Str. N. Bălcescu nr. 26, cod 700117, Iaşi Tel.: 0232 268014, Fax: 0232 267705
canfamphys00132-0232
4
KENACOMB®, PREPARATIONS I D Triamcinolone Acetonide - Neomycin - Nystatin - Gramicidin Compound Indications: Corticosteroid-responsive inflammatory o r pruntic dermatoses caused, threatened o r complicated b y infection d u e t o bacteria and/or candida. Pruritus a n i a n d pruritus vulvae (cream only). T h e 0.025 formulations a r e f o r u s e o n extensive lesions, o r dermatoses which a r e chronic, mild, o r highly sus- ceptible t o topical corticosteroid therapy, o r f o r maintenance therapy o f dermatoses previously controlled by a 0.1 formula- tion. Contraindications: Tuberculous a n d most viral lesions o f t h e skin, including herpes simplex, vaccinia and varicella. Fungal lesions o f t h e skin, except candidiasis. Patients with history o f hypersensitivity t o a n y o f th e components. N ot f o r ophthalmic use; n ot t o be applied t o t h e external auditory canal o f patients perforated eardrums o r with otitis media. Occlusive therapy contraindicated i n patients with atopic dermatits. Pre- cautions: Because o f t h e potential hazard o f nephrotoxicity a n d ototoxicity, avoid prolonged use o r u s e o f large amounts i n t h e treatment o f skin infections following bums, trophic ulceration a n d otherconditions where absorption o f neomycin i s possible. A s with any antibiotic preparation, prolonged u s e m a y result i n overgrowth o f nonsusceptible organisms, including fungi other than Candida. Constant observation o f t h e patient i s essential. Should superinfection d u e t o nonsusceptible organisms occur, Kenacomb should b e discontinued a nd appropriate therapy instituted. Although adrenal suppression a n d other systemic adverse effects a r e rare with topical corticosteroid preparations, their possible occurrence must b e kept i n mind, particularly when these preparations a r e used over large areas or f o r a n extended period oftime. Occasionally, a patient w h o has beenon prolonged therapy m a y develop symptoms of steroid withdrawal when themedication is stopped. T h e u s e o f occlusive dressings i s no t recommended with products containing anti-infective I f local irritation sensitization develops, t h e tion should be discontinued and appropriate therapy instituted. Patients should be advised t o inform subsequent physicians o f t h e prior us e o f corticosteroids. When applied t o moist intertrigi- nous areas, oleaginous ointments in general m ay be irritating a n d a r e no t recommended. Pregnancy and Lactation: T h e safety o f topical steroid preparations during pregnancy and lactation h a s n o t been absolutely established; therefore, th e potential benefit of useshould b e weighed against possible hazard t o t h e fetus o r t h e nursing infant. Articles i n current medical literature indicate an increase in th e incidence o f patients allergic t o neomycin. Neomycin itself m a y cause a n allergic otitis extema. Systemic neomycin toxicity has occurred rarely following topical administration; tinnitus a n d deafness have been reported. T h e possibility o f such a reaction should be bome i n mind. Topical steroids should beused with caution o n lesions close t o t h e eye. Prolonged use o f topical corticosteroid products m ay produce atrophy o f t h e skin and subcutaneous tissues, particularly o n flexor surfaces and o n t h e face. I f this is noted, discontinue u s e t h e Topical corticosteroids should beused with caution in patients with stasis dermatitis a n d other skin diseases associated with impaired circulation. I f a symptomatic response i s no t noted within a week, discontinue the local application of coricosteroids and re-evaluate t h e patient. Gramicidin absorption following topical administration i s unlikely; however, hemolysis m a y occur should th e drug enter the blood. I f gramicidin is allowed t o come i n close proximity t o t h e sub-arachnoid space, a chemical arachnoiditis m a y occur. T h e possibility o f hypersensi- tivity t o ethylenediamine, a constituent o f Kenacomb cream, should b e bome i n mind. Adverse Effects: Hypersensitivity t o nystatin i s extremely uncommon. Sensitivity reactions following t h e topical u s e o f gramicidin o r triamcinolone acetonide a r e rarely encountered. Neomycin: see Precautions. Buming, itch- ing, irritation, dryness, erythema, folliculitis, hypertrichosis, acneiform eruptions, tinnitus, deafness a n d hypopigmentation have been reported with topical corticosteroids. When steroid preparations a r e used f o r long periods in intertriginous areas or under occlusive dressings, striae m a y occur Damage t o colla- gen, which constitutes a middle layer o f t h e tympanic mem- brane, ma y occur Delayed healing a n d systemic effects, includ- i n g adrenal suppression and subcapsular cataracts, m a y occur i f absorbed in appreciable amounts. Dosage: Cream: ru b into affected areas 2 t o 3 times daily. Ointment: Apply a thin film t o t h e affected areas 2 t o 3 times daily. Mild Cream & Ointment: 3 o r 4 times daily. Supplied: Cream a n d Ointment: Each g contains: trimcinolone acetonide 1 mg, neomycin base ( a s sulfate) 2 . 5 mg , gramicidin 2 5 0 A g , nystatin 100 00 0 units. The cream is formulated i n a perfumedaqueous vanishing cream base which permits i ts useeven in moist intertriginous areas. I t also contains polysorbate 6 0 , alcohol, aluminum hydroxide concentrated wet gel, titanium dioxide, silicone fluid, propylene glycol, ethylenedi- amine, hydrochloric acid, white petroleum, polyoxyethylene fatty alcohol ether, methyl a n d propyl parabens an d sorbitol solution. Tubes o f 1 5 , 3 0 a n d 6 0 g . T h e ointment i s formulated i n protective Plastibase (Squibb plasticized hydrocarbon gel), a polyethylene a n d mineral oi l g e l base. Tubes o f 1 5 , 3 0 a n d 6 0 g . Kenacomb Mild: Kenacomb formula a s above but with triam- cinolone acetonide concentration o f 0.025 . Tubes o f 3 0 g (cream and ointment). Ue J o X ~ WJSQUIBB ivision of/de Bristol-Myers Squibb Canada Inc. Belleville. Ontano K 8 N 5E9 PRESCRIBING INFORMATION floctafenine 200 m g an d 4 0 0 m g tablets. THERAPEUTIC CLASSIFICATION: Analgesic. ACTIONS: IDARAC (floctafenine) i s a n anthranilic acid deriva- tive which h a s analgesic a n d anti-inflammatory properties. T h e analgesic activity i s comparable t o that o f other mild analgesics i n t h e relief o f acute pain. Floctafenine hasbeen shown t o inhibit i n vitro biosynthesis o f prostaglandins PGE2and PGF2a. Gastro- intestinal bleeding determined b y daily fecal blood loss, w a s shown in o n e clinical trial t o b e approximately 1 . 