Acetaminophen is a good choice for analgesia, and fever reduction in nursing mothers. Amounts in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare.

The increase in survival rate of β-thalassemia (β-thal) patients allowed for the appearance and manifestation of several complications in almost every organ system. Priapism in β-thal patients is rarely reported in the literature. We herein report and investigate the occurrence of two cases of priapism in two young patients with β-thal intermedia (β-TI). The potential mechanisms are due to either a cellular mechanism involving a thrombus obstructing the efferent venules of the corpora cavernosa leading to priapism, or a recently elucidated functional mechanism that causes alteration of nitric oxide (NO) response of the penis, ultimately causing priapism. This should incite clinicians for a close follow-up and monitoring of high risk patients who are susceptible to developing priapism.

Fixed drug eruption is an uncommon adverse drug reaction caused by delayed cell-mediated hypersensitivity. Levocetirizine is an active (R)-enatiomer of cetirizine and there have been a few reports of fixed drug eruption related to these antihistamines. We experienced a case of levocetirizine-induced fixed drug eruption and cross-reaction with other piperazine derivatives confirmed by patch test. A 73-year-old female patient presented with recurrent generalized itching, cutaneous bullae formation, rash and multiple pigmentation at fixed sites after taking drugs for common cold. She took bepotastine besilate (Talion®) and levocetirizine (Xyzal®) as antihistamine. She took acetaminophen, pseudoephedrine 60 mg / triprolidine 2.5 mg (Actifed®), dihydrocodeinebitartrate 5 mg / di-methylephedrine hydrochloride 17.5 mg / chlorpheniramine maleate 1.5 mg / guaifenesin 50 mg (Codening®) and aluminium hydroxide 200 mg / magnesium carbonate 120 mg (Antad®) at the same time. Patch test was done with suspected drugs and the result was positive with levocetirizine. We additionally performed patch test for other antihistamines such as cetirizine, hydroxyzine, fexofenadine and loratadine. Piperazine derivatives (cetirizine and hydroxyzine) were positive, but piperidine derivatives (fexofenadine and loratadine) were negative to patch test. There was no adverse drug reaction when she was challenged with fexofenadine. We report a case of levocetirizine-induced fixed drug eruption confirmed by patch test. Cross-reactions were only observed in the piperazine derivatives and piperidine antihistamine was tolerant to the patient.

A highly efficient, selective and specific method for simultaneous quantitation of triprolidine and pseudoephedrine in human plasma by liquid chromatography-ion trap-tandem mass spectrometry coupled with electro spray ionization (LC-ESI-ion trap-tandem MS) has been validated and successfully applied to a clinical pharmacokinetic study. Both targeted compounds together with the internal standard (gabapentin) were extracted from the plasma by direct protein precipitation. Chromatographic separation was achieved on a C(18) ACE((R)) column (50.0mmx2.1mm, 5mum, Advance Chromatography Technologies, Aberdeen, UK), using an isocratic mobile phase, consisting of water, methanol and formic acid (55:45:0.5, v/v/v), at a flow-rate of 0.3mL/min. The transition monitored (positive mode) was m/z 279.1-->m/z 208.1 for triprolidine, m/z 165.9-->m/z 148.0 for pseudoephedrine and m/z 172.0-->m/z 154.0 for gabapentin (IS). This method had a chromatographic run time of 5.0min and a linear calibration curves ranged from 0.2 to 20.0ng/mL for triprolidine and 5.0-500.0ng/mL for pseudoephedrine. The within- and between-batch accuracy and precision (expressed as coefficient of variation, %C.V.) evaluated at four quality control levels were within 94.3-106.3% and 1.0-9.6% respectively. The mean recoveries of triprolidine, pseudoephedrine and gabapentin were 93.6, 76.3 and 82.0% respectively. Stability of triprolidine and pseudoephedrine was assessed under different storage conditions. The validated method was successfully employed for the bioequivalence study of triprolidine and pseudoephedrine formulation in twenty six volunteers under fasting conditions.

