Methods and kits for treating fever in children with a combination of ibuprofen and acetaminophen

Abstract

Provide various dosage forms, including dosage methods and regimens for treating fever in children, as well as formulations and kits. One dosage regimen or method for treating a child with fever includes administering a dose to a child, the dose comprising a) a predetermined amount of ibuprofen, and b) a predetermined amount of acetaminophen, the predetermined amount being determined by the child's weight. Various carriers, such as liquid, solid, and semi-solid, can be used in the formulation. Provide a dosage chart that includes the amount of ibuprofen and acetaminophen compound in the formulation.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 63 / 294,286, filed December 28, 2021, the entire disclosure of which is incorporated herein by reference.

[0002] FIELD OF THEINVENTION The present invention relates generally to methods and regimens for administration and various dosage forms, including formulations and formulation kits, for treating fever in children. More specifically, the dosage forms include a combination of ibuprofen and acetaminophen in specific amounts. [Background technology]

[0003] In recent years, parents have become more concerned about when and how to treat their children with painkillers and antipyretics to reduce fever. Fever is one of the most common pediatric symptoms (Schmidtt BD, (1984), Pediatrics, 74(5 Pt 2):929-36) and one of the most common reasons parents seek medical attention for their children, often in emergency departments. Medical experts call this phenomenon "feverphobia," or parental misunderstanding of children's fevers (Doria M et al., (2019), Int J Environ Res Public Health, 16(22):4487 (9 pages)). Lack of knowledge can lead parents to overtreat children with fevers or give subtherapeutic doses of antipyretics. As a result, some children are at risk of suffering from the toxic effects of these drugs, while others are frequently taken to emergency rooms or clinics for fevers that do not seem to respond to conventional medicines.

[0004] Children with a fever may feel hot to the touch, have sweaty or clammy skin, start shivering, have an increased heart rate (known as tachycardia), and breathe faster (known as tachypnea). These symptoms are relatively harmless in most cases, but they can cause parents to become anxious and believe their child is sicker than they actually are. Fever in children may indicate a more dangerous condition, and fever can provide pediatricians with valuable information about the underlying cause of the fever. Acetaminophen (also known as paracetamol) is the most widely used antipyretic drug in children because it has antipyretic and analgesic properties and is relatively safe.

[0005] Linder et al. (Linder M et al., (1999), Isr Med Assoc J, 1(3):158-60) conducted a study to assess parental knowledge levels regarding antipyretic dosing, sources of that knowledge, when and how parents decide to treat their children, and the reported effectiveness of that treatment. Linder et al. found that 24.1% of parents gave their febrile children less than the recommended daily dose of acetaminophen. Parents in the study population, like those in other studies, incorrectly assumed that a household teaspoon holds 5 ml, when the correct volume is 3 ml. A second cause of underdosing was parents' failure to modify the dose as the child grew older and heavier. Inappropriately low doses may lead to unnecessary visits to the clinic or emergency room by children brought by concerned parents who believe that the fever will resist treatment.

[0006] Recently, it has been suggested that a combination of ibuprofen and acetaminophen may be more effective at reducing fever in febrile children, but there is no consensus in the medical literature.

[0007] For example, Erleqyn-Lajeuness et al. (Arch Dis Child, (2006), Arch Dis Child, 91(5):414-6) report a trial of 15 mg / kg paracetamol, 5 mg / kg ibuprofen, or a combination of paracetamol and ibuprofen in febrile children aged 6 months to 11 years. The combination group showed a greater reduction in fever compared with the groups receiving ibuprofen or paracetamol alone, but the reduction was less than 0.5°C, within the margin of error. Erleqyn-Lajeuness et al. opine that a difference of 0.5°C is not clinically significant enough to justify routine use of the combination.

[0008] Sarrell EM et al. (Arch Pediatr Adolesc Med, 160(2):197-202) reported that alternating acetaminophen and ibuprofen treatment of fevers in children was more effective than treating fevers in children with either drug alone. They found no long-term complications. They point out that all study participants visited a physician for treatment, minimizing the risk of underdosing.

