Bromazepam is a benzodiazepine medication used to treat anxiety disorders, insomnia, and panic disorders. Like other benzodiazepines, it works by enhancing the effects of a neurotransmitter called gamma-aminobutyric acid (GABA) in the brain, which helps to calm the central nervous system. Bromazepam is known for its anxiolytic (anxiety-reducing), sedative, and muscle relaxant properties. It's typically prescribed for short-term use due to the risk of tolerance, dependence, and withdrawal symptoms with prolonged use.
Bromazepam inhibits neuronal excitability by increasing the permeability of chloride ions via binding to GABA receptors.
It is used in the short-term treatment of severe and symptomatic anxiety.
Bromazepam Dose in Adults
Bromazepam Dose in the treatment of Anxiety:
- When starting treatment, the usual dose is between 6 to 18 milligrams each day, split into smaller doses throughout the day. It's important not to continue this initial treatment for more than a week without checking with your doctor to see if you need to keep taking it.
- The right amount of bromazepam for you can range from 6 to 30 milligrams each day, but there's not much experience with doses higher than 60 milligrams a day.
- For people who are not feeling well or are weak, the starting dose is usually lower: 3 milligrams each day, divided into smaller doses. Your doctor might adjust this dose carefully based on how you respond and how well you tolerate the medication.
Bromazepam Dose in Children
- Not recommended.
Pregnancy Risk Factor: C
- Taking benzodiazepines like bromazepam during pregnancy can be risky for the baby.
- Studies on animals have shown that they can cause problems in fetal development.
- During the first trimester, there's a higher chance of birth defects like heart problems or cleft lip/palate if the mother takes these medications.
- Even later in pregnancy, using benzodiazepines can lead to issues in the baby like an irregular heartbeat and in the newborn like feeling cold, weak muscles, breathing problems, trouble eating, or withdrawal symptoms.
Bromazepam uses during breastfeeding:
- Bromazepam and its byproducts are likely to be present in breast milk, so it's generally not advised to use it while breastfeeding, according to the manufacturer's recommendation.
- There have been reports of babies becoming drowsy, less active, or losing weight when their mothers used certain benzodiazepines, as noted in studies like the one by Iqbal in 2002.
Bromazepam Dose in Renal Disease:
- The manufacturer's instructions don't specify any changes in dosage for people with kidney problems.
- However, it's recommended to start treatment cautiously and adjust the dosage carefully in these cases.
Bromazepam dose in Liver disease:
- For individuals with mild to moderate liver problems, the manufacturer's instructions don't suggest any changes in dosage. However, it's advisable to begin treatment cautiously and adjust the dosage carefully in these situations.
- On the other hand, if someone has severe liver impairment, using bromazepam is not recommended at all.
Frequency not defined:
- Central nervous system:
- Ataxia
- Dizziness
- Drowsiness
- Drug abuse
Contraindications to Bromazepam include:
- If someone is allergic to bromazepam, other benzodiazepines, or any part of the medication, or if they have myasthenia gravis (a muscle weakness disorder), narrow-angle glaucoma (an eye condition), severe liver problems, serious breathing issues, or sleep apnea, they shouldn't take bromazepam.
Warnings and Precautions
Anterograde amnesia:
- Taking benzodiazepines like bromazepam can sometimes lead to a type of memory loss called anterograde amnesia.
CNS depression:
- Bromazepam can cause central nervous system (CNS) depression, which might make it harder to think clearly or move normally.
- This effect could be stronger if someone takes it with other medications that also affect the CNS, like certain antidepressants, or if they drink alcohol.
- People taking bromazepam should be careful when doing activities that need mental alertness, such as driving or operating machinery, and they should be warned about these risks.
Paradoxical reactions
- Some people might have unexpected reactions to benzodiazepines like bromazepam, such as acting more active or aggressive than usual.
- These reactions, known as paradoxical reactions, have been seen in various studies, including one by Mancuso in 2004.
