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| Calmepam |
Anxiolytic a Sedative
lb the Medical Ft Pharmaceutical Professions
COMPOSITION
Each tablet contains bromazepam 1.5 or 3 mg.
PHARMPCO KIN ETICS
Bromazepam is absorbed completely through the gastrointestinal tract and its peak plasma concentration is reached within one to tsar hours after oral administration. The plasma- elimination half life ranges from 7.9 to 19.3 hours. It is metabolized in the liver into inactive metabolites which are excreted entirely as glucuronide conjugates of 3-hydroxybromazepam (27%), 3-hydrosyhenzoylpyridine derivative (40%), intact bromazepam (2.3%) and intact benzoylpyridine derivative (0.66%).
Bromazepam is a base in nature and about 70% of it is bound to plasma proteins.
PROPERtIES El ACtIONS
Calmepam is a paridylbenzodiazepine compound which has anxiolytic muscle relaxant, sedative, hypnotic anticonvulsant, and amnestic effects.
INOICATIONS
- Anxiety
Tension state and agitation
- Control of muscle spasm
_________ - Management of alcohol withdrawal symptoms
- Patients undergoing minor surgical procedures endoscopy and curdioversion
- Insomnia due to anniety
Functional disturbances of the cardiovascular system, such as pseudoangina pectoris, precordial anuiety tachycardia and emotiogenic hypertension
Functional disturbances of respiratory system, such as: dyspneu and hyperventilation
- Functional disturbances of the genitourieury tract, such as irritable bludder and urinary frequency
- Functional disturbances of the gastrointestinal tract such as, epigastric pain, irritable bowel syndrome and ulcerative colitis
- Calmepam can be also useful in cases of neurodermutitis and eczema. As well as in the treatment of psychogenic headache and psychosomatic disorders.
ooSat Eu AOMINISTRATION
Malts: The optimum dosage and frequency of administration of Calmepam should be based on the individual patient the severity of symptoms and previous psychotropic drug history The usual dosage in general practice is from 3 mg to 16 mg daily in divided doses.
In exceptional circumstances in hospitalised patients, up to mauimum daily dosage of 60 mg, in divided doses, may be given.
Use in elderly: tlderly patients ore more sensitive to the actions of Calmepam; doses should not exceed half normally recommended.
The lowest dose which can control symptoms should be used. Treatment should not be continued at the fall dose beyond four weeks. Long-term chronic use is not recommended. Treatment should always he tapered off gradually Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses ure reduced. Specialist
helpmaybeyppsprigte.
Children: Culmepam is not for paediatric use.
CONTRA-INOICs,TIONS, tAARNINGS, ETC.
Contra—indications: Patients with known sensitivity to benzodiazepines; acute pulmonary insufficiency; respiratory depression; phobic or obsessional states; chronic psychosis. °USE IN PREGNANCY a LACtATION:
There is no evidence as to drag safety in human pregnancy nor is there evidence from animal work that it is free from hazard.
Oo not use dsring pregnancy especially during the time and last trimesters, unless there use compelling reasons.
The administration of high doses or prolonged administration of low doses of benzodiazepines in the last trimester of pregnancy has been reported to produce irregularities in the foetal heart rate, and hypotonia, poor sucking and hypothermia in the neonate.
Benzodiazepines have been detected in breast milk. If possible, the use of Calmepam should be avoided during lactation.
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