Generic Carbamazepine ER (Tegrital CR Tablets)

Generic Carbamazepine ER Tablets
© Clearsky Pharmacy
Generic Carbamazepine ER (Tegrital CR Tablets) is
known as an anticonvulsant or anti-epileptic medicine is
used to prevent and control seizures. It is used to treat
Partial seizures with complex symptomatology,
Generalized tonic-clonic seizures (grand mal) and
Mixed seizure patterns which include the above, or other
partial or generalized seizures.

Tegrital CR Tablets
Tegrital CR Tablets are manufactured
by Novartis India Limited.
(Website: www.novartis.in)

Carbamazepine Tablets – Brand Names
Carbamazepine tablets are available
as Tegretol, Tegretol XR, Tegrital,
Tegrital CR, Carbadac, Carbatol,
Carmaz, Fobigone, Gemtol, Gemtol
CR, Mazetol, Mazetol SR, Versitol,
Versitol Rtd, Versizur, Zen, Zen
Retard, and Zeptol.

Active Ingredient
The active ingredient contained in Tegrital CR
tablets is Carbamazepine. Each tablet of
Tegrital CR contains 200 mg, 300 mg or 400
mg of Carbamazepine.

Chemical Structure
The structure of Carbamazepine is given
below:

Uses of Tegrital CR Tablets
Tegrital CR Tablets (Generic Carbamazepine
ER) is a prescription medication used to treat
certain types of seizures (partial, tonic-clonic,
mixed) and certain types of nerve pain
(trigeminal neuralgia and glossopharyngeal
neuralgia).
This medicine works by decreasing the spread
of seizure activity in the brain and restoring the
normal balance of nerve activity.

Generic Carbamazepine ER Dosage
➢Epilepsy: The initial dosage is 100 mg to 200 mg once or
twice daily. The dosage should be slowly raised until an
optimum response is obtained which is generally at 400 mg
2 to 3 times daily. In some patients 1600 mg or even 2000
mg daily may be appropriate.
➢Acute mania and maintenance treatment of bipolar
affective disorders: The dosage range is about 400 mg to
1600 mg daily, the usual dosage being 400 to 600 mg daily
given in 2 to 3 divided doses. In acute mania, the dosage
should be increased rather quickly, whereas small dosage
increments are recommended for maintenance therapy
of bipolar disorders in order to ensure optimal tolerability.
The dosage of Tegrital CR tablets (Generic
Carbamazepine ER) is given below:

Tegrital CR Tablets Dosage
➢Alcohol-withdrawal syndrome: The average dosage: 200
mg 3 times daily. In severe cases, it can be raised during the
first few days (e.g. to 400 mg 3 times daily). At the start of
treatment for severe withdrawal manifestations, Tegrital CR
should be given in combination with sedative-hypnotic
drugs (e.g. clomethiazole, chlordiazepoxide). After the acute
stage has abated, Tegrital CR can be continued as
monotherapy.
➢Trigeminal neuralgia: The initial dosage of 200 to 400 mg
should be slowly raised daily until freedom from pain is
achieved (normally at 200 mg 3 to 4 times daily). The dosage
should then be gradually reduced to the lowest possible
maintenance level. Maximum recommended dose is 1200
mg/day.
The dosage of Generic Carbamazepine ER
(Tegrital CR tablets) is given below:

Tegrital CR Tablets Dosage
➢Painful diabetic neuropathy: The average dosage:
200 mg 2 to 4 times daily.
➢Diabetes insipidus centralis: The average dosage for
adults: 200 mg 2 to 3 times daily.
The dosage of Generic Carbamazepine ER
(Tegrital CR tablets) is given below:

Storage Instructions
Tegrital CR Tablets (Generic
Carbamazepine ER) have to be stored
at controlled room temperature i.e. from
25°C (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
Haematological effects: Agranulocytosis and aplastic
anaemia have been associated with Carbamazepine ER
(Tegrital CR Tablets). However, due to the very low
incidence of these conditions, meaningful risk estimates
for Tegrital CR are difficult to obtain.
Serious dermatologic reactions: Serious
dermatologic reactions, including toxic epidermal
necrolysis (TEN; also known as Lyell’s syndrome)
and Stevens-Johnson syndrome (SJS), have been
reported very rarely with this medicine.
Patients with serious dermatological reactions may
require hospitalization.

