Treatment FAQ

which drugs is used to treatment severe acne clozapine

by Junius D'Amore Published 2 years ago Updated 1 year ago
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Tetracyclines are the most widely prescribed class of antibiotic for acne. 2  There are several antibiotics within the class, including tetracycline, in both 500-milligram (mg) and 250-mg formulations. The usual starting dose is 500 mg twice a day continued until a significant decrease in acne lesions is seen.

Full Answer

What is the most popular acne drug?

Popular Acne Drugs. Isotretinoin ( Accutane, sotret, claravis, amnesteem, myorisan, zenatane) is an expensive drug used to treat severe acne that has not responded to other therapy like antibiotics. This drug is slightly more popular than comparable drugs. It is available in multiple brand and generic versions.

What are topical acne agents?

Topical acne agents. What are Topical acne agents? Topical acne agents are creams, gels, lotions, and washes that are used on the skin and contain ingredients that treat acne. They are typically used for mild acne, although some may be used for the treatment of severe acne in conjunction with prescription medicines.

What are systemic medications for acne treatment?

Oral medications, also called systemic medications, work internally to improve the skin. You take them by mouth. Some medications you'll take just once a day, others you'll take more often, ideally at the same time every day.

How does clozapine work?

Clozapine is an antipsychotic medication. It works by changing the actions of chemicals in the brain. Clozapine is used to treat severe schizophrenia, or to reduce the risk of suicidal behavior in people with schizophrenia or similar disorders. Clozapine is available only from a certified pharmacy under a special program.

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What is the medication clozapine most often used to treat?

Clozapine is used to treat severely ill patients with schizophrenia who have used other medicines that did not work well. It is also used to lower risk of suicidal behavior in patients with schizophrenia or schizoaffective disorder.

What can clozapine treat?

Clozapine is an atypical antipsychotic medication, which can be used to treat schizophrenia.

What is the most serious risk related to clozapine treatment?

The most severe and potentially life-threatening clozapine-related blood dyscrasias is neutropenia, which may eventually develop into clozapine-induced agranulocytosis or granulocytopenia.

Which of the following is the most serious side effect of clozapine?

These can be symptoms of a very serious problem with your heart. Clozapine may cause drowsiness, blurred vision, convulsions (seizures), or to have trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries.

Is clozapine a good drug?

Open clinical trials conducted in the early 1970s suggest that clozapine is an effective antipsychotic drug that lacks extrapyramidal side-effects. Clozapine was found to be superior in 79% of the controlled trials that compared it with another antipsychotic drug.

What is leponex used for?

Risk of recurrent suicidal behavior: Clozapine (Leponex) is indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state.

When should clozapine be used?

Primary indications for clozapine in patients with schizophrenia or schizoaffective disorder are schizophrenia symptoms partially or fully resistant to treatment with other antipsychotic drugs, or accompanied by persistent suicidal or self-injurious behavior.

What drugs should not be taken with clozapine?

Other medications can affect the removal of clozapine from your body, which may affect how clozapine works. Examples include fluvoxamine, rifamycins (such as rifabutin, rifampin), saquinavir, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

What is the brand name for clozapine?

Clozapine is available under the following different brand names: Clozaril, FazaClo ODT, and Versacloz.

What is clozapine 100mg used for?

Clozapine is a medication that works in the brain to treat schizophrenia. It is also known as a second generation antipsychotic (SGA) or atypical antipsychotic. Clozapine rebalances dopamine and serotonin to improve thinking, mood, and behavior.

Is clozapine a high risk medication?

Clozapine is an antipsychotic medicine used to treat schizophrenia. But it can cause serious side effects.

What's the side effects of clozapine?

SIDE EFFECTS: Drooling, drowsiness, dizziness, headache, shaking (tremor), vision problems (e.g., blurred vision), weight gain, and constipation may occur. Many of these effects (especially drowsiness) lessen as your body gets used to the medication.

Before Taking This Medicine

You should not take clozapine if you have ever developed a severe infection or severe allergic reaction while taking this medicine.Clozapine is not...

