Usage
- Diclofenac + Drotaverine is prescribed for the management of pain associated with smooth muscle spasms, such as abdominal pain (including irritable bowel syndrome and biliary colic), renal colic, and dysmenorrhea (menstrual cramps). It is also used to treat pain and inflammation associated with musculoskeletal conditions, such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
- Pharmacological Classification: Analgesic (pain reliever), Anti-inflammatory, Antispasmodic.
- Mechanism of Action: Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis, which are mediators of pain and inflammation. Drotaverine is an antispasmodic that directly relaxes smooth muscles, relieving spasms and cramping.
Alternate Names
No internationally recognized alternate names exist for this specific combination. Regional variations may occur.
- Brand Names: Some popular brands include, but are not limited to, Vetalgin, Drotin DS.
How It Works
- Pharmacodynamics: Diclofenac reduces pain and inflammation by inhibiting COX enzymes, thus decreasing prostaglandin production. Drotaverine directly relaxes smooth muscles by inhibiting phosphodiesterase-IV, leading to increased intracellular cyclic adenosine monophosphate (cAMP) and reduced intracellular calcium levels.
- Pharmacokinetics: Both drugs are well-absorbed orally. Diclofenac is metabolized in the liver, primarily by CYP2C9, and excreted renally. Drotaverine is also metabolized in the liver and excreted primarily in the bile and to a lesser extent in urine.
- Mode of Action: Diclofenac acts by inhibiting COX-1 and COX-2 enzymes, reducing prostaglandin synthesis. Drotaverine acts by inhibiting phosphodiesterase-IV, leading to smooth muscle relaxation.
- Elimination Pathways: Diclofenac is primarily excreted renally, while Drotaverine is excreted primarily in bile and, to a lesser extent, in urine.
Dosage
Standard Dosage
Adults:
- The typical adult dose is Diclofenac 50 mg + Drotaverine 80 mg, one to three times a day.
- For dysmenorrhea, an initial dose of Diclofenac 100 mg followed by 50 mg doses may provide better relief.
Children:
- Pediatric dosing should be individualized and carefully considered by a physician.
- Children aged 1-6 years can typically take Drotaverine 20 mg three to four times a day.
- Children over 6 years can typically start with Drotaverine 40 mg.
- Diclofenac dosing in children varies based on the specific formulation and indication. Consultation with a physician is essential.
Special Cases:
- Elderly Patients: Dose adjustments may be needed based on renal function.
- Patients with Renal Impairment: Dose reduction is necessary depending on the degree of impairment.
- Patients with Hepatic Dysfunction: Caution and dose adjustments are advised.
- Patients with Comorbid Conditions: Careful consideration should be given to patients with cardiovascular disease, gastrointestinal disorders, or bleeding tendencies.
Clinical Use Cases
- Intubation, Surgical Procedures, Mechanical Ventilation, Intensive Care Unit (ICU) Use, and Emergency Situations: Diclofenac + Drotaverine is not typically indicated for these specific clinical scenarios. Other analgesics and/or anesthetics are generally preferred.
Dosage Adjustments
Dose modifications are required based on individual patient characteristics, including renal and hepatic function, age, and comorbidities. Close monitoring is crucial, especially in patients with renal or hepatic impairment.
Side Effects
Common Side Effects
Nausea, vomiting, dry mouth, dizziness, headache, constipation, diarrhea, dyspepsia, abdominal pain, rash, and drowsiness.
Rare but Serious Side Effects
Gastrointestinal bleeding or ulceration, allergic reactions (including anaphylaxis), cardiovascular events (such as myocardial infarction and stroke), hepatotoxicity, renal impairment, and blood dyscrasias.
Long-Term Effects
Chronic use of NSAIDs like diclofenac is associated with an increased risk of gastrointestinal complications and cardiovascular events.
Adverse Drug Reactions (ADR)
Severe allergic reactions (e.g., anaphylaxis, angioedema), gastrointestinal bleeding, myocardial infarction, stroke, Stevens-Johnson syndrome.
