Bromazepam Mylan 6 mg Uses, Dosage, Side Effects, Precautions & Warnings
Active ingredients: Bromazepam
what is BROMAZEPAM MYLAN used for and indication?
This medication is recommended in the treatment of anxiety when it is accompanied by troublesome disorders, or in the prevention and / or treatment of symptoms linked to alcohol withdrawal.
PRESENTATION (S) AVAILABLE FOR BROMAZEPAM MYLAN 6 MG
3 PVC-aluminum blister (s) of 10 tablet (s)
|Active substance (s)||for one tablet: bromazepam (6 mg)|
|Pharmaceutical form||quadrisis tablet|
|Route (s) of administration||oral|
|Social security reimbursement rate||65%|
|Laboratory (s)||MYLAN SAS|
|Conditions of issue||available by simple prescription|
BROMAZEPAM MYLAN Dosage
In all cases, treatment will be initiated at the lowest effective dose and the maximum dose will not be exceeded.
In current practice
In adults , the beginning of treatment, the mean daily dose of BROMAZEPAM is 6 mg per day, spread most often as follows:
- 1/4 tablet in the morning (1.5 mg)
- 1/4 tablet at noon (1.5 mg)
- 1/2 tablet in the evening (3 mg).
It must then be individually adapted according to the therapeutic response.
- Depending on the severity of the anxiety to be treated: in ambulatory patients, the dosage is between 6 and 18 mg; in subjects whose severity of the anxiety syndrome requires hospitalization, it is possible to prescribe higher doses, 24 or even 36 mg per day.
- In children, the elderly, renal or hepatic insufficiency : it is recommended to reduce the dosage, by half for example.
- Treatment should be as brief as possible. The indication will be reviewed regularly especially in the absence of symptoms.
- The overall duration of treatment should notexceed 8 to 12 weeks for the majority of patients, including the dose reduction period (see section warnings and precautions for use).
- In some cases, it may be necessary to extend the treatment beyond the recommended periods. This assumes precise and repeated assessments of the patient’s condition.
Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal : brief treatment of the order of 8 to 10 days.
BROMAZEPAM MYLAN Contraindications
Do not take Bromazepam Mylan 6 mg tablet in the following cases:
- known allergy to this class of products or to one of the components of the drug,
- severe respiratory failure,
- sleep apnea syndrome ( breathing pauses during sleep ),
- severe liver failure,
- myasthenia gravis ( disease characterized by an excessive tendency to muscle fatigue ).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
How To Take BROMAZEPAM MYLAN ?
- Oral route.
- Swallow this medicine with a glass of water.
Duration of the treatment
- The duration of treatment should be as short as possible and should not exceed 8 to 12 weeks.
how does BROMAZEPAM MYLAN work?
The absorption of bromazepam is between 0.5 and 4 hours. Bioavailability is of the order of 65%.
- The volume of distribution ranges from 0.5 to 2 L / kg.
- Protein binding is approximately 75%.
- Steady state plasma concentrations are reached within 4 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 cross 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 metabolism of benzodiazepines, which explains the negligible percentage (1 to 3%) of unchanged bromazepam found in the urine.
- Bromazepam is quantitatively metabolized into two main metabolites: 3-hydroxy-bromazepam (which is also active; its participation in the pharmacological effect is low) and 2- (2-amino-5-bromo-3-hydroxybenzoyl) pyridine. These metabolites are then glucuronidated, resulting in water-soluble substances excreted in the urine. In the urine, the fraction of unchanged bromazepam is negligible (2%) compared to the glucuronide derivatives of 3-hydroxy-bromazepam and 2- (2-amino-5-bromo-3-hydroxybenzoyl) pyridine which represent respectively 27% and 40% of the administered dose.
- The plasma elimination half-life of bromazepam is 20 hours.
- The total plasma clearance of bromazepam, calculated after intravenous administration, is 45 ml / min on average.
POPULATIONS AT RISK
Elderly subjects :
- The hepatic metabolism decreases and therefore the total clearance with an increase in the concentrations at equilibrium, the free fraction and the half-lives. It is therefore important to reduce the doses, at least initially.
Patients with hepatic insufficiency :
- An increase in the half-life is noted, with a drop in total plasma clearance.
How To Store BROMAZEPAM MYLAN ?
- Keep this medication out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton. The expiration date refers to the last day of that month
- No special storage conditions.
- Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment .
BROMAZEPAM MYLAN Side Effects
Like all medicines, Bromazepam Mylan can cause side effects, although not everybody gets them.
They are related to the dose ingested and the individual sensitivity of the patient.
Neuro-psychiatric adverse effects .
