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Equetro (Carbamazepine XR) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Equetro Side Effects Center

What Is Equetro?

Equetro (carbamazepine xr) is an anticonvulsant (anti-seizure) medication used to treat seizures and nerve pain such as trigeminal neuralgia and diabetic neuropathy. Equetro is also used to treat bipolar disorder.

What Are Side Effects of Equetro?

Common side effects of Equetro include:

Dosage for Equetro

The recommended initial dose of Equetro is 400 mg/day given in divided doses, twice daily.

What Drugs, Substances, or Supplements Interact with Equetro?

Many other medicines could cause a drug interaction if taken together with Equetro. Tell your doctor all medications and supplements you use.

Equetro During Pregnancy or Breastfeeding

During pregnancy, Equetro should be used only when prescribed. It may harm a fetus. Since untreated bipolar disorder or seizures can be serious conditions, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, consult your doctor. If you are pregnant, prenatal care including tests for defects is recommended. Birth control pills, patches, implants, and injections may not work if taken with this medication. Discuss birth control with your doctor. This medication passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Equetro (carbamazepine xr) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Equetro Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: sudden mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, irritable, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • a skin rash, no matter how mild;
  • loss of appetite, right-sided upper stomach pain, dark urine;
  • slow, fast, or pounding heartbeats;
  • anemia or other blood problems--fever, chills, sore throat, mouth sores, bleeding gums, nosebleeds, pale skin, easy bruising, unusual tiredness, feeling light-headed or short of breath; or
  • low levels of sodium in the body--headache, confusion, severe weakness, feeling unsteady, increased seizures.

Common side effects may include:

  • dizziness, loss of coordination, problems with walking;
  • nausea, vomiting; or
  • drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Equetro (Carbamazepine XR)

 

Equetro Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

  • Serious Dermatologic Reactions: Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome [see WARNINGS AND PRECAUTIONS
  • Aplastic anemia/agranulocytosis [see WARNINGS AND PRECAUTIONS]
  • Drug Reaction with Eosinophilia and Systemic Symptoms/Multiorgan Hypersensitivity [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
  • Embryofetal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Abrupt Discontinuation and Seizure Risk [see WARNINGS AND PRECAUTIONS]
  • Hyponatremia [see WARNINGS AND PRECAUTIONS]
  • Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS]
  • Drug Interaction with Non-Nucleoside Reverse Transcriptase Inhibitors [see WARNINGS AND PRECAUTIONS]
  • Liver Damage [see WARNINGS AND PRECAUTIONS]
  • AV Heart Block [see WARNINGS AND PRECAUTIONS]
  • Hepatic Porphyria [see WARNINGS AND PRECAUTIONS]
  • Increased Intraocular Pressure [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most commonly reported adverse reactions (≥5% in the EQUETRO group and at least twice placebo) in the pooled 3-week placebo-controlled trials in patients with acute mania associated with Bipolar I Disorder (Studies 1 and 2) were dizziness, somnolence, nausea, vomiting, ataxia, constipation, pruritus, dry mouth, asthenia, blurred vision, and speech disorder [see Clinical Studies]. The EQUETRO doses used were 400 to 1600 mg per day.

(Incidence > 2% and greater than placebo)

Adverse Reactions EQUETRO®
(N = 251)		 Placebo
(N = 248)
Dizziness 44% 12%
Somnolence 32% 13%
Nausea 29% 10%
Vomiting 18% 3%
Ataxia 15% 0.4%
Constipation 10% 5%
Pruritus 8% 2%
Dry Mouth 8% 3%
Asthenia 8% 4%
Rash 7% 4%
Blurred vision 6% 2%
Speech Disorder 6% 0.4%
Hypertension 3% 0.4%
Paresthesia 2% 1%
Thinking abnormal 2% 0.4%
Tremor 3% 1%
Twitching 2% 1%
Vertigo 2% 1%

Postmarketing Experience

The following adverse reactions have been identified during post approval use of EQUETRO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nervous System: confusion, diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, tinnitus.

Digestive System: gastric distress, abdominal pain, diarrhea, anorexia.

Laboratory Tests: thyroid function tests (T3, T4)- decreased values

Other: lupus erythematosus-like syndrome

One case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

Additional Adverse Reactions Associated With Carbamazepine

The following is a list of additional adverse reactions identified in clinical trials or postmarketing reports of other forms of carbamazepine and not reported above for EQUETRO. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Nervous System

Isolated cases of neuroleptic malignant syndrome have been reported in carbamazepine use both with and without concomitant use of other psychotropic drugs.

