A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tegretol Indications, Dosage, Storage, Stability - Carbamazepine
Tegretol Indications, Dosage, Storage, Stability - Carbamazepine
Epilepsy: Carbamazepine is indicated for use as an anticonvulsant
drug. Evidence supporting efficacy
of carbamazepine
as an anticonvulsant was derived from active drug-controlled studies
that enrolled patients with the following seizure
types:
Partial seizures with complex
symptomatology
(psychomotor, temporal lobe). Patients with these seizures appear
to show greater improvement
than those with other types.
Generalized tonic-clonic seizures (grand mal).
Mixed seizure patterns
which include the above, or other partial or generalized seizures.
Absence seizures (petit mal) do not appear to be controlled by
carbamazepine
(see PRECAUTIONS, General).
Trigeminal Neuralgia: Carbamazepine is indicated in the
treatment of the pain associated
with true trigeminal
neuralgia.
Beneficial results have also been reported in glossopharyngeal
neuralgia.
This drug is not a simple
analgesic and should
not be used for the relief of trivial aches or pains.
DOSAGE AND ADMINISTRATION
TABLE 1A - Dosage Information: Tablets and Suspension
| Indication |
Initial Dose |
| Tablet |
Suspension |
| Epilepsy |
|
|
| 6-12 years of age |
100 mg
b.i.d. |
1/2 teaspoon
q.i.d. |
| (200 mg/day) |
(200 mg/day) |
|
| >12 years of age |
200 mg
b.i.d. |
1 teaspoon
q.i.d. |
| (400 mg/day) |
(400 mg/day) |
|
| Trigeminal Neuralgia |
100 mg
b.i.d. on the first
day |
1/2 teaspoon
q.i.d. |
| (200 mg/day) |
(200 mg/day) |
|
TABLE 1B - Dosage Information: Tablets and Suspension
|
Subsequent Dose |
Maximum Dose |
|
Tablet |
Suspension |
Tablet or Suspension |
| Epilepsy |
|
|
|
| 6-12 years of age |
Add up to 100 mg
per day at weekly intervals,
t.i.d. or q.i.d. |
Add up to 1 teaspoon
(100 mg) per day at
weekly intervals, t.i.d.
or q.i.d. |
1000 mg/24 hours |
| > 12 years of age |
Add up to 200 mg
per day at weekly intervals,
t.i.d. or q.i.d. |
Add up to 2 teaspoons (200 mg) per
day at weekly intervals, t.i.d. or q.i.d. |
1000 mg/24 hours: 12-15 years |
| 1200 mg/24 hours: over 15 years |
|
|
|
| 1600 mg/24 hours: adults in rare instances |
|
|
|
| Trigeminal Neuralgia |
Add up to 200 mg
per day in increments
of 100 mg every 12 hrs. |
Add up to 2 teaspoons (mg) per
day q.i.d. |
1200 mg/24 hours |
Monitoring of blood levels
has increased the efficacy
and safety of anticonvulsants (see PRECAUTIONS,
Laboratory Tests). Dosage should be adjusted to the needs of
the individual patient. A low initial daily dosage
with a gradual increase is advised. As
soon as adequate control is achieved, the dosage
may be reduced very gradually to the minimum effective level. Medication
should be taken with meals.
Since a given dose of
carbamazepine
suspension will
produce higher peak levels than the same dose
give as the tablet, it
is recommended to start with low doses (children 6-12 years: 1/2
teaspoon four times
a day) and to increase slowly to avoid unwanted side
effects.
Conversion Of Patients From Oral Carbamazepine Tablets To Carbamazepine
Suspension: Patients should be converted by administering the
same number of mg per
day in smaller, more frequent doses (i.e., twice a day tablets
to three times a day suspension).
Epilepsy
(see INDICATIONS
)
Adults And Children Over 12 Years Of Age
Initial: Either 200 mg
twice a day for tablets and extended release tablets or 1 teaspoon
four times a day for suspension
(400 mg per
day). Increase at weekly intervals by adding up to 200 mg
per day using a twice a
day regimen of extened
release or three times
a day or four times a day regimen until the optimal response
is obtained. Dosage generally should not exceed 1000 mg
daily in children 12 to 15 years of age, and 1200 mg daily in patients
above 15 years of age. Doses up to 1600 mg
daily have been used in adults in rare instances.
Maintenance: Adjust dosage
to the minimum effective
level, usually 800-1200 mg
daily.
Children 6 - 12 Years Of Age
Initial: Either 100 mg
twice a day for tablets or 1/2 teaspoon four times a day for suspension
(200 mg per
day). Increase at weekly intervals by adding up to 100 mg
per day using a three times
a day or four times a day regimen
until the optimal response
is obtained. Dosage generally should not exceed 1000 mg
daily.
Maintenance: Adjust dosage
to the minimum effective
level, usually 400-800 mg
daily.
Combination Therapy: Carbamazepine may be used alone or
with other anticonvulsants. When added to existing anticonvulsant
therapy, the drug should
be added gradually while the other anticonvulsants are maintained
or gradually decreased, except phenytoin, which may have to be increased
(see PRECAUTIONS and DRUG
INTERACTIONS).
Trigeminal Neuralgia
(see INDICATIONS
)
Initial: On the first day, either 100 mg
twice a day for tablets or 1/2 teaspoon
four times a day for suspension
for a total daily dose of 200 mg. This daily dose
may be increased by up to 200 mg
a day using increments of 100 mg
every 12 hours for tablets or 50 mg
(1/2 teaspoon) four times a day for suspension,
only as needed to achieve freedom from pain. Do not exceed 1200
mg/daily.
Maintenance: Control of pain can be maintained in most patients
with 400 mg to 800 mg
daily. However, some patients may be maintained on as little as
200 mg daily, while others
may require as much as 1200 mg
daily. At least once every
3 months throughout the treatment
period, attempts should be made to reduce
the dose to the minimum
effective level or even to discontinue the drug.
HOW SUPPLIED
No information provided.
Storage
Do not store above 86°F (30°C).
Dispense in tight, light-resistant container
(USP).
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