Diazepam (Diazepam)

Trade Name : Diazepam

Teva Pharmaceuticals USA, Inc.

GEL

Strength 2.5 mg/.5mL

DIAZEPAM Benzodiazepine [EPC],Benzodiazepines [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Diazepam (Diazepam) which is also known as Diazepam and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 2.5 mg/.5mL per ml. Read more

Diazepam (Diazepam) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel contains 5 mg/mL diazepam, propylene glycol, ethyl alcohol (10%), hydroxypropyl methylcellulose, sodium benzoate, benzyl alcohol (1.5%), benzoic acid and water. Diazepam rectal gel is clear to slightly yellow and has a pH between 6.5 - 7.2.
  • Diazepam, the active ingredient of diazepam rectal gel, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2-1,4-benzodiazepin-2-one. The structural formula is as follows:
  • No data
  • Diazepam rectal gel is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory, patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity.
  • Evidence to support the use of diazepam rectal gel was adduced in two controlled trials (see CLINICAL PHARMACOLOGY, CLINICAL STUDIES subsection) that enrolled patients with partial onset or generalized convulsive seizures who were identified jointly by their caregivers and physicians as suffering intermittent and periodic episodes of markedly increased seizure activity, sometimes heralded by nonconvulsive symptoms, that for the individual patient were characteristic and were deemed by the prescriber to be of a kind for which a benzodiazepine would ordinarily be administered acutely. Although these clusters or bouts of seizures differed among patients, for any individual patient the clusters of seizure activity were not only stereotypic but were judged by those conducting and participating in these studies to be distinguishable from other seizures suffered by that patient. The conclusion that a patient experienced such unique episodes of seizure activity was based on historical information.
  • Diazepam rectal gel is contraindicated in patients with a known hypersensitivity to diazepam. Diazepam rectal gel may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
  • No data
  • No data
  • Diazepam rectal gel adverse event data were collected from double-blind, placebo-controlled studies and open-label studies. The majority of adverse events were mild to moderate in severity and transient in nature.
  • Two patients who received diazepam rectal gel died seven to 15 weeks following treatment; neither of these deaths was deemed related to diazepam rectal gel.
  • The most frequent adverse event reported to be related to diazepam rectal gel in the two double-blind, placebo-controlled studies was somnolence (23%). Less frequent adverse events were dizziness, headache, pain, abdominal pain, nervousness, vasodilatation, diarrhea, ataxia, euphoria, incoordination, asthma, rhinitis, and rash, which occurred in approximately 2-5% of patients.
  • Approximately 1.4% of the 573 patients who received diazepam rectal gel in clinical trials of epilepsy discontinued treatment because of an adverse event. The adverse event most frequently associated with discontinuation (occurring in three patients) was somnolence. Other adverse events most commonly associated with discontinuation and occurring in two patients were hypoventilation and rash. Adverse events occurring in one patient were asthenia, hyperkinesia, incoordination, vasodilatation and urticaria. These events were judged to be related to diazepam rectal gel.
  • In the two domestic double-blind, placebo-controlled, parallel-group studies, the proportion of patients who discontinued treatment because of adverse events was 2% for the group treated with diazepam rectal gel, versus 2% for the placebo group. In the diazepam rectal gel group, the adverse events considered the primary reason for discontinuation were different in the two patients who discontinued treatment; one discontinued due to rash and one discontinued due to lethargy. The primary reason for discontinuation in the patients treated with placebo was lack of effect.
  • Diazepam is a Schedule IV controlled substance and can produce drug dependence. It is recommended that patients be treated with diazepam rectal gel no more frequently than every five days and no more than five times per month.
  • Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving diazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence.
  • Abrupt discontinuation of diazepam following chronic regular use has resulted in withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating). The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuation of benzodiazepines taken continuously at therapeutic levels for several months.
  • Two patients in the clinical studies received more than twice the target dose; no adverse events were reported.
  • Previous reports of diazepam overdosage have shown that manifestations of diazepam overdosage include somnolence, confusion, coma, and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. Hypotension may be combated by the use of levarterenol or metaraminol. Dialysis is of limited value.
  • Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment. The complete flumazenil package insert, including CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, should be consulted prior to use.
