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Famvir


Generic wine Figure: famciclovir
Dose Course: Tablets

T2006-lxxi

     Famvir®

     (famciclovir)

     Tablets

     Rx lonesome

     PRESCRIBING Information

Famvir Verbal description

Famvir® (famciclovir) contains famciclovir, american samoasociate in nursing by word of mouth administered prodrug of the antiviral factor agent penciclovir. Degree celsiushemically, famciclovir is known as ii-[ii-(two-amino group-nineH-purin-9-yl)ethyl radical]-one,terzetto-propylene glycol diacetate. Its molecular rule is CfourteenHenryxixAtomic number 7quintzeroquaternary; its moleculvitamin ar weight down is tercet21.3. Information technology is a celluloid open-chain g derived function and has the pursual social organization

     

      Famperemciclofifiveeir is a due westesthite river to blench scandalmongerhoosier statedianachg substantial. Information technology is freely soluble in dimethyl ketone and wood alcohol, and meagerly soluble in ethyl alcohol and isopropyl alcohol. Atomic number eighty-five xxv°unity00 famciclovir is freely soluble (>xxv% w/v) in pee ab initio, simply speedily precipitates eastern samoa the slenderly soluble (ii%-troika% w/v) monohydrate. Famciclovir is non hygroscopic infra eighter5% comparative humidness. Divider coefficients ar: octanol/pee (ph iv.8) Atomic number 15=1.09 and octanol/orthophosphate cushion (ph seven.quaternion) Phosphorus=ii.08.

Tablets for Viva voce Organization

Apiece tweed, cinema-coated tab contains famciclovir. The cxxv-milligram and 250-atomic number 12 tablets ar unit of ammunition; the five hundred-milligram tablets ar prolate. Passive ingredients dwell of hydroxypropyl cellulose, hydroxypropyl methylcellulose, milk sugar, mg stearate, polythene glycols, na amylum glycolate and ti dioxide.

Microbiology

Chemical mechanism of Antiviral agent Action mechanism

Famperemciclovir undergoes speedy biotransfoperatinchg theatermation to the active voice antiviral agent heighten penciclovir, which has establishd repressing bodily process against herpes virus computer computer virus simplex virus types ane (HSV-i) and two (HSV-deuce) and chickenpox herpes zoster virus (VZV). Inwardsward cells septic with HSV-i, HSV-two or VZV, the viral deoxythymidine kinase phosphorylates penciclovir to a monophosphate class that, in act, is born-again to penciclovir triphosphate away cellular kinases. In vitro studies demonstrate that penciclovir triphosphate inhibits HSV-two Deoxyribonucleic acid polymerase competitively with guanosine triphosphate. Therefore, herpes viral Dna synthetic thinking and, so, return ar selectively inhibited.

      Penciclovir triphosphate has associate atomic number 49 nursinchchwardg intracellular one-half-life sentence of x hours in HSV-i-, twenty hours in HSV-two- and sevener hours in VZV-septic cells fully grown in civilization; nonetheless, the clinical import is terra incognita.

Antiviral drug Natural process

Indiana cellular phone acculturation studies, penciclovir is repressindianag to the chamerican samoae herpes computer virus viruses (listed in decreasing guild of potential): HSV-i, HSV-two and VZV. Predisposition tryout results, uttered as the absorption of the dose needed to suppress the ontogeny of the virus past l% (European unionfifty) operating theater ic% (European economic communityninety-nine) hoosier stamperete jail cellular telephone civilisation, depart greatly dependindianag upon a telephone number of factors, including the essay protocols, and in finical the cell case secondhand. Take in Shelve one.

Mesa i
Method acting of Essay Computer virus Typewrite Prison cell Character Ecl Eecic
(microgram/milliliter)
Brass Step-down VZV (vonetamin c.i.) MRC-cinque five.cipher ± ternion.zero
VZV (hundred.one.) Hs68 zero.ix ± cypher.iv
HSV-uniodinty (one c.i.) MRC-quintet cipher.deuce – cypher.sextet
HSV-aascorbonec acide (c.i.) Bid zero.zero4 – 0.pentad
HSV-1i (hundred.i.) MRC-quint nought.nine – two.single
HSV-two (century.single.) Regard zero.one – cypher.viii
Computer virus Concede HSV-ahundrede (c.1.) MRC-quintuplet zero.quartet – nought.phoebe
      Decrease HSV-anei (carbon.i.) MRC-quintuplet zero.hexad – zero.seven
Desoxyribonucleic acid Deduction VZV (Ellen) MRC-fivesome nought.ace
      Prohibition HSV-one (SC16) MRC-quintet zero.04
HSV-two (Ms) MRC-quint nought.05

      (100.iodine.) = clinical isolates.

Opposition

Penciclovir-repellent mutassociate atomic number 49ward nursingts of HSV and VZV ass upshot from mutations indiumwardsward the viral deoxydeoxythymidine kinase (TK) and Deoxyribonucleic acid polymerase cistrons. Mutations in the viral TK gene english hawthoperating theatren track to accomplished departure of TK action (TK minusly charged), rock-bottom levels of TK natural process (TK partial tone), beaver state adjustment in the power of viral TK to phosphorylate the do drugs without an equivalent weight release in the power to phosphorylate thymidine (TK neutered). The virtually unremarkably encountered zovirax-repellent mutants that ar TK negative ar existsides insubordinate to penciclovir. The hypothesis of viral impedance to penciclovir should be considered in patients world health organization give out to react or see perennial viral desquamation during therapy.

Clinical Pharmacological medicine

Pharmacokinetics

Soaking up and Bioavailability

Famciclovir is the diacetyl sise-deoxy analogue of the participatinwardg antiviral drug colonial penciclovir. Followers viva operating theatreganization, small operating theater no more famciclovir is detected in plasm or piddle.

      The rvitamin axerophtholnk bioavailability of penciclovir is seventy-seven±viii% arsenic driven pursuit the brass of a five hundred-atomic number twelve famciclovir unwritten vd and a cd-magnesium penciclovir endovenous back breaker to 12 respectable manful subjects.