- The risk of these reactions might be higher in teenagers, older adults, or people with a history of alcohol problems, psychiatric conditions, or certain personality disorders.
Activities that are sleep-related:
- Benzodiazepines like bromazepam have been linked to dangerous behaviors during sleep, such as sleep-driving, cooking and eating food, and making phone calls while still asleep.
- Studies, including one by Dolder in 2008, have observed these activities in people taking benzodiazepines.
Depression
- It's not advised to use bromazepam in individuals who have depression or psychosis.
Use of drugs:
- Bromazepam should be used carefully in patients who have a history of drug abuse or are currently struggling with acute alcoholism.
- There's a risk of becoming dependent on the medication, both psychologically and physically, especially with long-term use.
- Tolerance to the drug's effects can also develop over time.
Hepatic impairment
- Bromazepam should be used cautiously in patients with mild or moderate liver problems, as they may need a dose adjustment.
- However, it's not recommended for individuals with severe liver impairment.
Renal impairment
- If someone has kidney problems, they should use bromazepam cautiously, as they might need a dose adjustment.
Respiratory disease:
- Bromazepam can potentially slow down breathing, so it should be used cautiously in people with existing or chronic respiratory problems.
- It's especially important to be careful if using it alongside other medications that also affect breathing.
- If someone has severe respiratory disease, they shouldn't use bromazepam at all.
Bromazepam (United States: Not available): Drug Interaction
|
Risk Factor C (Monitor therapy) |
|
|
Abiraterone Acetate |
May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). |
|
Alcohol (Ethyl) |
CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). |
|
Alizapride |
May enhance the CNS depressant effect of CNS Depressants. |
|
Brexanolone |
CNS Depressants may enhance the CNS depressant effect of Brexanolone. |
|
Brimonidine (Topical) |
May enhance the CNS depressant effect of CNS Depressants. |
|
Bromopride |
May enhance the CNS depressant effect of CNS Depressants. |
|
Cannabidiol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Cannabis |
May enhance the CNS depressant effect of CNS Depressants. |
|
Chlorphenesin Carbamate |
May enhance the adverse/toxic effect of CNS Depressants. |
|
CNS Depressants |
May enhance the adverse/toxic effect of other CNS Depressants. |
|
CYP1A2 Inhibitors (Moderate) |
May decrease the metabolism of CYP1A2 Substrates (High risk with Inhibitors). |
|
Deferasirox |
May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). |
|
Dimethindene (Topical) |
May enhance the CNS depressant effect of CNS Depressants. |
|
Doxylamine |
May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. |
|
Dronabinol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Esketamine |
May enhance the CNS depressant effect of CNS Depressants. |
|
Fosphenytoin |
Benzodiazepines may increase the serum concentration of Fosphenytoin. Shortterm exposure to benzodiazepines may not present as much risk as chronic therapy. |
|
HydrOXYzine |
May enhance the CNS depressant effect of CNS Depressants. |
|
Kava Kava |
May enhance the adverse/toxic effect of CNS Depressants. |
|
Lofexidine |
May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. |
|
Magnesium Sulfate |
May enhance the CNS depressant effect of CNS Depressants. |
|
Melatonin |
May enhance the sedative effect of Benzodiazepines. |
|
MetyroSINE |
CNS Depressants may enhance the sedative effect of MetyroSINE. |
|
Minocycline |
May enhance the CNS depressant effect of CNS Depressants. |
|
Mirtazapine |
CNS Depressants may enhance the CNS depressant effect of Mirtazapine. |
|
Nabilone |
May enhance the CNS depressant effect of CNS Depressants. |
|
Obeticholic Acid |
May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). |
|
Peginterferon Alfa-2b |
May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). |
|
Phenytoin |
Benzodiazepines may increase the serum concentration of Phenytoin. Short-term exposure to benzodiazepines may not present as much risk as chronic therapy. |
|
Piribedil |
CNS Depressants may enhance the CNS depressant effect of Piribedil. |
|
Pramipexole |
CNS Depressants may enhance the sedative effect of Pramipexole. |
