Senna 176mg/5ml Syrup

Manufacturer PHARMACEUTICAL ASSOCIATES Active Ingredient Sennosides Liquid and Syrup(SEN oh sides) Pronunciation SEN-uh
It is used to treat constipation.
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Drug Class
Laxative, Stimulant
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Pharmacologic Class
Anthraquinone Laxative
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Pregnancy Category
Category C (generally considered low risk for short-term use, but consult physician)
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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?

Senna is a type of laxative that helps you have a bowel movement by stimulating your intestines. It's used for short-term relief of occasional constipation. It usually works within 6 to 12 hours, so it's often taken at bedtime.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.

Do not take any other medications within 2 hours of taking this drug.
If you are taking this medication once a day, take it at bedtime.
Some formulations of this medication require shaking before use. Make sure you know if your specific product needs to be shaken before using it.
When taking a liquid dose, measure it carefully using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring device.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:
Store it at room temperature in a dry place, avoiding the bathroom.
Protect the medication from heat sources.
* Keep all medications in a secure location, out of the reach of children and pets.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Increase fluid intake (especially water) to help soften stools and prevent dehydration.
  • Increase dietary fiber (fruits, vegetables, whole grains) to promote regular bowel movements.
  • Engage in regular physical activity to stimulate bowel function.
  • Do not use for more than 7 days unless directed by a doctor.
  • Do not use if you have abdominal pain, nausea, or vomiting unless directed by a doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 17.2 mg sennosides (equivalent to 0.49 mL of 176mg/5mL syrup) once daily at bedtime
Dose Range: 8.6 - 50 mg

Condition-Specific Dosing:

constipation: Initial dose 17.2 mg sennosides (0.49 mL of 176mg/5mL syrup) once daily, may increase up to 50 mg sennosides (1.42 mL of 176mg/5mL syrup) daily in divided doses. Do not use for more than 7 days without medical advice.
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Pediatric Dosing

Neonatal: Not established (generally not recommended)
Infant: Not established (generally not recommended)
Child: 2-6 years: 4.3 mg sennosides (0.12 mL of 176mg/5mL syrup) once daily at bedtime. Max 8.6 mg/day. 6-12 years: 8.6 mg sennosides (0.24 mL of 176mg/5mL syrup) once daily at bedtime. Max 17.2 mg/day. Consult physician for use in children under 6 years.
Adolescent: 12 years and older: Same as adult dosing, 17.2 mg sennosides (0.49 mL of 176mg/5mL syrup) once daily at bedtime. Max 50 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, use with caution.
Moderate: No specific adjustment, use with caution due to potential for electrolyte imbalance with prolonged use.
Severe: Use with caution; avoid prolonged use due to risk of electrolyte disturbances (e.g., hypokalemia) and fluid imbalance. Monitor electrolytes.
Dialysis: Use with caution; avoid prolonged use. Monitor electrolytes closely.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: No specific adjustment.
Severe: No specific adjustment, but use with caution in patients with severe liver disease due to potential for electrolyte disturbances.

Pharmacology

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Mechanism of Action

Sennosides are prodrugs that are metabolized by colonic bacteria into active metabolites (rhein anthrones). These active metabolites stimulate colonic peristalsis by direct action on the colonic mucosa and nerve plexus, increasing the motility of the large intestine. They also increase water and electrolyte secretion into the colon, leading to a softer stool consistency and increased stool volume.
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Pharmacokinetics

Absorption:

Bioavailability: Low systemic absorption of active metabolites (rhein anthrones). Sennosides themselves are not absorbed.
Tmax: Not applicable for sennosides (prodrug). Active metabolites (rhein anthrones) reach peak concentration in the colon within 6-12 hours.
FoodEffect: Food does not significantly alter efficacy, but taking with food may reduce gastrointestinal upset.

Distribution:

Vd: Not available (limited systemic distribution of active metabolites).
ProteinBinding: Not available (limited systemic distribution).
CnssPenetration: Limited

Elimination:

HalfLife: Not precisely defined for active metabolites due to colonic metabolism; effect duration is 6-12 hours.
Clearance: Not available (primarily fecal elimination of active metabolites).
ExcretionRoute: Primarily fecal (active metabolites). A small amount of metabolites may be excreted renally, causing reddish-brown discoloration of urine.
Unchanged: Negligible systemic absorption of unchanged sennosides.
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Pharmacodynamics

OnsetOfAction: 6-12 hours
PeakEffect: Not distinctly defined, effect builds over 6-12 hours.
DurationOfAction: Effect lasts until bowel evacuation, typically within 12 hours of administration.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
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 medical help right away:
- 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
- Stomach pain or cramps
- Any other side effects that bother you or do not go away

Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. 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
  • Failure to have a bowel movement after using the laxative
  • Signs of dehydration (e.g., excessive thirst, dry mouth, dizziness, decreased urination)
  • Muscle weakness or irregular heartbeat (may indicate electrolyte imbalance)
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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.
If you experience any of the following health issues:
+ Bowel blockage
+ Abdominal pain
+ Upset stomach
+ Rectal bleeding
+ Vomiting
+ Changes in bowel habits that persist for more than 2 weeks

