Phospho-Soda Oral Solution

Phospho-Soda Oral Solution

Manufacturer:

Casen Recordati

Distributor:

Apex Pharma Marketing

Marketer:

Euro Asia Medico
Full Prescribing Info
Contents
Disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate.
Description
Phospho-Soda contains 10.8 g of Disodium phosphate dodecahydrate and 24.4 g of Sodium dihydrogen phosphate dihydrate per 45 mL.
Excipients/Inactive Ingredients: The other ingredients are: glycerin, sodium saccharin, ginger-lemon flavour (ginger oil, alcohol, lemon oil, citric acid, water); sodium benzoate and purified water.
Indications/Uses
Phospho-soda is a laxative. It is used in cases of severe constipation. Phospho-soda is used to prepare the bowel for a surgical procedure or a bowel examination.
Dosage/Direction for Use
Always use this medicine exactly as the doctor or pharmacist has told the patient. Check with the doctor or pharmacist if not sure.
Attention: Drink enough water or clear liquids to prevent complete dehydration or hypovolemia (low volume of blood circulating in the body).
Clear liquid means water, clear soup (not thick), fruit juice without pulp, tea or black coffee, clear beverages not containing carbonic gas.
Use as Laxative: It is recommended that patient use this medicine 30 minutes before lunch or in the evening before bedtime. It is recommended that the patient first drink a glass of liquid before taking Phospho-soda.
Always dilute the quantity indicated in a glass of cold water (±120 mL). (See table.)

