ABSTRACT
Painful menstrual cramps during or around the time of the monthly cycle are known as dysmenorrhea. The estimated global prevalence in women of reproductive age ranges from 45% to 95%. It has a significant negative impact on regular activities and productivity at work. However, despite the severe consequences on quality of life, primary dysmenorrhea (PD) is underdiagnosed. Dysmenorrhea has complex pathogenesis. It involves the release of prostaglandins and activation of the nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) inflammasome and also includes the involvement of other mediators such as bradykinin, histamine and acetylcholine. Even though nonsteroidal anti-inflammatory drugs (NSAIDs) remain the most common type of pain medication, the question of which one should be the most preferred is still open to debate. The current review examines the existing evidence for the pathogenesis of PD and makes evidence based and clinical experience based recommendations for the use of mefenamic acid and its combination in the treatment of dysmenorrhea. Mefenamic acid alleviates PD by inhibiting endometrial prostaglandin formation, restoring normal uterine activity, and reducing the inflammatory response by inhibiting the NLRP3 inflammasome and reducing the release of cytokines such as interleukin (IL)-1?. It is also known to have bradykinin antagonist activity. Dicyclomine has a dual action of blocking the muscarinic action of acetylcholine in postganglionic parasympathetic effect or regions and acting directly on uterine smooth muscle by blocking bradykinin and histamine receptors to relieve spasms. According to the experts, mefenamic acid and dicyclomine act synergistically by acting on the different pathways of dysmenorrhea by blocking multifactorial agents attributed to the cause of dysmenorrhea. Hence, the combination of mefenamic acid and dicyclomine should be the preferred treatment option for dysmenorrhea.
ABSTRACT
Abstract: The study describes method development and subsequent validation of HPTLCmethod for simultaneous estimation of paracetamol (PCM), diclofenac sodium (DCL) anddicyclomine hydrochloride (DICY) in marketed combined tablet dosage form. The drugs wereextracted from marketed tablet dosage form: Spasmodart. The separation was carried out onaluminium sheet precoated with silica gel 60 F254 using toluene: ethylacetate: methanol: formicacid (5.5:3.5:2:0.02, v/v/v/v) as a mobile phase. The spots were scanned densitometrically at266 nm wavelength for paracetamol and diclofenac sodium. The plate was then dipped in panisaldehyde reagent and spots of dicyclomine hydrochloride were scanned at 638 nmwavelength. The Rf values of paracetamol, diclofenac sodium and dicyclomine hydrochloridewere found to be 0.41, 0.71and 0.24 respectively. Calibration curves were linear in range of3250-9750ng/spot, 500-1500ng/spot and 200-600ng/spot for PCM, DCL and DICY respectively.The limit of detection (LOD) for paracetamol, diclofenac sodium and dicyclomine hydrochloridewere found to be 812.5, 125 and 50ng/spot respectively. The suitability of this method forquantitative determination of compounds was proved by validation in accordance with ICHGuidelines. Therefore this method can be applied for routine analysis of these drugs in tabletformulation.
ABSTRACT
Authors describe a case of angioedema in a male child due to over-the-counter (OTC) use of fixed dose combination (FDC) of Tab. dicyclomine hydrochloride (20mg) and paracetamol (500mg) for abdominal pain. Use of OTC drugs in children without a doctor抯 suggestion can lead to unnecessary medication use and is not free of risks. Here, there is a probable causal relationship between the suspected drug and angioedema according to WHO-UMC criteria for Causality Assessment. This case was also reported to the Pharmacovigilance Programme of India (PvPI) through PvPI ADR android application.
ABSTRACT
Ever since the information technology revolution hit India in a big way, substance abuse has been rising in incidence by leaps and bounds, mainly because of the ease with which such substances can be procured through the Internet. There has been a significant shift from conventional drugs of abuse such as cannabis and heroin to newer drugs such as designer amphetamines, phencyclidine, and ketamine. But because these drugs are covered by the Narcotic Drugs and Psychotropic Substances Act, there has been a recent trend towards abuse of pharmaceutical agents such as pentazocine, propoxyphene and buprenorphine. Spasmo-Proxyvon® is a popular brand of antispasmodic from Wockhardt which contains paracetamol (acetaminophen), dicyclomine, and dextropropoxyphene. This combined drug formulation sold as gelatin capsules is easily available, and is increasingly being abused for its opioid effect. A few cases of such addiction resulting in death are being reported.