VALIUM 10mg. Tablets.

$360.00$945.00

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SKU: VALIUM-10

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Description

FORMULATION:

Diazepam 10mg.

 

 

BOXED WARNING

DOSAGE & INDICATIONS

 

For the treatment of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Oral dosage (oral solution or regular tablets)
Adults

2 to 10 mg PO 2 to 4 times per day depending upon the severity of the symptoms. Use lower initial adult doses for the debilitated adult patient. A maximum daily dosage has not been defined by the manufacturer, but commonly implied limit is 40 mg/day in divided doses for ambulatory use.

Geriatric Adults

2 to 2.5 mg PO 1 to 2 times per day, increasing the dose according to response and patient tolerability. A maximum daily dosage has not been defined, but commonly the adult limits are 40 mg/day in divided doses for ambulatory use. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of anxiolytics in long-term care facility (LTCF) residents. Max: 5 mg/day PO in residents meeting the criteria for treatment, except when documentation is provided showing that higher doses are necessary to maintain or improve the resident’s functional status. In addition, the facility should attempt periodic tapering of the medication or provide documentation of medical necessity in accordance with OBRA guidelines.

Infants 6 months and older, Children, and Adolescents

Initially, 1 to 2.5 mg PO 3 to 4 times per day. The dose may be increased as needed and tolerated.

Intravenous and Intramuscular dosage
Adults

2 to 5 mg IM or IV for moderate anxiety disorders and symptoms of anxiety; repeat in 3 to 4 hours if necessary. For severe anxiety disorders and symptoms of anxiety, 5 to 10 mg IM or IV; repeat in 3 to 4 hours if necessary.

For the treatment of acute alcohol withdrawal.
Intravenous dosage
Adults

Until it is known how the patient will respond, a dose of 10 mg IV initially, followed by 5 to 10 mg IV every 3 to 4 hours as needed. Doses of 5 to 10 mg IV may be given every hour if required. Some patients may require massive doses of benzodiazepines during the acute phase of ethanol withdrawal. Intravenous doses of 270 mg over 45 minutes and 2,335 mg over a period of 4 days have been reported.

For the treatment of muscle spasm due to local pathology such as muscle or joint inflammation or trauma; athetosis; stiff-man syndrome; tetanus; or spasticity due to upper motor neuron diseases such as cerebral palsy.
Oral dosage (oral solution or regular tablets)
Adults

2 to 10 mg PO 3 to 4 times per day.

Geriatric

2 to 2.5 mg PO 1 to 2 times per day, increasing the dose according to response and patient tolerability.

Infants >= 6 months, Children, and Adolescents

Initially, 1 to 2.5 mg PO 3 to 4 times per day. The dose may be increased as needed and tolerated.

Intravenous and Intramuscular dosage
Adults

5 to 10 mg IM or IV initially, repeated every 3 to 4 hours as needed. For tetanus, larger doses may be required.

Children >= 5 years and Adolescents

5 to 10 mg IM or IV every 3 to 4 hours as needed.

Infants and Children < 5 years

1 to 2 mg IM or IV every 3 to 4 hours as needed.

For the treatment of status epilepticus or for treatment of drug-induced seizures.
NOTE: Many clinicians now prefer IV lorazepam over IV diazepam for the acute treatment of seizures.
Intravenous dosage
Adults

5—10 mg IV initially, repeated at 10—15 minute intervals to a maximum dosage of 30 mg. The dosage may be repeated in 2—4 hours if needed.

Children >= 5 years and Adolescents

1 mg IV every 2—5 minutes to a maximum of 10 mg. The dose may be repeated in 2—4 hours.

Infants and Children < 5 years

0.2—0.5 mg IV every 2—5 minutes to a maximum dose of 5 mg. Repeat in 2—4 hours as needed.

Neonates†

Initial doses of 0.1—0.15 mg/kg IV repeated as needed every 10 minutes were administered to pediatric patients as young as 2 weeks of age in a retrospective study. The mean dose of total diazepam required to control status epilepticus was 0.38 mg/kg IV (range 0.09—0.71 mg/kg IV) and it was successful in terminating seizures in 11 of 16 patients (69%). NOTE: Not recommended as a first-line agent due to sodium benzoate and benzoic acid in the injection (see Precautions and How Supplied).

For adjunctive treatment of seizures other than status epilepticus in selected, refractory patients with partial seizures or generalized tonic-clonic seizures who require intermittent use of diazepam to control bouts of increased seizure activity.
Oral dosage (oral solution or regular tablets)
Adults

2 to 10 mg PO 2 to 4 times per day. The manufacturer, however, notes that diazepam is not useful as sole therapy and may not be effective as adjunctive therapy for longer than 4 months.

Geriatric

2 to 2.5 mg PO 1 to 2 times per day, increasing the dose according to response and patient tolerability.

Infants >= 6 months, Children, and Adolescents

Initially, 1 to 2.5 mg PO 3 to 4 times per day. The dose may be increased as needed and tolerated.

