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11-107 Anaad 5.2
‘Syarat lain Memenuhi persyaratan. seperti tertera pada
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Fenetapan lar Lakukansepet yang teen pada
Pencepan Kar Garam Ba Nanogen Oreo
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it/pada pan glombangscrpan mais ein
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Bowe Pmertoc igAMES Drug Information 2008
by Gerald K. McEvoy (Eaton
Publisher: Amer Soc of Heath System; (December 2003)
By OkDokKeYfolowing oral administration. Chlorpheniramine undergoes N-eakylation to form
‘monodesmattylchlorpheniramine and didesmethylchlorpheniramine, buts principally
‘metabolized to other (at last 2} unidentinted metaboltes. Chiowphoniramine and ts
metabolites are apparenty excreted almost completly in urine. Urinary excretion of
CHlorpheriramine and its N-dealkylated metabolites varis with urinary pH and urine
flow, decreasing substantially as urinary PH increases and urine tow decreases,
Following a single orl or IV dose of chlorphenramine maleate in healthy individuals
with normal renal and hepatc function in one study, about 20% of the dose was.
excreted in urine within 24 hours and 35% within 48 hours, and less than 1% was
‘excreted in feces within 48 hours; about 3-7% ofthe dose was excreted in urine 2s
Unchanged crug within 48 hours, 2-4% as monodesmethychlorphenramine, 12% as
idesmethyichorphenramine, andthe remainder as unidentified metabolites. In other
‘Studies in heathy inivduals with normal renal and hepatic function, about 20% of @
Single orl dose was excreted in urine as unchanged crug, 20% as
‘monedesmethyichlorphoniramine, and 5% as didesmethyichiorpheniramine,
Chemistry and Stability
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CChlorpheniramine fers from brompheriramine inthe substitution of a chiorne atom for
the bromine atom ofthe latter comoound. Dexchiorpheniramine, the dextro isomer, i
‘approximately twice a2 activa ae racam chlorpheniramine oh a weight Basie.
CChorpheniramine maleate and dexchiorpheriramine maleate occur as while, odoress,
cxstaline powders, Chiorhenramine maleate has solubilies of approximately 250
‘mgiml in water and 100 mg'ml in alcohol st 25°C. Dexehiorpheriramine maleate has
Solubilties of approximately 0.9 g/ml in water and 0.5 giml. in alcohol at 25°C.
CChiorpheniramine tannate occurs as a ight tan to buf or yelowishtan, amorphous, ne
powder having not more than a slight characteristic odor the tannate is sighty souble
+ Stability
CChlorpheniramine maleate and dexchiorpheniramine maleate preparations generally
shouldbe stored at a temperature less than 40°C, preferably at 15-30°C.
CChlorpheniramine maleate cral soliton and dexchlorphenirarine maleate oral solutionola 0 i
Peete an
11-107 Anaad 5.2
‘Syarat lain Memenuhi persyaratan. seperti tertera pada
ioe
Fenetapan lar Lakukansepet yang teen pada
Pencepan Kar Garam Ba Nanogen Oreo
an bok Tinos salsa lebih kung 25 mg
Malet BUF, artkan dala 20 masa
abet dan 350) dan perakukansepet ade
Larstan yj,
Zarda ban spe yang ere pada Gorm
‘asa Nien OrgonkeSi
Peder Ula sigan Lenton bot den, Lorian
it/pada pan glombangscrpan mais ein
‘ang 264m Hang juni dalam ne ee
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11-107 Anaad 5.2
‘Syarat lain Memenuhi persyaratan. seperti tertera pada
ioe
Fenetapan lar Lakukansepet yang teen pada
Pencepan Kar Garam Ba Nanogen Oreo
an bok Tinos salsa lebih kung 25 mg
Malet BUF, artkan dala 20 masa
abet dan 350) dan perakukansepet ade
Larstan yj,
Zarda ban spe yang ere pada Gorm
‘asa Nien OrgonkeSi
Peder Ula sigan Lenton bot den, Lorian
it/pada pan glombangscrpan mais ein
‘ang 264m Hang juni dalam ne ee
Disolust<1231>
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Jarutan baku Klay
yang soma padaAMES Drug Information 2008
by Gerald K. McEvoy (Eaton
Publisher: Amer Soc of Heath System; (December 2003)
By OkDokKeYChlorpheniramine Maleate,
Dexchlorpheniramine Maleate
Chlorpheniramine is an alkylamine (propylamine)-dervatve, fist generation
pthistamine.
