MANAGING ANTERIOR SEGMENT INFECTIONS IN CHILDREN

Size: px
Start display at page:

Download "MANAGING ANTERIOR SEGMENT INFECTIONS IN CHILDREN"

Transcription

1 MANAGING ANTERIOR SEGMENT INFECTIONS IN CHILDREN Rachel A. Stacey Coulter, OD, MSEd, FAAO, Diplomate BVPPO Julie A. Tyler, OD, FAAO Nova Southeastern University College of Optometry, Fort Lauderdale, FL Please silence all mobile devices and remove items from chairs so others can sit. Unauthorized recording of this session is prohibited.

2 Disclosure Statement: Rachel'A.' 'Stacey 'Coulter,'OD,' MSEd,'FAAO,'Diplomate'BVPPO None Julie'A.'Tyler,'OD,'FAAO Virtual'advisory'board' optometric'educators,'shire

3 Considerations+in+managing+children+as+patients The$ever'changing$pediatric$patient Developmental$differences$among$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$ pediatric$age$groups Infants$ birth$to$one$year Toddlers$ one$to$three$years Preschool$ three$to$five$years School$age$ five$to$twelve$years Adolescents$ thirteen$to$eighteen$years

4 Differences)in)pharmacokinetic)responses)to) medications) Differences greatest in infants Differences in. Drug absorption Distribution Metabolism and excretion

5 Prescribing*challenges* Pediatric)Use)section Manufacturer s)drug)insert Age)for)which)the)drug)is)approved,)any) associated)side)effects)and)outcomes Off<label)prescribing) Pediatric)Use)section)states, Safety)and)effectiveness)in)children) have)not)been)established HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN (amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by bacteria INDICATIONS AND USAGE AUGMENTIN is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following: Lower respiratory tract infections (1.1) Acute bacterial otitis media (1.2) Sinusitis (1.3) Skin and skin structure infections (1.4) Urinary tract infections (1.5) DOSAGE AND ADMINISTRATION Adults and Pediatric Patients > 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours. (2.1, 2.2) Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. (2.2) Neonates and infants < 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Use of the 125 mg/5 ml oral suspension is recommended. (2.2) DOSAGE FORMS AND STRENGTHS Formulations and amoxicillin/clavulanate content are: Tablets: 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg tablets are scored. (3) Powder for Oral Suspension: 125 mg/31.25 mg per 5 ml, 200 mg/28.5 mg per 5 ml, 250 mg/62.5 mg per 5 ml, 400 mg/57 mg per 5 ml (3) Chewable Tablets: 125 mg/31.25 mg, 200 mg/28.5 mg, 250 mg/62.5 mg, 400 mg/57 mg (3) FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Lower Respiratory Tract Infections 1.2 Acute Bacterial Otitis Media 1.3 Sinusitis 1.4 Skin and Skin Structure Infections 1.5 Urinary Tract Infections 1.6 Limitations of Use 2 DOSAGE AND ADMINISTRATION 2.1 Adults 2.2 Pediatric Patients 2.3 Patients with Renal Impairment 2.4 Directions for Mixing Oral Suspension 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 4.1 Serious Hypersensitivity Reactions 4.2 Cholestatic Jaundice/Hepatic Dysfunction 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions 5.2 Hepatic Dysfunction 5.3 Clostridium difficile-associated Diarrhea 5.4 Skin Rash in Patients with Mononucleosis 5.5 Potential for Microbial Overgrowth 5.6 Phenylketonurics 5.7 Development of Drug-Resistant Bacteria Reference ID: CONTRAINDICATIONS History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to AUGMENTIN or to other beta-lactams (e.g., penicillins or cephalosporins) (4) History of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN. (4) WARNINGS AND PRECAUTIONS Serious (including fatal) hypersensitivity reactions: Discontinue AUGMENTIN if a reaction occurs. (5.1) Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. (5.2) Clostridium difficile-associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. (5.3) Patients with mononucleosis who receive AUGMENTIN develop skin rash. Avoid AUGMENTIN use in these patients. (5.4) Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. (5.5) ADVERSE REACTIONS The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%) (6.1) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at or FDA at FDA-1088 or DRUG INTERACTIONS Co-administration with probenecid is not recommended. (7.1) Concomitant use of AUGMENTIN and oral anticoagulants may increase the prolongation of prothrombin time. (7.2) Coadministration with allopurinol increases the risk of rash. (7.3) AUGMENTIN may reduce efficacy of oral contraceptives. (7.4) USE IN SPECIFIC POPULATIONS Pediatric Use: Modify dose in patients 12 weeks or younger. (8.4) Renal impairment; Dosage adjustment is recommended for severe renal impairment (GFR< 30mL/min). (2.3, 8.6) See 17 for PATIENT COUNSELING INFORMATION and FDAapproved patient labeling. Revised: 01/2013 XXXXXXXXX 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Probenecid 7.2 Oral Anticoagulants 7.3 Allopurinol 7.4 Oral Contraceptives 7.5 Effects on Laboratory Tests 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Labor and Delivery 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Dosing in Renal Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 12.4 Microbiology 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

6 Prescribing*challenges:*Off1label* considerations Eye$drops$and$dermatologic$preparations$are$the$most$likely$ prescribed$off6label$medications Off6label$education$and$prescribing$considerations Check$package$insert$and$FDA$website$for$warnings$or$contraindications!Example:$$Doxycycline$and$other$tetracycline$analogues$cause$ abnormalities$in$children$younger$than$eight Discuss$whether$or$not$the$drug$has$been$approved$for$pediatric$use Document$the$decision6making$process$and$the$parent s/guardian s$consent$ in$the$medical$record.

