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Diazepam  10mg is a prescription medicine used to treat the symptoms of Anxiety, Endoscopy, Alcohol Withdrawal, Muscle Spasm, Seizure Disorder and Sedation. Diazepam may be used alone or with other medications.

Description

What is diazepam 10mg?

Diazepam is a benzodiazepine (ben-zoe-dye-AZE-eh-peens). It is thought that diazepam works by enhancing the activity of certain neurotransmitters in the brain.

Diazepam is used to treat anxiety disorders, alcohol withdrawal symptoms, or muscle spasms.

Diazepam is sometimes used with other medications to treat seizures.

Diazepam Important Information

You should not use this medicine if you are allergic to diazepam or similar medicines (KlonopinXanax, and others), or if you have myasthenia gravis, severe liver disease, narrow-angle glaucoma, a severe breathing problem, or sleep apnea.

MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Fatal side effects can occur if you use this medicine with opioid medicine, alcohol, or other drugs that cause drowsiness or slow your breathing.

Do not give this medication to a child younger than 6 months old.

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Before taking this diazepam 10mg

You should not use this medicine if you are allergic to diazepam or similar drugs (Klonopin, Xanax, and others), or if you have:

  • myasthenia gravis (a muscle weakness disorder);
  • severe liver disease;
  • a severe breathing problem;
  • sleep apnea (breathing stops during sleep); or
  • alcoholism, or addiction to drugs similar to diazepam.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • glaucoma;
  • asthmaemphysemabronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;
  • kidney or liver disease;
  • epilepsy or other seizure disorder;
  • a drug or alcohol addiction; or
  • mental illness, depression, or suicidal thoughts or behavior.
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When treating seizures, do not start or stop taking diazepam during pregnancy without your doctor’s advice. Diazepam may cause harm to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Tell your doctor right away if you become pregnant while taking this medicine for seizures.

When treating anxiety, alcohol withdrawal, or muscle spasms: If you take this medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Diazepam can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Diazepam is not approved for use by anyone younger than 6 months old. Do not give this medicine to a child without a doctor’s advice.

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How should I take diazepam 10mg?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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Diazepam may be habit-forming. Misuse of habit-forming medicine can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. Do not use not a kitchen spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Diazepam should be used for only a short time. Do not take this medicine for longer than 4 months without your doctor’s advice.

Do not stop using this medicine suddenly, or you could have increased seizures or unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Call your doctor at once if you feel that this medicine is not working as well as usual, or if you think you need to use more than usual.

While using this medicine, you may need frequent blood tests at your doctor’s office.

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Store at room temperature away from moisture, heat, and light. Keep track of your medicine. Diazepam is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

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Do not keep leftover diazepam. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

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What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of diazepam can be fatal.

Overdose symptoms may include extreme drowsiness, loss of balance or coordination, limp or weak muscles, or fainting.

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What should I avoid while taking diazepam?

Do not drink alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Grapefruit may interact with diazepam and lead to unwanted side effects. Avoid the use of grapefruit products.

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Diazepam side effects

Get emergency medical help if you have signs of an allergic reaction to diazepamhives; difficult breathing; swelling of your face, lips, tongue, or throat.

Diazepam can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • weak or shallow breathing;
  • severe drowsiness or feeling like you might pass out;
  • depressed mood, thoughts of suicide or hurting yourself;
  • confusion, hallucinations;
  • anxiety, panic attacks, trouble sleeping;
  • hyperactivity, agitation, aggression, hostility;
  • unusual risk-taking behavior; or
  • new or worsening seizures.
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The sedative effects of diazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking this medicine.

Common diazepam side effects may include:

  • drowsiness;
  • tired feeling;
  • muscle weakness; or
  • loss of coordination.

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.

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What other drugs will affect diazepam?

Taking diazepam with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, opioid pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with diazepam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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Uses

Diazepam is used to treat anxietyalcohol withdrawal, and seizures. It is also used to relieve muscle spasms and to provide sedation before medical procedures. This medication works by calming the brain and nerves. Diazepam belongs to a class of drugs known as benzodiazepines.

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How to use Diazepam

Read the Medication Guide provided by your pharmacist before you start taking diazepam and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

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If you are using the concentrated solution, use the medicine dropper provided and mix the measured dose with a small amount of liquid or soft food (such as applesauce, pudding). Take all of the mixture right away. Do not store the mixture for later use.