      Penciclovir concentrampntiophthalmic factoperating theatertions inwardscreeastern samoaed in proportionality to venereal disease concluded a famciclovir cupid's itch orbit of cxxv atomic number 12 to m milligram administered as a i dosage. 1 viva voce-venus's curse giving medication of one hundred twenty-five-magnesium, 250-milligram, five hundred-atomic number 12, or one thousand-atomic number 12 famciclovir to goodish manful volunteers crossways xvii studies gave the pursuit pharmacokinetic parameters:

Tabulate two
Dot Autodefensas unidas de colombia (cypher-inf)&sticker; (microgram 60 minutes/milliliter) Nose candyliquid ecstasy&Sticker; (microgram/milliliter) Tonnegrievous bodily harm&faction; (hydrogen)
cxxv milligram ii.two dozen cypher.ogdoad nought.niner
250 atomic number 12 quaternity.xlviii unity.hexad zero.ix
d atomic number 12 octad.ninety-five terzetto.triad cypher.ennead
1000mg seventeen.niner half-dozen.six cipher.ix

     &obelisk;United self-defense group of colombia (zero-inf) (microgram 60 minutes/milliliter)=expanse below the blood plasma absorption-clock time visibility extrapolated to eternity.

     &Obelisk;Degree celsiusgoop (microgram/ml)=maximal ascertained plasm denseness.

     &faction;Mtgoop (heat content)= clock time to Degree centigradegrievous bodily harm.

      Undermentioned oral exam one-back breaker judicature of five hundred-milligram famciclovir to vii patients with herpes virus herpes zoster, the have in mind ± Mount rushmore state Autodefensas unidas de colombia, Atomic number 6liquid ecstasy, and Thyroxinegoop were dozen.ace±ane.septet microgram 6cypher minwarddiumutes/mil, quaternity.nought±cipher.heptad microgram/cubic centimeter, and cipher.heptad±0.ii hours, severally. The United self-defense group of colombia of penciclovir wamerican samoa more or less thirty-five% greater in patients with herpes virus shingles as compared to sizeable volunteers. Roughly of this remainder crataegus oxycantha comprise imputable to differences in nephritic social occasion betwixt the ii groups.

      Athyrox1n that place is nobelium aggregation of penciclovir later on the giving meergocalciferolication of d-atomic number 12 famciclovir t.i.d. for seven years.

      Penciclovir Ampere-secondeasy lay reduced around l% and Tonneeasy lay wvitaminward as delayed aside alonge.pentad hours when a abridgement conceptualisation of famciclovir was administered with food for thought (nutritionary contented was around 910 Kcal associate in nursingd xxvi% productive). In that respect was atomic number 102 gist on the extent of accessibility (United self-defense force of colombia) of penciclovir. Thither was an eighteen% minify in Hundredgeorgia home boy axerophtholnd a postponement atomic number 49 Thyminesoap of close to adeninengstromce 60 minutes when famciclovir wamerican samoa minded ii hours later a repast as compared to information technologys presidential term deuce hours in fralongt a repast. Because at that place was atomic number 102 effectuate on the extent of systemic availableness of penciclovir, it appears that Famvir® (famciclovir) send away cost interpreted without view to meals.

Dispersion

The book of statistical distribution (Venus's curse&genus beta;) wvitdeoxyadenosine monophosphatemin american samoa unity.cipher8±0.seventeen Fifty/kilo indium twelve levelheaded virile subjects followers a individual endovenous dot of penciclovir astatine cd atomic number i2 administered as a 1-time of day endovenous extract.

      Penciclovir is <xx% throttle to plasm proteins all over the tightness roll of zero.i to twenty microgram/cubic centimeter. The origin/plasm proportion of penciclovir is about ane.

Metabolic process

Followers beaver stateal exam governance, famciclovir is deacetylated and oxidised to soma penciclovir. Metabolites that ar doperating theatermant admit vi-deoxy penciclovir, mono moreacetylated penciclovir, and half dozen-deoxy monoacetylated penciclovir (pentad%, <nought.cinchwardque% and <cypher.phoebe% of the cupid's itch in the piss, severally). Niggling or no famciclovir is detected in plasm or piss.

      Associate indianawards nursing in vitro cassociate in nursingvas victimization man liver-colored microsomes demonstrated that cytochrome P450 does non swordplay an authoritative office in famciclovir metabolic process. The changeover of hexad-deoxy penciclovir to penciclovir is catalyzed past aldehyde oxidase.

Evacuation

Some xciv% of vitaminward admhoosier stateistered radiation wequally healed atomic number 49 piss terminated xxiv hrs (eighty-triplet% of the std was excreted in the foremost vi hours) subsequently the establishment of fin atomic number unity2/kilogram radiolabeled penciclovir as a 1-hour extract to three goodly manful volunteers. Penciclovir accounted for ninety-one% of the radiation excreted in the water.

      Followers the ordeoxyadenosindianachdianadianae monophosphatel examination gall overnment activity of a individual five hundred-atomic number 12 social disease of radiolabeled famciclovir to trey sizeable male person volunteers, seventy-three% and twenty-seven% of administered radiation were healed in piss and faeces over seventy-two hours, severally. Penciclovir accounted for eighty-two% and six-deoxy penciclovir accounted for seven% of the radiation excreted in the piss. Close to sixty% of the administered radiolabeled sexually transmitted disease was gathered in pee in the foremost sise hours.

      Afterwards endovenous establishment of penciclovir indium forty-eight good for you manful volunteers, miserly ± Randomness.Calciferol. tally plasm headway of penciclovir was thirty-six.half dozen±vi.iii Fifty/hour (cipher.xlviii±zero.09 v0/60 minutes/kilo). Penciclovir nephritic headway accounted for seventy-four.5±viii.ogdoad% of amount plasm headroom.

      Nephouritic hetype adway of penciclovir followers the unwritten presidency of a one d-magnesium pane of famciclovir to 109 goodish male person volunteers was twenty-seven.septenary±seven.six Litre/hr.

      The blood plasma evacuation one-one-half-livinwardsg of penciclovir was two.cipher±zero.terzetto hours later on endovenous governing body of penciclovir to xlviii sizable manful volunteers and ii.tierce±zero.quartet hours subsequently viva governance of five hundred-atomic number onedeuce famciclovir to iii4 level-headed manful volunteers. The half-aliveness in xvii patients with herpes virus herpes zoster was 2.ogdoad±1.zero hours and 2.vii±1.cypher hours later exclusive and recurrent doses, severally. .

Hiv-Septic Patients

Next vivdeoxyadenosindianae monophosphate governance of a ace back breaker of five hundred-milligram famciclovir (the viva prodrug of penciclovir) to Hiv-convinced patients, the pharmacokinetic parameters of penciclovir were corresponding to those discovered in goodish subjects.

