Postgraduate Medicine
ISSN: 0032-5481 (Print) 1941-9260 (Online) Journal homepage: http://www.tandfonline.com/loi/ipgm20
High-fiber diet for diabetes James W. Anderson MD, Belinda Maness Smith RD & Patti Bazel Geil MS, RD To cite this article: James W. Anderson MD, Belinda Maness Smith RD & Patti Bazel Geil MS, RD (1990) High-fiber diet for diabetes, Postgraduate Medicine, 88:2, 157-168, DOI: 10.1080/00325481.1990.11704705 To link to this article: http://dx.doi.org/10.1080/00325481.1990.11704705
Published online: 17 May 2016.
Submit your article to this journal
View related articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ipgm20 Download by: [Monash University Library]
Date: 03 July 2016, At: 07:17
High-fiber diet for diabetes Safe and effective treatment
James W. Anderson, MD Belinda Maness Smith, RD
Patti Bazel Geil, MS, RD
Downloaded by [Monash University Library] at 07:17 03 July 2016
Preview Besides controlling hyperglycemia, a high-carbohydrate, high-fiber diet can lower serum lipid levels notably. Thus, the risk of cardiovascular disease, which is elevated in diabetic patients, is reduced. The authors describe the benefits and review practical aspects of managing diabetes the high-fiber way. They also provide a sample meal plan for home use.
More than 11 million people in the United States have diabetes. 1 The incidence will probably increase by about 500,000 new cases yearly because obesity, a major contributing factor to diabetes, is becoming more common. 1 This increase coupled with the declining death rate from diabetes will greatly add to the number of diabetic patients requiring medical care in the next decade. Treatment of diabetes and its ophthalmic, neurologic, and cardiovascular complications is costly, totalling an estimated $20.4 billion in 1987 for direct and indirect costs. 2 Effective, economical treatment could significantly lower these costs. Although diet is considered the cornerstone of diabetes treatment, insulin and drug therapy often take the leading role. Of the $1.7 billion spent in 1987 for outpatient care, 47% went for insulin and oral sulfonylureas.2 Ironically, use of excess exogenous insulin can suppress endogenous secretion and worsen insulin resistance. 3 Oral sulfonylureas do increase insulin secretion and sensitivity, but they are often used as a substitute rather than an adjunct to
diet and exercise. 4 Diet therapy is cost-effective, well-tolerated, and safe but is often neglected because of the time, education, and behavior modifications required.
Goals in management of diabetes In the past, management of diabetes focused primarily on control of blood glucose. Today, physicians know that control of lipid levels is also vitally important. Death caused by heart disease occurs two to three times more often among persons with diabetes than among those without diabetes.4 Hypercholesterolernia is the major risk factor for atherosclerosis, and average serum lipid levels are higher in diabetic than nondiabetic persons. 5 The risk for heart disease increases with each additional life-style risk, such as obesity, hypertension, and tobacco use. Figure 1 shows how diabetes contributes to atherosclerosis. Hyperlipidernia, glycosylation of lipoproteins, platelet dysfunction, arterial wall changes, hyperinsulinemia, hypertension, and obesity combine to accelerate atherosclerosis in diabetic patients.6 Achieving and maintaining
VOL 88/NO 2/AUGUST 1990IPOSTGRADUATE MEDICINE • FI8EA FOR DIAIIET1ES
desirable serum lipid levels have emerged as primary goals in management of diabetes. Evidence indicates that for every 1% reduction in plasma cholesterol level, there is an estimated 2% reduction in coronary artery disease. 7 Classification of cholesterol levels in adults from the National Cholesterol Education Program is summarized in table 1.8 Total cholesterol and low-density lipoprotein (LDL) cholesterol levels that are considered borderline for nondiabetic persons are probably of concern in diabetic patients. Major cardiovascular risk factors in diabetic patients are hypercholesterolernia, hypenriglyceridernia, hypertension, and smoking. Obesity, inactivity, and poor stress management are secondary factors that should also be addressed. Thus, at the University of Kentucky Metabolic Research Group, Lexington, management goals for adult diabetic patients are the following: • Fasting plasma glucose less than 150mgldU • Glycosylated hemoglobin (hemoglobin A 1J less than 7% • Serum cholesterol less than 200 mgldL • Fasting serum triglycerides less than 250 mgldL • LDL cholesterol less than 130 mgldL • High-density lipoprotein (HDL) cholesterol: in men, more than 45 mgldL; in women, more than 55 mgldL continued
157
Downloaded by [Monash University Library] at 07:17 03 July 2016
Many factors (eg, hyperlipidemia, platelet aggregation, dysinsulinemia) work together to accelerate atherosclerosis in diabetic patients.
