AusPAR: Rifaximin - Therapeutic Goods Administration
... Rifaximin is not intended to be absorbed systemically. It is intended to exert its effect locally in the gastrointestinal tract. An absolute bioavailability study of rifaximin is not feasible because of the low solubility of the drug substance. Evidence of low systemic absorption of rifaximin is pro ...
... Rifaximin is not intended to be absorbed systemically. It is intended to exert its effect locally in the gastrointestinal tract. An absolute bioavailability study of rifaximin is not feasible because of the low solubility of the drug substance. Evidence of low systemic absorption of rifaximin is pro ...
DOXOrubicin vials - Sagent Pharmaceuticals
... cumulative doses ranging from 300 mg/m2 to 500 mg/m2 when doxorubicin HCl is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess LVEF before and regularly during and after treatment with doxorubicin HCl [see Warnings and Precaution ...
... cumulative doses ranging from 300 mg/m2 to 500 mg/m2 when doxorubicin HCl is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess LVEF before and regularly during and after treatment with doxorubicin HCl [see Warnings and Precaution ...
(Acetaminophen) in products with and without opioid: an analysis
... survive with no permanent damage; in more than 90% of these cases, the patients will recover completely.3 However, there are hundreds of deaths every year in the United States caused by acetaminophen poisoning, and the mortality rates for patients with acute liver failure caused by acetaminophen ove ...
... survive with no permanent damage; in more than 90% of these cases, the patients will recover completely.3 However, there are hundreds of deaths every year in the United States caused by acetaminophen poisoning, and the mortality rates for patients with acute liver failure caused by acetaminophen ove ...
SCIENTIFIC DISCUSSION
... receiving antiepileptic drug (AED) treatment. The prevalence of active epilepsy, 5-10/1000, is one of the highest among serious neurological disorders with more than 50 million people affected worldwide. Two peaks of incidence are observed, in early childhood and among elderly people. Some patients ...
... receiving antiepileptic drug (AED) treatment. The prevalence of active epilepsy, 5-10/1000, is one of the highest among serious neurological disorders with more than 50 million people affected worldwide. Two peaks of incidence are observed, in early childhood and among elderly people. Some patients ...
AusPAR: Metformin HCI / Linagliptin
... Linagliptin is a selective orally administered DPP-4 inhibitor that acts to lower blood glucose by extending the half-life of glucagon-like peptide 1 (GLP-1). GLP-1 lowers blood glucose by augmenting the glucose-stimulated insulin release and limiting glucagon secretion, and is associated with slowi ...
... Linagliptin is a selective orally administered DPP-4 inhibitor that acts to lower blood glucose by extending the half-life of glucagon-like peptide 1 (GLP-1). GLP-1 lowers blood glucose by augmenting the glucose-stimulated insulin release and limiting glucagon secretion, and is associated with slowi ...
1.3.1 LEVITRA-Annotated PM dated 06-Mar-2015
... duration) have been reported infrequently with the use of PDE5 inhibitors, including LEVITRA. The incidence of priapism may increase when PDE5 inhibitors are used in combination with intrapenile injections containing vasoactive agents, or other drugs with a known risk of priapism. In the event of an ...
... duration) have been reported infrequently with the use of PDE5 inhibitors, including LEVITRA. The incidence of priapism may increase when PDE5 inhibitors are used in combination with intrapenile injections containing vasoactive agents, or other drugs with a known risk of priapism. In the event of an ...
How close are you to your blood pressure and
... previously had an allergic reaction to CADUET or to any of the inactive ingredients. It is not for those with liver problems. And it is not for women who are nursing, pregnant, or may become pregnant. If you take CADUET, tell your doctor if you feel any new muscle pain or weakness. This could be a s ...
... previously had an allergic reaction to CADUET or to any of the inactive ingredients. It is not for those with liver problems. And it is not for women who are nursing, pregnant, or may become pregnant. If you take CADUET, tell your doctor if you feel any new muscle pain or weakness. This could be a s ...
IN THE UNITED STATES DISTRICT COURT WESTERN DISTRICT
... that the cardiovascular events “are clearly there” and called it a “shame.” Wall Street Journal, Nov. 1, 2004, p. A1. Merck’s public statements (and specifically to prescribing doctors, through literature and sales rep visits, such as Mr. Hodge’s prescribing physician, M.D.) continued to reject any ...
