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ROBAXIN- metho carbamo l tablet, film co ated Actient Pharmaceuticals, LLC ---------robaxin ® / robaxin® -7 50 (methocarbamol tablets, US P) Rx Only DESCRIPT ION ro baxin® /ro baxin® -750 (metho carbamo l tablets, USP), a carbamate derivative o f g uaifenesin, is a central nervo us system (CNS) depressant with sedative and musculo skeletal relaxant pro perties. The chemical name of metho carbamo l is 3-(2-metho xypheno xy)-1,2-pro panedio l 1-carbamate and has the empirical fo rmula C 11 H15 NO 5 . Its mo lecular weig ht is 24.24. The structural formula is sho wn belo w. Metho carbamo l is a white po wder, sparing ly so luble in water and chlo ro fo rm, so luble in alco ho l (o nly with heating ) and pro pylene g lyco l, and inso luble in benzene and n-hexane. ro baxin® is available as a lig ht o rang e, ro und, film-co ated tablet co ntaining 50 0 mg o f metho carbamo l, USP fo r o ral administratio n. T he inactive ing redients present are co rn starch, FD&C Yello w 6 , hydro xypro pyl cellulo se, hypro mello se, mag nesium stearate, po lyso rbate 20 , po vido ne, pro pylene g lyco l, saccharin so dium, so dium lauryl sulfate, so dium starch g lyco late, stearic acid, titanium dio xide. ro baxin® -750 is available as an o rang e capsule-shaped, film-co ated tablet co ntaining 750 mg o f metho carbamo l, USP fo r o ral administratio n. In additio n to the inactive ing redients present in ro baxin®, robaxin® -750 also co ntains D&C Yello w 10 . CLINICAL PHARMACOLOGY T he mechanism o f actio n o f metho carbamo l in humans has no t been established, but may be due to general central nervo us system (CNS) depressio n. It has no direct actio n o n the co ntractile mechanism of striated muscle, the mo to r end plate o r the nerve fiber. Pharmaco kinetics In healthy vo lunteers, the plasma clearance o f metho carbamo l rang es between 0 .20 and 0 .8 0 L/h/kg, the mean plasma eliminatio n half-life rang es between 1 and 2 ho urs, and the plasma pro tein binding rang es between 4 6 % and 50 %. Metho carbamo l is metabo lized via dealkylatio n and hydro xylatio n. Co njug atio n o f metho carbamo l also is likely. Essentially all metho carbamo l metabo lites are eliminated in the urine. Small amo unts o f unchang ed metho carbamo l also are excreted in the urine. Special po pulatio ns Elderly T he mean (± SD) eliminatio n half-life o f metho carbamo l in elderly healthy vo lunteers (mean (± SD) ag e, 6 9 (± 4 ) years) was slig htly pro lo ng ed co mpared to a yo ung er (mean (± SD) ag e, 53.3 (± 8 .8 ) years), healthy po pulatio n (1.5 (± 0 .4 ) ho urs versus 1.1 (±0 .27) ho urs, respectively). T he fractio n o f bo und metho carbamo l was slig htly decreased in the elderly versus yo ung er vo lunteers (4 1 to 4 3% versus 4 6 to 50 %, respectively). Renally impaired T he clearance o f metho carbamo l in 8 renally-impaired patients o n maintenance hemo dialysis was reduced abo ut 4 0 % co mpared to 17 no rmal subjects, altho ug h the mean (± SD) eliminatio n half-life in these two g ro ups was similar: 1.2 (± 0 .6 ) versus 1.1 (±0 .3) ho urs, respectively. Hepatically impaired In 8 patients with cirrho sis seco ndary to alco ho l abuse, the mean to tal clearance o f metho carbamo l was reduced appro ximately 70 % co mpared to that o btained in 8 ag e- and weig ht-matched no rmal subjects. The mean (± SD) eliminatio n half-life in the cirrho tic patients and the no rmal subjects was 3.38 (± 1.6 2) ho urs and 1.11 (± 0 .27) ho urs, respectively. T he percent o f metho carbamo l bo und to plasma pro teins was decreased to appro ximately 4 0 to 4 5% co