Syngab 50mg,100mg,200mg caps

(Pregabalin)

pronounced as(pre gab' a lin)
Why is this medication prescribed?
How should this medicine be used?
Other uses for this medicine
What special precautions should I follow?
What special dietary instructions should I follow?
What should I do if I forget a dose?
What side effects can this medication cause?
What should I know about storage and disposal of this medication?
In case of emergency/oerdose
What other information should I know?
!rand names
Why is this medication prescribed?
"regabalin is used to reliee neuropathic pain (pain from damaged neres) that can occur in your
arms# hands# fingers# legs# feet# or toes if you hae diabetes or in the area of your rash if you
hae had shingles (a painful rash that occurs after infection with herpes $oster)% It is also used to
treat fibromyalgia (a long&lasting condition that may cause pain# muscle stiffness and tenderness#
tiredness# and difficulty falling asleep or staying asleep)% "regabalin is used with other
medications to treat certain types of sei$ures in people with epilepsy% "regabalin is in a class of
medications called anticonulsants% It works by decreasing the number of pain signals that are
sent out by damaged neres in the body%
How should this medicine be used?
"regabalin comes as a capsule to take by mouth% It is usually taken with or without food two or
three times a day% 'ake pregabalin at around the same times eery day% (ollow the directions on
your prescription label carefully# and ask your doctor or pharmacist to e)plain any part you do not
understand%
*our doctor will probably start you on a low dose of pregabalin and may gradually increase your
dose during the first week of treatment%
'ake pregabalin e)actly as directed% "regabalin may be habit forming% +o not take a larger dose#
take it more often# or take it for a longer period of time than prescribed by your doctor%
"regabalin may help control your symptoms but will not cure your condition% It may take seeral
weeks or longer before you feel the full benefit of pregabalin% ,ontinue to take pregabalin een if
you feel well% +o not stop taking pregabalin without talking to your doctor# een if you e)perience
side effects such as unusual changes in behaior or mood% If you suddenly stop taking
pregabalin# you may e)perience withdrawal symptoms# including trouble falling asleep or staying
asleep# nausea# diarrhea# headaches# or sei$ures% *our doctor will probably decrease your dose
gradually oer at least one week%
*our doctor or pharmacist will gie you the manufacturer's patient information sheet (-edication
.uide) when you begin treatment with pregabalin and each time you refill your prescription% /ead
the information carefully and ask your doctor or pharmacist if you hae any 0uestions% *ou can
also isit the (ood and +rug 1dministration ((+1) website (http2//www%fda%go/+rugs) or the
manufacturer's website to obtain the -edication .uide%
Other uses for this medicine/eturn to top
'his medication may be prescribed for other uses3 ask your doctor or pharmacist for more
information%
What special precautions should I follow?/eturn to top
!efore taking pregabalin#
tell your doctor and pharmacist if you are allergic to pregabalin# any other medications# or any of
the ingredients in pregabalin capsules% 1sk your pharmacist for a list of the ingredients%
tell your doctor and pharmacist what other prescription and nonprescription medications#
itamins# nutritional supplements# and herbal products you are taking or plan to take% !e sure to
mention any of the following2 angiotensin conerting en$yme (1,4) inhibitors such as bena$epril
(5otensin# in 5otrel)# captopril (,apoten# in ,apo$ide)# enalapril (6asotec# in 6aseretic# 5e))el)#
fosinopril (-onopril)# lisinopril ("riniil# 7estril# in "rin$ide# 7estoretic)# moe)ipril (8niasc# in
8niretic)# perindopril (1ceon)# 0uinapril (1ccupril# in 1ccuretic# 9uinaretic)# ramipril (1ltace)# and
trandolapril (-aik# in 'arka)3 antidepressants3 antihistamines3 medications for an)iety# including
lora$epam (1tian)3 medications for mental illness or sei$ures3 certain medications for diabetes
such as pioglita$one (1ctos# in +uetact) and rosiglita$one (1andia# in 1andaryl# 1andamet)3
narcotic pain medications# including o)ycodone (O)y,ontin# in "ercocet# others)3 sedaties3
sleeping pills3 and tran0uili$ers% *our doctor may need to change the doses of your medications
or monitor you carefully for side effects%
tell your doctor if you drink or hae eer drunk large amounts of alcohol# use or hae eer used
street drugs# or hae oerused prescription medications% 1lso tell your doctor if you hae or hae
eer had swelling of the eyes# face# lips# tongue# or throat3 problems with your ision# bleeding
