Name/Title
Package InsertsEntry/Object ID
2014.2.3297A-DScope and Content
A small envelope containing package inserts for Valium and Dalmane, and a business card for the sales rep for Roche Pharmaceutical Company. The inserts are folded accordion style.Context
A) Envelope states " VALIUM & DALMANE PACKAGE INSERTS
B) IMPOTANT INFORMATION
In the enclosed publication there is mention of uses and/or doses beyond the scope of the approved labeling for the subject product. Use of the subject product in any areas and on any dosage regimen except those included in the attached complete prescribing information is not recommended.
ROCHE LABORATORIES Division of Hoffman-La Roche Inc.
Nutley, New Jersey 07110
A.H.F.S. Category 28: 16.08
VALIUM ® ROCHE
(diazepam) tablets
* For relief of tension and anxiety alone or whenever somatic complaints are concomitants of emotional factors.
* As an adjunct in skeletal muscle spasm associated with local pathology, cerebral palsy, athetosis, stiff- man syndrome.
DESCRIPTION: Valium (diazepam) is a benzodiazepine derivative developed through original Roche research. . . . . . . .
PHARMACOLOGY: In animals, Valium (diazepam) appears to act on parts of the limbic system, the thalamus and hypothalamus, and induces calming effects. . . . .
Oral LD50 of diazepam is 720 mg/kg in mice and 1240 mg/kg in rats . . . . . .
Reproduction Studies: A series of rat reproduction studied was performed with diazepam in oral doses of 1, 10, 80 and 100 mg/kg there was a decrease in the number of pregnancies and surviving offspring in these rats. Neonatal survival of rats at doses . . . . .
In humans, measurable blood levels of Valium (diazepam) were obtained in maternal and cord blood, indicating placental transfer of the drug.
INDICATIONS: Valium (diazepam) is useful in the symptomatic relief of tension and anxiety states resulting from stressful circumstance or whenever somatic complaints are concomitants of emotional factors. . . . . . . .
In acute alcohol withdrawal, Valium (diazepam) may be useful in the symptomatic relief of acute agitation, tremor, impending or acuter delirium tremens and hallucinosis.
Valium (diazepam) is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm t local pathology (such as inflammation of the muscle, or joints, or secondary to trauma); spasticity caused by upper . . . . . . .
Oral Valium (diazepam) may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
CONTRADICTIONS: Valium (diazepam) is contraindicated in patients with a known hypersensitivity to this drug and, because of lack of sufficient clinical experience, in children under 6 months of age. . . . . . . .
WARNINGS: Valium (diazepam) is not of value in the treatment of psychotic patients and should not be employed in lieu of appropriate treatment. . . . . . .
As with other agents which have anticonvulsant activity, when Valium (diazepam) is used as an adjunct in treating convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal seizures may require and increase in dosage of standard anticonvulsant medication. . . . . . .
Since Valium (diazepam) has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other CNS-depressant drugs during Valium (diazepam) therapy.
Physical and Psychological Dependence: Withdrawal symptoms (similar in character to those noted with barbiturates and alcohol) have occurred following abrupt discontinuance of diazepam (. . . . . . . ) These were usually limited to those patients who had received excessive doses very an extended period of time. Particularly addiction-prone individuals . . . . .
Use in Pregnancy: Use of any drug in pregnancy, lactation in women of childbearing age requires that the potential benefit of the drug be weighed against its possible hazard to mother and child. (. . . .).
Management of Overdosage: Manifestations of Valium (diazepam) over dosage include somnolence, confusion, coma and diminished reflexes. Respiration ,pulse and blood pressure should be monitored, as in all cases of overdosage, . . . . . .General supportive measures should be employed, . . . . . . . Hypertension may be combined . . . . . Dialysis is of limited value. As with the management . . . . .
PRECAUTIONS: If Valium (diazepam) is to be combined with other psychotropic agents or anticonvulsant drugs, . . . . . . . . . The usual precautions are indicated for severely depressed patients or those in whom there is any evidence of latent depression; . . . . . . . . The usual precautions in treating patients with impaired renal or hepatic function should be observed.
