Usage
- Aceclofenac + Drotaverine is prescribed for the treatment of abdominal pain, specifically pain caused by smooth muscle spasms in the gastrointestinal tract (e.g., irritable bowel syndrome or IBS), dysmenorrhea (menstrual cramps), biliary colic (gallbladder pain), renal colic (kidney stones), and other conditions involving smooth muscle spasms. It can also be used for pain and inflammation associated with conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
- Pharmacological Classification: Analgesic (pain reliever), Anti-inflammatory, Antispasmodic.
- Mechanism of Action: This combination medication works through two distinct mechanisms: Aceclofenac inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis and thus decreasing pain and inflammation. Drotaverine is an antispasmodic that inhibits phosphodiesterase-4 (PDE-4), leading to smooth muscle relaxation and reduced spasms.
Alternate Names
While “Aceclofenac + Drotaverine” represents the generic name, the specific nomenclature might vary regionally.
- Brand Names: Aceclo Spas, Drotin A, Dronac A, Amps Drota, Dreloset A, Acerest, StayHappi Drotaverine+Aceclofenac, among others. There may be other brand names depending on the manufacturer and region.
How It Works
- Pharmacodynamics: Aceclofenac exerts its analgesic and anti-inflammatory effects by inhibiting COX-1 and COX-2 enzymes. This leads to a decrease in prostaglandin synthesis, which are mediators of pain and inflammation. Drotaverine directly relaxes smooth muscles, primarily in the gastrointestinal and genitourinary tracts, relieving spasms and associated pain.
- Pharmacokinetics: Both drugs are absorbed orally. Aceclofenac is metabolized in the liver, while Drotaverine is metabolized by the liver and plasma esterases. Both drugs are primarily eliminated via renal excretion. More precise data on their half-life, bioavailability, and specific metabolic pathways may be necessary for detailed clinical use.
- Mode of Action: Aceclofenac acts by non-selectively inhibiting COX enzymes, thereby reducing prostaglandin production. Drotaverine’s antispasmodic action involves inhibiting PDE-4, which increases intracellular cyclic AMP (cAMP) and leads to smooth muscle relaxation by interfering with calcium channels.
- Elimination Pathways: Both Aceclofenac and Drotaverine are primarily eliminated through renal excretion (via the kidneys), although hepatic metabolism (liver) plays a role in their processing.
Dosage
Standard Dosage
Adults:
- The typical adult dose is one tablet of Aceclofenac 100mg + Drotaverine 80mg twice daily, taken after meals. The maximum dose is usually two tablets per day.
Children:
- This combination is generally not recommended for children due to limited safety and efficacy data. Drotaverine alone may be used in children, but dosing must be carefully adjusted based on age and weight, typically starting at 20 mg three to four times daily for children aged 1-6 years, with adjustments made for older children.
Special Cases:
- Elderly Patients: Start with a lower dose and monitor closely for side effects. Dose adjustments might be needed based on renal function.
- Patients with Renal Impairment: Dose reduction may be required depending on the degree of impairment.
- Patients with Hepatic Dysfunction: Careful monitoring is necessary, and dose adjustment may be required in patients with moderate to severe hepatic impairment.
- Patients with Comorbid Conditions: Use with caution in patients with cardiovascular disease, hypertension, diabetes, and other relevant conditions. Individualized dosing may be necessary.
Clinical Use Cases
- Intubation/Surgical Procedures/Mechanical Ventilation/ICU Use/Emergency Situations: While Aceclofenac + Drotaverine is not typically employed in these acute care settings, Drotaverine alone can be used to address smooth muscle spasms in specific situations, such as during biliary or renal colic. The dose and route of administration depend on the clinical scenario and should be guided by specialist consultation.
Dosage Adjustments
- Dosage adjustments should be based on patient-specific factors such as renal and hepatic function, age, and concomitant medications. Genetic polymorphism impacting drug metabolism should also be considered, though specific guidelines might require further investigation.
Side Effects
Common Side Effects
- Nausea, Vomiting, Diarrhea, Dizziness, Headache, Indigestion, Dry mouth, Abdominal pain, Drowsiness.
Rare but Serious Side Effects
- Allergic reactions (rash, itching, swelling), Gastrointestinal bleeding, Peptic ulcers, Severe hepatic dysfunction, Renal impairment.
Long-Term Effects
- Long-term use of NSAIDs like Aceclofenac can increase the risk of cardiovascular events and gastrointestinal complications. Prolonged use should be avoided unless clinically necessary and under strict medical supervision.
Adverse Drug Reactions (ADR)
- Severe allergic reactions (anaphylaxis), Stevens-Johnson syndrome, Toxic epidermal necrolysis, Acute renal failure, Gastrointestinal perforation.