Rectal dosage

NOTE: It is recommended that rectal diazepam be used to treat no more than five episodes per month and no more than one episode every five days.
NOTE: The Diastat 2.5 mg dose may also be used as a partial replacement dose for patients who expel a portion of the first dose.

Adults, Adolescents and Children 12 years of age

0.2 mg/kg PR. Doses should be rounded upward to the next available dosage strength. A second dose, if needed, may be given 4 to 12 hours after the first dose.

Geriatric and Debilitated patients

0.2 mg/kg PR. Doses should be rounded downward to reduce the likelihood of ataxia or oversedation. A second dose, if needed, may be given 4 to 12 hours after the first dose.

Children 6 – 11 years

0.3 mg/kg PR. Doses should be rounded upward to the next available dosage strength. A second dose, if needed, may be given 4 to 12 hours after the first dose.

Children 2—5 years

0.5 mg/kg PR. Doses should be rounded upward to the next available dosage strength. A second dose, if needed, may be given 4 to 12 hours after the first dose.

For amnesia induction or for preprocedure sedation induction.
Intravenous dosage
Adults (prior to cardioversion)

5—15 mg IV 5—10 minutes before the procedure.

Adults (prior to endoscopy)

Dose may be titrated up to 20 mg IV, depending on response and patient tolerability.

Infants†, Children†, and Adolescents†

0.05—0.1 mg/kg IV initially, titrate slowly to a maximum dose of 0.25 mg/kg IV.

Oral dosage
Adults

10 mg PO 45—60 minutes prior to procedure.

Infants†, Children†, and Adolescents† (for procedures or conscious sedation)

0.2—0.4 mg/kg PO 45—60 minutes prior to procedure. Maximum dose is 20 mg PO.

For the treatment of benzodiazepine withdrawal†.
Oral dosage
Adults

Because benzodiazepine withdrawal is more pronounced with shorter-acting agents, diazepam has been proposed as the benzodiazepine of choice for managing withdrawal. Diazepam-equivalent doses have been established for some other benzodiazepines. Diazepam should be tapered off in increments of 0.5 to 2 mg per week over a period of 4 to 16 weeks.

For febrile seizure prophylaxis†.
Oral dosage
Infants and Children 6 months—5 years

Children ranging in age from 6 months to 5 years and who had at least one febrile seizure were randomized to receive oral diazepam 0.33 mg/kg PO every 8 hours during each episode of fever until the child was afebrile for at least 24 hours or placebo. An 82% reduction in the rate of recurrent febrile seizures was observed in the diazepam group. Although diazepam is effective in preventing recurrent febrile seizures, due to the risk of adverse events and the lack of long term complications from simple febrile seizures, the American Academy of Pediatrics does not recommend routine use of intermittent diazepam for febrile seizure prophylaxis.

For the treatment of agitation† in intensive care unit patients.
Intravenous or Oral dosage
Adults

Single doses of 2 to 5 mg IV or PO have been recommended. Repeat doses should be based on clinical response.

For the treatment of acute chloroquine overdose† in combination with epinephrine.
Intravenous dosage
Adults

Eleven cases of acute chloroquine overdose (total ingested dose ranged 5 to 12 g) were treated with diazepam 2 mg/kg IV over 30 minutes in combination with IV epinephrine, general anesthesia with thiopental, and FiO2 40%. Diazepam was continued at a dose of 1 to 2 mg/kg/day IV for 2 to 4 additional days. Other vasopressors and/or inotropic agents were used as necessary. Ten of 11 patients were discharged alive from the hospital. The one patient who died had ingested the largest total dose (15 g) of chloroquine.

For the treatment of insomnia†.
Oral dosage
Adults

2 to 10 mg PO at bedtime has been used ; dosage must be titrated and individualized according to patient response.

Geriatric Adults

See adult dose. Use is not recommended as a hypnotic due to the long half-life of diazepam, the availability of safer sleep agents, and the increased sensitivity to benzodiazepines (e.g., ataxia, psychomotor impairment, syncope, falls) within the geriatric population.

†Indicates off-label use

MAXIMUM DOSAGE

Adults

Dosage must be individualized. Suggested maximum doses: 40 mg/day PO in divided doses for chronic ambulatory uses. A maximum dose has not been specifically defined by the manufacturer for emergent conditions.

Geriatric

Dosage must be individualized. Suggested maximum dose: 40 mg/day PO in divided doses for many chronic ambulatory uses. A maximum dose has not been specifically defined by the manufacturer for emergent conditions.

Adolescents

Dosage must be individualized. Suggested maximum dose: 0.6 mg/kg IV in 8 hour period for acute anxiety.

Children

Dosage must be individualized. Suggested maximum dose: 0.6 mg/kg IV in 8 hour period for acute anxiety.

Infants

Maximum dosage not established.

Neonates

Maximum dosage not established.

DOSING CONSIDERATIONS

Hepatic Impairment

Dosage should be modified depending on clinical response and degree of hepatic impairment, but no quantitative recommendations are available.

Renal Impairment

Dosage should be modified depending on clinical response and degree of renal impairment, but no quantitative recommendations are available; active and inactive diazepam metabolites are excreted by the kidney.

