TM Owner Novartis
Tegretol XR 400mg Tablet
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Indications & Clinical Uses
- Tegretol-XR 400mg tablets contain extended-release carbamazepine, made by Novartis, and are taken once or twice daily.
- Tegretol-XR is indicated only for epilepsy - partial seizures with complex symptomatology, generalized tonic-clonic seizures, and mixed seizure patterns - in adults and children; unlike immediate-release Tegretol (Sr 3335), it is not approved for trigeminal neuralgia.
- Tegretol-XR is also a different product from Equetro, a separate extended-release carbamazepine brand approved for bipolar disorder; Tegretol-XR itself carries no psychiatric indication, so it should not be confused with, or substituted for, either the immediate-release tablet or a psychiatric formulation.
Side Effects
- Boxed warning: as with immediate-release Tegretol, Tegretol-XR can cause serious, sometimes fatal, dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, with a much higher risk in people carrying the HLA-B*1502 gene variant, who should be screened before starting; it can also cause aplastic anemia and agranulocytosis.
- The most frequent effects are dizziness, drowsiness, unsteadiness, nausea and vomiting, particularly when treatment starts.
- Seek urgent care for rash, fever, mouth ulcers, unusual bruising, or yellowing of the skin or eyes, which can signal a serious blood or skin reaction.
Precautions & Warnings
- Tegretol-XR tablets must be swallowed whole and never crushed, chewed or split, since this destroys the extended-release mechanism and can cause a rapid, unsafe rise in carbamazepine levels.
- It is contraindicated with a history of bone marrow depression, hypersensitivity to carbamazepine, or use of MAO inhibitors or nefazodone.
- Regular blood counts, sodium and liver monitoring are recommended, and HLA-B*1502 testing is advised in at-risk populations.
- Do not stop Tegretol-XR abruptly, as this can trigger seizures.
- Carbamazepine can harm a developing fetus, so discuss contraception and pregnancy planning with your healthcare provider, and use caution when driving.
Avoid Interactions
- Macrolide antibiotics, azole antifungals, diltiazem, verapamil, cimetidine and grapefruit juice raise carbamazepine levels and toxicity risk, while rifampin, phenytoin, phenobarbital and felbamate lower levels and can reduce seizure control.
- Tegretol-XR reduces the effectiveness of hormonal contraceptives, warfarin, corticosteroids, cyclosporine and lamotrigine, so an additional contraceptive method and closer monitoring of these other medicines are advised.
- Combining it with lithium or other drugs affecting the central nervous system raises the risk of neurotoxicity, and concurrent MAO inhibitors or nefazodone must be avoided altogether.
- Tell your healthcare provider about every prescription, over-the-counter medicine and supplement you use before starting Tegretol-XR, including herbal products.
References
Frequently Asked Questions
Tegretol-XR (extended-release carbamazepine) 400mg tablets treat epilepsy, including partial seizures, generalized tonic-clonic seizures and mixed seizure patterns, taken once or twice daily. Unlike immediate-release Tegretol, it is not approved for trigeminal neuralgia, bipolar disorder, or any other psychiatric condition.
Take Tegretol-XR tablets once or twice daily with food, at the same times each day. Swallow tablets whole with water - never crush, chew or split them, since this destroys the extended-release coating and can cause a rapid, unsafe rise in drug levels.
Common effects are dizziness, drowsiness, unsteadiness, nausea and vomiting, especially early in treatment. Tegretol-XR carries a boxed warning for rare but serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) and for aplastic anemia and agranulocytosis - report rash, fever or bruising urgently.
Avoid grapefruit juice, MAO inhibitors, nefazodone, and drugs like macrolide antibiotics or azole antifungals, which raise carbamazepine levels. It can make hormonal contraceptives less effective, so use an additional method and tell your provider about all other medicines.
Take a missed Tegretol-XR dose as soon as you remember, unless it is nearly time for the next one - then skip it and resume your normal schedule. Never double up, and never stop Tegretol-XR suddenly, since this can trigger seizures.
No. Tegretol-XR is approved only for epilepsy, despite the sheet category sometimes listing 'Psychiatry'. Extended-release carbamazepine for bipolar mania is sold under a different brand, Equetro; Tegretol-XR should not be used, or swapped, for that psychiatric indication.
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