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loxapine
Overview
What is Adasuve?
ADASUVE, a typical antipsychotic, is an inhalation powder of loxapine supplied in a single-use, disposable inhaler containing 10 mg of loxapine base. ADASUVE is a drug-device combination product.
Active Ingredient:
ADASUVE is a single-use, drug-device combination product that provides rapid systemic delivery by inhalation of a thermally-generated aerosol of loxapine. Oral inhalation through the product initiates the controlled rapid heating of a thin film of excipient-free loxapine to form a thermally-generated drug vapor. The vapor condenses into aerosol particles that are dispersed into the airstream created by the patient inhaling through the mouthpiece.
Each product is packaged inside a sealed foil pouch. The product is a white to off-white plastic unit, with a mouthpiece on one end and a pull-tab protruding from the other end.
Removal of a pull-tab from the product renders it ready for use, as indicated by illumination of a green light. After inhalation through the mouthpiece, successful dosing is signaled by the green light turning off.
Under standardized test conditions, ADASUVE, 10 mg delivers 9.1 mg of loxapine out of the mouthpiece.
What does Adasuve look like?
What are the available doses of Adasuve?
ADASUVE is an inhalation powder supplied in a single-use, disposable inhaler containing 10 mg of loxapine base.
What should I talk to my health care provider before I take Adasuve?
In general, no dose adjustment for ADASUVE is required on the basis of a patient’s age, gender, race, smoking status, hepatic function, or renal function.
How should I use Adasuve?
ADASUVEis a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
“Psychomotor agitation” is defined in DSM-IV as “excessive motor activity associated with a feeling of inner tension.” Patients experiencing agitation often manifest behaviors that interfere with their care (e.g., threatening behaviors, escalating or urgently distressing behavior, self-exhausting behavior), leading clinicians to the use of rapidly absorbed antipsychotic medications to achieve immediate control of the agitation
The efficacy of ADASUVE was established in one study of acute agitation in patients with schizophrenia and one study of acute agitation in patients with bipolar I disorder
.
Limitations of Use:
As part of the ADASUVE REMS Program to mitigate the risk of bronchospasm, ADASUVE must be administered only in an enrolled healthcare facility
Must be administered only by a healthcare professional ()
10 mg by oral inhalation using an inhaler ()
Administer only a single dose within any 24-hour period ()
Prior to administering, screen all patients for a history of pulmonary disease, and examine patients (including chest auscultation) for respiratory abnormalities (e.g. wheezing) ()
Refer to Full Prescribing Information for important instructions on use of the ADASUVE inhaler ()
After administration, monitor patients for signs and symptoms of bronchospasm at least every 15 minutes for at least one hour ()
What interacts with Adasuve?
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What are the warnings of Adasuve?
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What are the precautions of Adasuve?
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What are the side effects of Adasuve?
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What should I look out for while using Adasuve?
ADASUVE is contraindicated in patients with the following:
Bronchospasm
ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access
on site to supplies and personnel trained to manage acute bronchospasm and ready access to emergency response services
[see Warnings and Precautions (
,
)]
.
Facilities
must
have a short-acting bronchodilator (e.g. albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm.
Prior to administering ADASUVE, screen patients regarding a current
diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE
[see Dosage and Administration (
,
) and Contraindications (
)]
.
Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS
[see Warnings and Precautions (
)].
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. ADASUVE is not approved for the treatment of patients with dementia-related psychosis
[see Warnings and Precautions (
)].
What might happen if I take too much Adasuve?
Signs and Symptoms of Overdosage
As would be expected from the pharmacologic actions of loxapine, the clinical findings may include CNS depression, unconsciousness, profound hypotension, respiratory depression, extrapyramidal symptoms, and seizure.
Management of Overdosage
For the most up to date information on the management of ADASUVE overdosage, contact a certified poison control center (1-800-222-1222 or www.poison.org). Provide supportive care including close medical supervision and monitoring. Treatment should consist of general measures employed in the management of overdosage with any drug. Consider the possibility of multiple drug overdosage. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Use supportive and symptomatic measures.
How should I store and handle Adasuve?
Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Clindamycin in 5% Dextrose Injection in Cryovac plastic containers is a sterile solution of clindamycin phosphate with 5% dextrose. Each 50 mL contains clindamycin phosphate equivalent to 300 mg, 600 mg or 900 mg clindamycin. The single dose Cryovac plastic containers are available as follows:Exposure of pharmaceutical products to heat should be minimized. It is recommended that Cryovac plastic containers be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid temperatures above 30° C. Clindamycin in 5% Dextrose Injection in Cryovac plastic containers is a sterile solution of clindamycin phosphate with 5% dextrose. Each 50 mL contains clindamycin phosphate equivalent to 300 mg, 600 mg or 900 mg clindamycin. The single dose Cryovac plastic containers are available as follows:Exposure of pharmaceutical products to heat should be minimized. It is recommended that Cryovac plastic containers be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid temperatures above 30° C.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
ADASUVE is contraindicated in patients with the following:Bronchospasm
ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access
on site to supplies and personnel trained to manage acute bronchospasm and ready access to emergency response services
[see Warnings and Precautions (
,
)]
.
Facilities
must
have a short-acting bronchodilator (e.g. albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm.
Prior to administering ADASUVE, screen patients regarding a current
diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE
[see Dosage and Administration (
,
) and Contraindications (
)]
.
Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS
[see Warnings and Precautions (
)].
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. ADASUVE is not approved for the treatment of patients with dementia-related psychosis
[see Warnings and Precautions (
)].
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.
In vitro
Antagonism has been demonstrated between clindamycin and erythromycin. Because of possible clinical significance, the two drugs should not be administered concurrently.
ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest . Administer ADASUVE only in an enrolled healthcare facility that has immediate access on site to supplies and personnel trained to manage acute bronchospasm and ready access to emergency response services. Facilities must have a short-acting bronchodilator (e.g. albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm .
Prior to administering ADASUVE, screen patients regarding a current diagnosis or history of asthma, COPD, and other lung disease associated with bronchospasm, acute respiratory symptoms or signs, current use of medications to treat airways disease, such as asthma or COPD; and examine patients (including chest auscultation) for respiratory abnormalities (e.g., wheezing) . Monitor patients for symptoms and signs of bronchospasm (i.e., vital signs and chest auscultation) at least every 15 minutes for a minimum of one hour following treatment with ADASUVE . ADASUVE can cause sedation, which can mask the symptoms of bronchospasm.
Because clinical trials in patients with asthma or COPD demonstrated that the degree of bronchospasm, as indicated by changes in forced expiratory volume in 1 second (FEV1), was greater following a second dose of ADASUVE, limit ADASUVE use to a single dose within a 24 hour period.
Advise all patients of the risk of bronchospasm. Advise them to inform the healthcare professional if they develop any breathing problems such as wheezing, shortness of breath, chest tightness, or cough following treatment with ADASUVE.
The following adverse reactions are discussed in more detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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