How Should I Take Clozapine?

Take clozapine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dos...

What Happens If I Miss A Dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to...

What Should I Avoid While Taking Clozapine?

Clozapine can cause severe dizziness, slow heartbeats, fainting, or seizures. Do not take more of this medicine than recommended. Be careful if you...

Clozapine Dosing Information

Usual Adult Dose for Schizophrenia:Initial dose: 12.5 mg orally once or twice a dayTitration and Maintenance: May increase total daily dose in incr...

What Other Drugs Will Affect Clozapine?

Clozapine can cause a serious heart problem, especially if you use certain medicines at the same time. Tell your doctor about all medicines you use...

What is clozapine used for?

Clozapine tablets are indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior , based on history and recent clinical state. Suicidal behavior refers to actions by a patient that put him/herself at risk for death.

How many mg is clozapine?

Clozapine tablets are available as 25 mg, 50 mg, and 100 mg round, pale-yellow, uncoated tablets with a facilitated score on one side and as a 200 mg oval shape, pale-yellow, uncoated tablet with a facilitated score on one side.

How long does it take for myocarditis to show up on clozapine?

Myocarditis most frequently presents within the first two months of Clozapine treatment. Symptoms of cardiomyopathy generally occur later than Clozapine-associated myocarditis and usually after 8 weeks of treatment. However, myocarditis and cardiomyopathy can occur at any period during treatment with Clozapine.

What are the symptoms of clozapine overdose?

The most commonly reported signs and symptoms associated with Clozapine overdose are: sedation, delirium, coma, tachycardia, hypotension, respiratory depression or failure; and hypersalivation. There are reports of aspiration pneumonia, cardiac arrhythmias, and seizure. Fatal overdoses have been reported with Clozapine, generally at doses above 2500 mg. There have also been reports of patients recovering from overdoses well in excess of 4 g.

How often should I re-initiate Clozapine?

When restarting Clozapine tablets in patients who have discontinued Clozapine tablets (i.e., 2 days or more since the last dose), re-initiate with 12.5 mg once daily or twice daily. This is necessary to minimize the risk of hypotension, bradycardia, and syncope [see Warnings and Precautions (5.3) .] If that dose is well-tolerated, the dose may be increased to the previously therapeutic dose more quickly than recommended for initial treatment.

What percentage of the population has reduced activity of CYP2D6?

A subset (3% to 10%) of the population has reduced activity of CYP2D6 (CYP2D6 poor metabolizers). These individuals may develop higher than expected plasma concentrations of Clozapine when given usual doses.

Can Clozapine be used for heart failure?

Use Clozapine cautiously in patients with cardiovascular disease (history of myocardial infarction or ischemia, heart failure, or conduction abnormalities), cerebrovascular disease, and conditions which would predispose patients to hypotension (e.g., concomitant use of antihypertensives, dehydration and hypovolemia).

How to keep taking Clozapine?

Keep taking this medicine (clozapine tablets) as you have been told by your doctor or other health care provider, even if you feel well. Have blood work checked as you have been told by the doctor . Talk with the doctor. You will need to have heart function tests while taking this medicine (clozapine tablets).

Can you breastfeed while taking Clozapine?

Do not breast-feed while you take this medicine (clozapine tablets). This is not a list of all drugs or health problems that interact with this medicine (clozapine tablets). Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems.

Can clozapine cause low blood pressure?

Low blood pressure, passing out, slow heartbeat, and heart attacks have happened with this medicine (clozapine tablets). These problems can be deadly. Do not take more than you were told or raise your dose faster than you were told. Tell your doctor if you have heart problems or brain problems.

Can you share Clozapine with others?

Do not share your drugs with others and do not take anyone else's drugs. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (clozapine tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.

Can you take Clozapine if you have dementia?

Tell your doctor if you have lots of fluid loss or if you take drugs for high blood pressure. There is a higher chance of death in older adults who take this medicine (clozapine tablets) for mental problems caused by dementia.

