Restoril

About Generic Restoril (Temazepam)

Restoril may be an ethical drug prescribed to treat symptoms of sleep disorder. Benzodiazepine is also used alone or with different medications.

Restoril belongs to a category of medication referred to as Sedative/Hypnotics.

It is not renowned if benzodiazepine is safe and effective in youngsters.

Restoril might cause serious aspect effects including:

  • confusion
  • agitation
  • hostility
  • hallucinations
  • anxiety
  • memory issues
  • depressed mood
  • thoughts of suicide or pain yourself

Get medical facilitate promptly, if you’ve got any of the symptoms listed higher than.

The most common aspect effects of benzodiazepine include:

  • day-time temporary state or “hangover” feeling
  • headache
  • dizziness
  • tiredness
  • nausea
  • feeling nervous

DOSAGE AND ADMINISTRATION

While the counseled usual adult dose is fifteen mg before retiring, 7.5 mg is also decent for a few patients, et al may have thirty mg. In transient sleep disorder, a 7.5 mg dose is also decent to boost sleep latency. In old or debilitated patients, it’s counseled that medical aid be initiated with seven.5 mg till individual responses area unit determined.

DESCRIPTION

Restoril™ (temazepam) Capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, area unit for oral administration.

  • 7.5 mg, 15 mg, 22.5 mg, and thirty mg Capsules

Active Ingredient: Restoril USP

7.5 mg Capsules

Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, atomic number 12 stearate, red iron chemical compound, pigment.

15 mg Capsules

Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, atomic number 12 stearate, red iron chemical compound, pigment.

May also include: n-butyl alcohol, FD&C Blue #1/Brilliant Blue FCF metal Lake, iron chemical compound red, isopropanol, humectant, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol.

22.5 mg Capsules

Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, atomic number 12 stearate, red iron chemical compound, pigment.

May also include: n-butyl alcohol, FD&C Blue #1/Brilliant Blue FCF metal Lake, iron chemical compound red, isopropanol, humectant, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol.

30 mg Capsules

Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, atomic number 12 stearate, red iron chemical compound, pigment.

May also include: n-butyl alcohol, FD&C Blue #1/Brilliant Blue FCF metal Lake, iron chemical compound red, isopropanol, humectant, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol.

INDICATIONS

Restoril™ (temazepam) is indicated for the short-run treatment of sleep disorder (generally seven to ten days).

The clinical trials performed in support of effectualness were a pair of weeks in length with the ultimate formal assessment of sleep latency performed at the tip of treatment.

SIDE EFFECTS

During controlled clinical studies within which 1076 patients received Restoril at time of day, the drug was well tolerated. aspect effects were typically gentle and transient.

The following adverse events are rumored less often (0.5% to 0.9%):

  • Central systema nervosum – eating disorder, ataxia, equilibrium loss, tremor, inflated dreaming
  • Cardiovascular – dyspnea, palpitations
  • Gastrointestinal – regurgitation
  • Musculoskeletal – ache
  • Special Senses – perspiration, burning eyes

Amnesia, hallucinations, horizontal move, and inexplicable reactions as well as restlessness, overstimulation and agitation were rare (less than zero.5%).

DRUG INTERACTIONS

The concomitant use of benzodiazepines and opioids will increase the danger of metastasis depression due to actions at completely different receptor sites within the central nervous system that management respiration. Benzodiazepines move at GABAA sites and opioids move primarily at alphabetic character receptors. once benzodiazepines and opioids area unit combined, the potential for benzodiazepines to considerably worsen opioid-related metastasis depression exists.

Drug Abuse and Dependence

Abuse and addiction area unit separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical functions, typically together with alternative mind-blowing substances. Physical dependence could be a state of adaptation that’s manifested by a particular withdrawal syndrome that may be made by abrupt stop, fast dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance could be a state of adaptation within which exposure to a drug induces changes that end in a diminution of 1 or a lot of the drug’s effects over time. Tolerance could occur to each the specified and unsought effects of medication and should develop at completely different rates for various effects.

It is characterized by the following behaviors:

  • impaired management over drug use,
  • compulsive use,
  • continuing use despite hurt, and desire.

Dependency could be a treatable malady, utilizing a multidisciplinary approach, however relapse is common. Restoril could be a drug in Schedule IV.

