Romelex
Romelex Uses, Dosage, Side Effects, Food Interaction and all others data.
Romelex is a pyridylbenzodiazepine compound with anxiolytic properties. In low dosage, it diminishes anxiety, tension and nervousness. In high dosage, the sedative and muscle-relaxant properties appear.
Romelex is a lipophilic, long-acting benzodiazepine and with sedative, hypnotic, anxiolytic and skeletal muscle relaxant properties. It does not possess any antidepressant qualities. Romelex, like other benzodiazepines, presents a risk of abuse, misuse, and dependence. According to many psychiatric experts, Romelex has a greater abuse potential than other benzodiazepines because of fast resorption and rapid onset of action.
| Trade Name | Romelex |
| Generic | Bromazepam |
| Bromazepam Other Names | Bromacepam, Bromazepam, Bromazepamum |
| Weight | 3mg |
| Type | Tablet |
| Formula | C14H10BrN3O |
| Weight | Average: 316.153 Monoisotopic: 315.000724604 |
| Protein binding | 70% |
| Groups | Approved, Illicit, Investigational |
| Therapeutic Class | Benzodiazepine sedatives |
| Manufacturer | Helicon Pharmaceutek Pakistan (pvt) Ltd, |
| Available Country | Pakistan |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Romelex is used for the following diseases:
* Emotional disturbances: Anxiety and tension states, as adjuvant therapy for anxiety in depressed patients, nervous tension, restlessness, and anxiety- and tension- related insomnia. As an adjuvant to treatment of underlying disease responsible for functional or psychosomatic impairments of various organs caused by anxiety and tension.
* Cardiovascular and respiratory systems: Pseudoangina pectoris, precordial anxiety, tachycardia, emotiogenic hypertension, dyspnea, and hyperventilation.
* Gastrointestinal tract: Irritable bowel syndrome, ulcerative colitis, epigastric pain, spasm, meteorism, and diarrhoea.
* Urogenital tract: Irritable bladder, urinary frequency and dysmenorrhea.
* Other psychosomatic disturbances: Psychogenic headache, psychogenic dermatoses.
Romelex is suitable for treatment of anxiety and tension states due to chronic organic disease and as an adjuvant to psychotherapy in psychoneurosis.
Romelex is also used to associated treatment for these conditions: Acute Anxiety, Severe Anxiety
How Romelex works
Romelex binds to the GABA-A receptor producing a conformational change and potentiating its inhibitory effects. Other neurotransmitters are not influenced.
Dosage
Romelex dosage
Adults: The optimum dosage and frequency of administration of Romelex is based on the individual patient, the severity of symptoms and previous psychotropic drug history.
Average dose for outpatient therapy: 1.5 - 3 mg 3 times daily.
Severe cases, especially in hospitals: 6 - 12 mg 2 - 3 times daily.
Treatment of outpatients should begin with low doses, gradually increasing to the optimum level. In general, the total duration of treatment should not exceed 8-12 weeks including a tapering-off period. In certain cases, treatment may need to be continued beyond the maximum recommended duration but only after a careful reassessment of the patient's condition and indications.
Elderly patients: Doses should not exceed half those normally recommended.
Children: Romelex is not for paediatric use.
Romelex tablets are for oral administration
Side Effects
Common side effects include drowsiness, sedation, unsteadiness and ataxia. These are dose-related and may persist into the following day, even after a single dose. Other side effects are rare and include headache, vertigo, hypotension, gastrointestinal upsets, skin rashes, visual disturbances and urinary retention.
Precaution
In patients with chronic pulmonary insufficiency, and in patients with chronic renal or hepatic disease, dosage may need to be reduced.
Romelex should not be used alone to treat depression or anxiety associated with depression.
Romelex should be used with extreme caution in patients with a history of alcohol or drug abuse.
Interaction
Phenothiazines, barbiturates, MAO inhibitors and psychoactive drugs may potentiate the action of Romelex and should not be given concurrently.
Food Interaction
- Avoid alcohol. Ingesting alcohol may increase the sedative and CNS depressant effects of bromazepam.
- Take with or without food. Taking bromazepam with food may reduce its Cmax and AUC.