... that the cardiovascular events “are clearly there” and called it a “shame.” Wall Street Journal, Nov. 1, 2004, p. A1. Merck’s public statements (and specifically to prescribing doctors, through literature and sales rep visits, such as Mr. Hodge’s prescribing physician, M.D.) continued to reject any ...
1 40-9182 CARBIDOPA and LEVODOPA TABLETS, USP Revised
... As with levodopa, care should be exercised in administering the combination product, to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias. In such patients, cardiac function should be monitored with particular care during the period of initi ...
... As with levodopa, care should be exercised in administering the combination product, to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias. In such patients, cardiac function should be monitored with particular care during the period of initi ...
Hemoperfusion - Hyderabad Nephrology forum
... Treatment: for 48-72h, change of the membrane when diffusion performance drops Anticoagulation: Heparin, Citrate Available studies: Despite two RCT showing broad cytokine removal there is very limited human data with the septeX membrane ...
... Treatment: for 48-72h, change of the membrane when diffusion performance drops Anticoagulation: Heparin, Citrate Available studies: Despite two RCT showing broad cytokine removal there is very limited human data with the septeX membrane ...
Avastin : EPAR - Scientific Discussion
... carcinoma of the colon or rectum. The CHMP considered that a positive benefit risk had only been demonstrated in combination with intravenous 5-fluorouracil/folinic acid or intravenous 5fluorouracil/folinic acid/irinotecan. The scientific discussion in this report focuses on this indication. Colorec ...
... carcinoma of the colon or rectum. The CHMP considered that a positive benefit risk had only been demonstrated in combination with intravenous 5-fluorouracil/folinic acid or intravenous 5fluorouracil/folinic acid/irinotecan. The scientific discussion in this report focuses on this indication. Colorec ...
Nitrofurantoin - IARC Monographs on the Evaluation of
... Netherlands and Spain (Chemical Information Services, 1989-90). ln Sweden, sales ...
... Netherlands and Spain (Chemical Information Services, 1989-90). ln Sweden, sales ...
Medications
... PURPOSE: To evaluate the IOP lowering effect of brinzolamide (1.0%) as an adjunctive therapy to latanoprost (0.005%) in patients with open-angle glaucoma or ocular hypertension METHODS: • 14 patients with open-angle glaucoma or ocular hypertension who had been using latanoprost for more than 6 month ...
... PURPOSE: To evaluate the IOP lowering effect of brinzolamide (1.0%) as an adjunctive therapy to latanoprost (0.005%) in patients with open-angle glaucoma or ocular hypertension METHODS: • 14 patients with open-angle glaucoma or ocular hypertension who had been using latanoprost for more than 6 month ...
HIGHLIGHTS OF PRESCRIBING
... Morphine Sulfate Oral Solution is available in three concentrations: 10 mg per 5 mL, 20 mg per 5 mL and 100 mg per 5 mL (20 mg/mL). Take care when prescribing and administering Morphine Sulfate Oral Solution to avoid dosing errors due to confusion between different concentrations and between mg and ...
... Morphine Sulfate Oral Solution is available in three concentrations: 10 mg per 5 mL, 20 mg per 5 mL and 100 mg per 5 mL (20 mg/mL). Take care when prescribing and administering Morphine Sulfate Oral Solution to avoid dosing errors due to confusion between different concentrations and between mg and ...
TYLENOL® with Codeine
... About 70 to 80% of the administered dose of codeine is metabolized by conjugation with glucuronic acid to codeine-6-glucuronide (C6G) and via O-demethylation to morphine (about 5 to 10%) and N-demethylation to norcodeine (about 10%) respectively. UDP-glucuronosyltransferase (UGT) 2B7 and 2B4 are the ...
... About 70 to 80% of the administered dose of codeine is metabolized by conjugation with glucuronic acid to codeine-6-glucuronide (C6G) and via O-demethylation to morphine (about 5 to 10%) and N-demethylation to norcodeine (about 10%) respectively. UDP-glucuronosyltransferase (UGT) 2B7 and 2B4 are the ...
Regulatory requirements for the development of medicinal products
... always necessary to support an indication in this population age-appropriate, normal laboratory values and clinical measurements should be used in such studies. long-term studies or surveillance data (chronic therapy or during the posttherapy period) may be needed to determine possible effects on sk ...