A lot of severe withdrawal symptoms have typically been restricted to those patients World Health Organization received excessive doses over AN extended amount of your time. Typically, milder withdrawal symptoms (e.g., depression and insomnia) are rumored following abrupt ending of benzodiazepines taken unendingly at therapeutic levels for many months. Consequently, when extended medical aid at doses over fifteen mg, abrupt discontinuance ought to typically be avoided and a gradual dose tapering schedule followed. Caution should be exercised in administering Restoril to people renowned to be addiction-prone or to those whose history suggests they’ll increase the dose on their own initiative. it’s fascinating to limit continual prescriptions while not adequate medical oversight.

WARNINGS

Concomitant use of benzodiazepines, as well as temazepam, and opioids could lead to profound sedation, metabolic process depression, coma, and death. attributable to these risks, reserve concomitant prescribing of those medicine to be used in patients for whom various treatment choices ar inadequate.

Advise each patients and caregivers regarding the risks of metabolic process depression and sedation once temazepam is employed with opioids. Advise patients to not drive or operate significant machinery till the consequences of concomitant use with the opioid are determined (see DRUG INTERACTIONS).

Sleep disturbance is also the presenting manifestation of AN underlying physical and/or psychiatrical disorder. Consequently, a call to initiate symptomatic treatment of sleep disorder ought to solely be created once the patient has been rigorously evaluated. The failure of sleep disorder to remit once seven to ten days of treatment could indicate the presence of a primary psychiatrical and/or medical sickness that ought to be evaluated. Worsening of sleep disorder is also the consequence of AN unrecognized psychiatrical or physical disorder as could the emergence of recent abnormalities of thinking or behavior. Such abnormalities have additionally been reported to occur in association with the employment of medication with central systema nervosum depressant activity, as well as those of the depressant category. as a result of a number of the worrisome adverse effects of benzodiazepines, as well as temazepam, seem to be dose connected (see PRECAUTIONS and indefinite quantity AND ADMINISTRATION), it’s vital to use very cheap attainable effective dose. old patients are particularly in danger.

Some of these changes is also characterized by attenuated inhibition, e.g., aggressiveness and sociableness that appear out of character, like that seen with alcohol. other forms of activity changes may occur, for instance, freaky behavior, agitation, hallucinations, and depersonalization. advanced behaviors like “sleep-driving” (i.e., driving whereas not totally awake once body process of a sedative drug, with blackout for the event) are reported. These events will occur in sedative hypnotic- naïve in addition as in sedative-hypnotic-experienced persons. though behaviors like “sleep-driving” could occur with temazepam alone at therapeutic doses, the employment of alcohol and alternative central nervous system depressants with temazepam seems to extend the chance of such behaviors, as will the employment of temazepam at doses surpassing the utmost counseled dose. thanks to the chance to the patient and also the community, termination of temazepam ought to be powerfully thought-about for patients United Nations agency report a “sleep-driving” episode. alternative advanced behaviors (e.g., making ready and ingestion food, creating phone calls, or having sex) are reported in patients United Nations agency aren’t totally awake once taking a sedative drug. like “sleepdriving”, patients typically don’t bear in mind these events. blackout and alternative neuro-psychiatric symptoms could occur erratically. In primarily depressed patients, worsening of depression, as well as self-destructive thinking has been reported in association with the employment of sedative/hypnotics.

It will seldom be determined with certainty whether or not a specific instance of the abnormal behaviors listed on top of is drug induced, spontaneous in origin, or a result of an underlying psychiatrical or physical disorder. all the same, the emergence of any new activity sign or symptom of concern needs careful and immediate analysis.

Withdrawal symptoms (of the drug of abuse type) have occurred once the abrupt termination of benzodiazepines (see misuse And Dependence).

Because temazepam will cause somnolence and a attenuated level of consciousness, patients, significantly the old, are at higher risk of falls.

Severe hypersensitivity reaction And Anaphylactoid Reactions

Rare cases of angioedema involving the tongue, vocal organ or cartilaginous structure are reported in patients once taking the primary or future doses of sedative-hypnotics, as well as temazepam. Some patients have had extra symptoms like symptom, throat closing, or nausea and disgorgement that counsel hypersensitivity reaction. Some patients have needed medical aid within the emergency department. If angioedema involves the tongue, vocal organ or cartilaginous structure, airway obstruction could occur and be fatal. Patients United Nations agency develop angioedema once treatment with temazepam shouldn’t be rechallenged with the drug.

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