Doral

DRUG DESCRIPTION

DORAL® (brand of quazepam) Tablets contain 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 formula:

DORAL  ( quazepam) Structural Formula Illustration

Quazepam has the empirical formula C17H11CIF4N2S, and a molecular weight of 386.8. It is a white crystalline compound, soluble in ethanol and insoluble in water. Each DORAL® Tablet contains either 7.5 or 15 mg of quazepam. The inactive ingredients for DORAL® (quazepam tablets) Tablets 7.5 or 15 mg include cellulose, corn starch, FD&C Yellow No. 6 Al Lake, lactose, magnesium stearate, silicon dioxide, and sodium lauryl sulfate.

What are the possible side effects of quazepam (Doral)?

Quazepam may cause a severe allergic reaction. Stop taking quazepam and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using quazepam and call your doctor at once if you have a serious side effect such as:

  • worsening insomnia;
  • confusion, anxiety, slurred speech, unusual thoughts or behavior;
  • hallucinations, agitation, aggression;
  • weak or shallow breathing;
  • fast or...

Read All Potential Side Effects and See Pictures of Doral »

What are the precautions when taking quazepam tablets (Doral)?

Before taking quazepam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (e.g., lorazepam, diazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, mental/mood problems (e.g., depression, panic disorder), lung problems (e.g., pulmonary insufficiency, sleep apnea), seizures, personal or family history of regular use/abuse of drugs/alcohol/other substances.

This drug may make you dizzy or drowsy or cause temporary blurred vision. Do not drive, use machinery, or do any activity that...

Read All Potential Precautions of Doral »


Doral Consumer (continued)

SIDE EFFECTS: Dizziness, loss of coordination, or blurred vision may occur. To minimize falls, remember to get up slowly when rising from a seated or lying position. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: confusion, unusual feelings of well-being (euphoria), uncontrolled movements (tremor), restlessness, memory loss, sweating, mental/mood changes (e.g., hallucinations, agitation, anxiety, unusual/disturbing thoughts, depression, rare thoughts of suicide), increased or vivid dreams, vision changes, fainting.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), unusual paleness, unusual tiredness, fast/pounding/irregular heartbeat, yellowing of the eyes/skin, dark urine.

Some people who take sleep medications have reported getting out of bed and sleepwalking, driving, eating, talking on the phone, or having sex while not fully awake. Often they do not remember these activities. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor immediately. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking quazepam.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking quazepam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (e.g., lorazepam, diazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, mental/mood problems (e.g., depression, panic disorder), lung problems (e.g., pulmonary insufficiency, sleep apnea), seizures, personal or family history of regular use/abuse of drugs/alcohol/other substances.

This drug may make you dizzy or drowsy or cause temporary blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially drowsiness, dizziness, loss of coordination, and confusion.

Quazepam must not be used during pregnancy. Other medications in this class have caused birth defects when used in the first three months of pregnancy. Other medications in this class have also caused unusual drowsiness, feeding problems, and liver problems in newborns when used at or near the time of delivery, or withdrawal symptoms in newborns when used for a long time during pregnancy. If you are a woman of childbearing age, use an effective form of birth control while taking this drug. If you plan to become pregnant, stop taking this drug before doing so. If you become pregnant or think you may be pregnant, inform your doctor immediately.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Doral Patient Information Including Side Effects

Brand Names: Doral

Generic Name: quazepam (Pronunciation: KWAY ze pam)

  • What is quazepam (Doral)?
  • What are the possible side effects of quazepam (Doral)?
  • What is the most important information I should know about quazepam (Doral)?
  • What should I discuss with my healthcare provider before taking quazepam (Doral)?
  • How should I take quazepam (Doral)?
  • What happens if I miss a dose (Doral)?
  • What happens if I overdose (Doral)?
  • What should I avoid while taking quazepam (Doral)?
  • What other drugs will affect quazepam (Doral)?
  • Where can I get more information?

What is quazepam (Doral)?

Quazepam is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Quazepam affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia).

Quazepam is used to treat insomnia symptoms, such as trouble falling or staying asleep.

Quazepam may also be used for other purposes not listed in this medication guide.

What are the possible side effects of quazepam (Doral)?

Quazepam may cause a severe allergic reaction. Stop taking quazepam and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using quazepam and call your doctor at once if you have a serious side effect such as:

  • worsening insomnia;
  • confusion, anxiety, slurred speech, unusual thoughts or behavior;
  • hallucinations, agitation, aggression;
  • weak or shallow breathing;
  • fast or pounding heartbeats;
  • muscle stiffness in your tongue, jaw, or neck;
  • problems with urination; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • daytime drowsiness (or during hours when you are not normally sleeping);
  • amnesia or forgetfulness;
  • muscle weakness, lack of balance or coordination;
  • dizziness, vision problems;
  • nightmares;
  • headache, blurred vision, depressed mood;
  • feeling nervous, excited, or irritable;
  • impotence, loss of interest in sex;
  • mild itching or skin rash;
  • nausea, diarrhea, stomach pain, loss of appetite; or
  • dry mouth, increased thirst.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about quazepam (Doral)?

Quazepam may cause a severe allergic reaction. Stop taking quazepam and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Take quazepam only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking quazepam and talk with your doctor about another treatment for your sleep disorder.

Do not use this medication if you are allergic to quazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), or triazolam (Halcion).

This medication can cause birth defects in an unborn baby, or withdrawal symptoms in a newborn. Do not use quazepam if you are pregnant.

Before taking quazepam, tell your doctor if you have any breathing problems, kidney or liver disease, or a history of depression, mental illness, suicidal thoughts, or addiction to drugs or alcohol.

Quazepam may be habit-forming and should be used only by the person it was prescribed for. Quazepam should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Quazepam should be used for only a short time to treat insomnia. After 7 to 10 nights of use, talk with your doctor about whether or not you should keep taking quazepam.

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