2 m L after 16 mg/day o f floctafenine compared t o 10.4 m L after2400 mg/day o f acetylsalicylic acid. I n normal volunteers, IDARAC w a s well absorbed after oral administrationand peak plasma levels were attained 1 - hours after administration and declined i n a biphasic manner, with an initial ( a phase) half-life o f approx- imately 1 hour and a later ( , phase) half-life o f approximately 8 hours. Floctafenine and i ts metabolites d o n o t accumulate following oral administration o f multiple doses. After oral an d intravenous administration o f '4C-labelled IDARAC, urinary excretion accounted f o r 4 0 a n d fecal a n d biliary excretion accounted f o r 60 o f t h e recovered radioactivity. T he main urinary metabolites a r e floctafenic acid a nd i t s conjugate with minimal amounts o f free floctafenine. INDICATIONS: IDARAC (floctafenine) i s indicated f o r short-term u s e i n acute pain o f a n d moderate severity. CONTRAINDICATIONS: IDARAC (floctafenine) i s contraindicated in patients with peptic ulceror a n y other active inflammatory disease o f t h e gastrointestinal tract, a n d i n patients w h o have demonstrated a hypersensitivity t o t h e drug. WARNINGS: U s e I Pregnancy: T h e u s e o f IDARAC (floctafenine) i n women o f child-bearing potential requires that t h e likely benefit o f t h e drug b e weighed against t h e possible risk t o th e mother a n d fetus. Since there i s no information o n t h e excretion o f floctafenine i n breast milk, u s e o f t h e drug in women w h o a r e nursing is n o t recommended. Use I n Children: T h e safety a n d efficacy o f IDARAC in children have n o t been established a n d therefore i t s u s e in this age g ro up i s n o t recommended. T h e safety a n d efficacy o f long-term u s e o f IDARAC have n o t been established. PRECAUTIONS: IDARAC (floctafenine) should be used with caution in patients with impaired renal function. I n clinical trials with IDARAC dysuria, without apparent changes in renal function, w as reported. T h e incidence o f dysuria w a s greater i n males than i n females a n d occurred primarily i n t h e first morning voiding. I t h a s n o t been established whether dysuria i s related t o dose and/or duration o f drug administration. Patients takinganticoagulant medica- tion m a y b e given IDARAC with caution. Alterations in pro- thrombin time have been observed only in clinical trials where t h e administration o f IDARAC w as extended beyond t w o weeks. IDARAC should b e used with caution i n patientswith a history o f peptic ulcer o r other gastrointestinal lesions. ADVERSE REAC- TIONS: The most commonly occurring side effects reported during IDARAC (floctafenine) therapy were: Central Nervous System: Drowsiness, dizziness, headache, insomnia, nervous- ness, irritability. Gastrointestinal System: Nausea, diarrhea, abdominal pain o r discomfort, heartburn, constipation, abnor- m al liver function, gastrointestinal bleeding. Urogenital Sys- tem: Dysuria, burning micturition, polyuria, strong smelling urine, urethritis a n d cystitis. Other less frequently occurring side effects were: tinnitus, blurred vision, dr y mouth, thirst, bitter taste, anorexia, stomach cramps, flatulence, h o t flushes an d sweating, tachycardia, weakness a n d tiredness. Allergic- type Reactions: Maculopapular skin rash, pruritis, urticaria, redness and itching o f the face a n d neck. SYMPTOMS A N D TREATMENT O F OVERDOSE: N o cases o f overdose have been reported with IDARAC (floctafenine), therefore n o specific information o n symptoms o r treatment i s available. Standard procedures t o evacuate gastric contents, maintain urinary output an d provide general supportive care should b e employed. DOSAGEAND ADMINISTRATION: T h e usual adult dose o f IDARAC (floctafenine) i s 2 0 0 t o 400 m g every 6 8 hours a s required. Th e recommended daily dose i s 1200 m g. IDARAC i s recommended f o r short-term management o f acute pain. T e tablets should b e taken with aglassof water. IDARAC i s n o t recommended f o r u s e i n children. AVAILABIL- ITY: IDARAC tablets a r e available as round, biconvex, creamy white tablets containing 2 0 0 m g floctafenine withthe markings W o n o ne side an d o n the other side I with 200 below; a n d a s round, biconvex, creamy white tablets containing 4 0 0 mg floctafenine with the markings W onone side and on t h e other side I with 400 below. IDARAC i s available i n bottles o f 100 tablets. Store at room temperature, protected from light. IDARAC i s a Schedule F (prescription) drug. Product mono- graph available upon request. Division o f Sterling Drug Ltd. Aurora,Ontario L 4 G Reg. Trade Markt **Registered User *,: vous eablissez avec v o s patientes e s t important. Montrez-vous attentif e t encouragez v o s patientes A participer A l a prise d e decisions d e facon A c e qu'elles restent maitresses d e l a situa- tion. ,askatoon O f Time a n d Talk Rejictions on relationships C linical psychologist D r Nina Woulff h a s been teaching asser- tiveness training f o r 1 5 years, wading daily into t h e treacherous waters of relationships - between spouses a n d between parents a n d teenagers. D i - rector o f t h e Dartmouth Branch o f t h e Atlantic Child Guidance Centre, a n d lecturer with t h e Department o f Psychiatry a t Dalhousie, Woulff spoke a t t h e 25th Maritime Conjoint in Charlottetown, sharing opinion, i n - sight, and experience i n a n informal lecture. H e r C an Assertiveness Be Unhealthy For Families launched discussion on a host o f issues an d con- tradictions i n modern relationships. Reflections a r e more than 1000 hours yearly ofinformation on relationships o n television. With such a glut of i n - formation, w h y d o people request speakers such a s me? A partial definition o f assertiveness: T o present a balanced view o f your strengths a s well a s your vulnerabili- ties; t o make clear statements with rel- atively little anxiety about your values a n d ideas. Aggression implies yell- ing, assertiveness implies coherence: I t i s a l o t easier t o b e aggressive than assertive. In taking the step from unassertive t o assertive: Y o u c a n teach people all
-
Upload
abdelazizismail685662 -
Category
Documents
-
view
218 -
download
0
Transcript of canfamphys00132-0232
7/27/2019 canfamphys00132-0232
http://slidepdf.com/reader/full/canfamphys00132-0232 1/4
KENACOMB®,PREPARATIONS I DT r i a m c i n o l o n e A c e t o n i d e - N e o m y c i n -N y s t a t i n - G r a m i c i d i n CompoundI n d i c a t i o n s : C o r t i c o s t e r o i d - r e s p o n s i v e i n f l a m m a t o r y o r p r u n t i cd e r m a t o s e s c a u s e d , t h r e a t e n e d o r c o m p l i c a t e d b y i n f e c t i o n d u et o b a c t e r i a a n d / o r c a n d i d a . P r u r i t u s a n i a n d p r u r i t u s v u l v a e( c r e a m o n l y ) . T h e 0 . 0 2 5 f o r m u l a t i o n s a r e f o r u s e o n e x t e n s i v el e s i o n s , o r d e r m a t o s e s w h i c h a r e c h r o n i c , m i l d , o r h i g h l y s u s -c e p t i b l e t o t o p i c a l c o r t i c o s t e r o i d t h e r a p y , o r f o r m a i n t e n a n c et h e r a p y o f d e r m a t o s e s p r e v i o u s l y c o n t r o l l e d b y a 0 . 1 f o r m u l a -
t i o n . C o n t r a i n d i c a t i o n s : T u b e r c u l o u s a n d m o s t v i r a l l e s i o n s o ft h e s k i n , i n c l u d i n g h e r p e s s i m p l e x , v a c c i n i a a n d v a r i c e l l a . F u n g a ll e s i o n s o f t h e s k i n , e x c e p t c a n d i d i a s i s . P a t i e n t s w i t h a h i s t o r y o fh y p e r s e n s i t i v i t y t o a n y o f t h e c o m p o n e n t s . N o t f o r o p h t h a l m i cu s e ; n o t t o b e a p p l i e d t o t h e e x t e r n a l a u d i t o r y c a n a l o f p a t i e n t sw i t h p e r f o r a t e d e a r d r u m s o r p a t i e n t s w i t h o t i t i s m e d i a . O c c l u s i v et h e r a p y c o n t r a i n d i c a t e d i n p a t i e n t s w i t h a t o p i c d e r m a t i t s . P r e -c a u t i o n s : B e c a u s e o f t h e p o t e n t i a l h a z a r d o f n e p h r o t o x i c i t y a n do t o t o x i c i t y , a v o i d p r o l o n g e d u s e o r u s e o f l a r g e a m o u n t s i n t h et r e a t m e n t o f s k i n i n f e c t i o n s f o l l o w i n g b u m s , t r o p h i c u l c e r a t i o na n d o t h e r c o n d i t i o n s w h e r e a b s o r p t i o n o f n e o m y c i n i s p o s s i b l e .A s w i t h a n y a n t i b i o t i c p r e p a r a t i o n , p r o l o n g