Skin

onychomadesis, acute generalized exanthematous pustulosis (AGEP).

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982- 5438 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Pharmacokinetic Effects Of Other Drugs On EQUETRO

Drugs That Inhibit Cytochrome P450 3A4 (CYP3A4)

EQUETRO is metabolized primarily by CYP3A4 to the active carbamazepine-10,11-epoxide, which is further metabolized to the trans-diol by epoxide hydrolase. Inhibitors of CYP 3A4 and/or epoxide hydrolase can increase plasma levels of EQUETRO and its active metabolites, increasing plasma concentrations of EQUETRO and the risk of adverse reactions. It may be necessary to reduce the EQUETRO dose if used concomitantly with inhibitors of CYP3A4 and/or epoxide hydrolase. The following drugs are CYP3A4 inhibitors:

Acetazolamide, aprepitant, azole antifungals (e.g., ketoconazole, itraconazole, fluconazole, voriconazole), cimetidine, ciprofloxacin, clarithromycin, dalfopristin, danazol, dantrolene, delavirdine, diltiazem, erythromycin, fluoxetine, fluvoxamine, grapefruit juice, ibuprofen, isoniazid, loratadine, nefazodone, niacinamide, nicotinamide, olanzapine, omeprazole, oxybutynin, quinine, quinupristin, ticlopidine, troleandomycin, valproate, verapamil, zileuton.

Drugs That Inhibit Epoxide Hydrolase And CYP3A4

Clarithromycin, erythromycin, loxapine, quetiapine, and valproate also inhibit epoxide hydrolase, resulting in increased levels of the active metabolite carbamazepine-10,11-epoxide [see CLINICAL PHARMACOLOGY].

Drugs That Induce CYP3A4

CYP3A4 inducers can decrease serum concentrations of EQUETRO and decrease its effectiveness. It may be necessary to increase the dose of EQUETRO if used concomitantly with a CYP3A4 inducer. Such drugs include the following:

Aminophylline, cisplatin, doxorubicin, felbamate, phosphenytoin, methsuximide, phenobarbital, phenytoin, primidone, rifampin and theophylline.

Pharmacokinetic Effects Of EQUETRO On Other Drugs

EQUETRO is a potent inducer of hepatic 3A4 and is also known to be an inducer of CYP1A2, 2B6, 2C9/19 and may therefore reduce plasma concentrations of co-medications mainly metabolized by CYP 1A2, 2B6, 2C9/19 and 3A4, through induction of their metabolism. When used concomitantly with EQUETRO, monitoring of concentrations or dosage adjustment of these agents may be necessary.

EQUETRO decreases the concentrations of the following drugs through induction of their metabolism:

Oral Contraceptives (CYP3A4 Substrates)

EQUETRO is a strong inducer of CYP3A4. EQUETRO can increase the metabolism of certain oral contraceptives (through CYP3A4 induction), leading to significantly lower concentrations. This can cause contraceptive failure or breakthrough bleeding. Consider alternatives to oral contraceptives that are significantly affected by induction of CYP3A4; or consider alternatives to EQUETRO.

Delavirdine And Other Non-Nucleoside Reverse Transcriptase Inhibitors (CYP3A4 Substrates)

Through induction of CYP3A4, EQUETRO increases the metabolism of delavirdine and certain non-nucleoside reverse transcriptase inhibitors and significantly reduces the plasma concentrations of these drugs. This can cause inadequate antiviral activity, loss of virologic response, and possible resistance to delavirdine or other non-nucleoside reverse transcriptase inhibitors. Therefore, the use of EQUETRO with these non-nucleoside reverse transcriptase inhibitors is contraindicated [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Nefazodone (CYP3A4 Substrate)

The use of EQUETRO is contraindicated with the use of nefazodone because the concomitant use may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect of nefazodone.

Warfarin (CYP1A2 and CYP3A4 Substrate)

Through induction of CYP1A2 and CYP3A4, EQUETRO decreases the concentration of warfarin and decreases its anticoagulant effectiveness.

Aripiprazole

When carbamazepine is added to aripiprazole, the aripiprazole dose should be doubled. Additional dose increases should be based on clinical evaluation. If carbamazepine is later withdrawn, the aripiprazole dose should be reduced.

Tacrolimus

When carbamazepine is used with tacrolimus, monitoring of tacrolimus blood concentrations and appropriate dosage adjustments are recommended.

Temsirolimus

The use of concomitant strong CYP3A4 inducers such as carbamazepine should be avoided with temsirolimus. If patients must be coadministered carbamazepine with temsirolimus, an adjustment of temsirolimus dosage should be considered.