Table 1. National Cholesterol Education Program classification of cholesterol levels in adults Total cholesterol Desirable :
=ca :::l'tl lll'
.:2.
0
Fiber and lipid control When studying the effects of high fiber intake on glycemic control, we soon discovered that fiber also lowers serum lipid levels. In our studies, a high-carbohydrate, high-fiber diet lowered serum cholesterol values an average of 30% for type I diabetes and 24% for type 11 diabetes. 6 Fasting serum triglyceride levels decreased an average of 5%, although the responses varied. Compared with a high-carbohydrate, low-fiber diet, a high-carbohydrate, high-fiber diet reduces serum triglyceride levels. 4 The diet developed for home use provides 55% to 60% of calories as carbohydrate and 25 g of dietary fiber per 1,000 kcal. Long-term use of such a diet maintained serum cholesterol values 15% to 20% lower
Type 11 diabetes
200
c
0 HCF
Diet
c
HCF
Figure 2. Metabolic response of 25 men with type I diabetes and 25 with type 11 diabetes to control (C) and high-carbohydrate, high-fiber (HCF) diets. Asterisk indicates significant difference. Adapted from Anderson.'
and serum triglyceride values 40% lower than initial values in a patient who was on a traditional diabetic diet. 6 High-fiber diets also lowered blood pressure 10% in diabetic men compared with controls.6 Water-soluble fibers are particularly effective at lowering lipid levels. When hypercholesterolemic men were followed up for 99 weeks after starting a high-carbohydrate, highfiber diet supplemented with oat bran or dried beans, their total
VOL 88/NO 2/AUGUST 1990/POSTGRADUATE MEDICINE • FIBER FOR DIABETES
serum cholesterol and LD L cholesterol values averaged 22% and 29% lower, respectively, than initial values, and HDL cholesterol values averaged 9% higher.' 5 Fasting serum triglyceride values decreased 21% in the first 3 weeks and remained stable thereafter. Weight loss is another benefit of a high-carbohydrate, high-fiber diet. Obesity contributes to both hyperglycemia and hyperlipidemia. By slowing gastric emptying and the recontinued 159
Obesity contributes to hyperglycemia and hyperlipidemia. A high-carbohydrate, high-fiber diet encourages weight loss.
Downloaded by [Monash University Library] at 07:17 03 July 2016
Table 2. High-carbohydrate, high-fiber exchange system Exchange
Size
kcal
Grams/serving Protein Fat
Carbohydrate
Fiber
2
0
15
2
0
5
2
Starches Bread Pasta, grains. starchy vegetables Rice Crackers
1f3 cup 2-6
Vegetables
1/2
Fruits
60
0
0
15
2.5
Cereals
1f2-1 cup or 1 small 1 oz
90
3
0
20
4
Beans
1f2 cup
95
7
0
17
5
Milk, skim
1 cup
85
8
0.5
12
0
50
8
2
0
0
45
0
5
0
0
70 1 slice 1/2 cup
cup
Proteins Red meat, poultry, cheese Fish Tofu
2 oz 21f2 oz
Fats Oil Dressing Margarine
1 tsp 2 tsp 1 tsp
25
1 oz
To calculate high-carbohydrate, high-fiber meal plan: 1. Estimate energy requirements 2. Distribute kcal among food groups 3. Convert kcal to grams 4. Translate grams into high-carbohydrate, high-fiber exchanges 5. Distribute exchanges into meals and snacks Adapted from Anderson. "
160
FIBEA FOR DIABETES • VOL 88/NO 2/AUGUST 1990IPOSTGRADUATE MEDICINE
Downloaded by [Monash University Library] at 07:17 03 July 2016
Cereals and beans (eg, kidney, pinto) are good sources of water-soluble fiber.
