ABSTRACT. In India. Fixed Dose Combinations(FDCs) have drawn the attention of health service providers and the service recipients. Therefore, the development of fixed dose combinations (FDCs) is becoming increasingly important from a public health perspective. The objective was to study the prescribing pattern and to assess the rationality of fixed dose combinations using seven point criteria. During the study period a total of 100 patients were enrolled based on inclusion and exclusion criteria. The study population includes an overall 56% male with an average age of 46.15 ± 19.33 years. A total of 538 drugs were prescribed to the patient with a mean of 5.38±5.77.The major therapeutic category of drugs prescribed were antibiotics (30.03%), antihypertensives (12.63%) and others (13.01%).The study population had 130 FDCs in which again antibiotics topped the list, followed by Anti-diabetics. Among these 92 contributed to antibiotic FDCs belonging to 15 different groups. The average interaction ...
The purpose of this study is to compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in
This trial will compare the efficacy of fixed combination levamlodipine/telmisartan with levamlodipine in patients with stage 2 hypertension. The primary
Pharmacokinetic (PK) Parameter: AUCtau of SOF, its Major Metabolite (GS-331007), VEL and VOX. [ Time Frame: Cohorts 1 and 2 (6 to , 18 years of age): predose, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose at Week 2 or 4; Cohort 3 (3 to , 6 years of age): predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose at Week 2 or 4 ...
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This eMedTV segment wraps up this look at drugs that may interfere with Loryna, such as protease inhibitors. However, because not all interactions may have been included in this article, this page reminds readers to discuss the issue with their doctor.
Learn about how drug mixing can heighten the effects of the individual drugs as well as contribute to the development of additional health issues.
Serious Adverse Events are reported by treatment group (Combination/Tablet+Capsule [N=38] or Tablet+Capsule/Combination [N=39]). For Other Adverse Events, the Combination/Tablet+Capsule group includes all subjects who received Combination Tablet (N=76) and the Tablet+Capsule/Combination group includes all subjects who received Tablet+Capsule (N=77 ...
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Fixed-dose combination drugs have been used for some time in certain therapeutic categories such as antihypertensives, although they were often reserved for second- or third-line therapy. With the revolution in the survival rates of patients suffering from human immunodeficiency virus (HIV) infection that occurred with the implementation of fixed-drug combination products for this, this delivery technology received a boost of confidence as well as an influx of creative applications to other diseases. For the past several years, a number of fixed-dose combination drugs have been introduced for a variety of diseases, some for the first time in a particular disease category. With this in mind, this STIX Market Research report focuses on the impact of fixed-dose combination drug technology on various therapeutic categories, as well as providing assessments and projections of this technology overall and the impact on the patient compliance and effectiveness.. Specifically the aim of this report is to ...
A phase III trial for the fixed-combination netarsudil/latanoprost agent (Roclatan, Aerie Pharmaceuticals)reports positive results. The company plans to submit a NDA for the drug in early 2018.
U.S. Food & Drug Administration (FDA), April 5, 2016.. On April 4, 2016 FDA approved DESCOVY, a two-drug fixed dose combination tablet containing 2 HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), emtricitabine (FTC) and tenofovir alafenamide (TAF). Each DESCOVY tablet contains 200 mg of FTC and 25 mg of TAF (equivalent to 28 mg of tenofovir alafenamide fumarate).. DESCOVY is not a complete regimen for the treatment of HIV-1 infection and must be combined with other antiretroviral agents to form a complete regimen.. The approval is based on a relative bioavailability trial demonstrating FTC and TAF exposures were similar between DESCOVY and GENVOYA (elvitegravir/cobicistat/FTC/TAF). A clinical trial to evaluate the efficacy and safety of DESCOVY was not required because the safety and efficacy of FTC and TAF was established previously in clinical trials with GENVOYA.. TAF 25 mg provides for TAF exposures that match or exceed those observed in patients receiving GENVOYA, ensuring ...
How is Diazepam and Methohexital (drug combination) abbreviated? D-M stands for Diazepam and Methohexital (drug combination). D-M is defined as Diazepam and Methohexital (drug combination) very rarely.