|
ROPINIRole |
CNS Depressants may enhance the sedative effect of ROPINIRole. |
|
Rotigotine |
CNS Depressants may enhance the sedative effect of Rotigotine. |
|
Rufinamide |
May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. |
|
Selective Serotonin Reuptake Inhibitors |
CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. |
|
Teduglutide |
May increase the serum concentration of Benzodiazepines. |
|
Tetrahydrocannabinol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Tetrahydrocannabinol and Cannabidiol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Trimeprazine |
May enhance the CNS depressant effect of CNS Depressants. |
|
Yohimbine |
May diminish the therapeutic effect of Antianxiety Agents. |
|
Risk Factor D (Consider therapy modification) |
|
|
Blonanserin |
CNS Depressants may enhance the CNS depressant effect of Blonanserin. |
|
Buprenorphine |
CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. |
|
Chlormethiazole |
May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. |
|
Cimetidine |
May increase the serum concentration of Bromazepam. Management: Consider use of bromazepam with an H2-antagonist that is not a potent CYP inhibitor (e.g., ranitidine) or alternatively, consider use of cimetidine with a benzodiazepine that does not undergo oxidative metabolism (e.g., lorazepam). |
|
CloZAPine |
Benzodiazepines may enhance the adverse/toxic effect of CloZAPine. Management: Consider decreasing the dose of (or possibly discontinuing) benzodiazepines prior to initiating clozapine. |
|
Droperidol |
May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. |
|
Flunitrazepam |
CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. |
|
FluvoxaMINE |
May increase the serum concentration of Bromazepam. Management: With concomitant fluvoxamine, consider use of a benzodiazepine that does not undergo oxidative metabolism (e.g., lorazepam). If bromazepam is initiated in patients receiving fluvoxamine, monitor closely for increased bromazepam levels/adverse effects. |
|
HYDROcodone |
CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
Methadone |
Benzodiazepines may enhance the CNS depressant effect of Methadone. Management: Clinicians should generally avoid concurrent use of methadone and benzodiazepines when possible; any combined use should be undertaken with extra caution. |
|
Methotrimeprazine |
CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. |
|
Opioid Agonists |
CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
OxyCODONE |
CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
Perampanel |
May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. |
|
Suvorexant |
CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. |
|
Tapentadol |
May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
Theophylline Derivatives |
May diminish the therapeutic effect of Benzodiazepines. |
|
Vemurafenib |
May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). Management: Consider alternatives to such combinations whenever possible, particularly if the CYP1A2 substrate has a relatively narrow therapeutic index. Drugs listed as exceptions to this monograph are discussed in separate drug interaction monographs. |
|
Zolpidem |
CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. |
|
Risk Factor X (Avoid combination) |
|
|
Azelastine (Nasal) |
CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). |
|
Bromperidol |
May enhance the CNS depressant effect of CNS Depressants. |
|
OLANZapine |
May enhance the adverse/toxic effect of Benzodiazepines. Management: Avoid concomitant use of parenteral benzodiazepines and IM olanzapine due to risks of additive adverse events (e.g., cardiorespiratory depression). Olanzapine prescribing information provides no specific recommendations regarding oral administration. |
|
Orphenadrine |
CNS Depressants may enhance the CNS depressant effect of Orphenadrine. |
|
Oxomemazine |
May enhance the CNS depressant effect of CNS Depressants. |
|
Paraldehyde |
CNS Depressants may enhance the CNS depressant effect of Paraldehyde. |
|
Sodium Oxybate |
Benzodiazepines may enhance the CNS depressant effect of Sodium Oxybate. |
|
Thalidomide |
CNS Depressants may enhance the CNS depressant effect of Thalidomide. |
Monitor:
Respiratory, Cardiovascular, and Mental Status:
- Be cautious if you have breathing problems, heart issues, or mental health conditions.
