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Composition:


active ingredients: sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate.


100 ml of rectal solution contains: sodium dihydrogen phosphate dihydrate equivalent to sodium dihydrogen phosphate monohydrate 16 g; disodium phosphate dodecahydrate equivalent to disodium phosphate heptahydrate 6 g;


excipients: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate


(E 216), purified water.


Dosage form. Rectal solution.


Basic physical and chemical properties: transparent colorless solution.


Pharmacotherapeutic group.


Drugs that affect the digestive system and metabolism. Laxatives. Enemas.


ATX code A06A G20.


Pharmacological properties.


Pharmacodynamics.


The drug, when administered rectally, acts as a saline laxative. The accumulation of fluid in the lower intestine causes filling and promotes peristalsis and motility of the intestine, causing emptying of only the rectum, Sigmoid and part or all of the descending colon.


Pharmacokinetics.


Absorption in the colon is minimal, but it has been reported that approximately 25% of individuals with normal renal function experienced asymptomatic hyperphosphatemia after oral administration of intestinal preparations containing sodium phosphate, which exceeded the normal level of phosphorus by 2-3 times. Under normal conditions, the strongest absorption of phosphorus is observed in the small intestine, to which drugs administered rectally do not penetrate.


Clinical characteristics.


Indications.


Episodic constipation.


Cases that require colon cleansing, such as before and after colon surgery, during and after childbirth, before proctoscopy, sigmoidoscopy, or colonoscopy, and before X-ray examination of the colon.


Contraindications.


- Hypersensitivity to active substances or to any other substance that is part of the drug;


- enlargement of the colon (megacolon);


- anorectal stenosis;


- narrowing or incomplete opening of the anus or rectum;


- Hirschsprung's disease;


- suspected intestinal obstruction;


- suspected paralytic intestinal obstruction;


- suspected: appendicitis; perforation/damage or obstruction of the bowel; active inflammatory disease of the large intestine (for example, Crohn's disease or ulcerative colitis);


- undiagnosed rectal bleeding;


- kidney failure;


- congestive heart failure;


- a recent illness or feeling weak or thirsty;


- abdominal pain (abdominal pain);


- dehydration and a condition in which the ability to absorb increases or the ability to defecate decreases;


- children's age;


- simultaneous use with other drugs containing sodium phosphate.


Interactions with other drugs and other types of interactions.


You should inform your doctor if the patient has recently used any other prescription or over-the-counter medications, including:


medications used to treat hypertension or angina (calcium channel blockers); diuretics (diuretics); certain medications used for psychiatric disorders (lithium); any other medications that may cause dehydration or affect the level of electrolytes (potassium, sodium, phosphates, or water) in the body.

Use with caution in patients taking the above medications, as there is a risk of hyperphosphatemia, hypocalcemia, hypokalemia, hypernatremic dehydration and acidosis.


Since hypernatremia is associated with low lithium levels, concomitant use of the drug and lithium therapy can lead to a decrease in serum lithium levels and a decrease in effectiveness.


Application features.


Do not use in the presence of nausea, vomiting or abdominal pain without a doctor's prescription.


In the case of bowel movements due to taking this medication, you should drink plenty of fluids to prevent dehydration, especially in diseases that can lead to dehydration, or in the case of medications that can reduce the glomerular filtration rate, for example, diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors, e.g. enalapril, ramipril, lisinopril), angiotensin receptor blockers (ARBs, e.g. losartan, candesartan, eprosartan, irbesartan, olmesartan, Telmisartan, valsartan) or nonsteroidal anti-inflammatory drugs (NSAIDs).


Since the drug contains sodium phosphates, there is a risk of increased concentrations of sodium and phosphate, as well as a decrease in serum calcium and potassium concentrations, which can lead to hypernatremia, hyperphosphatemia, hypocalcemia and hypokalemia with clinical signs similar to tetany and renal failure. Electrolyte imbalance is of particular concern to children suffering from megacolon or any other condition in which enema fluid retention occurs, and to patients with comorbidities. For this reason, the drug should be prescribed with caution to elderly or emaciated patients and patients with uncontrolled arterial hypertension, ascites, heart diseases, changes in the rectal mucosa (ulcers, cracks), colostomy, who use diuretics or other medications that affect the balance of electrolytes, drugs that can prolong the QT interval (for example, amiodarone, arsenic trioxide, astemizole, azithromycin, erythromycin, clarithromycin, chlorpromazine, cisapride, citalopram, domperidone, terfenadine, procainamide), or patients with an electrolyte imbalance that has been observed before, as hypocalcemia, hypokalemia, hyperphosphatemia, or hypernatremia may occur. Use with caution in patients taking medications that affect renal perfusion, renal function, or hydration. If electrolyte imbalance is suspected and patients have a history of hypophosphatemia, electrolyte levels should be monitored before and after the drug is administered.


