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Marked cyclic leukocytosis-leukopenia in chronic myelogenous leukemia
Li braxB Each capsule contains 5 mg chlordiazepoxrde and 2 5 mg clidrnium Br.
HCI
Before prescribing, please consult complete product information, a summary of which follows:
Abstracts of papers in this issue
indications: Based on a revrew of this drug by the Natronal Academy of Scrences-Natronal Research Councrl and/or other informatron, FDA has classrfred the rndrcatrons as follows “Possrbly” effective as adfunctrve therapy rn the treatment of peptrc ulcer and !n the treatment of the Irritable bowel syndrome irrrrtable colon, spastrc colon, mucous colrtls) and acute enterocol~t1s Final classrficatron of the less~than-effective rndlcatrons requires further rnvestrgatlon Contraindications: Pattents with glaucoma: prostatrc hypertrophy and benign bladder neck obstruc tion; known hypersensrtrvrty to chlordrazepoxrde hvdrochionde and:or cfrdrnrum bromrde Warnings: Caution patrents about possrble combrned effects with alcohol and other CNS depressants As wrth all CNSactrng drugs. caution patients agarnst hazardous occupatrons requrnng complete mental alertness (e g., operatrng machrnery, drivrng). Though phystcai and psychofogrcal dependence have rarely been reported on recommended doses, use cautron In admrnrsterrng Lrbrium” (chlordrazepoxrde hydrochloride) to known addictron-prone rndrvrduals or those who mrght Increase dosage: wrthdrawal symptoms (rncludrng convulsions), following drscontinuation of the drug and stmilar to those seen wrth barbiturates, have been reported. Use of any drug rn pregnancy, lactatron, or rn womer of childbearing age requires that Its potential benefits be weighed against rts possible hazards As wrth all anticholrnerglc drugs, an mhrbrtrng effect on lactatron may occur Precautions: in elderly and debilitated, lrmrt dosage to smallest effective amount to preclude development of ataxia, oversedatron or confusron (not more than two capsules per day rnltlally; mcrease gradually as needed and tolerated). Though generally not recommended, if combrnation therapy with other psychotropics seems tndrcated. carefully consider pharmacologrc effects of agents, partrcularly potentratrng drugs such as MAO rnhrbrtors and phenothrazrnes. Observe usual precautrons rn presence of impalred renal or hepatic function. Paradoxical reactrons fe g., excitement. strmulatlon and acute rage) have been reported in psychratric patrents. Employ usual precautions In treatment of anxiety states wrth evrdence ot Impending depressron, surcidal tendencres may be present and protective measures necessary. Varrable effects on blood coagulatron have been re ported very rarely In patrents recerving the drug and oral antfcoagufants: causal relationship has not been establrshed clrnrcally Adverse Reactions: No srde effects or manifestations not seen wrth efther compound alone have been reported with Librax. When chlordrarepoxlde hydrochloride 1s used alone, drowsiness, ataxra and confusion may occur, especrally rn the elderly and debill+ tated. These are avordable rn most instances by proper dosage adjustment. but are also occasionally observed at the lower dosage ranges. In a few Instances syncope has been reported. Also encountered are rsolated instances of skrn eruptions, edema, minor menstrual rrregularitres, nausea and constrpation. extrapyramrdal symptoms, Increased and decreased Irbrdo-all Infrequent and generally controlled wrth dosage reduction: changes rn EEG patterns (low-voltage fast activity) may appear dunng and after treatment, blood dyscrasras (including agranulocytosrs), jaundrce and hepatrc dysfunction have been reported occasronally wrth chlordrazepoxrde hydrochloride, making penodrc blood counts and liver function tests advisable during protracted therapy. Adverse effects reported with Lrbrax are typrcal of antichoknergrc agents, I e.,dryness of mouth, blumng of vision, onnary hesitancy and constipation Constipatron has occurred most often when Lrbrax therapy is combined wtth other spasmolytrcs and/or low resrdue drets