[0009] Hay AD et al. (BJM, (2008), 2008 Sep 2, 337:a1302) conducted a review of three trials comparing the combination of paracetamol and ibuprofen with either drug alone in febrile children. They concluded that despite parents' and clinicians' desire to consider the combination of ibuprofen and acetaminophen in febrile children, the evidence from the three trials was insufficient to demonstrate a clinically important reduction in fever with the combination. They cautioned against observed drawbacks of the combination therapy, including the potential risk of over- and / or under-dosing, increased costs, potential adverse effects, and potential increased fever phobia.

[0010] Pursell E (Arch Dis Child, (2011), 96(12):1175-9) conducted a systematic review of studies comparing combined paracetamol and ibuprofen treatment with paracetamol or ibuprofen alone. According to Pursell, of the six studies reviewed, those with data available to evaluate the effectiveness of the three treatments in reducing temperature in febrile children, demonstrated statistically significant benefits, but only small clinically significant benefits. Pursell suggested that the potential risk of overdosing due to increased fever phobia resulting from parental anxiety about administering two drugs instead of one outweighed the small benefits observed.

[0011] Wong T (Cochrane Database Syst Rev, (2013), 2013(10):CD009572) completed an intervention review of trials comparing combination treatment of paracetamol and ibuprofen (given together in a single dose or alternating) with paracetamol and ibuprofen monotherapy in children with fever. Wong concluded that while there is some evidence to support the finding that combination treatment may be more effective in reducing children's febrile condition than the individual monotherapies, there is no conclusive evidence comparing improvement in patient discomfort, nor is there conclusive evidence on the effectiveness of alternating administration of both drugs rather than given in a single dose.

[0012] Although national and international guidelines for the management of fever in children and adolescents are available, inappropriate practices remain on the part of both parents and healthcare professionals. The primary goal of returning a child's temperature to normal may lead to inappropriate drug selection or unnecessary combinations / changes of antipyretic treatments, i.e., fever phobia also caused by the dissemination of unscientific information and social media. Over-the-counter drugs acetaminophen and ibuprofen are available commercially for the treatment of fever in children, but there is a great deal of confusion regarding the dosage and frequency of administration. The standard weight-based dosages (15 mg / kg and 10 mg / kg, respectively) and frequency of administration (every 4 hours and every 6 hours, respectively) of acetaminophen and ibuprofen vary, increasing fever phobia and creating the possibility that caregivers may over- or under-administer either drug, which may result in inappropriate treatment or dangerous side effects, respectively.

[0013] Therefore, it is increasingly important for pediatricians to continue to provide parents with adequate information to evaluate the development of signs of possible discomfort in children, rather than focusing only on temperature. In fact, there is no clear and unequivocal definition of discomfort in the literature. Therefore, clarifying the degree of discomfort in children with fever, and the tools that can be used to assess it, would help recommend that antipyretic measures are appropriate only when fever is accompanied by discomfort.

[0014] There is a need for a dosing regimen that takes advantage of the improvements observed in treating febrile children with a combination of ibuprofen and acetaminophen while reducing fever phobia. There is also a need for a system that ensures correct dosing for a particular patient and prevents potentially harmful under- or overdosing. It is an object of the present invention to take advantage of the benefits of the combination of acetaminophen and ibuprofen to treat fever in children and administer the maximum effective dose that is safe and effective. The present invention overcomes the problem of fever phobia by parents and other health care providers by providing a weight-based dosing system. The present invention provides a means to treat febrile children by administering the safest and maximum possible dose of acetaminophen and ibuprofen together, eliminating the guesswork and anxiety surrounding the dosage and frequency regimen of either drug alone. Summary of the Invention

[0015] Generally, the present invention relates to the treatment of pediatric patients with fever. Methods and regimens of administration and various dosage forms, including formulations and formulation kits, for treating fever in children are provided.

