DIASTAT PRESCRIBING INFORMATION PDF

An extreme increase in activity and talking mania New or worse anxiety Other unusual changes in behavior or mood New or worse depression How can I watch for early symptoms of suicidal thoughts or actions? Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

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Contact Us The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider.

All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries. Use of this site signifies your agreement to the Legal Notice and Privacy Policy.

Prolonged sleepiness has been observed in infants treated with diazepam. Therefore, diazepam rectal gel is not recommended for use in children under six months of age. The controlled trials demonstrating the effectiveness of diazepam rectal gel included children two years of age and older.

Clinical studies have not been conducted to establish the efficacy and safety of diazepam rectal gel in children under two years of age. Pregnancy Category D - No clinical studies have been conducted with diazepam rectal gel in pregnant women. Data from several sources raise concerns about the use of diazepam during pregnancy. Use with caution if you have breathing difficulties such as asthma or pneumonia , kidney or liver disease, or are elderly.

Talk to your doctor if any of these conditions apply to you, or if you are not sure if any of these conditions apply to you. Diazepam rectal gel can cause drug addiction. Use no more than every five days and no more than five times per month.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www. You may also contact Bausch Health Companies Inc. Customer Service at Please click here for full Prescribing Information including Boxed Warning regarding potentially fatal interactions with opioids.

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Diazepam Rectal Gel

Contact Us The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries. Use of this site signifies your agreement to the Legal Notice and Privacy Policy. Prolonged sleepiness has been observed in infants treated with diazepam.

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Diastat Description Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel is clear to slightly yellow and has a pH between 6. Diazepam, the active ingredient of diazepam rectal gel, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydromethylphenyl-2H-1,4-benzodiazepinone. GABA, the major inhibitory neurotransmitter in the central nervous system, acts at this receptor to open the membrane channel allowing chloride ions to flow into neurons. Entry of chloride ions causes an inhibitory potential that reduces the ability of neurons to depolarize to the threshold potential necessary to produce action potentials.

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For the treatment of status epilepticus or for treatment of drug-induced seizures. Moderate Methyldopa infromation associated with sedative effects. If a benzodiazepine is necessary, a dosage adjustment of the multi-day regimen may be necessary depending on the clinical situation e. Oxazepam and temazepam plasma concentrations are usually undetectable. The syringe s should be labeled with appropriate information including the date and time the ampule was opened. Doses should be rounded downward to reduce the likelihood of ataxia or oversedation. Moderate Consider a dose diastaat of diazepam as clinically appropriate, if adverse reactions occur when administered with cannabidiol.

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