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Sinacet5 mg
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Medicine overview
Indications of Sinacet 5 mg
Levocetirizine is indicated in the treatment of symptoms associated with allergic conditions such as-
perennial allergic rhinitis
seasonal allergic rhinitis
chronic idiopathic urticaria
Theropeutic Class
Non-sedating antihistamines
Pharmacology
Sinacet 5 mg is a preparation of Sinacet 5 mg.
Absorption
Levocetirizine is the active (levo) isomer of Cetirizine.
Distribution
It is a new highly effective and well-tolerated non-sedating antihistamine with potent antiallergic properties.
Metabolism
It has a two-fold higher affinity for H1-receptors than Cetirizine.
Excretion
Levocetirizine has a rapid and long-lasting action, allowing once-a-day administration.
Dosage & Administration of Sinacet 5 mg
Adults and children 12 years of age and older
Dosage:5 mg once daily in the eveningChildren 6 to 11 years of age: 2.5 mg once daily in the eveningChildren 6 months to 5 years of age: 1.25 mg (1/2 teaspoon oral solution) once daily in the eveningRenal Impairment: Adjust the dose in patients 12 years of age and older with decreased renal function
| Condition | Dosage | Notes |
|---|---|---|
| Adults and children 12 years of age and older | 5 mg once daily in the eveningChildren 6 to 11 years of age: 2.5 mg once daily in the eveningChildren 6 months to 5 years of age: 1.25 mg (1/2 teaspoon oral solution) once daily in the eveningRenal Impairment: Adjust the dose in patients 12 years of age and older with decreased renal function |
Dosage of Sinacet 5 mg
Adult and children 12 years of age and older
Dosage:The recommended dose is 5 mg once daily
Children 6 to 11 years of age
Dosage:The recommended dose is 2.5 mg (½ tablet or 1 teaspoon oral solution) once daily
Children 6 months to 5 years of age
Dosage:The recommended dose is 1.25 mg (½ teaspoon oral solution) once daily
Pediatric use
Dosage:The recommended dose for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older
Geriatric use
Dosage:In clinical studies, each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients
Hepatic impairment
Dosage:No dosage adjustment is required in patients with solely hepatic impairment
Renal impairment
Dosage:Mild renal impairment (creatinine clearance: 50-80 ml/min): a dose of 2.5 mg once daily is recommended
Moderate renal impairment (creatinine clearance
Dosage:30-50 ml/min): a dose of 2.5 mg once every other day is recommended
Severe renal impairment (creatinine clearance
Dosage:10-30 ml/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended
End-stage renal disease patients (creatinine clearance
Dosage:<10 ml/min) and patients undergoing hemodialysis: should not receive Levocetirizine
| Condition | Dosage | Notes |
|---|---|---|
| Adult and children 12 years of age and older | The recommended dose is 5 mg once daily | |
| Children 6 to 11 years of age | The recommended dose is 2.5 mg (½ tablet or 1 teaspoon oral solution) once daily | |
| Children 6 months to 5 years of age | The recommended dose is 1.25 mg (½ teaspoon oral solution) once daily | |
| Pediatric use | The recommended dose for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older | |
| Geriatric use | In clinical studies, each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients | |
| Hepatic impairment | No dosage adjustment is required in patients with solely hepatic impairment | |
| Renal impairment | Mild renal impairment (creatinine clearance: 50-80 ml/min): a dose of 2.5 mg once daily is recommended | |
| Moderate renal impairment (creatinine clearance | 30-50 ml/min): a dose of 2.5 mg once every other day is recommended | |
| Severe renal impairment (creatinine clearance | 10-30 ml/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended | |
| End-stage renal disease patients (creatinine clearance | <10 ml/min) and patients undergoing hemodialysis: should not receive Levocetirizine |
Interaction of Sinacet 5 mg
Levocetirizine is not known to have any interactions with other drugs.
Contraindications
Hypersensitivity to levocetirizine, cetirizine or its parent compound hydroxyzine. Patients with severe renal impairment (creatinine clearance: <10 ml/min) should not be administered levocetirizine.
Side Effects of Sinacet 5 mg
Generally, levocetirizine is well tolerated. However, a few side effects like headache, dry mouth, fatigue and skin rash have been reported rarely.
Pregnancy & Lactation
Pregnancy: The safety of Levocetirizine in pregnancy has not been established. Therefore, it should be used with caution during pregnancy and only if the potential benefits to the mother outweigh any risks to the foetus.Lactation: Levocetirizine passes into breast milk. So, it should be used with caution in nursing mothers and only if the expected benefit to the mother is greater than the risk to the nursing infant.
Precautions & Warnings
Epileptic patients and patients at risk of convulsions. Renal impairment. Pregnancy and lactation.
Overdose Effects of Sinacet 5 mg
No clinically relevant adverse events have been reported in case of overdose. However in the event of overdosage, symptomatic and supportive treatment is recommended.
Storage Conditions
Store at a temperature not exceeding 30°C in a dry place. Protect from light.
Use In Special Populations
Paediatric use: Not recommended for use in children less than 6 years of age.
Drug Classes
Non-sedating antihistamines
Mode Of Action
This preparation contains Sinacet 5 mg. Levocetirizine is the active (Levo) isomer of cetirizine. It is a new highly effective and well-tolerated nonsedating antihistamine with potent antiallergic properties. It has a two-fold higher affinity for H1 receptors than cetirizine. Levocetirizine has a rapid and long-acting action, allowing once-a-day administration.
Pregnancy
Pregnancy Catagory B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, levocetirizine should be used during pregnancy only if clearly needed. Since levocetirizine is excreted in breast milk it is not recommended for use by nursing mothers.
Frequently Asked Questions
What is Sinacet 5 mg used for?
Levocetirizine is indicated in the treatment of symptoms associated with allergic conditions such as- perennial allergic rhinitis seasonal allergic rhinitis chronic idiopathic urticaria
What is the dosage of Sinacet 5 mg?
Adult and children 12 years of age and older: The recommended dose is 5 mg once daily.Children 6 to 11 years of age: The recommended dose is 2.5 mg (½ tablet or 1 teaspoon oral solution) once daily.Children 6 months to 5 years of age: The recommended dose is 1.25 mg (½ teaspoon oral solution) once daily.Pediatric use: The recommended dose for the treatment of the uncomplicated skin manifestations …
What are the side effects of Sinacet 5 mg?
Generally, levocetirizine is well tolerated. However, a few side effects like headache, dry mouth, fatigue and skin rash have been reported rarely.
Who should not take Sinacet 5 mg?
Hypersensitivity to levocetirizine, cetirizine or its parent compound hydroxyzine. Patients with severe renal impairment (creatinine clearance: <10 ml/min) should not be administered levocetirizine.
What precautions should be taken with Sinacet 5 mg?
Epileptic patients and patients at risk of convulsions. Renal impairment. Pregnancy and lactation.
Is Sinacet 5 mg safe during pregnancy and breastfeeding?
Pregnancy: The safety of Levocetirizine in pregnancy has not been established. Therefore, it should be used with caution during pregnancy and only if the potential benefits to the mother outweigh any risks to the foetus.Lactation: Levocetirizine passes into breast milk. So, it should be used with caution in nursing mothers and only if the expected benefit to the mother is greater than the risk to …
Disclaimer
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.