Warnings
Pharmacogenomics: There is growing evidence of
the role of different HLA alleles in predisposing
patients to immune-mediated adverse reactions.
Association with HLA-A*3101: Human Leukocyte
Antigen (HLA) -A*3101 may be a risk factor for the
development of hypersensitivity syndrome and
cutaneous adverse drug reactions such as SJS, TEN,
DRESS, AGEP and maculopapular rash.
Association with HLA-B*1502: Retrospective studies
in patients of Han Chinese and Thai origin found a
strong correlation between SJS/TEN skin reactions
associated with Carbamazepine tablets and the
presence in these patients of the Human Leukocyte
Antigene (HLA)-B*1502 allele.

Tegrital CR Tablets
Contraindications
Tegrital CR tablets are contraindicated in patients with a
hypersensitivity to Carbamazepine, to any of the tricyclic
compounds, such as Amitriptyline, Desipramine, Imipramine,
Protriptyline, Nortriptyline, etc., or any other component of
this medication.
Similarly, on theoretical grounds its use with monoamine
oxidase(MAO) inhibitors is not recommended. Before
administration of Tegrital CR, MAO inhibitors should be
stopped for a minimum of 14 days, or longer if the clinical
situation permits.
Co-administration of Carbamazepine and Nefazodone could
result in insufficient plasma concentrations of Nefazodone and
its active metabolite to achieve a therapeutic effect.
Coadministration of Carbamazepine with Nefazodone is also
contraindicated.

Generic Carbamazepine ER Side Effects
➢The most frequently observed Generic Carbamazepine ER
side effects, particularly during the initial phases of therapy, are
dizziness, drowsiness, unsteadiness, nausea, and vomiting. To
minimize the possibility of such reactions, therapy should be
started at the lowest dosage recommended.
➢Inform your doctor at once if you have:
➢fever, tired feeling, weakness, confusion, pale skin, feeling light-
headed or short of breath;
➢easy bruising, unusual bleeding (nose, mouth, vagina, or
rectum), purple or red pinpoint spots under your skin;
➢slow, fast, or pounding heartbeats;
➢confusion, vision problems, hallucinations;
➢ nausea, upper stomach pain, itching, loss of appetite, dark
urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
➢little or no urinating;
➢swelling, rapid weight gain;

Generic Carbamazepine ER Side Effects
➢Inform your doctor at once if you have:
➢problems with your fingernails or toenails;
or
➢severe skin reaction -- fever, sore throat,
swelling in your face or tongue, burning in
your eyes, skin pain, followed by a red or
purple skin rash that spreads (especially in
the face or upper body) and causes
blistering and peeling.

Generic Carbamazepine ER Overdose
Some of the symptoms of an overdose may
include agitation,shakiness, disorientation,
fainting, vomiting, difficulty breathing, fast and
irregular heartbeat, blurred vision and slurred
speech
The first signs and symptoms appear after 1 to
3 hours. Neuromuscular disturbances are the
most prominent. Cardiovascular disorders are
generally milder, and severe cardiac
complications occur only when very high doses
have been ingested. The lowest known lethal
dose: adults, 3.2 gms and children 1.6 gms.

Tegrital CR Tablets Overdose
The prognosis in cases of severe poisoning is
critically dependent upon prompt elimination of the
drug, which may be achieved by inducing vomiting,
irrigating the stomach, and by taking appropriate
steps to diminish absorption.
If these measures cannot be implemented without
risk on the spot, the patient must be transferred at
once to a hospital, while ensuring that vital functions
are safeguarded. There is no specific antidote.
Gastric lavage. Even when more than 4 hours have
elapsed following ingestion of the medicine, the
stomach must be repeatedly irrigated, especially if
the patient has also consumed alcohol.

Carbamazepine During Pregnancy
Carbamazepine (Tegrital CR 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 during pregnancy and
congenital malformations, including spina
bifida.
Carbamazepine and its epoxide metabolite
are excreted in breast milk.

Tegrital CR Tablets
For more details on
Tegrital CR Tablets click here
Tegrital CR Tablets (Generic Carbamazepine
ER) by Novartis India Limited.

Generic Carbamazepine ER (Tegrital CR Tablets)

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