e d u s e m a y r e s u l t i no v e r g r o w t h o f n o n s u s c e p t i b l e o r g a n i s m s , i n c l u d i n g f u n g i o t h e rt h a n C a n d i d a . C o n s t a n t o b s e r v a t i o n o f t h e p a t i e n t i s e s s e n t i a l .S h o u l d s u p e r i n f e c t i o n d u e t o n o n s u s c e p t i b l e o r g a n i s m s o c c u r ,K e n a c o m b s h o u l d b e d i s c o n t i n u e d a n d a p p r o p r i a t e t h e r a p yi n s t i t u t e d . A l t h o u g h a d r e n a l s u p p r e s s i o n a n d o t h e r s y s t e m i ca d v e r s e e f f e c t s a r e r a r e w i t h t o p i c a l c o r t i c o s t e r o i d p r e p a r a t i o n s ,t h e i r p o s s i b l e o c c u r r e n c e m u s t b e k e p t i n m i n d , p a r t i c u l a r l yw h e n t h e s e p r e p a r a t i o n s a r e u s e d o v e r l a r g e a r e a s o r f o r a ne x t e n d e d p e r i o d o f t i m e . O c c a s i o n a l l y , a p a t i e n t w h o h a s b e e n o np r o l o n g e d t h e r a p y m a y d e v e l o p s y m p t o m s o f s t e r o i d w i t h d r a w a lw h e n t h e m e d i c a t i o n i s s t o p p e d . T h e u s e o f o c c l u s i v e d r e s s i n g si s n o t r e c o m m e n d e d w i t h p r o d u c t s c o n t a i n i n g a n t i - i n f e c t i v ea g e n t s . I f l o c a l i r r i t a t i o n o r s e n s i t i z a t i o n d e v e l o p s , t h e p r e p a r a -t i o n s h o u l d b e d i s c o n t i n u e d a n d a p p r o p r i a t e t h e r a p y i n s t i t u t e d .P a t i e n t s s h o u l d b e a d v i s e d t o i n f o r m s u b s e q u e n t p h y s i c i a n s o ft h e p r i o r u s e o f c o r t i c o s t e r o i d s . W h e n a p p l i e d t o m o i s t i n t e r t r i g i -n o u s a r e a s , o l e a g i n o u s o i n t m e n t s i n g e n e r a l m a y b e i r r i t a t i n ga n d a r e n o t r e c o m m e n d e d . P r e g n a n c y a n d L a c t a t i o n : T h e s a f e t yo f t o p i c a l s t e r o i d p r e p a r a t i o n s d u r i n g p r e g n a n c y a n d l a c t a t i o nh a s n o t b e e n a b s o l u t e l y e s t a b l i s h e d ; t h e r e f o r e , t h e p o t e n t i a lb e n e f i t o f u s e s h o u l d b e w e i g h e d a g a i n s t p o s s i b l e h a z a r d t o t h ef e t u s o r t h e n u r s i n g i n f a n t . A r t i c l e s i n c u r r e n t m e d i c a l l i t e r a t u r ei n d i c a t e a n i n c r e a s e i n t h e i n c i d e n c e o f p a t i e n t s a l l e r g i c t on e o m y c i n . N e o m y c i n i t s e l f m a y c a u s e a n a l l e r g i c o t i t i s e x t e m a .S y s t e m i c n e o m y c i n t o x i c i t y h a s o c c u r r e d r a r e l y f o l l o w i n g t o p i c a la d m i n i s t r a t i o n ; t i n n i t u s a n d d e a f n e s s h a v e b e e n r e p o r t e d . T h ep o s s i b i l i t y o f s u c h a r e a c t i o n s h o u l d b e b o m e i n m i n d . T o p i c a ls t e r o i d s s h o u l d b e u s e d w i t h c a u t i o n o n l e s i o n s c l o s e t o t h e e y e .P r o l o n g e d u s e o f t o p i c a l c o r t i c o s t e r o i d p r o d u c t s m a y p r o d u c e
a t r o p h y o f t h e s k i n a n d s u b c u t a n e o u s t i s s u e s , p a r t i c u l a r l y o nf l e x o r s u r f a c e s a n d o n t h e f a c e . I f t h i s i s n o t e d , d i s c o n t i n u e u s eo f t h e c o r t i c o s t e r o i d . T o p i c a l c o r t i c o s t e r o i d s s h o u l d b e u s e d w i t hc a u t i o n i n p a t i e n t s w i t h s t a s i s d e r m a t i t i s a n d o t h e r s k i n d i s e a s e sa s s o c i a t e d w i t h i m p a i r e d c i r c u l a t i o n . I f a s y m p t o m a t i c r e s p o n s ei s n o t n o t e d w i t h i n a w e e k , d i s c o n t i n u e t h e l o c a l a p p l i c a t i o n o fc o r i c o s t e r o i d s a n d r e - e v a l u a t e t h e p a t i e n t . G r a m i c i d i n a b s o r p t i o nf o l l o w i n g t o p i c a l a d m i n i s t r a t i o n i s u n l i k e l y ; h o w e v e r , h e m o l y s i sm a y o c c u r s h o u l d t h e d r u g e n t e r t h e b l o o d . I f g r a m i c i d i n i sa l l o w e d t o c o m e i n c l o s e p r o x i m i t y t o t h e s u b - a r a c h n o i d s p a c e , ac h e m i c a l a r a c h n o i d i t i s m a y o c c u r . T h e p o s s i b i l i t y o f h y p e r s e n s i -t i v i t y t o e t h y l e n e d i a m i n e , a c o n s t i t u e n t o f K e n a c o m b c r e a m ,s h o u l d b e b o m e i n m i n d . A d v e r s e E f f e c t s : H y p e r s e n s i t i v i t y t on y s t a t i n i s e x t r e m e l y u n c o m m o n . S e n s i t i v i t y r e a c t i o n s f o l l o w i n gt h e t o p i c a l u s e o f g r a m i c i d i n o r t r i a m c i n o l o n e a c e t o n i d e a r er a r e l y e n c o u n t e r e d . N e o m y c i n : s e e P r e c a u t i o n s . B u m i n g , i t c h -i n g , i r r i t a t i o n , d r y n e s s , e r y t h e m a , f o l l i c u l i t i s , h y p e r t r i c h o s i s ,a c n e i f o r m e r u p t i o n s , t i n n i t u s , d e a f n e s s a n d h y p o p i g m e n t a t i o nh a v e b e e n r e p o r t e d w i t h t o p i c a l c o r t i c o s t e r o i d s . W h e n s t e r o i dp r e p a r a t i o n s a r e u s e d f o r l o n g p e r i o d s i n i n t e r t r i g i n o u s a r e a s o ru n d e r o c c l u s i v e d r e s s i n g s , s t r i a e m a y o c c u r D a m a g e t o c o l l a -g e n , w h i c h c o n s t i t u t e s a m i d d l e l a y e r o f t h e t y m p a n i c m e m -b r a n e , m a y o c c u r D e l a y e d h e a l i n g a n d s y s t e m i c e f f e c t s , i n c l u d -i n g a d r e n a l s u p p r e s s i o n a n d s u b c a p s u l a r c a t a r a c t s , m a y o c c u r i f
a b s o r b e d i n a p p r e c i a b l e a m o u n t s . D o s a g e : C r e a m : r u b i n t oa f f e c t e d a r e a s 2 t o 3 t i m e s d a i l y . O i n t m e n t : A p p l y a t h i n f i l m t ot h e a f f e c t e d a r e a s 2 t o 3 t i m e s d a i l y . M i l d C r e a m & O i n t m e n t : 3 o r4 t i m e s d a i l y . S u p p l i e d : C r e a m a n d O i n t m e n t : E a c h g c o n t a i n s :t r i m c i n o l o n e a c e t o n i d e 1 m g , n e o m y c i n b a s e ( a s s u l f a t e ) 2 . 5m g , g r a m i c i d i n 2 5 0 A g , n y s t a t i n 1 0 0 0 0 0 u n i t s . T h e c r e a m i sf o r m u l a t e d i n a p e r f u m e d a q u e o u s v a n i s h i n g c r e a m b a s e w h i c hp e r m i t s i t s u s e e v e n i n m o i s t i n t e r t r i g i n o u s a r e a s . I t a l s o c o n t a i n sp o l y s o r b a t e 6 0 , a l c o h o l , a l u m i n u m h y d r o x i d e c o n c e n t r a t e d w e tg e l , t i t a n i u m d i o x i d e , s i l i c o n e f l u i d , p r o p y l e n e g l y c o l , e t h y l e n e d i -a m i n e , h y d r o c h l o r i c a c i d , w h i t e p e t r o l e u m , p o l y o x y e t h y l e n ef a t t y a l c o h o l e t h e r , m e t h y l a n d p r o p y l p a r a b e n s a n d s o r b i t o ls o l u t i o n . T u b e s o f 1 5 , 3 0 a n d 6 0 g . T h e o i n t m e n t i s f o r m u l a t e d i np r o t e c t i v e P l a s t i b a s e ( S q u i b b p l a s t i c i z e d h y d r o c a r b o n g e l ) , ap o l y e t h y l e n e a n d m i n e r a l o i l g e l b a s e . T u b e s o f 1 5 , 3 0 a n d 6 0 g .K e n a c o m b M i l d : K e n a c o m b f o r m u l a a s a b o v e b u t w i t h t r i a m -c i n o l o n e a c e t o n i d e c o n c e n t r a t i o n o f 0 . 0 2 5 . T u b e s o f 3 0 g
( c r e a m a n d o i n t m e n t ) . Ue J o
X~ W J S Q U I B Bi v i s i o n o f / d e B r i s t o l - M y e r s S q u i b b C a n a d a I n c .