In elderly and debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia or oversedation (. . . . . . .).
ADVERSE REACTIONS: Side effects most commonly reported were drowsiness, fatigue and ataxia. . . . Infrequently encountered were confusion, . . . , . . , . . ,. . . ., . . .; should these occur, use of the drug should be discontinued.
Because of isolated reports of neutropenia and jaundice, periodic blood counts and liver function tests are advisable during long-term therapy. . . . .
DOSAGE AND ADMINISTRATION: Dosage should be individualized for maximum beneficial effect. . . . , there will be some who may require higher doses. . . . .
Adults USUAL DAILY DOSE:
Symptomatic Relief of Depending on severity of symptoms
Tension and Anxiety . . . . . . . . . . . . .
. . . . . . . . .
Symptomatic Relief in . . . . . . . . . . . . . , . . . . . .
Acute Alcohol . . . . . . . . . . . . . . . . . . . as needed
Adjunctively for Relief of . . . . . . . . . . . , 3 or 4 times daily
Skeletal Muscle Spasm
Adjunctively in Convulsive . . . . . . , 2 to 4 times daily
Disorders.
Geriatric Patients, or in the . . . . . . . . . . . . . . ;
presencer of debilitating increase gradually as needed and tolerated
disease.
Children:
Because of varied responses . . . . . . . . . . . . . ;
to CNS-acting drugs, . . . . . . increase gradually as needed and tolerated
. . . . . Not for use in children
under 6 months.
HOW SUPPLIED: For oral administration, Valium (diazepam) scored tablets - . . . . ; . . . . ; - . . . . . ; . . . . . ; Prescription Packs of 50, available singly and in trays of 10.
THIS PRODUCT INFORMATION ISSUED SEPTEMBER 1974
ROCHE LABORATORIES Division of Hoffman-La Roche Inc.
Nutley, New Jersey 07110
_______________________________________________________________________
C)
IMPOTANT INFORMATION
In the enclosed publication there is mention of uses and/or doses beyond the scope of the approved labeling for the subject product. Use of the subject product in any areas and on any dosage regimen except those included in the attached complete prescribing information is not recommended.
ROCHE LABORATORIES Division of Hoffman-La Roche Inc.
Nutley, New Jersey 07110
A.H.F.S. Category 28: 24
FOR RELIEF OF INSOMNIA
DALMANE ® ROCHE
(flurazepam hydrochloride)
Capsules
DESCRIPTION: Flurazepam hydrochloride is a chemically 7-chloro-1-[2-(diethylamino) ethyl] -5-(o-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one dihydrochloride. . . . . . . . and the following structural formula.
DALMANE ® (flurazepam hydrochloride)
ACTIONS: In animal studies, flurazepam hydrochloride reduced the pressure response to electrical stimulation of the hypothalamus, and increased the arousal threshold to stimulation of the amygdala and hypothalamus; however, the exact site and mode of action are unknown.
INDICATIONS: Dalmane is a hypnotic agent useful i all types of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakening. Dalmane can be used . . . .
Since insomnia is often transient and intermittent, . . . . . . .
CONTRADICTIONS: Dalmane is contraindicated in patients with known hypersensitivity to the drug.
WARNINGS: Patients receiving Dalmaner should be cautioned about possible combined effects with alcohol and other CNS depressants. Patients should be cautioned against hazardous occupations . . . . . . .
Usage in Pregnancy: The safety of Dalmane in women who are or who may become pregnant has not been established; hence it should be given only when the potential benefits have been weighed against possible hazard to mother and child.(. . . .)
DALMANE ® (flurazepam hydrochloride)
Usage in Children: Clinical investigations of Dalmane have not been carried out in children. Therefore, the drug is not currently recommended for use in persons under 15 years of age.
Physical and Psychological Dependence: Physical and psychological dependence have not been reported or observed in persons taking recommended doses of Dalmane. However, . . . . . It is desirable to limit repeated prescriptions without adequate medical supervision.