ADMINISTRATION

Oral Administration

The dose of the oral concentrate solution should be added to 30 ml or more of liquid (e.g., water, juices, carbonated, soda-like beverages) or to semi-solid foods (e.g., applesauce, pudding) prior to administration.

Injectable Administration

Strict aseptic technique must always be maintained during handling of parenteral products. Diazepam injectable emulsion (Dizac) contains no antimicrobial preservatives and can support rapid growth of microorganisms.
Following parenteral administration, patients should be kept under observation for a period of 3 to 8 hours or longer, based on the patient’s clinical response and rate of recovery.
Replace parenteral therapy with oral therapy as soon as possible.
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Intravenous Administration

Diazepam injection solution:
No dilution necessary. Dilution may cause precipitation.
Diazepam emulsified injection:
For intravenous administration only. Diazepam emulsified injection should be prepared for single patient use only.
Diazepam emulsified injection should be prepared for use just prior to initiation of each individual treatment procedure.
The injection emulsion should be drawn into sterile syringes immediately after ampules are opened. The syringe(s) should be labeled with appropriate information including the date and time the ampule was opened.
Administration should commence promptly and be completed within 6 hours after the ampules have been opened.
Any unused portion of diazepam emulsified injection reservoirs, dedicated administration tubing and/or solutions containing diazepam emulsified injection must be discarded after the end of parenteral treatment or at 6 hours, whichever occurs sooner.
The IV line should be flushed every 6 hours and at the end of treatment procedure to remove residual diazepam emulsified injection. Do not use if there is evidence of separation of the phases of the emulsion.
Intravenous injection:
Do not administer rapidly because respiratory depression or hypotension may develop. Monitor heart rate, respiratory rate, and blood pressure during IV use.
A large vein should be used to avoid thrombosis. If a large vein is not available, inject into the tubing of a flowing IV solution as close as possible to the vein insertion.
Do not add diazepam emulsified injection to infusion sets containing PVC. Do not administer diazepam emulsified injection through filters with a pore size less than 5 microns because this could restrict the flow of the emulsion and/or cause the breakdown of the emulsion.
Adults: inject IV slowly at a rate not exceeding 5 mg/minute.
Infants and children: inject IV slowly at a rate not exceeding 1—2 mg/minute.

Intramuscular Administration

Intramuscular injection (Diazepam injection solution only):
This route is usually not recommended due to slow and erratic absorption.
Inject deeply into a large muscle mass. Aspirate prior to injection to avoid injection into a blood vessel.

Rectal Administration

Patients/Caregivers should thoroughly read and understand the administration steps for diazepam rectal gel.
NOTE: Inspect product before preparation and administration. Small cracks have been noted at the base of the plastic tip of the applicators with resultant leakage of the medication when the plunger is depressed, preventing full dosing and potentially resulting in a sub-optimal therapeutic response. If a cracked syringe is noted, notify your dispensing pharmacist to inspect the product. U.S. Pharmacists should contact Rx Hope at 1—800—511—2120 for replacement product.
Diastat AcuDial is available in the following delivery system units: 2.5 mg, 10 mg, and 20 mg. The available doses from the 20 mg delivery system are 10 mg, 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 2.5 mg dose may also be used as a partial replacement dose for patients who may expel a portion of the first dose.

Diastat AcuDial preparation:
NOTE: A pharmacist must Dial in the Dose and Lock the rectal syringe prior to dispensing the product to the patient. It is ready when the “Green Ready Band” in clearly visible.
Hold barrel of the syringe with the cap pointed downward. Grasp cap with the other hand and turn to adjust dose. The prescribed dose should appear in the window. Grasp and push the locking ring upward to lock both sides of the ring.
If the ring is locked at an incorrect dose, call 1—877—361—2719.

Administration steps:
Put person on their side where they can not fall.
Get the medicine and the syringe. To remove protective cover from syringe, push up with thumb and pull. Ensure that both the cap and seal pin are removed.
If an AcuDial syringe is being used, confirm the correct dose by looking at the dose shown on the syringe display window. Also, the green ‘ready’ band should be visible.
Lubricate rectal tip with lubricating jelly.
Turn person on side facing you and bend upper leg forward to expose rectum. Separate buttocks to expose rectum.
Gently insert syringe tip into rectum (rim should be snug against rectal opening) and slowly count to 3 while gently pushing the plunger in until it stops. Slowly count to 3 before removing the syringe from the rectum.
Slowly count to 3 while holding the buttocks together to prevent leakage.
Keep person on the side facing you, note time given and continue to observe.
If an AcuDial syringe was used, pull the plunger out and then replace and push in to expel any remaining drug into the sink or toilet.

STORAGE

Generic:
– Discard opened bottle after 90 days
– Protect from light
– Store at controlled room temperature (between 68 and 77 degrees F)
Diastat:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Dizac:
– Protect from light
– Store at controlled room temperature (between 68 and 77 degrees F)
Valium:
– Store at controlled room temperature (between 68 and 77 degrees F)

Additional information

months

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Tablets

90 tablets, 180 tablets, 270 tablets

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