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Motrin" Tablets (ibuprofen. Upjohn) Contraindications: Individuals hypersensitive to it, or with the syndrome of nasal polyps, angioedema. and bronchospastic reactivity to aspirin, iodides, or other nonsteroidal anti-inflammatory agents. Anaphylactoid reactions have occurred in such patients. Warnings: Peptic ulceration and gastrointestinal bleeding, sometimes severe, have been reported. Ulceration, perforation, and bleeding may end fatally. An association has not been established. Motrin should be given under close supervision to patients with a history of upper gastrointestinal tract disease, only after consulting ADVERSE REAC-TIONS- In patients with active peptic ulcer and active rheumatoid arthritis, nonulcerogenic drugs, such as gold, should be tried. If Motrin must be given, the patient should be under close supervision for signs of ulcer perloration or gastrointestinal bleeding. Chronic studies in rats and monkeys have shown mild renal toxicity characterized by papillary edema and necrosis. Renal papillary necrosis has rarely been shown in humans treated with Motrin. Precautions: Blurred and/or diministied vision, scotomata, and/or changes in color vision have been reported. If these develop, discontinue Motrin and the patient should have an ophthalmologic examination, including central visual fields and color vision testing. Fluid retention and edema have been associated with Motrin; use with caution in patients with a history of cardiac decompensation or hypertension. Motrin is excreted mainly by the kidneys. In patients with renal impairment, reduced dosage may be necessary, Prospective studies of MofnV?. safety in patients with chronic renal failure have not been done. Motrin can inhibit platelet aggregation and prolong bleeding time. Use with caution in persons with intrinsic coagulation defects and those on anticoagulant therapy. Patients should report signs or symptoms of gastrointestinal ulceration or bleeding, blurred vision or other eye symptoms, skin rash, weight gain, or edema. To avoid exacerbation of disease or adrenal insufficiency, patients on prolonged corticosteroid tfierapy should have therapy tapered slowly when Motrin is added. The antipyretic, anti-inflammatory activity of Motrin may mask inflammation and fever. Drug interactions. Aspirin: used concomitantly may decrease Motrin blood levels. Coiymar//7. bleeding has been reported in patients taking Motrin an6 coumarin. Pregnancy and nursing mothers: Motrin should not be taken during pregnancy nor by nursing mothers. Adverse Reactions The most frequent type of adverse reaction occurring with Motrin is gastrointestinal, of which one or more occurred m 4% to 16% of the patients. Incidence Greater Than 1% (but less than 3%) -Probable Causal Relationship Gastrointestinal: Nauseaf epigastric painf heartburnf diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of Gl tract (bloating and flatulence); Central Nervous System: Dizziness^ headache, nervousness: Dermatologic: Rash'^ {including maculopapular type), pruritus; Special Senses: Tinnitus; Metabolic/Endocrine: Decreased appetite; Cardiovascular: Edema, fluid retention (generally responds promptly to drug discontinuation; see PRECAUTIONS), Incidence Less Than 1%-Probable Causal Relationship Gastrointestinal: Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests; Central Nervous System: Depression, insomnia, confusion, emotional lability, somnolence, aseptic meningitis with fever and coma; Dermatologic: Vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia; Special Senses: Hearing loss, amblyopia (blurred and/or diminished vision, scotomata, and/or changes in color vision) (see PRECAUTIONS); Hematologic: Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs" positive), thrombocytopenia with or without purpura, eosinophilia. decreases in hemoglobin and hematocrit; Cardiovascular: Congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations; Allergic: Syndrome of abdominal pain, fever, chills, nausea and vomiting, anaphylaxis, bronchospasm (see CONTRAINDICATIONS): Renal: Acute renal failure in patients with preexisting, significantly impaired renal function, decreased creatinine clearance, polyuria, azotemia, cystitis, hematuria: Miscellaneous: Dry eyes and mouth, gingival ulcer, rhinitis. Incidence Less Than1%-Causal Relationship Unknown*' Gastrointestinal: Pancreatitis; Central Nervous System: Paresthesias, hallucinations, dream abnormalities, pseudotumor cerebri; Dcrmatologic: Toxic epidermal necrolysis, photoallergic skin reactions: Special Senses: Conjunctivitis, diplopia, optic neuritis: Hematologic: Bleeding episodes (e.g,, epistaxis, menorrhagia): Metabolic/Endocrine: Gynecomastia. hypoglycemic reaction: Cardiovascular: Arrhythmia (sinus tachycardia, sinus bradycardia); Allergic: Serum sickness, lupus erythematosus syndrome, Henoch-Schbnlein vasculitis; Renal: Renal papillary necrosis. ''Reactions occurring in 3% to 9% of