Dosage and Administration
+ Administration
Chlorpheniramine maleate, chiofbheniramine tannate, and dexthiofpheniramine
maleate are administered orally
Ghilotbheniramine maleate 16-ma extended-release core tablets containing the drug in
‘an immediate-release outer shell and in an extended-release matrix core should be
‘swallowed whole; the extended-release core tablets should not be divided, crushed,
chewed, or dissolved. The extended-release core tablais should be taken wit Mui.
Patients should be advised that the matrix core of the tablets does not completely
dissolve and may be passed in the stool
+ Dosage
Dosage of chlorheriramine and dexchlotpheniramine shouldbe inavidalzes
according tothe pation’sresporse and lerance, Dosage of dexclorphenramine
taleato' approximately 0% thet of chlorgnenramne maleate,
‘Chiorbheniramine Maleate
For sal-medication in aduts and ciren 12 years of age and older, the usual oral
dosage f chlorpheniramine maleate alone oF hn fxed-combinaion preparations 's 4 mq
very 48 hours, not fo exceed 24 mgin 24 hours. Aternatvely, for selfmedication,
Adults and children 12 years of age and older may recawve an extended-release
formulation containing 8 or 12 mq ofthe drug twice daily inthe moming and evening,
not to exceed 24 mg in 24 hours. The usual oral dosage of ehlorpheniramine maloata
fione orn fxed-combination preparation for self medication in chidren 6 to younger
than 12 years of ae is 2 mg every 4-6 hours, not to exceed 12.mg in 24 hours. Und
the direction ofa crician, cron 2fo younger than 6 years of age may receive 1 ma
every 4-6 hours, not to exceed 6 ma in 24 hours. Under the directon of a ciniien,
shilren 6 to younger than 12 years of age may be given an extended-release
formulation containing &'mg of tho drug once daly at bedtime or during the day, a3
indicated. For fxed-combination preparations, lower maximum dally ehlophentamine
maleate dosages may be necessary because of oer inaredents (2. acetaminophen,
Pseudoephedrine hydrochloride) included inthe formulations.
The usual dosage of chilofoheniramine maleate as the 16-ma extended-release core
tablets containing the drug in an immediate-reloase outer shell (4 mg) and in an
‘extonded-release matrix core (12.mg) for adults and children 12 years of age and older
Is 1 tablet (16 ma total once dally at 24-hour intervals. The manufacturer recommends
that this dosage not be exceeded. The extended-release core tablets should not be& CLINICAL
PHARMACOLOGY
14th Edition
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ramine Maleate
Theophylline
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Terbatas
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Terbatas
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Kemasan tidak lebih
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kemasan tidak lebih
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Penggunaan tidak lebih
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Kadar < 150 mg pertablet,
emasan tidak lebih dari
4 tablet.
Penggunaan Wak lebih
dari 1 tablet per kal,
‘maksimum 2 kali schati.
Kadar ¢ 150 mg pertablet,
‘kemasan tidak lebih dari
4 tablet.
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British
National
Formulary
March 2011194 3.4.1 Antinistamines BNF 61
BNE for Chien, 2-5 yours 251mg3- tes dy, Breateedng se ates shove
5-2 years Sag 34 tines daly Sideeflects sere above
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Prognancy see rots above pce 208m pack = 78 Lape 2AMES Drug Information 2008
by Gerald K. McEvoy (Eaton
Publisher: Amer Soc of Heath System; (December 2003)
By OkDokKeYChiorpheniramine Maleate, Dexchiorpheniramine Maleate
Introduction
Dosage and Administration
+ Administration
CChiorphenicamine maleate, chlorpheniramine tannate, and dexchlorpheniramine
‘maleate aro adminstered orally,
CChiorphenicamine maleate 16-mo extended-release core tables containing the drug in
‘an mmmediate-release outer shel and in an extended-release matix core shou be
‘swallowed whole the extended-lease core tablets should not be dred, crushed.
fssolve and may be passed inthe sical
Dosage
Dosage of chiorpheniramine and dexchlorsheniramine should be indvidualzed
ecording tothe pallens response and tolerance. Dosage of dexchlorpheniramine
fate 1s approximately 50% that of chlorsheniamine maleate.
