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Diazepam is a benzodiazepine used to treat anxiety, acute alcohol withdrawal, and seizures, also used to relieve muscle spasms

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Diazepam 5mg

Diazepam is a benzodiazepine used to treat anxiety, acute alcohol withdrawal, and seizures, also used to relieve muscle spasms and to provide sedation before medical procedures.   It works by enhancing the effects of a certain natural chemical in the body (GABA)

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Diazepam 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 empirical formula is C 1613ClN 2O and the molecular weight is 284.75. The structural formula is as follows:

Chemical Structure

Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose.

Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10.

Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1.

Indications and Usage for Diazepam

Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.

Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome.

Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.

The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

General Precautions

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.

Diazepam Dosage and Administration

Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.

ADULTS:USUAL DAILY DOSE:
Management of Anxiety Disorders and Relief of Symptoms of Anxiety.Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily
Symptomatic Relief in Acute Alcohol Withdrawal.10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed
Adjunctively for Relief of Skeletal Muscle Spasm.2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients, or in the presence of debilitating disease.2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated
PEDIATRIC PATIENTS:
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months.1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated

Discontinuation or Dosage Reduction of Diazepam

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam tablets or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactionsand DRUG ABUSE AND DEPENDENCE: Dependence).

Overdosage

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, hypotonia, hypotension, 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 respiration, pulse, and blood pressure. Vomiting should be induced (within 1 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 prescriber should 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.

MEDICATION GUIDE
DIAZEPAM (dye az’ e pam) TABLETS, C-IV
What is the most important information I should know about Diazepam Tablets?

  • Diazepam tablets are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.Get emergency help right away if any of the following happens:
    • Shallow or slowed breathing,
    • Breathing stops (which may lead to the heart stopping),
    • Excessive sleepiness (sedation)

    Do not drive or operate heavy machinery until you know how taking diazepam with opioids affects you.

  • Risk of abuse, misuse, and addiction.There is a risk of abuse, misuse, and addiction with benzodiazepines, including diazepam, which can lead to overdose and serious side effects including coma and death.
    • Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including diazepam.These serious side effects may also cause delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
    • You can develop an addiction even if you take diazepam tablets exactly as prescribed by your healthcare provider.
    • Take diazepam tablets exactly as your healthcare provider prescribed.
    • Do not share your diazepam tablets with other people .
    • Keep diazepam tablets in a safe place and away from children.

Physical dependence and withdrawal reactions.Diazepam tablets can cause physical dependence and withdrawal reactions.

  • Do not suddenly stop taking diazepam tablets.Stopping diazepam tablets suddenly can cause serious and life- threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions.
    Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
  • Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months,including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
  • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
  • Do not take more diazepam tablets than prescribed or take diazepam tablets for longer than prescribed.
What are diazepam tablets?

  • Diazepam tablets are a prescription medicine used:
    • to treat anxiety disorders
    • for the short-term relief of the symptoms of anxiety
    • to relieve the symptoms of alcohol withdrawal including agitation, shakiness (tremor), sudden and severe mental or nervous system changes (delirium tremens) and seeing or hearing things that others do not see or hear (hallucinations)
    • along with other medicines for the relief of muscle spasms
    • along with other medicines to treat seizure disorders
  • Diazepam tablets are a federal controlled substance (C-IV) because it contains diazepam that can be abused or lead to dependence.Keep diazepam tablets in a safe place to prevent misuse and abuse. Selling or giving away diazepam tablets may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
  • It is not known if diazepam tablets are safe and effective in children under 6 months of age.
  • It is not known if diazepam tablets are safe and effective for use longer than 4 months.
Do not take diazepam tablets if you:

  • are allergic to diazepam or any of the ingredients in diazepam tablets. See the end of this Medication Guide for a complete list of ingredients in diazepam tablets.
  • have a disease that can cause muscle weakness called myasthenia gravis
  • have severe breathing problems (severe respiratory insufficiency)
  • have severe liver problems
  • have a sleep problem called sleep apnea syndrome
Before you take diazepam tablets, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have lung disease or breathing problems
  • have liver or kidney problems
  • are pregnant or plan to become pregnant. Diazepam tablets may harm your unborn baby. You and your healthcare provider should decide if you should take diazepam tablets while you are pregnant.
  • are breastfeeding or plan to breastfeed. Diazepam passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take diazepam tablets. Do not breastfeed while taking diazepam tablets.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking diazepam tablets with certain other medicines can cause side effects or affect how well diazepam tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

How should I take diazepam tablets?

  • Take diazepam tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much diazepam tablets to take and when to take it.
  • Talk to your healthcare provider about slowly stopping diazepam tablets to avoid withdrawal symptoms.
  • If you take too much diazepam tablets, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of diazepam tablets?
Diazepam tablets may cause serious side effects, including:

  • See ” What is the most important information I should know about diazepam tablets?
  • Seizures.Taking diazepam tablets with other medicines used to treat epilepsy can cause an increase in the number or severity of grand mal seizures.
  • Diazepam tablets can make you sleepy or dizzy, and can slow your thinking or motor skills.
    • Do not drive, operate heavy machinery, or do other dangerous activities until you know how diazepam tablets affect you.
    • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking diazepam tablets without first talking to your healthcare provider.When taken with alcohol or drugs that cause sleepiness or dizziness, diazepam tablets may make your sleepiness or dizziness much worse.
  • Like other antiepileptic drugs, diazepam tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • trouble sleeping (insomnia)
  • acting on dangerous impulses
  • attempts to commit suicide
  • feeling agitated or restless
  • new or worse anxiety or irritability
  • an extreme increase in activity and talking (mania)
  • new or worse depression
  • new or worse panic attacks
  • acting aggressive, being angry, or violent
  • other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?

  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
The most common side effects of diazepam tablets include:

  • drowsiness
  • muscle weakness
  • fatigue
  • loss of control of body movements (ataxia)
These are not all the possible side effects of diazepam tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects Here
How should I store diazepam tablets?

  • Store diazepam tablets in a tightly closed container between 68°F to 77°F (20°C to 25°C) and out of the light.
  • Keep diazepam tablets and all medicines out of the reach of children .
General information about the safe and effective use of diazepam tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use diazepam tablets for a condition for which it was not prescribed. Do not give diazepam tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about diazepam tablets that is written for health professionals.
What are the ingredients in diazepam tablets?
Active ingredient:diazepam
Inactive ingredients:anhydrous lactose, magnesium stearate, and microcrystalline cellulose. The 5 mg tablets also contain D&C Yellow No. 10 and the 10 mg tablets also contain FD&C Blue No. 1.
Medication Guides available Here
Manufactured by:
walgreens

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