▶ Specification : 10T
▶ Category : Antihistamines
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Cetirizine Dihydrochloride 10mg
1. Adults and children 6 years and older : Orally administer 10mg once a day as cetirizine dihydrochloride before sleep.
2. For patients sensitive to adverse reaction, administer 5mg each in the morning and evening.
3. Increase or reduce according to symptoms.
4. Moderately severe to sever renal impairment patients : Administration interval should be adjusted depending on patient’s renal function. Consult the following table when adjusting doses. Creatinine clearance in terms mL/min units is necessary to use this dose table. CLcr(mL/min) is calculated from the measured serum creatinine (mg/dL) value using the following formula.
1. Seasonal and perennial allergic rhinitis, allergic conjunctivitis, chronic idiopathic hives, itchiness of skin
2. Eczema or dermatitis due to concomitant use with hydrocortisone external preparations
1. The following persons should not take this drug.
1) Patients with hypersensitivity to this drug and hydroxyzine or piperazine derivatives, or a history of the same
2) Patients with renal failure (creatinine clearance <10mL/min)
3) Pregnant or potentially pregnant women, nursing mothers
4) Children less than 6 years
5) This drug contains lactose. Do not administer to patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption (only for preparations containing lactose)
2. Persons taking this drug should not take the following drugs
1) In a study with multiple administration of theophylline (once a day, 400mg) and cetirizine, whereas the pharmacokinetics of theophylline did not change when administered together with cetirizine, the clearance rate of cetirizine was slightly (16%) lowered.
2) In a study with multiple administration of ritonavir (600mg, twice a day) and cetirizine (10mg/day), whereas ritonavir breakdown changed slightly (-11%) when administered with cetirizine, exposure to cetirizine increased by approximately 40%.
3. Do not do the following while taking this drug
1) Minute amounts of this drug are secreted through breast milk; discontinue breastfeeding while administering.
2) As with other antihistamines, do not administer with excessive amounts of alcohol.
4. The following persons should consult a physician, dentist, or pharmacist before taking this drug.
1) Renal impairment patients (high blood concentration may be sustained)
2) Liver impairment patients (high blood concentration may be sustained)
3) Elderly patients (high blood concentration may be sustained)
This drug is mainly excreted through the kidneys. Excessive blood concentration may be sustained in elderly patients who generally have lowered renal function. Begin administration at low doses, and if anomalies are confirmed, reduce dose or discontinue administration, and take appropriate action.
4) Epilepsy patients and patients with risk of seizure
5) This drug may increase the risk of urine retention; use with caution in patients with urine retention precursors (e.g. spinal lesions, prostatic hyperplasia).
5. In the following cases, immediately discontinue administration of this drug and consult a physician, dentist or pharmacist. If possible, the patient should take this document with him/her when consulting.
1) Symptoms and action for overdosage
- Symptoms : Symptoms observed after overdosage of cetirizine are usually associated with central nervous system effects or influences considered to be anticholinergic effects. Adverse reactions reported after administration of at least 5 times the recommended daily dose are as follow : confusion, diarrhea, dizziness, fatigue, headache, malaise, dilation of pupils, itchiness, nervousness, calmness, stupor, sleepiness, tachycardia, tremors and urine retention.
- Action : No particular antidotes for cetirizine are reported. For overdosage of this drug, treatment and adjuvant therapy depending on symptoms is recommended. Consider gastric lavage if patient has taken drug not long ago.
Cetirizine is not effectively removed by dialysis.
2) Psychoneural : Drowsiness, headache, sometimes malaise, sense of paralysis, adynamia, anxiety, sensory deficits, rarely light and temporary languor, fatigue, dizziness, heaviness of head, excitation, spasm, motor disorder, dystonia, fainting, tremors, aggressiveness, confusion, depression, hallucination, insomnia, tick disorder, loss of memory, amnestic disorder, suicidal ideation
3) Digestive system : Sometimes thirstiness, dry lips, nausea, loss of appetite, stomach discomfort, indigestion, abdominal pains, stomach cramps, abdominal discomfort, diarrhea, rarely vomiting, gastroenteric disorder, chilitis, taste disorder, increased appetite
4) Circulatory system : Rarely tachycardia, arrhythmia, elevated blood pressure, sometimes palpitations
5) Blood : Vasculitis, sometimes reduced leukocyte count, elevated neutrocyte count, elevated lymphocyte count, elevated eosinocyte count, rarely increased monocyte count and platelet count. Rarely, lowered platelet count may appear. Observe sufficiently, and if anomalies are confirmed, discontinue administration and take appropriate action.