Contraindications
- Hypersensitivity to Aceclofenac or Drotaverine.
- Active peptic ulcer or gastrointestinal bleeding.
- Severe hepatic impairment.
- Severe renal impairment.
- Severe heart failure.
- Third trimester of pregnancy.
Drug Interactions
- CYP450 Interactions: Aceclofenac is primarily metabolized by CYP2C9, so inhibitors or inducers of this enzyme can alter its metabolism. More information is needed on specific CYP interactions for Drotaverine.
- Other Drug Interactions: Anticoagulants (warfarin), Lithium, Methotrexate, Digoxin, Other NSAIDs, Antihypertensives, Alcohol.
- Food and Lifestyle Factors: Alcohol should be avoided, as it can increase the risk of gastrointestinal side effects. The effect of smoking or grapefruit juice on this drug combination is not fully elucidated in the provided sources.
Pregnancy and Breastfeeding
- Pregnancy: Aceclofenac + Drotaverine is generally contraindicated during the third trimester. Use during the first and second trimesters should only be considered if the potential benefits outweigh the risks.
- Breastfeeding: Limited data are available on the excretion of these drugs in breast milk. It’s generally recommended to avoid use during breastfeeding.
Drug Profile Summary
- Mechanism of Action: Aceclofenac: COX inhibitor (NSAID), reducing inflammation and pain; Drotaverine: PDE-4 inhibitor, causing smooth muscle relaxation.
- Side Effects: Nausea, vomiting, diarrhea, dizziness, headache, indigestion, GI bleeding (rare).
- Contraindications: Hypersensitivity, active peptic ulcer, severe hepatic/renal impairment, 3rd-trimester pregnancy.
- Drug Interactions: Anticoagulants, lithium, methotrexate, digoxin, other NSAIDs, alcohol.
- Pregnancy & Breastfeeding: Generally avoided.
- Dosage: Adults: 100mg/80mg twice daily after meals. Pediatric use not recommended.
- Monitoring Parameters: Liver and kidney function tests, blood pressure, signs of GI bleeding.
Popular Combinations
The combination of Aceclofenac and Drotaverine itself is a popular combination due to the synergistic action of pain relief and muscle relaxation. There might be other popular drug combinations used for specific conditions like IBS which might include drugs like anticholinergics, depending on the specific diagnosis and clinical presentation, but details are unavailable in the sources provided.
Precautions
- General Precautions: Assess for allergies, hepatic and renal function, cardiovascular risks.
- Specific Populations: Avoid or use with caution in pregnant/breastfeeding women, children, and elderly patients.
- Lifestyle Considerations: Avoid alcohol; monitor driving ability due to potential dizziness or drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Drotaverine?
A: The typical adult dose is one tablet of Aceclofenac 100mg + Drotaverine 80mg twice daily, taken after meals. Dosage may vary depending upon individual health and the condition being treated.
Q2: What conditions is Aceclofenac + Drotaverine used to treat?
A: It is used to treat conditions involving abdominal pain and smooth muscle spasms, such as irritable bowel syndrome (IBS), menstrual cramps (dysmenorrhea), biliary colic, renal colic, and certain inflammatory conditions.
Q3: Can Aceclofenac + Drotaverine be used in children?
A: It’s generally not recommended for pediatric use due to limited safety and efficacy data. Drotaverine might be used alone in children at adjusted doses, following pediatric guidelines.
Q4: What are the common side effects of Aceclofenac + Drotaverine?
A: Common side effects include nausea, vomiting, diarrhea, dizziness, headache, indigestion, and dry mouth.
Q5: Are there any serious side effects I should be aware of?
A: While rare, serious side effects can include allergic reactions, gastrointestinal bleeding, and hepatic or renal impairment. Seek immediate medical attention if these occur.
Q6: Can I drink alcohol while taking this medication?
A: Alcohol should be avoided, as it can increase the risk of gastrointestinal side effects.
Q7: Can I take Aceclofenac + Drotaverine if I’m pregnant or breastfeeding?
A: Consult with a doctor. It is contraindicated in the third trimester of pregnancy, and use during breastfeeding is generally not recommended.
Q8: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is close to the time for your next dose. Do not double the dose.
Q9: How does Aceclofenac + Drotaverine interact with other medications?
A: It can interact with anticoagulants, lithium, methotrexate, digoxin, and other NSAIDs. Inform your doctor about all medications you are currently taking.
Q10: Does Aceclofenac + Drotaverine affect driving ability?
A: It can cause dizziness or drowsiness in some patients. Caution is advised while driving or operating machinery.
