeptic phenomena, such as discomfort, gastralgia, heartburn (after excess consumption of ethanol, nicotine, coffee, medication, errors in the diet) (suspension in bottles 250 ml);
- discomfort or epigastric pain, heartburn, acidic eructation after errors in the diet, excessive consumption of alcohol, coffee, nicotine, etc.) (suspension in bottles 250 ml);
- Dyspeptic phenomena, such as discomfort or epigastric pain, heartburn, acidic eructation after errors in the diet, excessive consumption of ethanol, coffee, nicotine, etc. (suspension in sachet 15 ml);
- Dyspeptic phenomena, such as discomfort or epigastric pain, heartburn, acidic eructation arising from the use of certain medicines (including NSAIDs, GCS), and their prevention (suspension in a 15 ml sachet).
DOSING MODE
The drug is intended for oral administration only by persons over 15 years of age.
Suspension in bags
Before use, the suspension in the bag should be homogenized, carefully stretching it between the fingers. The contents of the sachet are taken in an undissolved form.
Maalox В® takes 1 packet with a 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 packets (90 ml of suspension per day).
When reflux-esophagitis drug take 30-60 minutes after eating.
With gastric ulcer, the drug is taken 30 minutes before meals.
The course of treatment should not exceed 2-3 months.
With occasional use, for example, with discomfort after errors in the diet, take 15 ml once.
Suspension in vials
Before use, the vial should be shaken.
Assign 15 ml (1 tablespoon) 3-4 times a day 1-2 hours after meals and at night. The dose should not exceed 6 tablespoons per day.
When reflux-esophagitis the drug is taken a short time after eating.
The course of treatment should not exceed 2-3 months.
With occasional use, for example, with discomfort after errors in the diet, take 15 ml once.
Patients with impaired renal function should avoid the use of Maalox В® in high doses and / or for a long time.
SIDE EFFECT
While observing the recommended dosing regimen, side effects are rare.
Definition of the frequency of adverse effects (according to the WHO classification): infrequently (≤ 0.1% and <1%); the frequency is unknown (it is not possible to estimate the incidence from the available data).
On the part of the immune system: the frequency is unknown - hypersensitivity reactions, anaphylactic reactions.
Allergic reactions: the frequency is unknown - itching, hives, angioedema.
From the digestive system: infrequently - diarrhea, constipation.
From the side of metabolism: frequency is unknown - hypermagnesia, hyperaluminia, hypophosphatemia (with long-term treatment or intake in high doses, or when taken in standard doses at low phosphate levels in food), which can lead to increased bone resorption, hypercalciuria, osteomalacia.
CONTRAINDICATIONS
- severe renal failure;
- hypersensitivity to active substances and other components of the drug;
- intolerance to fructose (due to the presence of sorbitol in the formulation);
- children and adolescence up to 15 years;
hypophosphatemia.
Carefully
- Aluminum hydroxide can cause constipation, an overdose of magnesium salts can lead to a weakening of intestinal peristalsis; in patients from the high-risk group (patients with renal insufficiency, elderly people), taking high doses of the drug may cause or aggravate bowel obstruction and intestinal obstruction.
- Aluminum hydroxide is poorly absorbed from the digestive tract, therefore, in patients with normal kidney function, systemic exposure is rare. However, long-term treatment, the use of the drug in excessively high doses, or the use of the drug in usual doses against the background of a decrease in the intake of phosphates with food, can lead to phosphate deficiency (due to binding of aluminum to phosphate), which is accompanied by increased bone resorption and hypercalciuria with a risk of developing osteomalacia. Treatment of patients at risk of developing phosphate deficiency or prolonged use of the drug should be performed under medical supervision.
- In case of impaired renal function (when Maalox В® is taken in such patients, plasma concentrations of magnesium and aluminum may increase, and with prolonged use of Maalox В® in high doses, including high therapeutic doses, it is possible to develop encephalopathy, dementia, microcytic anemia or aggravation of osteomalacia caused by dialysis.