lease of gut hormones, a high fiber intake helps increase satiety. Also, high-fiber foods are less energy-dense and take longer to eat. When the amount of carbohydrates and highfiber food is increased, intake of fat and cholesterol is automatically reduced by displacement. Additionally, recent evidence has more clearly defined the role of fiber in the prevention and regression of colon cancer. 16
High-carbohydrate, high-fiber nutrition plan
Our high-carbohydrate, high-fiber diet for home use provides the following: • 55% to 60% of calories from carbohydrates (about two thirds from complex carbohydrates) • 15% to 20% protein (minimum of 45 g daily) • 20% to 25% fat or less (10% or less as saturated fat) • 200 mg or less cholesterol daily (100 mg/1,000 kcal) • 40 to 50 g total dietary fiber daily (25 g/1,000 kcal) • 10 to 15 g soluble fiber daily The high-carbohydrate, highfiber exchange system (table 2) simplifies diet calculation. 17 The cereal and bean groups help to ensure adequate intake of water-soluble fiber. Table 3 illustrates a typical highcarbohydrate, high-fiber maintenance menu, and table 41ists selected sources of water-soluble fiber. Although food sources of water-soluble fiber are preferred, fiber supplements may be advisable for certain patients, such as those with or at risk for heart continued on page 164
Table 3. Sample 1,800-kcal high-carbohydrate, high-fiber menu for home use Breakfast Oatmeal (dry) Peach slices, raspberries, and almonds Whole wheat toast Corn oil margarine Spice tea Multivitamin-mineral supplement
112 cup 112 cup
4 slices 2 tsp 1 cup
1
Lunch Tuna in pita bread Eggless mayonnaise Tomato slices and sprouts Fresh orange Pumpkin oat bran muffin Skim milk
2 halves 1 tsp 112 cup
1 small 1 1 cup
Dinner Spinach salad Light Italian dressing Rye crackers Kidney bean lasagna Steamed broccoli Whole wheat bread stick Corn oil margarine
112 cup
1 tbsp 6 small 8 oz 2 stalks 1 1 tsp
Snack Bran flakes Skim milk
2/3 cup
1 cup
Table 4. Sources of water-soluble fiber Source
Serving
Oat bran
113 cup (28 g) dry 112 cup (42 g) dry 1!3 cup (27 g) dry 112 cup (41 g) dry 1 medium 112 cup (cooked)
Oatmeal Oat bran muffin Beans (eg, kidney, pinto) Psyllium Soyfiber
VOL 88/NO 2/AUGUST 1990/PQSTGRADUATE MEDICINE • FIBER FOR DIABETES
1 tsp (7 g) 1 tsp (4 g)
Total fiber (g)
Water-soluble fiber (g)
4.4
6.6
2.0 3.0
2.8 4.3
2.0
1.3
3.3
1.6
6.7
2.0
3.4
2.9 0.8
3.0
161
Downloaded by [Monash University Library] at 07:17 03 July 2016
Brief Summary, Clllllralndlclllons' Patients who have llad allerg~ reactioos to NAPROSYI( ANAPROX or ANAPROX OS or rn whom aspirill or other NSAJDs indu "''Avoid use. l'ldlatrfc Use, Single doses of 2.5-5 mgi\g las naproxen suspension), wrth total dally dose not exceeding 15 mgi\g/day, are safe rn chil· dren over 2 yea" of age. Adverse Reactions, In a study, Gl reactions were more frequent and severe in rheumatoid arthrrtis patients on 1650 mg/day naproxen sodium tllan rn those on 825 mg/day. In children wrth juvenile arthrrt~. rash and prolonged bleeding times were more frequent. Gl and CNS reactioos about the same, and other reactioos less frequent tllan in adults. Incidence Greater Tllan 1%, Probable Causal Relatiooship, GL The most frequent comp~ints re~ted to the Gl tract. constipatioo~ heartburn~ abdominal pain~ nausea,• dyspepsia, diarrhea, sto· matrt~. CNS headache,• diuiness~ drowsiness~ light·headedness, vertigo Derrnatologrc, rtchrng lprurrtus)~ skrn eruptioos~ ecchymoses~ sweatrng, pur pura. Special Senses, tinnrtus~ hearrng disturbances, visual disturbances. Car· diovascular, edema,• dyspnea,• palprtatioos. GeneraL thi"t. •1ncrdence of reported reactioo 3%-9%. Where unmarl!ed, incidence less tllan 3% lnci· dence Less Tllan I%, Probable