Click on icon to see table/diagram/image

After administration of the solution it is recommended to drink an additional glass of water. In children in particular, it is recommended to drink an additional glass of liquid for the purpose of preventing dehydration.
If no intestinal transit is seen in the 6 hours following the use of the first or the second dose, discontinue immediately the administration of the product and talk to a doctor.
Dependency and intestinal problems may occur if the patient uses this medicine frequently or on the long term.
Use as Bowel Cleansing: For use in adults only. Do not use in children under 18 years of age. Do not exceed the quantity prescribed. To prevent vomiting, it is recommended to drink a glass of clear liquid before taking Phospho-soda.
Elderly patients: The same dose as in adults.
The doses of Phospho-soda start the day before the patient's hospital appointment. For appointments before 12 pm, follow the recommendations applied to the morning. For appointments fixed after 12 pm, follow the recommendations applied to the afternoon.
Morning appointments: The day before the examination: 7h00: As breakfast, drink a glass of clear liquid or water; if possible, it is recommended that the patient drinks several glasses.
1st dose: Immediately after it, dilute 45 mL of Phosphosoda in half a glass of cold water (±120 mL), and drink 1 or more large glasses (240 mL) of cold water. Drink all possible additional liquids to make up for the fluid loss occurring during intestinal transit.
13h00: Do not take food at lunch. Instead of food, drink at least 3 glasses (720 mL) of a clear liquid or water; the patient can drink more if the patient wants.
19h00: Do not have dinner. Instead of food, drink 1 glass (240 mL) of a clear liquid or water; the patient can drink more if the patient wants.
2nd dose: Immediately after it, dilute 45 mL of Phospho-soda in half a glass of cold water (±120 mL), and drink 1 or more large glasses (240 mL) of cold water. Continue taking all additional possible liquid until midnight. Taking high amounts of clear liquid can cleanse the bowel before the procedure.
Afternoon appointment: The day before the examination: 13h00: Lunch: light meal, then do not take more solid food until after the examination.
19h00: Do not have dinner. Instead of food, drink 1 glass of a clear liquid or water; the patient can drink more if the patient wants.
1st dose: Immediately after it, dilute 45 mL in half a glass of cold water (±120 mL), and drink 1 or more large glasses (240 mL) of cold water. Drink all possible additional liquids to make up for the fluid loss occurring during intestinal transit. At night, drink at least 3 glasses (720 mL) of clear liquid or water in the evening; the patient can drink more if the patient wants.
Day of the examination: 7h00: As breakfast, drink a glass of clear liquid or water; if possible, it is recommended that the patient drinks several glasses.
2nd dose: Immediately after it, dilute 45 mL in half a glass of cold water (±120 mL), and drink 1 or more large glasses (240 mL) of cold water. Drink all possible additional liquids to make up for the fluid loss occurring during intestinal transit. Taking high amounts of clear liquid can cleanse the bowel before the procedure. Continue taking all additional possible liquids until 8:00.
This medicine acts usually about half an hour to 6 hours following bowel administration.
The doctor will decide the time that the patient will have to use Phospho-soda.
If the patient takes more Phospho-soda than the recommended dose: High doses of Phospho-soda are dangerous. These can cause excess phosphate and sodium and deficit of calcium and potassium in blood. These disorders can cause body acidification, which can sometimes be fatal.
In case of overdosage or accidental intake, the following symptoms can occur: dehydratation, hypotension, tachycardia, slowing down of pulse, cardiac arrest, shock, acceleration of breathing, respiratory problems, gasping, seizures, large bowel paralysis, anxiety, pain in the lower abdomen.
Cases of complete recovery after overdosage have been reported, both in children receiving Phospho-soda accidentally and patients with constipation.
In case of overdosage, it is essential to restore water balance.
Intravenous administration of 10% calcium gluconate may be sometimes necessary.
Hospitalisation is recommended.
If the patient forgets to take Phospho-soda: If  the patient must use Phospho-soda as preparation for a bowel examination, tell the doctor so that new measures can be taken for the examination.
Do not take a double dose to make up for a forgotten dose.
Overdosage
High doses of Phospho-soda are dangerous. These can cause excess phosphate and sodium and deficit of calcium and potassium in blood. These disorders can cause body acidification, which can sometimes be fatal.
In case of overdosage or accidental intake, the following symptoms can occur: dehydratation, hypotension, tachycardia, slowing down of pulse, cardiac arrest, shock, acceleration of breathing, respiratory problems, gasping, seizures, large bowel paralysis, anxiety, pain in the lower abdomen.
Cases of complete recovery after overdosage have been reported, both in children receiving Phospho-soda accidentally and patients with constipation.
In case of overdosage, it is essential to restore water balance.
Intravenous administration of 10% calcium gluconate may be sometimes necessary.
Hospitalisation is recommended.
Contraindications
If the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in Excipients/Inactive Ingredients under Description).
If the patient suffers from nausea or stomach ache; there might be a possibilty of kidney malfunction; If the patient is younger than 18 years, the patient should not use Phospho-soda as bowel cleansing (but the patient can use it as laxative; see Dosage & Administration); In case of: renal problems; overactivity of the parotid glands (primary hyperparathyroidism) associated with high concentrations of calcium in blood; cardiac decompensation (heart failure); ascites (fluid accumulation in the abdominal cavity); known or suspected occlusion in the stomach or the bowel; colon hypertrophy (megacolon); perforation in the gastrointestinal tract; bowel occlusion (ileus); progressing inflammatory bowel disease (such as Crohn's disease or bleeding rectal colitis).
