Paracetamol Syrup Research Articles

Study of Formulation of Pharmaceutical Solution Form of Paracetamol in the Pediatric Clinical Practice

AIM of the study was selection of 2 different formulations of paracetamol of 2.5% (125 mg/5 mL) in the Pediatric practice. Paracetamol is widely used in the form of the syrup, with usual percentage of acting ingredient of 125 mg/5 mL. Both samples of the paracetamol syrup were monitored each day regarding organoleptic features (potential changes in color, smell, transparency, crystallization, etc.), whilst in monthly intervals (1 month, 2 months, 3 months, 4 months and 5 months) content of the paracetamol was analyzed, with the spectrophotometric method (HPLC). Content of the paracetamol in both syrup formulations has not incurred any change even after a period of 6 months of storage, which showed that these two formulations are appropriate ones. From six different formulations of the paracetamol syrup in percentage of 2.5% (125 mg/5 ml) as more appropriate are: fifth formulation which can be considered, without no doubt, as most appropriate one because of its relatively low cost, an stabilized pH, a quite likeable taste and as such also consequently acceptable in the pediatric practice. In some cases, mainly during the winter, the crystallization of the paracetamol in the lid, walls and bottom of the bottle was ascertained also. Syrup of paracetamol 2.5% (125 mg/5 mL) as per the formulation 5 experimented by our side can be recommended as most appropriate to be produced in industrial conditions for purposes of pediatric practice.

A randomized, double-blind, placebo-controlled trial of paracetamol and ketoprofren lysine salt for pain control in children with pharyngotonsillitis cared by family pediatricians

BackgroundTo evaluate the analgesic effect and tolerability of paracetamol syrup compared to placebo and ketoprofen lysine salt in children with pharyngotonsillitis cared by family pediatricians.MethodsA double-blind, randomized, placebo-controlled trial of a 12 mg/kg single dose of paracetamol paralleled by open-label ketoprofren lysine salt sachet 40 mg. Six to 12 years old children with diagnosis of pharyngo-tonsillitis and a Children's Sore Throat Pain (CSTP) Thermometer score > 120 mm were enrolled. Primary endpoint was the Sum of Pain Intensity Differences (SPID) of the CSTP Intensity scale by the child.Results97 children were equally randomized to paracetamol, placebo or ketoprofen. Paracetamol was significantly more effective than placebo in the SPID of children and parents (P < 0.05) but not in the SPID reported by investigators, 1 hour after drug administration. Global evaluation of efficacy showed a statistically significant advantage of paracetamol over placebo after 1 hour either for children, parents or investigators. Patients treated in open fashion with ketoprofen lysine salt, showed similar improvement in pain over time. All treatments were well-tolerated.ConclusionsA single oral dose of paracetamol or ketoprofen lysine salt are safe and effective analgesic treatments for children with sore throat in daily pediatric ambulatory care.

Inaccuracies in dosing drugs with teaspoons and tablespoons

We aimed to evaluate the potential inaccuracies in administering the desired dose of drugs with teaspoons and tablespoons. We collected all the different teaspoons/tablespoons that were available in 25 households in the area of Attica, Greece and measured their volume capacity (ml). A total of 71 teaspoons and 49 tablespoons were provided by the 25 women (mean age 48.0 years) study participants. When these utensils were filled with water, the volume capacity of the 71 teaspoons and 49 tablespoons ranged from 2.5 to 7.3 ml (the mean and the median volume was 4.4 ml). When the standardised teaspoon was used, the volume ranged from 3.9 to 4.9 ml among the total of the 25 study participants. When a subset of five study participants filled this teaspoon with paracetamol syrup, mean volume was 4.8 ml. Teaspoons and tablespoons are unreliable dosing devices, and thus their use should no longer be recommended.

Influence of the Ageing Phenomenon on the Low-Frequency Electrical Impedance Behavior of Naphazoline Hydrochloride Solutions and Paracetamol Syrup

The influence of the ageing process on the low frequency behavior of some electrical parameters of naphazoline hydrochloride solutions at 0.5% and 1% in concentration and of 2% paracetamol syrup, is studied. The impedance measurements were performed, in the range between 200Hz and 1MHz, using an impedance analyzer and a cell for liquids with plane parallel electrodes whose separation can be changed by using a set of spacers, provided by the manufacturer, in order to get better control of the influence of electrodes polarization effect. The ageing state was artificially generated by dilution and/or heating separated procedures. The results show that this dielectric technique can be used as a good quality complementary control technique.

Single dose caudal tramadol with bupivacaine and bupivacaine alone in pediartic inguinoscrotal surgeries.