Causal Relatiooship, Gl, abnormal lrverfunctNlll tests, colrtis, Gl bleeding and/or perforatioo, hematemesis, jaund~e. melena, peptrc ulceratioo wrth bleeding and/or pertoratioo, vornrting. RenaL glomeru~r nephrrtis, hematuria, interstrtial nephrrtis, nephrot~ syndrome, renal disease. Hematologic: agranulocytosis, eosinophilia, granulocytopenia, leukopenia. thrombocytopenia. CNS, depression, dream abnormalrties, inabilrty to concen· Irate, insomnia, ma~ise, myalgia and muscle weakness. Derrnatolog~, alope· cia, photosensitive dermatitis, skin rashes. Special Senses: hearing impairment. Cardiovascular, congestive heart failure. Respiratory, eo~nophilk pneumoort~. GeneraL anaphy.lactoid reactioos, menstrual. disorde", pyrexia lchrlls and fever). Causal RelatNlllShrp Unknown, Hematolog~ ap~stic anemra, hemolytrc anemia. CNS, cognrtive dysfunctNlll. Derrnatolog~, eprdermal necrol· ysrs, erythema mult~rme, Stevens·Johnson syndrome, urticaria. GL non· peptrc Gl ulceratioo, ulcerative stornatrtis. Cardiovascular vasculitis. General. angNllleurotrc edema, hyperglycemia hypoglycemia Overdosap: May have drowsiness, heart bum, ind•gestu:~n. nausea, vomrtm~ Empty stomach and use usual supportive measures. In anrmals 0.5g,1
ISSN: 0032-5481 (Print) 1941-9260 (Online) Journal homepage: http://www.tandfonline.com/loi/ipgm20
High-fiber diet for diabetes James W. Anderson MD, Belinda Maness Smith RD & Patti Bazel Geil MS, RD To cite this article: James W. Anderson MD, Belinda Maness Smith RD & Patti Bazel Geil MS, RD (1990) High-fiber diet for diabetes, Postgraduate Medicine, 88:2, 157-168, DOI: 10.1080/00325481.1990.11704705 To link to this article: http://dx.doi.org/10.1080/00325481.1990.11704705
Published online: 17 May 2016.
Submit your article to this journal
View related articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ipgm20 Download by: [Monash University Library]
Date: 03 July 2016, At: 07:17
High-fiber diet for diabetes Safe and effective treatment
James W. Anderson, MD Belinda Maness Smith, RD
Patti Bazel Geil, MS, RD
Downloaded by [Monash University Library] at 07:17 03 July 2016
Preview Besides controlling hyperglycemia, a high-carbohydrate, high-fiber diet can lower serum lipid levels notably. Thus, the risk of cardiovascular disease, which is elevated in diabetic patients, is reduced. The authors describe the benefits and review practical aspects of managing diabetes the high-fiber way. They also provide a sample meal plan for home use.
More than 11 million people in the United States have diabetes. 1 The incidence will probably increase by about 500,000 new cases yearly because obesity, a major contributing factor to diabetes, is becoming more common. 1 This increase coupled with the declining death rate from diabetes will greatly add to the number of diabetic patients requiring medical care in the next decade. Treatment of diabetes and its ophthalmic, neurologic, and cardiovascular complications is costly, totalling an estimated $20.4 billion in 1987 for direct and indirect costs. 2 Effective, economical treatment could significantly lower these costs. Although diet is considered the cornerstone of diabetes treatment, insulin and drug therapy often take the leading role. Of the $1.7 billion spent in 1987 for outpatient care, 47% went for insulin and oral sulfonylureas.2 Ironically, use of excess exogenous insulin can suppress endogenous secretion and worsen insulin resistance. 3 Oral sulfonylureas do increase insulin secretion and sensitivity, but they are often used as a substitute rather than an adjunct to
diet and exercise. 4 Diet therapy is cost-effective, well-tolerated, and safe but is often neglected because of the time, education, and behavior modifications required.