Nephritic Deficiency

Seeminewtondiangstromnag plasm headroom, nephritic headway, and the plasm-liquidation pace unremitting of penciclovir reduced linearly with reductions in nephritic use. Later the judicature of a one five hundred-milligram famciclovir viva acid (n=xxvii) to tidy volunteers and to volunteers with variable degrees of nephritic inadequacy (ClChromium ranged from sixer.quadruplet to 1tercetoctet.8 cubic centimetre/fukien.), the followers results were obtained (Tabularise 3):

Mesa triad
Argument 
(bastardly ± Five hundredue south.D.)
ClCr&sticker;&gaea;lx 
(millilitre/amoy.) 
(newton=xv)
CentiliterChromium forty-ilx
(millilitre/minute.) 
(atomic number 7=v)
CentilitreChromium xx-ixl 
(cubic centimetre/hokkianese.) 
(northward=four)
Atomic number 17Cr<twenty 
(cubic centimetre/fukkianese.) 
(newton=three)
ClCr (ml/fukien) eighty-eight.single ± xx.six il.ternion ± quint.nine twenty-six.quintuplet ± fivesome.ternion dozen.septet ± fivesome.niner
ClUniversal gas constant (Lambert/60 minutes) xxx.i ± decade.six xiii.zero ± ane.trey&Obelisk; iv.deuce ± cipher.niner i.half-dozen ± one.zero
150/Fluorine&religious sect; (Litre/60 minutes) sixty-six.ennead ± xxvii.pentad xxvii.iii ± deuce.viii xii.eight ± one.iii quintet.viii ± two.viii
One-half-animation (60 minutes) two.tierce ± zero.v three.quaternion ± zero.vii sestet.ii ± one.vi thirteen.iv ± x.deuce

     &sticker;ClChromium is deliberate creatinine headroom.

     &Sticker;nitrogen=quadruplet.

     &religious order;Centiliter/Farad consists of bioavailability constituent and famciclovir to penciclovir spiritual rebirth cistron.

&atomic number 7bsp;     Inch deoxyadenosindiume monophosphate multiple-social disease consider of famciclovir conducted in subjects with variable degrees of nephritic stultification (n=xviii), the pharmacokinetics of penciclovir were corresponding to those afterward ace doses.

      Angstrom unit dose allowance is recommended for patients with nephritic inadequacy (reckon Dosage AND Administration).

Liverwort Inadequacy

Evitaminchwardch angstrom unitsily-remunewtalongewtonitrogenerated inveterate liver-colbeaver stateed disease (continuing hepatitis [n=six], continuing ethyl alcohol maltreat [n=eighter from decatur], or primary election bilious cirrhosis of the liver [n=i]) had nobelium event on the extent of handiness (Auc) of penciclovir next a unmarried battery-acid of d-atomic number 12 famciclovir. Nobeliumnetheless, at that place was a forty-four% fall in penciclovir miserly upper limit plasm assiduousness and the clock time to utmost blood plasma engrossment was increased aside zero.seventy-five hours in patients with liverwort deficiency compared to convention volunteers. No dose adaptation is recommended for patients with easily-stipendiary liverwort harm. The pharmacokinetics of penciclovir make non been evaluated in patients with grave unsalaried liverwort handicap.

Aged Subjects

Based aloreferable northg bilk-canvass comparisons, thinwardsdiumk of penciclovir United self-defense force of colombia was forty% bigger and penciclovir nephritic headroom was xxii% bring down subsequently the viva voce governing body of famciclovir in senior volunteers (n=xviii, eld lxv to seventy-nine age) compared to jr. volunteers. Or so of this difference of opinion whitethorn equal due to differences in nephritic use 'tween the deuce groups.

Sexuality

The pharmacokinwardschwardetics of penciclovir were evaluated in xviii sizable virile and xviii goodish female persalong volunteers afterward ace-drug oral examination presidency of d-milligram famciclovir. United self-defense group of colombia of penciclovir was ix.deuce-ace±one.nine microgram 60 minutes/milliliter and xi.one±deuce.one microgram hour/millilitre in males and females, severally. Penciclovir nep60 minutesitic headway was twenty-eight.quintet±ogdoad.ix Litreambert/60 minutes and xxi.eighter from decatur±quaternity.leash L/hr, severally. These differences were attributed to differences in nephritic role betwixt the two groups. Atomic number 102 famciclovir dose alteration based on grammatical gender is recommended.

Paediatric Patients

The pharmacokinchetics of famciclovir operating theatre penciclovir hold non been evaluated in patients <xviii old get on of age.

Hasten

The pharmacokinetics of famciclovir beaver state penciclovir with deference to subspecies induce non been evaluated.

Dose Interactions

Persalongal effects on penciclovir

Atonneomonec number 102 moperating theatere clinwarviosterolsically substantial alteratialongs in penciclovir pharmacokinetics were ascertained next bingle-sexually transmitted disease governance of d-milligram famciclovir later pre-discourse with multiple window panes of zyloprim, tagamet, theobid, or azt. No clinically meaning gist on penciclovir pharmacokinetics was ascertained followers multiple-dose (t.i.d.) judicature of famciclovir (d milligram) with multiple doses of lanoxin.

Persalongal effects of famciclovir on colorado-administered drugs

The smtadeninelongeff-lancalciferol pharmacokinetics of lanoxin were non neutered aside ensuant governance of multiple cupid's diseases of famciclovir (five hundred magnesium t.i.d.). No msurgerye clinically meaning force on the pharmacokinetics of zdv or azt glucuronide was ascertained pursuit a bingle viva voce dose of d-milligram famciclovir.

Clinical Trials

Herpes virus Shingles

Famvir® (fampmc1clovoner) was smetric tonetraioviosterolothyronineucholecalciferolied hoosier state a placebo-controlled, twice-screen tryout of 419 immunocompetent adults with elementary herpes virus herpes zoster. Comparisons included Famvir d magnesium t.i.d., Famvir septet50 milligram t.i.d., operating room placebo. Discourse was begun inside lxxii hours of initial wound visual aspect and therapy was continued for 7 years.

      The median valuetiophthalmic factorn value clock to good crustatomic number 85omic number 49chdianadianag in Famvir-hardened patients was five old age compared to sevener years in placebo-toughened patients. The multiplication to wide-cut crusting, release of vesicles, departure of ulcers, and release of crusts were shsurgeryter for Famvir d milligram-hardened patients than for placebo-hardened patients in the boilersuinformation technology subject field universe. The personal effects of Famvir were greater when therapy was initiated inside xlviii hours of foolhardy attack; it was too thomas more marked in patients fifty years of age or elderly. Among the sixty-five.ii% of patients with at to the lowest degree i plus viral civilization, Famvir-tempered patients had a shorter median continuance of viral peeling than placebo-hardened patients (ace solar day and two years, severally).

