- 1 [highlight]Important to know about Oxazepam Tablets ?[/highlight]
- 2 [highlight]What is oxazepam 10 mg used for? and indication [/highlight]
- 3 [highlight]Oxazepam Tablets Dosage[/highlight]
- 4 [highlight]How it works Seresta[/highlight]
- 5 [highlight]Oxazepam Tablets Side Effects[/highlight]
- 6 [highlight]Oxazepam Tablets Interactions[/highlight]
- 7 [highlight]Seresta Warnings and Precautions[/highlight]
- 8 [highlight]Oxazepam Tablets Drive and use machines[/highlight]
- 9 [highlight]Oxazepam Tablets and PREGNANCY / BREAST FEEDING / FERTILITY:[/highlight]
- 10 [highlight]What should I do if I miss a dose from Oxazepam Tablets?[/highlight]
- 11 [highlight]What happens if I overdose from Oxazepam Tablets ?[/highlight]
- 12 [highlight]What is Forms and Composition Oxazepam Tablets?[/highlight]
[highlight]Important to know about Oxazepam Tablets ?[/highlight]
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.
[highlight]What is oxazepam 10 mg used for? and indication [/highlight]
- Symptomatic treatment of severe and / or disabling anxiety disorders.
- Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal.
[highlight]Oxazepam Tablets Dosage[/highlight]
Reserved for adults.
– Dose :
In all cases, treatment will be initiated at the lowest effective dose and the maximum dose will not be exceeded.
. Anxiety : The 50 mg form is especially adapted to psychiatry and severe cases.
Usual dosage: 25 to 150 mg / day, ie 1/2 to 3 tablets in 3 or 4 doses.
In general, reserve the most important catch for the evening.
Moderate on the first day, the dose is increased if necessary on the following days in increments of 25 to 50 mg, until the desired efficacy.
- . Alcohol withdrawal : 15 to 30 mg 3 or 4 times a day.
- . In the elderly, renal failureIt is recommended to reduce the dosage, half for example.
– Duration :
- . 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 section on warnings and precautions for use).
- 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.
[highlight]How it works Seresta[/highlight]
ATC Code: N05BA.
(N: central nervous system).
– Oxazepam belongs to the class of benzodiazepines 1-4 and pharmacodynamic activity qualitatively similar to that of other compounds of this class
- muscle relaxant,
These effects are linked to a specific agonist action on a central receptor belonging to the complex “GABA-OMEGA macromolecular receptors”, also called BZ1 and BZ2 and modulating the opening of the chlorine channel.
[highlight]Oxazepam Tablets Side Effects[/highlight]
Description of adverse effects
Like all medicines, SERESTA 50 mg scored tablets can cause side effects, although not everybody gets them.
Possible side effects are related to the dose ingested and the individual sensitivity of the patient.
Adverse reactions that may occur during the first hours after taking the drug:
Memory problems as well as disorders affecting the control of your movements.
Effects contrary to the desired effect:
In some people, this medicine can cause reactions that are contrary to the desired effect: insomnia, nightmares, agitation, irritability, tension, changes in consciousness, even potentially dangerous behavior (aggression towards oneself or one’s entourage, as well as disorders of the body). behavior and automatic acts).
If any of these reactions occur, contact your doctor as soon as possible.
Adverse effects affecting your brain and / or your nerves:
- · Memory problems (memory lapses), which can occur at doses prescribed by your doctor (the risk increases in proportion to the dose).
- · Behavioral disorders, changes in consciousness, irritability, aggression, agitation.
- · Physical and psychological dependence, even at doses recommended by your doctor, with withdrawal syndrome or rebound at the end of treatment.
- · Sensations of divinity, headaches.
- · Drowsiness, decreased alertness, confusion or coma when using high doses (especially during suicide attempts) or in the elderly or subject poly-medicated including psychotropic.
- · Insomnia.
- · Difficulty coordinating certain movements.
- · Nightmares, tension.
- · Changes in libido.
Side effects affecting the skin:
· Pimples (rashes), with or without itching.
General side effects:
· Muscle weakness, fatigue, malaise, fall with potential risk of fracture especially in the elderly
Side effects affecting the eyes:
· Double vision.
Few cases of hypotension have occurred especially in patients treated for arterial hypertension.
Due to the presence of yellow-orange S (E110), risk of allergic reactions.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
[highlight]Oxazepam Tablets Interactions[/highlight]
ASSOCIATION DECONSEILLEE :
Increase by alcohol sedative effect of benzodiazepines and relatives. Altered alertness can make driving and using machines dangerous.
Avoid taking alcoholic drinks and drugs containing alcohol.
