1. Clinical Overview
A fixed-dose combination oral suspension containing an antispasmodic (Camylofin) and an analgesic-antipyretic (Paracetamol). Camylofin is a musculotropic antispasmodic that directly relaxes smooth muscle, while Paracetamol acts centrally to relieve pain and reduce fever. This combination is specifically formulated for pediatric and adult patients requiring relief from colicky pain associated with smooth muscle spasm, such as in infantile colic, renal colic, or biliary colic, along with associated pain and fever.
| Onset | Duration | Bioavailability |
|---|---|---|
| Paracetamol: 30-60 minutes. Camylofin: 15-30 minutes for onset of spasmolytic effect. | Paracetamol: 4-6 hours. Camylofin: 4-6 hours. | Paracetamol: ~85% (oral). Camylofin: Data specific to oral suspension is limited; it is well absorbed from the GI tract. |
2. Mechanism of Action
The combination works synergistically. Camylofin acts directly on smooth muscle cells of the gastrointestinal, biliary, urinary, and uterine tracts, inhibiting phosphodiesterase and increasing intracellular cyclic AMP. This leads to relaxation of spasmodic smooth muscle, relieving colic. Paracetamol acts centrally by inhibiting the cyclooxygenase (COX) pathway, particularly COX-2 in the brain, reducing the synthesis of prostaglandins involved in pain perception and fever regulation. It has minimal peripheral anti-inflammatory effect.
3. Indications & Uses
- Symptomatic relief of abdominal colic (infantile colic, intestinal colic)
- Renal colic (as adjunctive therapy)
- Biliary colic (as adjunctive therapy)
- Dysmenorrhea (primary spasmodic dysmenorrhea)
4. Dosage & Administration
Adult Dosage: 10 ml (2 teaspoonfuls) three to four times a day, or as directed by the physician. Maximum: 40 ml per day.
Administration: Shake the bottle well before use. Use the measuring cup or spoon provided. Can be taken with or without food. If GI upset occurs, administer with food. Do not use for more than 5 days for pain or 3 days for fever in children without consulting a doctor. For adults, do not use for more than 10 days unless directed by a physician.
5. Side Effects
Common side effects may include:
- Dry mouth
- Blurred vision (transient)
- Drowsiness/sedation
- Constipation
- Nausea
- Dizziness
- Sweating
6. Drug Interactions
| Drug | Effect | Severity |
|---|---|---|
| Warfarin and other Coumarin anticoagulants | Paracetamol may potentiate anticoagulant effect, increasing INR and risk of bleeding, especially with chronic high-dose use. | Major |
| Isoniazid | Increases risk of Paracetamol hepatotoxicity by inducing CYP2E1. | Major |
| Anticholinergic drugs (e.g., Atropine, Tricyclic antidepressants, Antipsychotics) | Additive anticholinergic side effects (dry mouth, constipation, urinary retention, blurred vision). | Moderate |
| Metoclopramide, Domperidone | Camylofin may antagonize the prokinetic effect on GI smooth muscle. | Moderate |
| Cholestyramine | Reduces absorption of Paracetamol if taken within 1 hour. | Moderate |
| Alcohol (chronic, heavy use) | Induces CYP2E1, increasing risk of Paracetamol hepatotoxicity even at therapeutic doses. | Major |
| Probenecid | May decrease Paracetamol clearance, increasing its levels. | Minor |
| 5-HT3 Antagonists (Ondansetron) | Potential for additive constipation. | Minor |
7. Patient Counselling
- DO use the measuring device provided. DO NOT use a household spoon.
- DO inform your doctor if you are taking any other medicines, especially blood thinners (warfarin).
- DO NOT consume alcohol while on this medication.
- DO NOT take with other Paracetamol-containing products (cold & flu remedies).
- DO store the bottle tightly closed, away from light and moisture.
- DO shake the bottle well before each use.
8. Toxicology & Storage
Overdose: Stage 1 (0-24h): Nausea, vomiting, anorexia, malaise, pallor, diaphoresis. Stage 2 (24-72h): Right upper quadrant pain, elevated liver enzymes, oliguria. Stage 3 (72-96h): Peak hepatotoxicity (jaundice, coagulopathy, encephalopathy), renal failure, myocardial necrosis. Camylofin overdose: Exaggerated anticholinergic effects - severe dry mouth, dilated pupils, tachycardia, hyperthermia, hallucinations, seizures, respiratory depression.
Storage: Store at a temperature not exceeding 30°C. Protect from light and moisture. Keep the bottle tightly closed. Keep out of reach and sight of children. Do not use after the expiry date printed on the label. Do not freeze.