Goals in management of diabetes In the past, management of diabetes focused primarily on control of blood glucose. Today, physicians know that control of lipid levels is also vitally important. Death caused by heart disease occurs two to three times more often among persons with diabetes than among those without diabetes.4 Hypercholesterolernia is the major risk factor for atherosclerosis, and average serum lipid levels are higher in diabetic than nondiabetic persons. 5 The risk for heart disease increases with each additional life-style risk, such as obesity, hypertension, and tobacco use. Figure 1 shows how diabetes contributes to atherosclerosis. Hyperlipidernia, glycosylation of lipoproteins, platelet dysfunction, arterial wall changes, hyperinsulinemia, hypertension, and obesity combine to accelerate atherosclerosis in diabetic patients.6 Achieving and maintaining
VOL 88/NO 2/AUGUST 1990IPOSTGRADUATE MEDICINE • FI8EA FOR DIAIIET1ES
desirable serum lipid levels have emerged as primary goals in management of diabetes. Evidence indicates that for every 1% reduction in plasma cholesterol level, there is an estimated 2% reduction in coronary artery disease. 7 Classification of cholesterol levels in adults from the National Cholesterol Education Program is summarized in table 1.8 Total cholesterol and low-density lipoprotein (LDL) cholesterol levels that are considered borderline for nondiabetic persons are probably of concern in diabetic patients. Major cardiovascular risk factors in diabetic patients are hypercholesterolernia, hypenriglyceridernia, hypertension, and smoking. Obesity, inactivity, and poor stress management are secondary factors that should also be addressed. Thus, at the University of Kentucky Metabolic Research Group, Lexington, management goals for adult diabetic patients are the following: • Fasting plasma glucose less than 150mgldU • Glycosylated hemoglobin (hemoglobin A 1J less than 7% • Serum cholesterol less than 200 mgldL • Fasting serum triglycerides less than 250 mgldL • LDL cholesterol less than 130 mgldL • High-density lipoprotein (HDL) cholesterol: in men, more than 45 mgldL; in women, more than 55 mgldL continued
157
Downloaded by [Monash University Library] at 07:17 03 July 2016
Many factors (eg, hyperlipidemia, platelet aggregation, dysinsulinemia) work together to accelerate atherosclerosis in diabetic patients.
Table 1. National Cholesterol Education Program classification of cholesterol levels in adults Total cholesterol Desirable :
=ca :::l'tl lll'
.:2.
0
Fiber and lipid control When studying the effects of high fiber intake on glycemic control, we soon discovered that fiber also lowers serum lipid levels. In our studies, a high-carbohydrate, high-fiber diet lowered serum cholesterol values an average of 30% for type I diabetes and 24% for type 11 diabetes. 6 Fasting serum triglyceride levels decreased an average of 5%, although the responses varied. Compared with a high-carbohydrate, low-fiber diet, a high-carbohydrate, high-fiber diet reduces serum triglyceride levels. 4 The diet developed for home use provides 55% to 60% of calories as carbohydrate and 25 g of dietary fiber per 1,000 kcal. Long-term use of such a diet maintained serum cholesterol values 15% to 20% lower
Type 11 diabetes
200
c
0 HCF
Diet
c
HCF
Figure 2. Metabolic response of 25 men with type I diabetes and 25 with type 11 diabetes to control (C) and high-carbohydrate, high-fiber (HCF) diets. Asterisk indicates significant difference. Adapted from Anderson.'
