Product Elements:
Temazepam temazepam temazepam temazepam starch, corn anhydrous lactose magnesium stearate sodium lauryl sulfate fd&c red no. 40 titanium dioxide alcohol isopropyl alcohol butyl alcohol shellac potassium hydroxide propylene glycol ferrosoferric oxide opaque body opaque cap 7;5;mg;novel;120
Indications and Usage:
Indications and usage temazepam capsules, usp are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules, usp should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
Warnings:
Warnings sleep disturbance may be the presenting manifestation of an underlying physical and/or psychiatric disorder. consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated. the failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. worsening of insomnia may be the consequence of an unrecognized psychiatric or physical disorder as may the emergence of new abnormalities of thinking or behavior. such abnormalities have also been reported to occur in association with the use of drugs with central nervous system depressant activity, including those of the benzodiazepine class. because some of the worrisome adverse effects of benzodiazepines, including temazepam, appear to be dose related (see precautions and dosage and administration ), it is important to use the lowest possible effective dose. elderly p
Read more...atients are especially at risk. some of these changes may be characterized by decreased inhibition, e.g., aggressiveness and extroversion that seem out of character, similar to that seen with alcohol. other kinds of behavioral changes can also occur, for example, bizarre behavior, agitation, hallucinations, and depersonalization. complex behaviors such as âsleep-drivingâ (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. these events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons. although behaviors such as sleep-driving may occur with temazepam alone at therapeutic doses, the use of alcohol and other cns depressants with temazepam appears to increase the risk of such behaviors, as does the use of temazepam at doses exceeding the maximum recommended dose. due to the risk to the patient and the community, discontinuation of temazepam should be strongly considered for patients who report a âsleep-drivingâ episode. other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. as with sleep-driving, patients usually do not remember these events. amnesia and other neuro-psychiatric symptoms may occur unpredictably. in primarily depressed patients, worsening of depression, including suicidal thinking has been reported in association with the use of sedative/hypnotics. it can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation. withdrawal symptoms (of the barbiturate type) have occurred after the abrupt discontinuation of benzodiazepines (see drug abuse and dependence ).
General Precautions:
General since the risk of the development of oversedation, dizziness, confusion, and/or ataxia increases substantially with larger doses of benzodiazepines in elderly and debilitated patients, 7.5 mg of temazepam is recommended as the initial dosage for such patients. temazepam should be administered with caution in severely depressed patients or those in whom there is any evidence of latent depression; it should be recognized that suicidal tendencies may be present and protective measures may be necessary. the usual precautions should be observed in patients with impaired renal or hepatic function and in patients with chronic pulmonary insufficiency. if temazepam is to be combined with other drugs having known hypnotic properties or cns-depressant effects, consideration should be given to potential additive effects. the possibility of a synergistic effect exists with the co-administration of temazepam and diphenhydramine. one case of stillbirth at term has been reported 8 hours after
Read more...a pregnant patient received temazepam and diphenhydramine. a cause and effect relationship has not yet been determined (see contraindications ).
Dosage and Administration:
Dosage and administration while the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. in transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. in elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.
Contraindications:
Contraindications benzodiazepines may cause fetal harm when administered to a pregnant woman. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. reproduction studies in animals with temazepam were performed in rats and rabbits. in a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling mortality. teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered skeletal variants, in a second study at doses of 240 mg/kg or higher. in rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship. although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls. at doses of 40 mg/kg or higher, there was an increased incidence of the 13th rib variant when compared to the incidence in concurrent and historical controls. temazepam is contraindicated in women who are or may become pregnant. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. patients should be instructed to discontinue the drug prior to becoming pregnant. the possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.
Adverse Reactions:
Adverse reactions during controlled clinical studies in which 1076 patients received temazepam at bedtime, the drug was well tolerated. side effects were usually mild and transient. adverse reactions occurring in 1% or more of patients are presented in the following table: temazepam% incidence(n=1076) placebo% incidence(n=783) drowsiness 9.1 5.6 headache 8.5 9.1 fatigue 4.8 4.7 nervousness 4.6 8.2 lethargy 4.5 3.4 dizziness 4.5 3.3 nausea 3.1 3.8 hangover 2.5 1.1 anxiety 2.0 1.5 depression 1.7 1.8 dry mouth 1.7 2.2 diarrhea 1.7 1.1 abdominal discomfort 1.5 1.9 euphoria 1.5 0.4 weakness 1.4 0.9 confusion 1.3 0.5 blurred vision 1.3 1.3 nightmares 1.2 1.7 vertigo 1.2 0.8 the following adverse events have been reported less frequently (0.5% to 0.9%): central nervous system - anorexia, ataxia, equilibrium loss, tremor, increased dreaming cardiovascular - dyspnea, palpitations gastrointestinal â vomiting musculoskeletal â backache special senses - hyperhidrosis, burning eyes amnesi
Read more...a, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%).