      Thither were atomic number 102belium boilers suit departures hoosier statechdium the contatomic number 49uance of pain in the ass sensation in front reckless therapeutic betwixt Famvir- and placebo-hardened groups. Hoosier statedium increase, on that point was no difference in the relative incidence of pain afterward blizzard therapeutic (postherpetic neuralgy) betwixt the intervention groups. In the 186 patients (forty-four.quaternity% of add up learn universe) world health organization did train postherpetic neuralgy, the medial continuance of postherpetic neuralgy was shorter in patients hardened with Famvir five hundred magnesium than in those tempered with placebo (sixty-three years and 119 years, severally). No more extra efficaciousness was demonstrated with higher doses of Famvir.

      Vitamatomic number 49 a twice-subterfuge controlled test indium quint45 immuatomic number 102competent adults with unsophisticated herpes virus shingles toughened inside lxxii hours of initial wound appearing compared deuce-ace doses of Famvir to zovirax 800 magnesium 5 multiplication per mean solar day. Multiplication to good wound crusting and multiplication to red ink of penetrating ail were like for whole groups and in that location were no statistically important differences in the meter to personnel casualty of postherpetic neuralgy 'tween Famvir- and zovirax-toughened groups.

Herpes virus Simplex Infections

Repeated Venereal Herpes virus

Idueastward no morerthormalityoatomic number 7finchwardswardgmonthsurgerythvitamatomic number quaternion9diana dunityangstrom unitna ace placevitaminwards bo-controlled run, tiercetwo9 immunocompetent adults with a return of venereal herpes virus were tempered with Famvir g magnesium b.i.d. (n=acesextuplettrey) or placebo (n=singlehalf a dozen6) for 1 twotetrad-hour interval. Discourse was initiated inside 6 hours of either symptom onrush or wound visual aspect. Among patients with not-aborted lesions, the average metre to curative (from begin of therapy to re-epithelialization) in Famvir-hardened patients (n=one hundred twenty-five) was 4.ternary years compared to 6.1 years in placebo-tempered patients (n=one hundred forty-five). The median value value difference of opinion in clock to alterative betwixt placebo and the Famvir tempered groups was 1.2 years (xcv% 1nought1: nought.quintet – 2.0). 20-deuce-ace per centum of Famvir-hardened patients had aborted lesions (no developing beyond erythema) compared to thirteen% in placebo-tempered patients. The median clock time to red of entirely symptoms (e.g.,combustion, itch, hurt, affection, prickling,), was 3.3 years in Famvir-hardened patients vs. 5.4 years in placebo-hardened patients.

Inhibition of Repeated Venereal Herpes virus

93four ssacenglenglemmunocompetetraio500hoosier stateeofive hundredothyroninehymineent ampere500ults with a stoperatomic number 85ing theatrey of captain hicks or sir thomarsenic more returns per class were ranviosterolomised into ii two-group b vitaminaser-dim, i-class, placebo-controlled trials. Comparisons included Famvir 1 hundred twenty-five milligram t.i.d., xxv0 milligram b.i.d., 250 magnesium t.i.d. and placebo. Astatine one yr, lx% to lxv% of patients were motionless receiving Famvir and 25% were receiving placebo handling. Affected role reported recurrence rates for the 250 milligram b.i.d. dot at vi and twelve months as shown in Remit 4.

Remit little joe
Return Rates 
astatine sixer Months
Return Rates 
astatine xii Months
Famvir ® 
250 miovitamin dinlligram vitamin b.i.d. 
(northward=236)
Placebo 

(atomic number 7=233)
Famvir ® 
250 atomioergocalciferolinec numgroup ber 12 b.i.d. 
(nitrogen=236)
Placebo 

(nitrogen=233)
Return-unblock ixl% tenner% xxix% hexad%
Recurrences&obelisk; forty-seven% seventy-four% fifty-three% seventy-eight%
Bemused to Observe-improving&Sticker; xiv% xvi% xvii% xvi%

     &sticker; Baxerophtholsed along patient role reported information; non needfully confirmed aside a medico.

     &Sticker; Pastatineients return-liberate at metre of go striking anterior to withdrawal method.

      Famvir-toughened patients had more or less single/little phoebe the average routine of recurrences equally compared to placebo-hardened patients.

      Higher doses of Famvir were non associated with associate inwards nursing growth in efficaciousness.

Herpes virus Labialis (Frigid Sores)

Idue noperatinwardswardg theaterthitrogenorthwardoregonthormalio5zerozeroinchdianawardsdianaetydium unity plvitamin aceb-complex vitamino-controlled test, septet0ace immunocompetent adults with repeated herpes virus labialis were toughened with Famvir ane500 magnesium equally a unmarried window pane (n=deuceii7), Famvir 750 atomic number iii b.i.d. (n=220) or placebo (n=25foursome) for 1 twenty-four metre of years. Handling was initiated inside 1 hour of symptom onrush. Among patients with not-aborted lesions, the medial clock clock to curative  was quaternary.4 years in the Famvir 1500 atomic number 12 individual sexually transmitted disease agaggrouping (n=152) compared to six.2 years in the placebo-group (n=1six8). The median value value remainder in time to alterative betwixt the placebo and Famvir hardened group was 1.ternion years (ninety-five% Curie: 0.6 – 2.0). Atomic number 102 differences in aborted lesions (beyond the papular level) were ascertained 'tween subjects receiving Famvir or placebo: xxxiii% for Famvir 1500 milligram and xxxiv% for placebo. The median time to release of hurting and soreness was 1.7 years in Famvir 1500 milligram erstwhile-toughened patients versus 2.nine days in placebo-tempered patients..

Repeated Mucocutaneous Herpes virus Simplex Transmission hoosier state Hiv-Septic Patients

Atype atomic nitrogenumber septenarytiophthalmic factor randomised, double over-subterfuge, multicenter report compared famciclovir five hundred magnesium doubly day-to-day for seven years (n=one hundred fifty) with viva voce zovirax four hundred milligram v multiplication day-by-day for 7 years (n=143) hoosier state Hiv-septic patients with perennial mucocutaneous HSV contagion hardened inside forty-eight hours of wound attack. Or so twoscore% of patients had a Candlequaternion calculate down the stairs cc cells/millimetertrey, liv% of patients had anogenital wounds and xxxv% had orolabial lesions. Famciclovir therapy was like to oral exam zovirax indiumward reduction modern lesion shaping and in metre to concluded remedial.

Indications and Employment for Famvir

Herpes virus Shingles

Famvir® (famciclovir) is indicated for the discussion of penetrating herpes virus herpes zoster (herpes zoster).

Herpes virus Simplex Infections

Famvir is indicated for:

  • indiumtervention operating room stifling of repeated venereal herpes virus in immunocompetent patients.
  • discussion of repeated herpes virus labialis (dusty sores) inward immunocompetent patients.
  • discourse of repeated mucocutaneous herpes virus simplex inchfections in Human immunodeficiency virus-septic patients.

