Magnesia Cinfa 200Mg/Ml Oral Suspension 260Ml

Magnesia Cinfa (200 Mg/Ml Oral Suspension 1 Bottle 260 Ml)

magnesium hydroxide

ACTION AND MECHANISM

- [ANTIACID], [ANTIULCERA PEPTICA]. Magnesium hydroxide is capable of neutralizing gastric hydrochloric acid, giving rise to magnesium chloride and water. Produces an increase in gastric pH, decreasing the irritant action of acid and pepsin on the mucosa. The antacid effects depend on the rate of gastric emptying. Fasting lasts 20-60 minutes, while with food they last up to 3 hours.

- [LAXATIVE]. Magnesium hydroxide is also an osmotic laxative, since by not being absorbed it is capable of increasing the osmotic gradient in the intestine, drawing water into the intestinal lumen. It decreases the consistency of the stool and increases its volume, favoring peristalsis. The effects take about 3-6 hours to appear.

PHARMACOKINETICS

Orally:

- Absorption: Magnesium hydroxide is insoluble, so it is not absorbed in the intestine. When reacting with hydrochloric acid, it produces a certain amount of magnesium chloride, which is partially absorbed (15-30%).

Food: The administration of magnesium hydroxide with food determines the time of appearance of the effects and their duration. The presence of food delays gastric emptying, increasing the duration of the antacid effects and delaying the laxative effects. If there is no food, the release of small amounts of gastric juices into the duodenum occurs, therefore the duration of the antacid effects decreases and laxatives are accelerated.

- Elimination: Unabsorbed magnesium is eliminated with feces. The small amount that is absorbed is eliminated through the kidneys, and to a lesser extent with milk and sweat.

Pharmacokinetics in special situations:

- Renal failure: In case of renal failure, there could be a decrease in the elimination of magnesium, with the consequent risk of hypermagnesemia.

INDICATIONS

- Symptomatic treatment of occasional [CONSTIPATION].

- Symptomatic and temporary treatment of [GASTRIC HYPERACIDITY].

POSOLOGY

- Adults, the elderly and adolescents from 12 years of age, oral:

* Suspension:

- Constipation: 5-10 ml (1-2 g)/24 h. Maximum daily dose: 25 ml (5 g) in a single dose or divided into 2 doses as needed.

- Gastric hyperacidity: 2.5-5 ml (0.5-1 g)/24 h. Maximum dose 12.5 ml (2.5 g)/24h.

Administer preferably in the morning, since the laxative effects usually appear after 3-6 h. Then drink a full glass of water (200 ml).

In case of hyperacidity, administer preferably after meals or at bedtime.

DOSAGE IN RENAL FAILURE

* CrCl > 30 ml/min: Caution, watching for possible hypermagnesemia

* ClCr < 30 ml: its use is not recommended due to the risk of hypermagnesemia.

RULES FOR CORRECT ADMINISTRATION

- Suspension: ingest directly, or mixed in water, juices or infusions. It is advisable to take each dose with plenty of liquid (200 ml, a full glass).

CONTRAINDICATIONS

- Hypersensitivity to any component of the medication.

- Situations that could be aggravated by the laxative effect, such as [INTESTINAL OBSTRUCTION], [INTESTINAL PERFORATION], chronic [INFLAMMATORY BOWEL DISEASE], [APENDICITIS] or [TOXIC MEGACOLON]. Logically, it should not be used in patients with [DIARRHEA].

- Severe renal failure (CLcr less than 30 ml/minute). The safety and efficacy of magnesium hydroxide have not been evaluated, so given the possible risk of hypermagnesemia, the use of this medication is not recommended.

PRECAUTIONS

- [RENAL INSUFFICIENCY]. In case of renal insufficiency, an accumulation of magnesium may occur, with the consequent risk of hypermagnesemia. In patients with mild or moderate renal insufficiency (CLcr between 30-90 ml/minute) a dose readjustment may be necessary. The efficacy and safety of this drug in patients with severe renal insufficiency (CLcr less than 30 ml/minute) have not been evaluated, therefore its use is not recommended.

- Symptoms of intestinal obstruction. Before starting treatment with a laxative, it is advisable to perform a differential diagnosis of intestinal obstruction in patients with symptoms such as [NAUSEA], [VOMITING] or [ABDOMINAL PAIN] of unknown origin, or [ABDOMINAL DISTENSION].

- Long-term treatment. Antacids eliminate the symptoms related to acid diseases, which are common to those of malignant processes such as [CANCER OF THE STOMACH] or [CANCER OF THE ESOPHAGUS]. Therefore, there is a risk of delaying the diagnosis of these processes.

PRECAUTIONS RELATED TO EXCIPIENTS

- This medicine contains sorbitol. Patients with hereditary [FRUCTOSE INTOLERANCE] should not take this medicine.

- This medicine contains sucrose. Patients with hereditary [FRUCTOSE INTOLERANCE], glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medication.

- This medicine contains sucrose. Its use in oral liquids and pharmaceutical forms that remain in contact with the mouth for some time can harm the teeth.

