EO 003.01 - Part 28 - Nervous System Drugs
... The onset of effect and duration of effect vary for each of the different opioids. Side Effects Some opioids are more likely than others to cause certain side effects. • Feeling sleepy. • Dizziness. • Dry mouth. • Upset stomach or throwing up. • Hard stools (constipation). • Headache • Weakness ...
... The onset of effect and duration of effect vary for each of the different opioids. Side Effects Some opioids are more likely than others to cause certain side effects. • Feeling sleepy. • Dizziness. • Dry mouth. • Upset stomach or throwing up. • Hard stools (constipation). • Headache • Weakness ...
Platelet inhibitory activity and pharmacokinetics of prasugrel
... pharmacokinetics of prasugrel (CS-747, LY640315), a novel thienopyridine antiplatelet agent in healthy volunteers. Twenty-four subjects were randomized into four groups of six in a double-blind, placebo-controlled trial. One subject in each group received placebo and five subjects received prasugrel ...
... pharmacokinetics of prasugrel (CS-747, LY640315), a novel thienopyridine antiplatelet agent in healthy volunteers. Twenty-four subjects were randomized into four groups of six in a double-blind, placebo-controlled trial. One subject in each group received placebo and five subjects received prasugrel ...
Oxcarbazepine
... concentrations (Cmax; 1.05 to 1.74 mg/L) are reached within 2 hours after a single dose of oxcarbazepine 600mg taken after an overnight fast. The Cmax of MHD (5.44 to 8.85 mg/L) is reached after about 4 to 6 hours and the area under the plasma concentration-time curve ranges from 80 to 220 mg/L • h. ...
... concentrations (Cmax; 1.05 to 1.74 mg/L) are reached within 2 hours after a single dose of oxcarbazepine 600mg taken after an overnight fast. The Cmax of MHD (5.44 to 8.85 mg/L) is reached after about 4 to 6 hours and the area under the plasma concentration-time curve ranges from 80 to 220 mg/L • h. ...
AERIUS® AERIUS KIDS®
... have not been established. Geriatrics (> 65 years of age): In a multiple dose study with AERIUS 5 mg, subjects >65 years of age (n=17) had AUC and Cmax values 20% greater and plasma elimination half-life approximately 30% longer than in younger subjects; however, these changes are not considered to ...
... have not been established. Geriatrics (> 65 years of age): In a multiple dose study with AERIUS 5 mg, subjects >65 years of age (n=17) had AUC and Cmax values 20% greater and plasma elimination half-life approximately 30% longer than in younger subjects; however, these changes are not considered to ...
Prescribing Information
... ACTOS than in placebo-treated patients and is dose-related [see Adverse Reactions (6.1)]. In postmarketing experience, reports of new onset or worsening edema have been received. ACTOS should be used with caution in patients with edema. Because thiazolidinediones, including ACTOS, can cause fluid re ...
... ACTOS than in placebo-treated patients and is dose-related [see Adverse Reactions (6.1)]. In postmarketing experience, reports of new onset or worsening edema have been received. ACTOS should be used with caution in patients with edema. Because thiazolidinediones, including ACTOS, can cause fluid re ...
Diphenhydramine versus nonsedating antihistamines for acute
... Fexofenadine. Fexofenadine is a highly specific, H1receptor antagonist with a safety profile similar to placebo.4,9,43 Unlike loratadine or cetirizine, fexofenadine is truly nonsedating, showing no dose-related increase in sedation, even at doses as high as 360 mg/day.47,48 The effects of fexofenadi ...
... Fexofenadine. Fexofenadine is a highly specific, H1receptor antagonist with a safety profile similar to placebo.4,9,43 Unlike loratadine or cetirizine, fexofenadine is truly nonsedating, showing no dose-related increase in sedation, even at doses as high as 360 mg/day.47,48 The effects of fexofenadi ...
1. Clinical Pharmacology
... • Opioid antagonists (naloxone and naltrexone): Buprenorphine has affinity for µ opioid receptors similar to the opioid antagonists. In the event of overdose of buprenorphine, very high doses of naloxone may be required to partially reverse its effects. Cases have been reported in which naloxone in ...
... • Opioid antagonists (naloxone and naltrexone): Buprenorphine has affinity for µ opioid receptors similar to the opioid antagonists. In the event of overdose of buprenorphine, very high doses of naloxone may be required to partially reverse its effects. Cases have been reported in which naloxone in ...
Wolfe - Intranasal naloxone in safe injection setting
... the case is consistent with heroin overdose An intramuscular dose of naloxone (Narcan) is administered and the patient is successfully resuscitated. Unfortunately, the medic suffers a contaminated needle stick after providing the intramuscular injection. The patient admits to being infected w ...
