Ternal tablets

Ternal

  • Active Ingredient: Carbamazepine
  • 400 mg, 200 mg, 100 mg
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What is Ternal?

The active ingredient of Ternal brand is carbamazepine. Carbamazepine is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and pain.

Used for

Ternal is used to treat diseases such as: Bipolar Disorder, Borderline Personality Disorder, Cluster-Tic Syndrome, Cyclothymic Disorder, Diabetic Peripheral Neuropathy, Dystonia, Epilepsy, Occipital Neuralgia, Peripheral Neuropathy, Reflex Sympathetic Dystrophy Syndrome, Schizoaffective Disorder, Trigeminal Neuralgia, Vulvodynia.

Side Effect

Possible side effects of Ternal include: numbness, tingling, pain, or weakness in the hands and feet; stiffness of the limb; diarrhea; bone or joint pain; fainting; loss of memory; muscle trembling, jerking, or stiffness.

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Ternal

An anticonvulsant used to manage partial seizures and generalised tonic-clonic seizures in children, bipolar disorder and trigeminal neuralgia; in contrast to valproate, Ternal is associated with better seizure control, fewer seizures and longer time to first seizure.

Adverse effectsDizziness, drowsiness, unsteadiness, nausea, vomiting, myelosuppression (up to 8-fold increase) in aplastic anaemia and agranulocytosis, rash, hair loss.

4.1.1.2 Identification

A. Melting point (2.2.14): 189–193°C.

B. Infrared absorption spectrophotometry (2.2.24).

Comparison : Ternal CRS.

Preparation: examine the substances as disks without prior treatment.

Ternal

Pharmacologic class: Iminostilbene derivative

Therapeutic class: Anticonvulsant

Pregnancy risk category D

SJS/TEN And HLA-B*1502 Allele

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 Ternal 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.

Across Asian populations, notable variation exists in the prevalence of HLA-B*1502. Greater than 15% of the population is reported positive in Hong Kong, Thailand, Malaysia, and parts of the Philippines, compared to about 10% in Taiwan and 4% in North China. South Asians, including Indians, appear to have intermediate prevalence of HLA-B*1502, averaging 2% to 4%, but higher in some groups. HLA-B*1502 is present in less than 1% of the population in Japan and Korea.

HLA-B*1502 is largely absent in individuals not of Asian origin (e.g., Caucasians, African-Americans, Hispanics, and Native Americans).

Prior to initiating Tegretol therapy, testing for HLA-B*1502 should be performed in patients with ancestry in populations in which HLA-B*1502 may be present. In deciding which patients to screen, the rates provided above for the prevalence of HLA-B*1502 may offer a rough guide, keeping in mind the limitations of these figures due to wide variability in rates even within ethnic groups, the difficulty in ascertaining ethnic ancestry, and the likelihood of mixed ancestry. Tegretol should not be used in patients positive for HLA-B*1502 unless the benefits clearly outweigh the risks. Tested patients who are found to be negative for the allele are thought to have a low risk of SJS/TEN (see BOXED WARNING and PRECAUTIONS, Laboratory Tests).

Over 90% of Tegretol treated patients who will experience SJS/TEN have this reaction within the first few months of treatment. This information may be taken into consideration in determining the need for screening of genetically at-risk patients currently on Tegretol.

The HLA-B*1502 allele has not been found to predict risk of less severe adverse cutaneous reactions from Tegretol such as maculopapular eruption (MPE) or to predict Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

Limited evidence suggests that HLA-B*1502 may be a risk factor for the development of SJS/TEN in patients of Chinese ancestry taking other antiepileptic drugs associated with SJS/TEN, including phenytoin. Consideration should be given to avoiding use of other drugs associated with SJS/TEN in HLA-B*1502 positive patients, when alternative therapies are otherwise equally acceptable.

Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: certain azole antifungals (isavuconazonium, voriconazole), orlistat.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Other medications can affect the removal of Ternal from your body, which may affect how Ternal works. Examples include macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's wort, among others.

Ternal can speed up the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include artemether/lumefantrine, boceprevir, certain drugs used to prevent blood clots (anticoagulants such as apixaban, rivaroxaban), certain calcium channel blockers (such as nifedipine, nimodipine), nefazodone, HIV NNRTIs (such as delavirdine, efavirenz, etravirine, rilpivirine), praziquantel, ranolazine, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while taking this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and narcotic pain relievers (such as codeine, hydrocodone).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain lab tests (such as thyroid function, some pregnancy tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Warnings

  • This medication contains Ternal. Do not take Tegretol, Equetro, Epitol, Tegretol XR, Ternal Chewtabs, Ternal CR, Carbatrol, Teril, or Carnexiv if you are allergic to Ternal or any ingredients contained in this drug
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Hematologic

Very common (10% or more): Leucopenia

Very rare (less than 0.01%): Agranulocytosis, aplastic anemia, pure red cell aplasia, megaloblastic anemia, acute intermittent porphyria, reticulocytosis, hemolytic anemia

Frequency not reported: Aplastic anemia, pancytopenia, bone marrow depression, leukopenia, thrombophlebitis, thromboembolism, adenopathy

Thrombocytopenia is the most common hematologic effect of Ternal and may be either mild and transient or severe. Significant decreases in white blood cell counts may occur although the values may still be within the normal range. Often counts will return to baseline during continued therapy, and therefore, discontinuation of Ternal may not be necessary. Dose reductions may also result in normalization of white blood cell counts. Aplastic anemia has been reported (although many of the reported cases had confounding exposures to other medications). The manufacturer reports an incidence of 2 per 1,000,000 patients for aplastic anemia and 6 per 1,000,000 patients for agranulocytosis. Cases of reticulocytosis have been reported rarely in association with Ternal therapy as well. In addition, cases of hemolytic anemia and erythroid arrest have been reported.

Both humoral and nonimmune mechanisms have been implicated in the etiology of Ternal-induced bone marrow suppression.

7. Pregnancy and breastfeeding

There's no firm evidence Ternal is harmful to an unborn baby. However, for safety, your doctor will only advise you to take it in pregnancy if the benefits of the medicine outweigh the risks.

It's important for you and your baby to stay well during pregnancy. If you become pregnant while taking carbamezapine, tell your doctor or nurse straight away. Do not stop taking it without talking to your doctor first.

If you have epilepsy, it's important that it's treated during pregnancy as seizures can harm you and your unborn baby.

For more information about how Ternal can affect you and your baby during pregnancy, read this leaflet on the Best Use of Medicines in Pregnancy (BUMPS) website.

8. Cautions with other medicines

There are some medicines that may interfere with the effects of Ternal.

Tell your doctor if you are taking any of these medicines:

  • medicines for your heart such as warfarin, apixaban, rivaroxaban or diltiazem
  • antibiotics or antifungals such as clarithromycin, erythromycin or fluconazole
  • medicines used for depression or anxiety such as amitriptyline, citalopram or mirtazapine
  • ciclosporin, tacrolimus or sirolimus - immunosuppressants used after transplant operations, but also sometimes to treat arthritis or psoriasis
  • medicines used to treat HIV or AIDS such as dasubavir or ritonavir
  • have taken medicines called monoamine oxidase inhibitors (MAOIs), used to treat depression - these can affect Ternal even if they've been stopped for a few weeks


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