and serum triglyceride values 40% lower than initial values in a patient who was on a traditional diabetic diet. 6 High-fiber diets also lowered blood pressure 10% in diabetic men compared with controls.6 Water-soluble fibers are particularly effective at lowering lipid levels. When hypercholesterolemic men were followed up for 99 weeks after starting a high-carbohydrate, highfiber diet supplemented with oat bran or dried beans, their total
VOL 88/NO 2/AUGUST 1990/POSTGRADUATE MEDICINE • FIBER FOR DIABETES
serum cholesterol and LD L cholesterol values averaged 22% and 29% lower, respectively, than initial values, and HDL cholesterol values averaged 9% higher.' 5 Fasting serum triglyceride values decreased 21% in the first 3 weeks and remained stable thereafter. Weight loss is another benefit of a high-carbohydrate, high-fiber diet. Obesity contributes to both hyperglycemia and hyperlipidemia. By slowing gastric emptying and the recontinued 159
Obesity contributes to hyperglycemia and hyperlipidemia. A high-carbohydrate, high-fiber diet encourages weight loss.
Downloaded by [Monash University Library] at 07:17 03 July 2016
Table 2. High-carbohydrate, high-fiber exchange system Exchange
Size
kcal
Grams/serving Protein Fat
Carbohydrate
Fiber
2
0
15
2
0
5
2
Starches Bread Pasta, grains. starchy vegetables Rice Crackers
1f3 cup 2-6
Vegetables
1/2
Fruits
60
0
0
15
2.5
Cereals
1f2-1 cup or 1 small 1 oz
90
3
0
20
4
Beans
1f2 cup
95
7
0
17
5
Milk, skim
1 cup
85
8
0.5
12
0
50
8
2
0
0
45
0
5
0
0
70 1 slice 1/2 cup
cup
Proteins Red meat, poultry, cheese Fish Tofu
2 oz 21f2 oz
Fats Oil Dressing Margarine
1 tsp 2 tsp 1 tsp
25
1 oz
To calculate high-carbohydrate, high-fiber meal plan: 1. Estimate energy requirements 2. Distribute kcal among food groups 3. Convert kcal to grams 4. Translate grams into high-carbohydrate, high-fiber exchanges 5. Distribute exchanges into meals and snacks Adapted from Anderson. "
160
FIBEA FOR DIABETES • VOL 88/NO 2/AUGUST 1990IPOSTGRADUATE MEDICINE
Downloaded by [Monash University Library] at 07:17 03 July 2016
Cereals and beans (eg, kidney, pinto) are good sources of water-soluble fiber.
lease of gut hormones, a high fiber intake helps increase satiety. Also, high-fiber foods are less energy-dense and take longer to eat. When the amount of carbohydrates and highfiber food is increased, intake of fat and cholesterol is automatically reduced by displacement. Additionally, recent evidence has more clearly defined the role of fiber in the prevention and regression of colon cancer. 16
High-carbohydrate, high-fiber nutrition plan
Our high-carbohydrate, high-fiber diet for home use provides the following: • 55% to 60% of calories from carbohydrates (about two thirds from complex carbohydrates) • 15% to 20% protein (minimum of 45 g daily) • 20% to 25% fat or less (10% or less as saturated fat) • 200 mg or less cholesterol daily (100 mg/1,000 kcal) • 40 to 50 g total dietary fiber daily (25 g/1,000 kcal) • 10 to 15 g soluble fiber daily The high-carbohydrate, highfiber exchange system (table 2) simplifies diet calculation. 17 The cereal and bean groups help to ensure adequate intake of water-soluble fiber. Table 3 illustrates a typical highcarbohydrate, high-fiber maintenance menu, and table 41ists selected sources of water-soluble fiber. Although food sources of water-soluble fiber are preferred, fiber supplements may be advisable for certain patients, such as those with or at risk for heart continued on page 164