  • This section is intended primarily for the prescriber; however, the prescriber should also be aware of the dosing information and directions for use provided in the patient package insert.
  • A decision to prescribe diazepam rectal gel involves more than the diagnosis and the selection of the correct dose for the patient.
  • First, the prescriber must be convinced from historical reports and/or personal observations that the patient exhibits the characteristic identifiable seizure cluster that can be distinguished from the patientu2019s usual seizure activity by the caregiver who will be responsible for administering diazepam rectal gel.
  • Second, because diazepam rectal gel is only intended for adjunctive use, the prescriber must ensure that the patient is receiving an optimal regimen of standard anti-epileptic drug treatment and is, nevertheless, continuing to experience these characteristic episodes.
  • Third, because a non-health professional will be obliged to identify episodes suitable for treatment, make the decision to administer treatment upon that identification, administer the drug, monitor the patient, and assess the adequacy of the response to treatment, a major component of the prescribing process involves the necessary instruction of this individual.
  • Fourth, the prescriber and caregiver must have a common understanding of what is and is not an episode of seizures that is appropriate for treatment, the timing of administration in relation to the onset of the episode, the mechanics of administering the drug, how and what to observe following administration, and what would constitute an outcome requiring immediate and direct medical attention.
  • Diazepam Rectal Gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg delivery system and 20 mg delivery system. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg, and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam Rectal Gel delivery system is available in the following three presentations:
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F) [See USP Controlled Room Temperature].
  • Diazepam Rectal Gel 10 mg delivery system and 20 mg delivery system
  • INSTRUCTIONS FOR CAREGIVERS FROM PHARMACY
  • FOR EACH SYRINGE:
  • SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.
  • The instructions are also available on the bottom of each drug product package.
  • CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.
  • Valium is a registered trademark of Roche Pharmaceuticals.
  • Distributed by:n n North Wales, PA 19454
  • Manufactured By:n n San Antonio, TX 78215
  • 9435000n Rev. A 2/2015
  • Diazepam Rectal Geln- Diazepam Rectal Gel Rectal Delivery System
  • CIV
  • IMPORTANT
  • Read first before using
  • To the caregiver using Diazepam Rectal Gel:
  • Please do not give Diazepam Rectal Gel until:
  • To the caregiver using Diazepam Rectal Gel 10 mg rectal delivery system or 20 mg rectal delivery system
  • Please do not give Diazepam Rectal Gel 10 mg rectal delivery system or 20 mg rectal delivery system until
  • 1.
  • 2.
  • 3.
  • 4.
  • Please do not administer Diazepam Rectal Gel until you feel comfortable with how to use Diazepam Rectal Gel. The doctor will tell you exactly when to use Diazepam Rectal Gel. When you use Diazepam Rectal Gel correctly and safely you will help bring seizures under control. Be sure to discuss every aspect of your role with the doctor. If you are not comfortable, then discuss your role with the doctor again.
  • To help the person with seizures:
  • u221a
  • u221a
  • u221a
  • u221a
  • To know what responses to expect:
  • u221a You need to know how soon seizures should stop or decrease in frequency after giving Diazepam Rectal Gel.
  • u221a You need to know what you should do if the seizures do not stop or there is a change in the personu2019s breathing, behavior or condition that alarms you.
  • If you have any question or feel unsure about using the treatment, before using Diazepam Rectal Gel.
  • When to treat. n- Based on the doctoru2019s directions or prescription.
  • ________________________________________________________
  • ________________________________________________________
  • Special considerations.
  • Diazepam Rectal Gel should be used with caution:
  • Discuss beforehand with the doctor any additional steps you may need to take if there is leakage of Diazepam Rectal Gel or a bowel movement.
  • Patientu2019s Diazepam Rectal Gel dosage is:
  • Patientu2019s resting breathing rate_________u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Patientu2019s current weight____________
  • Confirm current weight is still the same as when Diazepam Rectal Gel was prescribed____________
  • Check expiration date and always remove cap before using. Be sure seal pin is removed with the cap.
  • TREATMENT 1
  • Important things to tell the doctor.
  • Things to do after treatment with Diazepam Rectal Gel.
  • Stay with the person for 4 hours and make notes on the following:
  • TREATMENT 2
  • ------------------------------------------------------------------------------------------------------------
  • Important things to tell the doctor.
  • Things to do after treatment with Diazepam Rectal Gel.
  • Stay with the person for 4 hours and make notes on the following:
  • HOW TO ADMINISTER AND DISPOSAL
  • Diazepam Rectal Gel CIV
  • Distributed by:n n North Wales, PA 19454
  • DPT Laboratories, LTD.
  • Rev. A 2/2015
  • No data
  • No data
  • No data

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