To determine the postoperative analgesic effect of Tramadol when given with caudally administered Bupivacaine in children undergoing inguinoscrotal surgeries. Quasi-experimental study. Department of Anaesthesia, Dow University of Health Sciences and Civil Hospital Karachi, from July 2005 to March 2006. A total of 60 children, undergoing inguinoscrotal surgeries, aged from 1 to 12 years, ASA 1 and 2, were included. The patients were divided into two equal groups. The group given Bupivacaine with Tramadol was called 'group BT' and the group which was given only Bupivacaine was labeled as 'group B'. Group BT was given 0.25%,0.8 ml/kg Bupivacaine and Tramadol 2 mg/kg while the other group B was given 0.25%, 0.8 ml/kg Bupivacaine through caudal route after induction of general anesthesia. No other analgesic was given intraoperatively. The postoperative pain was evaluated by using visual analogue scale/Ocher's face scale/CHEOPS and sedation was assessed by 5 points sedation score at immediate postoperative period 1, 2,3,4,6, 12 and 24 hours. Supplemental analgesia in the form of paracetamol suppositories and syrup Ibuprofen was given accordingly. SaO2, pulse, blood pressure, and motor block were monitored in all the patients. Addition of Tramadol with Bupivacaine resulted in meaningfully increased postoperative analgesic period (16.06 +/- 4.04 hours). No other side effects like respiratory depression, pruritus, urinary retention were found in both the groups except for nausea and vomiting. The demand for supplemental analgesia was more in the patients belonging to B group than BT group. The sedation scores were similar in both the groups. The use of Tramadol as an additive with local anesthetics can prolong the postoperative analgesic period when administered caudally. Its use is safe in children.

Caudal Additives in Pediatrics: A Comparison Among Midazolam, Ketamine, and Neostigmine Coadministered with Bupivacaine

Single-shot "kiddie caudal" with bupivacaine alone is losing popularity because of its duration of 4-8 h. In a prospective randomized double-blind clinical study, we assessed and compared the efficacy of ketamine, midazolam, and neostigmine coadministered with bupivacaine in a caudal epidural to provide intraoperative and postoperative pain relief. Eighty children (ASA status I) aged 5-10 yr undergoing unilateral inguinal herniotomy were allocated randomly in equal numbers (n = 20) into 4 groups to receive a caudal injection of 0.25% bupivacaine (1 mL/kg) with or without ketamine (0.5 mg/kg), midazolam (50 microg/kg), and neostig-mine (2 microg/kg), after the induction of standardized general anesthesia without premedication. Monitoring for pain, sedation, postoperative nausea/vomiting, dizziness, and pruritus was performed by anesthesiologists blinded to the study allocation. The time to first analgesic administration (paracetamol syrup) was longer (P < 0.05) in the bupivacaine-neostigmine group and the bupivacaine-midazolam group than in the other groups. Undesirable effects, such as emesis, pruritus, and dizziness, were comparable in all groups. However, the incidence of hallucination was more frequent in the bupivacaine-ketamine group compared with the other groups. This study shows that single-shot caudal coadministration of bupivacaine-neostigmine and bupivacaine-midazolam was associated with an extended duration of postoperative pain relief.

The effect of taste masking agents on in situ gelling pectin formulations for oral sustained delivery of paracetamol and ambroxol

The aim of this study was to examine the influence of polyhydric alcohols (taste masking agents) on the rheological properties of in situ gelling pectin formulations and on the in vitro and in vivo release of paracetamol and ambroxol from these formulations. Gelation of orally administered pectin solutions containing calcium in complexed form occurred on release of calcium in the acidic environment of the stomach. Inclusion of 10% (w/v) sorbitol in 2% (w/v) pectin sols reduced the viscosity and ensured Newtonian flow properties. Xylitol and mannitol in similar concentrations were less effective in reducing viscosity; sucrose increased viscosity and caused non-Newtonian flow. The in vitro release of paracetamol from 2% (w/v) pectin gels formulated with 10% (w/v) of sorbitol, erythritol, xylitol or mannitol, and of ambroxol from 2% (w/v) pectin gels containing 10% (w/v) sorbitol, followed diffusion-controlled kinetics. Pectin gels (2%, w/v) containing sorbitol (10%, w/v) sustained the release of paracetamol in the rat stomach and bioavailabilities of approximately 90% of those from an orally administered paracetamol syrup were achieved. Sustained release of ambroxol from in situ gelling formulations was achieved with pectin concentrations of 1.5 and 1% (w/v) and a sorbitol concentration of 10% (w/v).

