- HYPNOTICS & SEDATIVES
- PSYCHOTHERAPEUTIC DRUGS
- Pharmaceutical Form : Film coated tablets
- Composition : Zolpidem Tartrat 5 mg / F.C. Tab
- Active Substance : Zolpidem Tartrat
TRANCOMED (zolpidem Tartrate), is a non-benzodiazepine hypnotic of the imidazopyridine class and is
available in 5-mg and 10-mg strength tablets for oral administration.
TRANCOMED (zolpidem Tartrate) is indicated for the short-term treatment of insomnia such as : trouble falling asleep. – waking up too early in the morning . – waking up often during the night .
TRANCOMED has been shown to decrease sleep latency and increase the duration of sleep Hypnotics should generally be limited to 7 to 10 days of use, and reevaluation of the patient is recommended if they are to be taken for more than 2 to 3 weeks.
TRANCOMED should not be prescribed in quantities exceeding a 1-month supply
None known .
SIDE EFFECTS :
* Most commonly observed adverse events are drowsiness , dizziness , difficulty with coordination .
* Body as a whole : asthenia
* Central and peripheral nervous system : ataxia, confusion, insomnia, vertigo
*gastrointestinal system : hiccup
* special senses :diplopia , vision abnormal .
* because some of the important adverse effects of Zolpidem appear to be dose related , it is important to use The smallest possible effective dose , especially in the elderly .
* Generally Memory problems are not common while taking TRANCOMED
PRECAUTIONS : *Since TRANCOMED, like other sedative/hypnotic drugs, has CNS-depressant effects.
It should only be ingested immediately prior to going to bed. and Patients should be cautioned not to work with occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle .*
TRANCOMED should not be taken with alcohol. because of the potentially additive effects when combined with it .
* The recommended dosage in the elderly and/or debilitated patients is 5 mg to decrease the possibility of side effects .
* As with other sedative/hypnotic drugs, TRANCOMED should be administered with caution to patients exhibiting signs or symptoms of depression
* Tolerance may happen when use TRANCOMED for long time , they may lose their effectiveness to help patients to sleep .
* Safety and effectiveness in pediatric patients below the age of 18 have not been established.
* Caution is advisable in using TRANCOMED in patients with diseases that could effect metabolism or hemodynamic responses .
* precaution should be observed if TRANCOMED is prescribed to patients with compromised respiratory function .
PREGNANCY AND NURSING MOTHERS
* The use of TRANCOMED in nursing mothers is not recommended.* it is classified in Pregnancy Category B this drug should be used during pregnancy only if clearly needed.
DRUG INTERACTIONS :
* An additive effect on psychomotor performance between alcohol and zolpidem was demonstrated
* Any drug with CNS-depressant effects could potentially enhance the CNS-depressant effects of zolpidem.
* TRANCOMED had no effect on digoxin kinetic and did not effect prothrombin time when given with Warfarin in normal
* clinical data indicate that zolpidem does not cross-react with benzodiazepines , opiates , barbiturates ,
cocaine , cannabinoids , or amphetamines in two standard urine drug screens
DRUG ABUSE AND DEPENDENCE :* rare reports of abuse , dependence and withdrawal have been received since persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk of habituation and dependence, they should be under careful surveillance when receiving zolpidem or any other hypnotic
OVER DOSAGE:*The Signs and symptoms of overdose with zolpidem alone has ranged from somnolence to light coma
*The Recommended treatment General symptomatic and supportive measures should be used along with immediate gastriclavage where appropriate .
*Intravenous fluids should be administered as needed. As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored
DOSAGE AND ADMINISTRATION
The recommended dose for adults is 10 mg immediately before bedtime. and dosage adjustment may be necessary when TRANCOMED is administered with agents having known CNS-depressant effects because of the potentially additive effects
The total TRANCOMED dose should not exceed 10 mg.
Storage condition :
Store up to 30o C -away from light – out of reach of children .
TRANCOMED 5 : box of 20 film ctd tablet TRANCOMED 10 : box of 20 film ctd tablet