Drotaverine to improve progression of labour among parturient women- a case control study

Background: Prolonged labour contributes to increased perinatal and maternal morbidity. Pharmacological interventions can hasten cervical dilation and help obstetrician to accomplish the delivery in the shortest possible time without compromising maternal and fetal safety. Aims and objectives were to evaluate the acceleration effect of drotaverine on the dilatation of the cervix in both primigravidae and multigravida and compare it with control group.Methods: A total of 70 patients were studied (35 in drotaverine group and 35 in control group). The inclusion criteria were pregnancy with at least 37 weeks completed, cervical dilatation 3-4 cm, regular uterine contractions and cephalic presentation. The study group received 40 mg drotaverine hydrochloride i.m. in active phase of labour, control group received standard delivery care. Parameters such as duration of first and second stage of labour, mode of delivery, neonatal outcome and side effects to drug was recorded.Results: 6 subjects from the study group and 4 from the control group developed complications in first stage of labour and were taken up for operative delivery and hence they were excluded from calculation of various labour parameters. The mean rate of cervical dilatation with drotaverine was 2.26 cm/hour, while it was 1.67 cm/hour without any intervention (p value <0.05). Mean duration of active phase of first stage of labor was 3.09 hours in drotaverine group against 4.98 hours in study group (p value <0.05). There were no significant untoward effects noted in either of the groups.Conclusions: Drotaverine was found to be an effective and safe drug in shortening the duration of the first stage of labor without any significant detrimental effects on the mother and newborn. Drotaverine did not interfere with uterine contractility and there was no increased incidence of operative deliveries.

Drotaverine to improve progression of labour among parturient women- a case control study

Background: Prolonged labour contributes to increased perinatal and maternal morbidity. Pharmacological interventions can hasten cervical dilation and help obstetrician to accomplish the delivery in the shortest possible time without compromising maternal and fetal safety. Aims and objectives were to evaluate the acceleration effect of drotaverine on the dilatation of the cervix in both primigravidae and multigravida and compare it with control group.Methods: A total of 70 patients were studied (35 in drotaverine group and 35 in control group). The inclusion criteria were pregnancy with at least 37 weeks completed, cervical dilatation 3-4 cm, regular uterine contractions and cephalic presentation. The study group received 40 mg drotaverine hydrochloride i.m. in active phase of labour, control group received standard delivery care. Parameters such as duration of first and second stage of labour, mode of delivery, neonatal outcome and side effects to drug was recorded.Results: 6 subjects from the study group and 4 from the control group developed complications in first stage of labour and were taken up for operative delivery and hence they were excluded from calculation of various labour parameters. The mean rate of cervical dilatation with drotaverine was 2.26 cm/hour, while it was 1.67 cm/hour without any intervention (p value <0.05). Mean duration of active phase of first stage of labor was 3.09 hours in drotaverine group against 4.98 hours in study group (p value <0.05). There were no significant untoward effects noted in either of the groups.Conclusions: Drotaverine was found to be an effective and safe drug in shortening the duration of the first stage of labor without any significant detrimental effects on the mother and newborn. Drotaverine did not interfere with uterine contractility and there was no increased incidence of operative deliveries.

High Performance Liquid Chromatographic Determination of the Ternary Mixture of Caffeine, Dipyrone and Drotaverine Hydrochloride in Tablet Dosage Form.

This work describes a simple, rapid, and reliable HPLC method for the simultaneous determination of caffeine (CAF), dipyrone (DIP) and drotaverine hydrochloride (DRV). Chromatographic separation was achieved using a reversed phase Waters Symmetry C18 (3.9×150 mm, 5 μm particle size) column with gradient elution of the mobile phase composed of 0.05 M orthophosphoric acid and acetonitrile. The gradient elution started with 15% (by volume) acetonitrile ramped up linearly to 60% in 3 min then kept at this percentage till the end of the run. The flow rate was 1mL/min. Quantification was based on measuring peak areas at 210 nm. The analytes were resolved with retention times 1.47, 2.39 and 7.17 min for DIP, CAF and DRV, respectively. Analytical performance of the proposed procedure was validated with respect to system suitability, linearity, ranges, precision, accuracy, robustness, detection and quantification limits. The linearity ranges were 10-200, 5-100 and 5-100 μg/mL for DIP, CAF and DRV, respectively. The validated HPLC method was applied to the simultaneous determination of the three drugs in several laboratory-prepared mixtures of different ratios. Finally, laboratory made tablets containing the three drugs were assayed using the developed procedure where no interfering peaks were encountered from the tablet additives.