ADVICE TO THE PATIENT

- Before starting a treatment against constipation, lifestyle habits should be modified. An adequate daily intake of fluids and fiber is recommended, as well as a quick response to the stimulus of defecation and physical exercise.

- This medication should not be used by patients with intestinal obstructions.

- When used as an antacid, it is recommended to take this medicine after meals.

- When used as a laxative, it is recommended to take this medication on an empty stomach before breakfast.

- If after 1 week of use, constipation does not improve, persists or worsens, you should consult your doctor or pharmacist.

- Check with your doctor and/or pharmacist if constipation worsens, or if symptoms such as nausea or vomiting, abdominal swelling or fever appear.

SPECIAL WARNINGS

- Perform a differential diagnosis in patients suspected of intestinal obstruction.

- If the patient experiences symptoms such as dyspepsia, dysphagia, a feeling of satiety, symptoms of gastric bleeding, such as melena, hematemesis or anemia, or unexplained weight loss, the existence of esophageal or gastric carcinoma must be ruled out before administering this medication.

- Before starting a treatment, the patient must be properly hydrated and their electrolyte levels be normal. Treatment should not be started if these levels are altered.

- In elderly or debilitated patients, it is recommended to periodically monitor electrolyte levels.

INTERACTIONS

- Ulipristal acetate-based emergency contraceptive. Increased gastric pH can reduce plasma concentrations of the contraceptive, reducing its effectiveness. Concomitant use is not recommended.

- NSAIDs (mefenamic acid, tolfenamic acid, flurbiprofen, ibuprofen). Clinical cases have been described in which magnesium hydroxide accelerated the absorption of anti-inflammatories. The mechanism of action is unknown.

- Atenolol. Cases have been described in which antacids decreased the absorption of atenolol by almost 50%, possibly due to the increase in pH, which would reduce the rate of dissolution of the beta-blocker. Although the interaction has not produced symptoms, it may be significant, so it is recommended to separate the administration of both drugs by at least 2 hours.

- Atorvastatin. Decreases in atorvastatin serum concentrations of up to 35% have been observed without affecting the efficacy of atorvastatin. The effect may be due to a decrease in absorption due to an increase in pH or to the formation of insoluble complexes. It is recommended to distance the administration of both drugs at least 2 h.

- Bisphosphonates (tiludronic acid). Decreases in tiludronate absorption of up to 60% have been reported when administered with magnesium hydroxide. The effect could be due to the formation of insoluble complexes. Although this interaction has not been proven with other bisphosphonates, it cannot be ruled out. It is recommended to distance the taking of both medications at least 2 h.

- Cimetidine. Several studies have shown that the administration of cimetidine with antacids can decrease the absorption of the antiulcer agent, although this effect is highly variable, with decreases in bioavailability of 3-48%. The importance of this effect is highly variable, but as a general rule, it is recommended to separate the administration of both drugs by at least 2 hours.

- Chlorpromazine. Clinical cases have been described in which the administration of antacids decreased the bioavailability of chlorpromazine by up to 20%, with the consequent risk of loss of its therapeutic effects. The causes of this interaction are unknown, but it could be due to physical adsorption of chlorpromazine by the antacid. It is recommended to distance the administration of both drugs at least 2 h.

- Digoxin. It has been found that magnesium hydroxide could decrease the absorption of digoxin, since it can adsorb digoxin on its surface. It is recommended to distance the administration of both drugs at least 2 h.

- Eltrombopag. Possible reduction of eltrombopag absorption by formation of insoluble chelates with polyvalent cations. Administer eltrombopag at least 4 hours before or after this drug.

- Erlotinib. Possible reduction in erlotinib levels, due to reduced absorption. Antacids increase gastric pH, which could decrease erlotinib solubility, absorption, and therapeutic effects. It is recommended to administer at least 4 hours before or 2 hours after the daily dose of the antineoplastic.

- Phenytoin. There have been some cases of patients in which the administration of antacids could decrease the bioavailability of phenytoin. The cause of this effect is unknown, but it could be due to changes in the solubility of phenytoin, by varying gastric pH, and by increased peristalsis. It is recommended to distance the administration of both drugs at least 2 h.

- Gabapentin. Some decrease in gabapentin levels has been observed when administered together with or within two hours of taking an antacid with magnesium hydroxide and algeldrate. It is recommended to administer gabapentin 2 hours before an antacid.

- ACEI (captopril, fosinopril). Decreases in bioavailability of 45% for captopril and 30% for fosinopril have been described in some studies when used with antacids. The mechanism of action is not known. Loss of antihypertensive effects may occur, so it is recommended to separate the administration of both drugs by at least 2 hours.

- Ketoconazole. It has been found that antacids could decrease the absorption of ketoconazole, with the possible loss of therapeutic efficacy. It is recommended to distance the administration of both drugs at least 2 h.

