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At least 73 records · Page 4Linked to original sources
PubMed2001

Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; partial final rule for combination drug products containing a bronchodilator. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule establishing that cough-cold combination drug products containing any oral bronchodilator active ingredient in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient are not generally recognized as safe and effective and are misbranded for over-the-counter (OTC) use. FDA is issuing this final rule after receiving no public comments on the agency's proposed nonmonograph status of these specific combination drug products, which was issued in the form of a tentative final monograph for OTC cough-cold combination drug products. This final rule is part of the ongoing review of OTC drug products conducted by FDA.

Analgesics↗
PubMed1991

Long acting drug combinations in rheumatoid arthritis: a formal overview.

We compared the benefits and risks of combinations of long acting antirheumatic drugs with those of the same drugs used singly in the treatment of rheumatoid arthritis. We searched the literature through MEDLINE (1966-89), Index Medicus (1956-65), Excerpta Medica (1982-89), Science Citation Index (1982-89), and bibliographic review of located articles. Of a total of 341 citations, we identified 7 prospective trials that specifically addressed the stated purpose. We independently assessed the quality of the selected trials, using published methodological criteria and summarized the effect of treatment on arthritis activity and the incidence of side effects. The trials we evaluated tested various drug combinations. Because of deficiencies in methods and reporting, only 3 trials had sufficient quality to yield strong or moderately strong evidence. None conclusively demonstrated benefit of a drug combination: 2 suggested such benefit, including 1 also suggesting increased toxicity; the 3rd suggested only increased toxicity. The other 4 trials yielded weak evidence to support both increased efficacy and toxicity. The advantages of any antirheumatic drug combination remain unproven. Because these advantages are likely to be modest, they can only be shown in rigorously designed trials enrolling large numbers of patients. Methods and reporting of antirheumatic drug trials should be standardized to allow combining of study results.

Anti-Inflammatory Agents↗
PubMed1998

Fixed drug combinations in the treatment of hypertension: how to identify the optimal dose.

RATIONALE FOR DRUG COMBINATIONS: The most common reason for combining different drugs is to achieve an additional fall in arterial pressure. It therefore seems reasonable to combine drugs with different mechanisms of actions. NEED FOR CLINICAL TRIALS: However, the effects of combination therapy on the heart and other target organs remains poorly documented. Most of what we know with regard to combination therapy on hypertensive heart disease is based on extrapolation from monotherapy. The fact that two drugs when used separately are beneficial in a disorder does not necessarily imply that their combination is equally or more beneficial in the same disorder. Thus, it will become important to establish efficacy and safety of new drug combinations on hypertensive target organs and on morbidity and mortality by performing carefully designed clinical trials.

Antihypertensive Agents↗
PubMed1975

A controlled study in the use of combined drug therapy for metastatic breast cancer.

Three prospectivelyly planned and controlled cooperative clinical studies in the use of combination drug therapy for metastatic breast cancer are reported. Each study contained two drug regimen arms. A total of 326 evaluable patients were treated with one of the five various drug combinations employed. As the number of drugs used in each regimen was increased from two to five, a concommitant increase in remission rates from 50% to 75% was observed. Remission duration of approximately 8 months and survival from the onset of treatment, however, remained relatively constant at 13 to 16 months in all drug regimens. Patients achieving tumor remission survived an average of three times longer than those with progressive disease under therapy. The results are correlated to patient age and predominant metastatic type. Subjective improvement was definitely related to objective tumor regression or stabilization. Treatment was relatively well tolerated and well applicable to outpatient care. Dosage adjustments were often necessary during the initial phases of therapy. Combined cystostatic drug therapy is highly effective in the prognostically worst forms of metastatic breast cancer, and is the treatment of choice for younger patients with visceral type metastases.

Age Factors↗
PubMed1992

Drug combinations and interactions with class III agents.

Drug combinations with class III antiarrhythmic agents have not been studied systematically. There are data indicating that enhanced efficacy as evaluated by electrophysiologic studies can be obtained by combining sotalol and a type Ia drug or amiodarone with low-dose beta-blocking drugs. Combining amiodarone with a type Ia or Ic drug or with a beta-blocking drug can slow the rate of ventricular tachycardia to make the ventricular tachycardia hemodynamically well tolerated. Pharmacokinetic drug interactions with amiodarone are extensive. Recently, it has been shown that hepatic metabolism of amiodarone can be induced to enhance the conversion of amiodarone to N-desethylamiodarone. The physiologic effect of this drug transformation is uncertain. There should be few pharmacokinetic drug interactions with sotalol because this drug is almost completely absorbed, does not bind to plasma proteins, and is excreted unchanged by the kidneys.

Amiodarone↗
PubMed1992

A method of designing clinical trials for combination drugs.

Many pharmaceutical companies are now exploring combination drug therapies as an alternative to monotherapy. Consequently, it is of interest to investigate the simultaneous dose response relationship of two active drugs to select the lowest effective combination. In this paper, we propose a method for designing clinical trials for drug combinations that seems to offer several advantages over the 4 x 3 or even larger factorial studies that have been used to date. In addition, our proposed method provides a convenient formula for calculating the required sample size.

Clinical Trials as Topic↗
PubMed1981

The use of four-drug combination chemotherapy (D.A.V.E.) in the treatment of advanced Wilms' tumour.

A study was begun in 1971 at St. Bartholomew's Hospital with a combination of 4 drugs, dactinomycin (actinomycin D), adriamycin, vincristine and Endoxan (cyclophosphamide) (D.A.V.E.), together with surgery and radiation, in the treatment of stage III and stage IV Wilms' tumour. Seventy-one percent of the children treated achieved complete response. The median survival from diagnosis was 19 months, and in those children achieving complete response the median disease-free survival has not yet been reached. Toxicity was not a serious problem. The study group is compared with a group of children treated at this hospital before 1971. There is an improved survival in the children treated with D.A.V.E. Children who have relapsed with stage I or stage II disease may also respond. This four-drug combination was well tolerated and effective, and confirms recent experience suggesting that intensive multiple-drug regimens may be curative even in advanced disease.

Adolescent↗
PubMed2006

ICH guidance in practice: validated stability-indicating HPLC method for simultaneous determination of ampicillin and cloxacillin in combination drug products.

Ampicillin and cloxacillin were degraded together under different stress test conditions prescribed by International Conference on Harmonization. The samples so generated were used to develop a stability-indicating high performance liquid chromatographic (HPLC) method for the two drugs. The drugs were well separated from degradation products using a reversed-phase (C-18) column and a mobile phase comprising of acetonitrile:phosphate buffer (pH 5.0), which was delivered initially in the ratio of 15:85 (v/v) for 1 min, then changed to 30:70 (v/v) for next 14 min, and finally equilibrated back to 15:85 (v/v) from 15 to 20 min. Other HPLC parameters were: flow rate, 1 ml/min; detection wavelength, 225 nm; and injection volume, 5 microl. The method was validated for linearity, precision, accuracy, specificity and selectivity. It was also compared with the assay procedures given in British Pharmacopoeia for individual drugs. Similar results were obtained, indicating that the proposed single method allowed selective analysis of both ampicillin and cloxacillin, in the presence of their degradation products formed under a variety of stress conditions. The developed procedure was also applicable to the determination of instability of the drugs in commercial products.

Acetonitriles↗