- Patients with porphyria on hemodialysis.
- With Alzheimer's disease.
"When I'm pregnant."
PREGNANCY AND LACTATION
To date, no specific teratogenic effects have been identified with the use of Maalox В® during pregnancy, however, due to the lack of clinical experience of its use in pregnancy, appointment is possible only if the potential benefit of therapy for the mother justifies the potential risk to the fetus.
When using the drug in accordance with the dosing regimen, the absorption of aluminum hydroxide and magnesium salts in the mother's body is limited, so MaaloxВ® is recognized as compatible with breastfeeding.
In pre-clinical studies in animals, there is no clear indication of a teratogenic effect in aluminum hydroxide and magnesium hydroxide.
APPLICATION FOR FUNCTIONS OF THE LIVER
Use with caution in the violation of kidney function (with the Maalox В® preparation in such patients, an increase in plasma concentrations of magnesium and aluminum is possible, and with prolonged use of Maalox В® in high doses, including high therapeutic doses, the development of encephalopathy, dementia, microcytic anemia).
APPLICATION FOR CHILDREN
Contraindicated for children under 15 years.
SPECIAL INSTRUCTIONS
If, during treatment, symptoms from the GI tract persist for more than 10 days or if the condition worsens, then the diagnosis should be clarified and correction of treatment measures should be carried out.
A 2-hour interval between use of Maalox В® and other preparations should be observed.
Despite the fact that the drug is dispensed 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 and moderate renal insufficiency.
When Maalox В® is prescribed for patients with mild to moderate renal insufficiency, plasma concentrations of aluminum and magnesium must be carefully monitored, and in the case of their increase, the drug should be discontinued immediately.
Algeldrate with a low phosphate content in food can lead to the development of phosphorus deficiency in the body. Therefore, when it is used, especially long-term, it is necessary to ensure sufficient supply of phosphates with food.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive vehicles and work with mechanisms.
OVERDOSE
Symptoms: diarrhea, abdominal pain and vomiting are possible. In patients at risk of taking the drug in high doses can cause or aggravate bowel obstruction or intestinal obstruction.
Treatment: aluminum and magnesium are excreted in the urine. A loss of fluid and forced diuresis are performed. Patients with renal failure need hemodialysis or peritoneal dialysis.
DRUG INTERACTION
With simultaneous application with quinidine, it is possible to increase the serum concentrations of quinidine and the development of an overdose of quinidine.
With the simultaneous administration of Maalox В®, the absorption of the following drugs is reduced: the blockers of histamine H 2 receptors, propranolol, atenolol, cefdinir, cefpodoxime, metoprolol, chloroquine, prostacyclin, diflunizal, digoxin, bisphosphonates, ethambutol, isoniazid, fluoroquinolones, sodium fluoride , GCS (described for prednisolone and dexamethasone), indomethacin, ketoconazole, lincosamides, neuroleptics derivatives of phenothiazine, penicillamine, rosuvastatin, iron salts, levothyroxine sodium. In the case of a 2-hour interval between the administration of these preparations and the MaaloxВ® preparation and the 4-hour interval between administration of fluoroquinolones and MaaloxВ® preparation, this undesirable interaction can in most cases be avoided.
When using Maalox В® with polystyrene sulfonate (cayexalate) together , care should be taken because of the possible risk of decreased potassium binding by tar and the development of metabolic alkalosis in patients with renal insufficiency (for aluminum hydroxide and magnesium hydroxide) and intestinal obstruction (for aluminum hydroxide).
When aluminum hydroxide is combined with citrates, it is possible to increase plasma concentrations of aluminum, especially in patients with renal insufficiency.
TERMS OF RELEASE FROM PHARMACY
The drug is dispensed without a prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Do not freeze.
Shelf life of the suspension in bags is 3 years, in vials - 30 months.
Shelf life after the first opening of the vial is 6 months.