‘every 48 hours, not to exceed 24 ma in 24 houts. Atematively, or self-medication,
‘aduls and chidien 12 years of age and older may receive an extended-elease
formulation containing & or 12 ma ofthe crua twice daly inthe morning and evening,
‘oto exceed 24 mq in 24 hours. The usual oral dosage of chiorpheniramine maleate
‘alone orn xad-combinaton preparations for seffmedicatonin children 6 to younger
{han 12 years of age is. 2 ma every 4-6 hours, not to exceed 12 mq in 24 hours. Under
the drecion of a cincian,chidren 210 younger than 6 years of age may receive 11m
‘every 4-6 hours, not to exceed 6 mg in 24 hours, Under the irecion ofa cinicsan,
tikdren 6 to younger than 12 years of age may be given an extended-release
formulation containing 8 mg ofthe crug once day at bedtme or during the day, as
Indicated, Fo ired-combination preparations, lower maximum dally chlorpheniramine
‘maleate dosages may be necessary because of other ingredients (e.9.. acetaminophen,
‘Pseudoephedrine hydrochloride) included in the formulations.
“The usual dosage ofchlorpheniramine maleate as the 16-na extended-release core
{abiets containing tho drug in an immediate-eleaso outer sho (4 ma) and in an
‘oxlondod-olease matic core (12 mq) fr adults and children 12 years of age and older
{ist tablet (16 ma iota once dally at 24-hour intrvals. The manuiacturerrocommends
‘hat his dosage not be exceeded. The extended-release core tablets should nor beInjectable
Drugs Guide
Alistair Gray, Jane Wright, Vincent Goodey
and Lynn Bruce146 | CHloromphericol | Chiorphenamine moleate
References
1, Ashley, Curie A, es, The Renal Dra Handboo, Seen, Oxford: Radchife Medical Press, 200
2 Kasten Mf. Clindamycin, mevonidazle, and chloramphenicol. Mayo Clin Proc 1999; 748
825-833
Bibliography
‘SPC Kemicetine succinate injection (accessed 3 March 2009)
Chlorphenamine maleate
(chlorpheniramine maleate)
10mg/mL solution in Ll ampoules
+ Chlorphenamine maleate is a sedating antihistamine that causes 3 moderate degree of sedation;
stalo has antimuscatnic activity.
+ 4s indicated for acute urticaria, conto of allergic reactions wo insect bites and sings, anglo-
‘slema, drag and serum reactions, desesitistion reactions, hay fever, vasomotor shins, severe
pruritus of nonspecific igi.
+ tmay be given IV a an adjunct in the emergency treatinent of anaphylactic shock.
Pre-treatment checks
+ vod in patients taking monoamine oxida inhibitor up to
of extrapyramidal side-effects.
+ Use with caution in asthma, bronchitis or bronchiectasis sit may thicken secretions.
+ Use with cae in narrow-angle glaucoma, prostatic hyperttophy, usinary retention and pyloro-
days previously Because of sk
Ue wih eae in epilepay ait my Jeonvalaive threshold.
+ Chlorphenamine is thought to be stein acute porphyria.
Biochemical and other tests
‘Standard dose: 10m by SC, IM or 1V nection repeated up to fous times in 24 hours freq
(maximum 40mg in 24 hours.
Dose in hepatic impairment: avoid in severe liver disease; may cause Seaton,
Preparation and alinistration
1, Withdaw the required dose. May be diited to 10mL with NaCI 0.9% to facilitate slow
administration,
2. Giveby slow IV injection over 1 minute
3. Flush with Sm NaCl 0.9%,eae
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PHARMACOLOGY
12th EditionTABLE 16-2 Some, anhitaminic drugs nial use.
