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Anxopam
Bromazepam
Anxopam

Anxopam® tablet: Each tablet contains 3 mg Bromazepam BP.

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Pharmacology/Description

Bromazepam is a powerful psychotropic agent. In low dosage, it selectively reduces tension and anxiety. In high dosage, sedative and muscle-relaxing properties appear.

Indication

Emotional Disturbances: Acute tension and anxiety states, difficulties in interpersonal contact, agitation, insomnia, anxious and agitated depressive reactions. Functional disturbances in the cardiovascular and respiratory systems: Pseudoangina pectoris, precordial anxiety, tachycardia, emotiogenic hypertension, dyspnea and hyperventilation. In the gastrointestinal system: Irritable bowel syndrome, epigastric pain, spasm, bloating diarrhea etc. In the genitourinary system: Frequency, irritable bladder and dysmenorrhea. Psychosomatic disorder: Psychogenic headache, psychogenic dermatosis, asthma, gastric and duodenal ulcer and ulcerative colitis. Emotional reactions to chronic organic disease. Adjuvant to psychotherapy in psychoneurosis.

Dosage And Administration

Standard dosage: Average dosing for outpatient therapy: 1.5-3 mg up to three times daily. Severe cases, especially in hospital: 6-12 mg two to three times daily. These amounts are general recommendations and dosage should be individually determined. Treatment of outpatients should begin with low doses, gradually increasing to the optimum level. The duration of treatment should be as short as possible. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially if the patient is symptom free. The overall treatment generally should not be more than 8-12 weeks, including a tapering-off process. In certain cases, extension beyond the maximum treatment period may be necessary, if so, it should not take place without re-evaluation of the patient\'s status with special expertise. Special dosage instructions: Bromazepam is usually not indicated in children, but if the physician feels Bromazepam treatment is appropriate, then the dose should be adjusted to their low bodyweight (about 0.1-0.3 mg/kg bodyweight). Elderly patients and those with impaired hepatic function require lower doses because of individual variations in sensitivity and pharmacokinetics.

Side Effects

Bromazepam side effects are usually temporary and fade with continued treatment. Higher dosage also increases the risk of side effects. Common side effects: Drowsiness, fatigue, light-headedness, rebound insomnia (on stopping treatment), slurred speech. Less common side effects: Abdominal cramps, anxiety, constipation, dry mouth, hyperventilation, blurred vision, nausea, chest pain, change in sex drive, confusion, depression, headache, change in appetite, insomnia, unusual dreams, change in salivation, low blood pressure, racing heartbeat, fainting, nasal congestion, sweating, weight change, skin irritation, twitching or tremors, nervous or anxious state, sun sensitivity, respiratory infection, memory impairment, menstrual difficulties, and loss of coordination.

Contraindications

Bromazepam must not be administered to patients with known hypersensitivity to Benzodiazepines, severe respiratory insufficiency, severe hepatic insufficiency (Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency as they may cause encephalopathy) or sleep apnea syndrome.

Drug Interactions

As with all psychoactive substances, the effect of Bromazepam may intensified by alcohol. Concomitant intake with alcohol should be avoided. If Bromazepam is combined with other centrally active drugs, its central-sedative effect may be enhanced. These drugs may include antidepressants, hypnotics, narcotic analgesics, antipsychotics, anxiolytics/sedatives, antiepileptic drugs, sedative antihistamines and anesthetics. In the case of narcotic analgesics, enhancement of euphoria may also occur, leading to an increase in psychological dependence. Co-administration of Cimetidine may prolong the elimination half life of Bromazepam.

Precautions

Dependence: The use of Benzodiazepines and Benzodiazepine-like agents may lead to the development of physical and psychological dependence upon these products. The risk of dependence increases with dose and duration of treatment. Withdrawal: Once physical dependence has developed, termination of treatment will be accompanied by withdrawal symptoms. These may consists of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures. Amnesia: Anterograde amnesia may occur using higher therapeutic dosages (documented at 6 mg) the risk increasing at higher dosages. Specific patient groups: In patients with myasthenia gravis who are prescribed Bromazepam, care should be taken on account of pre-existing muscle weakness. Particular care is required in patients with chronic respiratory insufficiency due to the risk of respiratory depression. Effects on ability to drive or to use machines: Sedation, amnesia and impaired muscular function may adversely affect the ability to drive or to use machinery. This effect is increased if patient has taken alcohol. Pregnancy and nursing mothers: The safety of Bromazepam for use in human pregnancy has not been established. As Benzodiazepines pass into breast milk, nursing mothers should not take Bromazepam.

Over Dosage

As with other Benzodiazepines, intentional or accidental overdosage of Bromazepam alone is seldom life-threatening unless combined with other CNS depressants (including alcohol). Overdose of Benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. Following overdose with oral Benzodiazepines, vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken with the airway protected if the patient is unconscious. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce the absorption. Special attention should be paid to respiratory and cardiac function in intensive care.

Pharmaceutical Precautions

Store in a cool dry place protected from light. Keep out of reach of children.

Commercial Pack

Anxopam® tablet: Each box contains 3X10 tablets in blister pack.