B e l l e v i l l e . O n t a n o K 8 N 5 E 9
P R E S C R I B I N G I N F O R M A T I O N f l o c t a f e n i n e 2 0 0 m g a n d 4 0 0 m gt a b l e t s . T H E R A P E U T I C C L A S S I F I C A T I O N : A n a l g e s i c .A C T IO N S : I D A R A C ( f l o c t a f e n i n e ) i s a n a n t h r a n i l i c a c i d d e r i v a -t i v e w h i c h h a s a n a l g e s i c a n d a n t i - i n f l a m m a t o r y p r o p e r t i e s . T h ea n a l g e s i c a c t i v i t y i s c o m p a r a b l e t o t h a t o f o t h e r m i l d a n a l g e s i c si n t h e r e l i e f o f a c u t e p a i n . F l o c t a f e n i n e h a s b e e n s h o w n t o i n h i b i ti n v i t r o b i o s y n t h e s i s o f p r o s t a g l a n d i n s P G E 2 a n d P G F 2 a . G a s t r o -i n t e s t i n a l b l e e d i n g d e t e r m i n e d b y d a i l y f e c a l b l o o d l o s s , w a ss h o w n i no n e
c l i n i c a l t r i a lt o b e a p p r o x i m a t e l y 1 . 2 mL a f t e r 1 6m g / d a y o f f l o c t a f e n i n e c o m p a r e d t o 1 0 . 4 m L a f t e r 2 4 0 0 m g / d a y
o f a c e t y l s a l i c y l i c a c i d . I n n o r m a l v o l u n t e e r s , I D A R A C w a s w e l la b s o r b e d a f t e r o r a l a d m i n i s t r a t i o n a n d p e a k p l a s m a l e v e l s w e r ea t t a i n e d 1 - 2 h o u r s a f t e r a d m i n i s t r a t i o n a n d d e c l i n e d i n ab i p h a s i c m a n n e r , w i t h a n i n i t i a l ( a p h a s e ) h a l f - l i f e o f a p p r o x -i m a t e l y 1 h o u r a n d a l a t e r ( , p h a s e ) h a l f - l i f e o f a p p r o x i m a t e l y8 h o u r s . F l o c t a f e n i n e a n d i t s m e t a b o l i t e s d o n o t a c c u m u l a t ef o l l o w i n g o r a l a d m i n i s t r a t i o n o f m u l t i p l e d o s e s . A f t e r o r a l a n di n t r a v e n o u s a d m i n i s t r a t i o n o f ' 4 C - l a b e l l e d I D A R A C , u r i n a r ye x c r e t i o n a c c o u n t e d f o r 4 0 a n d f e c a l a n d b i l i a r y e x c r e t i o na c c o u n t e d f o r 6 0 o f t h e r e c o v e r e d r a d i o a c t i v i t y . T h e m a i nu r i n a r y m e t a b o l i t e s a r e f l o c t a f e n i c a c i d a n d i t s c o n j u g a t e w i t hm i n i m a l a m o u n t s o f f r e e f l o c t a f e n i n e . I N D I C A T I O N S : I D A R A C( f l o c t a f e n i n e ) i s i n d i c a t e d f o r s h o r t - t e r m u s e i n a c u t e p a i n o fm i l d a n d m o d e r a t e s e v e r i t y . C O N T R A I N D I C A T I O N S : I D A R A C( f l o c t a f e n i n e ) i s c o n t r a i n d i c a t e d i n p a t i e n t s w i t h p e p t i c u l c e r o ra n y o t h e r a c t i v e i n f l a m m a t o r y d i s e a s e o f t h e g a s t r o i n t e s t i n a lt r a c t , a n d i n p a t i e n t s w h o h a v e d e m o n s t r a t e d a h y p e r s e n s i t i v i t yt o t h e d r u g . W A R N I N G S : U s e I n P r e g n a n c y : T h e u s e o f I D A R A C( f l o c t a f e n i n e ) i n w o m e n o f c h i l d - b e a r i n g p o t e n t i a l r e q u i r e s t h a t
t h e l i k e l y b e n e f i t o f t h e d r u g b e w e i g h e d a g a i n s t t h e p o s s i b l e r i s kt o t h e m o t h e r a n d f e t u s . S i n c e t h e r e i s n o i n f o r m a t i o n o n t h ee x c r e t i o n o f f l o c t a f e n i n e i n b r e a s t m i l k , u s e o f t h e d r u g i nw o m e n w h o a r e n u r s i n g i s n o t r e c o m m e n d e d . U s e I n C h i l d r e n :T h e s a f e t y a n d e f f i c a c y o f I D A R A C i n c h i l d r e n h a v e n o t b e e ne s t a b l i s h e d a n d t h e r e f o r e i t s u s e i n t h i s a g e g r o u p i s n o tr e c o m m e n d e d . T h e s a f e t y a n d e f f i c a c y o f l o n g - t e r m u s e o fI D A R A C h a v e n o t b e e n e s t a b l i s h e d . P R E C A U T I O N S : I D A R A C( f l o c t a f e n i n e ) s h o u l d b e u s e d w i t h c a u t i o n i n p a t i e n t s w i t hi m p a i r e d r e n a l f u n c t i o n . I n c l i n i c a l t r i a l s w i t h I D A R A C d y s u r i a ,w i t h o u t a p p a r e n t c h a n g e s i n r e n a l f u n c t i o n , w a s r e p o r t e d . T h ei n c i d e n c e o f d y s u r i a w a s g r e a t e r i n m a l e s t h a n i n f e m a l e s a n do c c u r r e d p r i m a r i l y i n t h e f i r s t m o r n i n g v o i d i n g . I t h a s n o t b e e ne s t a b l i s h e d w h e t h e r d y s u r i a i s r e l a t e d t o d o s e a n d / o r d u r a t i o no f d r u g a d m i n i s t r a t i o n . P a t i e n t s t a k i n g a n t i c o a g u l a n t m e d i c a -t i o n m a y b e g i v e n I D A R A C w i t h c a u t i o n . A l t e r a t i o n s i n p r o -t h r o m b i n t i m e h a v e b e e n o b s e r v e d o n l y i n c l i n i c a l t r i a l s w h e r et h e a d m i n i s t r a t i o n o f I D A R A C w a s e x t e n d e d b e y o n d t w o w e e k s .I D A R A C s h o u l d b e u s e d w i t h c a u t i o n i n p a t i e n t s w i t h a h i s t o r y o fp e p t i c u l c e r o r o t h e r g a s t r o i n t e s t i n a l l e s i o n s . A D V E R S E R E A C -
T I O N S : T h e m o s t c o m m o n l y o c c u r r i n g s i d e e f f e c t s r e p o r t e dd u r i n g I D A R A C ( f l o c t a f e n i n e ) t h e r a p y w e r e : C e n t r a l N e r v o u sS y s t e m : D r o w s i n e s s , d i z z i n e s s , h e a d a c h e , i n s o m n i a , n e r v o u s -n e s s , i r r i t a b i l i t y . G a s t r o i n t e s t i n a l S y s t e m : N a u s e a , d i a r r h e a ,a b d o m i n a l p a i n o r d i s c o m f o r t , h e a r t b u r n , c o n s t i p a t i o n , a b n o r -m a l l i v e r f u n c t i o n , g a s t r o i n t e s t i n a l b l e e d i n g . U r o g e n i t a l S y s -t e m : D y s u r i a , b u r n i n g m i c t u r i t i o n , p o l y u r i a , s t r o n g s m e l l i n gu r i n e , u r e t h r i t i s a n d c y s t i t i s . O t h e r l e s s f r e q u e n t l y o c c u r r i n gs i d e e f f e c t s w e r e : t i n n i t u s , b l u r r e d v i s i o n , d r y m o u t h , t h i r s t ,b i t t e r t a s t e , a n o r e x i a , s t o m a c h c r a m p s , f l a t u l e n c e , h o t f l u s h e sa n d s w e a t i n g , t a c h y c a r d i a , w e a k n e s s a n d t i r e d n e s s . A l l e r g i c -t y p e R e a c t i o n s : M a c u l o p a p u l a r s k i n r a s h , p r u r i t i s , u r t i c a r i a ,r e d n e s s a n d i t c h i n g o f t h e f a c e a n d n e c k . S Y M P T O M S A N DT R E A T M E N T O F O V E R D O S E : N o c a s e s o f o v e r d o s e h a v e b e e nr e p o r t e d w i t h I D A R A C ( f l o c t a f e n i n e ) , t h e r e f o r e n o s p e c i f i ci n f o r m a t i o n o n s y m p t o m s o r t r e a t m e n t i s a v a i l a b l e . S t a n d a r dp r o c e d u r e s t o e v a c u a t e g a s t r i c c o n t e n t s , m a i n t a i n u r i n a r yo u t p u t a n d p r o v i d e g e n e r a l s u p p o r t i v e c a r e s h o u l d b ee m p l o y e d . D O S A G E A N D A D M I N I S T R A T I O N : T h e u s u a l a d u l td o s e o f I D A R A C ( f l o c t a f e n i n e ) i s 2 0 0 t o 4 0 0 m g e v e r y 6 t o 8h o u r s a s r e q u i r e d . T h e m a x i m u m r e c o m m e n d e d d a i l y d o s e i s
1 2 0 0 m g . I D A R A C i s r e c o m m e n d e d f o r s h o r t - t e r m m a n a g e m e n to f a c u t e p a i n . T h e t a b l e t s s h o u l d b e t a k e n w i t h a g l a s s o f w a t e r .I D A R A C i s n o t r e c o m m e n d e d f o r u s e i n c h i l d r e n . A V A I L A B I L -I T Y : I D A R A C t a b l e t s a r e a v a i l a b l e a s r o u n d , b i c o n v e x , c r e a m yw h i t e t a b l e t s c o n t a i n i n g 2 0 0 m g f l o c t a f e n i n e w i t h t h e m a r k i n g s W o n o n e s i d e a n d o n t h e o t h e r s i d e I w i t h 2 0 0 b e l o w ;a n d a s r o u n d , b i c o n v e x , c r e a m y w h i t e t a b l e t s c o n t a i n i n g 4 0 0m g f l o c t a f e n i n e w i t h t h e m a r k i n g s W o n o n e s i d e a n d o n t h eo t h e r s i d e I w i t h 4 0 0 b e l o w . I D A R A C i s a v a i l a b l e i n b o t t l e so f 1 0 0 t a b l e t s . S t o r e a t r o o m t e m p e r a t u r e , p r o t e c t e d f r o m l i g h t .I D A R A C i s a S c h e d u l e F ( p r e s c r i p t i o n ) d r u g . P r o d u c t m o n o -g r a p h a v a i l a b l e u p o n r e q u e s t .