- memory impairment (memory loss ), which can occur with therapeutic doses, the risk increasing in proportion to the dose,
- behavioral disturbances, changes in consciousness, irritability, aggressiveness, agitation,
- physical and psychological dependence, even at therapeutic doses with withdrawal or rebound syndrome upon discontinuation of treatment,
- feelings of intoxication, headaches, difficulty coordinating certain movements,
- confusion, decreased alertness or even drowsiness (particularly in the elderly), insomnia, nightmares, tension,
- changes in libido.
Skin side effects
- rashes, with or without itching.
General side effects
- muscle weakness, fatigue.
Ocular side effects
- double vision.
If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
BROMAZEPAM MYLAN Interactions
Not recommended associations
- Alcohol enhancement of the sedative effect of benzodiazepines and related drugs. Impaired vigilance can make driving and using machines dangerous. Avoid taking alcoholic drinks and drugs containing alcohol.
Associations to take into account
Concomitant use of sedative drugs such as benzodiazepines or related drugs such as Bromazepam Mylan 6 mg, four-scored tablet with opioids increases the risk of sedation, respiratory depression, coma and death due to an additive depressant effect on the patient’s body. Central Nervous System (CNS). The dosage and duration of concomitant use should be limited (see section 4.4).
Other central nervous system depressants
- Enhancement of the central depressant effect with morphine derivatives (analgesics, cough suppressants and substitution treatments other than buprenorphine); antipsychotics (neuroleptics); barbiturates; other anxiolytics; hypnotics; sedative antidepressants; sedative H1 antihistamines; central antihypertensive drugs; anticonvulsants; baclofen; thalidomide.
- Impaired vigilance can make driving and using machines dangerous.
- In addition, for morphine derivatives (analgesics, cough suppressants and substitution treatments), barbiturates: increased risk of respiratory depression, which may be fatal in the event of overdose, especially in the elderly.
- 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 adhere to the prescribed doses.
- Increased risk of collapse with respiratory and / or cardiac arrest.
- Pharmacokinetic interactions may occur when bromazepam is administered with drugs that inhibit the hepatic enzyme CYP3A4, by increasing the plasma levels of bromazepam.
- Caution should be exercised when co-administering bromazepam with potent CYP3A4 inhibitors (eg azole antifungals, protease inhibitors or certain macrolides) and a large dose reduction should be considered. In the case of narcotic analgesics, potentiation of euphoria may also occur, which may lead to increased psychic dependence.
Effects on ability to Drive and use machines
- Attention is drawn to drowsiness and decreased alertness associated with the use of this medication.
- The combination with other sedative or hypnotic drugs, and of course with alcohol, is not recommended when driving a car or using machines.
- If the duration of sleep is insufficient, the risk of impaired vigilance is further increased.
- Bromazepam Mylan 6 mg, four-scored tablet contains lactose
- If your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine.
Warnings and Precautions
If loss of effectiveness occurs with repeated use of the drug, do not increase the dose.
Risk of DEPENDENCE: this treatment can lead, especially in the event of prolonged use, to a state of physical and psychological dependence. Various factors seem to favor the onset of dependence:
- duration of treatment,
- history of other drug dependence or not, including alcoholic.
Addiction can occur even in the absence of these contributing factors.
For more information, talk to your doctor or pharmacist.
- Abruptly stopping this treatment may cause the appearance of a WITHDRAWAL phenomenon. This is characterized by the appearance, in a few hours or a few days, of signs such as severe anxiety, insomnia, muscle pain, but one can also observe restlessness, irritability, headaches, numbness or tingling of the extremities, abnormal sensitivity to noise, light or physical contact, etc., etc.
The modalities for stopping treatment should be defined with your doctor.
- The very PROGRESSIVE reduction of the doses and the spacing of the doses represent the best prevention of this phenomenon of withdrawal. This period will be longer as the treatment has been prolonged.
- Despite the gradual decrease in doses, a mild REBOUND phenomenon may occur, with TRANSITIONAL reappearance of symptoms (anxiety) which had justified the initiation of treatment.
- Memory problems as well as alterations in psychomotor functions are likely to appear within hours of taking the drug.
- In some subjects, this medication may cause reactions contrary to the desired effect: insomnia, nightmares, restlessness, nervousness, euphoria or irritability, tension, changes in consciousness, or even potentially dangerous behavior (aggression towards oneself or those around them , as well as behavioral disorders and automatic acts).
If one or more of these reactions occur, contact your doctor as soon as possible.
- Benzodiazepines and related products should be used with caution in the elderly, because of the risk of drowsiness and / or muscle relaxation which can promote falls, with often serious consequences in this population.