[0016] In one embodiment, the regimen or method for treating a child with fever comprises administering a dose to a child, the dose comprises a) a predetermined amount of ibuprofen, and b) a predetermined amount of acetaminophen, the predetermined amount being determined by the child's weight.A single-dose formulation may comprise a predetermined amount of ibuprofen and a predetermined amount of acetaminophen.The formulation may comprise various carriers, such as liquid, solid and semi-solid.

[0017] For example, liquid carriers such as drops, solutions, suspensions, emulsions, elixirs, and combinations thereof can be used in the formulation.In other examples, solids and semi-solids such as hard candies, popsicles, gelatin-based chewable candies, chewable tablets, gums, dissolving tablets, powders, capsules, lozenges, dissolving films, enemas, suppositories, ointments, creams, patches, gels, microneedles, packets, sachets, intranasal sprays, and combinations thereof can be used.

[0018] In other embodiments, a first formulation comprises a predetermined amount of ibuprofen and a second formulation comprises a predetermined amount of acetaminophen, and the first and second formulations are administered separately to a febrile child.

[0019] The present invention also provides various pharmaceutical formulations and dosage charts, which contain information on the amount of ibuprofen compound and acetaminophen compound in the formulation, and the exemplary weight of the febrile child to be treated.The dosage chart indicates the correct dosage of the formulation based on the weight of the febrile child to be treated.A pharmaceutical kit for treating febrile children is also provided.In one embodiment, the kit comprises: a) a formulation for treating febrile children, the formulation comprises a predetermined amount of ibuprofen compound and a predetermined amount of acetaminophen compound, and b) a dosage chart, the chart contains information on the amount of ibuprofen compound in the first formulation and the amount of acetaminophen compound in the second pharmaceutical formulation, and the exemplary weight of the child, and the dosage of the first and second pharmaceutical formulations is based on the weight of the febrile child to be treated. [Brief description of the drawings]

[0020] The novel features which characterize the invention are set forth in the appended claims, however the preferred embodiments of the invention together with further objects and attendant advantages will best be understood by reference to the following detailed description taken in conjunction with the drawings.

[0021] [Figure 1]FIG. 1 is a flow chart illustrating one embodiment of administration of a combined dose of ibuprofen and acetaminophen in accordance with the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] The present invention relates generally to methods and regimens for administration and various dosage forms, including formulations and formulation kits, for treating fever in children. More specifically, the dosage forms include a combination of ibuprofen and acetaminophen in specific amounts.

[0023] In one embodiment, the present invention relates to a dosing regimen or method for treating a child with fever comprising administering a dose to a child, the dose comprising a) a predetermined amount of ibuprofen, and b) a predetermined amount of acetaminophen, the predetermined amount being determined by the child's weight. The present invention also includes formulations and formulations for treating a child with fever.

[0024] As used herein, the term "fever" means that a patient has a body temperature of 38.0° C. (≧100.4° F.) or higher.

[0025] The term "child" or "pediatric" patient means one who is at least 6 months and under 12 years of age.

[0026] The term "dose" or "dosage" as used herein refers to any ingestible form of the pharmaceutical formulation of the present invention, including, but not limited to, solid, semi-solid and liquid compositions. Preferably, the liquid forms are either standard strength ibuprofen (100 mg per 5 ml) and acetaminophen (160 mg per 5 ml) or double the standard strength ibuprofen (100 mg per 2.5 ml) and acetaminophen (160 mg per 2.5 ml). In accordance with the present invention, these formulations contain specific, predetermined amounts of ibuprofen and acetaminophen, as further described below. Suitable liquid dosage forms include, for example, drops, solutions, suspensions, emulsions, elixirs, and the like. Solid and semi-solid dosage forms include, for example, tablets, capsules, gelatin-based capsules, powders, sachets, sachets, and the like.

