Medicinal Products

DIAZEPAM TEVA 5 mg

Generic drug of Valium Roche
Therapeutic Class: Neurology-Psychiatry
Active ingredients: Diazepam
laboratory: Teva Sante

Compressed
Box of 40
All forms

Indication

· Symptomatic treatment of severe and / or disabling anxiety

· Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal.

Dosage DIAZEPAM TEVA 5 mg Tablet Box of 40

The tablet is not a form suitable for children under 6 years (risk of mis-driving).

Use in children should be exceptional.

Dose

In all cases, treatment will be initiated at the lowest effective dose and the maximum dose will not be exceeded.

The usual adult dosage in anxiety is 5 to 20 mg per day.

In psychiatry: 20 to 40 mg a day.

For low dosages, the 2 mg dosage form is the most suitable.

In children, the elderly, the renal failure or the hepatic insufficiency: it is recommended to reduce the dosage, by half for example.

duration

The treatment should be as short as possible. The indication will be reviewed regularly especially in the absence of symptoms. The overall duration of treatment should not exceed 8 to 12 weeks for the majority of patients, including the dose reduction period (see Warnings and Precautions section ).

In some cases, it may be necessary to prolong the treatment beyond the recommended periods. This requires accurate and repeated assessments of the patient's condition.

Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal: short treatment of the order of 8 to 10 days.

Against indications

This medicine should never be used in the following situations:

Hypersensitivity to the active substance or any of the other ingredients,

· Severe respiratory failure,

· sleep apnea syndrome,

· Severe hepatic insufficiency, acute or chronic (risk of encephalopathy),

Myasthenia.

Adverse effects Diazepam Teva

They are related to the dose ingested, the individual sensitivity of the patient.

Neuropsychiatric side effects (see Warnings and precautions for use section )

· Anterograde amnesia, which can occur at therapeutic doses, the risk increasing in proportion to the dose,

· Behavior disorders, changes in consciousness, irritability, aggression, agitation,

· Physical and mental dependence, even at therapeutic doses with withdrawal syndrome or rebound at discontinuation of treatment,

· Lightheadedness, headache, ataxia,

Confusion, decreased alertness or drowsiness (particularly in the elderly), insomnia, nightmares, tension,

· Changes in libido.

Cutaneous adverse effects

· Skin rash, itchy or otherwise.

General side effects

· Muscular hypotonia, asthenia.

Ocular adverse effects

· Diplopia.

Very rare cases of increased transaminases and alkaline phosphatase, as well as jaundice, have been reported.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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