D i v i s i o n o f S t e r l i n g D r u g L t d .A u r o r a , O n t a r i o L 4 G 3 H 6
R e g . T r a d e M a r k t * * R e g i s t e r e d U s e r
*,:
v o u s e a b l i s s e z a v e c v o s p a t i e n t e s e s t
i m p o r t a n t . M o n t r e z - v o u s a t t e n t i f e t
e n c o u r a g e z v o s p a t i e n t e s A p a r t i c i p e rA l a p r i s e d e d e c i s i o n s d e f a c o n A c e
q u ' e l l e s r e s t e n t m a i t r e s s e s d e l a s i t u a -t i o n . , a s k a t o o n
Of T i m ea n d T a l kR e j i c t i o n s o n r e l a t i o n s h i p s
C l i n i c a l p s y c h o l o g i s t Dr N i n a
W o u l f f h a s b e e n t e a c h i n g a s s e r -
t i v e n e s s t r a i n i n g f o r 1 5 y e a r s , w a d i n g
d a i l y i n t o t h e t r e a c h e r o u s w a t e r s o f
r e l a t i o n s h i p s - b e t w e e n s p o u s e s a n d
b e t w e e n p a r e n t s a n d t e e n a g e r s . D i -r e c t o r o f t h e D a r t m o u t h B r a n c h o f
t h e A t l a n t i c C h i l d G u i d a n c e C e n t r e ,a n d l e c t u r e r w i t h t h e D e p a r t m e n t o f
P s y c h i a t r y a t D a l h o u s i e , W o u l f f s p o k e
a t t h e 2 5 t h M a r i t i m e C o n j o i n t i n
C h a r l o t t e t o w n , s h a r i n g o p i n i o n , i n -
s i g h t , a n d e x p e r i e n c e i n a n i n f o r m a ll e c t u r e . H e r C a n A s s e r t i v e n e s s B e
U n h e a l t h y F o r F a m i l i e s l a u n c h e d
d i s c u s s i o n o n a h o s t o f i s s u e s a n d c o n -
t r a d i c t i o n s i n m o d e r n r e l a t i o n s h i p s .R e f l e c t i o n s f o l l o w .
T h e r e a r e m o r e t h a n 1 0 0 0 h o u r s
y e a r l y o f i n f o r ma t i o n o n r e l a t i o n s h i p so n t e l e v i s i o n . W i t h s u c h a g l u t o f i n -
f o r m a t i o n , w h y d o p e o p l e r e q u e s t
s p e a k e r s s u c h a s m e ?
A p a r t i a l d e f i n i t i o n o f a s s e r t i v e n e s s :
T o p r e s e n t a b a l a n c e d v i e w o f y o u r
s t r e n g t h s a s w e l l a s y o u r v u l n e r a b i l i -t i e s ; t o m a k e c l e a r s t a t e m e n t s w i t h r e l -
a t i v e l y l i t t l e a n x i e t y a b o u t y o u r v a l u e sa n d i d e a s . A g g r e s s i o n i m p l i e s y e l l -
i n g , a s s e r t i v e n e s s i m p l i e s c o h e r e n c e : I t i s a l o t e a s i e r t o b e a g g r e s s i v e t h a n
a s s e r t i v e .
I n t a k i n g t h e s t e p f r o m u n a s s e r t i v e t oa s s e r t i v e : Y o u c a n t e a c h p e o p l e a l l
7/27/2019 canfamphys00132-0232
http://slidepdf.com/reader/full/canfamphys00132-0232 2/4
t h o s e o u t e r e x t e r n a l t r i c k s : s i t t i n g a u -t h o r i t a t i v e l y , m a k i n g e y e c o n t a c t , u s i n gt h e w o r d I a n d m a k i n g d e c l a r a t i v es t a t e m e n t s i n s t e a d o f a s k i n g v a g u e
q u e s t i o n s . A f t e r b e i n g t a u g h t t h e s es k i l l s , w e n o t i c e d a h i g h e r l e v e l o f a n x i -e t y . W h y ? F a r m o r e i m p o r t a n t t h a nt e a c h i n g p e o p l e a s s e r t i v e n e s s s k i l l s i s
t e a c h i n g t h e m w h a t t o d o w i t h a l l t h a ta n x i e t y . I t i s a m a t t e r o f l i m i t i n g i t n o te r a d i c a t i n g i t . T h e ' e n d r e s u l t ? Y o u
w i l l e x p e r i e n c e a n x i e t y , b u t y o u w i l l
c o n t r o l a n d m a n a g e i t .
W h a t c a u s e s t h e a n x i e t y i s a c h a n g e
o f a s e t o f b e l i e f s . I n d i v i d u a l s l i v e b y
c e r t a i n c o m m a n d m e n t s , l e a r n e d i nc h i l d h o o d ; a n d w e a r e o n l y h a l fa w a r e o f t h e m: many o f t h e m w e r e
n o t o v e r t l y s t a t e d o r w r i t t e n d o w n o n
a t a b l e t s o t h a t y o u c a n a n a l y z e t h e m .
T h e y a r e i m p l i c i t r u l e s r a t h e r t h a n
e x p l i c i t .
o s S _ P t n a o X t r tr X w T sM 1 1 1 1 1 ll i _ ¢ _I i l I I _ : KL 1rrb M m
D R N I N A W O U L F F : u n v t W s h o n z s r e l i n s k i s s @@@ @ @@@@@ @@@ @@ @ @@ @@@@@@@ @ @s s
R u l e s a r e o n l y r u l e s.F o r d o c t o r s o n l y : Y o u r t r a i n i n g a n d
S t a r t r e w r i t i n g t h e r u l e s . y o u r r o l e i s t o r e s p o n d a n d t o r e s p o n d * . q u i c k l y . T h a t i s a p p r o p r i a t e i n a m e d -
C o m p r o m i s e i s a n i n t e r e s t i n g w o r d i c a l e m e r g e n c y . I a m s u g g e s t i n g t h a tb e c a u s e i t m e a n s d i f f e r e n t t h i n g s t o a t h o m e , t r e a t i n g a s i t u a t i o n l i k e a
d i f f e r e n t p e o p l e . m e d i c a l e m e r g e n c y i s o v e r r e a c t i n g .* 0 0 0 0
7/27/2019 canfamphys00132-0232
http://slidepdf.com/reader/full/canfamphys00132-0232 3/4
~N izoaraI( k e t o c o n a z o l e 2 ) sh mpoo
T O P I C A L A N T I F U N G A L A G E N T
A C T I O N S
I n v i t r o s t u d i e s s u g g e s t t h a t t h e a n t i f u n g a l p r o p e r t i e s o f N I Z O R A L( k e t o c o n a z o l e ) m a y b e r e l a t e d t o i t s a b i l i t y t o i m p a i r t h e s y n t h e s i so f e r g o s t e r o l , a c o m p o n e n t o f f u n g a l a n d y e a s t c e l l m e m b r a n e sW i t h o u t t h e a v a i l a b i l i t y o f t h i s e s s e n t i a l s t e r o l , t h e r e a r e m o r p h o -l o g i c a l a l t e r a t i o n s o f t h e f u n g a l a n d y e a s t c e l l m e m b r a n e s m a n i f e s t e da s a b n o r m a l m e m b r a n o u s i n c l u s i o n s b e t w e e n t h e c e l l w a l l a n d t h ep l a s m a m e m b r an e . T h e i n h i b i t i o n o f e r g o s t e r o l s y n t h e s i s h a s b e e na t t r i b u t e d t o i n t e r f e r e n c e w i t h t h e r e a c t i o n s i n v o l v e d i n t h e r e m o v a lo f t h e 1 4 - a - m e t h y l g r o u p o f t h e p r e c u r s o r o f e r g o s t e r o l , l a n o s t e r o l .E x c e p t f o r i t s s p e c i f i c p h a r m a c o l o g i c e f f e c t , i . e . a s p o r o c i d a l o r f u n g i -c i d a l a c t i v i t y , k e t o c o n a z o l e w h e n f o r m u l a t e d i n a 2 s h a m p o o i sn o t e x p e c t e d t o e x e r t an y o t h e r p h a r m a c o d y n a m i c e f f e c t w h e na p p l i e d t o p i c a l l y o n t h e s k i n o r h a i r .
I N D I C A T I O N S
N I Z O R A L ( k e t o c o n a z o l e ) 2 s h a m p o o i s i n d i c a t e d f o r t h e t o p i c a lt r e a t m e n t a n d p r o p h y l a x i s o f p i t y r i a s i s c a p i t i s i n f e c t i o n s ( d a n d r u f f )i n w h i c h t h e y e a s t P i t y r o s p o r u m i s i n v o l v e d .
C O N T R A I N D I C A T I O N S
N I Z O R A L ( k e t o c o n a z o l e ) 2 s h a m p o o i s c o n t r a i n d i c a t e d i n p e r s o n s
w h o h a v e s h o w n h y p e r s e n s i t i v i t y t o t h e a c t i v e o r e x c i p i e n t i n g r e -d i e n t s o f t h i s f o r m u l a t i o n .
W A R N I N G S
I r r i t a t i o n m a y o c c u r w h e n N I Z O R A L s h a m p o o i s u s e d i m m e d i a t e l ya f t e r p r o l o n g e d t r e a t m e n t w i t h t o p i c a l c o r t i c o s t e r o i d s . T h e r e f o r e ,i t i s r e c o m m e n d e d t o w a i t f o r a b o u t 2 w e e k s a f t e r t r e a t m e n t w i t h
t o p i c a l c o r t i c o s t e r o i d s b e f o r e u s i n g N I Z O R A L s h a m p o o .
