Stool Softener 100mg Capsules

Manufacturer AMERISOURCE BERGEN DRUGS Active Ingredient Docusate Capsules and Tablets(DOK yoo sate) Pronunciation DOK yoo sate
It is used to treat constipation.
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Drug Class
Laxative, Stool Softener
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Pharmacologic Class
Anionic Surfactant
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Docusate is a stool softener that helps make your bowel movements easier to pass by allowing water and fats to get into the stool, making it softer. It does not make you 'go' immediately like a laxative, but works gradually over 1 to 3 days.
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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 your medication as directed, with or without food, and swallow it with a full glass of water.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from freezing temperatures. Keep it in a dry place, avoiding bathrooms and areas where children and pets can access it. Ensure all medications are stored safely and out of 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, consult your pharmacist for guidance on proper disposal or explore local drug take-back programs.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Increase fluid intake (especially water) to help with constipation.
  • Increase dietary fiber (fruits, vegetables, whole grains).
  • Engage in regular physical activity.
  • Do not use for more than 7 days unless directed by a doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 50 to 300 mg orally daily, usually 100 mg once or twice daily
Dose Range: 50 - 300 mg

Condition-Specific Dosing:

constipation: 100 mg orally once or twice daily
prevention_of_straining: 50 to 100 mg orally daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (some sources suggest 10-40 mg/day for infants >6 months, but generally not recommended without medical supervision)
Child: 2-12 years: 40 to 120 mg orally daily in 1-4 divided doses
Adolescent: 12-18 years: 50 to 300 mg orally daily, usually 100 mg once or twice daily
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific considerations; minimal systemic absorption

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Docusate is an anionic surfactant that lowers the surface tension of the stool, allowing water and fats to penetrate and mix with the fecal material. This softens the stool, making it easier to pass. It does not stimulate intestinal peristalsis.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (small amounts may be absorbed)
Tmax: Not well-defined due to minimal systemic absorption; therapeutic effect typically seen in 1-3 days
FoodEffect: Not significantly affected by food; can be taken with or without food

Distribution:

Vd: Not available (minimal systemic distribution)
ProteinBinding: Not available (minimal systemic absorption)
CnssPenetration: No

Elimination:

HalfLife: Not well-defined due to minimal systemic absorption
Clearance: Not well-defined
ExcretionRoute: Primarily fecal excretion via bile
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: 1 to 3 days
PeakEffect: Not applicable (gradual softening)
DurationOfAction: Continues as long as therapy is maintained

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or swelling of the mouth, face, lips, tongue, or throat.

Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. Many people have no side effects or only mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
- Stomach cramps
- Diarrhea
This list does not include all possible side effects. If you have concerns about side effects, consult your doctor.

Reporting Side Effects
For medical advice about side effects, contact your doctor. You can also 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 or cramping
  • Rectal bleeding
  • No bowel movement after 3 days of use
  • Nausea or vomiting
  • Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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 are currently taking mineral oil

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. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
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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.

Do not use this medication for more than 7 days without explicit instructions from your doctor to do so.

If you experience rectal bleeding or do not have a bowel movement after using this medication, consult your doctor promptly.

Unless advised by your doctor, avoid using other laxatives or stool softeners in conjunction with this medication.

If you are following a low-sodium or sodium-free diet, discuss this with your doctor, as some of these products contain sodium.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe abdominal cramping
  • Diarrhea
  • Electrolyte imbalance (rare with oral docusate alone)

What to Do:

Discontinue use. Symptomatic and supportive care. Call a poison control center or emergency services. Call 1-800-222-1222

Drug Interactions

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Moderate Interactions

  • Mineral oil (increased absorption of mineral oil, potentially leading to systemic toxicity)

Monitoring

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Routine Monitoring

Bowel movements

Frequency: Daily

Target: Regular, soft stools

Action Threshold: No bowel movement after 3 days, or worsening constipation

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Symptom Monitoring

  • Abdominal cramping
  • Diarrhea
  • Rectal bleeding
  • Nausea
  • Bloating

Special Patient Groups

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Pregnancy

Generally considered safe for use during pregnancy, as systemic absorption is minimal. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Low risk
Second Trimester: Low risk
Third Trimester: Low risk
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Lactation

Considered compatible with breastfeeding due to minimal systemic absorption and low levels excreted into breast milk. Monitor infant for diarrhea.

Infant Risk: Low risk (L3 - moderately safe)
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Pediatric Use

Use in children should be under medical supervision, especially for infants and young children. Dosing varies by age. Not for use in children under 2 years without physician guidance.

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Geriatric Use

Generally safe and effective in the elderly. Start with lower doses and titrate as needed. Ensure adequate hydration to prevent dehydration.

Clinical Information

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Clinical Pearls

  • Docusate is a stool softener, not a stimulant laxative; it works by making stools easier to pass, not by inducing bowel movements.
  • Onset of action is slow (1-3 days), so it's not suitable for acute, immediate relief of constipation.
  • Often used to prevent constipation and straining, especially post-surgery, post-partum, or in patients with hemorrhoids or cardiac conditions.
  • Advise patients to drink plenty of fluids while taking docusate to enhance its effect.
  • Avoid concomitant use with mineral oil due to increased absorption of mineral oil.
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Alternative Therapies

  • Bulk-forming laxatives (e.g., psyllium, methylcellulose)
  • Osmotic laxatives (e.g., polyethylene glycol, lactulose, magnesium hydroxide)
  • Stimulant laxatives (e.g., bisacodyl, senna) - for short-term use only
  • Lubricant laxatives (e.g., mineral oil - avoid with docusate)
  • Dietary and lifestyle modifications (increased fiber, fluids, exercise)
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Cost & Coverage

Average Cost: $5 - $20 per 30 capsules (100mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (often OTC, not covered by prescription plans)
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.