Please note that this is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems

with your doctor and pharmacist to ensure safe use. Before starting, stopping, or modifying the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
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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 a period exceeding 1 week unless specifically instructed to do so by your doctor. Additionally, refrain from using other laxatives or stool softeners without first consulting your doctor. If you experience rectal bleeding or fail to have a bowel movement after using this medication, promptly discuss these symptoms with your doctor. If you are pregnant, planning to become pregnant, or are currently breast-feeding, be sure to notify your doctor, as you will need to have a discussion about the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe diarrhea
  • Abdominal cramps
  • Fluid and electrolyte imbalance (especially hypokalemia)
  • Dehydration
  • Nausea
  • Vomiting

What to Do:

Discontinue use. Provide supportive care, including fluid and electrolyte replacement. In case of severe symptoms or accidental overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222).

Drug Interactions

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Major Interactions

  • Digoxin (risk of digoxin toxicity due to hypokalemia caused by prolonged senna use)
  • Antiarrhythmics (e.g., quinidine, amiodarone) (increased risk of arrhythmias due to hypokalemia)
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Moderate Interactions

  • Diuretics (thiazide, loop) (increased risk of hypokalemia)
  • Corticosteroids (increased risk of hypokalemia)
  • Licorice (increased risk of hypokalemia)
  • Other laxatives (increased risk of excessive laxation, dehydration, electrolyte imbalance)

Monitoring

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Baseline Monitoring

Assessment of constipation cause

Rationale: To rule out underlying medical conditions requiring different treatment and to ensure appropriate use of a stimulant laxative.

Timing: Prior to initiation of therapy

Electrolyte levels (especially potassium)

Rationale: To establish baseline, particularly if patient has pre-existing conditions or is on medications that affect electrolytes, or if prolonged use is anticipated.

Timing: Prior to initiation for chronic use or high-risk patients

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Routine Monitoring

Bowel movement frequency and consistency

Frequency: Daily during use

Target: Regular, soft, formed stools

Action Threshold: No bowel movement after 12-24 hours, or persistent diarrhea/abdominal pain

Hydration status

Frequency: Daily during use

Target: Adequate fluid intake, no signs of dehydration

Action Threshold: Signs of dehydration (e.g., dry mouth, decreased urination, dizziness)

Electrolyte levels (especially potassium)

Frequency: Periodically, if used for more than 7 days or in high-risk patients

Target: Within normal limits

Action Threshold: Hypokalemia or other electrolyte imbalances

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Symptom Monitoring

  • Abdominal pain or cramping (severe or persistent)
  • Nausea or vomiting
  • Diarrhea (excessive or persistent)
  • Rectal bleeding
  • Signs of dehydration (e.g., thirst, dry mouth, decreased urination, dizziness)
  • Weakness or muscle cramps (suggestive of electrolyte imbalance)

Special Patient Groups

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Pregnancy

Generally considered safe for short-term use during pregnancy when lifestyle modifications and bulk-forming laxatives are insufficient. However, prolonged or excessive use should be avoided due to the risk of electrolyte imbalance. Consult a healthcare provider before use.

Trimester-Specific Risks:

First Trimester: Low risk for short-term use.
Second Trimester: Low risk for short-term use.
Third Trimester: Low risk for short-term use.
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Lactation

Sennosides are minimally excreted into breast milk and are generally considered compatible with breastfeeding for short-term use. Monitor the infant for diarrhea.

Infant Risk: Low risk; potential for mild diarrhea in the infant, but generally well-tolerated.
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Pediatric Use

Use with caution and only under medical supervision for children under 6 years of age. Dosing must be age and weight-appropriate. Prolonged use can lead to fluid and electrolyte disturbances and laxative dependence.

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Geriatric Use

Start with the lowest effective dose. Elderly patients may be more susceptible to fluid and electrolyte imbalances (especially hypokalemia) and dehydration. Monitor closely for adverse effects. Avoid prolonged use.

Clinical Information

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Clinical Pearls

  • Senna is a stimulant laxative and should only be used for short-term relief of occasional constipation, typically for no more than 7 days.
  • Prolonged or excessive use can lead to laxative dependence, electrolyte disturbances (especially hypokalemia), and melanosis coli (a benign pigmentation of the colon).
  • Advise patients to increase fluid intake and dietary fiber to support bowel regularity and reduce reliance on laxatives.
  • Administer at bedtime for a morning bowel movement, as onset of action is 6-12 hours.
  • Urine may turn reddish-brown due to metabolites, which is harmless.
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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)
  • Peripherally acting mu-opioid receptor antagonists (PAMORAs) for opioid-induced constipation (e.g., methylnaltrexone, naloxegol)
  • Guanylate cyclase-C agonists (e.g., linaclotide, plecanatide)
  • Chloride channel activators (e.g., lubiprostone)
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Cost & Coverage

Average Cost: $5 - $20 per 237mL bottle (typical size)
Generic Available: Yes
Insurance Coverage: Generally not covered by prescription insurance as it is an OTC product, but may be covered by 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 this 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.