ABSTRACT
Background:Spasmolytics and NSAIDs are a therapy of choice in colic pain. However, the tolerability and effectiveness of this combination remains unexplored. The aim of this prospective, single-arm, open label, multicenter study was to evaluate the safety and effectiveness of Anafortan-N�(fixed-dose combination of camylofin dihydrochloride 50 mg + nimesulide 100 mg) in patients with acute colicky abdominal pain.Methods: In all, 295 patients with acute colicky abdominal pain and at least one episode of colicky pain in the last 24 hours were enrolled in this study. None of the patients were hospitalized. All patients were advised Anafortan-N畉ablets twice daily orally for 5 days. The safety of Anafortan-N畐as assessed by number and percentage of patients with adverse events (AEs) and change in the severity and frequency of AEs by the end of treatment. The tolerability was determined by number and percentage of patients who hadto discontinue the treatment due to AEs. The effectiveness was evaluated as percentage change in the mean intensity of pain score (based on a 100-mm visual analog scale) from baseline to end of treatment.Results: Overall, 14 (4.7%) patients reported 14 AEs, all of which were treatment-emergent and non-serious. Of the 14 AEs, 7 AEs were mild, 6 AEs were moderate, and 1 AE was severe. No serious adverse events (SAEs) were reported. No adjustment of the study medication was required in response to any of the AEs, and none of the AEs led to discontinuation of the study treatment. At end of treatment(EOT), the pain intensity significantly (p<0.0001) reduced to 1.7�49 with a mean change of -69.9�.42 from baseline, and the daily pain intensity significantly (p<0.0001) reduced to 0.1�38 with a mean change of -3.5�77 from baseline.Conclusions: Among Indian patients presenting with acute abdominal colicky pain, twice daily treatment with a FDC of camylofin dihydrochloride 50 mg and nimesulide 100 mg (Anafortan-N�) showed significant reduction in pain intensity with very few side effects, thereby confirming its safety, tolerability, and effectiveness in acute colicky abdominal pain.
ABSTRACT
Camylofin dihydrochloride is an anti-spasmodic drug available in India and other Latin American and African countries, for the treatment of abdominal colic and for acceleration of labor. Although, the drug has been in use for over six decades, with multiple citations in academic text books of repute, treatment protocols, and multiple research publications, there is no consolidated published information on the pharmacology and clinical details of camylofin. This drug statement/monograph is an attempt to collate and present scientific information that will come in handy to practicing obstetricians and gynaecologists, as well as other primary care physicians, when treating cases of abdominal colic or managing prolonged labor. Approved clinical indications, clinical pharmacology, dosage, contraindications, precautions, drug interactions, adverse effects, overdose and clinical evidence in different indications are covered herein.
ABSTRACT
Anti-spasmodic drugs like camylofin are used in obstetrics and gynaecological practice for broadly two conditions - spasmodic abdominal pain and management of prolonged labor. Camylofin has been in use in India for almost six decades. As a spasmolytic, camylofin has demonstrated good efficacy and tolerability, both in the management of abdominal spasmodic pain and in augmentation of labor. Literature evidences has suggested that camylofin has demonstrated a statistically significant superiority, such as higher spasmolytic potency compared to other anti-spasmodics like drotaverine, hyoscine and valethamate. In some studies, camylofin maintained the superior efficacy, despite being given as a single dose compared to repeat doses of comparator drugs. Also, in augmentation of labor, camylofin single dose demonstrated superior efficacy when the comparator arm was given a combination of two anti-spasmodic drugs i.e. hyoscine and valethamate in three doses at hourly intervals. Clinical studies in abdominal colic pain revealed significant superiority of the camylofin-paracetamol combination over dicylomine paracetamol combination, this despite the camylofin combination containing 300mg paracetamol as compared to the dicyclomine combination containing 500mg paracetamol. Similar results, highlighting better outcomes in abdominal colic of different types, was shown in studies comparing camylofin-diclofenac combination compared with hyoscine (in renal colic) and also camylofin-mefenamic acid combination compared with dicyclomine-mefenamic acid combination (in menstrual colic). All the above clinical study results resonate in the findings of a recent survey with gynaecologists across the country, which showed that camylofin is considered as the anti-spasmodic most suitable for female patients compared to drotaverine, dicyclomine and hyoscine. Given the availability of strong clinical trial data in Indian women patients, camylofin along with its combinations holds a strong place in the armamentarium of practicing obstetricians and gynaecologists and can be a preferred choice of therapy in treatment protocols of abdominal spasmodic pain and augmentation of labor.