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The dosage is based on your medical condition, age, and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Properly stop the medication when so directed.

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If you suddenly stop using this medication, you may have withdrawal symptoms (such as shaking, abdominal/muscle crampsvomitingsweatinganxiety, restlessness, seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used diazepam for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

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When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

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Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

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If directed by your doctor, take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Diazepam belongs to a class of drugs called Antianxiety Agents; Anxiolytics, Benzodiazepines; Skeletal Muscle Relaxants; Anticonvulsants, Benzodiazepine.

It is not known if Diazepam is safe and effective in children younger than 6 months of age.

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What are the possible side effects of Diazepam?

Diazepam may cause serious side effects including:

  • mood changes,
  • memory problems,
  • agitation,
  • hallucinations,
  • confusion,
  • restlessness,
  • depression,
  • trouble speaking,
  • trouble walking,
  • muscle weakness,
  • shaking,
  • trouble urinating,
  • yellowing of the eyes or skin (jaundice),
  • sore throat,
  • fever, and
  • chills
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Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Diazepam include:

  • drowsiness,
  • fatigue,
  • muscle weakness, and
  • problems with coordination

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Diazepam. For more information, ask your doctor or pharmacist.

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

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DESCRIPTION

Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1- methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The molecular formula is C16H13ClN2O and the molecular weight is 284.74. The structural formula is as follows:

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DIAZEPAM- diazepam Structural Formula Illustration

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Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam, USP. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The following coloring agents are employed:

2 mg – none
5 mg – FD&C Yellow No.6 Aluminum Lake
10 mg – FD&C Blue No. 1 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake.

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DRUG INTERACTIONS

If diazepam is to be combined with other centrally acting agents, careful consideration should be given to the pharmacology of the agents employed particularly with compounds that may potentiate or be potentiated by the action of diazepam, such as phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, sedative antihistamines, narcotics, barbiturates, MAO inhibitors and other antidepressants.

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Alcohol

Concomitant use with alcohol is not recommended due to enhancement of the sedative effect.

Antacids

Diazepam peak concentrations are 30% lower when antacids are administered concurrently. However, there is no effect on the extent of absorption. The lower peak concentrations appear due to a slower rate of absorption, with the time required to achieve peak concentrations on average 20 to 25 minutes greater in the presence of antacids. However, this difference was not statistically significant.

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Compounds Which Inhibit Certain Hepatic Enzymes

There is a potentially relevant interaction between diazepam and compounds which inhibit certain hepatic enzymes (particularly cytochrome P450 3A and 2C19). Data indicate that these compounds influence the pharmacokinetics of diazepam and may lead to increased and prolonged sedation. At present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole.

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Phenytoin

There have also been reports that the metabolic elimination of phenytoin is decreased by diazepam.

WARNINGS

Diazepam is not recommended in the treatment of psychotic patients and should not be employed instead of appropriate treatment.

Since diazepam has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other CNS-depressant drugs during diazepam therapy.

As with other agents that have anticonvulsant activity, when diazepam is used as an adjunct in treating convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the dosage of standard anticonvulsant medication. Abrupt withdrawal of diazepam in such cases may also be associated with a temporary increase in the frequency and/or severity of seizures.

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Pregnancy

An increased risk of congenital malformations and other developmental abnormalities associated with the use of benzodiazepine drugs during pregnancy has been suggested. There may also be nonteratogenic risks associated with the use of benzodiazepines during pregnancy. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in children born to mothers who have been receiving benzodiazepines late in pregnancy. In addition, children born to mothers receiving benzodiazepines on a regular basis late in pregnancy may be at some risk of experiencing withdrawal symptoms during the postnatal period.

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Diazepam has been shown to be teratogenic in mice and hamsters when given orally at daily doses of 100 mg/kg or greater (approximately eight times the maximum recommended human dose [MRHD = 1 mg/kg/day] or greater on a mg/m² basis). Cleft palate and encephalopathy are the most common and consistently reported malformations produced in these species by administration of high, maternally toxic doses of diazepam during organogenesis. Rodent studies have indicated that prenatal exposure to diazepam doses similar to those used clinically can produce long-term changes in cellular immune responses, brain neurochemistry, and behavior.

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In general, the use of diazepam in women of childbearing potential, and more specifically during known pregnancy, should be considered only when the clinical situation warrants the risk to the fetus. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should also be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug.