- Due to the presence of lactose, this medicine should not be used in case of galactosemia, glucose or galactose malabsorption syndrome or lactase deficiency (rare metabolic diseases).
Precautions for use
- This drug treatment alone cannot resolve the difficulties associated with anxiety. You should seek advice from your doctor. He will show you the behaviors that can help in the fight against anxiety.
- Taking this medication requires reinforced medical monitoring, especially in cases of renal failure, chronic liver disease, alcoholism and respiratory failure.
- This medicine does not treat depression. In the subject presenting a depression, it should not be used alone because it would allow the depression to evolve on its own account with persistence or increase of the suicidal risk.
- Alcohol intake is strictly discouraged during the treatment.
- IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
PREGNANCY & BREAST-FEEDING & FERTILITY
- Numerous data from cohort studies have not demonstrated the occurrence of malformative effects during exposure to benzodiazepines during the 1st 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 is less than 2/1000 after exposure to benzodiazepines during pregnancy, while the expected rate in the general population is 1 / 1,000.
- When taking benzodiazepines in high doses in the 2nd and / or 3rd trimesters of pregnancy, a decrease in active fetal movements and a variability of the fetal heart rate have been described. Treatment at the end of pregnancy with benzodiazepines, even at low doses, may be responsible in the newborn for signs of impregnation such as axial hypotonia, sucking disorders leading to low weight gain. These signs are reversible, but may last 1 to 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. Moreover, a neonatal withdrawal syndrome is possible, even in the absence of signs of impregnation. It is characterized in particular by hyperexcitability, restlessness and tremors of the newborn occurring at a distance from childbirth. The time to onset depends on the elimination half-life of the drug and can be important when this is long.
- In view of these data, as a precaution, the use of bromazepam is not recommended during pregnancy, whatever the term.
- If prescribing bromazepam to a woman of childbearing potential, she should be advised of the need to contact her doctor if pregnancy is planned or started so that he or she can reassess the benefit of the treatment.
- At the end of pregnancy, if it is really necessary to initiate treatment with bromazepam, avoid prescribing high doses and take into account, for monitoring the newborn, the effects described above.
Feeding with milk
- Bromazepam passes into breast milk; therefore the use of this medication during breast-feeding is not recommended.
What happens if I overdose from BROMAZEPAM MYLAN ?
- Benzodiazepines often cause drowsiness, ataxia, dysarthria, nystagmus. Overdose with bromazepam is rarely life threatening if the drug is taken alone, but it can cause signs of mental confusion, lethargy, slurred speech, lack of reflex, apnea, hypotension, hypotonia, cardio-respiratory depression, coma, and exceptionally death. The coma usually lasts only a few hours but it can be more prolonged and cyclical, especially in elderly patients. The respiratory depressant effects of benzodiazepines are more severe in patients with respiratory disease.
- Benzodiazepines increase the effects of other central nervous system depressants, including alcohol. The vital prognosis can be threatened, especially in cases of polyintoxication involving other depressants of the central nervous system (including alcohol).
- Monitor the patient’s vital signs and initiate supportive measures based on the patient’s clinical condition. In particular, patients may need symptomatic treatment of central cardio-respiratory and neurological effects.
- Further absorption of the drug should be avoided by an appropriate method, for example by administering activated charcoal within 1 to 2 hours. The administration of activated charcoal must be accompanied by protection of the airways in drowsy patients. In case of mixed ingestion, gastric lavage may be considered, but not systematically. Particular monitoring of cardio-respiratory functions in a specialized environment is recommended.
- In the event of severe CNS depression, consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under close supervision. Since flumazenil has a short half-life (approximately one hour), patients should be monitored after its effects have worn off. Flumazenil should be used with extreme caution in the presence of drugs that lower the seizure threshold (eg tricyclic antidepressants). See the prescribing information for flumazenil for more information.
What should I do if I miss a dose?
- Take the next dose at the usual time. Do not take a double dose to make up for the dose you forgot to take.
What happens if you stop taking BROMAZEPAM MYLAN ?
- Withdrawal and rebound phenomena (see Special warnings).
- If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse for more information.
What is Forms and Composition ?
WHAT BROMAZEPAM MYLAN 6 MG CONTAINS
The active substance is:
- Bromazepam ………… 6 mg
- For a quadrisisable tablet.
· The other ingredients are:
- Lactose monohydrate, microcrystalline cellulose, talc, magnesium stearate.
WHAT BROMAZEPAM MYLAN LOOKS LIKE AND CONTENTS OF THE OUTER CARTON
- This medication is in the form of a quadrisisable tablet. Box of 30.
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