0
ROCHE
A82
Roche Laboratorres Dlvislon of HoffmannLa Roche Inc Nutley. New Jersey 07 110
HCI
Before prescribing, please consult complete product information, a summary of which follows:
Abstracts of papers in this issue
indications: Based on a revrew of this drug by the Natronal Academy of Scrences-Natronal Research Councrl and/or other informatron, FDA has classrfred the rndrcatrons as follows “Possrbly” effective as adfunctrve therapy rn the treatment of peptrc ulcer and !n the treatment of the Irritable bowel syndrome irrrrtable colon, spastrc colon, mucous colrtls) and acute enterocol~t1s Final classrficatron of the less~than-effective rndlcatrons requires further rnvestrgatlon Contraindications: Pattents with glaucoma: prostatrc hypertrophy and benign bladder neck obstruc tion; known hypersensrtrvrty to chlordrazepoxrde hvdrochionde and:or cfrdrnrum bromrde Warnings: Caution patrents about possrble combrned effects with alcohol and other CNS depressants As wrth all CNSactrng drugs. caution patients agarnst hazardous occupatrons requrnng complete mental alertness (e g., operatrng machrnery, drivrng). Though phystcai and psychofogrcal dependence have rarely been reported on recommended doses, use cautron In admrnrsterrng Lrbrium” (chlordrazepoxrde hydrochloride) to known addictron-prone rndrvrduals or those who mrght Increase dosage: wrthdrawal symptoms (rncludrng convulsions), following drscontinuation of the drug and stmilar to those seen wrth barbiturates, have been reported. Use of any drug rn pregnancy, lactatron, or rn womer of childbearing age requires that Its potential benefits be weighed against rts possible hazards As wrth all anticholrnerglc drugs, an mhrbrtrng effect on lactatron may occur Precautions: in elderly and debilitated, lrmrt dosage to smallest effective amount to preclude development of ataxia, oversedatron or confusron (not more than two capsules per day rnltlally; mcrease gradually as needed and tolerated). Though generally not recommended, if combrnation therapy with other psychotropics seems tndrcated. carefully consider pharmacologrc effects of agents, partrcularly potentratrng drugs such as MAO rnhrbrtors and phenothrazrnes. Observe usual precautrons rn presence of impalred renal or hepatic function. Paradoxical reactrons fe g., excitement. strmulatlon and acute rage) have been reported in psychratric patrents. Employ usual precautions In treatment of anxiety states wrth evrdence ot Impending depressron, surcidal tendencres may be present and protective measures necessary. Varrable effects on blood coagulatron have been re ported very rarely In patrents recerving the drug and oral antfcoagufants: causal relationship has not been establrshed clrnrcally Adverse Reactions: No srde effects or manifestations not seen wrth efther compound alone have been reported with Librax. When chlordrarepoxlde hydrochloride 1s used alone, drowsiness, ataxra and confusion may occur, especrally rn the elderly and debill+ tated. These are avordable rn most instances by proper dosage adjustment. but are also occasionally observed at the lower dosage ranges. In a few Instances syncope has been reported. Also encountered are rsolated instances of skrn eruptions, edema, minor menstrual rrregularitres, nausea and constrpation. extrapyramrdal symptoms, Increased and decreased Irbrdo-all Infrequent and generally controlled wrth dosage reduction: changes rn EEG patterns (low-voltage fast activity) may appear dunng and after treatment, blood dyscrasras (including agranulocytosrs), jaundrce and hepatrc dysfunction have been reported occasronally wrth chlordrazepoxrde hydrochloride, making penodrc blood counts and liver function tests advisable during protracted therapy. Adverse effects reported with Lrbrax are typrcal of antichoknergrc agents, I e.,dryness of mouth, blumng of vision, onnary hesitancy and constipation Constipatron has occurred most often when Lrbrax therapy is combined wtth other spasmolytrcs and/or low resrdue drets
0
ROCHE
A82
Roche Laboratorres Dlvislon of HoffmannLa Roche Inc Nutley. New Jersey 07 110