Fixed-dose drug combinations are used to treat conditions like Parkinson s, HIV, malaria and tuberculosis, but these drugs lack approval and could put patients lives at risk.
Today the norm in modern cancer treatment is to use different forms of drug combinations. Recently anti-cancer treatment using drug combinations has gained increased attention due to the outstanding pharmacotherapeutic opportunities provided by combination therapies. However, the potential of this field is largely unexplored, partly due to the complexities associated with the astronomical number of possible combinations and partly due to the lack of means for quantifying clinically relevant adverse side effects in the early stages of the combination discovery and development process. This has resulted in relatively limited progress in this area. Motivated by this unfortunate state-of-affairs, the research reported in this thesis was aimed at developing and implementing computational and experimental methods to facilitate and accelerate the discovery and development of anti-cancer therapies. In paper I, the largely overlooked concept of therapeutic synergy is re-introduced and demonstrated to be ...
Thousands of fixed dose combination (FDC) drugs - where two or more drugs are combined in a set ratio in a single dose form, usually a tablet or capsule - are formulated, made and sold within India.
These so-called epigenetic therapy drugs, used together, achieved robust anti-tumor responses in human cancer cell lines and mice.
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The extracellular matrix (ECM) is a complex material that serves to stabilize tissues, promote cell attachment, and modulate cell functionality by specifically interacting with cell surface receptors. This material has been shown to play structural, bioch...
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Since Gilead is the most active sponsor, it follows that one of their drugs also tops the list of most commonly evaluated compounds. However, its interesting that the already approved sofosbuvir (SOF) is evaluated in 44 ongoing trials (Figure 3) while Gilead is only involved in 33 (Figure 2). SOF, which is already quite successful as the approved Sovaldi®, continues to undergo evaluation with other compounds from Gilead as well as in combination with drugs from other sponsors. Most SOF trials are Gilead sponsored and evaluate the drug as a fixed dose combination (FDC) with ledipasvir as the already approved combination known as Harvoni® or with the yet unnamed GS-5816. Some examples where SOF is co-administered with drugs from other sponsors include Mercks studies with their FDC of elbasvir + grazoprevir and BMS with their FDC of asunaprevir + daclatasvir + beclabuvir (data not shown).. FDCs continue to be of high interest for various reasons. They minimize the pill burden for patients to ...
Click to launch & play an online audio visual presentation by Prof. Ying Yuan on Design early phase drug combination trials: methods, part of a collection of online lectures.
Atazanavir (ATV) (or Reyataz) is generally used in combination with the boosting agent, ritonavir (ATV/r), and is currently being developed as a fixed-dose combination with the boosting agent cobicistat (ATV/cobi).
sciencehabit writes Pharmaceuticals often have side effects that go unnoticed until theyre already available to the public. Doctors and even the FDA have a hard time predicting what drug combinations will lead to serious problems. But thanks to people scouring the web for the side effects of the d...
In the first clinical trial in humans, researchers test a promising drug combination that could help fight the effects of cellular aging.
The abortion pill RU-486 has claimed two more lives, as informed by regulators who issued a warning that brought renewed calls for pulling the drug combination from the market.
Most study participants fulfilled ACR criteria for knee osteoarthritis,10 illustrating that this is a common and underdiagnosed condition within the community. The use of two combination tablets of ibuprofen/paracetamol was associated with significant improvements in pain relief, function and patient quality of life compared with paracetamol monotherapy for both short and long-term use. A significantly greater proportion of patients taking two combination tablets were responders at day 10 compared with paracetamol monotherapy, but not at study end. The level of absolute pain reduction achieved with one or two combination tablets was modest but of an order considered clinically relevant.32 33 The dose of ibuprofen used in this study was moderate, reflecting the non-prescription dose, the observed improved efficacy with the combination could therefore be due to paracetamol adding further cyclooxygenase inhibition to that provided by ibuprofen alone.. This combination tablet is designed for ...
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Sulfadoxine-Pyrimethamine Indo Farma is a medicine available in a number of countries worldwide. A list of US medications equivalent to Sulfadoxine-Pyrimethamine Indo Farma is available on the Drugs.com website.
