Usage
Camylofin + Paracetamol is prescribed for the symptomatic relief of abdominal pain and cramps, particularly those arising from spasms in the gastrointestinal, biliary, renal, and urinary tracts. It is also indicated for dysmenorrhea (painful menstruation).
Pharmacological Classification:
- Camylofin: Antispasmodic, Anticholinergic
- Paracetamol: Analgesic, Antipyretic
Mechanism of Action:
Camylofin acts as an antispasmodic by relaxing the smooth muscles of the gastrointestinal, biliary, urinary, and renal tracts. It has a dual mechanism, directly relaxing smooth muscle (musculotropic) and inhibiting acetylcholine’s action (neurotropic). Paracetamol provides pain relief and fever reduction by centrally inhibiting cyclooxygenase (COX) pathways, affecting pain signal processing and thermoregulation. Together, they provide synergistic relief from pain and spasms.
Alternate Names
While “Camylofin + Paracetamol” is the standard generic name, the combination is marketed under various brand names, including Anafortan, Anacred, Camyfyl, and Anapolis Syrup.
How It Works
Pharmacodynamics:
- Camylofin: Relaxes smooth muscle via a dual mechanism, reducing spasms and associated pain. It predominantly acts as a musculotropic agent, inhibiting phosphodiesterase IV, increasing cyclic AMP levels, and promoting smooth muscle relaxation by depleting intracellular calcium. It also has a milder neurotropic, anticholinergic effect, blocking acetylcholine binding to muscarinic receptors.
- Paracetamol: Exerts analgesic and antipyretic effects centrally by inhibiting COX pathways, thus modulating pain perception and thermoregulation in the hypothalamus. Its peripheral COX inhibition is minimal.
Pharmacokinetics:
- Camylofin: Data on its specific pharmacokinetic parameters (absorption, metabolism, and elimination) is limited.
- Paracetamol: Well-absorbed orally, extensively metabolized in the liver (primarily via glucuronidation and sulfation), with a small portion undergoing CYP450-mediated metabolism to a reactive metabolite, N-acetyl-p-benzoquinone imine (NAPQI). NAPQI is detoxified by glutathione but can accumulate in cases of overdose, leading to hepatotoxicity. Eliminated primarily in the urine as metabolites.
Receptor binding, enzyme inhibition, or neurotransmitter modulation:
- Camylofin: Inhibits phosphodiesterase IV, muscarinic receptor antagonist.
- Paracetamol: COX inhibitor.
Elimination pathways:
- Camylofin: Limited data available.
- Paracetamol: Primarily renal excretion of metabolites, with a minor portion excreted unchanged in the urine.
Dosage
Standard Dosage
Adults:
The typical adult dose is one tablet containing 50 mg of Camylofin and 325-500 mg of Paracetamol, taken thrice daily. The maximum daily dose of Paracetamol should not exceed 4 grams.
Children:
The safety and efficacy in children under 6 years of age have not been fully established. Dosing in older children should be carefully determined based on the child’s weight and the specific formulation (syrup or suspension). Refer to the following section based on available data: For children aged 6-12 years, Anapolis syrup (Camylofin 12.5 mg + Paracetamol 125mg/5ml) is commonly prescribed at 5-10 ml two to three times daily for a maximum of 5 days. For other formulations, always follow a physician’s advice and calculate the Paracetamol component based on the child’s weight (15mg/kg/dose, max 1g/dose, max 4 doses/24 hrs, max 4g/24 hrs)
Special Cases:
- Elderly Patients: Use with caution. Dosage adjustments may be required based on renal and hepatic function.
- Patients with Renal Impairment: Use with caution. Dose adjustment is recommended based on the degree of impairment.
- Patients with Hepatic Dysfunction: Use with caution, especially in severe liver disease. Reduce the dose or avoid use altogether in severe liver dysfunction.
- Patients with Comorbid Conditions: Use with caution in patients with glaucoma, prostatic hypertrophy, urinary retention, myasthenia gravis, pyloric or other mechanical stenoses, paralytic ileus, and porphyria.
Clinical Use Cases
Dosing for specific clinical situations like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations should be determined on a case-by-case basis by the treating physician. No standard recommendations are available for these specific clinical settings for this drug combination.
Dosage Adjustments
Adjustments are necessary based on individual patient factors like renal/hepatic impairment, pre-existing conditions, concomitant medications, age, and body weight (especially below 50kg). Close monitoring is essential, particularly in the elderly.
Side Effects
Common Side Effects:
Drowsiness, headache, dry mouth, nausea, vomiting, constipation, dizziness, blurred vision, skin rash, increased heart rate.