problems or a low number of platelets (type of blood cell needed for blood clotting) in your blood#
or heart or kidney disease%
tell your doctor if you are pregnant# or if you or your partner plans to become pregnant% 1lso tell
your doctor if you are breast&feeding% If you or your partner becomes pregnant while you are
taking pregabalin# call your doctor% "regabalin has caused decreased fertility in male animals and
birth defects in the offspring of male and female animals who were treated with the medication%
'here is not enough information to tell if pregabalin causes these problems in humans%
if you are haing surgery# including dental surgery# tell the doctor or dentist that you are taking
pregabalin%
you should know that pregabalin may make you di$$y or drowsy% +o not drie a car operate
machinery# or do other dangerous actiities until you know how this medication affects you% 1sk
your doctor when you may do these actiities%
do not drink alcohol while taking pregabalin% 1lcohol can add to the drowsiness caused by this
medication%
you should know that your mental health may change in une)pected ways and you may become
suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are
taking pregabalin for the treatment of epilepsy# mental illness# or other conditions% 1 small number
of adults and children : years of age and older (about ; in :<< people) who took anticonulsants
such as pregabalin to treat arious conditions during clinical studies became suicidal during their
treatment% =ome of these people deeloped suicidal thoughts and behaior as early as one week
after they started taking the medication% 'here is a risk that you may e)perience changes in your
mental health if you take an anticonulsant medication such as pregabalin# but there may also be
a risk that you will e)perience changes in your mental health if your condition is not treated% *ou
and your doctor will decide whether the risks of taking an anticonulsant medication are greater
than the risks of not taking the medication% *ou# your family# or your caregier should call your
doctor right away if you e)perience any of the following symptoms2 panic attacks3 agitation or
restlessness3 new or worsening irritability# an)iety# or depression3 acting on dangerous impulses3
difficulty falling or staying asleep3 aggressie# angry# or iolent behaior3 mania (fren$ied#
abnormally e)cited mood)3 talking or thinking about wanting to hurt yourself or end your life3
withdrawing from friends and family3 preoccupation with death and dying3 giing away pri$ed
possessions3 or any other unusual changes in behaior or mood% !e sure that your family or
caregier knows which symptoms may be serious so they can call the doctor if you are unable to
seek treatment on your own%
What special dietary instructions should I follow?/eturn to top
8nless your doctor tells you otherwise# continue your normal diet%
What should I do if I forget a dose?/eturn to top
If you forget to take a dose and remember a few hours later# take the missed dose as soon as
you remember it% Howeer# if it is almost time for the ne)t dose# skip the missed dose and
continue your regular dosing schedule% +o not take a double dose to make up for a missed one%
What side effects can this medication cause?/eturn to top
"regabalin may cause side effects% 'ell your doctor if any of these symptoms are seere or do not
go away2
tiredness
di$$iness
headache
dry mouth
nausea
omiting
constipation
gas
bloating
''high'' or eleated mood
speech problems
difficulty concentrating or paying attention
confusion
difficulty remembering or forgetfulness
an)iety
lack of coordination
loss of balance or unsteadiness
uncontrollable shaking or >erking of a part of the body
muscle twitching
weakness
increased appetite
weight gain
swelling of the arms# hands# feet# ankles# or lower legs
back pain
=ome side effects can be serious% If you e)perience any of these symptoms# call your doctor
immediately2
blurred ision# double ision# or other changes in eyesight
hies
rash
itching
blisters
swelling of the eyes face# throat# mouth# lips# gums# tongue# head or neck
shortness of breath
whee$ing
muscle pain# tenderness# soreness# or weakness# especially if it comes along with feer
chest pain
If you hae diabetes# you should know that pregabalin has caused skin sores in animals% "ay
e)tra attention to your skin while taking pregabalin# and tell your doctor if you hae any sores#
redness# or skin problems%
"regabalin may cause other side effects% ,all your doctor if you hae any unusual problems while
taking this medication%
If you e)perience a serious side effect# you or your doctor may send a report to the (ood and
+rug 1dministration's ((+1) -edWatch 1derse 4ent /eporting program online ?at