Phospho-soda should not be used in combination with other laxatives containing sodium phosphate.
Special Precautions
If the patient is already taking other medicines, (see Interactions).
In elderly people, the fluid and electrolyte (water-salt) balance may be impaired with the use of Phospho-soda. This disturbance may be fatal. Talk to the doctor before using Phospho-soda.
During the use of Phospho-soda, the patient tend to have more watery stools. It is very important that the patient drink as much water as possible.
Talk to the doctor or pharmacist before using Phospho-soda if the patient suffer from any of the following: heart disease, such as myocardial infarction or angina pectoris; hypotension; dehydration; slowing down of gastric or intestinal activity; colon inflammation; fluid and electrolyte imbalance.
If the patient does not absorb sufficient liquid.
If the patient is on a sodium-free (salt-free) diet.
After a gastrointestinal procedure, because gastrointestinal transit may be delayed.
If the patient have an artificial anus.
If the patient is taking anti-inflammatory analgesics (of NSAID type).
Children with congenital megacolon are exposed to a risk of dehydration caused by the sudden increase in sodium blood levels.
In case of use of diuretics and some antihypertensives, there is a risk of kidney malfunction.
This medicine takes usually about half an hour to 6 hours to act following administration. If no bowel movement is seen within 6 hours following the use of the first or the second dose of Phospho-soda, discontinue immediately and consult a doctor.
Dependency and intestinal problems may occur if the patient uses Phospho-soda frequently or on the long term.
The patient should speak to their doctor before using Phospho-soda if any warnings mentioned concerns the patient or has affected the patient in the past.
Driving and using machines: Phospo-soda may cause dizziness, probably as a result of dehydration. It can cause a mild to moderate effect on the ability to drive cars or use machines.
Use In Pregnancy & Lactation
Phospho-soda should not be used during pregnancy, unless its use is completely necessary and it is administered under medical monitoring.
It is not known whether Phospho-soda enters breast milk. Thus, if the patient wants to use Phospho-soda, collect the milk and dispose of it. Follow these steps from the last dose to 24 hours following the second dose (see Dosage & Administration). Do not breast-feed within 24 hours following the second dose of Phospho-soda.
If the patient is pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Adverse Reactions
Like all medicines, this medicine can cause side effects, although not everybody may experience them.
In each frequency group, the side effects are classified by decreasing severity order as follows: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1 000, <1/100); rare (≥1/10 000, <1/1 000); very rare (<1/10 000), not known (cannot be estimated from the available data).
Blood and lymphatic system disorders: Very rare: hypotension.
Immune system disorders: Very rare: hypersensitivity.
Metabolism and nutrition disorders: Uncommon: water deficit. Very rare: electrolyte balance disorders, mainly excess of phosphate and sodium and deficit of calcium and potassium in blood. These disorders can cause muscle cramps and acid intoxication.
Nervous system disorders: Very common: dizziness. Common: headache. Very rare: fainting.
Cardiac disorders: Uncommon: acceleration of pulse and transient hypotension can occur. Very rare: heart rhythm disorders, caused by electrolyte balance changes. This disorder is mild.
Gastrointestinal disorders: Very common: nausea, abdominal pain, abdominal distension, diarrhoea. Common: vomiting. The combination of a fasting state and a laxative effect can cause nausea. To prevent these symptoms, it is recommended to drink as much clear liquids as possible. Uncommon: the doctor may see small aphthae during the bowel examination. These disorders are not clinically significant and are self-limited.
Skin and subcutaneous tissue disorders: Very rare: allergic skin rash, itching.
Musculoskeletal and connective tissue disorders: Very rare: muscle cramps.
Renal and urinary disorders: Very rare: kidney failure, kidney stones and chronic kidney problems. Rare: formation of lime precipitates.
General disorders and administration site conditions: Very common: tremor, body weakness. Common: chest pain.
Drug Interactions
Ask the doctor if the patient is taking the following medicines: medicines for hypertension; medicines for heart diseases; diuretics (tablets for increasing urine); parathormone (medicine for osteoporosis); lithium or other products that may affect electrolyte balance; medicines that modify heart rhythm.
The use of Phospho-soda may delay or hinder intestinal absorption of medicines. This applies in particular to the following substances: contraceptives taken by oral route (by the mouth), medicines for controlling epilepsy, medicines used for diabetes, antibiotics. The concomitant use of other preparations based on sodium phosphate is not permitted. Tell the doctor or pharmacist if the patient is using, have recently used or might use any other medicines.
Phospho-soda with food and drink: This medicine contains 5.0 g of sodium per 45 mL bottle. Take into account that the patient may need to control the patient's dietary sodium intake.
Storage
Store this product below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist on how to throw away medicines that are no longer use. These measures will help protect the environment.
ATC Classification
A06AD10 - mineral salts in combination ; Belongs to the class of osmotically acting laxatives.
Presentation/Packing
Oral soln (colourless, ginger-lemon flavour, with no precipitation or turbidity) 45 mL.
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in