... always necessary to support an indication in this population age-appropriate, normal laboratory values and clinical measurements should be used in such studies. long-term studies or surveillance data (chronic therapy or during the posttherapy period) may be needed to determine possible effects on sk ...
Full Prescribing Information including BOXED WARNING
... Codeine is rapidly absorbed from the gastrointestinal tract. It is rapidly distributed from the intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen, and kidney. Codeine crosses the blood-brain barrier and is found in fetal tis ...
... Codeine is rapidly absorbed from the gastrointestinal tract. It is rapidly distributed from the intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen, and kidney. Codeine crosses the blood-brain barrier and is found in fetal tis ...
Exelon Patch
... For treatment interruption longer than 3 days, retitrate dosage starting at 4.6 mg/24 hours. (2.1) Consider dose adjustments in patients with (2.2): Mild to moderate hepatic impairment (8.6) Low (<50 kg) body weight (8.7) ...
... For treatment interruption longer than 3 days, retitrate dosage starting at 4.6 mg/24 hours. (2.1) Consider dose adjustments in patients with (2.2): Mild to moderate hepatic impairment (8.6) Low (<50 kg) body weight (8.7) ...
Comparison of the Effects of Pilocarpine Solution and Tablet on
... gland function either through a diminution of salivary flow ...
... gland function either through a diminution of salivary flow ...
Sumatriptan Succinate Injection - Pack Insert
... trials of sumatriptan succinate in subjects with migraine. Overall, the frequency of adverse reactions reported in the trials of cluster headache was generally lower than in the migraine trials. Exceptions include reports of paresthesia (5% sumatriptan succinate, 0% placebo), nausea and vomiting (4% ...
... trials of sumatriptan succinate in subjects with migraine. Overall, the frequency of adverse reactions reported in the trials of cluster headache was generally lower than in the migraine trials. Exceptions include reports of paresthesia (5% sumatriptan succinate, 0% placebo), nausea and vomiting (4% ...
Report of the National Lipid Association`s Statin Safety Task Force
... (prices include air-speeded delivery) 1 year $292. U.S. institutions 1 year $382. All other countries (prices include airspeeded delivery) 1 year $576. The Journal is not responsible for replacing missing issues unless the Circulation Department is notified of nonreceipt within 3 months of issue dat ...
... (prices include air-speeded delivery) 1 year $292. U.S. institutions 1 year $382. All other countries (prices include airspeeded delivery) 1 year $576. The Journal is not responsible for replacing missing issues unless the Circulation Department is notified of nonreceipt within 3 months of issue dat ...
Hydrocodone Bitartrate and Acetaminophen Tablets, USP
... was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β-hydroxymetabolite ...
... was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β-hydroxymetabolite ...
Theo-24®(theophylline anhydrous) Extended
... disease, 3-methylxanthine may accumulate to co ncentratio ns that appro ximate the unmetabo lized theophylline co ncentratio n. Caffeine co ncentratio ns are usually undetectable in adults reg ardless o f renal functio n. In neo nates, caffeine may accumulate to co ncentratio ns that appro ximate th ...
... disease, 3-methylxanthine may accumulate to co ncentratio ns that appro ximate the unmetabo lized theophylline co ncentratio n. Caffeine co ncentratio ns are usually undetectable in adults reg ardless o f renal functio n. In neo nates, caffeine may accumulate to co ncentratio ns that appro ximate th ...
Cyclizine lactate - Therapeutic Goods Administration
... Studies designed to detect drowsiness did not reveal sedation in healthy adults who took a single oral therapeutic dose (50 mg) of cyclizine lactate. Sedation of short duration was reported by subjects receiving intravenous cyclizine. Patients should not drive or operate machinery until they have de ...
... Studies designed to detect drowsiness did not reveal sedation in healthy adults who took a single oral therapeutic dose (50 mg) of cyclizine lactate. Sedation of short duration was reported by subjects receiving intravenous cyclizine. Patients should not drive or operate machinery until they have de ...
Paracetamol - IARC Monographs on the Evaluation of Carcinogenic
... 2. Production, Occurrence, Use and Analysis ...
... 2. Production, Occurrence, Use and Analysis ...
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.