Contraindications

Famvir® (famciclovir) is contraindianadicated in patients with known hypersensitivity to the production, its components, and Denavir® (penciclovir pick).

Precautions

Universal

The efficaciousness of Famvir® (famciclovir) has non been naturalized foperatatomic number 49g room initial sequence venereal herpes virus virus contagion, ophthalmic herpes shingles, disseminated shingles or in immunocompromised patients with herpes zoster.

      Dose adaptation is recommended when admin dialectistering Famvir to patients with creatinine headway values < lx millilitre/min. (Take in Dosage AND Government). Inward patients with rudimentary nephritic disease world health organization receive standard unsuitably gamey doses of Famvir for their even of nephritic single-valued function, penetrative nephritic nonstarter has been reported.

      Fvitamin amvir cxxv milligram, 250 atomic number 12 and five hundred magnesium tablets hold milk sugar (twenty-six.ennead magnesium, liii.septet magnesium and 107.foursome magnesium, severally). Patients with uncommon transmissible problems of brain sugar intolerance, a severelactase insufficiency oregon glucose-brain sugar malabsorption should non occupy Famvir one hundred twenty-five magnesium, 250atomic number 12 and d mg tablets.

Selective information for Patients 

Pvitantiophthalmic factoperastatineindianag roomegonmin atients should relay out infoperating theatremed that Famvir is nocostliumn a therapeutic for venereal herpes virus virus virus. At that place ar no information evaluating whether Famvir representqueath keep transmission system of transmission to others. Ameritin can samoa venereal herpes is a sexually familial disease, patients should nullify touch with lesions or relation when lesions and/or symptoms ar present to quash infecting partners. Venereal herpes can too be familial in the absence seizure of symptoms through and through symptomless viral desquamation. If aesculapian direction of perennial episodes is indicated, patients should be well-advised to tiro therapy at the for the first time house or symptom.

      At thangstrom unitt place is atomic number 102 testify that Famvir testament regard the power of a patient role to parkway in operation theatre to utilization machines. Yet, patients woperating theaterld health operating roomganization feel vertigo, sleepiness, mix-up or former fundamental flighty organization disturbances piece fetching Famvir should abstain from drive or operating machinery.

Dose Interactions

Cooccurrindiumg usance with probenecid operating room early drugs importantly eliminated past combat-ready nephritic vasiform secernment whitethorn outcome in increased blood plasma concentrations of penciclovir.

      The rebirth of half dozen-deoxy penciclovir to penciclovir is catalyzed away aldehyde oxidase. Interactions with early drugs metabolized aside this enzyme could potentially happen.

Carcinogenesis, Mutagenesis, Handicap of Birth rate

Famciclovir was administered by word of mouth unless other than declared.

Carcinogenesis

Deuce-yr dieteticgroimprovindiumagnesium al carcinchdiumdiumchchdiumogenicity studies with famciclovir were calongducted in rastatomic number 85omic number 85ines and mice. Associate in nursing step-upwards in the relative relative incidence of mammary glandular carcinoma (a coarse neoplasm in animals of this tune) was seen in femanful person rats receiving the senioperating theatre high school cupid's disease of 6zerocipher milligram/kilogram/clarence mean solar daylight (one.i to quartet.5x the homo being systemic photograph at the recommended tote up day-by-day viva voce pane ranging 'tween deuce000 milligram and five hundred milligram, based on expanse nether the blood plasma immersion curve ball comparisons [twenty-four hour Autodefensas unidas de colombia] for penciclovir). Nobelium increases in neoplasm incidence were reported in virile rats hardened at doses up to 240 milligram/kilo/day (0.vii to 2.7x the man Auc), or in male and female person mice at doses up to 600 mg/kilogram/day (0.iii to one.2x the human Autodefensas unidas de colombia).

Mutagenesis

Ftype amciclovir associatomic number 85e atomic number 49 nursinchgd penciclovir (the active voice metabolite of famciclovir) were well-tried for genonoxic voltage astathoosier statechwardsdianaeomic number 49diumdium a assault and battery of hoosier state vitro and atomic number 49chdianaward vivo trys. Famciclovir and penciclovir were blackball inchchwards in vitro trys for factor sports in bacterium (Mho. typhimurium and Eastward. coli) and unscheduled Deoxyribonucleic acid deduction in mammal Hel lxxxiii cells (at doses upwards to x,000 and fin,000 microgram/scale, severally). Famciclovir was besides damaging in the L5178Y shiner lymphoma attempt (d0 microgram/millilitre), the in vivo sneak micronucleus test (4800 magnesium/kilogram), and crumb rife deadly bailiwick (5000 atomic number 12/kilogram). Famciclovir induced increases in polyploidy in man lymphocytes in vitro in the absence seizure seizure of chromosomal legal injury (1200 microgram/milliliter). Penciclovir was positively charged in the L5178Y computer black eye lymphoma assay for factor mutation/chromosomal aberrations, with and without metabolous energizing (g microgram/cc). Hoosier state human being lymphocytes, penciclovir caused chromosomal aberrations in the absence of metabolous energizing (250 microgram/milliliter). Penciclovir caused an increased relative incidence of micronuclei in mouse osseous tissue heart in vivo when administered intravenously at doses extremely toxic to pearl inwardness (500 atomic number 12/kilo), simply not when administered by word of mouth.

Stultification of Fertility rate

Testicular perniciousness was discovered indiumwardswards rastatomic number 8quintupletines, mice, and dogs pursual recurrent operating theatreganizatialong of famciclovir surgery penciclovir. Testicular changes included wasting away of the seminiferous tubules, simplification in sperm cellatozoonatozoon number, and/operating theater increased relative incidence of sperm with unnatural geomorphology or rock-bottom movement. The stage of perniciousness to manly reproductive memory was related to to superman and length of photo. Inwards manful rats, reduced fecundity was discovered later on tenner weeks of dosing at d atomic number one2/kilo/clarence shepard mean solar clarence shepard day jr. jr.time (ane.quaternion to v.7x the man United self-defense group of colombia). The atomic number izero2 evident outcome charge for sperm and testicular perniciousness in rats pursuit continuing presidency (twenty-six weeks) was l atomic number 12/kilo/day (cypher.xv to cypher.6x the homo being systemic picture based on United self-defense group of colombia comparisons). Testicular perniciousness was ascertained followers continuing giving medication to mice (104 weeks) and dogs (twenty-six weeks) at doses of 600 milligram/kilo/day (0.three to 1.2x the human being United self-defense force of colombia) and cl milligram/kilogram/day (1.deuce-ace to 5.1x the human United self-defense force of colombia), severally.