7 Prescribing*challenges:*Off1label*considerations Best*source*! Dosage(and(Administration(section(of(package(insert If(not(available( other(common(adaptations(for(topical( pharmaceuticals Cut(Dose 1/2(adult(dose(for(children(<(2(yrs 2/3(adult(dose(for(children(ages(2( 3(yrs Decrease(frequency(of(dosing( When(available,(use(lower(percentage(of(mediation((eg,(olapatadine)

8 Determining&dosage ORAL%medications%adjusted%according%to%body%weight%(mg/kg/day)%and%many% medications%for%children%are prescribed)as)mg/kg,)mcg/kg)or)units/kg Weigh&patient&in&office;&don t&rely&on&reported&weight Four%Step%Approach: (1)%convert%pounds%to%kg%(1kg%=%2.2lb) (2)%calculate%the%dose%in%mg (3)%divide%dose%by%frequency%needed%for%oral%solutions/suspensions (4)%convert%mg/dose%to%mL Image:% GCh1blQPDEAQYAyABEgK9MfD_BwE&sku=477&utm_campaign=google_shopping&utm_medium=shopping&utm_source=google

9 Differences)in)diagnosis:))History Pediatric)patients)may)be)unable)or)unlikely)to)report)their)symptoms Diagnosis)often)made)by: Findings) History)reported)by)parent)or)caregiver)including: Duration Laterality Discharge Presence)of)pain)and)photophobia History)of)trauma)or)exposure)to)someone)else)with)red)eye

10 Common%Anterior%Segment%Infections%

11 Pediatric)Red)Eyes 1"%"primary"care"office"visits"="conjunctivitis Causes"of" red"eyes " infection,"allergy,"trauma,"dryness,"systemic" inflammation History Duration"symptoms Pain"present Photophobia Hx of"traumac high"or"low"velocity Prior"red"eyes/Previous"treatment

12 Blepharitis Pediatric)presentation Most)commonly)presents)in)children)age)6)5 10)yrs Symptoms)and)signs Injection)and/or)vessel)telangiectasia)along)lid) margin Hard,)fibrinous)crusts)and)scales) Occasional)misdirected)or)missing)lashes Staphylococcus overgrowth)5major)causative) factor)

13 Blepharitis Treatment(agents Lid(hygiene( Lid(scrubs( diluted(baby(shampoo(applied(to(lid(margins Commercial(wipes Systane lid(wipes((alcon)( Ocusoft lid(scrubs(available(in(a( baby (formulations Dandruff(ShampoosCseborrheic(blepharitis

14 Topical(agents Topical(antibiotic(options(when(indicated Erythromycin+ointment+ 1/2x+daily+x+2+weeks When+using+ointments,+apply+close+to+bedtime+to+decrease+ blur+ Azasite Conjunctivitis+dosing:+2x+daily+x+2+days,+then+1x+for+5+days Targets+Staphylococcus,AND+MGD+via+immunomodulatory+response Approved+>12+mos Expensive Fluoroquinolones Besivance (besifloxacin)+0.6%+ophthalmic+suspension Ciloxan (ciprofloxacin)+0.3%+solution Others/ ofloxacin,+moxifloxacin+and+gatifloxacin

15 Topical(Agents Topical(antibiotic/steroid(combinations Warranted(in(severe(cases,(to(eliminate(inflammation/(complications(of( bacteria((eg,(exotoxins)(with(concurrent(bacterial(overgrowth Ointments(may(be(easier(to(administer Options(include( Tobradex (tobramycin+and+dexamethasone+ophthalmic+suspension,+ Alcon)( Neomycin/polymyxin B/dexamethasone Considerations(in(Steroid(Use Side(effects( elevated(iop(and(cataract(formation If(HSV(is(culprit,(cornea(at(increased(risk(of(complications Clinicians(should(weigh(dosing(frequency(and(risks/benefits(

16 Blepharitis&? Oral Prescribing*oral*medications Azithromycin*(macrolide6type*antibiotic) Both*anti6inflammatory*and*antibacterial*properties Studies*in*adults*=*1*gram*for*3*weeks Approved*for*children*> age*six*months Example:*Treatment*options:* SINUSITIS&Dosing:&Child&dosage&(ages&6&months&to&17&years) Typical*dosage*is*10*mg/kg*of*body*weight*once*per*day*for*three*days.

17 Blepharitis+ Additional+considerations Additional)considerations:)Hypochlorous acid)treatments) (eg,%rx:%avenova [30%day%shelf%life%open],%Non;Rx:%HypoChlor Gel%0.02%%and%OcuSoft HypoChlor Spray%.02%[18month%shelf%life%open%or%closed) Manages)bacterial)overpopulation,)penetrates)biofilm,)inactivates) lipase)! Approved)for)blepharitis Spray)application!) Tea)tree)oil)treatments Nutrition

18 Hordeola Symptoms(and(signs Focal(infections(of(eyelid(glands Signs:( Localized(swelling,(pain(and(redness Pediatric(presentation Usually(caused(by(Staphylococcus,aureus

19 Hordeola Treatment)agents Warm)compress) apply)10>15)min Considerations: Topical)antibiotic)agents)> prevent) infection)spread)when) drainage/expression)is)significant,) especially)with)external)hordeolum Oral)antibiotics)may)be)needed)if) progresses)to)preseptal cellulitis Strategies)for)pediatric) compliance Freeze /music)game

20 Viral&conjunctivitis Symptoms(and(signs Usually(bilateral symptoms(starting(in(one(eye( and(progress(to(other(eye Red,(watery(eyes;(sometimes(small( (sub)conjunctival(hemorrhages Swollen(pre?auricular(nodes(in(children(with( developed(immune(systems Hx exposure(to(sick(people? Causes( usually(adenovirus,(although(hsv(&(varicella( zoster(possible

21 Viral&conjunctivitis Some&adenoviral&conjunctivitis&sub4types& (EKC)&! possible(delayed(corneal(response( with(sub3epithelial(infiltrates( (keratoconjunctivitis) Clinicians(should(emphasize(to(patient( and(parent(with(patient(education( regarding(expected(outcomes(and(the( importance(of(follow3up

22 Viral&conjunctivitis Pediatric)presentation Self1limiting)condition symptoms)usually)decrease)within)first)week Contagious)for)10121)days Palliative)measures)such)as)cool)compresses)and)artificial)tears)(PF) No)current)ophthalmic)agents)are)approved)for)adenoviral)infections

23 Prevent'spread'of'infection Educate(the(patient(and(caregiver(on(proper(hygiene(practices: Avoid(touching(the(eyes(or(eye(area. Use(disposable(tissues(and(wipes(instead(of(towels. Wash(hands(immediately(after(touching(the(eyes(or(eye(area. Don t(share(towels,(washcloths,(dishes,(cups(or(eating(utensils. Play(with(hard(surface(toys(that(can(be(thoroughly(cleaned. Discuss(the(need(to(keep(children(out(of(daycare(or(school( Complete(notes(or(documentation(required(for(absences(or(reentry

