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KADIAN® (morphine sulfate) Extended
KADIAN® (morphine sulfate) Extended

... When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to KADIAN, consider the following general points: Parenteral to Oral Morphine Ratio: Between 2 mg and 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typ ...
Medicines Control, Administration and Prescribing
Medicines Control, Administration and Prescribing

... division where a bespoke medicines policy exists (SH TQ 47). For the purpose of this policy, medicines are defined as any therapeutic, diagnostic or preventative substances administered to patients/clients or self-administered. This policy has been developed to manage the roles and risks associated ...
Addressing specific regulatory excipient requirements
Addressing specific regulatory excipient requirements

... composition (qualitative and quantitative) required. z Novel excipients and excipients presented as a mixture of compounds: Bibliographical data on the chemistry and on the toxicology and the field in which it is already used. z Annex 1: Mixed excipients: ready-for-use preparations. Quantitative and ...
Clinical Pharmacology of Boceprevir (BOC): Metabolism
Clinical Pharmacology of Boceprevir (BOC): Metabolism

... • Many drugs are CYP3A4 inhibitors o These interactions are understood and managed appropriately o CYP3A4 substrate drugs with toxicities often dose-titrated as standard practice o Many drug classes include alternatives that are not CYP3A4 substrates o No interaction with drugs metabolized by other ...
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP 10 mg
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP 10 mg

... and standing blood pressure to about the same extent with no compensatory tachycardia. Symptomatic postural hypotension is usually not observed although it can occur and should be anticipated in volume and/or salt depleted patients. (See WARNINGS.) In most patients studied, onset of antihypertensive ...
Coreg - GSK Source
Coreg - GSK Source

HIV / AIDS
HIV / AIDS

... failure to keep to treatment schedule; and drug interactions reducing blood levels of anti-HIV drugs. ...
s sanoFi avent 4  -6'  Lt ~,,'  2i
s sanoFi avent 4 -6' Lt ~,,' 2i

... Moreover, the type and severity of toxicity caused by these complexes may well be different from oxaliplatin. For example, in phase I/II clinical trials the Pt(DACH)(4-carboxyphalato) and Pt(DACH)(isocitrato) complexes both showed greater rhyelosuppression and less neurotaxicity than oxaliplatin .a' ...
Coaated stents: a new era
Coaated stents: a new era

... Meta-analysis has shown increased risk for 130/80 compared with 115/75, but no one has shown reducing the former to the latter actually helps "The benefits are probably so small that it's awfully hard to convince anybody that lowering the blood pressure within the ...
IMITREX® Nasal Spray Tear Sheet
IMITREX® Nasal Spray Tear Sheet

... CLINICAL TRIALS: The efficacy of IMITREX Nasal Spray in the acute treatment of migraine headaches was demonstrated in eight, randomized, double-blind, placebo-controlled studies, of which five used the recommended dosing regimen and used the marketed formulation. Patients enrolled in these five stud ...
process development and optimization for moisture activated dry
process development and optimization for moisture activated dry

... Granulation is the process in which primary powder particles are made to adhere to form larger, multi particle aggregates called granules. After granulation process the granules will either be packed (when used as a dosage form - powder), or they may be mixed with other excipients prior to tablet co ...
Combined use of ECT and psychotropic drugs
Combined use of ECT and psychotropic drugs

Epzicom Tablets
Epzicom Tablets

... In a published prospective, observational, epidemiological trial designed to investigate the rate of myocardial infarction (MI) in patients on combination antiretroviral therapy, the use of abacavir within the previous 6 months was correlated with an increased risk of MI. In a sponsor-conducted pool ...
Effects of nitrous oxide on diazepam sedation of young children
Effects of nitrous oxide on diazepam sedation of young children

... BoardTM in that not only does the head restraint prevent someundesirable movement,but it also facilitates the delivery of nitrous oxide by keeping the nasal hood directly over the nose. The auxiliary Velcro strap placed on the knees restricted squirming and usually prevented the legs from slipping o ...
Eryped 200 (erythromycin ethylsuccinate)  Suspension
Eryped 200 (erythromycin ethylsuccinate) Suspension

... bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physicians as soon as possible. Drug Interactions Theophylline Erythromycin use in patients who are receiving ...
Epinefrina. Adrenalina. Monografia del farmaco.
Epinefrina. Adrenalina. Monografia del farmaco.

... 0.15 or 0.30 mg depending upon the body weight of the patient. A dosage of 0.01 mg/kg body weight is recommended. EpiPen Jr, which provides a dosage of 0.15 mg, may be more appropriate for patients weighing less than 30 kg. However, the prescribing physician has the option of prescribing more or les ...


