Valium

Overdosage & Contraindications

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Management of Overdosage

Manifestations of Valium overdosage include somnolence, confusion, coma and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. Hypotension may be combated by the use of Levophed® (levarterenol) or Aramine (metaraminol). Dialysis is of limited value.

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. The complete flumazenil package insert, including CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, should be consulted prior to use.
CONTRAINDICATIONS

Valium Injection is contraindicated in patients with a known hypersensitivity to this drug; acute narrow angle glaucoma; and open angle glaucoma unless patients are receiving appropriate therapy.

Clinical Pharmacology

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ACTIONS

In animals, diazepam appears to act on parts of the limbic system, the thalamus and hypothalamus, and induces calming effects. Diazepam, unlike chlorpromazine and reserpine, has no demonstrable peripheral autonomic blocking action, nor does it produce extrapyramidal side effects; however, animals treated with diazepam do have a transient ataxia at higher doses. Diazepam was found to have transient cardiovascular depressor effects in dogs. Long-term experiments in rats revealed no disturbances of endocrine function. Injections into animals have produced localized irritation of tissue surrounding injection sites and some thickening of veins after intravenous use.

Valium Injection-Description

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VALIUM® Inj
brand of diazepam Injection

For relief of acute anxiety when rapid action is required In acute alcohol withdrawal As a useful adjunct in

· endoscopic procedures · skeletal muscle spasm associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome, tetanus · status epilepticus and severe recurrent convulsive seizures

As premedication in patients undergoing

· surgical procedures † cardioversion

DESCRIPTION

Each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% ethyl alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative.

Diazepam is a benzodiazepine derivative developed through original Roche research. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water and has a molecular weight of 284.74. Its structural formula is as follows:

Valium Injection-Warnings & Precautions

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When used intravenously, the following procedures should be undertaken to reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, and, rarely, vascular impairment: the solution should be injected slowly, taking at least 1 minute for each 5 mg (1 mL) given; do not use small veins, such as those on the dorsum of the hand or wrist; extreme care should be taken to avoid intra-arterial administration or extravasation.

Do not mix or dilute Valium with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer Valium directly IV, it may be injected slowly through the infusion tubing as close as possible to the vein insertion.

Extreme care must be used in administering Valium Injection, particularly by the IV route, to the elderly, to very ill patients and to those with limited pulmonary reserve because of the possibility that apnea and/or cardiac arrest may occur. Concomitant use of barbiturates, alcohol or other central nervous system depressants increases depression with increased risk of apnea. Resuscitative equipment including that necessary to support respiration should be readily available.

When Valium is used with a narcotic analgesic, the dosage of the narcotic should be reduced by at least one-third and administered in small increments. In some cases the use of a narcotic may not be necessary.

Valium Injection should not be administered to patients in shock, coma or in acute alcoholic intoxication with depression of vital signs. As is true of most CNS-acting drugs, patients receiving Valium should be cautioned against engaging in hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle.

Tonic status epilepticus has been precipitated in patients treated with IV Valium for petit mal status or petit mal variant status.

Usage in Pregnancy: An increased risk of congenital malformations associated with the use of minor tranquilizers (diazepam, meprobamate and chlordiazepoxide) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.

In humans, measurable amounts of diazepam were found in maternal and cord blood, indicating placental transfer of the drug. Until additional information is available, Valium Injection is not recommended for obstetrical use.

BRAND NAME: Valium

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DRUG CLASS: Diazepam is a member of the benzodiazepine family. Benzodiazepines are sedatives that cause dose-related depression of the central nervous system. They are useful in treating anxiety, insomnia, seizures, and muscle spasms.

PRESCRIPTION: yes

GENERIC AVAILABLE: yes

PREPARATIONS: Tablets (2mg, 5mg, 10mg).

STORAGE: Diazepam should be stored at room temperature in a tightly closed container.

PRESCRIBED FOR: Diazepam is used for the short-term relief of symptoms related to anxiety disorders. Diazepam is also used for the treatment of agitation, tremors, delirium, seizures, and hallucinations as a result of alcohol withdrawal. Diazepam is also used for relief of muscle spasms in certain neurological diseases. Diazepam is used to abort active seizures and can be combined with other drugs in treating severe recurrent seizures.

DOSING: Diazepam may be taken with or without food. Diazepam is metabolized by the liver and excreted mainly by the kidney. Dosages of diazepam may need to be lowered in patients with abnormal kidney function.

DRUG INTERACTIONS: Alcohol should be avoided by patients taking benzodiazepines. Diazepam can lead to addiction (dependency), especially at higher dosages over prolonged periods of time. Because of diazepam's addicting potential, dosages should never be increased by the patient. In patients addicted to diazepam, abrupt discontinuation of the medicine can lead to symptoms of withdrawal (insomnia, headaches, nausea, vomiting, lightheadedness, sweating, anxiety, and fatigue). Seizures can occur in more severe cases of withdrawal. Consequently, patients on diazepam for extended periods of time should slowly taper the medication under a doctor's supervision rather than abruptly stopping the medication. Tagamet can prolong the effects of diazepam and dosages may need to be decreased when these drugs are used together.

PREGNANCY: Benzodiazepines, such as diazepam, can cause fetal problems and should not be used in pregnancy.

NURSING MOTHERS: Benzodiazepines, such as diazepam, can cause fetal problems and should not be used in breast feeding mothers.

SIDE EFFECTS: The most frequent side effects of diazepam are drowsiness, fatigue, and ataxia (loss of balance). Rarely, diazepam causes a paradoxical reaction with excitability, muscle spasm, lack of sleep, and rage. Confusion, depression, speech problems, and double vision are also rare side effects of diazepam.

What is Valium (diazepam)?

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• Valium (diazepam) is in a class of drugs called benzodiazepines. Valium (diazepam) affects chemicals in the brain that may become unbalanced and cause anxiety, seizures, and muscle spasms.

• Valium (diazepam) is used to relieve anxiety, nervousness, and tension associated with anxiety disorders. It is also used to treat certain types of seizure disorders and muscle spasms.

• Valium (diazepam) may also be used for purposes other than those listed in this medication guide.

Valium diazepam

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What is the most important information I should know about Valium (diazepam)?

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Use caution when driving, operating machinery, or performing other hazardous activities. Valium (diazepam) will cause drowsiness and may cause dizziness. If you experience drowsiness or dizziness, avoid these activities.

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Avoid alcohol while taking Valium (diazepam). Alcohol may increase drowsiness and dizziness caused by Valium (diazepam). Alcohol may also increase the risk of having a seizure if Valium (diazepam) is being taken for a seizure condition

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Valium (diazepam) is habit forming. You can become physically and psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if Valium (diazepam) is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

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