A kinetic method for the accurate and sensitive determination of triprolidine has been described. The method is based on the alkaline oxidation of triprolidine with KMnO(4). At a fixed time of 20 min, the formed manganate ion is spectrophotometrically measured at 612 nm. The concentration of triprolidine is calculated using the calibration equation for the fixed time method. Beer's law was obeyed from 6 to 40 microg ml(-1) and the R.S.D. (n=10) was 0.97%. Recovery was 99.80%. The method is suitable for quantitative determination of triprolidine in the presence of co-formulated drugs, since pseudoephedrine hydrochloride, which is frequently co-formulated with triprolidine did not interfere with this assay. The intra- and inter-day R.S.D. values indicated the ruggedness of the method. The method has been applied successfully to commercial tablet dosage form. The results obtained agreed with those obtained by the BP method. The determination of triprolidine by the fixed-concentration and rate constant methods is feasible with the calibration equations obtained, but the fixed time method proves to be more applicable.

In order to assess the efficacy of Rinasek in symptomatic treatment of seasonal and nonseasonal rhinitis, 40 ambulatory otorhinolaryngologic patients were multicentrically examined in a placebo controlled double-blind study. Clinical and other findings show that the drug worked excellent in 46.6%, well in 13.3%, weak in 13.3% and in 10% of patients it had no effects. Consequently, Rinasek worked positively in 73.2%, and that is the best reason to recommend its application.

A capillary gas chromatographic method with nitrogen specific detection is presented for measuring pseudoephedrine and its major metabolite norpseudoephedrine in urine after derivatization with trifluoroacetic anhydride. After the oral intake of 49.2 mg pseudoephedrine (ACTIFED) the active substance is nearly quantitatively excreted in urine over a 48 hr period. From 1 to 7 percent is metabolized to norpseudoephedrine. The intake of acetazolamide results in a suppression of the pseudoephedrine concentration for at least 12 h. The diuretic effect after the intake of 1.51 mineral water could be compared with the effect obtained with 1 mg bumetanide and results in a decrease in pseudoephedrine concentration by a factor 4 for several hours.

To obtain information on the use of prescribed and non-prescribed drugs in the general population of children 1590 children were surveyed in 1984-5 by weekly questionnaires filled out by parents. Drugs were taken in 13% of the 26 weeks studied and on 9% of the 182 days. Use in the summer and winter was similar. More than half (56%) of all drugs were taken on Saturdays and Sundays. Boys took drugs on 11% of days and girls on 8% of days. Almost half (45%) of drugs taken were not prescribed. Drugs acting on the respiratory tract and on coughs accounted for 42.2% of the drugs used. Analgesics were taken on 14.0% of days and antimicrobials on 12.5%. Aspirin accounted for 14.9% of all drugs used in any one week and for 31.7% of drugs obtained without prescription. Aspirin, paracetamol, triprolidine-pseudoephedrine (Actifed), ampicillin or amoxycillin, and salbutamol were the drugs most frequently used. The widespread use of drugs obtained without prescription suggests that community pharmacists and parents would benefit from further education on the choice of treatment in relation to symptoms. Doctors should be aware of the extent of treatment with non-prescription drugs and consider playing a greater part in advising on its indications.

Difference spectrophotometric procedures are described for the assay of triprolidine hydrochloride, dextromethorphan hydrobromide and pseudoephedrine hydrochloride in Actifed preparations. Triprolidine is assayed by the measurement of the difference absorbance at 301 nm between equimolar solutions of the sample extract in 0.1 M sulphuric acid and 0.1 M sodium hydroxide in ethanol (20% v/v). Dextromethorphan and pseudoephedrine are assayed by measurement of the amplitudes in the second and fourth derivative spectra of the difference absorption spectrum of the sample solutions. The measured values are proportional to the concentrations of the drugs. The accuracy, precision and selectivity of the procedures are discussed. Applications of the assay are described for Actifed Compound Linctus, Actifed Syrup and Actifed Tablets.

