Zen Tablets (Generic Carbamazepine Tablets)

Zen Tablets (Generic Carbamazepine Tablets)
© The Swiss Pharmacy

Zen (Generic Carbamazepine Tablets) is used as an
anticonvulsant medicine to treat Partial seizures with
complex symptomatology (psychomotor, temporal lobe),
Generalized tonic-clonic seizures (grand mal) and Mixed
seizure patterns which include the above, or other partial or
generalized seizures. Carbamazepine is also used in the
treatment of the pain associated with true trigeminal
neuralgia.

Zen Tablets are manufactured by Intas Pharmaceuticals
Limited, India in the strengths of 100 mg and 200 mg.

Chemical Structure

The active ingredient contained in Zen tablets is
Carbamazepine.
100mg: Each uncoated dispersible Zen tablet
contains 100 mg of Carbamazepine.
200mg: Each uncoated Zen tablet contains 200 mg
of Carbamazepine.

Uses of Zen 100 mg and 200 mg Tablets:
Zen (Generic Carbamazepine Tablets) is used to treat certain types of
seizures (eg, partial seizures, tonic-clonic seizures) and bipolar disorder. It is
also used to relieve pain caused by trigeminal neuralgia (tic douloureux).
Zen is indicated for use as an anticonvulsant medication that is used to
treat:
1) Partial seizures with complex symptomatology (psychomotor, temporal
lobe). Patients with these seizures appear to show greater improvement
than those with other types.
2) Generalized tonic-clonic seizures (grand mal).
3) Mixed seizure patterns which include the above, or other partial or
generalized seizures.
Absence seizures (petitmal) do not appear to be controlled by
Carbamazepine.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html

Uses of Zen 100 mg and 200 mg Tablets:
Zen tablets are also used in the treatment of the pain associated with true
trigeminal neuralgia.
Beneficial results have also been reported in glossopharyngeal neuralgia.
This medicine is also used for the prophylaxis of manic-depressive
psychosis in patients unresponsive to lithium therapy.
This medicine is not a simple analgesic and should not be used for the relief
of trivial aches or pains.

Recommended Adult Dosage
For most patients (Adults and children over 12 years of age),
the starting dose of Zen Tablets (Generic Carbamazepine
Tablets) for the treatment of Epilepsy is 200 mg twice a day.
Dosage is to be increased at weekly intervals by adding up to
200 mg/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 in children 12 to 15
years of age, and 1200 mg daily in patients above 15 years of
age.

The maintenance dose for the treatment of Epilepsy : Adjust
dosage to the minimum effective level, usually 800mg to 1200
mg daily.
Treatment of Epilepsy In Children 6 to 12 years of age: The
initial dosage is 100 mg twice a day. Increase at weekly
intervals by adding up to 100 mg/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 400mg to 800 mg daily.

Trigeminal Neuralgia In Adults:
Initial Dosage: On the first day, 100 mg twice a day for a total
daily dose of 200 mg. This daily dose may be increased by up
to 200 mg/day using increments of 100 mg every 12 hours 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 400mg 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.

Contraindications
➔
Zen tablets are contraindicated in patients with a known hypersensitivity to
Carbamazepine or known sensitivity to any of the tricyclic compounds, such as
Amitriptyline, Desipramine, Imipramine, Protriptyline, Nortriptyline, etc. or any
component of the tablet.
➔
Use of Zen tablets (Generic Carbamazepine Tablets) with monoamine oxidase
inhibitors is not recommended. 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 and Nefazodone may result in
insufficient plasma concentrations of nefazodone and its active metabolite to
achieve a therapeutic effect. Co-administration of Carbamazepine with
Nefazodone is contraindicated.

Storage Instructions
Zen Tablets (Generic Carbamazepine Tablets) have
to be stored at controlled room temperature i.e. from
20°C to 25°C (68°F to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away from
children and pets.

Warnings
Serious and sometimes fatal dermatologic reactions, including toxic
epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been
reported with carbamazepine treatment. The risk of these events is estimated
to be about 1 to 6 per 10,000 new users in countries with mainly Caucasian
populations. However, the risk in some Asian countries is estimated to be
about 10 times higher. Carbamazepine (Zen tablets) should be discontinued
at the first sign of a rash, unless the rash is clearly not drug-related.
Retrospective case-control studies have found that in patients of Chinese
ancestry there is a strong association between the risk of developing
SJS/TEN with Carbamazepine treatment and the presence of an inherited
variant of the HLA-B gene, HLA-B*1502. The occurrence of higher rates of
these reactions in countries with higher frequencies of this allele suggests
that the risk may be increased in allele-positive individuals of any ethnicity.