24 Microbial)conjunctivitis Presentation Generally,.sticky.mucopurulent.discharge. Eyelids. stick.together Bacterial.Causes: Staphylococcus,aureus,,Staphylococcus,epidermis,,Streptococcus, pneumoniae,,moraxella,catarrhalis,,pseudomonas,and,haemophilus

25 Bacterial)conjunctivitis Topical(antibiotics(- broad-spectrum(antibiotic(effective(against( Gram((+),(Gram((-) Erythromycin(0.5%( Antibiotic(combination(options: polymyxin B(sulfate(and(trimethoprim(sulfate(ophthalmic(solution polymyxin B/bacitracin(ophthalmic(ointment(and(erythromycin(0.5%( Aminoglycosides: Pro:((Often(inexpensive Con:(Less(desirable(due(to(corneal(epithelial(toxicity(reaction( Azithromycin,(AzaSite Multiple( pros(and(cons

26 Specific'notes'on'topical'azithromycin,-AzaSite Effectivity:''Beneficial'for'acute'bacterial'conjunctivitis Unique'dosing'regimen:' Dosed'one'drop'twice'daily,'eight'to'12'hours'apart'x'two'days;' then'once'daily'for'next'five'days Total'='9'drops Viscous'vehicle'enhances'contact'with'the'eye'and'enables'rubbing' excess 'drop'along'lid'margins'to'target'concurrent'eyelid'infection Cons:'Cost'and'availability Oral'antibiotics Bacterial-conjunctivitis

27 Viral&(HSV)&keratitis&with&a& primary&corneal&defect Symptoms(and(signs( conjunctival(injection,( follicles,(corneal(staining(with(rose(bengal or( discrete(punctuate(defects,(classic(dendrite Pediatric(presentation

28 Viral&keratitis&with&a&primary&corneal&defect Antivirals Trifluridine 1%1 Dosed1up1to1nine1times1per1day1 Disadvantage18 corneal1toxicity1over1time Zirgan (ganciclovir)1ophthalmic1gel10.15% Less1corneal1toxicity1than1trifluridine,1less1frequent1dosing,1 gel1formulation1that1may1be1preferable Approved1age1> 21years1 Oral1consideration Co8management

29 Fungal'keratitis History( Contact(lens(wearer?(Trauma? Thickened,(feathery,(poorly(defined(corneal(lesion Not(responsive(to(antibiotic Pediatric(presentation Most(common(risk(factor(=(trauma(with(plants( material Also(associated(with(trauma(from(metal,( pieces,(firecrackers,(pencils Treatment(antifungals Topical Systemic(

30 Preseptal cellulitis Symptoms(and(signs Lid(swelling(and(redness Fever Discharge R/O(!orbital(cellulitis( Proptosis,(decreased(ocular(motility,(severe(pain,(APD,(optic( nerve(head(edema,(decreased(va Pediatric(presentation Caused(by(BSinusitis,(hordolea,(dacryocystitis,(trauma(and(insect(bite

31 Preseptal cellulitis Treatment Oral%antibiotics Augmentin%(amoxicillin%+clauvanate) Monitor%for%progression

32 Preseptal cellulitis

33 Additional)management)considerations

34 Preventing)spread)of)infection Educate(the(patient(and(caregiver(on(proper(hygiene(practices: Avoid(touching(the(eyes(or(eye(area. Use(disposable(tissues(and(wipes(instead(of(towels. Wash(hands(immediately(after(touching(the(eyes(or(eye(area. Don t(share(towels,(washcloths,(dishes,(cups(or(eating(utensils. Play(with(hard(surface(toys(that(can(be(thoroughly(cleaned. Discuss(the(need(to(keep(children(out(of(daycare(or(school( Complete(notes(or(documentation(required(for(absences(or(reentry

35 Scheduling+treatment Set$family$up$for$success Consider$family$schedules$ Coordinate$with$regular$family$activities$to$improve$compliance Recommend$caregiver$administer$the$medication$at$regular$family$ activities$(breakfast,$after$school,$bedtime$may$improve$compliance)

36 Communication Touching)base)with)patient s)family)and)other)providers When)prescribing)an)oral)medication,)follow)up)with)a)phone)call)to)check)on) the)patient s)status)and)review)any)concerns. Document)these)phone)calls)in)the)patient s)record.) Call)or)write)to)the)child s)pediatrician)regarding)the)condition)and)any) prescribed)medication.) Be)sure)to)document)this)communication)in)the)medical)record.)

37 Case%Studies

38 5"year'old'female'presents'with'itchy'eyelids,'reddened'lid' margins;'no'discharge Other'findings7 inferior'corneal'staining History' third'episode'in'five'months Most'likely'diagnosis? Management'options?

39 12#year(old(male(who$has$Spina$Bifida$presents$with$swollen$lids,$ itchy$red$eyes $and$watery$discharge Other$symptoms$: pain$and$severe$foreign:body$sensation History: His$mother$noted$started$a$few$days$earlier,$when$he$felt$ itchiness$in$his$right$eye$that$appeared$inflamed Most(likely(diagnosis? Management(options?

40 7"year'old'female'presents'painful,'swollen'left'eyelid'x'two'days' Other'findings'6 low6grade'fever;'swollen'left'preauricular node VA'20/20'OD'and'OS' Most'likely'Diagnosis? Management'options?

41 4"year'old'male'presents'with'a'red'eye,'that'is'not'resolving History'4 Being'treated'with'Polytrim (dosed'appropriately)' Findings4 Appears'to'be'keratoconjunctivitis with'significant' corneal'staining'(pek),'papillae,'and'mucopurulent'discharge.' What'is'your'next'step?

42 13#year(old(male(complains*of*intense*itching*x*several*weeks Other*findings7 swollen*eyelids,*injection,*chemosis,*large* papillae,*mucus*strings*and*strands*ou; OD*cornea*has*2*x*3* mm*area*of*excavation,*3+*anterior*chamber*reaction* Most(likely(diagnosis?( Management(options?