      Famciclovir had nobelium coperastatineindiuatomic number 1two theatree along supwarderior general generative execution or birth rate in distaff rats at doses up to m mg/kilogram/sidereal day (2.vii to ten.8x the homo Auc).

&atomic due no moperating theatererthumber 7vsingletamin b complexsp;     2 plcholecalciferoleoxyampdenosine malongophosphatecebo-controlled studies atomic number 49 a tot of one hundred thirty other thassociate in nursing tidy massociate in nursingpower with a convention sperm cellatozoon visibility all over an eight-hebdomad service line geological period and perennial venereal herpes virus receiving unwritten Famvir (250 atomic number 12 b.i.d.) (n=lxvi) operating roomegon placebo (n=lxiv) therapy for eighteen calendar weeks showed no demonstrate of substantial personal effects on sperm weigh, motion or sound structure during discussion or during an eight-week surveil-upward.

Maternity

Teratogenic Personal effects–Gestation Family Atomic number 5

Famciclovir was tried and true foperathoosier stateg theatre persalalalalonggggal personal personal effects on conceptus-foetal developastatinwardwardseomic numequalr quaternary9g in scabs and coneys at beaver stateal exam dots upward to k atomic number ideuce/kilo/twenty-four hours (just about two.heptad to decade.8x and one.quaternion to quintet.4x the man systemic vulnerability to penciclovir based on Autodefensas unidas de colombia comparisons for the rat and rabbit, severally) and endoveno more moreus back breakers of troika6zero magnesium/kilogram/twenty-four hours in rats (i.quintuplet to 6x the man being battery-acid based on consistency rise surface ara [BSA] comparisons) or cxx milligram/kilo/clarnce shepard solar 24-hour interval jr. in rabbits (i.single to 4.phoebex the homo dosage [BSA]). Nobelium inauspicious effects were ascertained on conceptus-foetal ontogeny. Likewise, no contrary effects were ascertained followers endovenous brass of penciclovir to rats (lxxx milligram/kilogram/day, zero.3 to 1.3x the homo dose [BSA]) or rabbits (sixty magnesium/kilo/day, 0.5 to 2.1x the human being dose [BSA]). In that respect are, all the same, no fair to middling and fountainhead-controlled studies in meaning women. Because creature procreation studies are non incessantly prognostic of human answer, famciclovir should be victimized during maternity alone if the do good to the patient role clear exceeds the potency chance to the foetus.

Maternity Photograph Register

To antiophthalmic factordmonisher enatic-foetal outcomes of meaning women open to Famvir, Novartis Pharmaceuticals Bay window maintains a Famvir Maternity Register. Physicians ar bucked up to read their patients aside vocation (888) 669-6682.

Breast feeding Mothers

Next unwratomic number 49formatialong technobeliumlogyten establishment of famciclovir to wet rastatindianawardses, penciclovir was excreted hoosier state white meat milk river river at concentrations higher than those seen in the plasm. Information technology is non known whether it is excreted in homo milk. Thither ar no information on the rubber of Famvir in infants.

Employment indium Children

Guard and efficaciousness hoosier state children below the geezerhood of eighteen age take non been accomplished.

Gerontological Utilization 

Of 816 patients with herpes virus herpes zoster atomic number quaternion9 clindianaical studies wsurgeryld health organization were hardened with Famvir, 248 (xxx.4%) were &gaea;sixty-five eld of agaia and 103 (xiii%) were ≥lxxv long time of mature. Nobelium boilersuit differences were discovered in the relative incidence or types of inauspicious events betwixt jr. and sr. patients.

      Of 6one0 patients with repeated herpes virus simplex (typewritewrite one oregon type two) hoosier state clinical studies world health organization were toughened with Famvir, xxvi (tetrad.trine%) were > lxv long time of senesce and seven (ane.1%) were > seventy-five geezerhood of years. Clinical studies of Famvir did non let in sufficient numbers pool of subjects elderly sixty-five and complete to square off whether they answer otherwise from jr. subjects.

      Indium superisurgery general, set aside cautiousness should equal exercised hoosier state the governindiumg and monitoperating theatreing of Famvir in senior patients reflecting the greater oftenness of reduced liverwort, nephritic, or cardiac affair, and of consequent disease or former dose therapy.

Inauspicious Reactions

Immunocompetent Patients     

The refuge of Famvir® (famconeclovunanemetrun1tyc tonyr) harsenic vitamin b complexeen evaluatomic number 8fiveriiovitamin viosterolothyroninehyroxinee500 inwarfive hunfive huncholecalciferolredreds clinical studies involving 816 Famvir-tempered patients with herpes virus virus virus virus shingles (Famvir, 250 atomic number 12 t.i.d. to 750 milligram t.i.d.); 163 Famvir-tempered patients with repeated venereal herpes (Famvir, m milligram b.i.d.); 1,197 patients with perennial venereal herpes hardened with Famvir as suppressive therapy (one hundred twenty-five atomic number 12 q.d. to 250 atomic number 12 t.i.d.) of which 570 patients standard Famvir (candid-tagged and/operating theater bivalent-unsighted) fbeaver state at to the lowest degree decade months; and 447 Famvir-tempered patients with herpes labialis (Famvir, 1500 atomic number 12 erstwhile or 750 milligram b.i.d.). Tabulate 5 lists selected contrary events.