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Labor And Delivery

Special care must be taken when diazepam is used during labor and delivery, as high single doses may produce irregularities in the fetal heart rate and hypotonia, poor sucking, hypothermia, and moderate respiratory depression in the neonates. With newborn infants it must be remembered that the enzyme system involved in the breakdown of the drug is not yet fully developed (especially in premature infants).

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Nursing Mothers

Diazepam passes into breast milk. Breastfeeding is therefore not recommended in patients receiving diazepam.

PRECAUTIONS

General

If diazepam is to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed – particularly with known compounds that may potentiate the action of diazepam, such as phenothiazines, narcotics, barbiturates, MAO inhibitors and other antidepressants (see DRUG INTERACTIONS).

The usual precautions are indicated for severely depressed patients or those in whom there is any evidence of latent depression or anxiety associated with depression, particularly the recognition that suicidal tendencies may be present and protective measures may be necessary.

Psychiatric and paradoxical reactions are known to occur when using benzodiazepines (see ADVERSE REACTIONS). Should this occur, use of the drug should be discontinued. These reactions are more likely to occur in children and the elderly.

A lower dose is recommended for patients with chronic respiratory insufficiency, due to the risk of respiratory depression.

Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse (see Drug Abuse And Dependence).

In debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia or oversedation (2 mg to 2.5 mg once or twice daily, initially, to be increased gradually as needed and tolerated).

Some loss of response to the effects of benzodiazepines may develop after repeated use of diazepam for a prolonged time.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

In studies in which mice and rats were administered diazepam in the diet at a dose of 75 mg/kg/day (approximately 6 and 12 times, respectively, the maximum recommended human dose [MRHD = 1 mg/kg/day] on a mg/m² basis) for 80 and 104 weeks, respectively, an increased incidence of liver tumors was observed in males of both species. The data currently available are inadequate to determine the mutagenic potential of diazepam. Reproduction studies in rats showed decreases in the number of pregnancies and in the number of surviving offspring following administration of an oral dose of 100 mg/kg/day (approximately 16 times the MRHD on a mg/m² basis) prior to and during mating and throughout gestation and lactation. No adverse effects on fertility or offspring viability were noted at a dose of 80 mg/kg/day (approximately 13 times the MRHD on a mg/m² basis).

Pregnancy

Teratogenic Effects

Pregnancy Category D.

(see WARNINGSPregnancy).

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 months have not been established.

Geriatric Use

In elderly patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia or oversedation (2 mg to 2.5 mg once or twice daily, initially to be increased gradually as needed and tolerated).

Extensive accumulation of diazepam and its major metabolite, desmethyldiazepam, has been noted following chronic administration of diazepam in healthy elderly male subjects. Metabolites of this drug are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Hepatic Insufficiency

Decreases in clearance and protein binding, and increases in volume of distribution and half-life has been reported in patients with cirrhosis. In such patients, a 2-fold to 5-fold increase in mean half-life has been reported. Delayed elimination has also been reported for the active metabolite desmethyldiazepam. Benzodiazepines are commonly implicated in hepatic encephalopathy. Increases in half-life have also been reported in hepatic fibrosis and in both acute and chronic hepatitis (see CLINICAL PHARMACOLOGYPharmacokinetics in Special PopulationsHepatic Insufficiency).

OVERDOSE

Overdose of benzodiazepines is usually manifested by central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, confusion, and lethargy. In more serious cases, symptoms may include ataxia, diminished reflexes, hypotoniahypotension, respiratory depression, coma (rarely), and death (very rarely). Overdose of benzodiazepines in combination with other CNS depressants (including alcohol) may be fatal and should be closely monitored.

Management Of Overdosage

Following overdose with oral benzodiazepines, general supportive measures should be employed including the monitoring of respirationpulse, and blood pressure. Vomiting should be induced (within one hour) if the patient is conscious. Gastric lavage should be undertaken with the airway protected if the patient is unconscious. Intravenous fluids should be administered. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid to respiratory and cardiac function in intensive care. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. Should hypotension develop, treatment may include intravenous fluid therapy, repositioning, judicious use of vasopressors appropriate to the clinical situation, if indicated, and other appropriate countermeasures. Dialysis is of limited value.

As with the management of intentional overdosage with any drug, it should be considered that multiple agents may have been ingested.