PRECAUTIONS: In elderly and debilitated patients, it is recommended that the dosage initially be limited to 15mg to preclude the development of . . . . . , . . . . . and/or . . . . If Dalmane is to be combined with other drugs . . . . .
The usual precautions are indicated for severely depressed patients . . . . .; particularly the recognition that . . . . .
Should Dalmane be used repeatedly, periodic blood counts and liver and kidney function tests should be performed. . . . . The usual precautions . . . . .
DALMANE ® (flurazepam hydrochloride)
ADVERSE REACTIONS: Dizziness, drowsiness, lightheadedness, . . ., . . . and . . . have occurred, . . . Severe sedation, . . , . . , . . . have been reported.
Also reported were: . . ., . . ,. . ., . . . . . . . . . There have also been rare occurrences of . . ., . . ., . . ., . . . Paradoxical reactions, . . ., . . ,. . . ., have also been reported in rare instances.
DOSAGE AND ADMINISTRATION: Dosage should be individualized for maximum beneficial effects. The usual adult dosage is . . . . In some patients . . . . . . In elderly and/or debilitated patients it is recommended . . . . . .
OVERDOSAGE: Manifestations of Dalmane overdosage include somnolence, confusion and coma.
DALMANE ® (flurazepam hydrochloride)
Respiration, pulse and blood pressure should be monitored as in all cases of drug overdosage. General supportive measures . . . . . . . Hypertension and CNS depression may be combated . . . . . . . . . As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested.
HOW SUPPLIED: Dalmane (flurazepam hydrochloride) capsules - . . . ; . . . . -; . . . . ; Prescription Paks of 30, available singly and in trays of 10.
ANIMAL PHARMACOLOGY AND TOXICOLOGY: Flurazepam hydrochloride is rapidly absorbed . . . . Studies in rats . . . indicated that the drug is widely distributed throughout body tissue. . . . . . .
The oral LD50 was 870 mg/kg in mice, . . . . . in rats and . . . . in rabbits. Chronic toxicity studies . . . . .
Reproduction Studies: A two-cycle reproduction study is rats was carried out at doses of 5 and 50 . . . .
DALMANE ® (flurazepam hydrochloride)
There were no teratogenic or other adverse effects related to the drug. In a second series . . . . . . . . . . .
In another reproduction study in rats . . . . . . . . no adverse effects on reproduction and no teratological changes were noted.
In rabbits . . . . . . . . . . . Twenty-three live litters were obtained in this study. . . . . . . . . without the occurrence of abnormalities in all eleven litters. In both studies, there were no significant differences between the control and treated groups in . . . . , . . , . . , . . , and . . .
CLINICAL STUDIES: Dalmane significantly reduced sleep induction time and increased sleep duration . . . . using a double-blind crossover design.
In eight controlled sleep research studies of . . . . . . . . . . . Dalmane, on average, induced sleep within 17 minutes and provided seven to eight hours of sleep. . . . . . . . while increasing total sleep time.
DALMANE ® (flurazepam hydrochloride)
No rebound of dream time as measured by REM ( . . .) was seen after withdrawal of Dalmane . . . . A minimal decrease of REM time was observed and reduction in Stage 4 time was noted after administration of Dalmane.
Eight insomniacs participated in a double-blind crossover research laboratory study in which the effects of . . . . . . were compared for 10 consecutive nights. Dalmane reduced sleep latency, . . . . ., . . . . .
THIS PRODUCT INFORMATION ISSUED SEPTEMBER 1974
ROCHE LABORATORIES Division of Hoffman-La Roche Inc.
Nutley, New Jersey 07110
___________________________________________________________________________________________
D)
A down-folded business card:
The front: 'J. Larry Boucher'
Inside top: the address and telephone number of Mr. Boucher
Inside bottom: ROCHE
PHARMACEUTICALS
HEALTH
EDUCATION _ INFORMATION_COMMUNICATIONS
CLINICAL LABORATORIES
Roche Laboratories*Division Of Hoffman-LaRoche Inc*Nutley, N.J. 07110Lexicon
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