43 Thank you for your interest and attention! Have questions? Please feel free to contact us Rachel'A.' 'Stacey 'Coulter,'OD,' MSEd,'FAAO,'Diplomate'BVPPO Julie A. Tyler, OD, FAAO

44 Please&remember&to&complete&your& session&evaluations&on&the&academy.18&meeting&app Tweet&about&this&session&using& the&official&meeting&hashtag& #Academy18+

Announcing an automatic patient savings program

Announcing an automatic patient savings program Pharmacy E change Volume 17, Number 3 August 2016 Web Version New from Mylan Generic for Doryx (doxycycline hyclate delayed-release tablets) 1,2 Now Available from Mylan in 50 mg and 200 mg dosage strengths

More information

WARNING: TENDON EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS

WARNING: TENDON EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS DECLESAU (dergrafloxacin) tablets, for oral use DECLESAU (dergrafloxacin) injection, solution for intravenous use WARNING: TENDON EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including

More information

AXITAB-CV TAB. COMPOSITION :

AXITAB-CV TAB. COMPOSITION : AXITAB-CV TAB. COMPOSITION : Each film coated tablet contains: Cefuroxime Axetil I.P. Eq. to Anhydrous 500mg. Potassium Clavulanate Diluted I.P. Eq. to Clavulanic Acid 125mg DESCRIPTION : Cefuroxime Axetil

More information

ADVERSE REACTIONS The most common (>10%) adverse reactions are hypercalcemia, nausea, and diarrhea. (6.

ADVERSE REACTIONS The most common (>10%) adverse reactions are hypercalcemia, nausea, and diarrhea. (6. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PHOSLYRA safely and effectively. See full prescribing information for PHOSLYRA. PHOSLYRA (calcium

More information

Annex I: Proposed Core Safety Profile (CSP) 4.3 Contraindications

Annex I: Proposed Core Safety Profile (CSP) 4.3 Contraindications Annex I: Proposed Core Safety Profile (CSP) 4.3 Contraindications Hypersensitivity to cefuroxime or to any of the excipients listed in section 6.1. Patients with known hypersensitivity to cephalosporin

More information

Staphylococcal enterocolitis: Adult Patients (18 years of age and older): 500 mg to 2 g orally in 3 or 4 divided doses for 7 to 10 days. (2.

Staphylococcal enterocolitis: Adult Patients (18 years of age and older): 500 mg to 2 g orally in 3 or 4 divided doses for 7 to 10 days. (2. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FIRVANQ safely and effectively. See full prescribing information for FIRVANQ. FIRVANQ (vancomycin

More information

3 DOSAGE FORMS AND STRENGTHS

3 DOSAGE FORMS AND STRENGTHS PATADAY- olopatadine hydrochloride solution/ drops Alcon Laboratories, Inc. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PATADAY safely

More information

ROSOBAC-1GM / ROSOBAC-FORT

ROSOBAC-1GM / ROSOBAC-FORT ROSOBAC-1GM / ROSOBAC-FORT ROSOBAC - 1GM. COMPOSITION : Each vial contains Sterile Cefoperazone Sodium IP Eq. to Anhydrous Cefoperazone - Sterile Sulbactam Sodium USP Eq. to Anhydrous Sulbactam - ROSOBAC

More information

Immodium / loprarmide

Immodium / loprarmide Immodium / loprarmide IMODIUM (loperamide hydrochloride) is indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease.

More information

FULL PRESCRIBING INFORMATION: CONTENTS*

FULL PRESCRIBING INFORMATION: CONTENTS* HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OTIPRIO safely and effectively. See full prescribing information for OTIPRIO. OTIPRIO (ciprofloxacin

More information

Page 1 of 13. CEFIXIME for oral suspension, 100 mg/5 ml CEFIXIME for oral suspension, 200 mg/5 ml For oral administration

Page 1 of 13. CEFIXIME for oral suspension, 100 mg/5 ml CEFIXIME for oral suspension, 200 mg/5 ml For oral administration HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use cefixime for oral suspension safely and effectively. See full prescribing information for cefixime

More information

Reference ID:

Reference ID: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LYSODREN safely and effectively. See full prescribing information for LYSODREN. LYSODREN (mitotane)

More information

VANLID Capsules (Vancomycin hydrochloride)

VANLID Capsules (Vancomycin hydrochloride) Published on: 22 Sep 2014 VANLID Capsules (Vancomycin hydrochloride) Composition VANLID Capsules Each capsule contains: Vancomycin Hydrochloride IP equivalent to Vancomycin.. 250 mg Approved colours used

More information

ZINEX. Composition Each tablet contains Cefuroxime (as axetil) 250 or 500 mg

ZINEX. Composition Each tablet contains Cefuroxime (as axetil) 250 or 500 mg ZINEX Composition Each tablet contains Cefuroxime (as axetil) 250 or 500 mg Tablets Action Cefuroxime axetil owes its bactericidal activity to the parent compound cefuroxime. Cefuroxime is a well-characterized

More information

M0BCore Safety Profile

M0BCore Safety Profile M0BCore Safety Profile Active substance: Aztreonam Pharmaceutical form(s)/strength: 500 mg, 1 g and 2 g powder for solution for injection and infusion NB! 75mg aztreonam for nebulisation to treat infections

More information

KEVEYIS (dichlorphenamide) tablets, for oral use Initial U.S. Approval: 1958

KEVEYIS (dichlorphenamide) tablets, for oral use Initial U.S. Approval: 1958 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEVEYIS safely and effectively. See full prescribing information for KEVEYIS. KEVEYIS (dichlorphenamide)

More information

High dose amoxicillin for sinusitis

High dose amoxicillin for sinusitis High dose amoxicillin for sinusitis Amoxil ( amoxicillin ) is a commonly used penicillin antibiotic. It is produced in tablets (500 mg 875 mg), capsules, chewable tablets and oral suspensions. 6-3-2018

More information

NEOSPORIN Ophthalmic Solution Sterile (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP)

NEOSPORIN Ophthalmic Solution Sterile (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP) NEOSPORIN Ophthalmic Solution Sterile (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP) NEOSPORIN SOLUTION DESCRIPTION NEOSPORIN Ophthalmic Solution (neomycin and polymyxin B

More information

Colistimethate FOR INJECTION, USP 10 DIGIT NDC STRENGTH SIZE WHOLESALE NUMBERS WEB LISTING. 150 mg*/vial 12