[0027] In a preferred embodiment, the single-dose formulation comprises a predetermined amount of ibuprofen and a predetermined amount of acetaminophen. A wide variety of carriers can be included in the formulation. In a preferred embodiment, the carrier is a liquid. For example, the liquid can be selected from the group consisting of drops, solutions, suspensions, emulsions, elixirs, and combinations thereof. These dosage forms include drops for ophthalmic administration and intravenous solutions. In another preferred embodiment, the carrier is a solid or semi-solid. For example, the solid or semi-solid carrier may be selected from the group consisting of hard candies, popsicles, gelatin-based chewable candies, chewable tablets or gums for oral administration; dissolving tablets, powders, particulate capsules (pellets or granules), troches or dissolving films for addition to food or for retention in the mouth; rectal capsules, enemas or suppositories for rectal administration; ointments, creams, patches, gels or microneedles for diffusion through the skin for systemic distribution; packets; sachets; and nasal sprays for insufflation.

[0028] A single formulation containing a prescribed amount of ibuprofen and a prescribed amount of acetaminophen can be given to a febrile child every six hours until the fever subsides.

[0029] In one embodiment, the dosage form has a specific portion that contains an ibuprofen compound and a specific portion that contains an acetaminophen compound, such that the composition is delivered in an immediate release manner after the formulation is administered to a child with fever.In a second embodiment, the dosage form of the formulation has a specific portion that contains an ibuprofen compound and a specific portion that contains an acetaminophen compound, such that the composition of both compounds is delivered in a sustained release manner after the formulation is administered to a child with fever.In a third embodiment, the ibuprofen compound is released in an immediate release manner and the acetaminophen compound is released in a sustained release manner.In yet another embodiment, the ibuprofen compound is released in a sustained release manner and the acetaminophen compound is released in an immediate release manner.

[0030] In one embodiment, the dosage is administered at a ratio of 10mg / kg of ibuprofen to about 15mg / kg of acetaminophen.As mentioned above, in one example, the carrier can be liquid, and the concentration of ibuprofen in the liquid is 100mg per 5ml; the concentration of acetaminophen in the liquid is 160mg per 5ml.In another example, the concentration of ibuprofen in the liquid is 100mg per 2.5ml; the concentration of acetaminophen in the liquid is 160mg per 2.5ml.

[0031] As mentioned above, in one embodiment, ibuprofen and acetaminophen compounds can be administered in one dosage form. That is, a single dosage formulation contains ibuprofen and acetaminophen compounds. Ibuprofen and acetaminophen are combined in one administration. In another embodiment, a dosage of a first compound (ibuprofen or acetaminophen) can be administered, and then a dosage of a second compound (ibuprofen or acetaminophen) can be administered. That is, a first formulation contains ibuprofen, and a second formulation contains acetaminophen, and these formulations are administered separately.

[0032] A first formulation containing a predetermined amount of ibuprofen and a second formulation containing a predetermined amount of acetaminophen may each be administered to a febrile child every six hours until the fever subsides.

[0033] The ibuprofen and acetaminophen dosages may contain a wide variety of additives to impart specific properties to the formulation. These additives are included in addition to the ibuprofen and acetaminophen. Suitable examples of additives include, but are not limited to, vitamins, oral care agents, flavoring agents, alkaline gastrointestinal agents, antacids, other medicines, and mixtures thereof.

[0034] Alkaline gastrointestinal agents, antacids, can be used to neutralize stomach acid and make the drug formulation available for absorption as soon as it enters the small intestine from the duodenum, helping to increase absorption.

[0035] FIG. 1 shows a flow chart for administering a dose comprising a) a predetermined amount of ibuprofen and b) a predetermined amount of acetaminophen, the predetermined amount being determined by the child's weight. In a first step, the pediatric patient is examined. In the present invention, the dosage form is intended for pediatric patients who are at least 6 months of age and have a fever of 38.0° C. (≧100.4° F.) or higher. In a second step, the health care provider consults a dosage chart, which may be provided in a kit as described further below. The dosage chart provides an accurate dosage based on the patient's weight. As described further below, Tables 1, 2, and 3 provide information regarding different dosage charts. Then, in a third step, the health care provider examines the pediatric patient to determine the effect of the dosage on the patient, in particular, whether the fever has subsided. Then, in a fourth step, the health care provider examines the pediatric patient and measures the patient's temperature. This fourth step is performed approximately 6 hours after administering the first dose.