P R E C A U T I O N S
I f a r e a c t i o n s u g g e s t i n g s e n s i i v i t y or c h e m i c a l i r r i t a t i o n s h o u l d o c c u r ,
us e o f N I Z O R A L s h a m p o o s h o u l d b e d i s c o n t i n u e d .N I Z O R A L s h a m p o o d o e s n o t p r o d u c e d e t e c t a b l e b l o o d l e v e l s a f t e rt o p i c a l a p p l i c a t i o n . H o w e v e r d u e t o t h e t e r a t o g e n i c n a t u r e o f t h ea c t i v e i n g r e d i e n t , k e t o c o n a z o l e , t h e u s e o f N I Z O R A L s h a m p o o i sn o t r e c o m m e n d e d i n p r e g n a n t o r n u r s i n g women.
A D V E R S E R E A C T I O N S
N I Z O R A L ( k e t o c o n a z o l e ) 2 s h a m p o o causes m i n i m a l s k i n a n ds c a l p i r r i t a t i o n . D u r i n g c l i n i c a l t r i a l s , 1 1 ( 2 . 1 ) o f 5 3 2 p a t i e n t s t r e a t e dw i t h a c t i v e s h a m p o o r e p o r t e d s i d e e f f e c t s : D r y , b r i t t l e h a i r ( 4 ) , greasy
h a i r ( 2 ) , h a i r l o s s ( 1 ) , i r r i t a t i o n ( 1 ) , e x f o l i a t i v e d e r m a t i t i s ( 1 ) , t i n yp u s t u l e s o n s c a l p ( 1 ) a n d d r y n e s s a n d i t c h i n g o f f o r e h e a d a n dc h e e k s ( 1 ) .
SYMPTOMS AN D T R E A T M E N T O F O V E R D O S A G E
O r a l i n g e s t i o n i s u s u a l l y f o l l o w e d b y nausea a n d v o mi ti ng d u e t ot h e d e t e r g e n t . I n t h e e v e n t o f a c c i d e n t a l o v e r d o s a g e , i n d u c e v o m i t i n go r c o n s i d e r g a s t r i c l a v a g e w i t h s o d i u m b i c a r b o n a t e , w i t h g e n e r a ls u p p o r t i v e measures as r e q u i r e d . I t h as b e e n r e p o r t e d t h a t k e t o -c o n a z o l e c a n n o t b e r e m o v e d b y h e m o d i a l y s i s .
D O S A G E AN D A D M I N I S T R A T I O NN I Z O R A L s h a m p o o s h o u l d b e a p p l i e d t o t h e w e t s c a l p , w o r k e d i n t oa l a t h e r a n d l e f t on f o r 3 - 5 m i n u t e s b e f o r e r i n s i n g w i t h w a t e r . A sw i t h o t h e r s h a m p o o s , c a r e s h o u l d b e t a k e n t o k e e p t h e s h a m p o oo u t o f t h e e y e s a n d o f f t h e e y e l i d s .T r e a t m e n t : T w i c e w e e k l y f o r 4 w e e k s .
P r o p h y l a x i s : O n c e every on e o r t w o w e e k s .
D O S A G E FORM
A v a i l a b i l i t y : N I Z O R A L ( k e t o c o n a z o l e ) 2 s h a m p o o i s s u p p l i e d i nH D P E f l a s k s w i t h 1 0 0 m L s h a m p o o c o n t a i n i n g 2 0 mg k e t o c o n a z o l ep e r gram.
S t o r a g e : N I Z O R A L 2 s h a m p o o s h o u l d b e s t o r e d a t r o o m t e m -
p e r a t u r e .
P r o d u c t M o n o g r a p h a v a i l a b l e on r e q u e s t .
R E F E R E N C E S : 1 . D e g r e e f H , R o s e n b e r g E W . : S e b o r r h o e i c d e r m a t i t i sa n d d a n d r u f f : a p l a c e f o r a n t i f u n g a l s . P r o c e e d i n g s o f a s a t e l l i t e s y m -
p o s i u m t o t h e S e c o n d I n t e r n a t i o n a l S k i n T h e r a p y S y m p o s i u m ,A n t w e r p , B e l g i u m, M a y 5 , 1 9 8 8 . D a t a on f i l e a t J a n s s e nP h a r m a c e u t i c a I n c . 2 . D e g r e e f H , J a c o b s P H, R o s e n b e r g E W , e t a l( e d s ) . : K e t o c o n a z o l e i n s e b o r r h o e i c d e r m a t i t i s a n d d a n d r u f f . A
R e v i e w . D a t a on f i l e a t J a n s s e n P h a r m a c e u t i c a I n c . 3 . G r e e n C A e ta l . : T r e a t m e n t o f s e b o r r h o e i c d e r m a t i t i s w i t h k e t o c o n a z o l e : II .
R e s p o n s e o f s e b o r r h o e i c d e r m a t i t i s o f t h e f a c e , s c a l p a n d t r u n k t ot o p i c a l k e t o c o n a z o l e . B r J D e r m a t o l 1 9 8 7 ; 1 1 6 : 2 1 7 - 2 2 1 .4 . Faergemann J . : A c t i v i t y o f t ri a zo le d e r i v a t i v e s a g a i n s t
P i t y r o s p o r u m o r b i c u l a r e i n v i t r o a n d i n v i v o . A n n a l s o f th e N ew Y o r k
Academy o f S c i e n c e s 1 9 8 8 ; 5 4 4 : 3 4 8 - 3 5 3 . 5 . S m i t h E B . :K e t o c o n a z o l e S h a m p o o , S e m i n a r s i n D e r m a t o l o g y 1 9 8 7 ; 6 ( 1 ) : 6 6 - 6 7 .
T h u l l i e z M . : I n : J a n s s e n i n t o u c h w i t h t h e s k i n . A b s t r a c t o fS a t e l l i t e S y m p o s i u m to t h e 1 7 t h W o r l d C o n g r e s s o f D e r m a t o l o g y ,B e r l i n , 1 9 87 , 4 7. 7 . T a n ew A . : A r a n d o m i z e d s t u d y w i t h k e t o c o n a z o l e
s h a m p o o 2 or S e l s u n ( s e l e n i u m s u l p h i d e 2 . 5 ) i n th e t r e a t m e n t
o f s e b o r r h o e i c d e r m a t i t i s a n d / o r d a n d r u f f . C l i n i c a l R e s e a r c h R e p o r t
R 4 1 4 0 0 / 1 7 2 , N o v e m b e r 1 9 8 7 . D a t a on f i l e a t J an s s e n P h a r m a -
c e u t i c a I n c . 8 . S c h r o o t e n P, D e D o nc k e r P . : 2 k e t o c o n a z o l e
s h a m p o o i n s e b o r r h o e i c d e r m a t i t i s a n d d a n d r u f f , A b s t r a c t o f t h eI n t e r n a t i o n a l S o c i e t y f o r Human a n d A n im a l M y c o l o g y , B a r c e l o n a ;I n : R e v i s t a / b d r i c a d e M i c o l o g i a 1 9 8 8 ; 5 ( 1 ) : 6 2 . 9 . S h u s t e r S ,B l a t c h f o r d , N . : S e b o r r h o e i c d e r m a t i t i s a n d d a n d r u f f : A f u n g a l d i s e a s e .A S y m p o s i u m , R o y a l S o c i e t y o f M e d i c i n e , L o n d o n , D e c e m b e r 1 9 8 7 .
D a t a on f i l e a t J a n s s e n P h a r m a c e u t i c a I n c . 1 0 . J a c o b s P H . :S e b o r r h o e i c D e r m a t i t i s : C a u s e s a n d M a n a g e m e n t . CUT/S M a r c h
1 9 8 8 ; 4 1 : 1 8 2 - 1 8 6 . 1 1 . N i z o r a l sh ampoo p r o d u c t m o n o g r a p h .
J A N S S E NP H A R M A C E U T I C A
- S R
A n t i - i n f l a m m a t o r y , a n a l g e s i c a g e n t
B r i e f p r e s c r i b i n g i n f o r m a t i o n :
A c t i o n s a n d C l i n i c a l P h a r m a c o l o g y : S U R G A M S R , a p r o p i o n i ca c i d d e r i v a t i v e , i s a N S A I a g e n t t h a t i n h i b i t s p r o s t a g l a n d i ns y n t h e t a s e e n z y m e s b u t w h o s e m e c h a n i s m o f a c t i o n i s n o tc o m p l e t e l y k n o w n .
I n v i t r o a n d e x v i v o s t u d i e s i n d i f f e r e n t e x p e r i m e n t a l m o d e l s w i t hc a r t i l a g e a n d c u l t u r e s o f h u m a n c h o n d r o c y t e s o b t a i n e d f r o mb i o p s y s p e c i m e n s h a v e s h o w n t h a t e x p o s u r e t o t i a p r o f e n i c a c i dd i d n o t d e p r e s s t h e b i o s y n t h e s i s o f p r o t e o g l y c a n s n o r a l t e r t h ed i f f e r e n t i a t i o n o f p r o t e o g l y c a n s s e c r e t e d . T h e d e g r a d a t i o n o fp r o t e o g l y c a n a g g r e g a t e s wa s i n h i b i t e d .