6) Immune system, skin and hypodermis : Light hypersensitivity, rarely hypersensitivity and hypersensitive shock, sometimes edema, itchiness, rashes, rarely hives, angioedema, and fixed drug eruption
7) Eyes : Rarely cloudiness of vision, conjunctivochalasis, eye control disorder, and oculogyration.
8) Ears and labyrinth : Vertigo
9) Liver : Sometimes liver impairment such as elevation of AST, ALT, ALP, total bilirubin, γ-GTP or LDH (initial symptoms : systemic malaise, loss of appetite, fever, nausea, etc.), and jaundice may appear. Observe sufficiently, and if anomalies are confirmed, discontinue administration and take appropriate action.
10) Kidneys : Sometimes elevated BUN, diabetes, blood in urine, rarely difficulty voiding, enuresis, and urine retention.
11) Other : Pharyngitis, cough, nosebleeds, bronchospasm, hearing anomalies, vision anomalies, sometimes chest pains, rarely menstrual irregularity, ringing in ears, rhinitis, and weight gain.
12) Itchiness and/or hives reported in some patients after discontinuation of cetirizine.
6. Other precautions when taking this drug
1) This drug suppresses intradermal reaction to allergens; preferably, do not administer this drug 3 to 5 days prior to performing allergen intradermal reaction testing.
2) Administration of 20 to 25mg/day to a healthy volunteer resulted in no adverse effects in terms of agility or response time. However, do not exceed dose in patients who operate vehicles or machinery. Whereas it appears that racemic bodies (enantiomers) will not increase the impact of alcohol (around 0.5g/L blood), concomitant administration of alcohol or other CNS suppressants may additionally lower wariness and result in functional disorders.
3) There are clinical reports of administering up to 20mg/day of this drug according to physician’s or pharmacist’s instructions when there was no improvement of symptoms with administration of 10mg/day of this drug.
4) The rate of absorption of cetirizine is reduced for about 1 hour by food, but the degree of absorption is not reduced.
7. Storage precautions
1) Keep out of reach from children.
2) Removing drugs from their original container and storing them in other container may lead to accidents due to misuse or lower quality; be sure to keep in tightly closed original container.
Cetirizine Dihydrochloride 10mg
1. Adults and children 6 years and older : Orally administer 10mg once a day as cetirizine dihydrochloride before sleep.
2. For patients sensitive to adverse reaction, administer 5mg each in the morning and evening.
3. Increase or reduce according to symptoms.
4. Moderately severe to sever renal impairment patients : Administration interval should be adjusted depending on patient’s renal function. Consult the following table when adjusting doses. Creatinine clearance in terms mL/min units is necessary to use this dose table. CLcr(mL/min) is calculated from the measured serum creatinine (mg/dL) value using the following formula.
1. Seasonal and perennial allergic rhinitis, allergic conjunctivitis, chronic idiopathic hives, itchiness of skin
2. Eczema or dermatitis due to concomitant use with hydrocortisone external preparations
1. The following persons should not take this drug.
1) Patients with hypersensitivity to this drug and hydroxyzine or piperazine derivatives, or a history of the same
2) Patients with renal failure (creatinine clearance <10mL/min)
3) Pregnant or potentially pregnant women, nursing mothers
4) Children less than 6 years
5) This drug contains lactose. Do not administer to patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption (only for preparations containing lactose)
2. Persons taking this drug should not take the following drugs
1) In a study with multiple administration of theophylline (once a day, 400mg) and cetirizine, whereas the pharmacokinetics of theophylline did not change when administered together with cetirizine, the clearance rate of cetirizine was slightly (16%) lowered.
2) In a study with multiple administration of ritonavir (600mg, twice a day) and cetirizine (10mg/day), whereas ritonavir breakdown changed slightly (-11%) when administered with cetirizine, exposure to cetirizine increased by approximately 40%.
3. Do not do the following while taking this drug
1) Minute amounts of this drug are secreted through breast milk; discontinue breastfeeding while administering.
2) As with other antihistamines, do not administer with excessive amounts of alcohol.
4. The following persons should consult a physician, dentist, or pharmacist before taking this drug.
1) Renal impairment patients (high blood concentration may be sustained)
2) Liver impairment patients (high blood concentration may be sustained)
3) Elderly patients (high blood concentration may be sustained)
This drug is mainly excreted through the kidneys. Excessive blood concentration may be sustained in elderly patients who generally have lowered renal function. Begin administration at low doses, and if anomalies are confirmed, reduce dose or discontinue administration, and take appropriate action.