Warnings
Patients with a history of adverse hematologic reaction to any drug
may be particularly at risk of bone marrow depression.
Carbamazepine (Zen tablets) has shown mild anticholinergic activity;
therefore, patients with increased intraocular pressure should be
closely observed during therapy.
Because of the relationship of the drug to other tricyclic compounds,
the possibility of activation of a latent psychosis and, in elderly patients,
of confusion or agitation should be borne in mind.
The use of Carbamazepine (Zen tablets) should be avoided in patients
with a history of hepatic porphyria (e.g., acute intermittent porphyria,
variegate porphyria, porphyria cutanea tarda). Acute attacks have been
reported in such patients receiving Carbamazepine therapy.

Warnings
Carbamazepine tablets administration has also been demonstrated to
increase porphyrin precursors in rodents, a presumed mechanism for
the induction of acute attacks of porphyria.
As with all antiepileptic drugs, Carbamazepine (Zen tablets) should be
withdrawn gradually to minimize the potential of increased seizure
frequency.
Before starting therapy, a detailed history and physical examination
should be made.
Carbamazepine should be used with caution in patients with a mixed
seizure disorder that includes atypical absence seizures, since in these
patients Carbamazepine has been associated with increased
frequency of generalized convulsion.

Possible Side Effects
Most commonly reported side effects with Carbamazepine (Zen
tablets) are CNS disturbances (e.g., drowsiness, headache,
unsteadiness on the feet, diplopia, dizziness), gastrointestinal
disturbances (nausea, vomiting), and allergic skin reactions.
The more serious side effects observed are the hematologic,
hepatic, cardiovascular and dermatologic reactions, which require
discontinuation of therapy.

Zen Tablets Overdosage
The presenting signs and symptoms of overdosage involve the central
nervous, cardiovascular, respiratory systems and the side effects
observed at the prescribed dose.
Central nervous system: CNS depression; disorientation, depressed level
of consciousness, somnolence, agitation, hallucination, coma; blurred
vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, initially
hyper-reflexia, later hyporeflexia; convulsions, psychomotor disturbances,
myoclonus, hypothermia, mydriasis.
Respiratory system: Respiratory depression, pulmonary oedema.
Cardiovascular system: Tachycardia, hypotension and at times
hypertension, conduction disturbance with widening of QRS complex;
syncope in association with cardiac arrest.
Gastro-intestinal system: Vomiting, delayed gastric emptying, reduced
bowel motility.

Zen Tablets Overdosage
Musculoskeletal system: There have been some cases which reported
rhabdomyolysis in association with carbamazepine toxicity.
Renal function: Retention of urine, oliguria or anuria; fluid retention, water
intoxication due to ADH-like effect of carbamazepine.
Laboratory findings: Hyponatraemia, possibly metabolic acidosis, possibly
hyperglycaemia, increased muscle creatine phosphokinase.

Treatment of Overdosage
There is no specific antidote for Carbamazepine (Zen tablets).
Management should initially be guided by the patient's clinical condition.
Admission to hospital is necessary. Measurement of the plasma level to
confirm Carbamazepine poisoning and to ascertain the size of the
overdose.
Evacuation of the stomach, gastric lavage, and administration of activated
charcoal.
Delay in evacuating the stomach may result in delayed absorption,
leading to relapse during recovery from intoxication.
Supportive medical care in an intensive care unit with cardiac monitoring
and careful correction of electrolyte imbalance.

Zen Tablets During Pregnancy
Carbamazepine (Zen Tablets) has been classified by the US FDA as
Pregnancy Category D.
Carbamazepine can cause fetal harm when administered to a pregnant
woman. Epidemiological data suggest that there may be an association
between the use of Carbamazepine (Zen tablets) during pregnancy
and congenital malformations, including spina bifida.
There have also been reports that associate Carbamazepine with
developmental disorders and congenital anomalies (e.g., craniofacial
defects, cardiovascular malformations, hypospadias and anomalies
involving various body systems).

Zen Tablets During Pregnancy
Developmental delays based on neurobehavioral assessments have
been reported.
In treating or counseling women of childbearing potential, the
prescribing physician will wish to weigh the benefits of therapy against
the risks.
If this drug is used during pregnancy, or if the patient becomes
pregnant while taking Zen tablets, the patient should be apprised of
the potential hazard to the fetus.

Zen Tablets (Generic Carbamazepine Tablets) are
manufactured by Intas Pharmaceuticals Limited, India.

Zen Tablets (Generic Carbamazepine Tablets)

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