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TEMAZEPAM is a brand name for Temazepam, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TEMAZEPAM (temazepam) is indicated for the symptomatic relief of transient and short-term insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings. The use of hypnotics should be restricted for insomnia where disturbed sleep results in impaired daytime…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Sleep disturbance may be the presenting manifestation of a 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.
TEMAZEPAM should always be prescribed at the lowest effective dose for the shortest duration possible. TEMAZEPAM can produce withdrawal signs and symptoms or rebound phenomena following abrupt discontinuation or rapid dose reduction (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Withdrawal; 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance).
Abrupt discontinuation should be avoided and treatment - even if only of short duration - should be terminated by gradually tapering the dosage schedule under close monitoring. Tapering should be tailored to the specific patient. Special attention should be given to patients with a history of seizure.
If a patient experiences withdrawal signs and symptoms, consider postponing the tap er or raising the benzodiazepine to the previous dosage prior to proceeding with a gradual taper. Geriatric patients in particular may be more sensitive to benzodiazepines (see 7 WARNINGS AND PRECAUTIONS, Falls and Fractures).
Long-term use of TEMAZEPAM should be avoided in elderly patients. Enhanced monitoring is recommended. 2 Recommended Dose and Dosage Adjustment Recommended Dose Adults: the recommended dose of TEMAZEPAM is 30 mg before retiring, 15 mg may be sufficient for some patients.
4 Geriatrics). 3 Pediatrics). Dosage Adjustment The lowest effective dose of TEMAZEPAM should be used. Treatment with TEMAZEPAM should usually not exceed 7 to 10 consecutive days. Use for more than 2 to 3 consecutive weeks requires complete re-evaluation of the patient.
Prescriptions for TEMAZEPAM should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply. An appropriate hypnotic dose should produce the desired hypnotic effect while avoiding oversedation and impairment of performance the next day.
TEMAZEPAM is intended only for short-term use and therefore, should not be prescribed in quantities exceeding those required for that cycle of administration. Prescription should not be renewed without further assessment of the patient's needs.
1 Adverse Reaction Overview In clinical trials, drowsiness, dizziness, and confusion occurred at a higher incidence in temazepam-treated patients as compared with placebo-treated patients. 9 % in clinical trials. There have been reports of falls and fractures in benzodiazepine users due to adverse reactions such as sedation, dizziness and ataxia (See 7 WARNINGS AND PRECAUTIONS, Falls and Fractures).
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction info rmation from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. During controlled clinical trials in which 1076 patients received temazepam at bedtime, the Adverse Events occurring in 1% or more of patients are listed below.
9%: Cardiac Disorders: dyspnea, palpitations. Eye disorders: burning eyes. Gastrointestinal disorders: vomiting. Metabolism and nutrition disorders: anorexia. Musculoskeletal and connective tissue disorder: backache. Nervous system disorders: ataxia, equilibrium loss, tremor, increased dreaming.
Skin and subcutaneous tissue disorders: hyperhidrosis. 5%: Eye disorders: horizontal nystagmus. Nervous system disorders: restlessness, overstimulation, agitation. 5 Post-Market Adverse Reactions Injury, Poisoning and Procedural Complications There have been reports of falls and fractures in benzodiazepine users due to ad verse reactions such as sedation, dizziness and ataxia.
The risk is increased in those taking concomitant sedatives (including alcoholic beverages), the elderly and debilitated patients. Dependence/Withdrawal Development of physical dependence and withdrawal following discontinuation of therapy has been observed with benzodiazepines such as temazepam.
1 Dosing considerations). 2 CONTRAINDICATIONS TEMAZEPAM is contraindicated in patients: with a known hypersensitivity to the drug, to other benzodiazepines or to any component of the drug’s formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. with myasthenia gravis. with sleep apnea syndrome. who in the past manifested paradoxical reactions to alcohol and/or sedative medications. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Addiction, Abuse and Misuse The use of benzodiazepines, including TEMAZEPAM, can lead to abuse, misuse, addiction, physical dependence and withdrawal reactions.
Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioids, alcohol or illicit drugs. Assess each patient’s risk prior to prescribing TEMAZEPAM Monitor all patients regularly for the development of these behaviours or conditions.
