the Agrylin
... non-delivering pregnant dams and their fully developed fetuses, and increased mortality in the pups born. In a placental transfer study, a single oral dose of [14C]-anagrelide hydrochloride was administered to pregnant rats on gestation Day 17. Drug-related radioactivity was detected in maternal and ...
... non-delivering pregnant dams and their fully developed fetuses, and increased mortality in the pups born. In a placental transfer study, a single oral dose of [14C]-anagrelide hydrochloride was administered to pregnant rats on gestation Day 17. Drug-related radioactivity was detected in maternal and ...
SANCTURA® Prescribing Informaiton
... clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of SANCTURA® was evaluated in controlled clinical trials in a total of 2975 patients, who were treated with SANCTURA® (N=1673) ...
... clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of SANCTURA® was evaluated in controlled clinical trials in a total of 2975 patients, who were treated with SANCTURA® (N=1673) ...
Nebivolol (Bystolic), a Novel Beta Blocker for Hypertension
... consisting of an ACE-inhibitor, an ARB, and/or a diuretic. Mild-to-moderate hypertension was defined as a diastolic BP of between 90 and 109 mm Hg. All participants underwent a 14-day screening and a beta-blocker washout period. The 669 patients were then randomly assigned to receive once-daily nebi ...
... consisting of an ACE-inhibitor, an ARB, and/or a diuretic. Mild-to-moderate hypertension was defined as a diastolic BP of between 90 and 109 mm Hg. All participants underwent a 14-day screening and a beta-blocker washout period. The 669 patients were then randomly assigned to receive once-daily nebi ...
Doxastad prolonged release tablet ENG SmPC
... Doxazosin is contraindicated in patients with hypersensitivity to the active substance, other types of quinazolines (e.g. prazosin, terazosin) or to any of the excipients listed in section 6.1 in patients with a history of orthostatic hypotension in patients with benign prostatic hyperplasia a ...
... Doxazosin is contraindicated in patients with hypersensitivity to the active substance, other types of quinazolines (e.g. prazosin, terazosin) or to any of the excipients listed in section 6.1 in patients with a history of orthostatic hypotension in patients with benign prostatic hyperplasia a ...
full Prescribing Information
... animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. 8.3 Nursing Mothers It is not known whether bedaquiline or its metabolites are excreted in human milk, but rat studies have shown that drug is concentrated in b ...
... animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. 8.3 Nursing Mothers It is not known whether bedaquiline or its metabolites are excreted in human milk, but rat studies have shown that drug is concentrated in b ...
PRODUCT INFORMATION CECLOR® (cefaclor monohydrate)
... of the infecting organism, severity of illness, the dose being administered and the variability in the peak plasma levels which occur with cefaclor. The plasma half-life in healthy subjects is independent of dosage form and averages 40-60 minutes. In elderly subjects (over age 65) with normal serum ...
... of the infecting organism, severity of illness, the dose being administered and the variability in the peak plasma levels which occur with cefaclor. The plasma half-life in healthy subjects is independent of dosage form and averages 40-60 minutes. In elderly subjects (over age 65) with normal serum ...
Colik
... There is no evidence of ill consequences during its use in pregnancy, although the drug should be avoided during the first trimester of pregnancy unless absolutely indicated. Safety during lactation has not been established, so it should not be used during lactation. Side effects Hyoscine butylbromi ...
... There is no evidence of ill consequences during its use in pregnancy, although the drug should be avoided during the first trimester of pregnancy unless absolutely indicated. Safety during lactation has not been established, so it should not be used during lactation. Side effects Hyoscine butylbromi ...
Introduction to Clinical Trials in Pharmaceutical Industry – From a SAS® Programmer’s Point of View
... new therapy or new way of using known treatment - Determine if a drug is safe and effective in humans - Determine at what doses the drug works best ...
... new therapy or new way of using known treatment - Determine if a drug is safe and effective in humans - Determine at what doses the drug works best ...
Ciclesonide vs. Fluticasone
... patients with exacerbations (RR 1.37, 95% CI 0.58 to 3.21) and data from a study that could not be pooled in the meta-analysis reported similar numbers of patients with exacerbations in both groups. None of the studies found a difference in adverse effects. No significant difference was found for 24 ...
... patients with exacerbations (RR 1.37, 95% CI 0.58 to 3.21) and data from a study that could not be pooled in the meta-analysis reported similar numbers of patients with exacerbations in both groups. None of the studies found a difference in adverse effects. No significant difference was found for 24 ...