Table 3. Sample 1,800-kcal high-carbohydrate, high-fiber menu for home use Breakfast Oatmeal (dry) Peach slices, raspberries, and almonds Whole wheat toast Corn oil margarine Spice tea Multivitamin-mineral supplement
112 cup 112 cup
4 slices 2 tsp 1 cup
1
Lunch Tuna in pita bread Eggless mayonnaise Tomato slices and sprouts Fresh orange Pumpkin oat bran muffin Skim milk
2 halves 1 tsp 112 cup
1 small 1 1 cup
Dinner Spinach salad Light Italian dressing Rye crackers Kidney bean lasagna Steamed broccoli Whole wheat bread stick Corn oil margarine
112 cup
1 tbsp 6 small 8 oz 2 stalks 1 1 tsp
Snack Bran flakes Skim milk
2/3 cup
1 cup
Table 4. Sources of water-soluble fiber Source
Serving
Oat bran
113 cup (28 g) dry 112 cup (42 g) dry 1!3 cup (27 g) dry 112 cup (41 g) dry 1 medium 112 cup (cooked)
Oatmeal Oat bran muffin Beans (eg, kidney, pinto) Psyllium Soyfiber
VOL 88/NO 2/AUGUST 1990/PQSTGRADUATE MEDICINE • FIBER FOR DIABETES
1 tsp (7 g) 1 tsp (4 g)
Total fiber (g)
Water-soluble fiber (g)
4.4
6.6
2.0 3.0
2.8 4.3
2.0
1.3
3.3
1.6
6.7
2.0
3.4
2.9 0.8
3.0
161
Downloaded by [Monash University Library] at 07:17 03 July 2016
Brief Summary, Clllllralndlclllons' Patients who have llad allerg~ reactioos to NAPROSYI( ANAPROX or ANAPROX OS or rn whom aspirill or other NSAJDs indu "''Avoid use. l'ldlatrfc Use, Single doses of 2.5-5 mgi\g las naproxen suspension), wrth total dally dose not exceeding 15 mgi\g/day, are safe rn chil· dren over 2 yea" of age. Adverse Reactions, In a study, Gl reactions were more frequent and severe in rheumatoid arthrrtis patients on 1650 mg/day naproxen sodium tllan rn those on 825 mg/day. In children wrth juvenile arthrrt~. rash and prolonged bleeding times were more frequent. Gl and CNS reactioos about the same, and other reactioos less frequent tllan in adults. Incidence Greater Tllan 1%, Probable Causal Relatiooship, GL The most frequent comp~ints re~ted to the Gl tract. constipatioo~ heartburn~ abdominal pain~ nausea,• dyspepsia, diarrhea, sto· matrt~. CNS headache,• diuiness~ drowsiness~ light·headedness, vertigo Derrnatologrc, rtchrng lprurrtus)~ skrn eruptioos~ ecchymoses~ sweatrng, pur pura. Special Senses, tinnrtus~ hearrng disturbances, visual disturbances. Car· diovascular, edema,• dyspnea,• palprtatioos. GeneraL thi"t. •1ncrdence of reported reactioo 3%-9%. Where unmarl!ed, incidence less tllan 3% lnci· dence Less Tllan I%, Probable Causal Relatiooship, Gl, abnormal lrverfunctNlll tests, colrtis, Gl bleeding and/or perforatioo, hematemesis, jaund~e. melena, peptrc ulceratioo wrth bleeding and/or pertoratioo, vornrting. RenaL glomeru~r nephrrtis, hematuria, interstrtial nephrrtis, nephrot~ syndrome, renal disease. Hematologic: agranulocytosis, eosinophilia, granulocytopenia, leukopenia. thrombocytopenia. CNS, depression, dream abnormalrties, inabilrty to concen· Irate, insomnia, ma~ise, myalgia and muscle weakness. Derrnatolog~, alope· cia, photosensitive dermatitis, skin rashes. Special Senses: hearing impairment. Cardiovascular, congestive heart failure. Respiratory, eo~nophilk pneumoort~. GeneraL anaphy.lactoid reactioos, menstrual. disorde", pyrexia lchrlls and fever). Causal RelatNlllShrp Unknown, Hematolog~ ap~stic anemra, hemolytrc anemia. CNS, cognrtive dysfunctNlll. Derrnatolog~, eprdermal necrol· ysrs, erythema mult~rme, Stevens·Johnson syndrome, urticaria. GL non· peptrc Gl ulceratioo, ulcerative stornatrtis. Cardiovascular vasculitis. General. angNllleurotrc edema, hyperglycemia hypoglycemia Overdosap: May have drowsiness, heart bum, ind•gestu:~n. nausea, vomrtm~ Empty stomach and use usual supportive measures. In anrmals 0.5g,1