T h e s e i n v i t r o r e s u l t s s u g g e s t a p o s i t i v e e f f e c t o f t i a p r o f e n i c a c i do n t h e j o i n t c a r t i l a g e u n d e r e x p e r i m e n t a l c o n d i t i o n s .
T h e c l i n i c a l s i g n i f i c a n c e o f t h e s e f i n d i n g s i s n o t k n o w n a n d w i l l
b e f u r t h e r i n v e s t i g a t e d .I n d i c a t i o n s a n d c l i n i c a l u s e : R e l i e f o f s i g n s a n d s y m p t o m s o fr h e u m a t o i d a r t h r i t i s a n d o s t e o a r t h r i t i s .
C o n t r a i n d i c a t i o n s : P e p t i c u l c e r o r a c t i v e i n f l a m m a t o r y d i s e a s e o ft h e G I s y s t e m . K n o w n o r s u s p e c t e d h y p e r s e n s i t i v i t y t o t h e d r u g .P a t i e n t s i n whom a c u t e a s t h m a t i c a t t a c k s , u r t i c a r i a , r h i n i t i s o r
o t h e r a l l e r g i c r e a c t i o n s a r e p r e c i p i t a t e d b y A S A o r N S A I D s , a s
f a t a l a n a p h y l a c t o i d r e a c t i o n s h a v e o c c u r r e d i n s u c h i n d i v i d u a l s .
W a r n i n g s : SURGAM S R s h o u l d b e g i v e n u n d e r c l o s e m e d i c a ls u p e r v i s i o n t o p a t i e n t s p r o n e t o G I t r a c t i r r i t a t i o n . P a t i e n t ss h o u l d i m m ed i a te l y c o n t a c t a p h y s i c i a n i f t h e y e x p e r i e n c esymptoms o r s i g n s s u g g e s t i v e o f p e p t i c u l c e r a t i o n o r G Ib l e e d i n g . F o r e l d e r l y , f r a i l a n d d e b i l i t a t e d p a t i e n t s , c o n s i d e r a t i o ns h o u l d b e g i v e n t o a l o w e r s t a r t i n g d o s e , w i t h i n d i v i d u a la d j u s t m e n t w h e n n e c e s s a r y a n d u n d e r c l o s e s u p e r v i s i o n . N o tr e c o m m e n d e d i n p r e g n a n c y a n d l a c t a t i o n , o r i n c h i l d r e n .
P r e c a u t i o n s : I f p e p t i c u l c e r i s s u s p e c t e d o r c o n f i r m e d or G Ib l e e d i n g o c c u r s , t i a p r o f e n i c a c i d s h o u l d b e d i s c o n t i n u e d ,a p p r o p r i a t e t r e a t m e n t a n d m o n i t o r i n g i n s t i t u t e d . T i a p r o f e n i c a c i ds h o u l d b e u s e d w i t h c a u t i o n i n p a t i e n t s w i t h c a r d i a cd e c o m p e n s a t i o n , h y p e r t e n s i o n a n d r e n a l d i s e a s e s . T i a p r o f e n i ca c i d s h o u l d b e u s e d w i t h c a u t i o n i n p a t i e n t s w i t h i m p a i r e d r e n a lf u n c t i o n , a n d t h e d o s a g e s h o u l d b e a d j u s t e d a c c o r d i n g l y . R e n a lf u n c t i o n s h o u l d b e m o n i t o r e d p e r i o d i c a l l y i n p a t i e n t s o n l o n g -t e r m t r e a t m e n t . SURGAM S R s h o u l d b e d i s c o n t i n u e d i f
s y m p t o m s o f v e s i c a l i r r i t a t i o n s h o u l d d e v e l o p . L i v e r f u n c t i o ns h o u l d b e m o n i t o r e d d u r i n g l o n g - t e r m t r e a t m e n t w i t h t h i s d r u g .S a f e t y o f S U R G A M S R i n p a t i e n t s w i t h l i v e r d i s e a s e h a s n o t b e e ne s t a b l i s h e d . SURGAM S R s h o u l d b e u s e d w i t h c a u t i o n i np a t i e n t s w i t h p o t e n t i a l f o r a b n o r m a l b l e e d i n g . T h e r a p y s h o u l d b ed i s c o n t i n u e d i f a p a t i e n t d e v e l o p s b l u r r e d a n d / o r d i m i n i s h e dv i s i o n a n d an o p h t h a l m ol o g i c al e x a m in a t i o n c a r r i e d o u t .T i a p r o f e n i c a c i d s h o u l d b e u s e d w i t h c a u t i o n i n t h e e l d e r l y , a n dt h e d o s a g e a d j u s t e d i n d i v i d u a l l y . P h y s i c i a n s h o u l d b e a l e r t t o t h ed e v e l o p m e n t o f i n f e c t i o n i n p a t i e n t s r e c e i v i n g t h i s d r u g .
D r u g I n t e r a c t i o n s : M a y i n t e r a c t w i t h a n t i c o a g u l a n t s , s u l -f o n y l u r e a , h y p o g l y c e m i c a g e n t s , s u l f o n a m i d e s , p h e n y t o i n ,
l i t h i u m a n d c e r t a i n c h e m o t h e r a p e u t i c a g e n t s s u c h a s
m e t h o t r e x a t e , t h e r e f o r e , c a u t i o n s h o u l d b e o b s e r v e d w h e n t h e s ed r u g s a r e u s e d c o n c u r r e n t l y . C o u l d i n t e r f e r e w i t h d i u r e t i c s i nh y p e r t e n s i o n .
A d v e r s e r e a c t i o n s : G a s t r o i n t e s t i n a l ( 1 6 ) ; i n d i g e s t i o n , n a u s e a ,
h e a r t b u r n , e p i g a s t r i c p a i n , v o m i t i n g , a b d o m i n a l p a i n , c o n s t -i p a t i o n , f l a t u l e n c e , d i a r r h e a , e n t e r o c o l i t i s , m e l e n a , r a r e i n c i d e n t so f g a s t r i c o r d u o d e n a l u l c e r a t i o n . C e n t r a l N e r v o u s S y s t e m( 6 . 2 ) ; d i z z i n e s s , d r o w s i n e s s , h e a d a c h e , d e p r e s s i o n , d i s -o r i e n t a t i o n , i n s o m n i a , t i n n i t u s , a n x i e t y , t i r e d n e s s / w e a k n e s s .C u t a n e o u s ( 2 . 1 ) ; r a s h , e r y t h e m a , p r u r i t i s , d r y s k i n , o n y -
c h o l y s i s . C a r d i o v a s c u l a r ( 1 . 1 ) ; h o t f l u s h e s , c h e s t p a i n ,a n g i n a , b r u i s i n g . R e n a l ( 1 . 1 ) ; o e d e m a , i n c o n t i n e n c e , p o l y u r i a ,o l i g u r i a . H e p a t i c f u n c t i o n t e s t s l e s s t h a n 1 . M i s c e l l a n e o u s( 2 . 2 0 / ) ; d r y m o u t h / t o n g u e , s t o m a t i t i s , n o s e b l e e d s . O t h e r s ( 0 . 1t o 0 . 5 ) ; e y e i t c h i n g / c o n j u n c t i v i t i s / r e d e y e s , m i n o r e y e u l c e r s ,b l u r r e d v i s i o n , a n o r e x i a , w e i g h t g a i n , cr a m p s , d y s p n e a , i n t e r -m e n s t r u a l b l e e d i n g / v a g i n a l s p o t t i n g , p a r e s t h e s i a o f f i n g e r s ,s n ee z in g , s w e at i ng , p a l p e b r a l o e d e m a , p a l p i t a t i o n s , v e r t i g o ,
t r e m o r , c y s t a l g i a , d y s u r i a , p o l l a k i u r i a , h e m at u ri a a n d c y s t i t i s .
D o s a g e a n d A d m in i s tr a t io n f o r R h e u m a t o i d A r t h r i t i s o r
O s t e o a r t h r i t i s : T h e i n i t i a l a n d m a i nt e n an c e d o s e i s 2 S u r g a m S Rc a p s u l e s o f 3 0 0 mg o nce d a i l y a t b e d t i m e . S u rg a m S R c a p s u l e ss h o u l d b e s w a l l o w e d w h o l e .
A v a i l a b i l i t y : SURGAM S R i s a v a i l a b l e a s 3 0 0 mg h a r d g e l a t i n
c a p s u l e s w i t h a t r a n s p a r e n t p i n k b o dy a nd o pa qu e m a r oo n ca p
p r i n t e d w i t h SURGAM S R on on e s i d e a n d t h e R o u s s e l l o g o on
t h e o t h e r , e a c h c o n t a i n i n g o f f - w h i t e s p h e r o i d a l p e l l e t s .
P r o d u c t m o n o g r a p h a v a i l a b l e on r e q u e s t .