The drug should be used with caution in patients with impaired renal function, in which the benefit of use will exceed the risk of hyperphosphatemia.


Repeated and prolonged use of the drug is not recommended, as it can be addictive. Injecting more than one enema within 24 hours can be harmful. If there are no doctor's instructions, the drug should not be used for more than one week.


Before using the drug, you should read the instructions for use and the rules for administration of the drug. Patients should be warned to stop Administration if they feel resistance, as the force of administration may cause local damage. Rectal bleeding after using the drug may indicate a serious condition. In this case, you should stop further use of the drug and consult your doctor.


Usually, emptying occurs about 5 minutes after applying the drug, so holding the enema for more than 5 minutes is not recommended. If there is no emptying after using the drug or if the retention time lasts more than 10 minutes, serious side effects may occur. In this case, you should stop further use of the drug and consult a doctor who will decide on the appointment of laboratory tests in order to identify possible deviations in electrolyte levels and minimize the risk of developing severe hyperphosphatemia.


The drug contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), so it can cause allergic reactions (possibly delayed).


Enema-Sella single enema is a solution for rectal use. DO NOT SWALLOW.

Use during pregnancy or lactation.


There are insufficient data to assess the potential risk of embryonic malformations or embryotoxic effects caused by the use of the drug, so the drug should not be used in case of pregnancy or suspected pregnancy.


The drug can only be used as prescribed by a doctor during or after childbirth.


Since the active ingredients contained in the preparation can get into breast milk, it is suggested to express breast milk within 24 hours after applying the enema and not use it for feeding.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


Unknown.


Dosage and administration.


The drug is intended for rectal use only.


You should follow the recommendations below, unless your doctor has given you other instructions.


Adults, including elderly patients:


1 bottle no more than 1 time a day or as prescribed by the doctor.


Procedure for enema administration:


1. the patient should remove the protective cover.


2. Lie on your left side with both legs bent at the knees.


3.with constant pressure, carefully insert the tip of the vial into the rectum so that it is directed towards the navel.


4.squeeze the bottle until all its contents pass into the intestines.


The administration should be discontinued if any resistance is felt. Forced administration may cause harm.


Note: there is no need to leave the bottle completely empty. The bottle contains a larger amount of solution than is necessary to achieve the desired effect, so a small liquid residue is acceptable.


5. carefully remove the tip from the rectum. Some liquid may leak out of the bottle.


6. stay in the same position until you feel a strong urge to empty your intestines, usually within 2-5 minutes.


7.after use, put the bottle back in its cardboard packaging for disposal.

If rectal bleeding is observed, You should immediately consult a doctor.


You need to be prepared for the appearance of an urge to empty the intestines within 5 minutes after applying the drug. This is normal and indicates that the drug is working. It is advisable to stay near the toilet until the effect of the drug weakens.


If there is no urge to defecate within the specified time, you should consult your doctor. Until then, you should no longer use the drug.


You should consume plenty of clear liquids, such as water, clear soups, herbal teas, black tea or black coffee, or beverages such as fruit juices without pulp (but not red or purple juices), to prevent dehydration. In general, you need to drink 250 ml every hour until the effect of the Drug Administration disappears. After that, it is necessary to drink a clear liquid, preferably water, to satisfy thirst after a clinical procedure or as directed by a doctor.


Children. Do not use in pediatric practice.


Overdose.


Given that the drug is almost not absorbed, overdose can only be accidental.


With overdose or prolonged use, hyperphosphatemia, hypocalcemia, hypernatremia, hypernatremic dehydration, acidosis and tetany may occur.


Recovery from toxic effects is usually achieved by rehydration. In severe cases, calcium and magnesium salts (10% calcium gluconate) should be administered to correct changes in electrolytes, while increasing the excretion of exogenous phosphorus, and dialysis should be performed.


If more than the required amount of the drug has been used or the drug has been accidentally swallowed (drunk), you should immediately inform your doctor. If possible, bring a bottle or cardboard box to show to your doctor.


Adverse reactions.


Adverse effects are listed below using the following frequency classification: very common (≥1/10); common (≥1/100 to rare (≥ 1/10, 000 to rare (


Very rarely (


Immune system disorders: hypersensitivity reactions (e.g. urticaria).


From the skin and subcutaneous tissue: blisters, itching, burning.


Metabolic disorders: dehydration, hyperphosphatemia, hypocalcemia, hypokalemia, hypernatremia, metabolic acidosis.


From the gastrointestinal tract: nausea, vomiting, abdominal pain, abdominal spasm, diarrhea, gastrointestinal pain, anal discomfort, proctalgia.


General disorders and conditions at the injection site: irritation of the anus, pain, burning, chills.


If any adverse reactions occur, you should stop treatment and consult a doctor.

Tags: Enem