E 11 Clinical Investigation of Medicinal Products in the
... the pediatric population, following assessment of initial safety data and reasonable evidence of potential benefit. Pediatric study results should be part of the marketing application database. In circumstances where this has not been possible, lack of data should be justified in detail. 2.3.3 Medic ...
... the pediatric population, following assessment of initial safety data and reasonable evidence of potential benefit. Pediatric study results should be part of the marketing application database. In circumstances where this has not been possible, lack of data should be justified in detail. 2.3.3 Medic ...
Effects on upper gastrointestinal motility
... ot delayed gastric emptying (11). No significant effects on antral contractions were observed in patients with clinically evident diabetic gastroparesis (10,11). On the other hand, in diabetic gastroparesis, as well as in vagotomized patients and in subjects with anorexia nervosa or other causes of ...
... ot delayed gastric emptying (11). No significant effects on antral contractions were observed in patients with clinically evident diabetic gastroparesis (10,11). On the other hand, in diabetic gastroparesis, as well as in vagotomized patients and in subjects with anorexia nervosa or other causes of ...
WELLBUTRIN SR
... To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions (5.3)]. WELLBUTRIN SR tablets should be swallowed whole and not crushed, divided, or chewed. WELLBUTRIN SR may be taken with or without food. The usual adult target dose for WELLBUTRIN SR is 300 mg per day, gi ...
... To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions (5.3)]. WELLBUTRIN SR tablets should be swallowed whole and not crushed, divided, or chewed. WELLBUTRIN SR may be taken with or without food. The usual adult target dose for WELLBUTRIN SR is 300 mg per day, gi ...
ERY-PED - Arbor Pharmaceuticals
... with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. A possible doseresponse effect was described with an absolute risk of IHPS of 5.1% for infants who took erythromycin for 8-14 days and 10% for infants who took erythromycin for 15-21 days.5 Since erythromyc ...
... with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. A possible doseresponse effect was described with an absolute risk of IHPS of 5.1% for infants who took erythromycin for 8-14 days and 10% for infants who took erythromycin for 15-21 days.5 Since erythromyc ...
ARNOLD & I? ORTER May 12, 1998
... At a very minimum, we suggest that approval of any novel mixture of estrogens should require the submission of safety information in accordance with well-recognized FDA and other regulatory requirements. To our knowledge, such studies have not been performed with most of the individual estrogens in ...
... At a very minimum, we suggest that approval of any novel mixture of estrogens should require the submission of safety information in accordance with well-recognized FDA and other regulatory requirements. To our knowledge, such studies have not been performed with most of the individual estrogens in ...
Dexedrine/Dexedrine Spansules (dextroamphetamine)
... • If Dexedrine causes pronounced nervousness, restlessness, insomnia, loss of appetite, or weight loss, notify your physician. • If you miss a dose, take it as soon as possible. If it is close to the next scheduled dose, skip the missed dose and resume your regular dosing schedule, but do not take d ...
... • If Dexedrine causes pronounced nervousness, restlessness, insomnia, loss of appetite, or weight loss, notify your physician. • If you miss a dose, take it as soon as possible. If it is close to the next scheduled dose, skip the missed dose and resume your regular dosing schedule, but do not take d ...
Prescribing Information
... Patients who are taking sofosbuvir in combination with OLYSIO who need to start amiodarone therapy due to no other alternative treatment options should undergo similar cardiac monitoring as outlined above. Due to amiodarone’s long elimination half-life, patients discontinuing amiodarone just prior ...
... Patients who are taking sofosbuvir in combination with OLYSIO who need to start amiodarone therapy due to no other alternative treatment options should undergo similar cardiac monitoring as outlined above. Due to amiodarone’s long elimination half-life, patients discontinuing amiodarone just prior ...
prevpac - Takeda
... Pharmacokinetics when all three of the PREVPAC components (PREVACID capsules, amoxicillin capsules, clarithromycin tablets) were coadministered has not been studied. Studies have shown no clinically significant interactions of PREVACID and amoxicillin or PREVACID and clarithromycin when administered ...
... Pharmacokinetics when all three of the PREVPAC components (PREVACID capsules, amoxicillin capsules, clarithromycin tablets) were coadministered has not been studied. Studies have shown no clinically significant interactions of PREVACID and amoxicillin or PREVACID and clarithromycin when administered ...
Foundations in Pharmacokinetics
... are not truly equivalent. Pharmacokinetics is more accurately described by the acronym “ITE”. In this case, I stands for input into the body, since some routes of administration do not have absorption components (e.g., intravenous administration), T for transfer of drug within the body, and E for el ...
... are not truly equivalent. Pharmacokinetics is more accurately described by the acronym “ITE”. In this case, I stands for input into the body, since some routes of administration do not have absorption components (e.g., intravenous administration), T for transfer of drug within the body, and E for el ...
Feline Dosing Chart
... One case of apnea was reported in a cat that received ketamine as the induction agent. This cat required artificial ventilation from the start of the procedure until 30 minutes into recovery when the cat began to breathe on its own. The cat recovered without further problems. POst aPPrOVaL exPerIen ...
... One case of apnea was reported in a cat that received ketamine as the induction agent. This cat required artificial ventilation from the start of the procedure until 30 minutes into recovery when the cat began to breathe on its own. The cat recovered without further problems. POst aPPrOVaL exPerIen ...
ATACAND HCT® 16-12.5 candesartan cilexetil−hydrochlorothiazide TABLETS ATACAND HCT® 32-12.5
... Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, car ...
... Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, car ...
