Clozapex Tablets – Antipsychotic Agent

NERVOUS SYSTEM /

COMPOSITION

  • Clozapex 100: Clozapine 100 mg.
  • Clozapex 25: Clozapine 25 mg.

PHARMACOLOGY

  • Absorption: Rapid and nearly complete.
  • Distribution: Rapid and extensive, crosses blood-brain barrier.
  • Duration of action: 4 to 12 hours.
  • Elimination: Renal 50%, Fecal 30%. Clozapine has little or no effect on serum prolactin. Extrapyramidal effects are reported to be rare or absent.

INDICATIONS

Schizophrenia: Clozapex is indicated in the management of severely ill schizophrenic patients who have falled to respond to other neuroleptic agents or who can not tolerate the adverse effects produced by those agents.

DOSAGE AND ADMINISTRATION

USUAL ADULT DOSE

Oral, initially 25 mg one to two times a day, the dosage being increased in increments of 25 to 50 mg a day to achieve a dose of 300 to 450 mg a day by the end of two weeks.

Subsequent dosage increment should not exceed 100 mg one or two times a week.

Usual adult prescribing limits: up to 900 mg a day.

CONTRAINDICATIONS

  • Hypersensitivity to the drug
  • history of drug induced granulocytopenia
  • agranulocytosis
  • impaired bone marrow function
  • alcoholic and other toxic psychosis
  • drug intoxication
  • comatose conditions
  • circulatory collapse
  • CNS depression
  • severe hepatic, renal or cardiac disease.

* Clozapex use should be avoided in patients with closed-angle glaucoma.

PRECAUTIONS & WARNINGS

Use in specific population

Pregnancy (Non-teratogenic effects)

Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates.

These complications have varied in severity: while in some cases symptoms have been self-limited; in other cases neonates have required intensive care unit support and prolonged hospitalization.

*These products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Clozapine may cause agranulocytosis

Clozapine (Clozapex) use should be limited for the treatment of resistant schizophrenic patients who have normal leukocyte findings; therefore, regular visits to physician to check progress of therapy and to laboratory for blood tests are mandatory.

Other Precautions

  • Avoid use of alcoholic beverages or other CNS depressants during therapy.
  • Avoid use of drugs with a substantial potential to depress bone marrow function and long-acting depot antipsychotics.
  • Care should be taken when administered to patients with ileus or prostatic hypertrophy.
  • Clozapex should be administered with caution to patients with epilepsy.
  • Increased mortality in elderly patients with dementia related psychosis.

SIDE EFFECTS

  • Granulocytopenia,
  • agranulocytosis,
  • eosinophilia,
  • unexplained leukocytosis.
  • dry mouth
  • accommodation difficulties
  • orthostatic hypotension
  • hypertension
  • tachycardia
  • hyperthermia
  • delirium
  • Drowsiness
  • fatigue,
  • dizziness
  • headache
  • EEG changes
  • seizures
  • rigidity.

DRUG INTERACTIONS

Clozapex interact with the following list of medicines. Keep your doctor, aware with all the medications you are taking.

  • Alcohol
  • MAO inhibitor
  • CNS depressants
  • bone marrow depressants
  • anticholinergics
  • lithium
  • digoxin
  • highly protein-bound medications
  • heparin
  • phenytoin
  • warfarin
  • hypotension-producing medications
  • narcotics
  • sedating antihistamines.

PACKAGE AND STORAGE

  • Tablets 100 mg: Packs of 30 and 50 tablets.
  • Tablets 25 mg: Packs of 30 and 50 tablets.

*Store at temperature not exceeding 30 °C.

Clozapex – Patient Information Leaflet

Clozapex Tablets – EN Information Leaflet

Clozapex Tablets – AR Information Leaflet

Storage

  • Store at temperature not exceeding 30°C.
  • Keep in dry place, protect from light.
  • Keep out of reach of children.

Related Arabic Articles

كلوزابكس [كلوزابين].. كل ما تحتاج ان تعرفة

كلوزابكس [كلوزابين] .. للفصام و علاج الإدمان
Clozapine
Clozapine
  • Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
  • Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sales the medicament.
  • The doctor and the pharmacist are experts in medicine. It’s benefits and risks.
  • Do not by yourself interrupt the period of treatment prescribed for you.
  • Do not repeat the same prescription without consulting your doctor.
  • Keep medicament out of children reach.

Council of Arab Health Ministers and Union of Arab Pharmacists

*ATC CODE: N05AH02 – Produced by: APEX Pharma – Egypt .

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