Contraindications
Hypersensitivity to diclofenac or drotaverine, active peptic ulcer disease, severe hepatic or renal impairment, history of aspirin-induced asthma, last trimester of pregnancy, and conditions predisposing to bleeding.
Drug Interactions
Diclofenac interacts with anticoagulants (warfarin), antihypertensives (ACE inhibitors, diuretics), other NSAIDs, lithium, methotrexate, and cyclosporine. Drotaverine may interact with levodopa and other anticholinergic drugs. Concomitant use with alcohol should be avoided.
Pregnancy and Breastfeeding
- Pregnancy: Diclofenac is contraindicated in the third trimester of pregnancy. Use in the first and second trimesters should be avoided unless the benefits outweigh the risks. Drotaverine use during pregnancy is generally not recommended due to limited safety data.
- Breastfeeding: Diclofenac is excreted in breast milk, and use during breastfeeding is generally discouraged. Drotaverine is also not recommended during breastfeeding.
Drug Profile Summary
- Mechanism of Action: Diclofenac: COX inhibitor; Drotaverine: Phosphodiesterase-IV inhibitor.
- Side Effects: Nausea, vomiting, GI issues, dizziness, headache. Serious side effects include GI bleeding, cardiovascular events, hepatotoxicity.
- Contraindications: Hypersensitivity, active peptic ulcer, severe hepatic/renal impairment, aspirin-induced asthma, late pregnancy.
- Drug Interactions: Anticoagulants, antihypertensives, lithium, methotrexate.
- Pregnancy & Breastfeeding: Not recommended.
- Dosage: Adults: Diclofenac 50 mg + Drotaverine 80 mg, 1-3 times/day. Pediatric dosing needs individual adjustment.
- Monitoring Parameters: Liver and renal function, blood pressure, signs of GI bleeding.
Popular Combinations
While Diclofenac + Drotaverine is itself a common combination, other drugs may be added depending on the specific indication, such as paracetamol for enhanced analgesic effects.
Precautions
- Assess for allergies, renal/hepatic dysfunction, cardiovascular disease, and bleeding disorders.
- Caution in pregnancy and breastfeeding.
- Use with caution in elderly patients and children.
- Avoid alcohol consumption while taking this medication.
- Caution when operating machinery due to potential dizziness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Diclofenac + Drotaverine?
A: The typical adult dose is Diclofenac 50 mg + Drotaverine 80 mg, one to three times a day. Pediatric and special population dosing require individual adjustments and medical advice.
Q2: What are the primary uses of this combination?
A: Primarily used to manage pain associated with smooth muscle spasms, including abdominal pain, renal colic, and dysmenorrhea. Also effective for musculoskeletal pain.
Q3: Are there any serious side effects I should be aware of?
A: Yes, though rare. Serious side effects include gastrointestinal bleeding, ulcers, cardiovascular events (heart attack, stroke), liver damage, and allergic reactions.
Q4: Can pregnant or breastfeeding women take this medication?
A: It’s generally not recommended due to potential risks to the fetus or baby. Consult a doctor for alternative options.
Q5: What are the common drug interactions I should know?
A: Significant interactions can occur with anticoagulants, other NSAIDs, antihypertensives, lithium, and methotrexate. Consult your doctor about all medications you are taking.
Q6: Are there any specific precautions for elderly patients?
A: Yes, elderly patients are more susceptible to adverse effects, especially with renal impairment. Careful monitoring and dose adjustments are crucial.
Q7: How should I take Diclofenac + Drotaverine?
A: Orally, with food to reduce the risk of gastrointestinal upset, as directed by the physician.
Q8: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose.
Q9: Can this combination be used for acute pain in the emergency room?
A: While it can be used for acute pain, other options are typically preferred in emergency situations. The physician will determine the best course of treatment.
Q10: How does Diclofenac + Drotaverine differ from taking Diclofenac or Drotaverine alone?
A: The combination offers dual action: pain and inflammation relief from Diclofenac and smooth muscle relaxation from Drotaverine, making it particularly useful for conditions involving both aspects, such as biliary colic or renal colic.
