Capitalizing on our strong medical experience and expert medical advisors, we bring forth hygienic array of Yashi-CBZ tablets that is chemically constituted of carbamazepine USP 200 mg. Carbamazepine is a synthetic chemical compound that belongs to the benzodiazepine class and is used as an analgesic and anticonvulsant drug. It functions by reducing the impact of pain causing nerve impulses and are also used for the treatment of bipolar disorder. The prescription suggested by the doctor should be strictly followed and the pill should be consumed whole without crushing or breaking into pieces. It should be stored at room temperature and kept away from direct sunlight, moisture or heat.
| Composition: |
- Each uncoated tablet contains: Carbamazepine USP 200 mg,
excipients Q S
|
| ATC Code: |
|
| Therapeutic Class: |
- Anti-epileptic, neurotropic and psychotropic agent, dibenzazepine derivative.
|
| Indications: |
- For epilepsy - generalized tonic-clonic and partial seizures.
Yashi-CBZ is not usually effective in absences (petit mal) and
myoclonic seizures. Moreover, seizure exacerbation may occur in
patients with atypical absences. For the paroxysmal pain of
trigeminal neuralgia. For the prophylaxis of manic-depressive
psychosis in patients unresponsive to lithium therapy.
|
| Dosage & administration: |
- Yashi-CBZ is given orally, usually in two or three divided doses.
Tablets may be taken after or between meals, with a little liquid
e.g. a glass of water.
|
| For Epilepsy: |
- The dose of Yashi-CBZ should be adjusted to the needs of the
individual patient to achieve adequate control of seizures. In the
treatment of epilepsy, the dose of carbamazepine usually requires
total plasma-carbamazepine concentrations of about 4 to 12
micrograms/mL (17 to 50 micromoles/L)
- Adults: Initially 100-200 mg once or twice daily is
recommended. This may be followed by slow increase until the best
response is obtained, often 800-1200mg daily. In some instances,
1600mg or even 2000mg daily may be necessary.Elderly: Due to the
potential for drug interactions, the dosage of YASHI-CBZ should be
selected with caution in elderly patients.
- Elderly: Due to the potential for drug interactions, the dosage of YASHI-CBZ should be selected with caution in elderly patients.
- Children and adolescents: YASHI-CBZ tablets are not
recommended for very young children.
- 5 to 10 years: 400 to 600 mg daily (2 to 3 × 200 mg
tablets per day, to be taken in divided
- 10 to 15 years: 600 to 1000mg daily (3 to 5 × 200 mg
tablets per day, to be taken in several divided doses)
- >15 years of age: 800 to 1200mg daily (same as adult
dose)
|
| For trigeminal neuralgia: |
- Slowly raise the initial dosage of 200-400mg daily until freedom
from pain is achieved (normally at 200mg 3-4 times daily). A dosage
of 200mg 3 or 4 times a day is sufficient to maintain a pain- free
state, but doses of 1600 mg Yashi-CBZ daily may be needed in some
patients. Once the pain is in remission, the dosage should be
gradually reduced to the lowest possible maintenance level. Maximum
recommended dose is 1200mg/day. When pain relief is obtained,
attempts should be made to gradually discontinue therapy, until
another attack occurs.
- Elderly:Due to drug interactions and different antiepileptic drug
pharmacokinetics, the dosage of yashi- CBZ should be selected with
caution in elderly patients. In elderly patients, an initial dose of
100mg twice daily is recommended and should be slowly raised daily
until freedom from pain is achieved (normally at 200mg 3 to 4 times
daily). The dosage should then be gradually reduced to the lowest
possible maintenance level. Maximum recommended dose is 1200mg/day.
When pain relief is obtained, attempts should be made to gradually
discontinue therapy, until another attack occurs. For the
prophylaxis of manic depressive psychosis in patients unresponsive
to lithium therapy: initial starting dose of 400mg daily, in divided
doses, increasing gradually until symptoms are controlled or a total
of 1600mg given in divided doses is reached. The usual dosage range
is 400-600mg daily, given in divided doses.
