Composition, form of production and packaging
? Suspension for ingestion (with lemon flavor) from white to pale yellow, homogeneous.
1 mini-package
algoldrate (aluminum hydroxide) (in the form of aluminum hydrated oxide) 460 mg,
which corresponds to an aluminum oxide content of 230 mg
magnesium hydroxide 400 mg
Auxiliary substances: sucrose solution 64% - 4913 mg, sorbitol liquid (non-crystallizing) - 200 mg, xanthan gum - 2.4 mg, guar - 5.6 mg, flavoring lemon-lime natural - 13.2 mg, sodium chloride - 4.8 mg.
4.3 ml (6 g) - mini-bags (sachets) made of aluminum foil (6) - packs of cardboard.
4.3 ml (6 g) - mini-bags (sachets) made of aluminum foil (10) - packs of cardboard.
4.3 ml (6 g) - mini-bags (sachets) made of aluminum foil (20) - packs of cardboard.
4.3 ml (6 g) - mini-bags (sachets) made of aluminum foil (30) - packs of cardboard.
4.3 ml (6 g) - mini-bags (sachets) made of aluminum foil (40) - packs of cardboard.
? Suspension for ingestion (with the taste of black currant) from white to pale yellow, homogeneous.
1 mini-package
algoldrate (aluminum hydroxide) (in the form of aluminum hydrated oxide) 460 mg,
which corresponds to an aluminum oxide content of 230 mg
magnesium hydroxide 400 mg
Excipients: sucrose solution 64% - 4913 mg, sorbitol liquid (non-crystallizing) - 200 mg, xanthan gum - 2.4 mg, guar - 5.6 mg, flavor of blackcurrant - 13.2 mg, sodium chloride - 4.8 mg.
4.3 ml (6 g) - mini-bags (sachets) made of aluminum foil (6) - packs of cardboard.
4.3 ml (6 g) - mini-bags (sachets) made of aluminum foil (10) - packs of cardboard.
4.3 ml (6 g) - mini-bags (sachets) made of aluminum foil (20) - packs of cardboard.
4.3 ml (6 g) - mini-bags (sachets) made of aluminum foil (30) - packs of cardboard.
4.3 ml (6 g) - mini-bags (sachets) made of aluminum foil (40) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
An antacid drug does not have systemic effects. Its antacid capacity is 20 mEq H + per mini pack (in vitro determination by the Rosset-Rice method). The drug neutralizes free hydrochloric acid, without causing secondary hypersecretion of hydrochloric acid. In connection with the increase in pH during its intake, the peptic activity of gastric juice decreases. It also has an adsorbent and enveloping action, due to which the effect of damaging factors on the mucous membrane of the stomach and duodenum decreases.
Maalox В® mini is able to eliminate or relieve heartburn for several hours. Due to the balance of its composition with respect to the influence on the motility of the gastrointestinal tract, the MaaloxВ® mini usually does not cause constipation. Magnesium hydroxide and algodrat pass X-rays.
PHARMACOKINETICS
Hydroxides of magnesium and aluminum are considered local action antacids that are practically not absorbed when administered orally at the recommended doses.
INDICATIONS
- Heartburn;
- belching with acidic contents.
DOSING MODE
The contents of 1-2 mini-packs are taken inside 1-1.5 hours after a meal or when heartburn occurs. If necessary, you can take an additional dose of the drug 2 hours after the previous reception. The maximum daily dose is 12 mini-packs. The course of treatment - no more than 2-3 months.
With occasional use, for example, with discomfort after the errors in the diet , take 1-2 mini-packs once.
With mild renal insufficiency, the maximum daily dose is 8 mini-packs. With renal failure of moderate severity, the maximum daily dose is 6 mini-packs.
Before opening the mini-package, you should carefully mix its contents, carefully stretching the bag between the fingers. Package contents squeezed into a spoon or into the mouth (take the suspension without first diluting).
SIDE EFFECT
While observing the recommended dosing regimen, side effects are negligible.
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
- hypersensitivity to active substances and other components of the drug;
- severe renal failure;
- hypophosphatemia;
- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption (due to the presence of sorbitol and sucrose in the formulation);
- Children and adolescence up to 15 years.
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. Long-term treatment, the use of the drug in excessively high doses or the use of the drug in standard 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 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 taking MaaloxВ® mini preparation in such patients, plasma concentrations of magnesium and aluminum may increase, and with prolonged use of MaaloxВ® mini preparation in high doses, including high therapeutic doses, the development of encephalopathy, dementia, microcytic anemia or aggravation of osteomalacia caused by dialysis.
- Patients with porphyria on hemodialysis.
- With Alzheimer's disease.
- With diabetes mellitus (in connection with the connection with the content of the preparation of sucrose).
"When I'm pregnant."
PREGNANCY AND LACTATION
To date, no specific teratogenic effects have been identified with the use of Maalox В® Mini in pregnancy, however, due to the lack of clinical experience, its use in pregnancy is possible only in low doses, for a short time and in cases where the potential benefit of therapy for the mother justifies the potential risk to the fetus.
When the drug is used in accordance with the dosing regimen, the absorption of aluminum hydroxide and magnesium salts in the mother's body is limited, so MaaloxВ® mini is recognized as compatible with breastfeeding.
In experimental animal studies, no clear data were available for the teratogenic effect of aluminum hydroxide and magnesium hydroxide.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe renal failure.
Caution should be used in patients with impaired renal function (possibly increased plasma concentrations of magnesium and aluminum, with prolonged use of Maalox В® mini in high doses, including high therapeutic doses, the development of encephalopathy, dementia, microcytic anemia ).
With mild renal insufficiency, the maximum daily dose is 8 mini-packs. With renal failure of moderate severity, the maximum daily dose is 6 mini-packs.
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under 15 years.
SPECIAL INSTRUCTIONS
If, during treatment, GI symptoms persist for more than 10 days or if the condition worsens, the diagnosis should be clarified and treatment adjusted.
A 2-hour interval between use of Maalox В® mini 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 over 15 and patients with renal insufficiency of mild and moderate severity.
It is necessary to avoid prolonged prescription of Maalox В® mini preparation for violations of kidney function. When Maalox В® is prescribed for mini patients with mild and moderate renal insufficiency, plasma concentrations of aluminum and magnesium must be carefully controlled, 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.
One mini-package contains 3.15 g of sucrose and 0.2 g of sorbitol, respectively, the maximum daily dose contains 37.80 g of sucrose and 2.4 g of sorbitol.
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® mini, 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 drugs and the MaaloxВ® mini preparation and the 4-hour interval between the administration of fluoroquinolones and MaaloxВ® mini preparation, this undesirable interaction can in most cases be avoided.
When using MaaloxВ® mini with polystyrene sulfonate (cayexalate) together , care should be taken because of the possible risk of decreased potassium binding potency and 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 the reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