Differences in the single-oral-dose pharmacokinetics and urinary excretion of paracetamol and its conjugates between Hong Kong Chinese and Caucasian subjects

The present study was conducted to determine if ethnic differences exist for single oral dose pharmacokinetics of paracetamol and its conjugates between Hong Kong Chinese and Caucasian subjects. Twenty healthy Chinese (n = 11) and Caucasian (n = 9) subjects, aged 21-44 years, 11 male and nine female, were given oral paracetamol syrup 20 mg/kg, following an overnight fast. Paracetamol and its metabolites (glucuronide, sulphate, cysteine and mercapturic acid conjugates) were measured in serial plasma samples (0.25, 0.5, 0.75, 1.0, 1.5, 2, 3,...,12, 24 h) and urine collections (0-24 h) by high-performance liquid chromatography. In Chinese subjects, the (mean range) peak plasma concentration of paracetamol was 23.8 mug/mL (17.9-32.3) and time to attain this peak 0.66 h (0.5-0.75). This was lower (P < 0.015) at 18.7 microg/mL (14.4-22.9) and achieved later (P < 0.033) at 1.06 h (0.5-2.0) in Caucasians. In Chinese subjects, plasma levels of glucuronide were lower, sulphate higher and cysteine conjugates significantly lower than in Caucasians (P < 0.05). Chinese subjects excreted 6% more sulphate and 5% less glucuronide. They also excreted significantly less mercapturic acid conjugates (P < 0.001). Chinese subjects show more rapid absorption of paracetamol, a tendency to produce less glucuronide but more sulphate conjugates and reduced production of cysteine and mercapturic acid conjugates. The latter may help to protect against hepatotoxicity following paracetamol overdose.

Survey of drugs sold in pharmacies in Afghanistan

To compare retail prices and manufacturers of drugs sold in pharmacies in the developing country Afghanistan. Jalalabad, Afghanistan, and pharmacies located around the secondary referral centre and teaching hospital Public Health hospital. Descriptive survey of 10 pharmacies, where hospital patients purchase medication. The pharmacies were interviewed about retail prices and manufacturers of paracetamol, chloroquine, metronidazole, ampicillin, and levamizole. Paracetamol tablets were offered by eight different producers (seven in Pakistan, one in the United Kingdom). The price range per tablet was Afghani 15-120 (mean Afghani 59). The different manufacturers (six in Pakistan, two in the United Kingdom, one in Germany, one in India) offered paracetamol syrup with a price range per bottle between Afghani 800-3000 (mean Afghani 1544). Chloroquine tablets were offered by six different producers (one in Pakistan, one in China, one in France, one in Iran, one in India, one in Germany). The price range per tablet was Afghani 45-100 (mean Afghani 76). Three producers from Pakistan offered chloroquine ampoules and the price range was Afghani 250-1020 (mean Afghani 412). Chloroquine syrup was offered by 11 different producers (eight in Pakistan, one in Afghanistan, one in India, one in France). The price range was Afghani 500-2000 (mean Afghani 1226). Metronidazole tablets were offered by five different producers (two in Pakistan, one in France, two in India). The price range was Afghani 60-300 (mean Afghani 175). Metronidazole syrup was offered by four different producers (three in Pakistan, one in France). The price range was Afghani 1000-4500 (mean Afghani 2800). Ampicillin capsules were offered by five different producers (one in Pakistan, one in the United Kingdom, one in India, two in Iran). The price range was Afghani 140-650 (mean Afghani 238). Ampicillin ampoules were offered by five different producers (one in China, one in Germany, one in India, one in France, one in Yugoslavia). The price range was Afghani 600-1700 (mean Afghani 1207). Ampicillin syrup was offered by eight different producers (six in Pakistan, one in China, one in the United Kingdom). The price range was Afghani 900-3500 (mean Afghani 2450). Levamizole tablets were offered by two producers from Pakistan, and three from India. The price range was Afghani 30-500 (mean Afghani 110). Up to 11 producers (chloroquine syrup) offered the same drug with price differences up to 1600% (levamizole).In developing countries with scarce resources for health care and no free health care, regulation and control of drugs could improve efficient use of resources and in hospital medicine patients should obtain all mediation from one supervised hospital pharmacy.