mpared to 4 6 to 50 % in the no rmal subjects. INDICAT IONS AND USAGE ro baxin® and ro baxin® -750 are indicated as an adjunct to rest, physical therapy, and o ther measures fo r the relief o f disco mfo rt asso ciated with acute, painful musculo skeletal co nditio ns. T he mo de o f actio n o f metho carbamo l has no t been clearly identified, but may be related to its sedative pro perties. Methocarbamo l do es no t directly relax tense skeletal muscles in man. CONT RAINDICAT IONS ro baxin® and ro baxin® -750 are co ntraindicated in patients hypersensitive to metho carbamo l o r to any o f the tablet co mpo nents. WARNINGS Since metho carbamo l may po ssess a g eneral CNS depressant effect, patients receiving ro baxin® o r ro baxin® -750 sho uld be cautio ned abo ut co mbined effects with alco ho l and o ther CNS depressants. Safe use o f ro baxin® and ro baxin® -750 has no t been established with reg ard to po ssible adverse effects upo n fetal develo pment. T here have been repo rts o f fetal and co ng enital abno rmalities following in utero expo sure to metho carbamo l. T herefo re, ro baxin® and ro baxin® -750 sho uld no t be used in wo men who are o r may beco me preg nant and particularly during early preg nancy unless in the judgment o f the physician the po tential benefits o utweig h the po ssible hazards (see PRECAUT IONS, Preg nancy). Us e In Activities Requiring Mental Alertnes s Metho carbamo l may impair mental and/o r physical abilities required fo r perfo rmance o f hazardo us tasks, such as o perating machinery o r driving a mo to r vehicle. Patients sho uld be cautio ned abo ut operating machinery, including auto mo biles, until they are reaso nably certain that metho carbamo l therapy do es no t adversely affect their ability to eng ag e in such activities. PRECAUT IONS Info rmatio n fo r Patients Patients sho uld be cautio ned that metho carbamo l may cause dro wsiness o r dizziness, which may impair their ability to o perate mo to r vehicles o r machinery. Because metho carbamo l may po ssess a g eneral CNS-depressant effect, patients sho uld be cautio ned abo ut co mbined effects with alco ho l and o ther CNS depressants. Drug Interactio ns See WARNINGS and PRECAUT IONS fo r interactio n with CNS drug s and alco ho l. Metho carbamo l may inhibit the effect o f pyrido stig mine bro mide. T herefo re, metho carbamo l sho uld be used with cautio n in patients with myasthenia g ravis receiving anticho linesterase ag ents. Drug /Labo rato ry T es t Interactio ns Metho carbamo l may cause a co lo r interference in certain screening tests fo r 5-hydro xyindo leacetic acid (5-HIAA) using nitro so naphtho l reag ent and in screening tests fo r urinary vanillylmandelic acid (VMA) using the Gitlo w metho d. Carcino g enes is , Mutag enes is , Impairment o f Fertility Lo ng -term studies to evaluate the carcino g enic po tential o f metho carbamo l have no t been perfo rmed. No studies have been co nducted to assess the effect o f metho carbamo l o n mutag enesis o r its po tential to impair fertility. Preg nancy Teratogenic Effects Pregnancy Category C Animal repro ductio n studies have no t been co nducted with metho carbamo l. It is also no t kno wn whether metho carbamo l can cause fetal harm when administered to a preg nant wo man o r can affect repro ductio n capacity. ro baxin® and ro baxin® -750 sho uld be g iven to a preg nant wo man o nly if clearly needed. Safe use o f ro baxin® and ro baxin® -750 has no t been established with reg ard to po ssible adverse effects upo n fetal develo pment. T here have been repo rts o f fetal and co ng enital abno rmalities following in