KRATIUM Tablet Ref.[27828] Active ingredients: Diazepam

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: Medochemie Ltd, p.o box 51409, Limassol, CY – 3505, Cyprus

4.1. Therapeutic indications

Diazepam tablets are indicated in treatment of:

  1. Anxiety disorder or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
  2. Muscle spasm
  3. Insomnia
  4. Epilepsy

It is also used in acute alcohol withdrawal; Diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.

4.2. Posology and method of administration

Kratium tablets are for oral 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 require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.

Anxiety disorders and transient symptoms of anxiety

Diazepam may be given for severe anxiety in oral doses of 2 mg three times daily to a maximum of 30 mg daily. If side effects occur at the recommended starting dose, the dose may be lowered.

Insomnia

The benzodiazepines have a limited role in insomnia and diazepam is used for the short-term management of insomnia associated with anxiety in a dose of 5 to 15 mg by mouth at bedtime. Doses of 1 to 5 mg at bedtime have been used in children to control night terrors and sleepwalking.

Diazepam may be given for premedication before general anaesthesia or to provide sedative cover for minor surgical or investigative procedures. Doses by mouth are in the range of 5 to 20 mg.

Epilepsy

Diazepam is used in a variety of seizures. It is given by mouth as an adjunct in some types of epilepsy; for this purpose, 2 to 60 mg may be given daily in divided doses.

Muscle spasm

Diazepam may be given by mouth in daily divided doses of 2 to 15 mg to alleviate muscle spasm. The dose may be increased in severe spastic disorders, such as cerebral palsy, to up to 60 mg daily in adults or up to 40 mg daily in children.
Symptoms of the alcohol withdrawal syndrome may be controlled by diazepam given by mouth in a dose of 5 to 20 mg, repeated if required after 2 to 4 hours; another approach is to give 10 mg three or four times on the first day reducing to 5 mg three or four times daily as required.

Dosage in patients with renal failure:

No dosage adjustment is required in patients with renal failure
Patients receiving greater than 15 milligrams/day should be under observation, due to an accumulation of active metabolites which are excreted by the kidneys.

Dosage in hepatic insufficiency

Metabolism of diazepam in patients with liver disease is impaired and the elimination half-life is prolonged. Because of reduced diazepam clearance in patients with cirrhosis, daily dosage should be reduced by about 50%.

Dosage in geriatric patients

Usual recommended initial oral dose is 2 to 2.5 milligrams once a day to twice a day initially; increase gradually as needed and tolerated.

4.9. Overdose

Impairment of consciousness is fairly rapid in poisoning by benzodiazepines. (1) Deep coma or other manifestations of severe depression of brainstem vital functions are rare; more common is a sleep-like state from which the patient can be temporarily roused by appropriate stimuli. There is usually little or no respiratory depression, and cardiac rate and rhythm remain normal in the absence of anoxia or severe hypotension. Since tolerance to benzodiazepines develops rapidly, consciousness is often regained while concentrations of drug in the blood are higher than those which induced coma. Anxiety and insomnia can occur during recovery from acute overdosage, while a full-blown withdrawal syndrome, possibly with major convulsions, can occur in patients who have previously been chronic users.

The treatment of benzodiazepine overdosage is generally symptomatic and supportive. Activated charcoal may be given to those patients who have taken more than 1 mg per kg body-weight of diazepam (or its equivalent) and who present within 1 hour. Gastric lavage is generally not advocated in overdoses of benzodiazepines alone. The specific benzodiazepine antagonist, flumazenil, is rarely required; if used expert advice is essential since serious adverse effects may occur in patients dependent on benzodiazepines. It should be used with extreme caution, if at all, in multiple drug overdoses or for the differential diagnosis of unclear cases of overdose.

6.3. Shelf life

Kratium 2mg, 5mg and 10mg tablets: 60 months.

6.4. Special precautions for storage

Store below 25°C in the original package, in order to protect from light and moisture.

6.5. Nature and contents of container

Kratium tablets 2mg are packed in PVC foil and Aluminium foil, packs of 40 tabs are available. PVC securitainers of 1000 tablets are also available.

Kratium tablets 5mg are packed in PVC foil and Aluminium foil, packs of 40 are available. PVC securitainers of 1000 tablets are also available.

Kratium tablets 10mg are packed in PVC foil and Aluminium foil, packs of 30, 40 and 100tablets are available. PVC securitainers of 1000 tablets are also available.

6.6. Special precautions for disposal and other handling

None.

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