Quazepam (Doral)

Trade Name : DORAL

Galt Pharmaceuticals, LLC

TABLET

Strength 15 mg/1

QUAZEPAM 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 Quazepam (Doral) which is also known as DORAL and Manufactured by Galt Pharmaceuticals, LLC. It is available in strength of 15 mg/1 per ml. Read more

Quazepam (Doral) 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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No data

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS
See full prescribing informationfor complete boxed warning.

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation (n n n , n n n ).n n n
The use of benzodiazepines, including DORAL, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing DORAL and throughout treatment, assess each patientu2019s risk for abuse, misuse, and addiction (n n n ).n n n
Abrupt discontinuation or rapid dosage reduction of DORAL after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue DORAL or reduce the dosage (n n n , n n n ).n n n

No data

DORAL is indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The effectiveness of DORAL has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of DORAL has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration. Because insomnia is often transient and intermittent, the prolonged administration of DORAL Tablets is generally not necessary or recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.
DORAL, a gamma-aminobutyric (GABAA) agonist, is indicated for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. (n n n )n nn

Use the lowest dose effective for the patient:

Recommended initial dose is 7.5 mg (n n n )n n n
Split the 15 mg tablet along the score line to achieve 7.5 mg dose (n n n )n n n
The elderly and debilitated may be more sensitive to benzodiazepines (n n n )n n n

Tablets, 15 mg, functionally scored, capsule-shaped, light orange, slightly white speckled tablets, impressed with the product identification number 15 on one side of the tablet, and the product name (DORAL) on the other.
15 mg functionally scored tablet, oral (n n n )n nn

DORAL is contraindicated in patients with known hypersensitivity to DORAL or other benzodiazepines. Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of DORAL. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Patients who develop such reactions should not be rechallenged with DORAL.
Contraindicated in patients with established or suspected sleep apnea, or with pulmonary insufficiency.

Hypersensitivity to DORAL or other benzodiazepines (n n n )n n n
Established or suspected sleep apnea, or chronic pulmonary insufficiency (n n n )n n n

No data

CNS depressant effects: Impaired alertness and motor coordination, including risk of daytime impairment. Caution patients against driving and other activities requiring complete mental alertness (n n n )n n n
The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. (n n n )n n n
Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. (n n n )n n n
Sleep driving and other complex behaviors while not fully awake. Risk increases with dose and concomitant CNS depressants and alcohol. Immediately evaluate any new onset behavioral changes (n n n )n n n
Worsening of depression or suicidal thinking may occur: Prescribe the least number of tablets feasible to avoid intentional overdose (n n n )n n n

The following serious adverse reactions are discussed in greater detail in other sections of the label:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The table shows adverse reactions occurring at an incidence of 1% or greater in relatively short-duration, placebo-controlled clinical trials of DORAL.
A double-blind, controlled sleep laboratory study (N=30) in elderly patients compared the effects of DORAL 7.5 mg and 15 mg to that of placebo over a period of 7 days. Both the 7.5 mg and 15 mg doses appeared to be well tolerated. Caution must be used in interpreting this data due to the small size of the study.
Most common adverse reactions (>1%): drowsiness, headache, fatigue, dizziness, dry mouth, dyspepsia (n n n )n nn
To report SUSPECTED ADVERSE REACTIONS, contact Galt Pharmaceuticals at 1-844-416-4284 or FDA at 1-800-FDA-1088 or n n n . n n n

The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.
Benzodiazepines, including DORAL, produce additive CNS depressant effects when co-administered with ethanol or other CNS depressants (e.g. psychotropic medications, anticonvulsants, antihistamines). Downward dose adjustment of DORAL and/or concomitant CNS depressants may be necessary because of additive effects.

CNS Depressants: downward dose adjustment may be necessary due to additive effects (n n n )n n n

No data

Pregnancy: Based on animal data, may cause fetal harm (n n n )n n n
Nursing Mothers: Administration of DORAL Tablets to nursing mothers is not recommended as DORAL and its metabolites are excreted in human milk. (n n n )n n n

No data

Contact a poison control center for up-to-date information on the management of benzodiazepine overdose.
Manifestations of DORAL overdose include somnolence, confusion, and coma. General supportive measures should be employed, along with immediate gastric lavage. Dialysis is of limited value. Flumazenil may be useful, but can contribute to the appearance of neurological symptoms including convulsions. Hypotension may be treated by appropriate medical intervention. Animal experiments suggest that forced diuresis or hemodialysis are of little value in treating DORAL overdose. As with the management of intentional overdose with any drug, the possibility of multiple drug ingestion should be considered.