Volume of Distribution
1.56 L/kg
Elimination Route
Bioavailability is 84% following oral administration. The time to peak plasma level is 1 - 4 hours. Romelex is generally well absorbed after oral administration.
Half Life
10-20 hours
Clearance
0.82 mL/min/kg.
Elimination Route
Urine (69%), as metabolites
Pregnancy & Breastfeeding use
Pregnancy: The safety of Romelex in pregnant women has not been established. Romelex should not be used during pregnancy, especially during the first and last trimesters, unless there are compelling reasons.
Lactation: Benzodiazepines have been detected in breast milk. If possible, the use of Romelex should be avoided during lactation.
Contraindication
Patients with known hypersensitivity to benzodiazepines; acute pulmonary insufciency; respiratory depression phobic or obsessional states; chronic psychosis.
Acute Overdose
Manifestations of overdosage include somnolence, confusion, and respiratory and cardiovascular depression with coma in severe cases.
Interaction with other Medicine
If Romelex is combined with other centrally acting drugs, such as neuroleptics, tranquilizers, antidepressants, hypnotics, narcotic analgesics and anaesthetics, its CNS sedation effect may be increased.
Storage Condition
Store in a cool dry place protected from light. Keep out of reach of children.
Innovators Monograph
You find simplified version here Romelex
FAQ
What is Romelex used for?
Romelex is mainly an anti-anxiety agent with similar side effects to Romelex. In addition to being used to treat anxiety or panic states, bromazepam may be used as a premedicant prior to minor surgery.
How safe is Romelex?
If not taken in accordance with a doctor's instructions, Romelex can cause serious physical harm and even lead to a fatal overdose, whilst using it for any length of time also exposes you to the risk of addiction.
What are the common side effects of Romelex?
Romelex is similar in side effects to other benzodiazepines. The most common side effects reported are drowsiness, sedation, ataxia, memory impairment, and dizziness.
How does Romelex work?
Romelex works to reduce anxiety by affecting certain substances in the brain called neurotransmitters.
Is Romelex safe in pregnancy?
If Romelex treatment is necessary during the last part of pregnancy, high doses should be avoided and withdrawal symptoms and/or floppy infant syndrome should be monitored in newborn.
Is Romelex safe in breastfeeding?
Romelex may be excreted into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Can I drink with Romelex?
People taking this medication should not consume alcohol since doing so can reduce the effectiveness of this medication and increase the risk of side effects.
Can I drive after taking Romelex?
Do not drive or operate machinery until you know how Romelex affects you. Romelex may cause drowsiness or dizziness in some people and therefore may affect alertness.
How much Romelex can I take daily?
Generally, the maximum adult dose of Romelex is 30 mg daily in divided doses. The usual dose is between 6 to 12 mg daily.
How long does it take for Romelex to take effect?
The time to peak plasma level is 1 - 4 hours. Romelex is generally well absorbed after oral administration.
How long do Romelex effects last?
Romelex have intermediate durations of action and may be detectable in the system for five days.
How much Romelex should I take to sleep?
Romelex was administered in a single dose of 1.5 mg one-half hour before bedtime to study its short-term action and the effect of its discontinuation on the sleep of 6 children suffering from night terrors.
How long should I take Romelex?
Romelex should be taken for short periods only (for example 2 to 4 weeks), unless advised otherwise by your doctor.
Who should not take Romelex?
Romelex is not recommended for use by children or adolescents under 18 years of age. Seniors: Seniors may be at increased risk of experiencing the sedative and impaired coordination effects of Romelex. They need to exercise extra caution, for example, to avoid falling when getting up during the night.
Can Romelex cause depression?
Depression: Romelex, like other benzodiazepines, has been known to cause mood swings and symptoms of depression.
Can Romelex cause high blood pressure?
In mild hypertensive patients, evening consumption of Romelex for a 2-week period did not affect BP, while it increased nocturnal HR.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention. An overdose of clonazepam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing. Overdose symptoms may include extreme drowsiness, confusion, muscle weakness, or coma.
Are Romelex bad for my kidneys?
Mixed with prescription muscle relaxers, Romelex can also damage liver and kidney function.
Can Romelex affects my liver?
During the chronic administration, the liver weight increased 30-40%, with concomitant enlargement of the liver.
Do Romelex affect fertility?
Romelex can affect fertility in a variety of ways.