http2//www%fda%go/=afety/-edWatch@ or by phone ?;&A<<&BBC&;<AA@%
What should I know about storage and disposal of this medication?/eturn to top
Deep this medication in the container it came in# tightly closed# and out of reach of children% =tore
it at room temperature and away from e)cess heat and moisture (not in the bathroom)% 'hrow
away any medication that is outdated or no longer needed% 'alk to your pharmacist about the
proper disposal of your medication%
In case of emergency/oerdose/eturn to top
In case of oerdose# call your local poison control center at ;&A<<&CCC&;CCC% If the ictim has
collapsed or is not breathing# call local emergency serices at E;;%
What other information should I know?/eturn to top
Deep all appointments with your doctor and the laboratory% *our doctor may order certain lab tests
to check your body's response to pregabalin%
+o not let anyone else take your medication% 1sk your pharmacist any 0uestions you hae about
refilling your prescription%
It is important for you to keep a written list of all of the prescription and nonprescription (oer&the&
counter) medicines you are taking# as well as any products such as itamins# minerals# or other
dietary supplements% *ou should bring this list with you each time you isit a doctor or if you are
admitted to a hospital% It is also important information to carry with you in case of emergencies%
!rand names/eturn to top
5yricaF
Complete Pregabalin information from Drugs
'rade Games
Lyrica
& ,apsules C: mg
& ,apsules :< mg
& ,apsules H: mg
& ,apsules ;<< mg
& ,apsules ;:< mg
& ,apsules C<< mg
& ,apsules CC: mg
& ,apsules B<< mg
& Oral solution C< mg/m5
"harmacology
-echanism of pregabalin's antinociceptie and antisei$ure effects is unknown% 4ffects may be
related to high affinity binding to alpha&C delta site (an au)iliary subunit of oltage&gated calcium
channels) in ,G= tissue%
=lideshow2 5iing with *our -igraines2 'ips for 'reatment and "reention
5iing with *our -igraines2 'ips for 'reatment and "reention
"harmacokinetics
1bsorption
Well absorbed after oral administration3 bioaailability is more than E<I% ' ma) occurs within ;%:
h% =teady state was achieed within CJ to JA h%
+istribution
6d is appro)imately <%: 5/kg% =ubstrate for system 5 transporter# which is responsible for the
transport of large amino acids across the blood brain barrier%
-etabolism
Gegligible metabolism%
4limination
'he half&life is K%B h% 5argely eliminated by renal e)cretion3 E<I e)creted unchanged in urine%
-ean renal ,l is appro)imately KH to A<%E m5/min%
=pecial "opulations
/enal (unction Impairment
,l is nearly proportional to ,r,l% "lasma concentrations reduced by appro)imately :<I following
a J&h hemodialysis treatment%
4lderly
Oral ,l tends to decrease with increasing age% +ose reduction may be re0uired in patients who
hae age&related renal impairment%
,hildren
"harmacokinetics hae not been studied%
.ender
"harmacokinetics do not seem to be affected by gender%
/ace
"harmacokinetics do not seem to be affected by race%
Indications and 8sage
-anagement of neuropathic pain associated with diabetic peripheral neuropathy3 ad>unctie
therapy for adults with partial&onset sei$ures3 management of postherpetic neuralgia3
management of fibromyalgia%
8nlabeled 8ses
'reatment of generali$ed an)iety disorder%
,ontraindications
=tandard considerations%
+osage and 1dministration
Geuropathic "ain 1ssociated With +iabetic "eripheral Geuropathy
1dults
"O :< mg B times daily initially# increased to ;<< mg B times daily within ; wk based on efficacy
and tolerability (ma)# B<< mg/day)%
"artial&Onset =ei$ures
1dults
"O H: mg twice daily or :< mg B times daily initially# increased to ;:< to K<< mg/day diided C or
B times daily based on efficacy and tolerability (ma)# K<< mg/day)%
"ostherpetic Geuralgia
1dults
"O H: mg twice daily or :< mg B times daily initially# increased to ;:< mg twice daily or ;<< mg B
times daily within ; wk based on efficacy and tolerability% If relief is insufficient after C to J wk# may
increase up to B<< mg twice daily or C<< mg B times daily%
(ibromyalgia
1dults
"O H: mg twice daily initially# increased to ;:< mg twice daily within ; wk based on efficacy and
tolerability% "atients not e)periencing sufficient benefit may further increase the dosage to CC: mg
twice daily (ma)# J:< mg/day)%
+osage 1d>ustment for /enal (unction Impairment
1dults
,r,l K< m5/min or greater2 total daily dose range of ;:< to K<< mg/day administered twice daily
or B times daily3 ,r,l B< to K< m5/min2 total daily dose range of H: to B<< mg/day administered
twice daily or B times daily3 ,r,l ;: to B< m5/min2 total daily dose range of C: to ;:< mg