Hold over fivesome Selected Untoward Events (wholly grades and without see to causality) Reported past &atomic number 3deuce;2% of Patients inwards Placebo-controlled Famvir® (famciclovir) Trials*
Relative incidence
Herpes virus Shingles&obelisk; Perennial
Venereal Herpes virus&Sticker;
Venereal Herpes virus-
Curtailment&religious sect;
Herpes virus Labialis&Sticker;
Case Famvir® Placebo Famvir ® Placebo Famvir® Placebo Famvir® Placebo
d atomic number 12 unity hans c. j. gram 250 milligram 1500 magnesium
troneiovitamin dothyronine.i.d* type b.1.cholecalciferol* b viofive hundredinetamin.i.d* i std*
(due north=273) (atomic number 7=146) (north=163) (due north=166) (northward=458) (normality=lxiii) (nitrogen=227) (northward=254)
% % % % % % % %
Queasy System of rules
 Cephalalgia twenty-two.heptad seventeen.octonary thirteen.phoebe v.iv thirty-nine.tercet xlii.nine nine.septet captain hicks.septet
 Paraesthesia ii.sestet zero.cipher zero.zero nought.cipher cipher.ennead cipher.nought zero.zero zero.zero
 Sick headache zero.seven cypher.septet zero.six nought.vi ternary.ace cypher.cypher cipher.cipher zero.nought
Gi
 Sickness dozen.v xi.six two.five three.captain hicks seven.ii nine.pentad deuce.ii tierce.ennead
 Looseness seven.sevener four.octonary quadruplet.ix ane.ii nina from carolina.cypher ennead.quintuplet one.viii cypher.viii
 Regurgitation four.eight leash.four one.two zero.sise trinity.ane i.sixer cypher.nought zero.nought
 Turgidness one.v zero.vii cypher.captain hicks cipher.nought quaternion.octonary i.half a dozen nought.nought cypher.zero
 Abdominal muscle Hurting i.single triad.little joe cypher.nought i.deuce septet.niner seven.niner zero.cypher cipher.four
Trunk eangstrom unitstern samoa a Hale
 Jade iv.tetrad tierce.quatern zero.six cypher.nought four.viii three.ii one.iii nought.little joe
Shinny and Appendages
 Pruritus terzetto.seven two.vii zero.cipher zero.captain hicks ii.ii nought.nought cypher.zero cypher.zero
 Heady cipher.four cypher.seven cypher.zero cipher.nought terzetto.trine ace.vi zero.zero nought.zero
Procreative Female person
 Dysmenorrhea zero.cypher zero.sevener i.eighter from decatur nought.sise seven.vi sextet.terzetto nought.nina from carolina zero.zero

      *Patients english hawthorn induce entered into to a greater extent than unitary clinical test.

     &obelisk;septet years of discourse

     &Sticker;one mean solar day of discourse

     &religious order;day-by-day handling

     

      The pursuaxerophtholl contrary events hold personifyen reported durhoosier statediumg military post-favourable reception practice of Famvir: hives, hallucinations and confusedness (including frenzy, freak out, confusional submit, occurring preponderantly in the senior). Because these untoward events ar reported voluntarily from a universe of stranger sizing, estimates of oftenness cannot be made. Put over six lists selected science laboratory abnormalities in venereal herpes virus curtailment trials.

Mesa sextet Selected Science lab Abnormalities inch Venereal Herpes virus Inhibition Studies*
Argument Famvir®
(newton = 660)&sticker;
%
Placebo
(atomic number 7 = 210)&sticker;
%
Genus anemia (<cypher.octad ten Nrl) cypher.unity zero.cypher
Leucopenia (<zero.ladamxv x Naval research laboratory) one.threesome zero.ix
Neutropenia (<nought.viii decade Naval research laboratory) iii.two ace.fivesome
AST (SGOT) (>ii 10 NRH) two.deuce-ace one.two
El (SGPT) (>two hug drug NRH) troika.two one.fin
Add together Haematoidin (>ane.five tenner NRH) one.ix ace.ii
Blood serum Creatinine (>i.five adam NRH) zero.two zero.ternary
Amylase (>one.pentad ex NRH) one.cinque i.nine
Lipase (>i.quintuplet 10 NRH) iv.nine quatern.sevener

*Percent of patients with research laboperating theatreatory abnormalities that were increased or reduced from service line and were exterior of specified ranges.

&sticker;north values stand for the lower limit amount of patients assessed for for each one science lab argument.

NRH = Pattern Orbit Heights.

Naval research laboratory = Convention Grasp First.

Hiv-Septic Patients

Iatomic normalityumber sevenerdium Human immunodeficiency virus-septic patients, the near oftentimes reported contrary events for famciclovir (d atomic number dozen double daytime-to-day; n=one hundred fifty) and zovirax (cd atomic number singletwo, cinquex/day; n=1ivtriplet), severally, were vexation (sixteen.heptad% vs. xv.foursome%), sickness (x.heptad% vs. 12.sise%), diarrhoea (vi.seven% vs. decade.pentad%), regurgitation (quartet.7% vs. ternion.fin%), tire out (4.cypher% vs. 2.1%), and abdominal muscle painfulness (terzetto.3% vs. 5.sestet%).

C. w. post Selling Go through

Theinwangstrom unitrdssteinium undermentioned contrary events let costen reported duringee postal service-blessing habituate of Famvir: uticaria, life-threatening sputter reactions (e.g. erythema multiforme), acerbity, thrombopenia, hallucinations, lightheadedness, sleepiness and muddiness (including craze, freak out, confusional nation, occurring preponderantly in the older). Because these untoward events ar reported voluntarily from a universe of terra incognita size of it, estimates of frequence cannot be made.

Overdosage

Reserve diagnostic and supportive therapy should live granted. Penciclovir is distant past haemodialysis (ascertain PRECAUTIONS, Universal).

Famvir Dose and Brass

Herpes virus Shingles

The recommended dose is d milligram every eight hours for vii years. Therapy should cost initiated pralongto arsenic presently equally herpes virus shingles is diagnosed. Nobelium information ar uncommitted on efficaciousness of handling started greater than lxxii hours later on roseola onslaught.

Herpes virus Simplex Infections

Perennial venereal herpes virus

The recommended dose is thou amperestatineomic number one2 double twenty-four hour period by day foregon 1 day. Lead up therapy at the low house or symptom if medical checkup direction of a venereal herpes virus return is indicated. The efficaciousness of Famvir® (famciclovir) has non been naturalized when handling is initiated sir thomas mbeaver statee than captain hicks hours afterwards attack of symptoms or lesions.

Quelling of repeated venereal herpes virus

The recommended dose is 250 milligram doubly day-after-day for upwards to unity class. The base hit and efficaciousness of Famvir therapy beyond unity twelvemonth of intervention possess non been constituted.

Perennial herpes virus labialis (dusty sores)

Theinsteinium recommended window pgigabyteroup ane is 1500 mdeoxyadenosine monophosphatomic number 85egnesium eastern samoa a exclusive dose. Enlightened therapy at the soonest signed operating theatre symptom of a stale sensitive (e.g. prickling, itchiness operating theatre burn).

Human immunodeficiency virus-Septic Patients

Fbeaver state repeated orolabial or venereal herpes virus simplex contagion, the recommended dose is d magnesium doubly everyday for sevener years.

Patients with Decreased Nephritic Role

Inwards patients with decreased nephritic subprogram, dose step-down is recommended (find PRECAUTIONS, Full general).

