Diazepam tablets, USP 2mg

Description

Diazepam tablets, USP 2mg, marketed as Valium in Germany from 1963 to 2015 (as Faustan in East Germany until 1990 ), is a psychoactive drug from the group of benzodiazepines with a relatively long half-life of 20 to 50 hours. Valium achieved a high level of awareness among the population – similar to aspirin – and was considered rose-colored glasses on prescription.  Diazepam is indicated for the treatment of anxiety, for the treatment of epileptic seizures, and for premedication before surgical and diagnostic interventions. Since long-term therapy with diazepam can lead to psychological and physical dependence, the active ingredient is primarily used in acute therapy – i.e. not longer than four to six weeks. Diazepam is included in the World Health Organization (WHO) List of Essential Medicines.

Areas of application 

In addition to its use for the symptomatic treatment of acute states of tension, excitement, and anxiety, diazepam is used as a premedication before surgical and diagnostic interventions. It is also used as a muscle relaxant and as an emergency therapeutic agent for the prophylaxis and anticonvulsant treatment of epileptic grand mal seizures and for the treatment of febrile convulsions in children. Diazepam is only justified as a sleeping pill if the diazepam effects during the day are desired at the same time.

Because of the risk of developing dependency, the duration of treatment should be as short as possible. Diazepam should be used with extreme caution in patients with a history of drug, alcohol, or other drug dependence.  Diazepam is also used intravenously (iv) as a life-saving antidote for chloroquine poisoning. 

Contraindications

Contraindications for treatment with diazepam are generally respiratory insufficiency (severe breathing difficulties), nocturnal breathing interruptions ( sleep apnea syndrome ), severe hepatic insufficiency (liver disease), myasthenia gravis (pathological muscle weakness ), as well as a history of dependence ( drugs, alcohol, other drugs) or acute intoxication with alcohol, sleeping pills, and painkillers or psychotropic drugs. 

dependency 

Diazepam, if taken regularly over a short period of time, can in particular cause psychological but also physical dependence. This applies not only to misuse but also to the therapeutic dose range. In Germany, around 1.9 million people are dependent on substances from the benzodiazepine class. Suddenly stopping therapy after prolonged use can cause severe withdrawal symptoms.

Use in Pregnancy

Some studies have described cardiac malformations, cleft lip/palate, and other complex malformations. Other studies could not confirm teratogenic effects. There are not enough studies about the later development of the child to be able to make reliable statements about it.  There are individual case reports of malformations and mental retardation in prenatally exposed children after overdoses and poisoning. Animal experiments have shown evidence of behavioral disorders in the offspring of dams given diazepam. 

If diazepam is taken regularly in the 2nd to 3rd trimester or in high doses before or during birth, serious adverse effects can occur in the newborn.

Diazepam tablets, USP 2mg

Adults

The short-term relief (2-4 weeks) only, of anxiety that is severe, disabling, or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic, or psychotic illness.

INDICATIONS AND USAGE

Diazepam tablets 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 tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens, and hallucinosis.

Diazepam tablets, USP 2mg is a useful adjunct for the relief of skeletal muscle spasms due to reflex spasms 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 tablets, USP 2mg 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.

CONTRAINDICATIONS

Diazepam tablets, USP 2mg 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 tablets are also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, and sleep apnea syndrome. They may be used in patients with open-angle glaucoma who are receiving appropriate therapy but are contraindicated in acute narrow-angle glaucoma.

Abuse, Misuse, and Addiction

The use of benzodiazepines, including diazepam tablets, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see DRUG ABUSE AND DEPENDENCE: Abuse).

Before prescribing Diazepam tablets, USP 2mg, and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of diazepam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of diazepam tablets along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drugs. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.

Dosage

2mg

QUANTITIES

• 100 PILLS
• 200 PILLS
• 300 PILLS

SALESPERSON

MICHEAL