Almaxicid (Suspension) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

A02AX (Antacids in combination with other agents)

Active Substances

Magnesium hydroxide (Ph.Eur.)

Algeldrate (Rec.INN)

Dosage Form

Almaxicid

Oral suspension: bottles 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, 50 ml, 55 ml, 60 ml, 65 ml, 70 ml, 75 ml, 80 ml, 85 ml, 90 ml, 95 ml, 100 ml, 110 ml, 120 ml, 130 ml, 140 ml, 150 ml, 160 ml, 170 ml, 180 ml, 190 ml, 200 ml, or 210 ml, etc.

Dosage Form, Packaging, and Composition

Oral suspension white or almost white in color with a characteristic odor; during storage, a layer of clear liquid may separate on the surface; vigorous shaking restores the homogeneity of the substance.

Excipients: hydrogen peroxide 30% solution – 8.2 mg, sorbitol – 16023 mg, hydroxyethylcellulose – 218 mg, methylparaben – 218 mg, propylparaben – 27.26 mg, butylparaben – 27.26 mg, sodium saccharin dihydrate – 16.36 mg, propylene glycol – 6540 mg, macrogol 4000 – 4360 mg, lemon oil – 32.7 mg, ethanol 96% – 1962 mg, purified water – up to 100 ml.

20 ml – bottles – cardboard packs.
25 ml – bottles – cardboard packs.
30 ml – bottles – cardboard packs.
35 ml – bottles – cardboard packs.
40 ml – bottles – cardboard packs.
45 ml – bottles – cardboard packs.
50 ml – bottles – cardboard packs.
55 ml – bottles – cardboard packs.
60 ml – bottles – cardboard packs.
65 ml – bottles – cardboard packs.
70 ml – bottles – cardboard packs.
75 ml – bottles – cardboard packs.
80 ml – bottles – cardboard packs.
85 ml – bottles – cardboard packs.
90 ml – bottles – cardboard packs.
95 ml – bottles – cardboard packs.
100 ml – bottles – cardboard packs.
110 ml – bottles – cardboard packs.
120 ml – bottles – cardboard packs.
130 ml – bottles – cardboard packs.
140 ml – bottles – cardboard packs.
150 ml – bottles – cardboard packs.
160 ml – bottles – cardboard packs.
170 ml – bottles – cardboard packs.
180 ml – bottles – cardboard packs.
190 ml – bottles – cardboard packs.
200 ml – bottles – cardboard packs.
210 ml – bottles – cardboard packs.
220 ml – bottles – cardboard packs.
230 ml – bottles – cardboard packs.
240 ml – bottles – cardboard packs.
250 ml – bottles – cardboard packs.
260 ml – bottles – cardboard packs.
270 ml – bottles – cardboard packs.
280 ml – bottles – cardboard packs.
290 ml – bottles – cardboard packs.
300 ml – bottles – cardboard packs.

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Acid-related disorder treatment agents; antacids; antacids, other combinations

Pharmacological Action

A combined agent whose action is due to its constituent components: it has antacid, adsorbent, enveloping, carminative, and choleretic effects.

The laxative effect of magnesium hydroxide balances the effect of algeldrate, which has the opposite effect on intestinal motility.

It neutralizes free hydrochloric acid in the stomach and reduces the activity of gastric juice. The residence time in the stomach is about 1 hour.

Pharmacokinetics

Absorption is low.

Indications

Acute gastritis; hyperacid gastritis; acute duodenitis; gastric and duodenal ulcer (in the acute phase); symptomatic ulcerative lesions of the stomach and duodenum of various origins; erosions of the mucous membrane of the upper gastrointestinal tract; reflux esophagitis; hiatal hernia; acute pancreatitis; exacerbation of chronic pancreatitis; hyperphosphatemia; discomfort, gastralgia, heartburn (after excessive consumption of ethanol, nicotine, coffee, medication use, dietary errors); fermentative or putrefactive dyspepsia (as part of combination therapy).

ICD codes

Dosage Regimen

Orally, 5-10 ml (suspension, gel) or 2-3 tablets 1-2 hours after meals and at bedtime; for gastric ulcer – 30 minutes before meals; if necessary, the single dose can be increased to 15 ml or 3-4 tablets.

After achieving the therapeutic effect – maintenance therapy with 5 ml or 1 tablet 3 times/day for 2-3 months.

Children from 4 to 12 months – 7.5 ml, children over 1 year – 15 ml 3 times/day.

For prevention, take 5-10 ml or 1-2 tablets before possible irritating effects on the gastrointestinal mucosa.

To increase effectiveness, tablets should be chewed or held in the mouth until completely dissolved.

The suspension or gel must be homogenized before use by shaking the bottle or thoroughly kneading the sachet between the fingers.

The contents of the sachet are squeezed into a spoon or into the mouth.

Adverse Reactions

From the digestive system: nausea, vomiting, change in taste sensations, constipation.

With long-term use in high doses: hypophosphatemia, hypocalcemia, hypercalciuria, osteomalacia, osteoporosis, hypermagnesemia, hyperaluminemia, encephalopathy, nephrocalcinosis, impaired renal function.

In patients with concomitant renal insufficiency: thirst, decreased blood pressure, hyporeflexia.

Contraindications

Hypersensitivity to algeldrate and magnesium hydroxide; chronic renal failure; pregnancy; Alzheimer’s disease; hypophosphatemia.

With caution children under 12 years of age, lactation period (breastfeeding).

Use in Pregnancy and Lactation

Use during pregnancy is contraindicated.

Use with caution during lactation (breastfeeding).

Use in Renal Impairment

Contraindicated in chronic renal failure.

Pediatric Use

Use with caution in children under 12 years of age.

Special Precautions

With long-term administration, ensure sufficient intake of phosphorus salts with food.

For adequate selection of a single dose, it is advisable to conduct an acute pharmacological test (after administering the suspension through a gastric tube and subsequent rinsing with 10 ml of water, the pH of the gastric juice is assessed after 1 hour; if the pH is below 3.5, a dose increase is necessary).

Drug Interactions

Reduces and slows the absorption of digoxin, indomethacin, salicylates, chlorpromazine, phenytoin, H₂-histamine receptor blockers, beta-blockers, diflunisal, ketoconazole and itraconazole, isoniazid, tetracycline antibiotics and quinolones (ciprofloxacin, norfloxacin, ofloxacin, enoxacin, grepafloxacin, etc.), azithromycin, cefpodoxime, pivampicillin, rifampin, indirect anticoagulants, barbiturates (they should be taken 1 hour before or 2 hours after taking antacids), fexofenadine, dipyridamole, zalcitabine, chenodeoxycholic and ursodeoxycholic acids, penicillamine, and lansoprazole.

M-cholinoreceptor blockers, by slowing gastric emptying, enhance and prolong the action of the drug.

Storage Conditions

Store at 8°C (46°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.