Can dementia be treated with Clozapine?

Sometimes these have been deadly. This medicine is not approved to treat mental problems caused by dementia. If you are 60 or older, use this medicine (clozapine tablets) with care. You could have more side effects.

Does Clozapine go away?

This problem may lessen or go away after stopping this medicine (clo zapine tablets), but it may not go away. The risk is greater with diabetes and in older adults, especially older women. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses.

What is a REMS for Clozapine?

FDA approved a shared REMS for clozapine to ensure that the benefits outweigh the risks. The REMS consists of the following: elements to assure safe use and implementation system. See https://www.accessdata.fda.gov/scripts/cder/rems/. Also see Restricted Distribution Program under Dosage and Administration.

How long to shake clozapine?

Prior to each use of clozapine oral suspension (Versacloz ), shake bottle for 10 seconds. Use the bottle adapter and calibrated oral dosing syringe supplied by the manufacturer to administer the dose directly into the mouth; do not store in syringe for later use.

Is Clozapine available for ANC?

Because of this risk, clozapine is available only through a restricted distribution program called the Clozapine REMS program, which ensures periodic monitoring of ANC. (See Restricted Distribution Program under Dosage and Administration.) Orthostatic Hypotension, Bradycardia, and Syncope.

Can Clozapine cause neutropenia?

Severe Neutropenia. Clozapine can cause severe neutropenia ( ANC <500/mm 3 ), which may lead to serious and potentially fatal infections. Patients initiating or continuing treatment with clozapine must have a baseline blood ANC before initiating clozapine therapy and regular ANC monitoring during treatment.

Is Clozapine approved for dementia?

Increased incidence of adverse cerebrovascular events (stroke and TIAs), including fatalities, observed in geriatric patients with dementia-related psycho sis treated with some atypical antipsychotic agents in placebo-controlled studies. Use with caution in patients with risk factors for stroke. Clozapine is not approved for the treatment of patients with dementia-related psychosis. (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis in Boxed Warning.)

Does Clozapine contain aspartame?

Clozapine orally disintegrating tablets contain aspartame, which is metabolized in the GI tract to phenylalanine; consult manufacturer's labeling for specific information regarding aspartame content of individual preparations and dosage strengths.

Is clozapine safe for seizures?

Risk of seizures, particularly at high dosages ( >600 mg daily) and/or in patients with elevated plasma clozapine concentrations; use with caution in patients with history of seizures or other predisposing factors (e.g., head trauma or other CNS pathology, concomitant use of drugs that lower the seizure threshold, alcohol abuse).

What ingredients are used to treat acne?

Avoid pore-clogging ingredients as well, such as algae extract, carrageenan, lanolin, myristyl myristate, octyl palmitate, octyl stearate-5, and oleth-3. Anti-acne ingredients work by removing dead skin cells, unclogging pores, or reducing bacteria numbers on the skin. Acne treatments usually contain one of the following ingredients ...

What are the other names for acne?

Other names: Acne Vulgaris; Blackheads; Breakouts; Cystic acne; Pimples; Whiteheads; Zits. Acne is a skin condition caused by dead skin cells sticking together and clogging up pores. Bacteria can play a role, too. A big trigger for the onset of acne is puberty. Better nutrition and living standards have seen the age of puberty, especially in girls, ...

What to do if you have acne?

Chemical peels. Steroid injections. If you have severe acne you need to be very proactive with skin cleansing and using acne treatment. Seeing a dermatologist early on for prescription products lessens the chances of being left with permanent scars.

How to reduce breakouts on face?

This doesn't mean scrubbing it raw several times a day with soap. It means gently cleansing it with a mild soap-free wash twice a day, every day.

What happens if you have a clogged pores?

If bacteria are also present, redness and swelling can occur resulting in the progression of the pimple into a cyst or nodule.

How to get rid of acne scars?

