Usage
- Dicyclomine + Tramadol is prescribed for the management of moderate to severe acute pain, particularly pain associated with gastrointestinal spasms or cramps, such as in irritable bowel syndrome (IBS) and other functional bowel disorders. It can also be used for other types of acute pain as well.
- Pharmacological Classification: Analgesic, Antispasmodic. Tramadol is an opioid analgesic, Paracetamol is a non-opioid analgesic and antipyretic, and dicyclomine is an anticholinergic antispasmodic.
- Mechanism of Action: Tramadol acts on opioid receptors in the central nervous system, reducing pain perception. It also inhibits the reuptake of serotonin and norepinephrine, further contributing to analgesia. Paracetamol inhibits prostaglandin synthesis, reducing pain and fever. Dicyclomine relaxes smooth muscles in the gastrointestinal tract by blocking acetylcholine, relieving spasms and cramps.
Alternate Names
- No internationally recognized non-proprietary name exists for this specific combination, as it is composed of three separate active ingredients.
- Brand Names: Numerous brand names exist depending on the manufacturer and region. Some examples based on Indian pharmaceutical market include Proxywel Spas Plus (which contains paracetamol in addition to dicyclomine and tramadol) and numerous other brand names exist for similar combination products with slight variations in ingredients and strengths. (Please note that brand names can change frequently. Consulting a current pharmaceutical directory is essential for the latest information).
How It Works
- Pharmacodynamics: Dicyclomine exerts its antispasmodic effects by blocking the action of acetylcholine at muscarinic receptors in the smooth muscle of the GI tract. Tramadol acts as a centrally acting analgesic, primarily through its action on mu-opioid receptors, and also inhibits the reuptake of norepinephrine and serotonin. Paracetamol’s mechanism is thought to involve central inhibition of COX enzymes as well as other mechanisms, leading to reduced pain and fever.
- Pharmacokinetics: Dicyclomine is well-absorbed orally. Tramadol is also well-absorbed after oral administration. Metabolism occurs primarily in the liver, with both drugs being metabolized by CYP enzymes, primarily CYP2D6 for tramadol and CYP3A4 for dicyclomine. Both drugs are primarily excreted in the urine. Paracetamol is rapidly absorbed from the gastrointestinal tract. It is primarily metabolized in the liver via conjugation with glucuronide and sulfate, and a small amount undergoes oxidative metabolism by CYP enzymes. Paracetamol is excreted primarily in the urine.
- Mode of Action: Dicyclomine competitively inhibits muscarinic receptors. Tramadol binds to mu-opioid receptors, modulating pain pathways in the CNS. It also blocks norepinephrine and serotonin reuptake. Paracetamol’s exact mode of action is debated, but likely involves COX inhibition and TRPA1 receptor modulation, acting centrally to modulate pain perception.
- Elimination Pathways: Dicyclomine is mainly excreted in the urine, both as the unchanged drug and metabolites. Tramadol is extensively metabolized in the liver, mostly through O-demethylation and N-demethylation and glucuronidation or sulfation, and eliminated primarily in the urine. Paracetamol is largely conjugated in the liver and excreted in the urine, primarily as glucuronide and sulfate conjugates.
Dosage
Standard Dosage
Adults:
- A common dosage form contains 10 mg dicyclomine, 325 mg paracetamol, and 50 mg of tramadol. One tablet is taken every 4-6 hours as needed for pain. Dosage should be individualized based on pain severity and patient response. Maximum daily doses should be considered for each individual drug (e.g. 4000 mg for paracetamol).
Children:
- This combination is generally not recommended for children under 12 years of age. Safety and efficacy have not been established in pediatric populations, and the combination of an opioid (tramadol) and an anticholinergic (dicyclomine) can have unpredictable effects on children. Alternative pain management strategies are preferred for this age group.
Special Cases:
- Elderly Patients: Lower starting doses may be necessary in elderly patients, along with careful monitoring for adverse effects due to potential age-related decrease in drug clearance and increased sensitivity.
- Patients with Renal Impairment: Dose adjustments are necessary based on the degree of renal impairment. Caution should be exercised due to the potential accumulation of both drugs and/or their metabolites.
- Patients with Hepatic Dysfunction: Dose reduction or avoidance may be necessary as both dicyclomine and tramadol are metabolized in the liver.
- Patients with Comorbid Conditions: Careful consideration is necessary in patients with conditions like glaucoma, prostatic hypertrophy, urinary retention, severe respiratory conditions, asthma, or a history of seizures, where the drugs’ effects may be exacerbated.
Clinical Use Cases
- Intubation, Surgical Procedures, Mechanical Ventilation, Intensive Care Unit (ICU) Use, Emergency Situations: The combination of dicyclomine and tramadol is typically not used in these settings. These situations often require specific pain management approaches tailored to the individual patient’s needs and the clinical context. Tramadol alone may be used in some cases, but careful monitoring for respiratory depression and other side effects is essential. Dicyclomine is not generally used in these settings.
Dosage Adjustments
- Dose adjustments are made based on the patient’s response to therapy, renal and hepatic function, age, and other comorbidities. For patients with renal or hepatic dysfunction, dose reductions may be required. Drug interactions with other medications must be considered.