R e f e r e n c e s : 1 . P h i l l i p s , G . , e t a l . C u r r . M e d . R e s . a n d O p i n . , V o l .1 0 , N o . 7 , 4 8 6 - 4 9 3 , 1 9 8 7 2 . B e r n s t e i n , R . , e t a l . D a t a on f i l e .
3 . H a z l e m a n , B . L . , e t a l . D a t a on f i l e . 4 . C a l i n , A. , e t a l . D r u g s 3 5( s u p p l 1 ) . 5 7 - 6 3 , 1 9 8 8 . 5 . E s s i g m a n , W . , e t a l . I n t J C l i n P h a r m
R e s V l I ( 4 ) 2 5 1 - 2 5 7 , 1 9 8 7 . 6 . W a r r i n g t o n , S . J . , e t a l . D r u g s 3 5
( s u p p l 1 ) . 9 0 - 9 4 , 1 9 8 8 .
R e g i s t e r e d trademark o f R o u s s e l U C L A F .
emember Surgam S R ,
2 caps once d a i l yPAABA
I C C ^A A B P MEMBER
R O U S S E L 'M I A R - 2 / / 9 1 R O U S S E L C A N A D A I NC
? . I A N C C F K I 1 a a n ~ ~ A D S U R - 2 2 L L V / 0 2 / 9 I O N T R E A L O l I t B E C A l _
P e o p l e i n t h e h e l p i n g p r o f e s s i o n a n d
t h o s e wh o a r e a t t r a c t e d t o t h e m t e n d
t o b e o v e r - r e s p o n s i b l e .* - 9
A p a r e n t ' s r o l e i s t o d e f i n e c l e a r l yw h a t y o u s t a n d f o r a n d s e n d a m e s -
s a g e o f w h e r e y o u s t a n d . Y o u a r e n o tr e s p o n s i b l e f o r s o m e o n e e l s e ' s h a p p i -n e s s .
A l l t h e e n e r g y p u t i n t o c h a n g i n g o t h -
e r p e o p l e i s w a s t e d e n e r g y . I t i s b e t t e r
t o p u t t h e e m p h a s i s o n c h a n g i n g
y o u r s e l f . Do n o t f o r c e p e o p l e t o
c h a n g e : A l l o w t h a t o t h e r s h a v e
c h o i c e s a f t e r y o u h a v e t a k e n a s t a n d .*
I w a n t p e o p l e t o s t o p a n d t h i n k i n -
s t e a d o f c o n s t a n t l y r e a c t i n g . T h a t i s
w h y t h e y a r e d y s f u n c t i o n a l , w h y t h e ya r e i n t h e r a p y . T h i n k a b o u t m o d e l s
a n d p a s t b e h a v i o r p a t t e r n s .* 9
Wh y t h e r e c e n t o b s e s s i o n w i t h r e l a -
t i o n s h i p s ? P e o p l e h a v e m o r e t i m e ,f e w e r c h i l d r e n , a n d w o r k f e w e r h o u r s .A l s o t h e a d v e n t o f w a s h i n g m a c h i n e s
a n d m i c r o w a v e s a l l o w a l o t m o r e f r e et i m e , p a r t i c u l a r l y f o r w o m e n .
* 0
I d o n ' t t h i n k r e l a t i o n s h i p s a r e w o r s e .P e o p l e j u s t t a l k a b o u t t h e m m o r e .
0
O n t h e p r o l i f e r a t i o n o f t a l k s h o w s
a b o u t r e l a t i o n s h i p s a n d t h e s p e c t a t o rs o c i e t y t h a t f e e d s t h e m : I d o n ' t t h i n ki t i s a l l t h a t b a d . P e o p l e h a v e a l w a y sb e e n c u r i o u s a b o u t l i f e , a b o u t o t h e rp e o p l e , a n d b e e n i n t e r e s t e d i n p e o p l ewh o a r e d i f f e r e n t . I f t h e y a r e w a t c h -
i n g , t h e y a r e t o l e r a t i n g a n d a c c e p t i n g .I t c a n b e p o s i t i v e i f y o u s h o w p e o p l ewh o h a v e s t r u g g l e d a n d s u r v i v e d .
O n s e l f - h e l p b o o k s o n r e l a t i o n s h i p s ,o f w h i c h s h e c o u n t e d 6 0 i n a l o c a lb o o k s t o r e : S o m e s e l f - h e l p b o o k s a r eg o o d b u t m o r e o f t e n t h a n n o t , t h e yc o n f u s e p e o p l e . T h e y c a n m a k e s u -p e r f i c i a l c h a n g e s i n a p e r s o n r a t h e r
t h a n b u i l d i n g - b l o c k c h a n g e s .
496sC anadIanyiulylPicU VOL3 le yu
4 9 6 C a n a d i a n F a m i l y P h y s i c i a n VOL 3 7 : F e b m a r y 1 9 9 1
M i s s i s s a u a a . O n t . * T r a d e m a r k C c '
M E M B E R
7/27/2019 canfamphys00132-0232
http://slidepdf.com/reader/full/canfamphys00132-0232 4/4
Wh y d o women s p e n d m o r e t i m e o n
t h e q u a l i t y o f r e l a t i o n s h i p s ? I t i s t h es o c i a l i z e d m a n d a t e o f women w h e t h -
e r t h e r e h a v e b e e n b o o k s o r n o t .-0
E v e r y t h e r a p i s t h a s h e r r u l e s .
G C h a r l o t e t o u m
T h e B u s i n e s s o fM e d i c i n eS t a y i n g c o s t - e f f i c i e n t
HXow d o y o u o r g a n i z e t o p r o v i d ec a r e t o p a t i e n t s ? G e r d d u B o i s ,
a u t h o r o f T h e B u s i n e s s o f M e d i c a l P r a c -t i c e , h a s d e v e l o p e d a t h o r o u g h a n d
s y s t e m a t i c a p p r o a c h t o t h e p r o b l e m .
A t t h e 1 9 9 0 M a r i t i m e C o n j o i n t , d u
B o i s o f f e r e d a f e w p o i n t e r s o n p r a c t i c e
m a n a g e m e n t , i n c l u d i n g , Do n o t
r e a d t h e h a n d b o o k a t o n e s i t t i n g ; r e a d
w h a t y o u n e e d w h e n y o u n e e d i t .
* O n a v e r a g e , r e n t a n d s t a f f c o n -
s u m e s o m e 60 o f t h e o v e r h e a dc o s t s ; o t h e r c o s t s a r e i n c i d e n t a l . I f y o u h a v e a h i g h o v e r h e a d , y o u
a r e o n a t r e a d m i l l . Y o u m u s t s e e
m o r e p a t i e n t s t o m e e t t h a t o v e r -h e a d , m u s t d e l e g a t e t o s t a f f a s a
r e s u l t , a n d c o n s e q u e n t l y r e q u i r es t a f f w i t h s p e c i f i c s k i l l s , s a y sd u B o i s .
* D o m o r e w i t h s t a f f , s p a c e , a n d
e q u i p m e n t a n d i n t u r n b e c o m e
m o r e c o s t - e f f i c i e n t .
* I n t h e w a i t i n g r o o m , a c c e n t w a l l s ,h a n g l o c a l a r t , i n s t a l l t r a c k l i g h t i n g ,
a n d i n c l u d e c h i l d r e n ' s t o y s . T h e s e
a r e m i n o r c h a n g e s , m a d e f o r e s t h e t -
i c r e a s o n s a n d f o r c o m f o r t .
* G i v e y o u r s t a f f p r i v a c y a n d a d e -q u a t e w o r k s p a c e . W i t h c o m p u t -
e r i z a t i o n , m o r e w o r k i s d e l e g a t e dt o t h e f r o n t o f f i c e s t a f f .
T r a i n t h e t e l e p h o n e s t a f f . T h e t e l e -
p h o n e i s t h e c r u c i a l i n s t r u m e n t . I f
y o u b e l i e v e y o u r s t a f f m e m b e r s r e p -r e s e n t y o u i n p e r s o n , t h e y a l s o r e p -
r e s e n t y o u o n t h e p h o n e . I t i s t h ee n t r y p o i n t i n t o t h e p r a c t i c e .
* C h a r t s o f t e n c a r r y u s e l e s s i n f o r m a -
t i o n a n d c o n s e q u e n t l y n e e d t o b e
r e w r i t t e n o r r e o r g a n i z e d . I f y o u
a r e n o t a n o r g a n i z e d p e r s o n , t h ec o m p u t e r w i l l n o t d o i t f o r y o u ,d u B o i s w a r n s . He d e v e l o p e d h i s
c h a r t s i n c o n s u l t a t i o n w i t h a g r o u p
o f p h y s i c i a n s a n d a f i l i n g c o m p a n y ,
a p r o c e s s t h a t t o o k t h e b e t t e r p a r to f a y e a r . T h e c h a r t s l i s t p a t i e n tp r o b l e m s o n t h e l e f t a n d p r o g r e s sn o t e s o n t h e r i g h t .
A n a v e r a g e f a m i l y p h y s i c i a n h a so v e r 2 0 0 0 c h a r t s . D o n o t r e w r i t eo l d c h a r t s ; s t a r t w i t h n e w p a t i e n t s .
S * a.
----~~~~~~