... the case is consistent with heroin overdose An intramuscular dose of naloxone (Narcan) is administered and the patient is successfully resuscitated. Unfortunately, the medic suffers a contaminated needle stick after providing the intramuscular injection. The patient admits to being infected w ...
AusPAR Attachment 2: Extract from the Clinical Evaluation Report
... Complicated urinary tract infection (UTI) is a heterogeneous clinical entity that includes UTI in the presence of factors that predispose to persistent or relapsing infection (e.g. indwelling catheters, urinary obstruction, instrumentation of the urinary tract), and pyelonephritis. According to the ...
... Complicated urinary tract infection (UTI) is a heterogeneous clinical entity that includes UTI in the presence of factors that predispose to persistent or relapsing infection (e.g. indwelling catheters, urinary obstruction, instrumentation of the urinary tract), and pyelonephritis. According to the ...
Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir
... NOTE: This submission was considered at the same time as the submission to register Viekira Pak RBV which contains applications for the Viekira Pak product presented as combination packs with different strengths of ribavirin (Submission number PM-201401438-1-2). The data in these submissions overlap ...
... NOTE: This submission was considered at the same time as the submission to register Viekira Pak RBV which contains applications for the Viekira Pak product presented as combination packs with different strengths of ribavirin (Submission number PM-201401438-1-2). The data in these submissions overlap ...
METHIMAZOLE - American Academy of Veterinary Pharmacology
... (Pharmacokinetic studies have demonstrated inhibition of the hepatic metabolism of benzimidazoles when administered to mice and sheep concurrently with methimazole. The clinical impact of the resulting prolonged residence of active intermediate metabolites is unknown.){R-33-35} ...
... (Pharmacokinetic studies have demonstrated inhibition of the hepatic metabolism of benzimidazoles when administered to mice and sheep concurrently with methimazole. The clinical impact of the resulting prolonged residence of active intermediate metabolites is unknown.){R-33-35} ...
DIPYRIDAMOLE TABLETS USP 25 MG, 50 MG AND 75 MG
... Other reactions from uncontrolled studies include diarrhea, vomiting, flushing and pruritus. In addition, angina pectoris has been reported rarely and there have been rare reports of liver dysfunction. On those uncommon occasions when adverse reactions have been persistent or intolerable, they have ...
... Other reactions from uncontrolled studies include diarrhea, vomiting, flushing and pruritus. In addition, angina pectoris has been reported rarely and there have been rare reports of liver dysfunction. On those uncommon occasions when adverse reactions have been persistent or intolerable, they have ...
Retinal-Vein Occlusion
... to 20/40 vision or better within 6 months, without treatment.23 Nevertheless, many patients continue to have poor vision in the affected eye. Among participants enrolled in the Branch Vein Occlusion Study, a randomized trial of the effects of laser treatment for branch retinal-vein occlusion, only a ...
... to 20/40 vision or better within 6 months, without treatment.23 Nevertheless, many patients continue to have poor vision in the affected eye. Among participants enrolled in the Branch Vein Occlusion Study, a randomized trial of the effects of laser treatment for branch retinal-vein occlusion, only a ...
diamorphine hydrochloride bp 5 mg lyophilisate for solution for
... suitable justification for the absence of an environmental risk assessment, stating that the proposed medicinal product will not be administered at higher dosage levels, for longer durations or for different indications than existing, marketed products. As such, the use of the proposed product is un ...
... suitable justification for the absence of an environmental risk assessment, stating that the proposed medicinal product will not be administered at higher dosage levels, for longer durations or for different indications than existing, marketed products. As such, the use of the proposed product is un ...
Evaluation and Management of Corneal Abrasions
... Corneal abrasions are commonly encountered in primary care. Patients typically present with a history of trauma and symptoms of foreign body sensation, tearing, and sensitivity to light. History and physical examination should exclude serious causes of eye pain, including penetrating injury, infecti ...
... Corneal abrasions are commonly encountered in primary care. Patients typically present with a history of trauma and symptoms of foreign body sensation, tearing, and sensitivity to light. History and physical examination should exclude serious causes of eye pain, including penetrating injury, infecti ...
Prescribing Information
... Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times amount of clindamycin and 3.6, ...
... Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times amount of clindamycin and 3.6, ...
1. Exposure Data - IARC Monographs
... more neoplasms were found in the drug-treated patients because subsequent thyroidectomy was more frequent in this group (30% of drug-treated patients, as compared with 0.5% of those initially treated with 131I and 1.2% of those treated with primary thyroidectomy), which provided more opportunity for ...