patients treated with Motrin. (Those reactions occurring in less than 3% of the patients are unmarked.) ^Reactions are classified under "Probable Causal Relationstiip" (PCR) if there has been one positive rechallenge or if three or more cases occur which might be causally related. Reactions are classified under "Causal Relationship Unknown" if seven or more events have been reported but the criteria for PCR have not been met. Overdosage: In cases of acute overdosage, the stomach should be emptied. The drug is acidic and excreted in the urine, so alkaline diuresis may be beneficial. Dosage and Administration: Do not exceed 2400 mg per day. If gastrointestinal complaints occur, administer with meals or milk. Rheumatoid arthritis and osteoarthritis, including flares of chronic disease: Suggested dosage is300,400, or 600 mg t.i.d. or q.i.d. Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain. Caution: Federal law prohibits dispensing without prescription. THE UPJOHN COMPANY Kalamazoo. Michigan 49001 USA J-9042-4 MED B-5-S July 1981 5pedfy Librnx Each capsule contains 5 mg chlordiazeponide HCI and 2.5 mg clldinium Br. Please consult complete prescribing information, a summary of which follows: Indications: Based on a review of this drug by the national Academy of Sciences—national Research Council and/or other Information, FDA has classified the indications as follows, "Possibly" effective, as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Final classification of the less-than-effective indications requires further investigation. Contraindications: Glaucoma, prostatic hypertrophy, benign bladder neck obstruction; hypersensitivity to chlordiazepoxide MCI and/or clidinium bromide. Warnings: Caution patients about possible combined effects with alcohol and other CMS depressants, and against hazardous occupations requiring complete mental alertness (eg., operating machinery, driving) Physical and psychological dependence rarely reported on recommended doses, but use caution in administering Ltbnum^ (chlordiazepoxide MCI/Roche) to known addiction-prone individuals or those who might increase dosage, withdrawal symptoms (including convulsions) reported following discontinuation of the drug. L/sd^e in Pregnancy: Use of minor tranquilizers during first trimester should almost always be avoided because of increased risk of congenital malformations as suggested in several studies. Consider possibility of pregnancy when instituting therapy. Advise patients to discuss therapy if they intend to or do become pregnant. As with all anticholinergics, inhibition of lactation may occur Precautions: In elderly and debilitated, limit dosage to smallest effective amount to preclude ataxia, oversedation, confusion (no more than 2 capsules/'day initially, increase gradually as needed and tolerated) Though generally not recommended, if combination therapy with other psychotropics seems indicated, carefully consider] pharmacology of agents, particularly potentiating drugs such as MAO inhibitors, phenothiazines. Observe usual precautions in presence of impaired renal or hepatic function. Paradoxical reactions reported in psychiatric patients. Employ usual precautions in treating anxiety states with evidence of impending depression, suicidal tendencies may be present and protective measures necessary Variable effects on blood coagulation reported very rarely in patients receiving the drug and oral anticoagulants, causal relationship not established Adverse Reactions: no side effects or manifestations not seen with either compound alone reported with Librax When chlordiazepoxide MCI IS used alone, drowsiness, ataxia, confusion may occur, especially in elderly and debilitated, avoidable in most cases by proper dosage adjustment, but also occasionally observed at lower dosage ranges. 5yncope reported in a few instances Also encountered Isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, Increased and decreased libido—all infrequent generally controlled with dosage reduction, changes in EEQ patterns may appear during and after treatment, blood dyscrasias (including agranulocytosis), Jaundice, hepatic dysfunction reported occasionally with chlor-diazepoxide hCI, making periodic blood counts and liver function tests advisable during protracted therapy. Adverse effects reported with Librax typical of anticholinergic agents, t.e, dryness of mouth, blurring of vision, urinary hesitancy, constipation. Constipation has occurred most often when Librax therapy is combined with other spasmolytics and/or low residue diets Roche Products Inc. Manati, Puerto Rico 00701
Object Description
Rating | |
Fixed Title * | NCHH-17: North Carolina Medical Journal [1940-Present] |
Document Title | North Carolina Medical Journal [1940-Present] |
Subject Topical Other | Public Health -- Periodicals.; Physicians -- North Carolina -- Directory.; Societies, Medical -- North Carolina -- Periodicals. |