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 prescribers hould be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. Caution should be observed in the use of flumazenil in epileptic patients treated with benzodiazepines. The complete flumazenil package insert, including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS, should be consulted prior to use.

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see Drug Abuse And Dependence).

QUESTION

Panic attacks are repeated attacks of fear that can last for several minutes.See Answer

CONTRAINDICATIONS

Diazepam tablets are contraindicated in patients with a known hypersensitivity to diazepam and, because of lack of sufficient clinical experience, in pediatric patients under 6 months of age. Diazepam is also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, and sleep apnea syndrome. It may be used in patients with open-angle glaucoma who are receiving appropriate therapy, but is contraindicated in acute narrow-angle glaucoma.

CLINICAL PHARMACOLOGY

Diazepam is a benzodiazepine that exerts anxiolytic, sedative, muscle-relaxantanticonvulsant and amnestic effects. Most of these effects are thought to result from a facilitation of the action of gamma aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system.

Pharmacokinetics

Absorption

After oral administration > 90% of diazepam is absorbed and the average time to achieve peak plasma concentrations is 1 to 1.5 hours with a range of 0.25 to 2.5 hours. Absorption is delayed and decreased when administered with a moderate fat meal. In the presence of food mean lag times are approximately 45 minutes as compared with 15 minutes when fasting. There is also an increase in the average time to achieve peak concentrations to about 2.5 hours in the presence of food as compared with 1.25 hours when fasting. This results in an average decrease in Cmax of 20% in addition to a 27% decrease in AUC (range 15% to 50%) when administered with food.

Distribution

Diazepam and its metabolites are highly bound to plasma proteins (diazepam 98%). Diazepam and its metabolites cross the blood-brain and placental barriers and are also found in breast milk in concentrations approximately one tenth of those in maternal plasma (days 3 to 9 post-partum). In young healthy males, the volume of distribution at steady-state is 0.8 to 1 L/kg. The decline in the plasma concentration-time profile after oral administration is biphasic. The initial distribution phase has a halflife of approximately one hour, although it may range up to > 3 hours.

Metabolism

Diazepam is N-demethylated by CYP3A4 and 2C19 to the active metabolite N-desmethyldiazepam, and is hydroxylated by CYP3A4 to the active metabolite temazepam. N-desmethyldiazepam and temazepam are both further metabolized to oxazepam. Temazepam and oxazepam are largely eliminated by glucuronidation.

Elimination

The initial distribution phase is followed by a prolonged terminal elimination phase (half-life up to 48 hours). The terminal elimination half-life of the active metabolite N-desmethyldiazepam is up to 100 hours. Diazepam and its metabolites are excreted mainly in the urine, predominantly as their glucuronide conjugates. The clearance of diazepam is 20 to 30 mL/min in young adults. Diazepam accumulates upon multiple dosing and there is some evidence that the terminal elimination half-life is slightly prolonged.

Pharmacokinetics In Special Populations

Children

In children 3 to 8 years old the mean half-life of diazepam has been reported to be 18 hours.

Newborns

In full term infants, elimination half-lives around 30 hours have been reported, with a longer average half-life of 54 hours reported in premature infants of 28 to 34 weeks gestational age and 8 to 81 days post-partum. In both premature and full term infants the active metabolite desmethyldiazepam shows evidence of continued accumulation compared to children. Longer half-lives in infants may be due to incomplete maturation of metabolic pathways.

Geriatric

Elimination half-life increases by approximately one hour for each year of age beginning with a halflife of 20 hours at 20 years of age. This appears to be due to an increase in volume of distribution with age and a decrease in clearance. Consequently, the elderly may have lower peak concentrations, and on multiple dosing higher trough concentrations. It will also take longer to reach steady-state. Conflicting information has been published on changes of plasma protein binding in the elderly. Reported changes in free drug may be due to significant decreases in plasma proteins due to causes other than simply aging.

Hepatic Insufficiency

In mild and moderate cirrhosis, average half-life is increased. The average increase has been variously reported from 2-fold to 5-fold, with individual half-lives over 500 hours reported. There is also an increase in volume of distribution, and average clearance decreases by almost half. Mean half-life is also prolonged with hepatic fibrosis to 90 hours (range 66 to 104 hours), with chronic active hepatitis to 60 hours (range 26 to 76 hours), and with acute viral hepatitis to 74 hours (range 49 to 129). In chronic active hepatitis, clearance is decreased by almost half.

 

 

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