Dulcolax 5mg EC Tablets

Manufacturer BOEHRINGER INGELHEIM CONSUMER Active Ingredient Bisacodyl Tablets(bis a KOE dil) Pronunciation bis-a-KOE-dil
It is used to treat constipation.
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Drug Class
Laxative, Stimulant
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Pharmacologic Class
Diphenylmethane derivative
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Pregnancy Category
Not formally assigned for OTC; generally considered low risk (Category B/C)
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FDA Approved
Sep 1953
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Bisacodyl is a laxative that helps you have a bowel movement by making your intestines move more and by bringing more water into your stool. It's used for short-term relief of constipation.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication with a full glass of water and swallow the tablet whole. Do not chew, break, or crush it.

Storing and Disposing of Your Medication

Store the medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program if available.

Missing a Dose

If you take this medication on a regular schedule and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Drink plenty of fluids (water, juices) while taking this medication to help prevent dehydration and aid in stool softening.
  • Increase dietary fiber intake (fruits, vegetables, whole grains) to help prevent future constipation.
  • Engage in regular physical activity to promote healthy bowel function.
  • Do not use for more than 7 days unless directed by a doctor.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 5-15 mg orally once daily
Dose Range: 5 - 15 mg

Condition-Specific Dosing:

constipation: 5-15 mg orally once daily, typically at bedtime for morning effect. Max 30 mg/day for severe cases under medical supervision.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: 5 mg orally once daily. Over 12 years: 5-15 mg orally once daily.
Adolescent: 12 years and older: 5-15 mg orally once daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for occasional use.
Moderate: No adjustment needed for occasional use.
Severe: Use with caution; monitor for electrolyte imbalance with prolonged use.
Dialysis: Use with caution; monitor for electrolyte imbalance with prolonged use.

Hepatic Impairment:

Mild: No adjustment needed for occasional use.
Moderate: No adjustment needed for occasional use.
Severe: No adjustment needed for occasional use.
Confidence: Medium

Pharmacology

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Mechanism of Action

Bisacodyl is a stimulant laxative that acts directly on the colonic mucosa to stimulate sensory nerve endings, which increases peristaltic contractions. It also increases fluid and electrolyte secretion into the colon, leading to increased stool volume and softening.
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Pharmacokinetics

Absorption:

Bioavailability: Very low systemic bioavailability (<5%) due to poor absorption and extensive first-pass metabolism.
Tmax: Not applicable for systemic absorption; onset of action for laxative effect is 6-12 hours (oral).
FoodEffect: Food, milk, antacids, or proton pump inhibitors can cause premature dissolution of the enteric coating, leading to gastric irritation (cramping, vomiting) and reduced efficacy.

Distribution:

Vd: Not available (minimal systemic distribution)
ProteinBinding: Not available (minimal systemic distribution)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 16 hours (for active metabolite desacetylbisacodyl)
Clearance: Not available
ExcretionRoute: Primarily fecal (as active metabolite and its glucuronide conjugate); small amount excreted renally as glucuronide.
Unchanged: Negligible systemic excretion of unchanged drug.
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Pharmacodynamics

OnsetOfAction: 6-12 hours (oral tablet)
PeakEffect: Not precisely defined for laxative effect, generally within duration of action.
DurationOfAction: Effect typically lasts until bowel evacuation, usually within 6-12 hours.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin (with or without fever)
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat

Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to monitor your response to the medication. If you notice any of the following side effects or any other unusual effects, contact your doctor for advice:
- Stomach pain or cramps

Note: This list is not exhaustive, and you may experience other side effects. If you have concerns or questions about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe abdominal pain, cramping, or nausea/vomiting (stop use and consult doctor).
  • Rectal bleeding or failure to have a bowel movement after using the laxative (may indicate a serious condition).
  • Signs of dehydration (e.g., excessive thirst, dizziness, decreased urination).
  • Signs of electrolyte imbalance (e.g., muscle weakness, irregular heartbeat).
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Bowel obstruction
+ Abdominal pain
+ Upset stomach
+ Rectal bleeding
+ Vomiting
+ Changes in bowel habits that last longer than 2 weeks
* If you have difficulty swallowing without chewing

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To ensure safe use, follow these guidelines:
- Do not use this medication for more than 1 week without explicit instructions from your doctor.
- Avoid using other laxatives or stool softeners unless your doctor advises you to do so.
- If you experience rectal bleeding or do not have a bowel movement after taking this medication, consult your doctor promptly.
- When taking this drug, refrain from consuming dairy products, calcium, or magnesium within 1 hour of administration.
- Additionally, do not take antacids within 1 hour before or 1 hour after taking this medication, as this may interfere with its effectiveness.