Description | Includes Transactions of the Society, -1960; 1961- , Transactions issued separately, bound in.; Includes Transactions of the auxiliary to the Medical Society of the State of North Carolina and Proceedings of the North Carolina Public Health Association. Official organ of the Medical Society of the State of North Carolina, 1940-May 1972; of the North Carolina Medical Society, June 1972-. Vols. for 1940-May 1972 published by the Medical Society of the State of North Carolina; June 1972- by the North Carolina Medical Society. |
Contributor | Medical Society of the State of North Carolina. Transactions.; Medical Society of the State of North Carolina.; North Carolina Medical Society.; North Carolina Medical Society. Transactions.; North Carolina Public Health Association. Proceedings. |
Publisher | [Winston-Salem] : North Carolina Medical Society [etc.], 1940- |
Repository | University of North Carolina at Chapel Hill. Health Sciences Library. |
Host | University of North Carolina at Chapel Hill |
Date | 1981 |
Identifier | NCHH-17-042 |
Form General | Periodicals |
Language | English |
Rights | This item is part of the North Carolina History of Health Digital Collection. Some materials in the Collection are protected by U.S. copyright law. This item is presented by the Health Sciences Library of the University of North Carolina at Chapel Hill for research and educational purposes. It may not be republished or distributed without permission of the Health Sciences Library. |
Digital Collection | North Carolina History of Health Digital Collection |
Sponsor | The North Carolina History of Health Digital Collection is an open access publishing initiative of the Health Sciences Library of the University of North Carolina at Chapel Hill. Financial support for the initiative was provided in part by a multi-year NC ECHO (Exploring Cultural Heritage Online) digitization grant, awarded by the State Library of North Carolina, and funded through the Library Services and Technology Act (LSTA). |
Volume Number | 42 |
Health Discipline | Medicine |
Digital Format | JPEG 2000 |
Print / Download PDF Version | http://archives.hsl.unc.edu/nchh/nchh-17/nchh-17-042.pdf |
Document Sort | all; nchh-17 |
Volume Link | http://dc.lib.unc.edu/cdm/search/collection/nchh/field/identi/searchterm/NCHH-17-042 |
Title Link | http://dc.lib.unc.edu/cdm/search/collection/nchh/field/documa/searchterm/NCHH-17 |
Catalog Record link | http://search.lib.unc.edu/search?R=UNCb1306322 |
Revision History | done |
Description
Fixed Title * | Page 650 (advert) |
Document Title | North Carolina Medical Journal [1940-Present] |
Subject Topical Other | Public Health -- Periodicals.; Physicians -- North Carolina -- Directory.; Societies, Medical -- North Carolina -- Periodicals. |
Description | Includes Transactions of the Society, -1960; 1961- , Transactions issued separately, bound in.; Includes Transactions of the auxiliary to the Medical Society of the State of North Carolina and Proceedings of the North Carolina Public Health Association. Official organ of the Medical Society of the State of North Carolina, 1940-May 1972; of the North Carolina Medical Society, June 1972-. Vols. for 1940-May 1972 published by the Medical Society of the State of North Carolina; June 1972- by the North Carolina Medical Society. |
Contributor | Medical Society of the State of North Carolina. Transactions.; Medical Society of the State of North Carolina.; North Carolina Medical Society.; North Carolina Medical Society. Transactions.; North Carolina Public Health Association. Proceedings. |
Publisher | [Winston-Salem] : North Carolina Medical Society [etc.], 1940- |
Repository | University of North Carolina at Chapel Hill. Health Sciences Library. |
Host | University of North Carolina at Chapel Hill |
Date | 1981 |
Identifier | NCHH-17-042-0232 |
Form General | Periodicals |
Page Type | all; all images; advertisement |
Language | English |
Rights | This item is part of the North Carolina History of Health Digital Collection. Some materials in the Collection are protected by U.S. copyright law. This item is presented by the Health Sciences Library of the University of North Carolina at Chapel Hill for research and educational purposes. It may not be republished or distributed without permission of the Health Sciences Library. |
Filename | ncmed421981mediv2_0232.jp2 |
Digital Collection | North Carolina History of Health Digital Collection |
Sponsor | The North Carolina History of Health Digital Collection is an open access publishing initiative of the Health Sciences Library of the University of North Carolina at Chapel Hill. Financial support for the initiative was provided in part by a multi-year NC ECHO (Exploring Cultural Heritage Online) digitization grant, awarded by the State Library of North Carolina, and funded through the Library Services and Technology Act (LSTA). |
Volume Number | 42 |
Issue Number | 9 |
Page Number | 650 |
Health Discipline | Medicine |
