- 1 Important to know about Temesta ?
- 2 Temesta indication and Uses
- 3 Temesta Dosage
- 4 How long does it take to work?
- 5 temesta side effects
- 6 Temesta Interactions
- 7 Temesta Warnings and Precautions
- 8 Drive and use machines
- 9 Temesta and PREGNANCY / BREAST FEEDING / FERTILITY:
- 10 What is Forms and Composition Temesta?
Important to know about Temesta ?
This medicine is recommended in the treatment of anxiety when it is accompanied by troublesome disorders, or in the prevention and / or treatment of manifestations related to alcohol withdrawal.
Temesta indication and Uses
- Symptomatic treatment of severe and / or disabling anxiety disorders.
- Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal.
tablet is not a form suitable for children under 6 years old (risk of miscarriage).
In all cases, treatment will be initiated at the lowest effective dose and the maximum dose will be not exceeded.
The usual dosage for adults is:
The first days of treatment:
- 1/2 tablet in the morning (0.5 mg)
- 1/2 tablet at noon (0.5 mg)
- tablet in the evening (1 mg)
The following days: the dosage will be adapted, gradually, according to the evolution (average daily dosage: 2 to 4 tablets, ie 2 to 4 mg per day).
In children, the elderly, the renal failure or the hepatic insufficiency : it is recommended to reduce the dosage, by half for example.
In severe cases and in psychiatry , where higher dosages may be warranted, use 2.5 mg tablets.
- The treatment should be as short as possible. The indication will be reviewed regularly especially in the absence of symptoms. The overall duration of treatment should not exceed 8 to 12 weeks for the majority of patients, including the dose reduction period (see Warnings and Precautions section ).
- In some cases, it may be necessary to prolong the treatment beyond the recommended periods. This requires accurate and repeated assessments of the patient’s condition.
Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal :
- Short treatment of the order of 8 to 10 days.
How long does it take to work?
- The resorption of lorazepam is rapid: tmax is between 0.5 and 4 hours. The bioavailability is high, of the order of 90%, and it is not impaired in case of intramuscular administration.
- The volume of distribution is 1 l / kg. The total plasma clearance of lorazepam is 55 ml / min. Protein binding is important, averaging 93%.
- The plasma elimination half-life of lorazepam is between 10 and 20 hours. The steady state plasma concentrations are reached in about 3 days.
- A concentration-effect relationship could not be established for this class of products due to the intensity of their metabolism and the development of tolerance.
- Benzodiazepines pass the blood-brain barrier as well as in the placenta and breast milk.
Metabolism and Elimination
- The liver plays a major role in the process of metabolizing benzodiazepines, which explains the negligible percentage (<10%) of unchanged lorazepam found at the urinary level. Inactivation of lorazepam is by glucuronidation, resulting in water-soluble substances eliminated in the urine.
Populations at risk
- · Elderly : The pharmacokinetic parameters are not modified.
- · Hepatic insufficiency (cirrhosis) : there is a doubling of the half-life.
- · Patients with renal failure : slowing down the elimination of glucuronide conjugates but no increase in the half-life of lorazepam.
- · Hemodialysis : it partially eliminates lorazepam.
temesta side effects
They are related to the ingested dose and the individual sensitivity of the patient.
The following side effects have been reported:
Very frequently (may affect more than 1 in 10 patients):
- · Decreased alertness or drowsiness (particularly in the elderly), insomnia.
Frequently (may affect up to 1 in 10 patients):
- · Difficulty coordinating certain movements, confusion,
- · Muscle weakness, fatigue.
Infrequently (may affect up to 1 in 100 patients):
- · Changes in libido.
The following undesirable effects have also been reported with lorazepam (TEMESTA):
- · Memory problems (memory lapses), which can occur at therapeutic doses, the risk increases in proportion to the dose,
- · Behavior disorders, changes in consciousness, irritability, aggression, agitation,
- · Physical and psychological dependence, even in therapeutic doses with withdrawal syndrome or rebound at the end of treatment,
- · Sensations of drunkenness, headaches, vertigo, pronunciation problems (dysarthria) and speech (difficulties in articulating),
- · Rash with or without itching.