Drug development
... dosage form, effects of food, % of absorption, and effect of the first pass through the liver. • Distribution includes peak and trough tissue concentrations and accumulation in serum, CSF, urine and bile. • Metabolism refers to organs and percentages of toxicity and teratogenicity of metabolites. • ...
... dosage form, effects of food, % of absorption, and effect of the first pass through the liver. • Distribution includes peak and trough tissue concentrations and accumulation in serum, CSF, urine and bile. • Metabolism refers to organs and percentages of toxicity and teratogenicity of metabolites. • ...
The muscarinic M1·receptor·selective antagonist, telenzepine, had
... ABSTRACT: In a double-blind, placebo-controlled, randomizcd, cross-over trial, we studied the effects of the muscarinic M,-receptor-selective antagonist (±)telenzepine (3 mg orally at 6 p.m. for S days) in 21 patients with chronic obstructive pulmonary disease (COPD). At enrolment all patients showe ...
... ABSTRACT: In a double-blind, placebo-controlled, randomizcd, cross-over trial, we studied the effects of the muscarinic M,-receptor-selective antagonist (±)telenzepine (3 mg orally at 6 p.m. for S days) in 21 patients with chronic obstructive pulmonary disease (COPD). At enrolment all patients showe ...
MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS
... failure are advised to administer maintenance doses from 250 up to 1,000 mg once every several days instead of daily. In anuria a recommended dose equals 1,000 mg every 7-10 days. If polysulfone membranes are used for haemodialysis (“high flux dialysis”) vancomycin elimination time is reduced. For p ...
... failure are advised to administer maintenance doses from 250 up to 1,000 mg once every several days instead of daily. In anuria a recommended dose equals 1,000 mg every 7-10 days. If polysulfone membranes are used for haemodialysis (“high flux dialysis”) vancomycin elimination time is reduced. For p ...
ZORVOLEX® (diclofenac) Capsules Fact Sheet
... NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gas ...
... NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gas ...
HYDROXYZINE
... • If hydroxyzine is used pre- or postoperatively, the dose of narcotic can be reduced • If anticholinergic agents are used with hydroxyzine, the anticholinergic effects may be enhanced • Hydroxyzine may reverse the vasopressor effect of epinephrine; patients requiring a vasopressor agent should use ...
... • If hydroxyzine is used pre- or postoperatively, the dose of narcotic can be reduced • If anticholinergic agents are used with hydroxyzine, the anticholinergic effects may be enhanced • Hydroxyzine may reverse the vasopressor effect of epinephrine; patients requiring a vasopressor agent should use ...
File - the Drug Card Database
... may be less in black patients) (losartan only). Adverse Reactions: CNS: dizziness, anxiety, depression, fatigue, headache, insomnia, weakness. CV: hypotension, chest pain, edema, tachycardia. Derm: rashes. EENT: nasal congestion, pharyngitis, rhinitis, sinusitis. GI: abdominal pain, diarrhea, drug-i ...
... may be less in black patients) (losartan only). Adverse Reactions: CNS: dizziness, anxiety, depression, fatigue, headache, insomnia, weakness. CV: hypotension, chest pain, edema, tachycardia. Derm: rashes. EENT: nasal congestion, pharyngitis, rhinitis, sinusitis. GI: abdominal pain, diarrhea, drug-i ...
Akistan eye drops solution
... Studies in man indicate that the peak concentration in the aqueous humour is reached about two hours after topical administration. After topical application in monkeys, latanoprost is distributed primarily in the anterior segment, the conjunctivae and the eyelids. Only minute quantities of the drug ...
... Studies in man indicate that the peak concentration in the aqueous humour is reached about two hours after topical administration. After topical application in monkeys, latanoprost is distributed primarily in the anterior segment, the conjunctivae and the eyelids. Only minute quantities of the drug ...
Highlights of FDA Activities – 7/1/13 – 7/31/13
... Olmesartan Medoxomil: Drug Safety Communication – Label Changes to Include Intestinal [Posted 7/3/13] Problems (Sprue-Like Enteropathy) Labeling of all olmesartan containing products (Benicar, Benicar HCT, Azor, Tribenzor, and generics) updated to include information on sprue-like enteropathy with t ...