Rare but Serious Side Effects:
Allergic reactions (e.g., skin rash, itching, facial swelling, difficulty breathing), liver damage (with Paracetamol overdose), blood disorders (anemia, neutropenia), QT interval prolongation (rare).
Long-Term Effects:
Potential long-term side effects are not well-documented. Chronic high doses of Paracetamol can contribute to renal impairment.
Adverse Drug Reactions (ADR):
Severe allergic reactions (anaphylaxis), Stevens-Johnson Syndrome (rare), toxic epidermal necrolysis (rare), acute liver failure (with Paracetamol overdose).
Contraindications
Hypersensitivity to Camylofin or Paracetamol, severe liver disease, gastrointestinal bleeding, glaucoma, myasthenia gravis, paralytic ileus, pyloric stenosis, prostatic hypertrophy with urinary retention, porphyria, mechanical stenoses, urinary retention, tachycardia.
Drug Interactions
Anticholinergics (e.g., atropine, scopolamine), cholinesterase inhibitors (e.g., neostigmine, pyridostigmine), alcohol, medications metabolized by CYP450 enzymes, anticoagulants, antihypertensives.
Pregnancy and Breastfeeding
Pregnancy: Use with caution. Consult a physician before use. While Paracetamol is generally considered safe, Camylofin’s safety in pregnancy is less established.
Breastfeeding: Avoid unless considered essential by the physician. Paracetamol is excreted in breast milk, and Camylofin’s effects on infants are not well-studied.
Drug Profile Summary
- Mechanism of Action: Camylofin: Antispasmodic, Anticholinergic. Paracetamol: Analgesic, Antipyretic.
- Side Effects: Drowsiness, headache, dry mouth, nausea, constipation, dizziness, allergic reactions.
- Contraindications: Hypersensitivity, severe liver disease, gastrointestinal bleeding, glaucoma, myasthenia gravis, urinary retention, mechanical bowel obstruction.
- Drug Interactions: Anticholinergics, cholinesterase inhibitors, alcohol, CYP450 substrates.
- Pregnancy & Breastfeeding: Caution advised. Consult a physician.
- Dosage: Adults: One tablet (Camylofin 50 mg + Paracetamol 325-500 mg) thrice daily. Pediatric: Consult a physician.
- Monitoring Parameters: Liver function tests (especially with prolonged use or higher doses of Paracetamol), symptoms of hypersensitivity.
Popular Combinations
While Camylofin + Paracetamol is a common fixed-dose combination, there are no other widely recognized combinations that include both these agents simultaneously.
Precautions
- Screen for allergies, pre-existing conditions (especially hepatic/renal disease), and drug interactions.
- Pregnant Women: Potential risks should be weighed against benefits.
- Breastfeeding Mothers: Avoid or consult a physician.
- Children & Elderly: Use with caution and adjusted dosing. Not recommended for children below 6.
- Menstruating Individuals: Indicated for dysmenorrhea.
- Lifestyle Considerations: Avoid alcohol, operate machinery with caution due to potential drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Camylofin + Paracetamol?
A: Adults: One tablet (Camylofin 50 mg + Paracetamol 325-500 mg) three times daily. For children aged 6-12, Anapolis Syrup is commonly prescribed at 5-10 ml two to three times daily, as directed by the physician. Children under 6: Not recommended. Dosage adjustments are required for elderly patients and those with renal or hepatic impairment.
Q2: How does Camylofin + Paracetamol work for abdominal pain?
A: Camylofin relaxes the abdominal muscles, reducing spasms, while Paracetamol relieves pain and reduces fever.
Q3: What are the common side effects?
A: Drowsiness, headache, dry mouth, nausea, vomiting, and constipation.
Q4: Can I take this medication if I am pregnant or breastfeeding?
A: Consult a physician before taking during pregnancy or breastfeeding, as the safety profile is not fully established, especially for Camylofin.
Q5: Can I drink alcohol while taking this medication?
A: No. Avoid alcohol due to an increased risk of side effects like liver damage and severe gastrointestinal bleeding.
Q6: Are there any drug interactions I should be aware of?
A: Yes, it can interact with anticholinergics, cholinesterase inhibitors, and other medications metabolized by CYP450 enzymes. Inform your doctor about all your current medications.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is almost time for the next dose. Do not double the dose.
Q8: What should I do if I experience severe side effects?
A: Discontinue the medication and seek immediate medical attention.
Q9: Is Camylofin + Paracetamol safe for patients with kidney disease?
A: Use with caution in patients with kidney disease. Dosage adjustments may be required. Consult a physician.
Q10: Is Camylofin + Paracetamol safe for patients with liver disease?
A: Use with caution in patients with liver disease, especially severe impairment. Consult a physician, as dose reduction or avoidance may be necessary.