Full Text | Motrin" Tablets (ibuprofen. Upjohn) Contraindications: Individuals hypersensitive to it, or with the syndrome of nasal polyps, angioedema. and bronchospastic reactivity to aspirin, iodides, or other nonsteroidal anti-inflammatory agents. Anaphylactoid reactions have occurred in such patients. Warnings: Peptic ulceration and gastrointestinal bleeding, sometimes severe, have been reported. Ulceration, perforation, and bleeding may end fatally. An association has not been established. Motrin should be given under close supervision to patients with a history of upper gastrointestinal tract disease, only after consulting ADVERSE REAC-TIONS- In patients with active peptic ulcer and active rheumatoid arthritis, nonulcerogenic drugs, such as gold, should be tried. If Motrin must be given, the patient should be under close supervision for signs of ulcer perloration or gastrointestinal bleeding. Chronic studies in rats and monkeys have shown mild renal toxicity characterized by papillary edema and necrosis. Renal papillary necrosis has rarely been shown in humans treated with Motrin. Precautions: Blurred and/or diministied vision, scotomata, and/or changes in color vision have been reported. If these develop, discontinue Motrin and the patient should have an ophthalmologic examination, including central visual fields and color vision testing. Fluid retention and edema have been associated with Motrin; use with caution in patients with a history of cardiac decompensation or hypertension. Motrin is excreted mainly by the kidneys. In patients with renal impairment, reduced dosage may be necessary, Prospective studies of MofnV?. safety in patients with chronic renal failure have not been done. Motrin can inhibit platelet aggregation and prolong bleeding time. Use with caution in persons with intrinsic coagulation defects and those on anticoagulant therapy. Patients should report signs or symptoms of gastrointestinal ulceration or bleeding, blurred vision or other eye symptoms, skin rash, weight gain, or edema. To avoid exacerbation of disease or adrenal insufficiency, patients on prolonged corticosteroid tfierapy should have therapy tapered slowly when Motrin is added. The antipyretic, anti-inflammatory activity of Motrin may mask inflammation and fever. Drug interactions. Aspirin: used concomitantly may decrease Motrin blood levels. Coiymar//7. bleeding has been reported in patients taking Motrin an6 coumarin. Pregnancy and nursing mothers: Motrin should not be taken during pregnancy nor by nursing mothers. Adverse Reactions The most frequent type of adverse reaction occurring with Motrin is gastrointestinal, of which one or more occurred m 4% to 16% of the patients. Incidence Greater Than 1% (but less than 3%) -Probable Causal Relationship Gastrointestinal: Nauseaf epigastric painf heartburnf diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of Gl tract (bloating and flatulence); Central Nervous System: Dizziness^ headache, nervousness: Dermatologic: Rash'^ {including maculopapular type), pruritus; Special Senses: Tinnitus; Metabolic/Endocrine: Decreased appetite; Cardiovascular: Edema, fluid retention (generally responds promptly to drug discontinuation; see PRECAUTIONS), Incidence Less Than 1%-Probable Causal Relationship Gastrointestinal: Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests; Central Nervous System: Depression, insomnia, confusion, emotional lability, somnolence, aseptic meningitis with fever and coma; Dermatologic: Vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia; Special Senses: Hearing loss, amblyopia (blurred and/or diminished vision, scotomata, and/or changes in color vision) (see PRECAUTIONS); Hematologic: Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs" positive), thrombocytopenia with or without purpura, eosinophilia. decreases in hemoglobin and hematocrit; Cardiovascular: Congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations; Allergic: Syndrome of abdominal pain, fever, chills, nausea and vomiting, anaphylaxis, bronchospasm (see CONTRAINDICATIONS): Renal: Acute renal failure in patients with preexisting, significantly impaired renal function, decreased creatinine clearance, polyuria, azotemia, cystitis, hematuria: Miscellaneous: Dry eyes and mouth, gingival ulcer, rhinitis. Incidence Less Than1%-Causal Relationship Unknown*' Gastrointestinal: Pancreatitis; Central Nervous System: Paresthesias, hallucinations, dream abnormalities, pseudotumor cerebri; Dcrmatologic: Toxic epidermal necrolysis, photoallergic skin reactions: Special Senses: Conjunctivitis, diplopia, optic neuritis: Hematologic: Bleeding episodes (e.g,, epistaxis, menorrhagia): Metabolic/Endocrine: Gynecomastia. hypoglycemic reaction: Cardiovascular: Arrhythmia (sinus tachycardia, sinus bradycardia); Allergic: Serum sickness, lupus erythematosus syndrome, Henoch-Schbnlein vasculitis; Renal: Renal papillary necrosis. ''Reactions occurring in 3% to 9% of patients treated with Motrin. (Those reactions occurring in less than 3% of the patients are unmarked.) ^Reactions are classified under "Probable Causal Relationstiip" (PCR) if there has been one positive rechallenge or if three or more cases occur which might be causally related. Reactions are classified under "Causal Relationship Unknown" if seven or more events have been reported but the criteria for PCR have not been met. Overdosage: In cases of acute overdosage, the stomach should be emptied. The drug is acidic and excreted in the urine, so alkaline diuresis may be beneficial. Dosage and Administration: Do not exceed 2400 mg per day. If gastrointestinal complaints occur, administer with meals or milk. Rheumatoid arthritis and osteoarthritis, including flares of chronic disease: Suggested dosage is300,400, or 600 mg t.i.d. or q.i.d. Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain. Caution: Federal law prohibits dispensing without prescription. THE UPJOHN COMPANY Kalamazoo. Michigan 49001 USA J-9042-4 MED B-5-S July 1981 5pedfy Librnx Each capsule contains 5 mg chlordiazeponide HCI and 2.5 mg clldinium Br. Please consult complete prescribing information, a summary of which follows: Indications: Based on a review of this drug by the national Academy of Sciences—national Research Council and/or other Information, FDA has classified the indications as follows, "Possibly" effective, as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Final classification of the less-than-effective indications requires further investigation. Contraindications: Glaucoma, prostatic hypertrophy, benign bladder neck obstruction; hypersensitivity to chlordiazepoxide MCI and/or clidinium bromide. Warnings: Caution patients about possible combined effects with alcohol and other CMS depressants, and against hazardous occupations requiring complete mental alertness (eg., operating machinery, driving) Physical and psychological dependence rarely reported on recommended doses, but use caution in administering Ltbnum^ (chlordiazepoxide MCI/Roche) to known addiction-prone individuals or those who might increase dosage, withdrawal symptoms (including convulsions) reported following discontinuation of the drug. L/sd^e in Pregnancy: Use of minor tranquilizers during first trimester should almost always be avoided because of increased risk of congenital malformations as suggested in several studies. Consider possibility of pregnancy when instituting therapy. Advise patients to discuss therapy if they intend to or do become pregnant. As with all anticholinergics, inhibition of lactation may occur Precautions: In elderly and debilitated, limit dosage to smallest effective amount to preclude ataxia, oversedation, confusion (no more than 2 capsules/'day initially, increase gradually as needed and tolerated) Though generally not recommended, if combination therapy with other psychotropics seems indicated, carefully consider] pharmacology of agents, particularly potentiating drugs such as MAO inhibitors, phenothiazines. Observe usual precautions in presence of impaired renal or hepatic function. Paradoxical reactions reported in psychiatric patients. Employ usual precautions in treating anxiety states with evidence of impending depression, suicidal tendencies may be present and protective measures necessary Variable effects on blood coagulation reported very rarely in patients receiving the drug and oral anticoagulants, causal relationship not established Adverse Reactions: no side effects or manifestations not seen with either compound alone reported with Librax When chlordiazepoxide MCI IS used alone, drowsiness, ataxia, confusion may occur, especially in elderly and debilitated, avoidable in most cases by proper dosage adjustment, but also occasionally observed at lower dosage ranges. 5yncope reported in a few instances Also encountered Isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, Increased and decreased libido—all infrequent generally controlled with dosage reduction, changes in EEQ patterns may appear during and after treatment, blood dyscrasias (including agranulocytosis), Jaundice, hepatic dysfunction reported occasionally with chlor-diazepoxide hCI, making periodic blood counts and liver function tests advisable during protracted therapy. Adverse effects reported with Librax typical of anticholinergic agents, t.e, dryness of mouth, blurring of vision, urinary hesitancy, constipation. Constipation has occurred most often when Librax therapy is combined with other spasmolytics and/or low residue diets Roche Products Inc. Manati, Puerto Rico 00701 |
Digital Format | JPEG 2000 |
Print / Download PDF Version | http://archives.hsl.unc.edu/nchh/nchh-17/nchh-17-042.pdf |
Document Sort | all; nchh-17 |
Volume Link | http://dc.lib.unc.edu/cdm/search/collection/nchh/field/identi/searchterm/NCHH-17-042 |
Title Link | http://dc.lib.unc.edu/cdm/search/collection/nchh/field/documa/searchterm/NCHH-17 |
Catalog Record link | http://search.lib.unc.edu/search?R=UNCb1306322 |
Revision History | done |
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