Gently wash your face twice a day and after sweating. Shampoo your hair regularly. Do not pick or squeeze your acne; this increases the risk of scars. Keep your hands off your face. Wash your hands before applying make-up. Be careful what you put on your face, and avoid ingredients that promote acne.

Is acne worse than other types of acne?

Unfortunately, some people suffer from acne worse than others. Bad acne tends to run in families - your mother, father, aunt or uncle probably had severe breakouts when they were a teenager. Some people also have naturally higher hormone levels and make more sebum, so their skin pores are always clogging up.

What are the side effects of Clozapine?

Check with your doctor immediately if any of the following side effects occur while taking clozapine: More common. Blurred vision. confusion.

Does Clozapine cause tardive dyskinesia?

Extrapyramidal symptoms that occur appear to be milder and less frequent than other antipsychotic drugs. There have been no reports of tardive dyskinesia directly attributable to clozapine; however, the syndrome has been reported in a few patients who were treated with other antipsychotics prior to receiving clozapine.

Does Clozapine need immediate medical attention?

Side effects not requiring immediate medical attention. Some side effects of clozapine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.

Can Clozapine cause severe neutropenia?

Severe Neutropenia; Orthostatic Hypotension; Bradycardia, and Syncope; Seizure; Myocarditis and Cardiomyopathy; Increased Mortality in Elderly Patients with Dementia -related PsychosisSevere Neutropenia: Clozapine can cause severe neutropenia, which can lead to serious and fatal infections. Patients initiating and continuing treatment with clozapine must have a baseline blood absolute neutrophil count (ANC) measured before treatment initiation and regular ANC monitoring during treatment.Clozapine is available only through a restricted program called the Clozapine Risk Evaluation Mitigation Strategy (REMS).Orthostatic Hypotension, Bradycardia, and Syncope: Risk is dose related. Starting dose is 12.5 mg. Titrate gradually and use divided dosages.Seizure: Risk is dose-related. Titrate gradually and use divided doses. Use with caution in patients with history of seizure or risk factors for seizure.Myocarditis, Cardiomyopathy and Mitral Valve Incompetence: Can be fatal. Discontinue and obtain cardiac evaluation if findings suggest these cardiac reactions.Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Clozapine is not approved for this condition.

What is the name of the drug that is used to treat acne?

Isotretinoin ( Accutane, sotret, claravis, amnesteem, myorisan, zenatane) is an expensive drug used to treat severe acne that has not responded to other therapy like antibiotics. This drug is slightly more popular than comparable drugs. It is available in multiple brand and generic versions.

What is the best antibiotic for acne?

Popular Acne Drugs. Cleocin (clindamycin) Drug class: Lincosamide Antibiotics. Clindamycin (Cleocin, Cleocin T, Evoclin) is a moderately priced antibiotic used to treat certain kinds of bacterial infections. It is also used on the skin to stop the growth of certain bacteria that cause acne. It is more popular than comparable drugs.

What is evoclin used for?

Clindamycin ( Cleocin, Cleocin T, Evoclin) is a moderately priced antibiotic used to treat certain kinds of bacterial infections. It is also used on the skin to stop the growth of certain bacteria that cause acne. It is more popular than comparable drugs.

What is the drug class of tretinoin?

Atralin (tretinoin) Drug class: Retinoids. Tretinoin ( Retin-A, Atralin, Avita) is a moderately priced drug used to treat acne and other skin conditions when applied topically. The oral form can treat a specific type of leukemia.

Is clindamycin covered by Medicare?

It is available in multiple generic and brand versions. Generic clindamycin is covered by most Medicare and insurance plans, but some pharmacy coupons or cash prices may be lower.

What is the best medicine for acne?

Oral Contraceptives for Acne in Women. Oral contraceptives, also known as birth control pills, are frequently used to treat acne in women. The drugs are able to reduce oil gland secretions by suppressing androgen hormones .

What is the best antibiotic for acne?

Oral antibiotics are used to treat moderate to severe acne, or persistent acne. The most common oral antibiotics prescribed for acne treatments are: Erythromycin. Tetracycline.

How do antibiotics help acne?