- Lansoprazole. Pharmacokinetic studies have shown a 13% reduction in the area under the curve and a 27% reduction in Cmax. The effects seem to be due to a lower absorption of lansoprazole due to the increase in pH. It is recommended to separate the administration of these medications by at least 1 h.

- Penicillamine. It has been found that antacids could decrease the absorption of penicillamine by around 35%, probably due to the formation of insoluble complexes. Due to the possible loss of therapeutic effect, it is recommended to separate the administration of both drugs by at least 2 hours.

- Sodium polystyrenesulfonate. There have been cases of patients undergoing treatment with magnesium hydroxide and polystyrene in which metabolic alkalosis occurred. The effect could be due to the union of polystyrene and magnesium, which would prevent magnesium from neutralizing bicarbonate ions, which would enter the blood, giving rise to alkalosis. It is recommended to avoid this association, especially in metabolically unstable patients.

- Prednisone. Significant reductions (25-50%) in the bioavailability of prednisone have been observed when administered with antacids. The mechanism of action is unknown, but it is recommended to distance the taking of both medications at least 2 h or replace prednisone with prednisolone.

- Quinidine. There have been clinical cases of patients with decreased renal clearance and quinidine toxicity when administered in combination with antacids. The effect could be due to an alkalization of the urine. It is recommended to avoid the combination, and if necessary, to monitor the dosage of quinidine.

- Quinolones (ciprofloxacin, enoxacin, sparfloxacin, moxifloxacin, norfloxacin, ofloxacin, perfloxacin). Many cases of significant reductions in the bioavailability of quinolones have been described when administered with antacids, which could even lead to therapeutic failure of the antibiotic. The effects could be due to the formation of insoluble complexes when the metal cations bind to the quinolone nucleus. It is recommended to distance the administration of both drugs at least 2 h.

- Ranitidine. Studies have shown that antacids could decrease plasma levels by around 30%, apparently due to decreased ranitidine absorption due to changes in pH. It is recommended to avoid this association or use at least low doses of antacids.

- Iron salts. Cases have been described in which magnesium hydroxide and other antacids decreased the absorption of iron salts. The effects could be due to the formation of poorly soluble complexes. It is recommended to distance the taking of these iron supplements and magnesium antacids at least 2 h.

- Salicylates (acetylsalicylic acid, salicylic acid). There have been cases of patients undergoing treatment with magnesium hydroxide and salicylates, in which there was a decrease in plasma salicylate levels, probably due to urine alkalinization. Loss of efficacy of salicylates could occur.

- Sulpiride. Pharmacokinetic studies have shown that antacids could reduce the bioavailability of sulpiride by up to 32%. It is recommended to distance the taking of both medications at least 2 h.

- Tetracyclines (chlortetracycline, demeclocycline, doxycycline, tetracycline). There have been many cases in which the administration of antacids decreased the bioavailability of tetracyclines, because they form insoluble complexes with di and trivalent cations. There is a risk of loss of efficacy, so the administration of both drugs must be separated by at least 2 h.

- Vitamin D. Magnesium competes with calcium in its absorption, both being facilitated by vitamin D. Patients treated with vitamin D and magnesium antacids could develop hypermagnesemia, especially in patients with renal failure. It is recommended to avoid such association.

PREGNANCY

Safety in animals: no data available.

Human Safety: Administer with caution due to risk of hypermagnesemia.

Effects on Fertility: No specific studies have been conducted in humans.

LACTATION

Safety in animals: no data available.

Safety in humans: Magnesium is excreted in small amounts in breast milk, but alterations have not been observed.

in infants. It can be used, although it is recommended to avoid excessive doses or prolonged consumption.

CHILDREN

Magnesium is excreted in small amounts with milk, so there have been cases of diarrhea in infants. However, serious effects are not expected, so it can be used, as long as it is not used in high doses or for long periods of time.

ADVANCED AGE

There is no recommendation for use in these patients.

ADVERSE REACTIONS

Adverse effects of magnesium hydroxide are generally mild and transient. The most characteristic adverse reactions are:

- Digestive. The appearance of [DIARRHEA] is common (1-9%).

- Hydroelectrolytic. In specific cases, especially in prolonged treatments or in patients with significant renal insufficiency, [HYPERMAGNESEMIA] could be produced (See Overdose).

OVERDOSE

Symptoms: After an overdose, the appearance of diarrhea is expected. If the overdose is severe, hypermagnesemia may develop. Symptoms of hypermagnesemia include flushing, thirst, hypotension, nausea, vomiting, asthenia, confusion, dizziness, blurred vision, ataxia, and muscle weakness. In the most serious cases, cardiac arrhythmias, respiratory depression, coma and even death from cardiac arrest may appear.

Treatment: The administration of the drug should be stopped immediately. Elimination of magnesium from the body should be accelerated by peritoneal dialysis and administration of calcium chloride. Forced diuresis may also be performed by administering diuretics such as furosemide or ethacrynic acid. In the event that hydroelectrolyte imbalances appear, electrolyte solutions may be administered.

Leaflet Magnesia Cinfa 200Mg/Ml Oral Suspension 260Ml