... Very recently, CARLSEN et al. [30] evaluated the overnight protection against EIA afforded by 25 and 50 µg of dry powder salmeterol in children. No significant differences in pre- and postexercise lung function were found between the two doses 12 h after inhalation. Despite differences in times of a ...
TIMOPTIC® in OCUDOSE
TIMOPTIC® in OCUDOSE

... patients with impaired cardiac function, coadministration should be avoided. Catecholamine-depleting drugs: Close observation of the patient is recommended when a beta blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects ...
Fact sheets
Fact sheets

... The following information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks” ...
Effective Over-the-Counter Acne Treatments
Effective Over-the-Counter Acne Treatments

... site. Generally, sodium sulfacetamide is considered less irritating than benzoyl peroxide and retinoic acid.50,52 Rare cases of erythema multiforme53 and Stevens–Johnson syndrome50,54,55 have been reported after topical ophthalmic use. Topical sodium sulfacetamide is contraindicated in patients with ...
Antiviral Agents, Topical Therapeutic Class Review (TCR) September 20, 2012
Antiviral Agents, Topical Therapeutic Class Review (TCR) September 20, 2012

... manufacturers. Search strategy included the use of all drugs in this class. Randomized, controlled trials studying agents within this class for the FDA-approved indications are considered the most relevant in this category. Studies included for analysis in the review were published in English, perfo ...
Study 33: Analysing a cross-over study. Statistical work and
Study 33: Analysing a cross-over study. Statistical work and

... purpose), this is  the primary objective of the study . The primary objective is assessed by measuring  and evaluating one or more primary endpoints and is often expressed in terms of reduced mortality  or other measures of efficacy, always in comparison with standard care or placebo. To support the ...
Table 3 - HAL Descartes
Table 3 - HAL Descartes

... screen for SOX10 gene deletions. Briefly, the 3 coding exons of the SOX10 gene, exon 4 of POLR2F and 4 regions located 5’ of SOX10 were amplified in two multiplex reactions. The beginning of exon 3 and the middle of the exon 5 coding sequences are not covered by the amplicons, however a deletion res ...
AusPAR: Doxycycline monohydrate
AusPAR: Doxycycline monohydrate

... It is claimed that the preferred blood level of doxycycline is between about 0.1 μg/mL and 1.0 μg/mL at steady state in order that the anti-collagenase effect is retained but to avoid antibacterial side effects on intestinal flora. The sponsor undertook a pharmacokinetic study in which the drug was ...
What is the risk of developing Serotonin Syndrome following
What is the risk of developing Serotonin Syndrome following

... Published cases involving tramadol and SSRIs causing serotonin syndrome are listed in Appendix 1. In the majority of these patients recovered, usually after withdrawal of one or more of the drugs, but in two cases the combination was fatal. There are two possible explanations for this interaction th ...
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Pharmacogenomics

Pharmacogenomics (a portmanteau of pharmacology and genomics) is the study of the role of genetics in drug response. It deals with the influence of acquired and inherited genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with drug absorption, distribution, metabolism and elimination, as well as drug receptor target effects. The term pharmacogenomics is often used interchangeably with pharmacogenetics. Although both terms relate to drug response based on genetic influences, pharmacogenetics focuses on single drug-gene interactions, while pharmacogenomics encompasses a more genome-wide association approach, incorporating genomics and epigenetics while dealing with the effects of multiple genes on drug response.Pharmacogenomics aims to develop rational means to optimize drug therapy, with respect to the patients' genotype, to ensure maximum efficacy with minimal adverse effects. Through the utilization of pharmacogenomics, it is hoped that drug treatments can deviate from what is dubbed as the “one-dose-fits-all” approach. It attempts to eliminate the trial-and-error method of prescribing, allowing physicians to take into consideration their patient’s genes, the functionality of these genes, and how this may affect the efficacy of the patient’s current and/or future treatments (and where applicable, provide an explanation for the failure of past treatments). Such approaches promise the advent of ""personalized medicine""; in which drugs and drug combinations are optimized for each individual's unique genetic makeup. Whether used to explain a patient’s response or lack thereof to a treatment, or act as a predictive tool, it hopes to achieve better treatment outcomes, greater efficacy, minimization of the occurrence of drug toxicities and adverse drug reactions (ADRs). For patients who have lack of therapeutic response to a treatment, alternative therapies can be prescribed that would best suit their requirements. In order to provide pharmacogenomic-based recommendations for a given drug, two possible types of input can be used: genotyping or exome or whole genome sequencing. Sequencing provides many more data points, including detection of mutations that prematurely terminate the synthesized protein (early stop codon).
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