Like topical antibiotics, oral antibiotics work by reducing Propionibacteria acnes (the bacteria responsible for acne breakouts). They also help decrease inflammation of the skin. Most people are started on a high dosage and moved to lower dosages as acne improves.

How does isotretinoin help with acne?

4 . Isotretinoin works by shrinking the sebaceous glands, reducing the amount of oil found on the skin. This, in turn, reduces the number of comedones (or pore blockages) produced.

Can acne be stubborn?

Even if your acne isn't necessarily severe, it might simply be stubborn. If you've tried topical treatments and your skin still isn't clearing up, oral medications can give your treatment the boost it needs so you can see actual results.

Is aldactone good for acne?

Aldactone (spironolactone) is another medication that is just for adult women only. It's not specifically an acne treatment but can be used in certain circumstances to treat hormonal fluctuations that contribute to breakouts.

Is it hard to treat acne?

Updated on November 18, 2019. There is no doubt that acne can be tough to treat. If you've tried several topical medications without success, or your acne is severe, oral medications are generally the next step in the treatment process. There are several options available, each of which carries its own risks and benefits.

What antibiotics are used for acne?

Two topical antibiotics are used: erythromycin 2% and clindamycin 1% . As is the case with oral antibiotics, topical formulations are thought to play a role in bacterial resistance.

What is the best treatment for acne?

Antibiotics. Oral antibiotics help treat inflammatory acne by destroying the bacteria that causes inflammation. Side effects of oral antibiotics vary among the selection: doxycycline, erythromycin, minocycline, sarecycline, tetracycline and trimethoprim/sulfamethoxazole.

What causes acne and comedones?

Acne occurs when the sebaceous glands in hair follicles, or pores, produce too much sebum (oil). This buildup of sebum combines with dead skin cells and bacteria, clogging the follicles and forming comedones (blackheads, whiteheads and pimples).

How do acne medications work?

Some acne medications work by bringing hormones to normal levels. Exfoliating skin. Getting rid of dead skin cells that combine with excess oil and other debris to block follicles is key for preventing the formation of blackheads, whiteheads and other blemishes. Killing bacteria.

What are the factors that determine the best acne treatment?

Key factors when determining the best acne medications include type, severity and cause. Potential side effects of acne medications must be considered when choosing treatment. Due to the variations in the underlying causes and severity of acne, it can sometimes be challenging to treat.

How does isotretinoin work?

Isotretinoin is an oral retinoid, derived from vitamin A, and works by shrinking sebaceous glands to prevent excess oil production. It is prescribed to treat severe nodular acne. Isotretinoin is available in strengths of 0.5–1.0 mg. It’s typically prescribed to be taken twice per day in strengths up to 2 mg in total.

What is salicylic acid used for?

Stronger concentrations of salicylic acid are prescribed to treat more severe acne. It is also used in chemical peels . OTC salicylic acid products such as cleansers and toners typically are used twice a day, morning and night. Creams and gels can be used as a spot treatment or to areas of breakouts.

What is the best treatment for acne?

Topical acne agents include antiseptic washes that contain ingredients to gently cleanse the skin; and creams, lotions, or gels that exfoliate the skin, inhibit bacterial growth, speed up skin cell renewal or decrease the formation of comedones.

What is topical acne cream?

Topical acne agents are creams, gels, lotions, and washes that are used on the skin and contain ingredients that treat acne. They are typically used for mild acne, although some may be used for the treatment of severe acne in conjunction with prescription medicines.