Colistimethate FOR INJECTION, USP 10 DIGIT NDC STRENGTH SIZE WHOLESALE NUMBERS WEB LISTING. 150 mg*/vial 12 Colistimethate FOR INJECTION, USP 10 DIGIT NDC STRENGTH SIZE WHOLESALE NUMBERS WEB LISTING 39822-0617-1 150 mg*/vial 1 ABC 10167618 Cardinal 5276001 11 DIGIT NDC Colistin base activity vial McKesson 3574043

More information

Xerava (eravacycline) NEW PRODUCT SLIDESHOW

Xerava (eravacycline) NEW PRODUCT SLIDESHOW Xerava (eravacycline) NEW PRODUCT SLIDESHOW Introduction Brand name: Xerava Generic name: Eravacycline Pharmacological class: Tetracycline antibiotic Strength and Formulation: 50mg; per vial; lyophilized

More information

M0BCore Safety Profile

M0BCore Safety Profile M0BCore Safety Profile Active substance: Aciclovir Pharmaceutical form(s)/strength: Tablets 200, 400 or 800 mg Dispersible tablets 200, 400 or 800 mg Oral suspensions 200 mg or 400 mg per 5 ml. Freeze

More information

VI.2 Elements for a public summary. VI.2.1 Overview of disease epidemiology

VI.2 Elements for a public summary. VI.2.1 Overview of disease epidemiology VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Sinus infection (Acute bacterial sinusitis) Sinus infection (upper respiratory infection) is short-lived infection of the sinuses,

More information

AMPICLOX TM Ampicillin-cloxacillin

AMPICLOX TM Ampicillin-cloxacillin AMPICLOX TM Ampicillin-cloxacillin QUALITATIVE AND QUANTITATIVE COMPOSITION AMPICLOX 500mg Capsules: Each capsule contains 250 mg ampicillin as Ampicillin Trihydrate and 250 mg cloxacillin as Cloxacillin

More information

Page 1 of 21. Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets USP. Infection

Page 1 of 21. Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets USP. Infection HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Cefuroxime Axetil Tablets USP safely and effectively. See full prescribing information for Cefuroxime

More information

Revised: 10/2016 FULL PRESCRIBING INFORMATION: CONTENTS*

Revised: 10/2016 FULL PRESCRIBING INFORMATION: CONTENTS* HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VERMOX CHEWABLE safely and effectively. See full prescribing information for VERMOX CHEWABLE. VERMOX

More information

Reference ID: single. Uncomplicated gonorrhea

Reference ID: single. Uncomplicated gonorrhea HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEFTIN safely and effectively. See full prescribing information for CEFTIN. CEFTIN (cefuroxime axetil)

More information

DOSAGE FORMS AND STRENGTHS Cream: Each gram contains 10 mg of ozenoxacin (1%) (3).

DOSAGE FORMS AND STRENGTHS Cream: Each gram contains 10 mg of ozenoxacin (1%) (3). HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XEPI TM safely and effectively. See full prescribing information for XEPI TM. XEPI TM (ozenoxacin)

More information

AEMCOLO (rifamycin) delayed-release tablets, for oral use. Initial U.S. Approval: 2018

AEMCOLO (rifamycin) delayed-release tablets, for oral use. Initial U.S. Approval: 2018 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AEMCOLO safely and effectively. See full prescribing information for AEMCOLO. AEMCOLO (rifamycin)

More information

Pharmaceutical form(s)/strength: Capsules, 200mg, 400mg, Oral suspensions, 90mg/5ml, 180mg/5ml, 36 mg/ml SI/H/PSUR/0002/002 Date of FAR:

Pharmaceutical form(s)/strength: Capsules, 200mg, 400mg, Oral suspensions, 90mg/5ml, 180mg/5ml, 36 mg/ml SI/H/PSUR/0002/002 Date of FAR: 0BCore Safety Profile Active substance: Ceftibuten Pharmaceutical form(s)/strength: Capsules, 200mg, 400mg, Oral suspensions, 90mg/5ml, 180mg/5ml, 36 mg/ml P-RMS: SI/H/PSUR/0002/002 Date of FAR: 14.02.2013

More information

Reference ID:

Reference ID: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEFAZOLIN injection safely and effectively. See full prescribing information for CEFAZOLIN injection.

More information

CONTRAINDICATIONS None (4)

CONTRAINDICATIONS None (4) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Cystadane safely and effectively. See full prescribing information for Cystadane. Cystadane (betaine

More information

CONTRAINDICATIONS None.

CONTRAINDICATIONS None. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAZEO safely and effectively. See full prescribing information for PAZEO. PAZEO (olopatadine hydrochloride

More information

Beta-lactamase production should have no effect on Azithromycin activity.

Beta-lactamase production should have no effect on Azithromycin activity. AZIMEX Composition Azimex 250 Capsules Each capsule contains Azithromycin (as dihydrate) 250 mg Capsules Azimex 500 mg Capsules Each capsule contains Azithromycin (as dihydrate) 500 mg Action Azithromycin

More information

Reference ID:

Reference ID: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRIFERIC safely and effectively. See full prescribing information for TRIFERIC. TRIFERIC (ferric

More information

Adults and Adolescents (13 years and older) Pharyngitis/tonsillitis (mild to moderate) 500 mg. every 12 hours. (mild to moderate) every 12 hours

Adults and Adolescents (13 years and older) Pharyngitis/tonsillitis (mild to moderate) 500 mg. every 12 hours. (mild to moderate) every 12 hours HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEFUROXIME AXETIL TABLETS safely and effectively. See full prescribing information for CEFUROXIME

More information

CEFADUR Tablet (Cefadroxil)

CEFADUR Tablet (Cefadroxil) Published on: 23 Sep 2014 CEFADUR Tablet (Cefadroxil) Composition CEFADUR-500 Each Film-coated tablet contains Cefadroxil IP equivalent to Cefadroxil anhydrous...500 CEFADUR 125 DT Each dispersible uncoated

More information

1 INDICATIONS AND USAGE. 1.1 Limitation of Use FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE. 1.1 Limitation of Use FULL PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRIFERIC safely and effectively. See full prescribing information for TRIFERIC. TRIFERIC (ferric

More information

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 1. NAME OF THE MEDICINAL PRODUCT Avopenin 800 mg film-coated tablets Avopenin 1 g film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Phenoxymethylpenicillin potassium 800 mg or 1 g For a full

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Keftid Capsules 250 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per Capsule Cefaclor Monohydrate Equivalent to Cefaclor 250.00mg For

More information

PRESCRIBING INFORMATION. Cloxacillin for Injection. Cloxacillin Powder for Solution (as cloxacillin sodium) 500mg powder/vial.

