Manufacturer: Intas Pharmaceuticals manufactures Intalith CR.
The uses of Intalith CR include:
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
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
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