How should I take Clozapine?

2 DOSAGE AND ADMINISTRATION Recommended starting oral dosage is 12.5 mg once daily or twice daily. ( 2.2 ) If well-tolerated, increase the total daily dosage in increments of 25 mg to 50 mg per day at target dosage of 150 mg to 225 mg twice per day by the end of two weeks. ( 2.2 ) Subsequently may increase the doage in increments up to 100 mg, once or twice weekly. ( 2.2 ) Maximum daily dosage is 450 mg twice daily. ( 2.2 ) Administer with or without food. Clozapine ODT may be allowed to disintegrate or chewed, and may be taken with or without water. See additional administration instructions in the full prescribing information. ( 2.2 ) See dosage modification based on ANC results. ( 2.3 , 2.4 ) See recommendations for discontinuing Clozapine ODT treatment ( 2.5 ), restarting Clozapine ODT after interrupting dosing (2.6), dosage modifications for drug interactions ( 2.7 ), dosage recommendations in patients with renal or hepatic impairment and CYP2D6 poor metabolizers ( 2.8 ) in the full prescribing information. Tablets rapidly disintegrate after placement in the mouth and may be chewed if desired. No water is needed. ( 2.2 ) 2.1 Absolute Neutrophil Count Testing Prior to Clozapine

What are the common side effects?

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Severe Neutropenia [see Warnings and Precautions (5.1) ] Orthostatic Hypotension, Bradycardia, and Syncope [see Warnings and Precautions (5.2) ] Falls [see Warnings and Precautions (5.3) ] Seizures [see Warnings and Precautions (5.4) ] Myocarditis, Pericarditis, Cardiomyopathy, and Mitral Valve Incompetence [see Warnings and Precautions (5.5) ] Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.6) ] Gastrointestinal Hypomotility with Severe Complications [see Warnings and Precautions (5.7) ] Eosinophilia [see Warnings and Precautions (5.8) ] QT Interval Prolongation [see Warnings and Precautions (5.9) ] Metabolic Changes (Hyperglycemia and Diabetes Mellitus, Dyslipidemia, and Weight Gain) [see Warnings and Precautions (5.10) ] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.11) ] Hepatotoxicity [see Warnings and Precautions (5.12) ] Fever [see Warnings and Precautions (5.13) ] Pulmonary Embolism [see Warnings and Precautions (5.14) ] Anticholinergic Toxicity [see Warnings and Precautions (5.15) ] In.

Who should not take Clozapine?

4 CONTRAINDICATIONS Clozapine ODT is contraindicated in patients with a history of hypersensitivity to clozapine (e.g., photosensitivity, vasculitis, erythema multiforme, or Stevens-Johnson Syndrome) or any other component of Clozapine ODT [see Adverse Reactions (6.2) ] .; Known hypersensitivity to clozapine or any other component of Clozapine ODT ( 4 ).

Can I take Clozapine during pregnancy?

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including Clozapine ODT, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Atypical Antipsychotics at1-866-961-2388 or visiting http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs, including Clozapine ODT, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery ( see Clinical Considerations ). Available data from published epidemiologic studies over decades of use with clozapine during pregnancy have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes ( see Data ). There are risks to the mother associated with untreated schizophrenia and with exposure to antipsychotics, including Clozapine ODT, during pregnancy ( see Clinical Considerations ). In animal reproduction studies, no adverse developmental effects were observed when clozapine was administered oral

Can children take Clozapine?

8.4 Pediatric Use Safety and effectiveness of clozapine in pediatric patients have not been established.

Does Clozapine interact with other medicines?

7 DRUG INTERACTIONS Concomitant use of Strong CYP1A2 Inhibitors : Reduce Clozapine ODT dose to one-third when coadministered with strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, enoxacin).; ( 2.7 , 7.1 ) Concomitant use of Strong CYP3A4 Inducers is not recommended.; ( 2.7 , 7.1 ) Discontinuation of CYP1A2 or CYP3A4 Inducers: Consider reducing Clozapine ODT dose when CYP1A2 (e.g., tobacco smoke) or CYP3A4 inducers (e.g., carbamazepine) are discontinued.; ( 2.7 , 7.1 ) Anticholinergic drugs: Concomitant use may increase the risk for anticholinergic toxicity.; ( 5.7 , 5.15 , 7.1 ) 7.1 Potential for Other Drugs to Affect Clozapine ODT Clozapine is a substrate for many cytochrome P450 isozymes, in particular CYP1A2, CYP3A4, and CYP2D6.; Use caution when administering Clozapine ODT concomitantly with drugs that are inducers or inhibitors of these enzymes..