[0036] The dosing regimens, methods, formulations and kits of the present invention are simple yet effective. The dosing regimens, methods, formulations and kits of the present invention are less confusing for parents and healthcare providers and more cost-effective. The present invention minimizes the possibility of underdosing, overdosing and serious side effects for patients.

[0037] The present invention is illustrated by the following examples which should not be construed as limiting the scope of the invention. EXAMPLES

[0038] Example 1

[0039] In this Example 1, a dosage of a first pharmaceutical formulation containing a) ibuprofen and b) acetaminophen was determined. Table 1 below shows dosage information that can be arranged in a variety of ways so that a healthcare provider can easily view it on a user-friendly chart or other display medium. The information in Table 1 includes an exact dosage based on the exact weight of the patient. In particular, with reference to Weight Example 1a in Table 1, an exact dosage of the pharmaceutical formulation for a child weighing 43.2 kg (95.0 lbs) is shown. In Weight Example 1a, the dosage contains ibuprofen in an amount of 432 mg and acetaminophen in an amount of 648 mg. The dosage is in the form of an oral liquid, and the amount of liquid containing the active ingredients (ibuprofen and acetaminophen) is 20.9 mL. In another example Weight Example 3g, the child weighs 24.0 kg (52.8 lbs). The dosage contains ibuprofen in an amount of 240 mg and acetaminophen in an amount of 360 mg in 11.6 mL of liquid carrier.

[0040] [Table 1-1] [Table 1-2]

[0041] *Note: The dosage in mg based on weight is the same as for the individual dosages, but the concentrations of ibuprofen and acetaminophen are twice as high as in the conventional oral solution form (100 mg ibuprofen in 2.5 ml instead of 100 mg in 5 ml, and 160 mg acetaminophen in 2.5 ml instead of 160 mg in 5 ml), making the volume of the combination drug similar to that of either individual drug.

[0042] Example 2

[0043] In Example 2, the information for the second dosage chart was determined with reference to Table 2. The information in Table 2 includes precise dosage amounts based on the weight range of the pediatric patient. That is, the main difference between Table 1 and Table 2 in Example 1 above is that the information in Table 1 is based on the precise weight of the pediatric patient, whereas the information in Table 2 is based on the weight range of the pediatric patient. The dosage amounts in Table 1 may be referred to as "precise dosage amounts," whereas the dosage amounts in Table 2 may be referred to as "standard dosage amounts."

[0044] In particular, with reference to weight examples 1a-1u in Table 2, a standard dosage range of the pharmaceutical formulation for children weighing 95.0 pounds to 71.6 pounds is shown. In weight examples 1a-1u, the dosage contains ibuprofen in an amount of 300 mg and acetaminophen in an amount of 480 mg. The dosage is in the form of an oral liquid, and the amount of liquid containing the active ingredients (ibuprofen and acetaminophen) is 15.0 mL. With reference to weight examples 3a-3k in Table 2, a standard dosage range of the pharmaceutical formulation for children weighing 59.8 pounds to 48.1 pounds is shown. In weight examples 3a-3k, the dosage contains ibuprofen in an amount of 200 mg and acetaminophen in an amount of 320 mg in 10 mL of liquid.

[0045] [Table 2-1] [Table 2-2]

[0046] *Note: The dosage in mg based on weight is the same as for the individual dosages, but the concentrations of ibuprofen and acetaminophen are twice as high as in the conventional oral solution form (100 mg ibuprofen in 2.5 ml instead of 100 mg in 5 ml, and 160 mg acetaminophen in 2.5 ml instead of 160 mg in 5 ml), making the volume of the combination drug similar to that of either individual drug.