utero expo sure to metho carbamo l. T herefo re, ro baxin® and ro baxin® -750 sho uld no t be used in wo men who are o r may beco me preg nant and particularly during early preg nancy unless in the judgment o f the physician the po tential benefits o utweig h the po ssible hazards (see WARNINGS). Nurs ing Mo thers Metho carbamo l and/o r its metabo lites are excreted in the milk o f do g s; ho wever, it is no t kno wn whether metho carbamo l o r its metabo lites are excreted in human milk. Because many drug s are excreted in human milk, cautio n sho uld be exercised when ro baxin® o r ro baxin® -750 is administered to a nursing wo man. Pediatric Us e Safety and effectiveness o f ro baxin® and ro baxin® -750 in pediatric patients belo w the ag e o f 16 have no t been established. ADVERSE REACT IONS Adverse reactio ns repo rted co incident with the administratio n o f metho carbamo l include: Body as a whole: Anaphylactic reactio n, ang io neuro tic edema, fever, headache Cardiovascular system: Bradycardia, flushing , hypo tensio n, synco pe, thro mbo phlebitis Digestive system: Dyspepsia, jaundice (including cho lestatic jaundice), nausea and vo miting Hemic and lymphatic system: Leuko penia Immune system: Hypersensitivity reactio ns Nervous system: Amnesia, co nfusio n, diplo pia, dizziness o r lig htheadedness, dro wsiness, inso mnia, mild muscular inco o rdinatio n, nystag mus, sedatio n, seizures (including g rand mal), vertig o Skin and special senses: Blurred visio n, co njunctivitis, nasal co ng estio n, metallic taste, pruritus, rash, urticaria OVERDOSAGE Limited info rmatio n is available o n the acute to xicity o f metho carbamo l. Overdo se o f metho carbamo l is frequently in co njunctio n with alco ho l o r o ther CNS depressants and includes the fo llo wing sympto ms: nausea, dro wsiness, blurred visio n, hypo tensio n, seizures, and co ma. In po st-marketing experience, deaths have been repo rted with an o verdo se o f metho carbamo l alo ne o r in the presence o f o ther CNS depressants, alco ho l o r psycho tro pic drug s. T reatment Manag ement o f o verdo se includes sympto matic and suppo rtive treatment. Suppo rtive measures include maintenance o f an adequate airway, mo nito ring urinary o utput and vital sig ns, and administratio n o f intraveno us fluids if necessary. T he usefulness o f hemo dialysis in manag ing o verdo se is unkno wn. DOSAGE AND ADMINIST RAT ION ro baxin® (metho carbamo l), 50 0 mg – Adults: Initial do sag e: 3 tablets q.i.d. Maintenance do sag e: 2 tablets q.i.d. ro baxin® -750 (metho carbamo l): 750 mg – Adults: Initial do sag e: 2 tablets q.i.d. Maintenance do sag e: 1 tablet q.4 h. o r 2 tablets t.i.d. Six g rams a day are reco mmended fo r the first 4 8 to 72 ho urs o f treatment. (Fo r severe co nditio ns 8 g rams a day may be administered). T hereafter, the do sag e can usually be reduced to appro ximately 4 g rams a day. HOW SUPPLIED ro baxin® (metho carbamo l tablets, USP) 50 0 mg tablets are light o rang e, round, film-coated tablets engraved with ROBAXIN 50 0 on the unscored side and SP above the score on the other side. They are supplied as follows: Bo ttles of 10 0 NDC 5224 4 -4 29 -10 robaxin ® -750 (methocarbamol tablets, USP) 750 mg tablets are o rang e, capsule-shaped, film-coated tablets engraved with ROBAXIN 750 on one side and SP on the other. They are supplied as follows: Bottles of 10 0 NDC 5224 4 -4 4 9 -10 Store at controlled room temperature, between 20 °C and 25°C (6 8 °F and 7 7 °F). Dis pens e in tight container. Distributed by: Actient Pharmaceuticals, LLC Lake Forest, Illinois 6 0 0 4 5 Printed in USA L4 4 4 9 F Rev1 0 3/11