DORAL contains quazepam, a trifluoroethyl benzodiazepine hypnotic agent, having the chemical name 7-chloro-5- (o-fluoro-phenyl)-1,3-dihydro-1-(2,2,2- trifluoroethyl)-2H-1,4-benzodiazepine-2-thione and the following structural
Quazepam has the empirical formula Cn n n Hn n n ClFn n n Nn n n S, and a molecular weight of 386.8. It is a white crystalline compound, soluble in ethanol and insoluble in water.n nn
Each DORAL Tablet contains 15 mg of quazepam. The inactive ingredients for DORAL Tablets include cellulose, corn starch, FD&C Yellow No. 6, lactose, magnesium stearate, silicon dioxide, and sodium lauryl sulfate.

No data

Carcinogenesis
DORAL showed no evidence of carcinogenicity in oral carcinogenicity studies in mice and hamsters.
Mutagenesis
DORAL was negative in the bacterial reverse mutation (Ames) assay and equivocal in the mouse lymphoma tk assay.
Impairment of Fertility
Reproduction studies in mice conducted with DORAL at doses equal to 60 and
180 times the human dose of 15 mg produced slight reductions in fertility rate. Similar reductions in fertility rate have been reported in mice dosed with other benzodiazepines, and is believed to be related to the sedative effects of these drugs at high doses

The effectiveness of DORAL was established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of DORAL was established in chronic insomnia in a sleep laboratory (polysomnographic) study of 28 nights duration. In the sleep laboratory study, DORAL significantly decreased sleep latency and total wake time, and significantly increased total sleep time and percent sleep time, for one or more nights.
DORAL 15 mg was effective on the first night of administration. Sleep latency, total wake time and wake time after sleep onset were still decreased and percent sleep time was still increased for several nights after the drug was discontinued. Percent slow wave sleep was decreased, and REM sleep was essentially unchanged. No transient sleep disturbance, such as u201crebound insomnia,u201d was observed after withdrawal of the drug in sleep laboratory studies in 12 patients using 15 mg doses.
A double-blind, controlled sleep laboratory study (N=30) in elderly patients compared the effects of DORAL 7.5 mg and 15 mg to that of placebo over a period of 7 days. Both the 7.5 mg and 15 mg doses appeared to be effective. Caution must be used in interpreting this data due to the small size of the study.

DORAL Tablets, 15 mg, functionally scored, capsule-shaped, light orange, slightly white speckled tablets, impressed with the product identification number 15 on one side of the tablet, and the product name (DORAL) on the other.
Store DORAL Tablets at controlled room temperature 20u00b0-25u00b0C (68u00b0-77u00b0F).

Advise the patient to read the FDA-approved patient labeling (n n n ).n nn
Risks from Concomitant Use with Opioidsn- [see Warnings and Precautions (n n n ), Drug Interactions (n n n )]n n n
Abuse, Misuse, and Addictionn- [see Warnings and Precautions (n n n ) and Drug Abuse and Dependence (n n n )]n n n
Withdrawal Reactionsn- [see Warnings and Precautions (n n n ) and Drug Abuse and Dependence (n n n )]n n n
CNS Depressant Effects and Next-Day Impairment
Tell patients that DORAL can cause next-day impairment, even in the absence of symptoms. Caution patients against driving or engaging in other hazardous activities or activities requiring complete mental alertness when using DORAL. Tell patients that daytime impairment may persist for several days following discontinuation of DORAL. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients n n n n
Severe Allergic Reactionsn- [see Warnings and Precautions (n n n )]n n n
Abnormal Thinking and Behavior Changen- [see Warnings and Precautions (n n n )]n n n
Suiciden- [see Warnings and Precautions (n n n )]n n n
Alcohol and Other Drugs
Pregnancy
Manufactured for: n n n Galt Pharmaceuticals, LLC. n n n Atlanta, GA 30339n nn
Printed in USA. 500494-09 Rev. 09/2020

No data

PRINCIPAL DISPLAY PANEL
NDC 61825-165-30n n n Doral (quazepam tablets, USP)n n n 15 mgn n n 30 Tabletsn n n Rx Onlyn nn

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Quazepam (Doral)

Trade Name : DORAL

TABLET

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Quazepam (Doral)

Trade Name : DORAL

TABLET

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

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