Softala-X
Softala-X Uses, Dosage, Side Effects, Food Interaction and all others data.
Softala-X works by stimulating enteric nerves to cause colonic contractions. It is also a contact laxative; it increases fluid and salt secretion. Action of bisacodyl on small intestine is negligible; stimulant laxatives mainly promote evacuation of the colon.
Patients should be counselled regarding abdominal pain, nausea, vomiting, or a change in bowel function that lasts longer than 2 weeks. It has a wide therapeutic index, as patients can take 5-15 mg orally. Patients taking bisacodyl should be counselled before taking the medication if they are already experiencing abdominal pain, nausea, vomiting, or a change in bowel function lasting longer than 2 weeks. Patients should also be counselled to stop taking the medication if they experience rectal bleeding or no bowel movement in 12 hours.
| Trade Name | Softala-X |
| Availability | Over the counter |
| Generic | Bisacodyl |
| Bisacodyl Other Names | Bisacodilo, Bisacodyl, Bisacodyle, Bisacodylum |
| Related Drugs | MiraLAX, erythromycin, Colace, docusate, Linzess, senna, magnesium oxide, polyethylene glycol 3350, Dulcolax, neomycin |
| Type | |
| Formula | C22H19NO4 |
| Weight | Average: 361.3906 Monoisotopic: 361.131408101 |
| Groups | Approved |
| Therapeutic Class | Stimulant purgatives |
| Manufacturer | |
| Available Country | Switzerland |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Softala-X is used for Constipation; Preparation for radiography; antepartum & postpartum care; Preparation for sigmoidoscopy or proctoscopy; colonoscopy; hemorrhoids & anal fissures. All conditions which require defecation to be facilitated.
Softala-X is also used to associated treatment for these conditions: Constipation, Occasional Constipation, Bowel irregularity, Bowel preparation therapy
How Softala-X works
Softala-X is deacetylated to the active bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM) by an intestinal deacetylase. BHPM can stimulate parasympathetic nerves in the colon directly to increase motility and secretions.
Softala-X stimulates adenylate cyclase, increasing cyclic AMP, leading to active transport of chloride and bicarbonate out of cells. Sodium ions, potassium ions, and water passively leave the cell; while sodium and chloride ions are unable to be reabsorbed.
Water is also be transported from the luminal side of cells into the vasculature by aquaporin 3. Softala-X decreases expression of aquaporin 3, preventing water from moving into the vasculature, which may contribute to increased water in the colon.
Softala-X directly stimulates parasympathetic nerves in the colon, stimulating contraction of longitudinal smooth muscle but not circular smooth muscle.
Dosage
Softala-X dosage
Constipation:
- Adult: 1-2 tab (5-10 mg) daily, relief in 6-12 hr.
- Adult/Pediatric: 1 suppository (10 mg) daily, relief in 15-30 min.
- Children <10 yr: 1 tab (5 mg) or 1 suppository (5 mg) daily.
For complete bowel clearance:
- >10 yr: 2-4 tab the night before & 1 adult suppository on the day of the procedure.
- <10 yr: 1 tab the night before & 1 pediatric suppositoryon the day of the procedure.
The max daily dose should not be exceeded.
Side Effects
Abdominal discomfort & diarrhea.
Toxicity
Patients experiencing an overdose of bisacodyl may present with more severe diarrhea and electrolyte imbalance. Patients should be treated with symptomatic and supportive measures.
The oral LD50 in rats is 4320 mg/kg, and in mice is 17500 mg/kg.
Precaution
Caution should be taken in pregnancy and children.
Interaction
Do not give antacids or milk within 1 hour of taking the drug (enteric coated)
Food Interaction
- Avoid milk and dairy products. Take at least 1 hour before or after antacids and milk.
- Take separate from antacids. Take at least 1 hour before or after antacids and milk.
Softala-X Drug Interaction
Moderate: furosemide, magnesium hydroxide, polyethylene glycol 3350, ondansetronUnknown: aspirin, lorazepam, diphenhydramine, docusate, duloxetine, omega-3 polyunsaturated fatty acids, sodium biphosphate / sodium phosphate, atorvastatin, pregabalin, metoprolol, acetaminophen / hydrocodone, acetaminophen, cyanocobalamin, ascorbic acid, cholecalciferol, cetirizine
Softala-X Disease Interaction
Major: inflammatory bowel disease, intestinal obstruction disorders, acute surgical abdomen, rectal bleeding
Volume of Distribution
Data regarding the volume of distribution of bisacodyl is not readily available. However, the volume of distribution of the active metabolite, BHPM, in lactating women is 181 L after a single dose and 289 L at steady state.
Elimination Route
Oral formulations of bisacodyl are only 16% bioavailable. A 10 mg enteric coated oral tablet reaches a Cmax of 26 ng/mL with a Tmax of 8 hours, while a 10 mg oral solution reaches a Cmax of 237 ng/mL with a Tmax of 1.7 hours. A 10 mg suppository reaches a Cmax of 0-64 ng/mL.
In lactating women, 10mg of oral bisacodyl reaches a Cmax of 20.5-195 ng/mL, with a Tmax of 3-4 hours, and a geometric mean AUC after a single dose of 471 h*ng/mL. After multiple doses, the geometric mean AUC decreases to 311 h*ng/mL.
