Manufacturer: Pacific Pharmaceuticals manufactures Lithicarb.

Uses:

The uses of Lithicarb include:
Indications

1.Treatment of mania and hypomania.

2.Lithium may also be tried in the treatment of some patients

with recurrent bipolar depression, for which treatment with

other antidepressants has been unsuccessful.

3.Prophylactic treatment of recurrent affective disorders.

Dosage and Administration

A simple treatment schedule has been evolved which, except for some minor variations, should be followed whether using LITHICARB FC therapeutically or prophylactically. The minor variations to this schedule depend on the elements of the illness being treated and these are described later.

1. In patients of average weight (70kg) an initial dose of 400-

1,200mg of LITHICARB FC may be given as a single daily

dose in the morning or on retiring. Alternatively, the dose

may be divided and given morning and evening. The tablets

should not be crushed, chewed or swallowed with hot

liquids. When changing from other lithium preparations

serum lithium levels should first be checked, then

2. LITHICARB FC therapy commenced at a daily dose as

close as possible to the dose of the other form of lithium.

As bioavailability varies from product to product (particularly

with regard to retard or slow release preparations), a

change of product should be regarded as initiation of new

treatment.

3. Four to five days after starting treatment (and never longer

than one week) a blood sample should be taken for the

estimation of serum lithium level.

4. The objective is to adjust the LITHICARB FC dose so as to

maintain the serum lithium level permanently within the

diurnal range of 0.5 - 1.5 mmol/L. In practice, the blood

sample should be taken between 12 and 24 hours after the

previous dose of LITHICARB FC. 'Target' serum lithium

concentrations at 12 and 24 hours are shown in Table 1.

LITHICARB FC tablets are scored, therefore they can be divided accurately to provide dosage adjustments as small as 125mg. Serum lithium levels should be monitored weekly until stabilisation is achieved.

Table 1. Target serum lithium concentrations

"Target" serum lithium concentration (mmol/L)

At 12 hours At 24 hours

Once daily dosage 0.7 - 1.0 0.5 - 0.8

Twice daily dosage 0.5 - 0.8

4. Lithium therapy should not be initiated unless adequate

facilities for routine monitoring of serum concentrations are

available. Following stabilisation of serum lithium levels,

the period between subsequent estimations can be

increased gradually but should not normally exceed three

months. Additional measurements should be made

following alteration of dosage, on development of

intercurrent disease, signs of manic or depressive relapse,

following significant change in sodium or fluid intake, or if

signs of lithium toxicity occur.

5. Whilst a high proportion of acutely ill patients may respond

within three to seven days of the commencement of

LITHICARB FC therapy, LITHICARB FC should be

continued through any recurrence of the affective

disturbance. This is important as the full prophylactic effect

may not occur for 6 to 12 months after the initiation of

therapy.

6. In patients who show a positive response to LITHICARB FC

therapy, treatment is likely to be long term. Careful clinical

appraisal of the patient should be exercised throughout

medication (see Precautions).

Treatment of Acute Mania, Hypomania and Recurrent Bipolar Depression:

It is likely that a higher than normal LITHICARB FC intake may be necessary during an acute phase and divided doses would be required here. Therefore, as soon as control of mania or depression is achieved, the serum lithium level should be determined and it may be necessary, dependent on the results, to lower the dose of LITHICARB FC and re-stabilise serum lithium levels. In all other details the described treatment schedule is recommended.

Prophylactic Treatment of Recurrent Affective Disorders

It is recommended that the described treatment schedule is followed.

Use in the Elderly:

In elderly patients or those below 50kg in weight, it is recommended that the starting dose be 400mg. Elderly patients may be more sensitive to undesirable effects of lithium and may also require lower doses in order to maintain normal serum lithium levels. It follows therefore that long term patients often require a reduction in dosage over a period of years.

Use in Children and Adolescents

Not recommended.