... Olmesartan Medoxomil: Drug Safety Communication – Label Changes to Include Intestinal [Posted 7/3/13] Problems (Sprue-Like Enteropathy) Labeling of all olmesartan containing products (Benicar, Benicar HCT, Azor, Tribenzor, and generics) updated to include information on sprue-like enteropathy with t ...
教案编写基本格式与要求
... of peptic ulcer disease act by non-receptor mechanism by neutralizing the gastric acid. Many drugs are similar to or have similar chemical groups to the naturally occurring chemical and have the ability to bind onto a receptor where one of two things can happen- either the receptor will respond or i ...
... of peptic ulcer disease act by non-receptor mechanism by neutralizing the gastric acid. Many drugs are similar to or have similar chemical groups to the naturally occurring chemical and have the ability to bind onto a receptor where one of two things can happen- either the receptor will respond or i ...
Melinta Therapeutics Announces FDA Acceptance of Investigational
... developing novel antibiotics to treat serious bacterial infections, announced today the U.S. Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for topical radezolid for the treatment of mild-to-moderate acne. Melinta and a partner are collaborating on the ...
... developing novel antibiotics to treat serious bacterial infections, announced today the U.S. Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for topical radezolid for the treatment of mild-to-moderate acne. Melinta and a partner are collaborating on the ...
meperidine - DavisPlus
... with increased intake of fluids and bulk and with laxatives to minimize constipating effects. Stimulant laxatives should be administered routinely if opioid use exceeds 2– 3 days, unless contraindicated. Prolonged use may lead to physical and psychological dependence and tolerance. This should not p ...
... with increased intake of fluids and bulk and with laxatives to minimize constipating effects. Stimulant laxatives should be administered routinely if opioid use exceeds 2– 3 days, unless contraindicated. Prolonged use may lead to physical and psychological dependence and tolerance. This should not p ...
Document
... • Table 3 gives the rate of observed adverse events. Indigestion was rather frequent in either group; 15/45 patients in the treatment and 14/45 in the placebo groups. • A subgroup analysis was also done after the patients who participated in the trial were questioned about a pre-trial history of ind ...
... • Table 3 gives the rate of observed adverse events. Indigestion was rather frequent in either group; 15/45 patients in the treatment and 14/45 in the placebo groups. • A subgroup analysis was also done after the patients who participated in the trial were questioned about a pre-trial history of ind ...
EUPPI for RPD
... Rizatriptan 40 mg (administered as either a single dose or as two doses with a 2-hour interdose interval) was generally well tolerated in over 300 patients; dizziness and somnolence were the most common drugrelated adverse effects. In a clinical pharmacology study in which 12 subjects received rizat ...
... Rizatriptan 40 mg (administered as either a single dose or as two doses with a 2-hour interdose interval) was generally well tolerated in over 300 patients; dizziness and somnolence were the most common drugrelated adverse effects. In a clinical pharmacology study in which 12 subjects received rizat ...
Getting your data in good shape for Non Linear Mixed Effects Modeling
... him/her the treatment and then we collect PK data for the next 24 hours. In theory the next dose should be given once the last PK sample has been taken. You cannot just replace all missing dose clock time by a default value for all patients, like 09:00. If the last PK sample has been taken at 09:15, ...
... him/her the treatment and then we collect PK data for the next 24 hours. In theory the next dose should be given once the last PK sample has been taken. You cannot just replace all missing dose clock time by a default value for all patients, like 09:00. If the last PK sample has been taken at 09:15, ...
Psychopharmacology and Other Biologic Treatments
... medications affecting the brain and behavior used to treat mental disorders including ...
... medications affecting the brain and behavior used to treat mental disorders including ...
Bilastine
Bilastine (trade name Bilaxten) is a second generation antihistamine drug for the treatment of allergic rhinoconjunctivitis and urticaria (hives).It exerts its effect as a selective histamine H1 receptor antagonist, and has a effectiveness similar to cetirizine, fexofenadine and desloratadine. It was developed in Spain by FAES Farma.Bilastine is approved in the European Union for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria, but it is not approved by the U.S. Food and Drug Administration for any use in the United States. Bilastine meets the current European Academy of Allergy and Clinical Immunology (EAACI) and Allergic Rhinitis and its Impact of Asthma (ARIA) criteria for medication used in the treatment of allergic rhinitis.Bilastine has been effective in the treatment of ocular symptoms and diseases of allergies, including rhinoconjuctivitis. Additionally, bilastine has been shown to improve quality of life, and all nasal and ocular symptoms related to allergic rhinitis.