ASSOCIATIONS TO BE TAKEN INTO ACCOUNT :
– Other central nervous system depressants: morphine derivatives (analgesics, antitussives and substitution treatments other than buprenorphine); neuroleptics; barbiturates; other anxiolytics; hypnotics; sedative antidepressants; sedative antihistamines H1; central antihypertensives; baclofen; thalidomide .
Increase of the central depression. Impairment of alertness can make driving and using machines dangerous.
In addition, for morphine derivatives (analgesics, antitussives and substitution treatments), barbiturates: increased risk of respiratory depression, which can be fatal in case of overdose.
– Buprenorphine : 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.
[highlight]Seresta Warnings and Precautions[/highlight]
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).
This medicine contains yellow-orange S and may cause allergic reactions.
The anxiolytic effect of benzodiazepines and related drugs may decrease progressively despite the use of the same dose for several weeks.
Any treatment with benzodiazepines and related substances, and more particularly in case of prolonged use, may lead to a state of physical and mental dependence.
Various factors seem to favor the occurrence of dependence:
- · Duration of treatment,
- · Dose,
- · History of other addictions, drug or not, including alcoholic.
Drug dependence may occur at therapeutic doses and / or in patients without individualized risk factors.
This condition can lead to cessation of treatment a withdrawal phenomenon.
Some symptoms are common and seemingly commonplace: 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 discontinuation. For short-acting benzodiazepines, and especially if given at high doses, symptoms may 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 their relatives may lead to a syndrome associating to varying degrees an alteration of the state 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 can be accompanied by potentially dangerous disorders for the patient or for others, such as:
- · Unusual behavior for the patient,
- · Self or hetero-aggressive behavior, particularly if the patient is trying to interfere with the patient’s activity,
- · Automatic driving with post-event amnesia.
These manifestations require the cessation of treatment.
Benzodiazepines and related drugs (like all drugs) persist in the body for a period of about 5 half-lives.
In the elderly or with impaired renal or hepatic function, 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 an equilibrium plateau that it is possible to devalue both the efficacy and the safety of the drug.
Dosage adjustment may be necessary.
Benzodiazepines and related products should be used with caution in the elderly, because of the risk of sedation and / or the muscle relaxant effect that can lead to falls, with often severe consequences in this population.
Precautions for use
Great caution is advised in cases of alcoholism or other drug dependence .
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.
MODALITIES PROGRESSIVE DARRET TREATMENT
They must be stated to the patient precisely.
In addition to the need for gradual decrease in doses, patients should be warned of a rebound phenomenon, in order to minimize the anxiety that could result from the symptoms related to this interruption, even progressive.
The patient must be warned of the possibly uncomfortable nature of this phase.
SUBJECT AGE, INSUFFICIENT RENAL, INSUFFICIENT HEPATIC
The risk of accumulation leads to a reduction in dosage, for example by half (see section 4.4).
In the case of respiratory failure, the depressant effect of benzodiazepines and related substances should be taken into account (since anxiety and agitation may be signs of a decompensation of the respiratory function which justifies the passage to the intensive care unit).
[highlight]Oxazepam Tablets Drive and use machines[/highlight]
Prevent vehicle drivers and machine users from the risk of drowsiness.
The combination with other sedative drugs should be discouraged or taken into account when driving or using machines ( see Interactions ).
If sleep time is insufficient, the risk of impaired alertness is further increased.
[highlight]Oxazepam Tablets and PREGNANCY / BREAST FEEDING / FERTILITY:[/highlight]
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 precaution, the use of oxazepam is not recommended during pregnancy for any term.
When prescribing oxazepam 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-evaluate the benefit of the treatment.
At the end of pregnancy, if it is really necessary to start treatment with oxazepam, avoid prescribing high doses and take into account the effects described above for monitoring the newborn.
[highlight]What should I do if I miss a dose from Oxazepam Tablets?[/highlight]
Take the next dose at the usual time. Do not take a double dose to make up for the dose you forgot to take.
[highlight]What happens if I overdose from Oxazepam Tablets ?[/highlight]
Immediately consult your doctor or pharmacist.
[highlight]What is Forms and Composition Oxazepam Tablets?[/highlight]
|FORMS and PRESENTATIONS|
10 mg tablet (white): Case of 30, under blister packs.
Hospital model: Box of 100, in blister packs. 50 mg breakable tablet (pink): 20-pack, blister packs. Hospital model: Box of 100, in blister packs.
|Oxazepam (INN)||10 mg|
Excipients (common): rice starch, microcrystalline cellulose, lactose, magnesium stearate, talc. Color (50 mg cp): orange-yellow aluminum lake.
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