... more neoplasms were found in the drug-treated patients because subsequent thyroidectomy was more frequent in this group (30% of drug-treated patients, as compared with 0.5% of those initially treated with 131I and 1.2% of those treated with primary thyroidectomy), which provided more opportunity for ...
Acetaminophen
... those individuals displaying an allergy or sensitivity to aspirin. It does not possess anti-inflammatory activity, but it will produce analgesia in a wide variety of arthritic and musculoskeletal disorders The usual adult dose is 325 to 650 mg every 4 to 6 hours. Doses of greater than 2.6 g/day ...
... those individuals displaying an allergy or sensitivity to aspirin. It does not possess anti-inflammatory activity, but it will produce analgesia in a wide variety of arthritic and musculoskeletal disorders The usual adult dose is 325 to 650 mg every 4 to 6 hours. Doses of greater than 2.6 g/day ...
PRODUCT MONOGRAPH UNIPHYL Theophylline Sustained
... considered. Overdoses of theophylline may cause serious side effects such as tachycardia, arrhythmias, seizures, vascular collapse and even death. These may occur without warning and may not be preceded by less severe side effects such as nausea or restlessness. ...
... considered. Overdoses of theophylline may cause serious side effects such as tachycardia, arrhythmias, seizures, vascular collapse and even death. These may occur without warning and may not be preceded by less severe side effects such as nausea or restlessness. ...
Product Information for Sitagliptin/Metformin
... Mechanism of Action Sitagliptin phosphate monohydrate Sitagliptin phosphate monohydrate is a member of a class of oral antihyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors, which improve glycaemic control in patients with type 2 diabetes by enhancing the levels of active incret ...
... Mechanism of Action Sitagliptin phosphate monohydrate Sitagliptin phosphate monohydrate is a member of a class of oral antihyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors, which improve glycaemic control in patients with type 2 diabetes by enhancing the levels of active incret ...
Prescribing Information for SEROQUEL XR - PI
... Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1)]. SEROQUEL XR is not approved for the treatment of patients with dementia-re ...
... Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1)]. SEROQUEL XR is not approved for the treatment of patients with dementia-re ...
STAXYN PRODUCT MONOGRAPH
... Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently with the use of PDE5 inhibitors, including vardenafil. The incidence of priapism may increase when PDE5 inhibitors are used in combination with intrapenile inject ...
... Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently with the use of PDE5 inhibitors, including vardenafil. The incidence of priapism may increase when PDE5 inhibitors are used in combination with intrapenile inject ...
Lamictal XR (lamotrigine) Extended-Release Tablets
... of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (aged 2 to 16 years) receiving immediate-release lamotrigine as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy ...
... of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (aged 2 to 16 years) receiving immediate-release lamotrigine as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy ...
Everolimus Novartis tablet ENG SmPC
... Novartis, are at increased risk of developing lymphomas or other malignancies, particularly of the skin (see section 4.8). The absolute risk seems related to the duration and intensity of immunosuppression rather than to the use of a specific medicinal product. Patients should be monitored regularly ...
... Novartis, are at increased risk of developing lymphomas or other malignancies, particularly of the skin (see section 4.8). The absolute risk seems related to the duration and intensity of immunosuppression rather than to the use of a specific medicinal product. Patients should be monitored regularly ...
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights
... Use of KADIAN as the First Opioid Analgesic There has been no evaluation of KADIAN as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient to adequate analgesia using an extended-release morphine, begin treatment using an immediate-release morp ...
... Use of KADIAN as the First Opioid Analgesic There has been no evaluation of KADIAN as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient to adequate analgesia using an extended-release morphine, begin treatment using an immediate-release morp ...
Ofloxacin
Ofloxacin is a synthetic antibiotic of the fluoroquinolone drug class considered to be a second-generation fluoroquinolone.Ofloxacin was first patented in 1982 (European Patent Daiichi) and received approval from the U.S. Food and Drug Administration (FDA) on December 28, 1990. Ofloxacin is sold under a wide variety of brand names as well as generic drug equivalents, for oral and intravenous administration. Ofloxacin is also available for topical use, as eye drops and ear drops (marketed as Ocuflox and Floxin Otic respectively in the United States and marketed as Optiflox, eylox respectively in Jordan and Saudi Arabia).Ofloxacin is a racemic mixture, which consists of 50% levofloxacin (the biologically active component) and 50% of its “mirror image” or enantiomer dextrofloxacin.Ofloxacin has been associated with adverse drug reactions, such as tendon damage (including spontaneous tendon ruptures) and peripheral neuropathy (which may be irreversible); tendon damage may manifest long after therapy had been completed, and, in severe cases, may result in lifelong disabilities.