EQUETRO
Generic: CARBAMAZEPINE
Basic Information
Manufacturer
Validus Pharmaceuticals LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
be478f3c-40f6-47cc-8ab9-f420a9372b1c
Indications & Usage
1INDICATIONS AND USAGE EQUETRO is: A mood stabilizer indicated for the treatment of acute manic or mixed episodes associated with bipolar I disorder ( 1.1 ) Indicated for the treatment of the pain associated with trigeminal neuralgia ( 1.2 ) An anti-epileptic drug (AED) indicated for the treatment of partial seizures with complex symptomatology, generalized tonic-clonic seizures, and mixed seizures ( 1.3 ) 1.1Acute Manic or Mixed Episodes associated with Bipolar I Disorder EQUETRO is indicated for treatment of patients with acute manic or mixed episodes associated with bipolar I disorder [see Clinical Studies ( 14.1 ) ] .
1.2 Pain of Trigeminal Neuralgia EQUETRO is indicated in the treatment of the pain associated with trigeminal neuralgia.
Beneficial results have also been reported in glossopharyngeal neuralgia.
This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.
1.3 Epilepsy EQUETRO is indicated for the treatment of partial seizures with complex symptomatology (e.g., psychomotor, temporal lobe), generalized tonic-clonic seizures (grand mal), and mixed seizure patterns, which include the seizure types listed here or other partial or generalized seizures.
Limitations of Usage EQUETRO is not indicated for the treatment of absence seizures (petit mal).Carbamazepine has been associated with increased frequency of generalized convulsions in these patients.
1.2 Pain of Trigeminal Neuralgia EQUETRO is indicated in the treatment of the pain associated with trigeminal neuralgia.
Beneficial results have also been reported in glossopharyngeal neuralgia.
This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.
1.3 Epilepsy EQUETRO is indicated for the treatment of partial seizures with complex symptomatology (e.g., psychomotor, temporal lobe), generalized tonic-clonic seizures (grand mal), and mixed seizure patterns, which include the seizure types listed here or other partial or generalized seizures.
Limitations of Usage EQUETRO is not indicated for the treatment of absence seizures (petit mal).Carbamazepine has been associated with increased frequency of generalized convulsions in these patients.
Adverse Reactions
6 ADVERSE REACTIONS 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 ( 5.1 ) Aplastic anemia/agranulocytosis [see Warnings and Precautions ( 5.2 )] Drug Reaction with Eosinophilia and Systemic Symptoms/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.3 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.4 )] Embryofetal Toxicity [see Warnings and Precautions ( 5.5 )] Abrupt Discontinuation and Seizure Risk [see Warnings and Precautions ( 5.6 )] Hyponatremia [see Warnings and Precautions ( 5.7 )] Cognitive and Motor Impairment [see Warnings and Precautions ( 5.8 )] Drug Interaction with Non-Nucleoside Reverse Transcriptase Inhibitors [see Warnings and Precautions ( 5.9 )] Liver Damage [see Warnings and Precautions ( 5.10 )] AV Heart Block [see Warnings and Precautions ( 5.11 )] Hepatic Porphyria [see Warnings and Precautions ( 5.12 )] Increased Intraocular Pressure [see Warnings and Precautions ( 5.13 )] Most common ( > 5% and 2 times placebo) adverse reactions were dizziness, somnolence, nausea, vomiting, ataxia, constipation, pruritus, dry mouth, asthenia, blurred vision, and speech disorder ( 6.1 ) 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.
6.1 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 ( 14.1 )] .
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% 6.2 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.
6.3 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 .
6.1 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 ( 14.1 )] .
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% 6.2 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.
6.3 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 .