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Clozapine

Illustration of the usual dosage form, not a product photo.

Chemical structure · PubChem CID 135398737

atypical antipsychoticBoxed warning: Severe neutropenia, orthostatic hypotension, seizures, myocarditis, dementia mortalityPrescription only (Schedule H)On NLEM 2022NPPA price ceilingJan Aushadhi listed

Clozapine

क्लोज़ापीन

Clozapine is an atypical antipsychotic tablet for severely ill people with schizophrenia who have not responded to other treatment. Its boxed warning covers severe low white blood cells, fainting, seizures, heart inflammation and higher death risk in elderly people with dementia.

Generic name: Clozapine
Used for: Severe schizophrenia that has not responded to standard antipsychotics, and reducing suicidal behaviour risk in schizophrenia.
Label used: Tablets label, oral, DailyMed set 61fe53d5, effective 2026-05
Prescription status (India): Prescription only (Schedule H) in the lists we checked
On NLEM 2022: Yes (Tablet 25 mg; Tablet 50 mg; Tablet 100 mg)
NPPA price ceiling: Yes (scheduled formulation)

More facts

Jan Aushadhi: Listed (4 product rows)
Banned combinations: None found in the list we checked

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Compiled from official drug labels and Indian government sources. Always follow your doctor's or pharmacist's advice.

Safety at a glance

AlcoholCaution in label textSee wording
PregnancyCaution in label textSee wording
BreastfeedingCaution in label textSee wording
DrivingCaution in label textSee wording
KidneyNot mentioned in label text
LiverCaution in label textSee wording

Taken only from the label text cited on this page. "Not mentioned" does not mean safe. Ask your doctor or pharmacist.

What is clozapine used for?

The label describes clozapine for severely ill adults with schizophrenia who do not respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and seizures, it is for those people only.

It is also described for reducing the risk of repeated suicidal behaviour in people with schizophrenia or schizoaffective disorder at chronic risk.

Treatment-resistant schizophrenia
Reducing recurrent suicidal behaviour in schizophrenia or schizoaffective disorder

Source1

How does clozapine work?

The label says how clozapine works is unknown. Its effect is thought to come from blocking dopamine D2 and serotonin 5-HT2A receptors.

It also blocks several other receptors in the brain.

Source1

How is clozapine usually taken?

This page covers the US label for clozapine tablets taken by mouth, with the dosing the label gives for adults.

This is label-level information, not personal advice. Indian pack labels may differ, and your prescriber's instruction always comes first.

For adults, the label describes starting at 12.5 mg once or twice daily, then raising by 25 to 50 mg a day if tolerated, to a target of 150 to 225 mg twice daily within two weeks. The maximum is 450 mg twice daily.

The label says it may be taken with or without food. A baseline blood count (ANC) is needed before starting, with regular tests during treatment.

Slow step-up from a low starting dose
Baseline and regular ANC blood tests
With or without food
Do not restart at full dose after a break without advice

Source1

What are the side effects of clozapine?

Common

Common effects in the label include sedation, dizziness, headache, tremor, fast heartbeat, low blood pressure, fainting, drooling, sweating, dry mouth, constipation, nausea and fever.
Sedation and dizziness
Drooling and dry mouth
Fast heartbeat and low blood pressure
Constipation
Fever

Serious: get help

Serious effects include severe low neutrophil counts, seizures, heart muscle inflammation, severe constipation, high blood sugar and weight gain.

Source1

Who should be careful with clozapine?

The boxed warning covers severe neutropenia with serious infections, low blood pressure with slow heartbeat and fainting, seizures, myocarditis and cardiomyopathy, and higher death risk in elderly people with dementia-related psychosis.

Care is needed with heart or brain blood vessel disease, a history of seizures, and conditions causing low blood pressure.

It is contraindicated in people with a known allergy to clozapine.

Severe neutropenia and infection
Fainting and low blood pressure
Seizure risk is dose-related
Heart inflammation and cardiomyopathy
Higher death risk in elderly people with dementia
Metabolic changes and liver effects

Source1

What medicines interact with clozapine?