:
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ani Ca sam we Stee tomodnat wan
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CLINICAL PHARMACOLOGY OF
H,RECEPTOR ANTAGONISTS
Clinical Uses
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H,-RECEPTOR ANTAGONISTS
“Th dealer sign to se
increta ana had notet on histamine ince‘AHES Drug Information 2004
by Gerald K. McEvoy (Elton
Publisher: Amer Soc of Heath System; (December 2003)
By OkDoKeYben established in children younger than 6 years of age or in those younger than 12,
years of age, respectively
+ Mutagenicity and Carcinogenicity
“The mutagenic and carcinogenic potentials of dexchlorpheriramine have not been
Sreaeny at own Agtatonsppete decreed lod
‘duodenal secretion ctayncese
isemodic anaemia hypotension rele
twsching-ncle weaken: nghmare-plpeatons
Allergic conditions 283
phorosentvtyreacton shin ections- ns
1 lode Agocdema chyna cet phe
+ ht aetar ee Cental esos system stilton
‘leona pychons in ads) epepaa hepa
SHOE erecrs, FURTHER MFORMATION Chien ae
ely patens aremoesscepabiet sees
‘spneonancy Most manacres of ntistamies a
ai), prado tab and wen
‘ret mit invryng amount though ot nen be
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‘nth Soda choede 0.9% us
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Dring ant eed rowsies rye
Dental practises Fermoy
"Indice estan doe nat apy
satin for nection
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{Bersaortarneane ur Sone 2.
tee nest ug |
beicemeasteriAMES Drug Information 2008
by Gerald K. McEvoy (Eaton
Publisher: Amer Soc of Heath System; (December 2003)
By OkDokKeYused in children younger than 12 years of age.
Dexchlorpheniramine Maleate
For seltynedication In adults and children 12 years of age and older, te usual oral
dosage of dexchorpheniramine maleate is mg every 4-6 hours, not to exceed 12.mq
In. 24 hours. The usual oral dosago ofthe drug for self‘mediation n chikren 6 to.
Younger than 12 years of age is 1 mg every 4-8 hours, not to exceed 6 ma in 24 hours.
Under the direction of @cinician,chiéren 2 to younger than 6 years of age may receve
(0.5 mg every 4-6 hours, not to axcood 3 mg in 24 hours.
‘The usual dosage of dexchlorpheniramine maleate as extended-release tablets i 4 or 6
img at bedtime or every 8-10 hours while awake in
CChlorpheniramine and dexchiorpheniramine share the toxic potentials of other
anthistamines, and the usual precautions of anthistamine therapy should be observed.
(See Cautions in the Anthistamines General Statement 4:00.)
a ry
2} and other individuals who must retict ther intake of phorylalanine should
be warned that Tiaminic® Cold & Allergy Softchews® chewable tablets and Tyleno®
Cold Mult-Symptom Children's chewable tablets contain aspartame (NutraSwoet®)
‘whieh is molabolzod in the Gl tract to phonvlaianine following ral administration.
Rynatuss® Pediatric and Ry-Tuss® Pediatric oral suspensions contain the dye tartrazine
(FDBC velow No.5), which may cause allergic reactions including bronchial asthma in
susceptble indivduas. Although the incidence of tartrazine sersitvty is lw,
‘requentiy occurs in patents who are sensitive to aspirin.
‘The possibilty that chiorpheniramine maleate extended-release core tablets rarely can
cause Gl obstruction, particularly in patients with severe narrowing ofthe esophagus,
Stomach, or intestine, should be considered, Patients with Gl obstuction or narrowing
Should not use the extended-release core tables without consuting a elcian. I
lbdominal pain or vomiting develops during therapy with these tablets, acinician
Should be contacted.
sdiatric Precautions.
Like other antihistamines, chlorpheniramine and dexchiorpheniramine should not be
used in premature or fulrierm necnates. (See Caulions: CNS Effects and Pediatic
Precautons,n he Antihistamines General Statement £00.) Conventional
chlorpheniramine preparations and exlended-elease preparations ofthe drug should be
Used in children younger than 6 years of age and in those younger than 12 years of age,
respectively, only under the rection and supervision of a physician. Safely and efleacy
Of chlorpherivamine maleate extended-release core tables In children younger than 12
Years of age have not been estabished. Safety and efficacy of dexchiorpheniramine in
Children younger than 2 years of age have not been established. Safety and efficacy of
fexlended relaace tablets containing 4 or 6 mg of dexchlorphentramine malate ave not