[0047] Example 3

[0048] In Example 3, information for the third dosage chart was determined, as shown in Table 3. The information in Table 3 includes exact dosage amounts based on the weight range of pediatric patients. Please note that the conversion from pounds to kilograms is not exact and has been rounded to integer ranges for ease of use. The information in Table 3 incorporates the information contained in Table 2 above. In particular, weight examples 1a-1u, 2a-2i, 3a-3k, 4a-4k, 5a-5i, and 6a-6h from Table 2 are included in Table 3. Table 3 also includes age information for pediatric patients. Age can be used as a reference, but the weight range should be the primary guiding factor for the dose to be administered.

[0049] [Table 3]

[0050] *Note: The dosage in mg based on weight is the same as for the individual doses, but the concentrations of ibuprofen and acetaminophen are twice as high as in the conventional oral solution forms (100 mg ibuprofen in 2.5 ml instead of 100 mg in 5 ml, and 160 mg acetaminophen in 2.5 ml instead of 160 mg in 5 ml), making the volume of the combination drug similar to that of either individual drug. Note that the conversion from pounds to kilograms is not exact and has been rounded to the whole number range for ease of use.

[0051] As described above in Tables 1, 2 and 3, different dosage charts are shown according to the present invention. As used herein, the term "dosage chart" refers to any display medium containing dosage information, including but not limited to cards, sheets, pads, posters, tables, outlines, tablets, graphics, and the like. The dosage charts can be in electronic or non-electronic format. The dosage charts include information regarding the amount of ibuprofen and acetaminophen compounds in the exemplary pharmaceutical formulations, as well as exemplary pharmaceutical formulations and exemplary weights of the febrile children to be treated. (Tables 1 and 2 include the exact weights of the children, and Table 3 includes the weight ranges of the children.) The dosage charts indicate the exact dosage of the formulations based on the weight of the febrile children to be treated. In the examples shown in Tables 1 and 2, the formulations include a liquid carrier, and the dosages are given in milliliters (ml). In the examples shown in Table 3, some examples relate to formulations that include a liquid carrier, and the dosages are given in milliliters (ml). Other examples relate to formulations that include a solid or semi-solid carrier, and the dosages are given in units of measurement.

[0052] The dosage chart can be used to treat a child with a fever according to the present invention. For example, in one method, a caregiver can first measure the child's temperature to determine whether the fever can be treated. If the fever can be treated, the child is weighed, and then the correct dosage of the pharmaceutical formulation (shown in Tables 1, 2, and 3 above) is delivered to the child. The caregiver then measures the child's temperature after a predetermined time to determine whether the child has a treatable fever. If the child still has a treatable fever, the correct dosage of the pharmaceutical formulation (shown in Tables 1, 2, and 3 above) is delivered to the child until the child's fever is gone.

[0053] The present invention also includes a pharmaceutical kit for treating children with fever.In one embodiment, the kit includes a) a formulation for treating children with fever, the formulation comprises a predetermined amount of ibuprofen compound and a predetermined amount of acetaminophen compound, and b) a dosage chart, the chart has information on the amount of ibuprofen compound in the first formulation and the amount of acetaminophen compound in the second pharmaceutical formulation, and the exemplary weight of children, and the dosage of the first and second pharmaceutical formulations is based on the weight of the child with fever to be treated.In another embodiment, the kit includes a) a first pharmaceutical formulation for treating children with fever, the first formulation comprises a predetermined amount of ibuprofen compound, b) a second pharmaceutical formulation for treating children with fever, the first formulation comprises a predetermined amount of acetaminophen compound, and c) the dosage chart.The kit can further include a means (e.g., measuring cup, measuring spoon, vial, tube, syringe, etc.) for measuring the dosage of the formulation so that the measured dosage can be delivered to children with fever. The kit may also have a delivery system in which the first and second formulations are contained in containers, such as ampoules, vials or tubes, such that the formulations can be administered simultaneously to a child.