TEMAZEPAM should be stored securely to avoid theft or misuse. TEMAZ EPAM (Temazepam Capsules) Page 5 of 31 Withdrawal Benzodiazepines, like TEMAZEPAM can produce severe or life-threatening withdrawal symptoms. Avoid abrupt discontinuation or rapid dose reduction of TEMAZEPAM.
Terminate treatment with TEMAZEPAM by gradually tapering the dosage schedule under close monitoring. (see 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance) Risks from Concomitant use with Opioids Concomitant use of TEMAZEPAM and opioids may result in profound sedation, respiratory depression, coma and death (see 7 WARNINGS AND PRECAUTIONS, General, Concomitant use with opioids).
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are not possible. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
TEMAZEPAM is contraindicated in patients: with a known hypersensitivity to the drug, to other benzodiazepines or to any component of the drug’s formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
with myasthenia gravis. with sleep apnea syndrome. who in the past manifested paradoxical reactions to alcohol and/or sedative medications.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4 Administration Capsules are for oral administration. 5 Missed Dose If the patient misses a dose, inform the patient to skip the missed dose and take the next dose at the regular dosing schedule.
Severe and life-threatening symptoms have been reported (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Addiction, Abuse and Misuse; 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance). TEMAZ EPAM (Temazepam Capsules) Page 15 of 31
1 Dosing Considerations Sleep disturbance may be the presenting manifestation of a 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.
TEMAZEPAM should always be prescribed at the lowest effective dose for the shortest duration possible. TEMAZEPAM can produce withdrawal signs and symptoms or rebound phenomena following abrupt discontinuation or rapid dose reduction (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Withdrawal; 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance).
Abrupt discontinuation should be avoided and treatment - even if only of short duration - should be terminated by gradually tapering the dosage schedule under close monitoring. Tapering should be tailored to the specific patient. Special attention should be given to patients with a history of seizure.
If a patient experiences withdrawal signs and symptoms, consider postponing the tap er or raising the benzodiazepine to the previous dosage prior to proceeding with a gradual taper. Geriatric patients in particular may be more sensitive to benzodiazepines (see 7 WARNINGS AND PRECAUTIONS, Falls and Fractures).
Long-term use of TEMAZEPAM should be avoided in elderly patients. Enhanced monitoring is recommended. 2 Recommended Dose and Dosage Adjustment Recommended Dose Adults: the recommended dose of TEMAZEPAM is 30 mg before retiring, 15 mg may be sufficient for some patients.
4 Geriatrics). 3 Pediatrics). Dosage Adjustment The lowest effective dose of TEMAZEPAM should be used. Treatment with TEMAZEPAM should usually not exceed 7 to 10 consecutive days. Use for more than 2 to 3 consecutive weeks requires complete re-evaluation of the patient.
Prescriptions for TEMAZEPAM should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply. An appropriate hypnotic dose should produce the desired hypnotic effect while avoiding oversedation and impairment of performance the next day.
TEMAZEPAM is intended only for short-term use and therefore, should not be prescribed in quantities exceeding those required for that cycle of administration. Prescription should not be renewed without further assessment of the patient's needs.
4 Administration Capsules are for oral administration. 5 Missed Dose If the patient misses a dose, inform the patient to skip the missed dose and take the next dose at the regular dosing schedule. 5 OVERDOSAGE Manifestations of acute overdosage of temazepam, as with other benzodiazepines, can be expected to reflect the increasing CNS effects of the drug and include somnolence, confusion and coma, with reduced or absent reflexes.
With large overdoses, respiratory depression, hypotension and finally coma will result. , syrup of ipecac 20 to 30 mL). General supportive measures should be employed. Maintenance of adequate pulmonary ventilation is essential and fluids should be administered intravenously to encourage diuresis.
The use of pressor agents, such as norepinephrine bitartrate or metaraminol, intravenously may be necessary to combat hypotension but only if considered essential. The value of dialysis in emergency therapy for benzodiazepine overdosage has not been determined.
If excitation occurs, barbiturates should not be used. It should be borne in mind that multiple agents may have been ingested. TEMAZ EPAM (Temazepam Capsules) Page 7 of 31 The benzodiazepine antagonist, flumazenil, is a specific antidote in known or suspected benzodiazepine overdose.
For management of a suspected drug overdose, contact […]