- · Double vision,
- · Hypersensitivity reactions, anaphylactic or anaphylactoid reactions (generalized allergic reaction that may be life-threatening),
- · Hyponatremia (low sodium in the blood),
- · Thrombocytopenia (drop in platelets), agranulocytosis (drop in white blood cells), pancytopenia (drop in red blood cells, white blood cells and blood platelets),
- · Hallucinations, depression, suicidal ideation, suicide attempt, coma, extra-pyramidal effects, tremors, convulsions, insomnia, nightmares, nervous tension,
- · Low blood pressure (hypotension),
- · Stopping breathing, respiratory depression, worsening of sleep apnea, worsening of obstructive pulmonary disease,
- · Heartache (nausea), constipation,
- · Jaundice, increased bilirubin,
- · Increased urinary excretion rate (inappropriate secretion of ADH),
- · Abnormal liver parameters (changes in some laboratory tests related to liver damage),
- · Hypothermia.
- Alcohol enhancement of the sedative effect of benzodiazepines and the like.
- Impairment of alertness can make driving and using machines dangerous.
- Avoid taking alcoholic drinks and drugs containing alcohol.
+ Sedative drugs: morphine derivatives (analgesics, antitussives and substitution treatments other than buprenorphine); neuroleptics; barbiturates; benzodiazepines; anxiolytics other than benzodiazepines; hypnotics; sedative antidepressants such as: amitriptyline, doxepin, mianserin, mirtazapine, trimipramine; sedative antihistamines H1; central antihypertensives; others: baclofen; thalidomide; pizotifene.
Increase of the central depression. Impairment of alertness can make driving and using machines dangerous.
Morphine derivatives (analgesics, antitussives and substitution treatments) : Increased risk of respiratory depression, which can be fatal in case of overdose.
- Increased risk of respiratory depression, which can be fatal in case of overdose.
- Increased risk of respiratory depression, which can be fatal.
- Carefully evaluate the benefit / risk ratio of this combination. Inform the patient of the need to respect the prescribed doses.
Temesta Warnings and Precautions
This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
The anxiolytic effect of benzodiazepines and related substances may decrease gradually despite the use of the same dose when administered for several weeks.
Any treatment with benzodiazepines and related drugs, especially with prolonged use, may result in a state of physical and mental dependence.
Various factors seem to favor the occurrence of dependence:
- · Duration of treatment,
- · Dose,
- · History of other drug addictions, including alcoholic.
- Drug dependence may occur at therapeutic doses and / or in patients without individualized risk factors.
- This state can lead to the cessation of treatment a withdrawal phenomenon.
- Some symptoms are common and seemingly trivial: insomnia, headache, severe anxiety, myalgia, muscle tension, irritability.
Other symptoms are more rare: agitation or even confusional episode, paresthesia of the extremities, hyperreactivity to light, noise, and physical contact, depersonalization, derealization, hallucinatory phenomena, convulsions.
Withdrawal symptoms may occur within days of stopping treatment. For short-acting benzodiazepines, and especially if given at high doses, symptoms may even occur in the interval between two doses.
The combination of several benzodiazepines may, regardless of the anxiolytic or hypnotic indication, increase the risk of drug dependence.
Cases of abuse have been reported.
This transient syndrome may manifest itself as an exacerbation of the anxiety that motivated treatment with benzodiazepines and the like.
AMNESIA AND ALTERATIONS OF PSYCHOMOTIC FUNCTIONS
Anterograde amnesia and alterations of the psychomotor functions are likely to appear in the hours following the taking.
In some subjects, benzodiazepines and related products may result in a syndrome associating to varying degrees an impairment of consciousness and behavioral and memory disorders:
Can be observed:
- · Worsening of insomnia, nightmares, agitation, nervousness,
- · Delusions, hallucinations, confuso-oniric state, psychotic type symptoms,
- · Disinhibition with impulsiveness,
- · Euphoria, irritability,
- · Anterograde amnesia,
- · Suggestibility.
This syndrome may be accompanied by potentially dangerous disorders for the patient or for others, such as:
- · Unusual behavior for the patient,
- · Self- or hetero-aggressive behavior, especially if the entourage is trying to hinder the activity of the
- · Automatic driving with post-event amnesia.
- These events require the cessation of treatment.
RISK OF ACCUMULATION
Benzodiazepines and related drugs (like all drugs) persist in the body for a period of about 5 half-lives (see section 5.2).