Adverse Reactions Table:
| | Temazepam% Incidence(n=1076) | Placebo% Incidence(n=783) |
| Drowsiness | 9.1 | 5.6 |
| Headache | 8.5 | 9.1 |
| Fatigue | 4.8 | 4.7 |
| Nervousness | 4.6 | 8.2 |
| Lethargy | 4.5 | 3.4 |
| Dizziness | 4.5 | 3.3 |
| Nausea | 3.1 | 3.8 |
| Hangover | 2.5 | 1.1 |
| Anxiety | 2.0 | 1.5 |
| Depression | 1.7 | 1.8 |
| Dry Mouth | 1.7 | 2.2 |
| Diarrhea | 1.7 | 1.1 |
| Abdominal Discomfort | 1.5 | 1.9 |
| Euphoria | 1.5 | 0.4 |
| Weakness | 1.4 | 0.9 |
| Confusion | 1.3 | 0.5 |
| Blurred Vision | 1.3 | 1.3 |
| Nightmares | 1.2 | 1.7 |
| Vertigo | 1.2 | 0.8 |
Overdosage:
Overdosage manifestations of acute overdosage of temazepam can be expected to reflect the cns effects of the drug and include somnolence, confusion, and coma, with reduced or absent reflexes, respiratory depression, and hypotension. the oral ld 50 of temazepam was 1963 mg/kg in mice, 1833 mg/kg in rats, and >2400 mg/kg in rabbits.
Description:
Description temazepam is a benzodiazepine hypnotic agent. the chemical name is 7-chloroâ-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2h-1,4-benzodiazepin-2-one, and the structural formula is: c 16 h 13 cln 2 o 2 mw = 300.74 temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol usp. temazepam capsules, usp, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg capsules active ingredient: temazepam usp 7.5 mg capsules inactive ingredients: corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, fd&c red #40 and titanium dioxide. may also include: sodium lauryl sulfate. imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg capsules inactive ingredients: corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, fd&c blue #1, fd&c yellow # 6, gelatin and titanium dioxide. may also include: sodium lauryl sulfate. imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg capsules inactive ingredients: corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, fd&c blue #1, fd&c red #40, gelatin and titanium dioxide. may also include: sodium lauryl sulfate. imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg capsules inactive ingredients: corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. may also include: sodium lauryl sulfate. imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. c:\documents and settings\spolina\desktop\tem-spl\structure.jpg
Clinical Pharmacology:
Clinical pharmacology pharmacokinetics in a single and multiple dose absorption, distribution, metabolism, and excretion (adme) study, using 3 h labeled drug, temazepam was well absorbed and found to have minimal (8%) first pass metabolism. there were no active metabolites formed and the only significant metabolite present in blood was the o-conjugate. the unchanged drug was 96% bound to plasma proteins. the blood level decline of the parent drug was biphasic with the short half-life ranging from 0.4 to 0.6 hours and the terminal half-life from 3.5 to 18.4 hours (mean 8.8 hours), depending on the study population and method of determination. metabolites were formed with a half-life of 10 hours and excreted with a half-life of approximately 2 hours. thus, formation of the major metabolite is the rate limiting step in the biodisposition of temazepam. there is no accumulation of metabolites. a dose-proportional relationship has been established for the area under the plasma concentration/
Read more...time curve over the 15 to 30 mg dose range. temazepam was completely metabolized through conjugation prior to excretion; 80% to 90% of the dose appeared in the urine. the major metabolite was the o-conjugate of temazepam (90%); the o-conjugate of n-desmethyl temazepam was a minor metabolite (7%).
How Supplied:
How supplied temazepam capsules usp 7.5 mg pink opaque cap and white opaque body, imprinted â7.5 mgâ on cap and ânovel 120â on the body in black ink. unit dose box of 30........ndc 0904-6436-04 bottle of 100 â¦â¦..ndc 0904-6436-60 dispense in a well-closed, light-resistant container with a child-resistant closure. storage: store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. *romazicon is the registered trademark of hoffman-laroche inc. **trademark of medical economics company, inc. manufactured by: novel laboratories, inc. somerset, nj 08873 distributed by: major pharmaceuticals 31778 enterprise drive livonia, mi 48150 usa
Package Label Principal Display Panel:
Principal display panel ndc 43353-152 - temazepam 7.5mg - rx only bottle label 7.5mg