Effect of Drotaverine Hydrochloride on Bladder Spasm after Transurethral Resection of Prostate / 中国康复理论与实践

@#Objective To explore the effect of Drotaverine hydrochloride on preventing bladder spasm after transurethral prostatectomy.Methods 124 patients after transurethral prostatectomy were divided into patient-controlled epidural analgesia pump group (group I, n=61) and Drotaverine hydrochloride group (group II, n=63). Group I received bupivacaine by patient-controlled epidural analgesia, and the pump was withdrawed after 72 h. Group II received Drotaverine hydrochloride by intramuscular injection, 80 mg every 12 h, and then orally taken after anal exhaust for 3 days. Bladder spasm and adverse reaction were recorded in both groups. Results There was no significant difference in bladder spasm between group I (11.48%) and group II (12.70%) (P>0.05), as well as in side reaction between group I (16.39%) and group II (17.46%) (P>0.05). Conclusion Drotaverine hydrochloride is effective on preventing bladder spasm after transurethral resection of the prostate, with small side effect.

Determination of drotaverine hydrochloride in dosage forms by its quenching effect on the luminescence of terbium complex.

A new, simple, sensitive luminescence method for the determination of drotaverine hydrochloride is developed and validated. The Drotaverine hydrochloride can remarkably quench the luminescence intensity of the Tb3+ ion in terbium complex with 1-bythyl-4-hydroxy-2-oxo-1,2-dihydroquinoline-3-carboxylic acid-(4-methyl-pyridin-2- yl)-amide (R) in aqueous solutions containing urotropine buffer (pH 7.5) at λex=317 nm and λem=545 nm. Under optimal conditions, the quenching of luminescence intensity is directly proportion to the concentration of Drotaverine hydrochloride in the range of 0.5-300 μg/mL and detection limit is 0.16μg/mL. This method was applied for the determination of Drotaverine hydrochloride in tablets “No-spa”.

Simultaneous estimation of drotaverine hydrochloride and paracetamol in bulk and tablet dosage form by RP-HPLC method.

A simple, rapid, reproducible, accurate and precise Reverse Phase HPLC method was developed for the quantitative simultaneous estimation of Drotaverine hydrochloride and Paracetamol in combined tablet dosage form. Drotaverine hydrochloride is an analog of papaver and is used mainly as an antispasmodic, smooth muscle relaxant. Paracetamol has analgesic and antipyretic activity. The chromatographic separation of both drugs was achieved with 250 x 4.6 mm, i.d 5 μm C-18 column using Methanol: water pH adjusted to 4.0 with O- Phosphoric acid. (60:40 v/v) at the flow rate of 1ml/min. The measurements were made at 243.0 nm using UV detector. The linearity range was found to be 5-80 μg/ml for Drotaverine hydrochloride and 5-70 μg/ml for Paracetamol. The coefficient of correlation for Drotaverine hydrochloride and Paracetamol was found to be 0.9994 and 0.9990 respectively. The retention time for Drotaverine hydrochloride and Paracetamol were 4.562 min and 8.146 min, respectively. The tailing factor for Drotaverine hydrochloride and Paracetamol was found to be 1.12 and 1.18 respectively. The percent recoveries obtained for Drotaverine hydrochloride and Paracetamol were found to be 99.85 and 99.92 respectively. The relative standard deviation for intraday and interday precision in tablet was always less than 2%. The method was validated for linearity, range, precision, accuracy, specificity, selectivity, intermediate precision, ruggedness, robustness, stability and suitability.