4) Epilepsy patients and patients with risk of seizure
5) This drug may increase the risk of urine retention; use with caution in patients with urine retention precursors (e.g. spinal lesions, prostatic hyperplasia).
5. In the following cases, immediately discontinue administration of this drug and consult a physician, dentist or pharmacist. If possible, the patient should take this document with him/her when consulting.
1) Symptoms and action for overdosage
- Symptoms : Symptoms observed after overdosage of cetirizine are usually associated with central nervous system effects or influences considered to be anticholinergic effects. Adverse reactions reported after administration of at least 5 times the recommended daily dose are as follow : confusion, diarrhea, dizziness, fatigue, headache, malaise, dilation of pupils, itchiness, nervousness, calmness, stupor, sleepiness, tachycardia, tremors and urine retention.
- Action : No particular antidotes for cetirizine are reported. For overdosage of this drug, treatment and adjuvant therapy depending on symptoms is recommended. Consider gastric lavage if patient has taken drug not long ago.
Cetirizine is not effectively removed by dialysis.
2) Psychoneural : Drowsiness, headache, sometimes malaise, sense of paralysis, adynamia, anxiety, sensory deficits, rarely light and temporary languor, fatigue, dizziness, heaviness of head, excitation, spasm, motor disorder, dystonia, fainting, tremors, aggressiveness, confusion, depression, hallucination, insomnia, tick disorder, loss of memory, amnestic disorder, suicidal ideation
3) Digestive system : Sometimes thirstiness, dry lips, nausea, loss of appetite, stomach discomfort, indigestion, abdominal pains, stomach cramps, abdominal discomfort, diarrhea, rarely vomiting, gastroenteric disorder, chilitis, taste disorder, increased appetite
4) Circulatory system : Rarely tachycardia, arrhythmia, elevated blood pressure, sometimes palpitations
5) Blood : Vasculitis, sometimes reduced leukocyte count, elevated neutrocyte count, elevated lymphocyte count, elevated eosinocyte count, rarely increased monocyte count and platelet count. Rarely, lowered platelet count may appear. Observe sufficiently, and if anomalies are confirmed, discontinue administration and take appropriate action.
6) Immune system, skin and hypodermis : Light hypersensitivity, rarely hypersensitivity and hypersensitive shock, sometimes edema, itchiness, rashes, rarely hives, angioedema, and fixed drug eruption
7) Eyes : Rarely cloudiness of vision, conjunctivochalasis, eye control disorder, and oculogyration.
8) Ears and labyrinth : Vertigo
9) Liver : Sometimes liver impairment such as elevation of AST, ALT, ALP, total bilirubin, γ-GTP or LDH (initial symptoms : systemic malaise, loss of appetite, fever, nausea, etc.), and jaundice may appear. Observe sufficiently, and if anomalies are confirmed, discontinue administration and take appropriate action.
10) Kidneys : Sometimes elevated BUN, diabetes, blood in urine, rarely difficulty voiding, enuresis, and urine retention.
11) Other : Pharyngitis, cough, nosebleeds, bronchospasm, hearing anomalies, vision anomalies, sometimes chest pains, rarely menstrual irregularity, ringing in ears, rhinitis, and weight gain.
12) Itchiness and/or hives reported in some patients after discontinuation of cetirizine.
6. Other precautions when taking this drug
1) This drug suppresses intradermal reaction to allergens; preferably, do not administer this drug 3 to 5 days prior to performing allergen intradermal reaction testing.
2) Administration of 20 to 25mg/day to a healthy volunteer resulted in no adverse effects in terms of agility or response time. However, do not exceed dose in patients who operate vehicles or machinery. Whereas it appears that racemic bodies (enantiomers) will not increase the impact of alcohol (around 0.5g/L blood), concomitant administration of alcohol or other CNS suppressants may additionally lower wariness and result in functional disorders.
3) There are clinical reports of administering up to 20mg/day of this drug according to physician’s or pharmacist’s instructions when there was no improvement of symptoms with administration of 10mg/day of this drug.
4) The rate of absorption of cetirizine is reduced for about 1 hour by food, but the degree of absorption is not reduced.
7. Storage precautions
1) Keep out of reach from children.
2) Removing drugs from their original container and storing them in other container may lead to accidents due to misuse or lower quality; be sure to keep in tightly closed original container.