PRESCRIBING INFORMATION. Cloxacillin for Injection. Cloxacillin Powder for Solution (as cloxacillin sodium) 500mg powder/vial. PRESCRIBING INFORMATION Pr Cloxacillin for Injection Cloxacillin Powder for Solution (as cloxacillin sodium) 500mg powder/vial 1g powder/vial 2g powder/vial 10g powder/vial STERILE Antibiotic SteriMax

More information

Beta-lactamase production should have no effect on Azithromycin activity.

Beta-lactamase production should have no effect on Azithromycin activity. AZIMEX Composition Azimex 250 Capsules Each capsule contains Azithromycin (as dihydrate) 250 mg Capsules & Powder Azimex 500 mg Capsules Each capsule contains Azithromycin (as dihydrate) 500 mg Azimex

More information

Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2)

Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MEPRON oral suspension safely and effectively. See full prescribing information for MEPRON oral suspension.

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Clonamox 125mg/5ml and 250mg/5ml Powder for Oral Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clonamox 125 mg/5 ml: Each 5ml

More information

PRESCRIBING INFORMATION. Cloxacillin Powder for Solution (as cloxacillin sodium) 500mg powder/vial. 1g powder/vial. 2g powder/vial.

PRESCRIBING INFORMATION. Cloxacillin Powder for Solution (as cloxacillin sodium) 500mg powder/vial. 1g powder/vial. 2g powder/vial. PRESCRIBING INFORMATION Pr Cloxacillin for Injection Cloxacillin Powder for Solution (as cloxacillin sodium) 500mg powder/vial 1g powder/vial 2g powder/vial 10g powder/vial STERILE Antibiotic SteriMax

More information

Uncomplicated skin and skin-structure 250 or 500 mg every hours Uncomplicated urinary tract infections 250 mg every 12 7 to 10

Uncomplicated skin and skin-structure 250 or 500 mg every hours Uncomplicated urinary tract infections 250 mg every 12 7 to 10 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEFTIN safely and effectively. See full prescribing information for CEFTIN. CEFTIN (cefuroxime axetil)

More information

Amoxitid 125 Suspension Each teaspoonful (5 ml) contains Amoxicillin (as trihydrate) 125 mg.

Amoxitid 125 Suspension Each teaspoonful (5 ml) contains Amoxicillin (as trihydrate) 125 mg. AMOXITID Composition Amoxitid 250 Capsules Each capsule contains Amoxicillin (as trihydrate) 250 mg. Capsules & Suspension Amoxitid 500 Capsules Each capsule contains Amoxicillin (as trihydrate) 500 mg.

More information

SUCRALFATE TABLETS, USP

SUCRALFATE TABLETS, USP 1234567890 10 210002-01 SUCRALFATE TABLETS, USP DESCRIPTION Sucralfate is an -D-glucopyranoside, -D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. It has the following structural formula:

More information

1 followed by 5 mg/kg once daily. ZITHROMAX (azithromycin) 250 mg and 500 mg Tablets and Oral Suspension Initial U.S.

1 followed by 5 mg/kg once daily. ZITHROMAX (azithromycin) 250 mg and 500 mg Tablets and Oral Suspension Initial U.S. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZITHROMAX safely and effectively. See full prescribing information for ZITHROMAX. Pharyngitis/tonsillitis

More information

Farmadol. Paracetamol 10 mg/ml INFUSION SOLUTION

Farmadol. Paracetamol 10 mg/ml INFUSION SOLUTION Farmadol Paracetamol 10 mg/ml INFUSION SOLUTION Composition Each ml contains: Paracetamol 10 mg Pharmacology Pharmacodynamic properties The precise mechanism of the analgesic and antipyretic properties

More information

GlucaGen (glucagon [rdna origin] for injection) Initial U.S. Approval: 1998

GlucaGen (glucagon [rdna origin] for injection) Initial U.S. Approval: 1998 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GlucaGen safely and effectively. See full prescribing information for GlucaGen. GlucaGen (glucagon

More information

Metabolism Paracetamol is metabolised in the liver and excreted in the urine mainly as glucuronide and sulphate conjugates.

Metabolism Paracetamol is metabolised in the liver and excreted in the urine mainly as glucuronide and sulphate conjugates. FEBRAMOL Composition Febramol 150 Suppositories Each suppository contains Paracetamol 150 mg. Suppositories, Tablets & Syrup Febramol 300 Suppositories Each suppository contains Paracetamol 300 mg. Each

More information

PACKAGE INSERT USP ANTIBIOTIC

PACKAGE INSERT USP ANTIBIOTIC Pr AMPICILLIN for Injection USP ANTIBIOTIC ACTIONS AND CLINICAL PHARMACOLOGY Ampicillin has a broad spectrum of bactericidal activity against many gram-positive and gramnegative aerobic and anaerobic bacteria.

More information

RECENT MAJOR CHANGES Warnings and Precautions, Hemophagocytic

RECENT MAJOR CHANGES Warnings and Precautions, Hemophagocytic HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine)

More information

Cefadroxil for Oral Suspension USP 250 mg/5 ml and 500 mg/5 ml

Cefadroxil for Oral Suspension USP 250 mg/5 ml and 500 mg/5 ml Cefadroxil for Oral Suspension USP 250 mg/5 ml and 500 mg/5 ml Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil for oral suspension and other antibacterial

More information

Page 1 of 32. Community-acquired pneumonia. 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.

Page 1 of 32. Community-acquired pneumonia. 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS.

