loxapine succinate
Pharmaranks rates Loxapine Succinate 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Loxapine Succinate is a medication used to treat Psychotic Disorders, Schizophrenia.
Generic · by Watson Labs
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Loxapine Succinate
- Form
- Capsule
- Strength
- Loxapine Succinate EQ 50MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- psychotic disorders, schizophrenia
- Manufacturer
- Watson Labs
- What the pharmacy pays
- ~$14.27 for 30 — not your price
- FDA application
- ANDA072062
- FDA boxed warning
- Yes — see the boxed warning
What is Loxapine Succinate?
From the FDA label:Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[ b,f ][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.1 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, benzyl alcohol, butyl paraben, edetate calcium disodium, gelatin, magnesium stearate, methyl paraben, polacrilin potassium, propyl paraben, sodium lauryl sulfate, sodium propionate, talc, and titanium dioxide. The printing ink contains black iron oxide, propylene glycol, potassium hydroxide, shellac, strong ammonia solution. Additionally, the 10 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6, the 25 mg capsule contains D&C Yellow No. 10 and FD&C Blue No. 1, and the 50 mg capsule contains FD&C Blue No. 1. The structurla formula of Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt.
How to use
Loxapine capsules are administered, usually in divided doses, two to four times a day. Daily dosage (in terms of base equivalents) should be adjusted to the individual patient’s needs as assessed by the severity of symptoms and previous history of response to antipsychotic drugs. Oral Administration Initial dosage of 10 mg twice daily is recommended, although in severely disturbed patients initial dosage up to a total of 50 mg daily may be desirable. Dosage should then be increased fairly rapidly over the first seven to ten days until there is effective control of symptoms of schizophrenia. The usual therapeutic and maintenance range is 60 mg to 100 mg daily. However, as with other drugs used to treat schizophrenia, some patients respond to lower dosage and others require higher dosage for optimal benefit. Daily dosage higher than 250 mg is not recommended. Maintenance Therapy For maintenance therapy, dosage should be reduced to the lowest level compatible with symptom control; many patients have been maintained satisfactorily at dosages in the range of 20 mg to 60 mg daily.
Side effects
CNS Effects: Manifestations of adverse effects on the central nervous system, other than extrapyramidal effects, have been seen infrequently. Drowsiness, usually mild, may occur at the beginning of therapy or when dosage is increased. It usually subsides with continued loxapine therapy. The incidence of sedation has been less than that of certain aliphatic phenothiazines and slightly more than the piperazine phenothiazines. Dizziness, faintness, staggering gait, shuffling gait, muscle twitching, weakness, insomnia, agitation, tension, seizures, akinesia, slurred speech, numbness, and confusional states have been reported. Neuroleptic malignant syndrome (NMS) has been reported (see WARNINGS ). Extrapyramidal Symptoms - Neuromuscular (extrapyramidal) reactions during the administration of loxapine have been reported frequently, often during the first few days of treatment. In most patients, these reactions involved parkinsonian-like symptoms such as tremor, rigidity, excessive salivation, and masked facies. Akathisia (motor restlessness) also has been reported relatively frequently. These symptoms are usually not severe and can be controlled by reduction of loxapine dosage or by administration of antiparkinson drugs in usual dosage. Dystonia - Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Loxapine is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
Warnings
Important safety information
Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Loxapine is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). Tardive Dyskinesia Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Given these considerations, antipsychotics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically. If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome. (See ADVERSE REACTIONS and Information for Patients sections.) Neuroleptic Malignant Syndrome (NMS) A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology. The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported. Loxapine, like other antipsychotics, may impair mental and/or physical abilities, especially during the first few days of therapy. Therefore, ambulatory patients should be warned about activities requiring alertness (e.g., operating vehicles or machinery) and about concomitant use of alcohol and other CNS depressants. Loxapine has not been evaluated for the management of behavioral complications in patients with mental retardation, and therefore, it cannot be recommended. Falls Loxapine may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.
Who should not take Loxapine Succinate
Loxapine is contraindicated in comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.). Loxapine is contraindicated in individuals with known hypersensitivity to dibenzoxazepines.
Overdose — what happens if you take too much
Signs and symptoms of overdosage will depend on the amount ingested and individual patient tolerance. As would be expected from the pharmacologic actions of the drug, the clinical findings may range from mild depression of the CNS and cardiovascular systems to profound hypotension, respiratory depression, and unconsciousness. The possibility of occurrence of extrapyramidal symptoms and/or convulsive seizures should be kept in mind. Renal failure following loxapine overdosage has also been reported. The treatment of overdosage is essentially symptomatic and supportive. Early gastric lavage and extended dialysis might be expected to be beneficial. Centrally-acting emetics may have little effect because of the antiemetic action of loxapine. In addition, emesis should be avoided because of the possibility of aspiration of vomitus. Avoid analeptics, such as pentylenetetrazol, which may cause convulsions. Severe hypotension might be expected to respond to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED SINCE ITS USE IN A PATIENT WITH PARTIAL ADRENERGIC BLOCKADE MAY FURTHER LOWER THE BLOOD PRESSURE. Severe extrapyramidal reactions should be treated with anticholinergic antiparkinson agents or diphenhydramine hydrochloride, and anticonvulsant therapy should be initiated as indicated. Additional measures include oxygen and intravenous fluids.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
There have been rare reports of significant respiratory depression, stupor and/or hypotension with the concomitant use of loxapine and lorazepam. The risk of using loxapine in combination with CNS-active drugs has not been systematically evaluated. Therefore, caution is advised if the concomitant administration of loxapine and CNS-active drugs is required.
May treat (source: NIH RxClass)
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Loxapine Succinate treat?
- Loxapine Succinate (Loxapine Succinate) may be used to treat psychotic disorders, schizophrenia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Loxapine Succinate rated?
- pharmaranks gives Loxapine Succinate a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Loxapine Succinate cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $14.27 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Geodon — about $9.48 on the same basis.
- Is there a coupon or discount for Loxapine Succinate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Loxapine Succinate. To pay less, Loxapine Succinate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Loxapine Succinate?
- Loxapine Succinate is marketed by Watson Labs. You can see Watson Labs's full profile, rating, and other products on pharmaranks.
- Is Loxapine Succinate a brand-name or generic drug?
- Loxapine Succinate is a generic medication; its active ingredient is Loxapine Succinate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Loxapine Succinate available over the counter?
- No. Loxapine Succinate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Loxapine Succinate come in?
- Loxapine Succinate is currently marketed as capsule, per the FDA's National Drug Code Directory.
- Is Loxapine Succinate FDA-registered?
- Loxapine Succinate is on record with the U.S. FDA under application number ANDA072062. You can verify this on its official FDA label.
- Has Loxapine Succinate been recalled by the FDA?
- Loxapine Succinate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Loxapine Succinate safe?
- There's no single safe-or-not verdict. pharmaranks gives Loxapine Succinate a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Loxapine Succinate?
- Loxapine Succinate's side effects are taken directly from its FDA label. From the label: CNS Effects: Manifestations of adverse effects on the central nervous system, other than extrapyramidal effects, have been seen infrequently. Drowsiness, usually mild, may occur at the beginning of therapy or when dosage is increased. It usually subsides with continued loxapine therapy.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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loxapine succinate
70/100