[0054] Although the present invention is primarily directed to dosage forms that combine ibuprofen and acetaminophen, it is understood that nonsteroidal anti-inflammatory compounds other than ibuprofen (e.g., naproxen) may be used, provided that the dosage is adjusted according to the particular drug in the formulation, and that analgesic and antipyretic compounds other than acetaminophen may also be used.

[0055] For pediatric patients aged 6 months to 12 years, the abbreviated and rounded standard oral dose of ibuprofen (by itself) typically ranges from about 50 mg to about 300 mg (Table 3). For liquid dosage forms (e.g., drops, solutions, emulsions, suspensions, or elixirs), this corresponds to 2.5 ml to 15 ml. Ibuprofen is administered no more frequently than every 6 hours. Similarly, for pediatric patients aged 6 months to 12 years, the abbreviated and rounded standard oral dose of acetaminophen (by itself) typically ranges from about 80 mg to about 480 mg (Table 3). For liquid dosage forms (e.g., drops, solutions, emulsions, suspensions, or elixirs), this corresponds to 2.5 ml to 15 ml. Acetaminophen is administered no more frequently than every 4 hours.

[0056] Here, according to the present invention, the concentration of the combination liquid dosage form (e.g., drops, solutions, emulsions, suspensions, or elixirs) is twice that of the standard dose. Thus, the volume used in the combination ibuprofen and acetaminophen liquid dosage form is the same as (i.e., less than) the volume used in the standard dose of ibuprofen when ibuprofen is administered alone. Similarly, the volume used in the combination ibuprofen and acetaminophen dosage form is the same as (i.e., less than) the amount of acetaminophen used in the common dose of acetaminophen when acetaminophen is administered alone. For example, a 55.1 pound (25 kg) child is administered a simplified, rounded standard dose of 200 mg (10 ml) of ibuprofen (see rows 3(a-k) of Table 3). The same child is administered a simplified, rounded standard dose of 320 mg (10 ml) of acetaminophen (see rows 3(a-k) of Table 3). Considering that the concentration of each drug in the combination liquid dosage form (e.g., drops, solutions, emulsions, suspensions, or elixirs) is twice that of the standard dose, the final volume of the combination dose is no more than that used in either standard dose of 200 mg ibuprofen and 320 mg acetaminophen, with a total volume of 10 ml (if two individual abbreviated rounded liquid doses were administered separately).

[0057] The present invention provides effective dosing regimens, methods, formulations and kits for treating pediatric patients with ibuprofen and acetaminophen in a safe and therapeutic manner. It should be understood that the compounds, compositions, formulations, regimens, methods, kits, etc. described and exemplified herein represent only some embodiments of the present invention. Those skilled in the art will appreciate that various modifications and additions can be made to the compounds, compositions, formulations, regimens, methods, kits, etc. without departing from the spirit and scope of the present invention. All such embodiments are intended to be encompassed by the claims.

Claims

1. A combination drug for treating a child with a fever, comprising a predetermined amount of an ibuprofen compound and a predetermined amount of an acetaminophen compound, wherein the predetermined amount of each compound is determined by the child's weight.

2. 10. The pharmaceutical combination of claim 1, wherein the single dose formulation comprises a predetermined amount of ibuprofen and a predetermined amount of acetaminophen.

3. 3. The pharmaceutical combination of claim 2, wherein the formulation comprises a carrier for a predetermined amount of ibuprofen and a predetermined amount of acetaminophen.

4. A pharmaceutical formulation for treating a febrile child, the formulation comprising a predetermined amount of an ibuprofen compound and a predetermined amount of an acetaminophen compound; and a dosage chart having information regarding the amount of an ibuprofen compound and the amount of an acetaminophen compound in the pharmaceutical formulation and exemplary child weights, wherein the dosage of the pharmaceutical formulation is based on the weight of the febrile child to be treated; 1. A medical kit for treating a child with fever, comprising:

5. 5. The pharmaceutical kit of claim 4, wherein the kit further comprises means for measuring a dose of the pharmaceutical formulation so that a measured dose can be administered to a child with a fever.

Images