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Indications and Usage For Clozapine

  • Treatment-Resistant Schizophrenia
    Clozapine tablets are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine tablets should be used only in pati…
  • Reduction in the Risk of Recurrent Suicidal Behavior in Schizophrenia or Schizoaffective Disorder
    Clozapine tablets are indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. Suicidal behavior refers to actions b…
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Clozapine Dosage and Administration

  • Required Laboratory Testing Prior to Initiation and During Therapy
    Prior to initiating treatment with Clozapine tablets, a baseline ANC must be obtained. The baseline ANC must be at least 1500/μL for the general population, and at least 1000/μL for patients with documented Benign Ethnic Neutropenia (BEN). To continue treatment, the ANC must be monitor…
  • Dosing Information
    The starting dose is 12.5 mg once daily or twice daily. The total daily dose can be increased in increments of 25 mg to 50 mg per day, if well-tolerated, to achieve a target dose of 300 mg to 450 mg per day (administered in divided doses) by the end of 2 weeks. Subsequently, the dose can b…
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Dosage Forms and Strengths

  • Clozapine Tablets USP, 25 mg are pale yellow colored, round, flat faced, bevel edged uncoated tablets debossed with ‘C facilitated scoreline (functional) C’ on one side and ‘54’ on the other side. Clozapine Tablets USP, 50 mg are pale yellow colored, round, flat faced, bevel edged uncoated tablets debossed with ‘C facilitated scoreline (functional) C’ on one side and ‘55’ on the other sid…
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Contraindications

  • Clozapine tablets are contraindicated in patients with a history of serious hypersensitivity to Clozapine (e.g., photosensitivity, vasculitis, erythema multiforme, or Stevens-Johnson Syndrome) or any other component of Clozapine tablets [see Adverse Reactions (6.2)].
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Warnings and Precautions

  • Severe Neutropenia
    Background Clozapine can cause neutropenia (a low absolute neutrophil count (ANC)), defined as a reduction below pre-treatment normal levels of blood neutrophils. The ANC is usually available as a component of the complete blood count (CBC), including differential, and is more relevant t…
  • Clozapine REMS Program
    Clozapine is only available through a restricted program under a REMS called the Clozapine REMS Program because of the risk of severe neutropenia. Notable requirements of the Clozapine REMS Program include: • 1. Healthcare professionals who prescribe Clozapine must be certified with t…
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Adverse Reactions

  • The following adverse reactions are discussed in more detail in other sections of the labeling: • 1. Severe Neutropenia [see Warnings and Precautions (5.1)] • 1. Orthostatic Hypotension, Bradycardia, and Syncope [see Warnings and Precautions (5.3)] • 1. Falls [see Warnings and Precautions (5.4)] • 1. Seizures [see Warnings and Precautions (5.5)] • 1. Myocarditis, Cardiomyo…
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Drug Interactions

  • Potential for Other Drugs to Affect Clozapine
    Clozapine is a substrate for many cytochrome P450 isozymes, in particular CYP1A2, CYP3A4, and CYP2D6. Use caution when administering Clozapine concomitantly with drugs that are inducers or inhibitors of these enzymes. CYP1A2 Inhibitors Concomitant use of Clozapine and CYP1A2 inhi…
  • Potential for Clozapine to Affect Other Drugs
    Concomitant use of Clozapine with other drugs metabolized by CYP2D6 can increase levels of these CYP2D6 substrates. Use caution when coadministering Clozapine with other drugs that are metabolized by CYP2D6. It may be necessary to use lower doses of such drugs than usually pre…
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Use in Specific Populations

  • Pregnancy
    Pregnancy Category B Risk Summary There are no adequate or well-controlled studies of Clozapine in pregnant women. Reproduction studies have been performed in rats and rabbits at doses up to 0.4 and 0.9 times, respectively, the maximum recommended human dose (MRHD) o…
  • Nursing Mothers
    Clozapine is present in human milk. Because of the potential for serious adverse reactions in nursing infants from Clozapine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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Overdosage

  • Overdosage Experience
    The most commonly reported signs and symptoms associated with Clozapine overdose are: sedation, delirium, coma, tachycardia, hypotension, respiratory depression or failure; and hypersalivation. There are reports of aspiration pneumonia, cardiac arrhythmias, and seizure. Fa…
  • Management of Overdosage
    There is no available specific antidote to an overdose of Clozapine. Establish and maintain an airway; ensure adequate oxygenation and ventilation. Monitor cardiac status and vital signs. Use general symptomatic and supportive measures. Consider the possibility of multiple-drug involve…
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Clozapine Description

  • Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is: Clozapine USP is available in pale yellow colored tablets of 25 mg, 50 mg, 100 mg, and 200 mg for oral administration. Active Ingredient: Clozapine Inactive Ingredients: colloidal silicon dioxide, corn st…
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Uses For Clozapine

  • Treatment-resistant Schizophrenia
    Management of treatment-resistant schizophrenia in severely ill patients who fail to respond adequately to standard antipsychotic therapy. Because of the risk of severe neutropenia and seizures, use only in patients who have failed to respond adequately to standard antipsychotic tr…
  • Suicide Risk Reduction in Schizophrenia and Schizoaffective Disorder
    Reduction in risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for reexperiencing suicidal behavior, based on history and recent clinical state. In the principal supportive study for this use, most patients als…
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Clozapine Dosage and Administration

  • General
    1. Prior to initiating clozapine therapy, obtain a baseline complete blood cell (CBC) count, including absolute neutrophil count (ANC). In the general population, baseline ANC must be ≥1500/mm3 before clozapine therapy can be initiated. In patients with documented benign ethni…
  • Dosage
    Orally disintegrating tablets and conventional tablets are bioequivalent; oral suspension and conventional tablets also are bioequivalent. Carefully adjust dosage according to individual requirements and response using lowest possible effective dosage. To minimize the risks of ort…
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Cautions For Clozapine

  • Contraindications
    1. History of serious hypersensitivity to clozapine (e.g., photosensitivity, vasculitis, erythema multiforme, Stevens-Johnson syndrome) or any ingredient in the formulation.
  • Common Adverse Effects
    Sedation, dizziness/vertigo, headache, tremor, tachycardia, hypotension, syncope, hypersalivation, sweating, dry mouth, visual disturbances, constipation, nausea, fever.
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Actions

  1. Exact mechanism of antipsychotic action not fully elucidated; may involve serotonergic, adrenergic, and cholinergic neurotransmitter systems in addition to more selective, regionally specific effec...
  2. Efficacy thought to be principally mediated through antagonist activity at dopamine type 2 (D2) and serotonin type 2A (5-HT2A) receptors.
  1. Exact mechanism of antipsychotic action not fully elucidated; may involve serotonergic, adrenergic, and cholinergic neurotransmitter systems in addition to more selective, regionally specific effec...
  2. Efficacy thought to be principally mediated through antagonist activity at dopamine type 2 (D2) and serotonin type 2A (5-HT2A) receptors.
  3. Binds to dopamine D1, D2, D3, D4, and D5 receptors; histamine H1 receptors; α1A-adrenergic and α2A-adrenergic receptors; serotonin 5-HT1A, 5-HT2A, 5-HT2C, 5-HT3, 5-HT6, and 5-HT7 receptors; and mus...

Advice to Patients

  1. Importance of advising patients and caregivers about risk of severe neutropenia and infection with clozapine. Inform patients and caregivers that clozapine is only available through the Clozapine R...
  2. Importance of immediately informing clinician if any signs or symptoms of infection (e.g., flu-like illness; fever; lethargy; general weakness or malaise; mucous membrane ulceration; skin, …
  1. Importance of advising patients and caregivers about risk of severe neutropenia and infection with clozapine. Inform patients and caregivers that clozapine is only available through the Clozapine R...
  2. Importance of immediately informing clinician if any signs or symptoms of infection (e.g., flu-like illness; fever; lethargy; general weakness or malaise; mucous membrane ulceration; skin, pharynge...
  3. Risk of orthostatic hypotension, particularly during initial dosage titration. Importance of patients immediately informing clinician if they feel faint, lose consciousness, or have signs or sympto...
  4. If therapy interrupted for ≥2 days, contact clinician for dosage instructions.

Preparations

  • Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Centerfor information on shortages of one or more of these preparations. Clozapine is available only through a shared REMS program, the Clozapine REMS program, that …
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