In the elderly or with renal or hepatic insufficiency, the half-life may be considerably longer. When taken repeatedly, the drug or its metabolites reach the equilibrium plateau much later and at a much higher level. It is only after obtaining a balance plateau that it is possible to evaluate both the efficacy and the safety of the drug.
Dosage adjustment may be necessary (see section 4.2).
Benzodiazepines and related products should be used with caution in the elderly, because of the risk of sedation and / or myorelaxant effect that may lead to falls, with often severe consequences in this population.
Precautions for use
Great caution is recommended in case of a history of alcoholism or other addictions, whether medicated or not (see section 4.5).
AT THE SUBJECT WITH A MAJOR DEPRESSIVE EPISODE
Benzodiazepines and related drugs should not be prescribed alone as they allow depression to progress on its own account with persistence or increased suicidal risk.
PROGRESSIVE STOPPING PROCEDURES FOR TREATMENT
They must be stated to the patient precisely.
In addition to the need for gradual decrease in doses, patients should be warned of the possibility of a rebound phenomenon, to minimize the anxiety that may arise from the symptoms related to this interruption, even progressive. The patient must be warned of the possibly uncomfortable nature of this phase.
Even more than in adults, the benefit / risk ratio will be carefully evaluated and the duration of treatment as short as possible. No clinical studies have been conducted in children with lorazepam.
SUBJECT AGE, INSUFFICIENT RENAL OR HEPATIC
The risk of accumulation leads to a reduction in dosage, for example by half (see section 4.4).
In patients with respiratory insufficiency, the depressant effect of benzodiazepines and related substances should be taken into account (especially since anxiety and agitation may be signs of a call for a decompensation of the respiratory function which justifies the transition to intensive care unit).
Drive and use machines
Prevent drivers of vehicles and machine users from the risk of drowsiness.
Combination with other sedating medicinal products should be discouraged or taken into account when driving or using machines (see section Interactions with other medicinal products and other forms of interaction ).
If sleep time is insufficient, the risk of impaired alertness is further increased.
Temesta and PREGNANCY / BREAST FEEDING / FERTILITY:
first trimester of pregnancy. However, in some case-control epidemiological studies, an increase in the occurrence of cleft lip and palate has been observed with benzodiazepines. According to these data, the incidence of cleft lip and palate in newborns would be less than 2/1000 after exposure to benzodiazepines during pregnancy while the expected rate in the general population is 1/1000.
- If benzodiazepines are taken in high doses at 2 nd and / or 3 rd trimesters of pregnancy, a decrease in fetal active movements and a variability in fetal heart rate have been described.
- Treatment with benzodiazepines at the end of pregnancy, even at low doses, may be responsible in the newborn for signs of impregnation such as axial hypotonia, sucking disorders resulting in low weight gain.
- These signs are reversible, but can last 1-3 weeks depending on the half-life of the prescribed benzodiazepine. At high doses, respiratory depression or apnea, and hypothermia may occur in the newborn.
- In addition, a syndrome of neonatal withdrawal is possible, even in the absence of signs of impregnation. It is characterized in particular by hyperexcitability, agitation and tremulations of the newborn occurring at a distance from the delivery.
- The time of onset depends on the elimination half-life of the drug and may be important when it is long.
- Given these data, as a precautionary measure, the use of lorazepam is not recommended during pregnancy, regardless of the term.
- When prescribing lorazepam to a woman of childbearing age, she should be advised of the need to contact her physician if a pregnancy is planned or started to re-assess the benefit of the treatment.
- At the end of pregnancy, if it is really necessary to start treatment with lorazepam, avoid prescribing high doses and take into account the effects described above for monitoring the newborn.
- The use of this medicine during breastfeeding is not recommended.
Immediately consult your doctor or pharmacist.
What is Forms and Composition Temesta?
|FORMS and PRESENTATIONS|
Breakable tablet * 1 mg (white stick): Box of 30, under blister packs. Breakable tablet * 2.5 mg (yellow stick): Box of 30, under blister packs. * The tablet can be divided into two equal doses.
|Lorazepam (DCI)||1 mg|
Excipients (common): lactose monohydrate, microcrystalline cellulose, magnesium stearate, lactose anhydrous, polacrilin potassium. Color: yellow aluminum lake of quinoline E104 (cp 2.5 mg).
Excipient with known effect: lactose.
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