Search interactions

Fluvoxamine, ciprofloxacin and other CYP1A2 inhibitors
Strong CYP3A4 inducers
Anticholinergic medicines
Changes in tobacco smoking
The label says to reduce the clozapine dose to one-third with strong CYP1A2 inhibitors such as fluvoxamine and ciprofloxacin.
Strong CYP3A4 inducers are not recommended.
Anticholinergic medicines may add to anticholinergic toxicity.
Stopping smoking or inducers like carbamazepine may raise clozapine levels.

Source1

How should clozapine be stored?

The label gives a storage range of 20 to 25 degrees C.

Follow the storage line on your own pack, and keep medicines out of the reach of children.

Source1

Is clozapine a prescription medicine in India?

In the Drugs Rules schedules we checked, clozapine is listed under Schedule H (serial and rule: Schedule H, serial 131 (rules 65 and 97)). Schedule H medicines are sold only on a registered doctor's prescription.

Clozapine is on the National List of Essential Medicines 2022. Listed forms include: Tablet 25 mg (page 102); Tablet 50 mg (page 102); Tablet 100 mg (page 102).

NPPA lists ceiling prices for scheduled clozapine formulations. The table shows the rows we found. Check NPPA directly for the current list.

The Jan Aushadhi (PMBJP) list we checked has 4 product rows that mention clozapine. We did not capture prices for them.

NPPA ceiling prices found in the lists we checked
List	Formulation and strength	Unit	Ceiling price (Rs)
All scheduled (NLEM 2015), as on 30.09.2020, page 6	Tablet 100 mg	1 Tablet	7.72
All scheduled (NLEM 2015), as on 30.09.2020, page 6	Tablet 25 mg	1 Tablet	2.51
All scheduled (NLEM 2015), as on 30.09.2020, page 6	Tablet 50 mg	1 Tablet	4.79

Source2 3 4 5

What is the price ceiling for clozapine?

NPPA ceiling prices set the most a seller can charge per unit for the listed formulations, before local taxes. They are ceilings, not the price you will always pay.

Jan Aushadhi lists clozapine products including Clozapine Tablets IP 25 mg 25 mg; Clozapine Tablets IP 50 mg 50 mg; Clozapine Tablets IP 100 mg 100 mg; Clozapine tablets IP 200mg 200mg. We have not shown a price for them. Check the pack and the seller for the actual price.

Source3 4

Frequently asked questions

Can I drink alcohol while taking clozapine?

The label notes alcohol abuse raises seizure risk. The label we reviewed does not give other advice. Ask your doctor or pharmacist.

Source1

Is clozapine safe in pregnancy and breastfeeding?

Newborns exposed in late pregnancy may have withdrawal or movement symptoms. Ask your doctor or pharmacist about pregnancy and breastfeeding.

Source1

Should clozapine be taken with food?

The label says it may be taken with or without food.

Source1

Can clozapine affect driving or alertness?

The label warns about sedation, dizziness and sudden loss of consciousness, so take care with driving. Ask your doctor or pharmacist.

Source1

Can children or older adults take clozapine?

The label warns of higher death risk in elderly people with dementia. The label we reviewed does not describe children. Ask your doctor or pharmacist.

Source1

Is clozapine on the NLEM and Jan Aushadhi list?

It is on NLEM 2022. Yes, several clozapine products are in the Jan Aushadhi list we checked.

Source2 3

Sources

1U.S. FDA-approved label (DailyMed) (61fe53d5-ed5c-4e45-9189-709d08d386cb) Open source · 2026-10-15
2National List of Essential Medicines 2022 (102) Open source · 2026-10-15
3NPPA price ceiling list (All scheduled (NLEM 2015) 6) Open source · 2026-10-15
4PMBJP (Jan Aushadhi) product list (p53:sno1190) Open source · 2026-10-15
5Drugs Rules 1945, Schedules (2022 consolidation) (Schedule H, Schedule H, serial 131 (rules 65 and 97)) Open source · 2026-10-15

Compiled by software from the sources above and checked by automated rules. Last checked: 2026-10-15 · How we use sources · Report a correction

This information is educational and is not a substitute for advice from your doctor or pharmacist. It does not tell you what dose you personally should take. In an emergency call 112.