Side Effects
Common Side Effects
- Nausea
- Vomiting
- Constipation
- Dry mouth
- Dizziness
- Drowsiness
- Blurred Vision
Rare but Serious Side Effects
- Seizures
- Serotonin syndrome
- Respiratory depression
- Allergic reactions (anaphylaxis)
- Hepatotoxicity (especially with paracetamol overdose)
Long-Term Effects
- Dependence and tolerance (with chronic tramadol use)
- Cognitive impairment (with chronic tramadol use)
Adverse Drug Reactions (ADR)
- Any severe manifestation of the above-mentioned side effects requires urgent medical attention. QT interval prolongation with tramadol.
Contraindications
- Hypersensitivity to any component of the medication
- Severe respiratory depression
- Acute or severe asthma
- Paralytic ileus
- Severe hepatic impairment
- Concurrent use of MAO inhibitors
Drug Interactions
- Other opioid analgesics
- Benzodiazepines and other CNS depressants
- Anticholinergic drugs (e.g., atropine)
- Serotonergic drugs (e.g., SSRIs, SNRIs)
- CYP2D6 inhibitors and inducers (tramadol is metabolized by CYP2D6)
- Alcohol
Pregnancy and Breastfeeding
- Pregnancy: This combination is generally avoided during pregnancy due to the potential risks associated with tramadol use, including neonatal withdrawal syndrome.
- Breastfeeding: This combination is not recommended during breastfeeding as both drugs can be excreted into breast milk and may pose a risk to the nursing infant.
Drug Profile Summary
- Mechanism of Action: Tramadol: Opioid receptor agonist, serotonin and norepinephrine reuptake inhibitor. Paracetamol: Central COX inhibitor, TRPA1 receptor modulator. Dicyclomine: Muscarinic receptor antagonist.
- Side Effects: Common: nausea, vomiting, constipation, dry mouth, dizziness, drowsiness, blurred vision. Serious: seizures, serotonin syndrome, respiratory depression.
- Contraindications: Hypersensitivity, respiratory depression, asthma, paralytic ileus, severe liver impairment, MAOI use.
- Drug Interactions: Other opioids, CNS depressants, anticholinergics, serotonergic drugs, CYP2D6 inhibitors/inducers, alcohol.
- Pregnancy & Breastfeeding: Avoid during both pregnancy and breastfeeding.
- Dosage: Adult: One tablet (10 mg dicyclomine, 325 mg paracetamol, 50 mg tramadol) every 4-6 hours as needed. Adjust dose based on individual patient needs and response.
- Monitoring Parameters: Respiratory rate, blood pressure, pain levels, liver function tests (with long-term use), signs of serotonin syndrome.
Popular Combinations
- This particular combination itself is fairly common in some regions, but it’s important to note that combinations with tramadol and paracetamol exist without dicyclomine. Dicyclomine itself is often given with paracetamol. The rationale for combining these drugs can be to achieve broader pain relief via multiple mechanisms and address the underlying spasms which may exacerbate pain.
Precautions
- Assess for allergies, history of seizures, respiratory, liver, or kidney disease before initiating therapy.
- Use caution in elderly patients, those with renal or hepatic impairment.
- Monitor for respiratory depression and other adverse effects.
- Avoid alcohol and other CNS depressants.
- Educate patients about potential side effects and precautions.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Dicyclomine + Tramadol + Paracetamol?
A: A common dose is one tablet (usually 10 mg dicyclomine, 325 mg paracetamol, and 50 mg tramadol) every 4-6 hours as needed for pain, with dose adjustments based on individual needs, age, and comorbidities.
Q2: Can this combination be used in children?
A: This combination is generally not recommended for use in children under 12.
Q3: What are the major drug interactions with this combination?
A: Major interactions can occur with alcohol, other opioids, CNS depressants (like benzodiazepines), anticholinergic drugs, and drugs that affect serotonin levels (such as SSRIs, MAOIs).
Q4: Is it safe to take this combination with alcohol?
A: No, it is not safe to take this medication with alcohol. Alcohol can potentiate the sedative effects of both tramadol and dicyclomine, increasing the risk of respiratory depression and other adverse events.
Q5: What are the symptoms of an overdose?
A: Overdose symptoms can include respiratory depression, seizures, loss of consciousness, and liver damage (related to paracetamol).
Q6: What should be done in case of an overdose?
A: Seek immediate medical attention. Supportive care including respiratory support and naloxone (for opioid overdose) may be necessary. N-acetylcysteine is an antidote for paracetamol overdose and should be administered promptly.
Q7: Can this medication be used during pregnancy or while breastfeeding?
A: This combination is generally contraindicated during pregnancy and breastfeeding due to the potential risks to the fetus or nursing infant.
Q8: Can patients with kidney or liver problems take this medication?
A: Patients with kidney or liver problems may require dosage adjustments or may be advised to avoid this combination entirely due to impaired drug clearance. Consult with a nephrologist or hepatologist for individualized recommendations.
Q9: Can this drug cause addiction?
A: Tramadol, a component of this combination medication, has the potential to be habit-forming with prolonged use.
Q10: What are the signs of serotonin syndrome?
A: Serotonin syndrome is a serious drug reaction that can occur with tramadol. Signs include agitation, confusion, rapid heart rate, high blood pressure, muscle rigidity or twitching, sweating, shivering, and diarrhea.