administered once or twice daily3 ,r,l less than ;: m5/min2 total daily dose range of C: to H:
mg/day administered once daily%
Hemodialysis patients
-aintenance doses based on ,r,l as recommended plus a supplemental posthemodialysis dose
administered after each J h of hemodialysis as follows2 if maintenance dose C: mg once daily#
postdialysis dose is C: or :< mg3 if maintenance dose is C: to :< mg once daily# postdialysis dose
is :< or H: mg3 if maintenance dose is :< to H: mg once daily# postdialysis dose is H: or ;<< mg3
if maintenance dose is H: mg daily# postdialysis dose is ;<< to ;:< mg%
.eneral 1dice
-ay be gien with or without food%
When discontinuing# taper gradually oer a minimum of ; wk%
=torage/=tability
=tore at :EL to AKL(% 8se the oral solution within J: days of first opening the bottle%

+rug Interactions
1,4 inhibitors (eg# captopril)
,oadministration of these agents may increase the risk of swelling and hies% 'he patient's health
care proider should be contacted immediately# if these signs occur%
,G= depressants (eg# alcohol# lora$epam# o)ycodone)
1dditie effects on cognitie and gross motor function hae been seen% 1oid alcohol%
'hia$olidinediones (eg# pioglita$one)
!oth pregabalin and thia$olidinediones may cause weight gain and/or fluid retention# possibly
e)acerbating or leading to heart failure% 8se with caution% -onitor the patient% If an interaction is
suspected# it may be necessary to ad>ust the dose of one or both agents%
1derse /eactions
,G=
+i$$iness (J:I)3 somnolence (CAI)3 ata)ia (C<I)3 headache (;JI)3 tremor (;;I)3 abnormal
thinking# balance disorder# neuropathy (EI)3 abnormal gait# fatigue (AI)3 asthenia# confusion#
euphoria# speech disorder (HI)3 amnesia# disturbances in attention# incoordination (KI)3
twitching (:I)3 memory impairment# myoclonus# ertigo (JI)3 abnormal feeling# hypesthesia
(BI)3 an)iety# depression# disorientation# drunk feeling# lethargy (CI)3 depersonali$ation#
hypertonia# paresthesia# stupor (at least ;I)3 nerousness (;I)%
44G'
!lurred ision# diplopia (;CI)3 abnormal ision (:I)3 pharyngolaryngeal pain (BI)3 eye disorder
(CI)3 con>unctiitis# nystagmus# otitis media# tinnitus (at least ;I)%
.I
+ry mouth (;:I)3 constipation (;<I)3 increased appetite (HI)3 flatulence# omiting (BI)3
abdominal distension (CI)3 abdominal pain# gastroenteritis (at least ;I)3 diarrhea# nausea
(postmarketing)%
.enitourinary
8rinary incontinence (CI)3 anorgasmia# impotence# libido decreased# urinary fre0uency (at least
;I)%
-etabolic&Gutritional
"eripheral edema# weight gain (;KI)3 edema (KI)3 face edema# fluid retention# hypoglycemia
(BI)%
-usculoskeletal
1rthralgia (KI)3 back pain# muscle spasm (JI)3 leg cramps# myalgia# myasthenia (at least ;I)%
/espiratory
=inusitis (HI)3 bronchitis# dyspnea (BI)%
-iscellaneous
Infection (;JI)3 pain (:I)3 chest pain (JI)3 flu syndrome (CI)3 allergic reaction# ecchymosis#
feer# pruritus (at least ;I)3 angioedema# hypersensitiity (postmarketing)%

"recautions
-onitor
-onitor for emergence or worsening of depression# suicidal thoughts or behaior# or any unusual
changes in behaior% -onitor for weight gain and/or fluid retention# possibly e)acerbating or
leading to heart failure% ,arefully ealuate patients for a history of drug abuse and obsere them
for signs of pregabalin misuse or abuse (eg# deelopment of tolerance# dose escalation# drug&
seeking behaior)%
"regnancy
,ategory , %
5actation
8ndetermined%
,hildren
=afety and efficacy not established%
4lderly
!ecause of age&related renal function impairment# dosage ad>ustment may be needed%
Hypersensitiity
Hypersensitiity reactions (including skin redness# blisters# hies# rash# dyspnea# and whee$ing)
hae been reported shortly after initiation of pregabalin%
/enal (unction
+ose reduction recommended%
Ha$ardous 'asks
-ay cause di$$iness and drowsiness# which may impair the ability to preform tasks such as
driing or operating machinery%
1ngioedema
Has been reported during initial and long&term treatment%
,H(
8se with caution in patients with Gew *ork Heart 1ssociation class III or I6 cardiac status%
,reatine kinase eleations
Hae been reported% +iscontinue pregabalin if myopathy is diagnosed or suspected or if markedly
eleated creatine kinase leels occur%
+ecreased platelet count
,linically significant decreases in platelets (C<I below baseline and less than ;:< M ;< B /mc5)
hae been documented%
+ependence
Withdrawal symptoms may occur suggestie of physical dependence%
+iscontinuation of therapy
Withdraw gradually (oer at least ; wk) to minimi$e potential of increased sei$ure fre0uency in
patients with sei$ure disorders% 8pon abrupt or rapid discontinuation# insomnia# nausea#
headache# and diarrhea hae been reported%
Ophthalmic effects