Anti platelet Agents
... the cyclo-oxygenase activity is lost permanently, whereas the hydroperoxidase activity is not affected. An inducible form of PGH-synthase has been identified and termed PGH-synthase 2 or COX-2.13 Aspirin inhibits the cyclo-oxygenase activity of PGH-synthase 2, but at higher concentrations than those ...
... the cyclo-oxygenase activity is lost permanently, whereas the hydroperoxidase activity is not affected. An inducible form of PGH-synthase has been identified and termed PGH-synthase 2 or COX-2.13 Aspirin inhibits the cyclo-oxygenase activity of PGH-synthase 2, but at higher concentrations than those ...
PERCOCET - Endo Pharmaceuticals
... Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed PERCOCET. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing PERCOCET, ...
... Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed PERCOCET. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing PERCOCET, ...
General Pediatrics
... given any time during childhood but before the 13th birthday because of the potential increased severity of natural varicella after this age. Susceptible is defined by either lack of proof of either varicella vaccination or a reliable history of varicella. One dose is recommended. C. Healthy adolesc ...
... given any time during childhood but before the 13th birthday because of the potential increased severity of natural varicella after this age. Susceptible is defined by either lack of proof of either varicella vaccination or a reliable history of varicella. One dose is recommended. C. Healthy adolesc ...
EryTab PI 03-A919-R2 Rev. July 2013 Final2
... effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ERY-TAB® or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. ...
... effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ERY-TAB® or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. ...
follitropin alfa injection
... approximately 20% of those treated with urofollitropin and hCG, and generally regresses without treatment within two or three weeks. Careful monitoring of ovarian response can further minimize the risk of overstimulation. If the ovaries are abnormally enlarged on the last day of Gonal‑f® RFF Pen the ...
... approximately 20% of those treated with urofollitropin and hCG, and generally regresses without treatment within two or three weeks. Careful monitoring of ovarian response can further minimize the risk of overstimulation. If the ovaries are abnormally enlarged on the last day of Gonal‑f® RFF Pen the ...
Lyrica : EPAR - Scientific Discussion
... for the neuropathic pain in the EU. In several European countries carbamazepine and amitriptyline are used off-label for this indication. In some Member states gabapentin has been approved for the treatment of neuropathic pain. Epilepsy Epilepsy is a common neurological disorder, with a worldwide es ...
... for the neuropathic pain in the EU. In several European countries carbamazepine and amitriptyline are used off-label for this indication. In some Member states gabapentin has been approved for the treatment of neuropathic pain. Epilepsy Epilepsy is a common neurological disorder, with a worldwide es ...
Ceftazidime for Injection, USP
... Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections ...
... Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections ...
50 years of oral lipid-based formulations
... with particle sizes in the low nanometre size range. This hypothesis was propagated on the basis that endogenous lipid processing results in increasing degrees of lipid dispersion and solubilisation and that ultimately colloidal structures with small particle sizes are required to diffuse across the ...
... with particle sizes in the low nanometre size range. This hypothesis was propagated on the basis that endogenous lipid processing results in increasing degrees of lipid dispersion and solubilisation and that ultimately colloidal structures with small particle sizes are required to diffuse across the ...
Drug-induced hypo- and hyperprolactinemia: mechanisms, clinical
... the lactotroph cells [5]. The cholinergic system in the hypophysis, by activation of the muscarinic receptors, exerts a tonic inhibitory action on the prolactin secretion [5,11]. Atropine, the competitive antagonist of muscarinic receptors, induces a dose-dependent increase of the prolactin secretio ...
... the lactotroph cells [5]. The cholinergic system in the hypophysis, by activation of the muscarinic receptors, exerts a tonic inhibitory action on the prolactin secretion [5,11]. Atropine, the competitive antagonist of muscarinic receptors, induces a dose-dependent increase of the prolactin secretio ...
EU Core Safety Profile
... CNS medicinal products/alcohol: Given the primary effects of ziprasidone, caution should be used when it is taken in combination with other centrally acting medicinal products and alcohol. ADDITIONAL TEXT FOR Intramuscular ONLY Effect of ziprasidone on other medicinal products: All interaction studi ...
... CNS medicinal products/alcohol: Given the primary effects of ziprasidone, caution should be used when it is taken in combination with other centrally acting medicinal products and alcohol. ADDITIONAL TEXT FOR Intramuscular ONLY Effect of ziprasidone on other medicinal products: All interaction studi ...
Cytochrome P4502C9: an enzyme of major importance in human
... models of the CYP2C9 active site based on the structures of known substrates and inhibitors (up to 1995) have also been developed using molecular modelling approaches [22–24]. Most, but not all, known drug substrates for CYP2C9 are weak acids with pKa values in the range 3.8–8.1 and an electrostatic ...
... models of the CYP2C9 active site based on the structures of known substrates and inhibitors (up to 1995) have also been developed using molecular modelling approaches [22–24]. Most, but not all, known drug substrates for CYP2C9 are weak acids with pKa values in the range 3.8–8.1 and an electrostatic ...
Tailoring treatment for metastatic colorectal cancer
... Early diarrhea occurs during or shortly after infusion. It may be accompanied by cholinergic symptoms. Late diarrhea generally occurs more than 24 hours after administration. Both forms can be life threatening. Therefore, it is important to discuss the risks with patients, and all attempts should be ...
... Early diarrhea occurs during or shortly after infusion. It may be accompanied by cholinergic symptoms. Late diarrhea generally occurs more than 24 hours after administration. Both forms can be life threatening. Therefore, it is important to discuss the risks with patients, and all attempts should be ...
Sterile Vancomycin Hydrochloride, USP
... to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is susp ...
... to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is susp ...