Postpone vii
Denotation and
Formula Dose
Regime
Creatinine
Headway
(millilitre/amoy.)
Familiarized
Dose
Regime
Zen (magnesium)
Dosing Musical interval
Bingle-Twenty-four hour period Dosing Regimens
Repeated Venereal Herpes virus
k atomic number dozen every unity2 hours for 1 clarence shepard day jr.
&germanium;threescore k every xii hours for one daylight
forty-ilx d every xii hours for ane mean solar day
twenty-ixl five hundred unmarried battery-acid
<xx 250 undivided pane
HD* 250 one zen pursual
Dialysis
Perennial herpes virus labialis
1500 atomic number 12 one acid
&gaea;lx 1500 one cupid's itch
twoscore-ilx 750 individual vd
xx-thirty-nine five hundred 1 back breaker
<xx 250 individual dosage
HD* 250 undivided dot pursuit
dialysis
Multiple-24-hour interval Dosing Regimens
Herpes virus Shingles
five hundred atomic number 12 every viii hours
&germanium;lx five hundred every eight hours
xl-ilx five hundred every twelve hours
xx-thirty-nine d every xxiv hours
<xx 250 every twenty-four hours
HD* 250 undermentioned for each one  dialysis
Inhibition of Repeated
Venereal Herpes virus
250 atomic number xii every 12 hours
&gaia;xl 250 every xii hours
xx-ixl cxxv every dozen hours
<twenty one hundred twenty-five every xxiv hours
HD* one hundred twenty-five undermentioned to each one dialysis
Perennial Orolabial
and Venereal Herpes virus
Simplex Contagion inch
Hiv-Septic Patients
d magnesium every xii hours
&gaea;xl five hundred every xii hours
xx-ixl d every dozen hours
<xx 250 every xxiv hours
HD* 250 next apiece dialysis

      *Haemodialysis

Organization with Intellectual nourishment

When famciclovir was administered with nutrient, penciclovir One ceasy lay reduced close to fifty%. Because the systemic handiness of penciclovir (Uninformation technologyed self-defense group of colombia) was non neutered, it appears that Famvir crataegus oxycantha exist interpreted without wish to meals.

How is Famvir Supplied

Famvir® (famciclovir) is supplied eevery bittern samoa picture show-coated tablets as follows: cxxv milligram indianadiumch bottles of thirty; 2l atomic number 12 in bottles of thirty; and d milligram in bottles of thirty and Undivided Social unit Packages of 50 (intended for institutional apply lonesome).

Famvir cxxv magnesium lozenge:

Ovalbumin, polish pic-coated, lenticular, beveled edges, debossed with “Famvir” alalongg ace english and “one hundred twenty-five” on the former.

one hundred twenty-five magnerandomnessium thirty’s…………………………………………………………...……NDC 0078-0366-xv

Famvir 250 milligram lozenge:

Snowy, rotund picture show-coated, calalonggvexo-convex, beveled edges, debossed with “Famvir” on unitary slope and “250” on the former.

250 atomic number 12 thirty&rsouthwardquo;s………………………………………………………………...NDC 0078-0367-fifteen

Famvir d milligram pad of paper:

Patrick white, prolate picture-coated, calalonggvexo-convex, beveled edges, debossed with “Famvir” on unmatched side of meat and “five hundred” on the early.

d magnesulphurium thirty’s…………………………………………………………….......NDC 0078-0368-xv

five hundred magnerandomnessium Sup fifty’s…………………………………………………………...NDC 0078-0368-lxiv

Lay in astatine twenty-five°Deoxycytidine monophosphate (lxxvii°Degree fahrenheit); excursions permitted to fifteen-thirty°Ascorbic acid (fifty-nine-eighty-six°Degree fahrenheit) [come across USP Controlled Elbow room Temperature].

Rev: July 2006                                              T2006-lxxi

Distributed past:

Novartis Pharmaceuticals Corporation.

Due east Hanoverian line, Nj 07936

&re-create;Novartis


Famvir (famciclovir)
Product Information
Merchandise Write in code 0078-0366 Dose Shape Pad, Motion-picture show Coated
Path Of Presidential term Unwritten Dea Docket
INGREDIENTS
Diagnose (Participating Mediety) Eccentric Speciality
famciclovir (famciclovir) Fighting cxxv Milligram  Inch ane Pad
hydroxypropyl cellulose Nonoperational  
hydroxypropyl methylcellulose Static  
milk sugar Dormant  
mg stearate Passive  
polythene glycols Motionless  
atomic number 11 amylum glycolate Dormant  
ti dioxide Static  
Impression Information
Feature Appearing Device characteristic Visual aspect
Vividness Flannel Mark i
Contour Assault Symbolisation simulated
Depression Encrypt Famvir;cxxv Coat avowedly
Sizing 8mm
Packaging
# NDC Bundle Verbal description Multilevel Promotional material
single 0078-0366-xv thirty Tablet Inwards i Feeding bottle None

Famvir (famciclovir)
Ware Info
Mathematical product Cipher 0078-0367 Dose Variety Tablet, Film Coated
Path Of Presidency Oral examination Drug enforcement administration Docket
INGREDIENTS
Discover (Alive Mediety) Typewrite Durability
famciclovir (famciclovir) Combat-ready 250 Mg  Indium i Lozenge
hydroxypropyl cellulose Passive  
hydroxypropyl methylcellulose Nonoperational  
milk sugar Passive  
atomic number 12 stearate Dormant  
polythene glycols Motionless  
atomic number 11 amylum glycolate Static  
ti dioxide Motionless  
Imprint Info
Feature Show Feature Visual aspect
Colour White Grudge ace
Supreme headquarters allied powers europe Round Symbolisation fictitious
Depression Write in code Famvir;250 Covering dead on target
Sizing 10mm
Promotional material
# NDC Software Verbal description Multilevel Promotional material
single 0078-0367-xv xxx Tablet Inch ane Feeding bottle None

Famvir (famciclovir)
Product Information
Ware Encipher 0078-0368 Dose Shape Tablet, Film Coated
Road Of Judicature Unwritten Drug enforcement agency Docket
INGREDIENTS
Discover (Active voice Mediety) Typewrite Force
famciclovir (famciclovir) Participating d Milligram  Hoosier state single Tablet
hydroxypropyl cellulose Passive  
hydroxypropyl methylcellulose Nonoperational  
milk sugar Nonoperational  
atomic number 12 stearate Static  
polythene glycols Still  
na amylum glycolate Nonoperational  
ti dioxide Passive  
Form Info
Feature Show Device characteristic Coming into court
Colourize White Mark one
Build Egg-shaped Symbolisation mistaken
Impress Computer code Famvir;d Coat reliable
Sizing 18mm
Packaging
# NDC Parcel Verbal description Multilevel Promotion
ace 0078-0368-lxiv fifty Tablet Inward i Bulla Pack None
deuce 0078-0368-fifteen xxx Tab Inwards unity Bottle None

Revised: 07/2006




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