Half Life
Data regarding the half life of bisacodyl is not readily available. The half life of the active metabolite, BHPM, in lactating women was 7.3 h after a single 10 mg oral dose and 10.0 h after multiple doses.
Clearance
Data regarding the clearance of bisacodyl is not readily available. The apparent plasma clearance of the active metabolite, BHPM, in lactating women after a single 10 mg oral dose is 272 mL/min and after multiple doses is 412 mL/min.
Elimination Route
The majority of bisacodyl is eliminated in the feces. 13.8-17.0% of a bisacodyl dose is eliminated in the urine as the active metabolite BHPM.
Pregnancy & Breastfeeding use
Softala-X has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of teratogenicity or fetotoxicity. No data are available from controlled human pregnancy studies. Softala-X should only be given during pregnancy when need has been clearly established.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HalfLytely and Softala-X Tablets Bowel Prep Kit is administered to a nursing woman.
Contraindication
Softala-X is contraindicated in ileus, intestinal obstruction, acute surgical abdominal conditions, severe dehydration. Appendicitis & acute inflammatory bowel diseases.
Acute Overdose
A laxative is a medicine used to produce bowel movements. Laxative overdose occurs when someone takes more than the normal or recommended amount of this medicine. This can be by accident or on purpose.
Most laxative overdoses in children are accidental. However, some people regularly take overdoses of laxatives to try to lose weight.
Storage Condition
Store at room temperature, between 15°C to 30°C. Store in a tightly closed container away from heat, moisture, and light.
Innovators Monograph
You find simplified version here Softala-X
Softala-X contains Bisacodyl see full prescribing information from innovator Softala-X Monograph, Softala-X MSDS, Softala-X FDA label
FAQ
What is Softala-X used for?
Softala-X can help you empty your bowels if you have constipation.Softala-X is also used in hospitals to help you empty your bowels before surgery or some examinations or treatments.
How safe is Softala-X?
Softala-X is safe and effective when used according to directions on the drug facts label.
How does Softala-X work?
Softala-X works by increasing activity of the intestines to cause a bowel movement.
What are the common side effects of Softala-X?
The most common side effects are feeling sick nausea, diarrhoea, stomach pain or cramps. Only give Softala-X to children and young people if a doctor or pharmacist recommends it. Do not take Softala-X tablets or use Softala-X suppositories every day for more than 5 days.
Is Softala-X safe during pregnancy?
Softala-X tablets or suppositories are not generally recommended if you are pregnant.
Is Softala-X safe during breastfeeding?
Softala-X is not absorbed from the gastrointestinal tract, and its active metabolite, which is absorbed, is not detectable in breastmilk.Softala-X can be taken during breastfeeding and no special precautions are required.
Can I drink alcohol with Softala-X?
Yes, you can drink alcohol with Softala-X.
What is the best time to take Softala-X?
Softala-X tablets take about 10-12 hours to work; therefore, they are best taken at bedtime. Do not chew or break the tablets. A suppository can be used instead of taking tablets.
Why is Softala-X taken at night?
Softala-X is usually taken the evening before a bowel movement is desired.Softala-X normally causes a bowel movement within 6 to 12 hours.
How long does Softala-X last?
The elimination half life of Softala-X is 16 hours. This means that the bowel stimulant medication is metabolized in the body and roughly half is gone after 16 hours with half the remaining medicine gone after another 16 hours.
Can Softala-X help weight loss?
Softala-X do not help with weight loss. They do not reduce the absorption of calories or nutrients.
Who should not take Softala-X?
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
What happens if I miss a dose o fSoftala-X?
Since Softala-X is used when needed, it does not have a daily dosing schedule.
If you are preparing for a medical test and you miss your dose, call your doctor for instructions.
What happens if I overdose of Softala-X?
Symptoms of overdose may include: severe stomach/abdominal pain or cramping, persistent nausea/vomiting/diarrhea. Keep all regular medical and laboratory appointments.
How many Softala-X can I take in a day?
Do not take Softala-X more than once a day or for more than 1 week without talking to your doctor.
Can Softala-X cause miscarriage?
No, Softala-X is not safe or recommended in pregnancy, especially during the first trimester, as it may cause birth defects or a miscarriage in the mother's womb.
Can Softala-X help weight loss?
Softala-X do not help with weight loss. They do not reduce the absorption of calories or nutrients.
Is Softala-X safe for long-term use?
Do not use this medicine for longer than directed by your doctor or health care professional. This medicine can be habit-forming. Long-term use can make your body depend on the laxative for regular bowel movements, damage the bowel, cause malnutrition, and problems with the amounts of water and salts in your body.
What happens if I take Softala-X everyday?
Do not take Softala-X every day for more than 5 days. If you take Softala-X for longer, your body can start to rely on it, rather than your bowels doing the work on their own. If you are still constipated after 5 days, talk to your doctor.
Can I take Softala-X in the morning?
Use one suppository daily. It will take between 10-60 minutes to work and therefore should preferably be used in the morning. It will usually have its effect within 30 minutes.