More information

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 11/2011

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 11/2011 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine)

More information

SUCRALFATE TABLETS, USP

SUCRALFATE TABLETS, USP 1234567890 10 210002 SUCRALFATE TABLETS, USP DESCRIPTION Sucralfate is an -D-glucopyranoside, -D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. It has the following structural formula:

More information

Core Safety Profile. Pharmaceutical form(s)/strength: Powder for solution for injection, 1 g LV/H/PSUR/0002/001 Date of FAR:

Core Safety Profile. Pharmaceutical form(s)/strength: Powder for solution for injection, 1 g LV/H/PSUR/0002/001 Date of FAR: Core Safety Profile Active substance: Ceftriaxone Pharmaceutical form(s)/strength: Powder for solution for injection, 1 g P-RMS: LV/H/PSUR/0002/001 Date of FAR: 14.10.2009 Section 4.2 (Posology and method

More information

Effective pain management begins with OFIRMEV (acetaminophen) injection FIRST Proven efficacy with rapid reduction in pain 1

Effective pain management begins with OFIRMEV (acetaminophen) injection FIRST Proven efficacy with rapid reduction in pain 1 Effective pain management begins with OFIRMEV (acetaminophen) injection FIRST Proven efficacy with rapid reduction in pain 1 Fast onset of pain relief with 7% reduction in visual analog scale (VAS) scores

More information

[Al(OH) 3. ] x [H 2. O]y

[Al(OH) 3. ] x [H 2. O]y CARAFATE (sucralfate) ral Suspension DESCRIPTIN CARAFATE ral Suspension contains sucralfate and sucralfate is an α-d-glucopyranoside, β-dfructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.

More information

TOUGH ON IMPETIGO GENTLE ON THE1 PATIENT. Demonstrated efficacy and safety1. New treatment option now available!

TOUGH ON IMPETIGO GENTLE ON THE1 PATIENT. Demonstrated efficacy and safety1. New treatment option now available! New treatment option now available! TOUGH ON IMPETIGO GENTLE ON THE1 PATIENT Demonstrated efficacy and safety1 Home Efficacy Safety Convenience (ozenoxacin) is indicated for the topical treatment of impetigo

More information

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: May 2009 LMT:2PI

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: May 2009 LMT:2PI HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine)

More information

VORAXAZE (glucarpidase) For Injection, for intravenous use Initial U.S. Approval: 2012

VORAXAZE (glucarpidase) For Injection, for intravenous use Initial U.S. Approval: 2012 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VORAXAZE safely and effectively. See full prescribing information for VORAXAZE. VORAXAZE (glucarpidase)

More information

DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 100 mg, 150 mg, and 200 mg; scored. (3.1, 16)

DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 100 mg, 150 mg, and 200 mg; scored. (3.1, 16) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS.

More information

*Sections or subsections omitted from the full prescribing information are not listed.

*Sections or subsections omitted from the full prescribing information are not listed. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EGATEN safely and effectively. See full prescribing information for EGATEN. EGATEN (triclabendazole)

More information

FULL PRESCRIBING INFORMATION

FULL PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BACTROBAN Nasal Ointment safely and effectively. See full prescribing information for BACTROBAN Nasal

More information

NEOSPORIN Ophthalmic Solution Sterile (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP)

NEOSPORIN Ophthalmic Solution Sterile (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP) NEOSPORIN Ophthalmic Solution Sterile (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP) DESCRIPTION Neosporin Ophthalmic Solution (neomycin and polymyxin B sulfates and gramicidin

More information

The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6Hpurin-6-one; it has the following structural formula:

The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6Hpurin-6-one; it has the following structural formula: Acyclovir Ointment, USP 5% DESCRIPTION Acyclovir, USP, is a synthetic nucleoside analogue active against herpes viruses. Acyclovir ointment, USP 5% is a formulation for topical administration. Each gram

More information

HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use epinastine hydrochloride ophthalmic solution safely and effectively. See full prescribing information

More information

See 17 for PATIENT COUNSELING INFORMATION.

See 17 for PATIENT COUNSELING INFORMATION. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NEVANAC* safely and effectively. See full prescribing information for NEVANAC. NEVANAC (nepafenac

More information

Reference ID:

Reference ID: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VERMOX safely and effectively. See full prescribing information for VERMOX. VERMOX (mebendazole)

More information

Reference ID:

Reference ID: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENDARI TM safely and effectively. See full prescribing information for ENDARI. ENDARI (L-glutamine

More information

PRESCRIBING INFORMATION

PRESCRIBING INFORMATION PRESCRIBING INFORMATION pdp-pyrazinamide Pyrazinamide Tablets, USP 500 mg Antimycobacterial / Antituberculosis Agent PENDOPHARM, Division of Pharmascience Inc.. 6111, Royalmount Ave, Suite 100 Montréal,

More information

Xifaxan. Xifaxan (rifaximin) Description

Xifaxan. Xifaxan (rifaximin) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.34 Subject: Xifaxan Page: 1 of 6 Last Review Date: December 8, 2017 Xifaxan Description Xifaxan (rifaximin)

More information

PENICILLIN V POTASSIUM - penicillin v potassium tablet, film coated Aurobindo Pharma Limited

PENICILLIN V POTASSIUM - penicillin v potassium tablet, film coated Aurobindo Pharma Limited PENICILLIN V POTASSIUM - penicillin v potassium tablet, film coated To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium and other antibacterial

More information

Reference ID:

Reference ID: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZINPLAVA safely and effectively. See full prescribing information for ZINPLAVA. ZINPLAVA (bezlotoxumab)

More information

NOVACEF Tablets (Cefuroxime axetil)

NOVACEF Tablets (Cefuroxime axetil) Published on: 6 Oct 2016 NOVACEF Tablets (Cefuroxime axetil) Composition NOVACEF 250 Tablets Each film-coated tablet contains: Cefuroxime Axetil, IP, equivalent to Cefuroxime. 250 mg NOVACEF 500 Tablets

More information

ALUNBRIG (brigatinib) Dosing Guide

ALUNBRIG (brigatinib) Dosing Guide ALUNBRIG (brigatinib) Dosing Guide INDICATION ALUNBRIG (brigatinib) is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)

More information

To report SUSPECTED ADVERSE REACTIONS, contact Avadel Pharmaceuticals (USA), Inc. at or FDA at FDA-1088 or

To report SUSPECTED ADVERSE REACTIONS, contact Avadel Pharmaceuticals (USA), Inc. at or FDA at FDA-1088 or HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KARBINAL ER safely and effectively. See full prescribing information for KARBINAL ER. Karbinal ER

More information

WARNING: CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA (CDAD) and COLITIS See full prescribing information for complete boxed warning.