If all three of the above are present a combination product delivering a twice-daily dose of 100 micrograms of fluticasone and 50 micrograms of salmeterol can be used for initial treatment. This is equivalent to two doses twice a day of the pMDI and one dose twice a day of the DPI. If any of the criteria above are not present a standard inhaled corticosteroid, for example beclometasone, should be used for initial treatment.. Once control is attained with the approach outlined above treatment should be reviewed and consideration given to stepping down to an inhaled corticosteroid alone in place of the combination product.. Action: Healthcare professionals should be aware of this change. This combination can be used to rapidly control asthma in suitable patients but treatment should be reviewed and stepped down once control is achieved.. ...
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respectively. The MAA for F/TAF is supported by data from Phase 3 clinical studies evaluating the safety and efficacy of E/C/F/TAF for the treatment of HIV-1 infection among treatment-naïve adults, in which the F/TAF-based regimen (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to F/TDF-based therapy (administered as E/C/F/TDF or Stribild®). The MAA is also supported by data from additional Phase 3 studies evaluating the F/TAF-based regimen (administered as E/C/F/TAF) among virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of F/TAF achieved the same drug levels in the blood as in E/C/F/TAF. Review of the MAA will be conducted by the EMA under the centralized procedure, which, when finalized, may lead to the grant of marketing authorization by the ...
To evaluate perindopril 3.5 mg/amlodipine 2.5 mg once daily, a novel fixed-dose combination adapted for first-step treatment in patients with hypertension. This fixed dose had to be equivalent to amlodipine 5 mg in terms of blood pressure effic
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US regulators have rejected Schering-Plough and Merck & Cos bid to get approval for a combination tablet of the firms big-selling Claritin and Singulair. - News - PharmaTimes
Quinine is a prescription drug used to treat uncomplicated (or mild) malaria. This eMedTV page offers more information on quinine, explaining the drugs dosing guidelines, possible side effects, and what your doctor needs to know prior to treatment.
5592 Abstract Although a number of methods for assessing drug interactions are available, most methods lack a means of selecting combinations of doses efficiently in planning such experiments. The power-maximized design, derived based on the uniform measures of all possible dose combinations of interest, is able to select the drug combinations (doses of each constituent drug) and to determine the required number of replicates at each combination in order to detect synergy, additivity or antagonism, with pre-specified statistical power for the experiment. An F-test is proposed to detect departures from additivity for combinations of two drugs. To explore the joint effect of the combination, a 3-dimensional combination index surface characterizes the interaction of a two-drug combination estimated using the B-splines. Synergism is manifested as a substantial drop in the combination index which is a 2-dimensional slice of the combination index surface. These methods were applied to evaluate SAHA ...
In a move that could lead to a new milestone for treatment in the evolution of the worldwide AIDS epidemic, a Food and Drug Administration (FDA) panel ...
Hello and thanks for posting. Yes, it can be entirely appropriate to change the dose or dose frequency of medications for people with kidney disfunction. Fixed dose combinations, like Epzicom...
If one were taking over-the-counter fish oil to achieve all the benefits of Omega-3s, would a better choice be the prescription fish oil, Omacor? Cost is not a factor, nor is lowering triglycerides. Th...
The fixed-dose combination of sacubitril and valsartan has been approved since November 2015 for adults with symptomatic chronic heart failure with reduced pump function.
This page contains brief information about the drug combination called PAD. The drugs in the combination are listed, and links to individual drug summaries are included.
This page contains brief information about the drug combination called CMF. The drugs in the combination are listed, and links to individual drug summaries are included.
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Drug Combo Shows Promise Against Cystic Fibrosis A two-drug combination shows promise in helping many cystic fibrosis patients, according to new studies.
People with diabetes often have a number of coexisting health problems. So in addition to insulin or diabetes pills, other drugs are often needed to control these problems-statins for high cholesterol, diuretics or beta-blockers for high blood...
Researchers sought to determine the most effective regimen of intermittent preventive treatment (IPT) against malaria for schoolchildren in the Democratic Republic of Congo. The children were given sulfadoxine/pyrimethamine (SP), SP plus piperaquine (SP/PQ), or no intervention. The SP group saw a reduction in anemia (10%), malaria parasitemia (19%), and clinical malaria (25%),