When considering use in children, note that different forms of this medication may be suitable for different age groups. Therefore, it is crucial to consult with your doctor before administering this drug to a child.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe abdominal cramps
  • Diarrhea
  • Significant fluid and electrolyte loss (especially potassium)
  • Dehydration
  • Hypotension
  • Muscle weakness

What to Do:

Discontinue use. Correct fluid and electrolyte imbalances. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Moderate Interactions

  • Antacids
  • Milk
  • H2-receptor antagonists (e.g., cimetidine, ranitidine)
  • Proton pump inhibitors (e.g., omeprazole, lansoprazole)
  • Diuretics (especially loop diuretics)
  • Corticosteroids

Monitoring

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Baseline Monitoring

Not typically required for OTC use.

Rationale: Bisacodyl is an OTC medication for short-term use.

Timing: Not applicable

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Routine Monitoring

Bowel movement frequency and consistency

Frequency: Daily during use

Target: Regular, soft stool

Action Threshold: No bowel movement after 3 days of use, or worsening constipation, or severe abdominal pain.

Abdominal pain/cramping

Frequency: Daily during use

Target: Minimal to none

Action Threshold: Severe or persistent abdominal pain, nausea, vomiting.

Signs of dehydration/electrolyte imbalance (with chronic/excessive use)

Frequency: As needed, if prolonged use occurs

Target: Normal hydration, no muscle weakness/cramps

Action Threshold: Dizziness, muscle weakness, irregular heartbeat, excessive thirst.

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Symptom Monitoring

  • Abdominal pain
  • Cramping
  • Nausea
  • Vomiting
  • Diarrhea
  • Dehydration (with overuse)
  • Electrolyte imbalance (with overuse, e.g., hypokalemia)

Special Patient Groups

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Pregnancy

Generally considered safe for occasional use during pregnancy, as systemic absorption is minimal. However, consult a healthcare provider before use.

Trimester-Specific Risks:

First Trimester: Low risk, minimal systemic absorption.
Second Trimester: Low risk, minimal systemic absorption.
Third Trimester: Low risk, minimal systemic absorption.
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Lactation

Considered safe for occasional use during breastfeeding. Minimal amounts of the active metabolite are excreted into breast milk, and adverse effects on the infant are unlikely.

Infant Risk: Low
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Pediatric Use

Use with caution and according to age-specific dosing. Not recommended for children under 6 years unless directed by a doctor. Prolonged use can lead to fluid and electrolyte imbalance.

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Geriatric Use

Use with caution. Elderly patients may be more susceptible to fluid and electrolyte disturbances, especially with prolonged or excessive use. Start with the lowest effective dose and ensure adequate hydration.

Clinical Information

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Clinical Pearls

  • Dulcolax (bisacodyl) is an enteric-coated tablet. Do not chew, crush, or break the tablet, as this will destroy the enteric coating and may cause gastric irritation.
  • Avoid taking bisacodyl with milk, antacids, or proton pump inhibitors (PPIs) within 1 hour, as these can prematurely dissolve the enteric coating.
  • Best taken at bedtime to produce a bowel movement the following morning (6-12 hours later).
  • Not intended for long-term daily use. Chronic use can lead to dependence, electrolyte imbalance, and damage to the colon (cathartic colon).
  • Ensure adequate fluid intake to prevent dehydration, especially when using laxatives.
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Alternative Therapies

  • Bulk-forming laxatives (e.g., psyllium, methylcellulose)
  • Osmotic laxatives (e.g., polyethylene glycol, magnesium hydroxide, lactulose)
  • Stool softeners (e.g., docusate sodium)
  • Lubricant laxatives (e.g., mineral oil)
  • Other stimulant laxatives (e.g., senna)
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Cost & Coverage

Average Cost: $5 - $15 per 30 tablets
Generic Available: Yes
Insurance Coverage: OTC (Over-the-Counter) - generally not covered by prescription plans, but may be eligible for FSA/HSA.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.