62 IBUPROFEN AND PARACETAMOL: EFFECTIVE ANTIPYRETICS IN CHILDREN WITH FEBRILE SEIZURES

Introduction The possibility to reduce the risk of febrile seizure (FS) recurrences with antipyretics has gained interest. To compare the antipyretic efficacy of Ibuprofen and Paracetamol in children with FS we performed a randomized, multiple dose, double blind, cross-over clinical trial. Study medication was either Ibuprofen syrup (5mg/kg per dose) or Paracetamol syrup (10mg/kg per dose) at 6 hours intervals during two days. No antibiotics were prescribed.Participants/Measurements 70 patients with a history of FS (mean age 2.1 years) were assigned to treatment at the occurrence of a fever with rectal temperature ≥ 38.5 °C. 22 patients were included during two fevers. Temperature was recorded at 0, 2, 4, 6, 12 and 24 hours after the first dose. Temperature at 4 hours, overall mean temperature and the highest temperature during treament were evaluated. Covariance analysis corrected for base-line temperature, age, weight and clinical fever diagnosis.Main Results Ibuprofen lowered temperature from 39.1 °C base-line to 37.7 °C overall mean, Paracetamol from 39.2 °C to 38.0 °C. Ibuprofen showed 0.50 °C more fever reduction at 4 hours after the initial dose (p=0.04). Also, overall mean temperature was 0.26 °C lower and the highest temperature was 0.30 °C lower during Ibuprofen treatment. In cross-over analysis respective differences were 0.66 °C (p=0.03), 0.40°C and 0.36 °C in favour of Ibuprofen. Two febrile seizures occurred during Ibuprofen treatment and three during Paracetamol treatment.Conclusions Ibuprofen and Paracetamol are effective antipyretics in children with a history of FS. In the studied doses Ibuprofen reduces fever more than Paracetamol. Future clinical trials may determine the value of antipyretic treatment as a prophylaxis of recurrent febrile seizures.

Paracetamol syrup induced diarrhoea

Paracetamol syrup induced diarrhoea

Diethylene glycol poisoning in Nigerian children.

Between June and September 1990, 47 children died at Jos University Teaching Hospital, Nigeria from ingestion of paracetamol syrup adulterated with diethylene glycol. Most of the children presented with anuria, fever, vomiting, diarrhoea and convulsions. Signs on admission were tachycardia, acidotic breathing, pallor, oedema and hepatomegaly. Laboratory findings included hyperkalaemia, acidosis, elevated creatinine level and hypoglycaemia. Management consisted of correction of dehydration and acidosis plus administration of antibiotics when indicated. None of the children had dialysis. All died within 2 weeks of admission. Proper government supervision of pharmaceutical companies and their agencies is urgently needed in order to prevent any future occurrence of such tragic deaths.

Antipyretic therapy

The absorption of paracetamol from syrup, tablet and two different suppository bases was compared in six adult volunteers using urinary excretion measurements. The total amount of paracetamol and its metabolites excreted and the peak excretion rates were lower from the suppository bases than from the oral dosage forms. Absorption was a little better from a polyethylene glycol suppository base than from a triglyceride base. The antipyretic efficacy of a paracetamol syrup and suppository at a dose of 10 mg/kg was compared in 30 children between the age of 4 months and 12 years, who had infections and a rectal temperature above 38.5 degrees C. Both dosage forms produced a significant decrease in temperature, the greatest fall being about 2 hours earlier with the oral dosage form. The syrup also seemed to be significantly (p less than 0.05) more effective (maximum fall of temperature 1.58 degrees C) in reducing fever than the suppository, which produced its greatest fall of temperature (1.24 degrees C) six hours after insertion of the suppository. From the practical point of view both forms can be regarded as safe and effective antipyretics.

Effect of oral midazolam in preventing postoperative emergence agitation in children

Introduction: Emergence from general anaesthesia can be complicated by the presence of agitation in children and thus presents a challenging situation for postanesthesia care providers. Several factors are associated with emergence agitation (EA). These include pain, preoperative anxiety, young age, poor adaptability, short time to recovery, among others. Objective: This study aimed to determine the effect of oral midazolam in preventing postoperative EA in children. Materials and Methods: This was a case–control study carried out among 80 healthy children aged 1–10 years scheduled for day-case surgery. The children were randomly assigned to receive either a syrup of paracetamol 10 mg/kg with injectable midazolam 0.5 mg/kg added to the syrup (Group A) or a placebo in the form of paracetamol syrup (Group B) at a dose of 10 mg/kg 30 min before induction of anesthesia. Patients' state of agitation was assessed every 5 min for the 1st h by means of an EA scale. Children with an agitation score of 3 or 4 were classified as agitated. Prolonged agitation was defined as a score of ≥3 lasting 15 min after arrival in the recovery room. Data were analyzed using the Statistical Software for Social Sciences version 20. Results: Eighty children aged 1–10 years were enrolled in the study. Majority of the procedures were circumcisions (48.75%), while urethral dilatation, examination under anesthesia, and tongue release were the least (1.25%). There was no statistically significant difference in the agitation state of the two groups (P = 0.60). Conclusion: Premedication with oral midazolam 0.5 mg/kg administered 30 min preoperatively does not prevent EA in all cases.