- For the prophylaxis of manic depressive psychosis in patients unresponsive to lithium therapy: Initial starting dose of 400mg daily, in divided doses, increasing gradually until symptoms are controlled or a total of 1600mg given in divided doses is reached. The usual dosage range is 400-600mg daily, given in divided doses.
|
| Pharmacological action: |
- The mechanism of action of carbamazepine, the active substance of
Yashi-CBZ, has only been partially elucidated. Carbamazepine
stabilizes hyperexcited nerve membranes, inhibits repetitive
neuronal discharges and reduces synaptic propagation of excitatory
impulses. It is conceivable that prevention of repetitive firing of
sodium-dependent action potentials in depolarized neurons via use-
and voltage-dependent blockade of sodium channels may be its main
mechanism of action. Whereas reduction of glutamate release and
stabilization of neuronal membranes may account for the
antiepileptic effects, the depressant effect on dopamine and
noradrenaline turnover could be responsible for the antimanic
properties of carbamazepine.
|
| Adverse effects: |
- Commonly occurring adverse effects are leucopenia,
thrombocytopenia, eosinophilia, oedema, fluid retention, weight
increase, hyponatraemia and blood osmolarity decreased due to an
antidiuretic hormone (ADH)-like effect, leading in rare cases to
water intoxication accompanied by lethargy, vomiting, headache,
confusion state, neurological disorders, ataxia, dizziness,
somnolence, diplopia, blurred vision, lenticular opacities,
conjunctivitis, nausea, dry mouth, urticaria, which may be severe
dermatitus allergic, fatigue, gamma-glutamyltransferase increase
(due to hepatic enzyme induction), blood alkaline phosphatase
increase.
|
| Contraindications: |
- Carbamazepine should not be used in patients with a history of
previous bone marrow depression, hypersensitivity to the drug, or
known sensitivity to any of the tricyclic compounds, such as
amitriptyline, desipramine, imipramine, protriptyline,
nortriptyline, etc. Before administration of carbamazepine, MAO
inhibitors should be discontinued for a minimum of 14 days, or
longer if the clinical situation permits. Co-administration of
carbamazepine with nefazodone is contraindicated.
|
| Warnings & precautions: |
- Carbamazepine should be used with caution in patients with a
mixed seizure disorder that includes atypical absence seizures due
to a possible increase in frequency of generalized convulsions.
Patients should exercise caution when driving a vehicle or operating
machinery. Caution should be exercised if alcohol is taken in
combination with carbamazepine therapy, due to a possible additive
sedative effect. Therapy of Yashi-CBZ should be prescribed with
caution only after critical benefit-to-risk appraisal in patients
with a history of cardiac conduction disturbance, including second
and third degree AV heart block, cardiac, hepatic or renal damage,
adverse hematologic or hypersensitivity reaction to other drugs,
including reactions to other anticonvulsants or interrupted courses
of therapy with carbamazepine. Carbamazepine can cause fetal harm
when administered to a pregnant woman hence not recommended
generally. Carbamazepine and its epoxide metabolite are transferred
to breast milk. Because of the potential adverse reactions in
nursing infants from carbamazepine, discontinuation of nursing or
the drug should be judged appropriately taking into account the
importance of the drug to the mother.
|
| Drug interactions: |
- Cytochrome P450 3A4 (CYP 3A4) is the main enzyme catalyzing
formation of the active metabolite carbamazepine 10, 11-epoxide.
Co-administration of inhibitors of CYP 3A4 may result in increased
carbamazepine plasma concentrations which could induce adverse
reactions. Co- administration of CYP 3A4 inducers might increase the
rate of carbamazepine metabolism, thus leading to potential
decreases in the carbamazepine serum level and therapeutic effect.
Similarly, discontinuation of a CYP3A4 inducer may decrease the rate
of metabolism of carbamazepine, leading to an increase in
carbamazepine plasma levels.
|
| Storage: |
- Store below temperature 25°C. Protect from moisture.
- Keep out of reach of children
|
| Presentation: |
- 500 tablets in a plastic jar
|
©
Yashica Pharmaceuticals Private Limited. All Rights Reserved (Terms
of Use)