- Pay attention to your breathing, heart rate, and how you feel mentally.
- Let your doctor know if you notice any changes in your breathing, heart rhythm, or mental state.
Periodic CBC and Liver Function Tests:
- Your doctor might suggest getting regular blood tests to check your blood count (CBC) and liver function.
- These tests help monitor how your body is responding to the medication over time.
- It's important to keep up with these tests as recommended by your doctor.
How to take Bromazepam?
- You can take bromazepam with or without food.
Mechanism of action of Bromazepam:
- Benzodiazepines like bromazepam attach to specific receptors on nerve cells in the brain, particularly in areas like the limbic system and reticular formation.
- When they bind to these receptors, they enhance the effects of a neurotransmitter called gamma-aminobutyric acid (GABA).
- This enhancement makes it easier for chloride ions to pass through the cell membrane, leading to a decrease in the excitability of the nerve cell.
- As a result, the brain becomes less responsive to stimulation, leading to feelings of calmness and relaxation.
- These receptors and effects are mainly linked to a subtype of GABA receptors called GABA-A receptors, rather than GABA-B receptors.
Absorption:
- Taking bromazepam with food can significantly reduce how much of it your body absorbs.
- However, it doesn't seem to affect how long it takes to reach its highest level in the blood or how long it stays in your body.
Distribution:
- The volume of distribution, which tells us how widely the drug is distributed in the body, is about 50 liters.
- About 70% of bromazepam in the blood is attached to proteins.
Metabolism:
- The liver breaks down bromazepam through processes called hydroxylation and glucuronidation.
Bioavailability:
- When you take bromazepam by mouth, about 60% of it reaches your bloodstream and has an effect.
Half-life elimination:
- Bromazepam stays in your body for about 20 hours on average.
- This time might be longer in older adults.
Time to peak, serum:
- It typically takes less than 2 hours for bromazepam to reach its highest level in the blood.
Excretion:
- Most of the bromazepam and its byproducts leave the body through urine, with about 69% being excreted this way.
Bromazepam International Brands:
- APO-Bromazepam
- Lectopam [DSC]
- MED Bromazepam
- TEVA-Bromazepam
- Akamon
- Anxyl
- Anxyrex
- Benedorm
- Brazepam
- Bromatop
- Bromazanil
- Bromaze
- Bromazepam-Eurogenerics
- Bromazin
- Bromidem
- Brominter
- Bropam
- Calmepam
- Durazanil
- Gityl
- Lekotam
- Lexatin
- Lexaurin
- Lexavrin
- Lexilium
- Lexopam
- Lexostad
- Lexotan
- Lexotanil
- Lexotanol
- Lexzepam
- Nervan
- Octanyl
- Otedram
- Quietiline
- Rem
- Sedamax
- Seniran
- Somalium
- Tenil
- Totasedan
- Tredum
- Zepam