Lapatinib

The use of carbamazepine with lapatinib should generally be avoided. If carbamazepine is started in a patient already taking lapatinib, the dose of lapatinib should be gradually titrated up. If carbamazepine is discontinued, the lapatinib dose should be reduced.

HIV Protease Inhibitors

Due to strong induction of CYP3A4 caused by carbamazepine, use of EQUETRO with HIV protease inhibitors is not recommended.

Other CYP1A2 And CYP3A4 Substrates

EQUETRO induces CYP1A2 and CYP3A4, leading to decreased concentrations of drugs metabolized by CYP3A4 or CYP1A2. It may be necessary to increase the doses of such drugs when used concomitantly with EQUETRO. Drugs metabolized by CYP3A4 or CYP1A2 include the following:

Acetaminophen, albendazole, alprazolam, aprepitant, buprenorphone, bupropion, buspirone, citalopram, clobazam, clonazepam, clozapine, cyclosporin, delavirdine, desipramine, diazepam, dicumarol, dihydropyridine calcium channel blockers (e.g., felodipine), doxycycline, ethosuximide, everolimus, felbamate, glucocorticoids, haloperidol, imatinib, itraconazole, lamotrigine, levothyroxine, lorazepam, methadone, methsuxamide, mianserin, midazolam, mirtazapine, nefazodone, olanzapine, oral and other hormonal contraceptives, oxcarbazepine, paliperidone, phenytoin, praziquantel, quetiapine, risperidone, sertraline, sirolimus, tadalafil, theophylline, topiramate, tiagabine, tramadol, triazolam, tricyclic antidepressants (e.g., imipramine, amitriptyline, nortriptyline), trazodone, valproate, warfarin , ziprasidone, and zonisamide.

EQUETRO increases the plasma levels of the following drugs by inhibition of their metabolism:

Clomipramine, Phenytoin, And Primidone

EQUETRO can increase the concentrations of clomipramine, phenytoin, and primidone. If a patient has been titrated to a stable dosage on one of these agents in this category, and then begins treatment with EQUETRO, it may be necessary to decrease the dose of these drugs.

Phenytoin

Phenytoin levels have been reported to increase or decrease in the presence of carbamazepine. There are multiple pharmacokinetic mechanisms for changes in phenytoin levels when used concomitantly with EQUETRO. Monitor phenytoin serum levels carefully when used concomitantly with EQUETRO.

Cyclophosphamide

Cyclophosphamide is an inactive prodrug and is converted to its active metabolite in part by CYP3A. The rate of metabolism and the leukopenic activity of cyclophosphamide are reportedly increased by chronic coadministration of CYP3A4 inducers. There is a potential for increased cyclophosphamide toxicity when coadministered with carbamazepine.

Pharmacodynamic Drug Interactions

Monoamine Oxidase Inhibitors

Concomitant treatment with EQUETRO is contraindicated during use of an MAOI or within 14 days after discontinuing an MAOI. Concomitant use can cause serotonin syndrome.

Lithium

Concomitant administration of EQUETRO and lithium can increase the risk of neurotoxic adverse reactions. Consider reducing the dose of lithium or EQUETRO when using these drugs concomitantly.

Isoniazid

Concomitant use of carbamazepine and isoniazid has been reported to increase isoniazid-induced hepatotoxicity.

CNS Depressants

The concomitant use of EQUETRO and other CNS depressants can increase the risk of respiratory depression, profound sedation, hypotension, and syncope. CNS depressants include: alcohol, opioid analgesics, benzodiazepines, tricyclic antidepressants, sedative/hypnotics, anticonvulsants, antipsychotics, antihistamines, anticholinergics, alpha and beta blockers, general anesthetics, muscle relaxants, and illicit CNS depressants. Consider reducing the dose of CNS depressants or EQUETRO when using these drugs concomitantly.

Chloroquine And Mefloquine

The anti-malarial drugs chloroquine and mefloquine can antagonize the activity of EQUETRO.

Neuromuscular Blocking Agents

Resistance to the neuromuscular blocking action of the nondepolarizing neuromuscular blocking agents pancuronium, vecuronium, rocuronium and cisatracurium has occurred in patients chronically administered carbamazepine. Whether or not carbamazepine has the same effect on other nondepolarizing agents is unknown. Patients should be monitored closely for more rapid recovery from neuromuscular blockade than expected, and infusion rate requirements may be higher.

Read the entire FDA prescribing information for Equetro (Carbamazepine XR)

&Copy; Equetro Patient Information is supplied by Cerner Multum, Inc. and Equetro Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.