Zolpidem tartrate tablets mylan

By | 01.08.2018

zolpidem tartrate tablets mylan

Zolpidem belongs to a class of drugs called sedatives. Due to the possibility of intentional overdose by the patient, the lowest amount of the drug that is feasible should be supplied to these patients. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Paediatric population Safety and effectiveness of zolpidem in paediatric patients under the age of 18 years have not been established. Not responsible for any price changes that has occurred. Caution should be exercised when zolpidem tartrate tablets are administered to a nursing woman. These results suggest that, for faster sleep onset, zolpidem tartrate tablets should not be administered with or immediately after a meal. New report reveals dangerous side effects of Ambien

Was very: Zolpidem tartrate tablets mylan

ZOLPIDEM TARTRATE COST 5MG ADDERALL 964
Zolpidem tartrate tablets mylan Tolerance Some loss of efficacy to the hypnotic mlyan of short-acting benzodiazepines and benzodiazapine-like agents may develop after repeated mylan for zolpidem few weeks. The risk of tablets increases with dose and duration tablwts treatment and is also greater in patients with a history of alcohol or drug abuse. Tartrate zolpidem should not be used during pregnancy especially in the first trimester. Central and Peripheral Nervous System: Zolpidem tartrate was evaluated in healthy volunteers tablets single-dose interaction studies for several CNS drugs. A routine dosage adjustment mylan zolpidem is not considered necessary, but patients, tartrate be advised that zolpidem of zolpidem with ketoconazole may enhance the sedative effects.
Zolpidem tartrate tablets mylan 113
ZOLPIDEM ER 12 5MG COUPONS WIPES OUT CROSSWORD Zolpidem dosage strengths vyvanse and alcohol

Safety and effectiveness of zolpidem in paediatric patients under the age of 18 years have not been established. Therefore, children and adolescents under 18 years of age should not be treated with Zolpidem. The available evidence from placebo-controlled clinical trials is presented in section 5. The cause of insomnia should be identified wherever possible.

The underlying factors should be treated before a hypnotic is prescribed. The failure of insomnia to remit after a day course of treatment may indicate the presence of a primary psychiatric or physical disorder, which should be evaluated. General information relating to effects seen following administration of benzodiazepines or other hypnotic agents which should be taken into account by the prescribing physician are described below.

Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazapine-like agents may develop after repeated use for a few weeks. Use of benzodiazepines or benzodiazapine-like agents may lead to the development of physical and psychological dependence of these products. The risk of dependence increases with dose and duration of treatment and is also greater in patients with a history of alcohol or drug abuse.

These patients should be under careful surveillance when receiving hypnotics. Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches or muscle pain, extreme anxiety and tension, restlessness, confusion, irritability and insomnia.

In severe cases the following symptoms may occur: A transient syndrome whereby the symptoms that led to treatment with a benzodiazepines or benzodiazepine like agent recur in an enhanced form, may occur on withdrawal of hypnotic agent. It may be accompanied by other reactions including mood changes, anxiety and restlessness. It is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms if they occur when the medicinal product is being discontinued.

There are indications that, in the case of benzodiazepines and benzodiazepine-like agents with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high. The duration of treatment should be as short as possible see section 4. Extension beyond these periods should not take place without re-evaluation of the situation.

It may be useful to inform the patient when treatment is started that it will be of limited duration. Benzodiazepines or benzodiazapine-like agents may induce anterograde amnesia. The condition usually occurs several hours after ingesting the product. In order to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 8 hours see section 4. When using benzodiazepines or benzodiazepine-like agents, reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, somnambulism and other nightly unconscious behaviours, like eating and car driving, inappropriate behaviour, increased insomnia and other adverse behavioural effects are known to occur.

Should this occur, use of the product should be discontinued. These reactions are more likely to occur in the elderly. The use of alcohol and other CNS-depressants with zolpidem appears to increase the risk of such behaviours, as does the use of zolpidem at doses exceeding the maximum recommended dose. Discontinuation of zolpidem should be strongly considered for patients who report such behaviours see section 4. Because of its pharmacological properties, zolpidem can cause drowsiness and reduced levels of awareness, which can lead to falls and thereby serious injury.

The risk of next-day psychomotor impairment, including impaired driving ability, is increased if:. Zolpidem should be taken in a single intake immediately at bedtime and not be re-administered during the same night. Elderly or debilitated patients should receive a lower dose: Due to the myorelaxant effect there is a risk of falls and consequent injury particularly for elderly patients when they get up at night.

Although dose adjustment is not necessary, caution should be exercised in patients with renal insufficiency see section 5. Caution should be observed when prescribing zolpidem to patients with chronic respiratory insufficiency since benzodiazepines have been shown to impair respiratory drive. It should also be taken into consideration that anxiety or agitation have been described as signs of deterioration of respiratory insufficiency.

Benzodiazepines and benzodiazapine-like agents are not indicated for the treatment of patients with severe hepatic insufficiency as they may precipitate encephalopathy. Use in patients with psychotic illness: Benzodiazepine and benzodiazepine-like agents should not be used alone to treat depression or anxiety associated with depression suicide may be precipitated in such patients. Zolpidem should be administered with caution in patients exhibiting symptoms of depression.

Suicidal tendencies may be present. Due to the possibility of intentional overdose by the patient, the lowest amount of the drug that is feasible should be supplied to these patients. Pre-existing depression may be unmasked during use of zolpidem. Since insomnia may be a symptom of depression, the patient should be re-evaluated if insomnia persists.

Use in patients with a history of drug or alcohol abuse: These patients should be under careful surveillance when receiving zolpidem since they are at risk of habituation and psychological dependence. Since this product contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Zolpidem should not be taken in combination with alcohol.

