Ireland - English - HPRA (Health Products Regulatory Authority)

parke davis & company - levobunolol - 0.5 per cent

Ireland - English - HPRA (Health Products Regulatory Authority)

parke davis & company - levobunolol - 1 per cent

United States - English - NLM (National Library of Medicine)

parke-davis div of pfizer inc - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 30 mg - dilantin is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. dilantin is contraindicated in patients with: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as dilantin, during pregnancy. physicians are advised to recommend that pregnant patients taking dilantin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the tollfree number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/ risk summary in humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. prenatal phenytoin exposure is associated with an increased incidence of major malformations, inc

United States - English - NLM (National Library of Medicine)

parke-davis div of pfizer inc - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 125 mg in 5 ml - dilantin is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. dilantin is contraindicated in patients with: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as dilantin, during pregnancy. physicians are advised to recommend that pregnant patients taking dilantin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the tollfree number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary in humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. prenatal phenytoin exposure is associated with an increased incidence of major malformations, including orofacial clefts and cardiac defects. in addition, the fetal hydantoin syndrome, a pattern of abnormalities including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits has been reported among children born to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy [see data] . there have been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy. administration of phenytoin to pregnant animals resulted in an increased incidence of fetal malformations and other manifestations of developmental toxicity (including embryofetal death, growth impairment, and behavioral abnormalities) in multiple species at clinically relevant doses [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. clinical considerations disease-associated maternal risk an increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. periodic measurement of serum phenytoin concentrations may be valuable in the management of pregnant women as a guide to appropriate adjustment of dosage [see dosage and administration (2.4, 2.8)] . however, postpartum restoration of the original dosage will probably be indicated [see clinical pharmacology (12.3)] . fetal/neonatal adverse reactions a potentially life-threatening bleeding disorder related to decreased levels of vitamin k-dependent clotting factors may occur in newborns exposed to phenytoin in utero . this drug-induced condition can be prevented with vitamin k administration to the mother before delivery and to the neonate after birth. data human data meta-analyses using data from published observational studies and registries have estimated an approximately 2.4-fold increased risk for any major malformation in children with prenatal phenytoin exposure compared to controls. an increased risk of heart defects, facial clefts, and digital hypoplasia has been reported. the fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digital hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies. animal data administration of phenytoin to pregnant rats, rabbits, and mice during organogenesis resulted in embryofetal death, fetal malformations, and decreased fetal growth. malformations (including craniofacial, cardiovascular, neural, limb, and digit abnormalities) were observed in rats, rabbits, and mice at doses as low as 100, 75, and 12.5 mg/kg, respectively. risk summary phenytoin is secreted in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for dilantin and any potential adverse effects on the breastfed infant from dilantin or from the underlying maternal condition. initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. a recommended daily maintenance dosage is usually 4 to 8 mg/kg. children over 6 years and adolescents may require the minimum adult dosage (300 mg/day) [see dosage and administration (2.3)]. phenytoin clearance tends to decrease with increasing age [see clinical pharmacology (12.3)] . lower or less frequent dosing may be required [see dosage and administration (2.7)] . the liver is the chief site of biotransformation of phenytoin; patients with impaired liver function, elderly patients, or those who are gravely ill may show early signs of toxicity. because the fraction of unbound phenytoin is increased in patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients. patients who are intermediate or poor metabolizers of cyp2c9 substrates (e.g., *1/*3, *2/*2, *3/*3) may exhibit increased phenytoin serum concentrations compared to patients who are normal metabolizers (e.g., *1/*1). thus, patients who are known to be intermediate or poor metabolizers may ultimately require lower doses of phenytoin to maintain similar steady-state concentrations compared to normal metabolizers. if early signs of dose-related central nervous system (cns) toxicity develop, serum concentrations should be checked immediately [see clinical pharmacology (12.5)].

United States - English - NLM (National Library of Medicine)

parke-davis div of pfizer inc - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 50 mg - dilantin infatabs are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. dilantin is contraindicated in patients with: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as dilantin, during pregnancy. physicians are advised to recommend that pregnant patients taking dilantin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the tollfree number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary in humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. prenatal phenytoin exposure is associated with an increas

United States - English - NLM (National Library of Medicine)

parke-davis div of pfizer inc - pregabalin (unii: 55jg375s6m) (pregabalin - unii:55jg375s6m) - pregabalin 82.5 mg - lyrica cr is indicated for the management of: efficacy of lyrica cr has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures. lyrica cr is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see warnings and precautions (5.1, 5.2), adverse reactions (6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. to provide information regarding the effects of in utero exposure to lyrica cr, physicians are advised to recommend that pregnant patients taking lyrica cr enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website h

United States - English - NLM (National Library of Medicine)

parke-davis - chloramphenicol (unii: 66974fr9q1) (chloramphenicol - unii:66974fr9q1) - ointment - chloramphenicol should be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated. bacteriological studies should be performed to determine the causative organisms and their sensitivity to chloramphenicol (see boxed warning). chloromycetin ophthalmic ointment, 1% (chloramphenicol ophthalmic ointment, usp) is indicated for the treatment of surface ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms. the particular antiinfective drug in this product is active against the following common bacterial eye pathogens: staphylococcus aureus streptococcus , including streptococcus pneumoniae escherichia coli haemophilus influenzae klebsiella/enterobacter species moraxella lucunata     (morax-axenfeld bacillus) neisseria species this product does not provide adequate coverage against: pseudomonas aeruginosa serratia marcescens this product is contraindicated in persons sensitive to any of its components.

United States - English - NLM (National Library of Medicine)

parke-davis div of pfizer inc - pregabalin (unii: 55jg375s6m) (pregabalin - unii:55jg375s6m) - pregabalin 25 mg - lyrica is indicated for: lyrica is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see warnings and precautions (5.2)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lyrica during pregnancy. to provide information regarding the effects of in utero exposure to lyrica, physicians are advised to recommend that pregnant patients taking lyrica enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary there are no adequate and well-controlled studies with lyrica in pregnant women. however, in animal reproduction studies, increased incidences of fetal structural abnor

United States - English - NLM (National Library of Medicine)

parke-davis div of pfizer inc - phenelzine sulfate (unii: 2681d7p965) (phenelzine - unii:o408n561gf) - phenelzine 15 mg - nardil has been found to be effective in depressed patients clinically characterized as "atypical," "nonendogenous," or "neurotic." these patients often have mixed anxiety and depression and phobic or hypochondriacal features. there is less conclusive evidence of its usefulness with severely depressed patients with endogenous features. nardil should rarely be the first antidepressant drug used. rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions. nardil should not be used in patients who are hypersensitive to the drug or its ingredients, with pheochromocytoma, congestive heart failure, severe renal impairment or renal disease, a history of liver disease, or abnormal liver function tests. the potentiation of sympathomimetic substances and related compounds by mao inhibitors may result in hypertensive crises (see warnings). therefore, patients being treated with nardil should not take sympathomimetic drugs (including amphetamines, co

United States - English - NLM (National Library of Medicine)

parke-davis div of pfizer inc - methsuximide (unii: 0g76k8x6c0) (methsuximide - unii:0g76k8x6c0) - methsuximide 300 mg - celontin is indicated for the control of absence (petit mal) seizures that are refractory to other drugs. methsuximide should not be used in patients with a history of hypersensitivity to succinimides.