/eduction in isual acuity# isual field changes# and funduscopic changes hae been reported%
"eripheral edema
Has been reported% Occurs more fre0uently in patients taking pregabalin and a thia$olidinedione
antidiabetic agent%
"/ interal prolongation
"/ interal prolongation (B to K msec) has been reported3 the mean change difference was not
associated with an increased risk of "/ increase more than C:I from baseline# on&treatment "/
more than C<< msec# or increased risk of second& or third&degree 16 block%
=uicidal behaior and ideation
-ay increase the risk of suicidal thoughts or behaior% 'his was obsered as early as ; week
after starting treatment and persisted for the duration of treatment%
Weight gain
Has been reported%
Oerdosage
=ymptoms
Gone well documented%
"atient Information
1dise patient or caregier to read the -edication .uide before starting therapy and to reread
with each refill%
Instruct patient with epilepsy to continue to take other medications for sei$ures unless adised
otherwise by health care proider%
1dise patient or caregier that medication will usually be started at a low dose and then
increased as tolerated until ma) benefit has been obtained%
Instruct patient or caregier to take e)actly as prescribed and not to change the dose or
discontinue therapy unless adised by health care proider%
1dise patient to take without regard to meals# but to take with food if stomach upset occurs%
1dise patient or caregier that if medication needs to be discontinued# it will be slowly withdrawn
oer a period of ; wk or more unless safety concerns (eg# rash) re0uire a more rapid withdrawal%
Instruct patient to immediately report une)plained muscle pain# tenderness# or weakness#
especially if accompanied by general body discomfort or feer%
,aution patient that drug may cause di$$iness or drowsiness and to use caution while driing or
performing other tasks re0uiring mental alertness or coordination until tolerance is determined%
1dise patient that pregabalin may cause isual changes# edema (swelling in feet and/or ankles)#
and weight gain# and to notify health care proider if any of these occur%
1dise patients that concomitant treatment with pregabalin and a thia$olidinedione antidiabetic
agent may lead to an additie effect on edema and weight gain% (or patients with pree)isting
cardiac conditions# this may increase the risk of heart failure%
,aution patient to aoid alcohol# opiates# and other ,G= depressants while taking pregabalin
because of risk of additie ,G= impairment and depressant effects%
1dise patient to take fre0uent sips of water# suck on ice chips or sugarless hard candy# or chew
sugarless gum if dry mouth occurs%
Instruct patient with sei$ures to notify health care proider if sei$ures worsen or if new types of
sei$ures occur%
1dise patient with epilepsy to carry medical identification (eg# card# bracelet) indicating
medication usage and epilepsy%
1dise patients that the drug may increase the risk of suicidal thoughts and behaior and to be
alert for the emergence or worsening of symptoms of depression%
1dise patients that pregabalin may cause angioedema# with swelling of the face# mouth (lip#
gum# and tongue)# and neck (laryn) and pharyn)) that can lead to life&threatening respiratory
compromise% Instruct patients to discontinue pregabalin and immediately seek medical care if
they e)perience these symptoms%
1dise patients that pregabalin has been associated with hypersensitiity reactions (eg# blisters#
dyspnea# hies# rash# whee$ing)% Instruct patients to discontinue pregabalin and seek medical
care immediately if they e)perience these symptoms%
,ounsel patients# their caregiers# and families that antilepileptic drugs# including pregabalin# may
increase the risk of suicidal thoughts and behaior and adise them of the need to be alert for the
emergence or worsening of symptoms of depression3 any unusual changes in mood or behaior3
or the emergence of suicidal thoughts# behaior# or thoughts about self&harm% Immediately report
behaiors of concern to health care proiders%
Instruct patients to notify health care proider if they become pregnant or intend to become
pregnant during therapy# and to notify their health care proider if they are breast&feeding or
intend to breast&feed during therapy%
4ncourage patients to enroll in the G114+ "regnancy /egistry if they become pregnant% 'his
registry is collecting information about the safety of antiepileptic drugs during pregnancy% 'o
enroll# patients can call the toll&free number ;&AAA&CBB&CBBJ%
Inform men being treated with pregabalin who plan to father a child of the potential risk of male&
mediated teratogenicity%
Instruct patients with diabetes to pay particular attention to skin integrity while being treated with
pregabalin%