The sedative effect may be enhanced when the product is used in combination with alcohol. This affects the ability to drive or use machines. Therefore, concomitant use of zolpidem with these drugs may increase drowsiness and next-day psychomotor impairment, including impaired driving ability see section 4. Also, isolated cases of visual hallucinations were reported in patients taking zolpidem with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine.

In the case of narcotic analgesics enhancement of euphoria may also occur leading to an increase in psychological dependence. Zolpidem tartrate appears to interact with sertraline. This interaction may cause increased drowsiness. Also, isolated cases of visual hallucinations were reported. Zolpidem is metabolised by some enzymes of the cytochrome Pfamily.

Since CYP3A4 plays an important role in zolpidem tartrate metabolism, possible interactions with drugs that are substrates or inducers of CYP3A4 should be considered. Co-administration of ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended. Co-administration of fluvoxamine may increase blood levels of zolpidem, concurrent use is not recommended. Similar effects might be expected also with other strong inducers of cytochrome Penzymes.

However when zolpidem tartrate was administered with itraconazole a CYP3A4 inhibitor its pharmacokinetics and pharmacodynamics were not significantly modified. The clinical relevance of these results is unknown. Co-administration of zolpidem with ketoconazole mg twice daily , a potent CYP3A4 inhibitor, prolonged zolpidem elimination half-life, increased total AUC, and decreased apparent oral clearance when compared to zolpidem plus placebo. The total AUC for zolpidem, when co-administered with ketoconazole, increased by a factor of 1.

A routine dosage adjustment of zolpidem is not considered necessary, but patients, should be advised that use of zolpidem with ketoconazole may enhance the sedative effects. No clinical significant pharmacokinetic interactions have been shown with selective serotonin reuptake inhibitors fluoxetine and sertraline. When zolpidem tartrate was administered with ranitidine, no significant pharmacokinetic interactions were observed.

Although animal studies have shown no teratogenic or embryotoxic effects, safety in pregnancy has not been established in humans. Therefore zolpidem should not be used during pregnancy especially in the first trimester. If zolpidem is prescribed to a woman of childbearing potential, she should be encouraged to contact her physician regarding discontinuance of the product if she intends to become or suspect that she is pregnant.

If, for compelling medical reason, zolpidem is administered during the late phase of pregnancy, or during labour, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected due to the pharmacological action of the product. Cases of severe neonatal respiratory depression have been reported when zolpidem tartrate was used with other CNS depressants at the end of pregnancy.

Infants born to mothers who took benzodiazepines or benzodiazepine-like agents chronically during the latter stages of pregnancy may develop withdrawal symptoms in the postnatal period as a result of physical dependence. There are insufficient data to evaluate the safety of using zolpidem while breast-feeding. Zolpidem passes into breast milk in small amounts. Zolpidem should therefore not be used by breast-feeding mothers since effects on the infant are not studied.

In order to minimise this risk a resting period of at least 8 hours is recommended between taking zolpidem and driving, using machinery and working at heights. Driving ability impairment and behaviours such as 'sleep-driving' have occurred with zolpidem alone at therapeutic doses. Furthermore, the co-administration of zolpidem with alcohol and other CNS depressants increases the risk of such behaviours see section 4.

Patients should be warned not to use alcohol or other psychoactive substances when taking zolpidem. These effects seem to be related with individual sensitivity and to appear more often within the hour following the drug intake if the patient does not go to bed or does not sleep immediately see section 4. There is evidence for a dose connection for reactions associated with use of zolpidem, especially certain CNS reactions and gastrointestinal events.

Theoretically they should be less if zolpidem is taken immediately before bedtime. They occur most frequently in elderly patients. Restlessness, aggression, delusion, anger, psychosis, abnormal behaviour, sleep walking see section 4. Somnolence, headache, dizziness, increased insomnia, cognitive disorders such as anterograde amnesia: Depressed level of consciousness. Ear and labyrinth disorders. Respiratory, thoracic and mediastinal disorders. Respiratory depression see section 4.

Elevated liver enzymes, hepatocellular, cholestatic or mixed liver injury. Rash, pruritus, urticaria, hyperhidrosis. Gait disturbance, drug tolerance, falls predominantly in elderly patients and when zolpidem was not taken in accordance with prescribing recommendation. These phenomena occur predominantly at the start of the therapy or in elderly patients and usually disappear with repeated administration.

Anterograde amnesia may occur during therapeutic dosages, the risk increasing at higher dosages. In order to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 8 hours. Amnestic effects may be associated with inappropriate behaviour see section 4. Pre-existing depression may become manifest during use of benzodiazepines or benzodiazepine-like agents see section 4. Reactions like restlessness, agitation, irritability, aggressiveness, delusions, rage, nightmares, increased insomnia, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects may occur when using benzodiazepines and benzodiazepine-like agents.

Such reactions are more likely to occur in the elderly see section 4. Use even at therapeutic dosages may lead to physical dependence: Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: In reports of overdose with zolpidem alone or with other CNS-depressant agents including alcohol , impairment of consciousness has ranged from somnolence to coma and fatal outcomes have been reported.

Individuals have fully recovered from overdoses up to mg of zolpidem, 40 times the recommended dose. General symptomatic and supportive measures should be used. Immediate gastric lavage should be used where appropriate. Intravenous fluids should be administered as needed. Ketoconazole Ketoconazole, a potent CYP3A4 inhibitor, increased the pharmacodynamic effects of zolpidem.

Consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together. We are located in Oceanside, California. Search over 70, items by Name, Item No. No It Have a question? Information on this site is provided for informational purposes only and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for diagnosing or treating a health problem or disease, or prescribing any medication.

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