Usage
- This combination medication is primarily used for the symptomatic relief of irritable bowel syndrome (IBS) and other functional gastrointestinal disorders involving abdominal pain and cramping. It can also be used to treat other conditions involving abdominal pain and muscle spasms.
- Pharmacological Classification: Dextropropoxyphene is an opioid analgesic, while Dicyclomine is an anticholinergic antispasmodic.
- Mechanism of Action: Dextropropoxyphene reduces pain perception by binding to mu-opioid receptors in the central nervous system. Dicyclomine relaxes the smooth muscles of the gastrointestinal tract by blocking the action of acetylcholine, a neurotransmitter that stimulates muscle contractions in the gut.
Alternate Names
- This combination medication doesn’t have a universally recognized international nonproprietary name (INN).
- Brand Names: Spasmol, Colitab, Spasmon, Colidex, Hyvon Spas HG, Parvon Spas, Spasmcare D, Spasmo Neurovon, Spasmocip Plus, Zoldex Spas.
How It Works
- Pharmacodynamics: Dextropropoxyphene acts as a mild opioid analgesic, binding to opioid receptors in the central nervous system, thus reducing pain perception. Dicyclomine acts as an anticholinergic, blocking acetylcholine’s effect on muscarinic receptors in the GI tract, leading to smooth muscle relaxation.
- Pharmacokinetics: Dextropropoxyphene is well-absorbed orally, metabolized in the liver, and primarily excreted in the urine. Dicyclomine is also absorbed orally, metabolized in the liver, and eliminated via renal and biliary pathways.
- Mode of Action: Dextropropoxyphene exerts its analgesic effect by binding to mu-opioid receptors in the CNS. Dicyclomine acts as an anticholinergic agent, blocking the action of acetylcholine at muscarinic receptors in the GI tract, leading to smooth muscle relaxation.
- Elimination Pathways: Dextropropoxyphene is primarily excreted in urine after hepatic metabolism. Dicyclomine is eliminated through both renal and biliary pathways following hepatic metabolism.
Dosage
It is important to note that Dextropropoxyphene has been withdrawn from the market in many countries due to safety concerns, particularly the risk of cardiac arrhythmias. Therefore, the following dosage information is provided for historical context and should not be interpreted as a recommendation for current use.
Standard Dosage
Adults (Historical): Dextropropoxyphene 65 mg + Dicyclomine 10mg every 4-6 hours.
Children: This medication is not recommended for use in children under 12 years of age. For older children, the dosage should be adjusted based on weight and clinical response under strict medical supervision.
Special Cases:
- Elderly Patients: Start with a lower dose and titrate cautiously based on individual tolerance and renal/hepatic function.
- Patients with Renal Impairment: Dosage adjustment may be required.
- Patients with Hepatic Dysfunction: Dosage adjustment may be required.
- Patients with Comorbid Conditions: Caution is advised in patients with breathing problems, liver or kidney disease, history of head injury, seizures, adrenal gland disorder, enlarged prostate, and digestive system disorders.
Clinical Use Cases
The use of this combination in specific clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations is not supported by current medical guidelines.
Dosage Adjustments
Dose modifications are necessary based on renal/hepatic dysfunction and other comorbid conditions. Always consult current clinical guidelines and consider the safety profile of dextropropoxyphene before considering its use.
Side Effects
Common Side Effects
Nausea, dry mouth, constipation, blurred vision, dizziness, drowsiness, headache.
Rare but Serious Side Effects
Cardiac arrhythmias, seizures, respiratory depression, hepatotoxicity.
Long-Term Effects
Chronic use can lead to opioid dependence and tolerance.
Adverse Drug Reactions (ADR)
Clinically significant ADRs include cardiac arrhythmias, respiratory depression, and allergic reactions, requiring immediate medical attention.
Contraindications
Hypersensitivity to either drug; Paralytic ileus; Severe respiratory depression; Acute asthma attacks; Obstructive uropathy; Glaucoma; Myasthenia gravis; Unstable cardiovascular status in acute hemorrhage; Infants under 6 months of age; Breastfeeding mothers. Pre-existing medical conditions should be evaluated.
Drug Interactions
Alcohol; Other opioid analgesics; Anticholinergic drugs; Sedatives; Tricyclic antidepressants; MAO inhibitors; Other medications metabolized by CYP450 enzymes. Concurrent use of many other medications should be avoided. Consult a healthcare professional for details.
Pregnancy and Breastfeeding
This combination is contraindicated during pregnancy and breastfeeding due to potential risks to the fetus/infant. Dextropropoxyphene can cause neonatal respiratory depression.
Drug Profile Summary
- Mechanism of Action: Opioid analgesic (dextropropoxyphene) and anticholinergic antispasmodic (dicyclomine).
- Side Effects: Nausea, dry mouth, constipation, blurred vision, dizziness, drowsiness, headache. Serious side effects include cardiac arrhythmias, seizures, and respiratory depression.
- Contraindications: Hypersensitivity, paralytic ileus, glaucoma, myasthenia gravis, severe respiratory or hepatic disease, infants under 6 months.
- Drug Interactions: Alcohol, other opioids, anticholinergics, sedatives, tricyclic antidepressants, MAOIs.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: (Historical) Adults: Dextropropoxyphene 65 mg + Dicyclomine 10mg every 4-6 hours; not recommended for children under 12.
- Monitoring Parameters: Respiratory rate, heart rate, blood pressure, mental status, liver function tests.
Popular Combinations
This combination medication is itself considered a fixed-dose combination, and it is not typically combined with other medications. However, paracetamol is often added to this combination for enhanced pain relief.
Precautions
- General Precautions: Pre-screening for allergies, metabolic disorders, organ dysfunction.
- Specific Populations: Risks to pregnant women and breastfeeding mothers; age-specific precautions for children and the elderly.
- Lifestyle Considerations: Avoid alcohol; caution with driving or operating machinery due to potential dizziness and drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Dextropropoxyphene + Dicyclomine?
A: Due to safety concerns, dextropropoxyphene is no longer recommended for use. This combination is not currently prescribed. Historically, the adult dose was 65 mg dextropropoxyphene + 10mg dicyclomine every 4-6 hours. This information is for historical reference only.
Q2: What are the common side effects?
A: Common side effects include nausea, dry mouth, dizziness, drowsiness, constipation, blurred vision, and headache.
Q3: Is this medication safe during pregnancy or breastfeeding?
A: No, this combination is contraindicated during pregnancy and breastfeeding due to potential risks to the fetus/infant.
Q4: What are the serious side effects I should be aware of?
A: Serious side effects can include cardiac arrhythmias, seizures, respiratory depression, and hepatotoxicity. Seek immediate medical attention if these occur.
Q5: Can I drink alcohol while taking this medication?
A: No, alcohol should be avoided as it can exacerbate side effects like drowsiness and dizziness.
Q6: Are there any drug interactions I should be aware of?
A: Yes, this combination can interact with numerous medications, including other opioids, anticholinergics, sedatives, antidepressants, and MAO inhibitors. Consult a healthcare professional for a comprehensive list of potential interactions.
Q7: What should I do if I miss a dose?
A: As this medication is no longer recommended, this question is not applicable in a current clinical setting. Generally, if a dose is missed, it should be taken as soon as remembered unless it’s close to the next scheduled dose. Do not double the dose.
Q8: What should I do in case of an overdose?
A: Seek immediate medical attention or contact a poison control center in case of an overdose.
Q9: What are the long-term effects of using this medication?
A: Chronic use of dextropropoxyphene can lead to opioid dependence and tolerance.