WARNING: CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA (CDAD) and COLITIS See full prescribing information for complete boxed warning. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CLINDAMYCIN IN 0.9% SODIUM CHLORIDE injection safely and effectively. See full prescribing information

More information

Days 2 through 5. Community-acquired pneumonia 500 mg as a single dose on Day. 1 followed by 5 mg/kg once daily

Days 2 through 5. Community-acquired pneumonia 500 mg as a single dose on Day. 1 followed by 5 mg/kg once daily HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZITHROMAX safely and effectively. See full prescribing information for ZITHROMAX. ZITHROMAX (azithromycin)

More information

13 NONCLINICAL TOXICOLOGY 5.1 Increased Bleeding Time Carcinogenesis, Mutagenesis, Impairment of 5.2 Delayed Healing

13 NONCLINICAL TOXICOLOGY 5.1 Increased Bleeding Time Carcinogenesis, Mutagenesis, Impairment of 5.2 Delayed Healing HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ILEVRO* (nepafenac ophthalmic suspension), 0.3% safely and effectively. See full prescribing information

More information

FULL PRESCRIBING INFORMATION. 1 INDICATIONS AND USAGE 1.1 Treatment of Influenza

FULL PRESCRIBING INFORMATION. 1 INDICATIONS AND USAGE 1.1 Treatment of Influenza HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RELENZA safely and effectively. See full prescribing information for RELENZA. RELENZA (zanamivir)

More information

LAMICTAL XR (lamotrigine) extended-release tablets, for oral use Initial U.S. Approval: 1994

LAMICTAL XR (lamotrigine) extended-release tablets, for oral use Initial U.S. Approval: 1994 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LAMICTAL XR safely and effectively. See full prescribing information for LAMICTAL XR. LAMICTAL XR

More information

Aerobic gram-positive microorganisms Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes

Aerobic gram-positive microorganisms Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes AZIMEX Composition Each 5 ml contains Azithromycin (as dihydrate) 200 mg Powder Action Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with

More information

WARNINGS AND PRECAUTIONS None.

WARNINGS AND PRECAUTIONS None. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PULMOZYME safely and effectively. See full prescribing information for PULMOZYME. PULMOZYME (dornase

More information

KHAPZORY (levoleucovorin) for injection, for intravenous use Initial U.S. Approval: 1952 (d,l-leucovorin)

KHAPZORY (levoleucovorin) for injection, for intravenous use Initial U.S. Approval: 1952 (d,l-leucovorin) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KHAPZORY safely and effectively. See full prescribing information for KHAPZORY. KHAPZORY (levoleucovorin)

More information

8 USE IN SPECIFIC POPULATIONS Patients with Open-Angle Glaucoma or Ocular Hypertension

8 USE IN SPECIFIC POPULATIONS Patients with Open-Angle Glaucoma or Ocular Hypertension 3 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Isopto Carpine safely and effectively. See full prescribing information for Isopto Carpine. Isopto

More information

Mesporin TM. Ceftriaxone sodium. Rapid onset, sustained action, for a broad spectrum of infections

Mesporin TM. Ceftriaxone sodium. Rapid onset, sustained action, for a broad spectrum of infections Ceftriaxone sodium Rapid onset, sustained action, for a broad spectrum of infections 1, 2, 3 Antibiotic with a broad spectrum of activity Broad spectrum of activity against gram-positive* and gram-negative

More information

NEW ZEALAND DATA SHEET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

NEW ZEALAND DATA SHEET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NEW ZEALAND DATA SHEET 1. PHENOXYMETHYLPENICILLIN AFT Phenoxymethylpenicillin-AFT (granules for oral solution, 125 mg/5 ml and 250 mg/ 5 ml) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Phenoxymethylpenicillin-AFT

More information

OTIPRIO an antibiotic medicine given to your child at the time of ear tube surgery

OTIPRIO an antibiotic medicine given to your child at the time of ear tube surgery Bring this Conversation Starter with you to your child s next doctor appointment an antibiotic medicine given to your child at the time of ear tube surgery Use this questionnaire to start a conversation

More information

NOVACLOX Capsules (Amoxycillin + Dicloxacillin)

NOVACLOX Capsules (Amoxycillin + Dicloxacillin) Published on: 10 Jul 2014 NOVACLOX Capsules (Amoxycillin + Dicloxacillin) Composition NOVACLOX Capsule Each capsule contains Amoxycillin Trihydrate IP equivalent to Amoxycillin...250 mg Dicloxacillin sodium

More information

History of hypersensitivity to AMPYRA or 4-aminopyridine (4)

History of hypersensitivity to AMPYRA or 4-aminopyridine (4) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AMPYRA safely and effectively. See full prescribing information for AMPYRA. AMPYRA (dalfampridine)

More information

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

2 QUALITATIVE AND QUANTITATIVE COMPOSITION SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Phenoxymethylpenicillin Sugar Free 250mg / 5ml Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains 277.2mg

More information

FIRDAPSE (amifampridine) tablets, for oral use Initial U.S. Approval: 2018

FIRDAPSE (amifampridine) tablets, for oral use Initial U.S. Approval: 2018 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FIRDAPSE safely and effectively. See full prescribing information for FIRDAPSE. FIRDAPSE (amifampridine)

More information

M0BCore Safety Profile

M0BCore Safety Profile M0BCore Safety Profile Active substance: Clindamycin Pharmaceutical form(s)/strength: 300mg/2 ml Ampulle, 600 mg/4 ml Ampulle, 900 mg/6 ml Ampulle, 75 mg/5 ml Granulat für orale Lösung, 150 mg Kapselnn,

More information

See 17 for PATIENT COUNSELING INFORMATION. Revised 01/2016

See 17 for PATIENT COUNSELING INFORMATION. Revised 01/2016 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MEGACE ES safely and effectively. See full prescribing information for MEGACE ES. MEGACE ES (megestrol

More information

Summary of Product Characteristics

Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Oramox (Amoxicillin Oral Suspension BP) 125mg / 5ml Summary of Product Characteristics 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of reconstituted suspension contains

More information

DALFAMPRIDINE Extended-release tablets, for oral use. Initial U.S. Approval: 2010

DALFAMPRIDINE Extended-release tablets, for oral use. Initial U.S. Approval: 2010 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DALFAMPRIDINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for

More information