A double-blind placebo controlled trial of Mucodyne (carbocisteine, Berk Pharmaceuticals), Actifed (triprolidine HC1 and pseudoephedrine HC1, Wellcome) and combined Mucodyne and Actifed in the treatment of middle-ear effusions is reported. The trial was undertaken to assess whether either preparation, alone or in combination, would reduce the number of children requiring surgical treatment for this condition. No statistical difference between the various groups in avoiding surgical treatment was detected. In those patients undergoing surgery, pre-operative treatment with Mucodyne was associated with a significantly greater number of ears restored to a normal appearance and middle ear function as measured by tympanometry. All patients relapsing after surgery belonged to the groups receiving placebo, Actifed or the combination of Mucodyne and Actifed prior to the operation.

63 patients were treated with the combination of pseudoephedrine hydrochloride and triprolidine hydrochloride (Actifed). Indications were infectious, allergic and vasomotoric rhinitis. The 63 patients divided in 32 children in the age of 2 to 12 years and 31 adults in the age of 14 to 56 years. The daily dose range depending on age was 90.0 to 180.0 mg pseudoephedrine hydrochloride and 3.75 to 7.5 mg triprolidine hydrochloride, applicated either as syrup or as tablets. All patients accepted the drug well. In 58 cases the effect of the drug for treatment of common cold was very good and good. Side-effects were not observed, apart from tiredness in 18 cases, which--however--did only occur at the first day of treatment.

Erythema multiforme usually presents as an acute inflammatory reaction involving the skin and mucous membranes. Systemic symptoms and organ involvement also can occur. The disease is associated with many illnesses and drugs. A two-year-old child presented to the Family Practice Center with a probable codeine-induced episode of erythema multiforme. The patient had been treated with Actifed-C Expectorant for a suspected viral upper respiratory tract infection. The rash was characteristic of erythema multiforme, but there was no involvement of mucous membranes. The rash quickly abated after the discontinuation of the drug and the administration of hydroxyzine. A viral cause for the rash could not be ruled out. When erythema multiforme is precipitated by a particular drug, discontinuation of the offending agent is necessary. The rash should disappear quickly. Adjunctive use of antihistamines may offer some benefit for the patient. Systemic corticosteroids may be necessary for more severe cases.

Two hundred and seventeen patients between 6 and 12 years of age suffering from acute cough took part in a randomized, single-blind study comparing 'Pholcolix' and 'Actifed' Compound. No significant difference in efficacy was demonstrated but analysis of palatability components (taste, smell, aftertaste and feeling in the mouth) showed numerical superiority for 'Pholcolix' for all parameters, with a high degree of significance for overall taste. 'Pholcolix' caused significantly fewer side-effects, with 'Actifed' Compound causing markedly more drowsiness after daytime dosage.

Records were studied of 500 children younger than 9 years of age with middle ear effusion who had received one of three treatment strategies: (1) administration of medication, including decongestants, antihistamines or antibiotics (or a combination), (2) administration of medication for a limited time and then surgical therapy if effusion did not resolve or (3) myringotomy done immediately with insertion of ventilation tubes and, in some cases, removal of adenoids. Early surgical intervention resulted in significantly shorter delay in hearing restoration. It did not result in a lower recurrence rate and it did not reduce the number of occasions when thick fluid, as compared with thin fluid, was found at operation. Four children for whom medical and surgical treatment failed were considered candidates for mild gain, low maximum-power-output hearing aids. All other children had normal hearing after treatment. Medication was successful in achieving this goal in 48 percent of the cases.

Pseudoephedrine and triprolidine, administered every 6 hours as a combination, made separate and distinct contributions to the treatment of allergic rhinitis. Furthermore, the combination was perceived by the patients as being clinically superior to either of its components or placebo.