Bromazepam brands in Pakistan:
|
Bromazepam [Tabs 3 Mg] |
|
|
Amaze |
Bryon Pharmaceuticals (Pvt) Ltd. |
|
Amzee |
Bloom Pharmaceuticals (Pvt) Ltd. |
|
Anxit |
Atco Laboratories Limited |
|
Anxolite |
Epla Laboratories (Pvt) Ltd. |
|
Anxoten |
Shafaz Pharma International (Pvt) Ltd. |
|
Anzonil |
Global Pharmaceuticals |
|
Brexotanil |
Dosaco Laboratories |
|
Brexxel |
High - Q International |
|
Brodan |
Danas Pharmaceuticals (Pvt) Ltd |
|
Brolite |
Standpharm Pakistan (Pvt) Ltd. |
|
Broma |
Pharmacare Laboratories (Pvt) Ltd. |
|
Bromalex |
Indus Pharma (Pvt) Ltd. |
|
Bromazemed |
Medifine Laboratories |
|
Bromazepam |
Shifa Laboratories.(Pvt) Ltd. |
|
Bromed |
Medicraft Pharmaceuticals (Pvt) Ltd. |
|
Bromota |
Orta Labs. (Pvt) Ltd. |
|
Bromotop |
Xenon Pharmaceuticals (Pvt) Ltd. |
|
Bropam |
Gray`S Pharmaceuticals |
|
Broz |
Universal Pharmaceuticals (Pvt) Ltd |
|
Brozam |
Bio Labs (Pvt) Ltd. |
|
Brozap |
Valor Pharmaceuticals |
|
Brozinil |
Umersons |
|
Brozit |
Star Laboratories (Pvt) Ltd. |
|
Calmease |
Wilsons Pharmaceuticals |
|
Cope |
Dr. Raza Pharma (Private) Limited |
|
Durazanil |
Tabros Pharma |
|
E-Ze |
Genix Pharma (Pvt) Ltd |
|
Exelza |
Z-Jans Pharmaceutical (Pvt) Ltd. |
|
Exonil |
Aries Pharmaceuticals (Pvt) Ltd |
|
Freedom |
Libra Pharmaceuticals (Pvt) Ltd |
|
Laxil |
Panacea Pharmaceuticals |
|
Leadopam |
Leads Pharma (Pvt) Ltd |
|
Lexapam |
Sharex Laboratories (Pvt.) Ltd. |
|
Lexilium |
Sami Pharmaceuticals (Pvt) Ltd. |
|
Lexotanil |
Roche Pakistan Ltd. |
|
Lorival |
Chas. A. Mendoza |
|
Mazimax |
Nova Med Pharmaceuticals |
|
Moodi |
Saydon Pharmaceutical Industries (Pvt) Ltd. |
|
Niquil |
Himont Pharmaceuticals (Pvt) Ltd. |
|
Pazam |
Global Pharmaceuticals |
|
Rekotnil |
Reko Pharmacal (Pvt) Ltd. |
|
Relaxin |
Macter International (Pvt) Ltd. |
|
Relaxital |
Nabiqasim Industries (Pvt) Ltd. |
|
Romaiz |
Lowitt Pharmaceuticals (Pvt) Ltd |
|
Romelex |
Helicon Pharmaceutek Pakistan (Pvt) Ltd. |
|
Sakoon |
Cirin Pharmaceuticals (Pvt) Ltd. |
|
Sedonil |
Adamjee Pharmaceuticals (Pvt) Ltd. |
|
Sonaril |
Rakaposhi Pharmaceutical (Pvt) Ltd. |
|
Tensium |
Werrick Pharmaceuticals |
|
Tojina |
Agp (Private) Ltd. |
|
Tranconil |
Geofman Pharmaceuticals |
|
Utanil |
Unexo Labs (Pvt) Ltd. |
|
Xytinil |
Platinum Pharmaceuticals (Pvt.) Ltd. |
|
Bromazepam [Tabs 6 Mg] |
|
|
Brodan |
Danas Pharmaceuticals (Pvt) Ltd |
|
Broma |
Pharmacare Laboratories (Pvt) Ltd. |
|
Broz |
Universal Pharmaceuticals (Pvt) Ltd |
|
Calmease |
Wilsons Pharmaceuticals |
|
E-Ze |
Genix Pharma (Pvt) Ltd |
|
Laxil |
Panacea Pharmaceuticals |
|
Lexotanil |
Roche Pakistan Ltd. |
|
Mazimax |
Nova Med Pharmaceuticals |
|
Bromazepam [Tabs 1.5 Mg] |
|
|
Brodan |
Danas Pharmaceuticals (Pvt) Ltd |
|
Sedonil |
Adamjee Pharmaceuticals (Pvt) Ltd. |
|
Yazd |
Wilshire Laboratories (Pvt) Ltd. |
