Philippines Product

Purcet Tablets

Purcet Tablets

Why you have been prescribed this medicine?

Allergic Rhinitis
Levocetirizine is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) in adults and children 6 years of age and older.

Chronic Idiopathic Urticaria
Levocetirizine is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

UNDESIRABLE EFFECTS
In therapeutic studies in women and men aged 12 to 71 years, 15.1% of the patients in the levocetirizine 5 mg group had at least one adverse drug reaction compared to 11.3% in the placebo group.
In therapeutic trials, the drop out rate due to adverse events was 1.0% (9/935) with levocetirizine 5 mg and 1.8% (14/771) with placebo.
Clinical therapeutic trials with levocetirizine included 935 subjects exposed to the drug at the recommended dose of 5 mg daily. From this pooling, following incidence of adverse drug reactions were reported at rates of 1 % or greater (common: >1/100, <1/10) under levocetirizine 5 mg or placebo:

[140- age (years)] x weight (kg) CL = (x 0.85 for women) 72 x serum creatinine (mg/dl)
Dosing Adjustments for Patients with Impaired Renal Function:

 

[140- age (years)] x weight (kg)

 

CL  =

 

 

(x 0.85 for women)

 

 

 

72 x serum creatinine (mg/dl)

 

Dosing Adjustments for Patients with Impaired Renal Function:

 

 

 

 

 

 

Group

 

Creatinine clearance (ml/min)

Dosage and frequency

Normal

 

>80

 

5 mg once daily

 

 

 

 

 

Mild

 

50 – 79

5 mg once daily

Moderate

 

30 – 49

5 mg once every 2 days

 

 

 

 

 

Severe

 

< 30

 

5 mg once every 3 days

End-stage renal disease -

 

< 10-

 

Contra-indicated

Patients undergoing dialysis

 

 

 

 

 

 

 

 

 


Further uncommon incidences of adverse reactions (uncommon >1/1000, <1/100) like asthenia or abdominal pain were observed.
The incidence of sedating adverse drug reactions such as somnolence, fatigue, and asthenia was altogether more common (8.1 %) under levocetirizine 5 mg than under placebo (3.1%).
Methyl parahydroxybenzoate and propyl parahydroxybenzoate can cause allergic reactions (possibly delayed).
In addition to the adverse reactions reported during clinical studies and listed above, very rare cases of the following adverse drug reactions have been reported in post-marketing experience.

Cardiac disorders:
Palpitations

Eyes disorders:
Visual disturbances

Hepatobiliary disorders:
Hepatitis

Immune system disorders:
Hypersensitivity including anaphylaxis

Respiratory, thoracic and mediastinal disorders:
Dyspnoea

Gastrointestinal disorders:
Nausea

Skin and subcutaneous tissue disorders:
Angioneurotic oedema, pruritus, rash, urticaria

Investigations:
Weight increased, abnormal liver function tests

Когда Вы должны проконсультироваться с вашим врачем ?

Если приближается время для принятия следующей дозы , проигнорируйте пропущенную дозу и примите следующую дозу как вам назначено.
В противном случае , примите дозу сразу , как только Вы вспомнили о ней и далее принимайте как обычно.

Things you MUST NOT DO while on this medicine?

The use of Levocetirizine tablet is not recommended in children aged less than 6 years.
Precaution is recommended with intake of alcohol .
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Hypersensitivity to levocetirizine, to any piperazine derivative, methyl parahydroxybenzoate, propyl parahydroxybenzoate, or any of the other excipients.
Severe renal impairment at less than 10 ml/min creatinine clearance.

What to do if you accidentally take too much (overdose) of the medicine?

Symptoms
Symptoms of overdose may include drowsiness in adults and initially agitation and restlessness, followed by drowsiness in children.

Management of overdoses
There is no known specific antidote to levocetirizine.
Should overdose occur, symptomatic or supportive treatment is recommended. Gastric lavage should be considered following short-term ingestion. Levocetirizine is not effectively removed by haemodialysis.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

STORAGE CONDITION
Store at temperatures not exceeding 30°C.

CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

AVAILABILITY
PVC/PVDC Alu. Blister pack of 10 tablets (Box of 10's and 30's)

MANUFACTURED BY
Kusum Healthcare Private Limited
SP-289(A) RIICO Indl. Area Chopanki
(Bhiwadi) Distt.-Alwar, Rajasthan, INDIA

IMPORTED AND DISTRIBUTED BY
Kusum Healthcare Pvt Ltd
Branch Office:
Unit 401, 4th Flr.
Peninsula Court Bldg
8735 Paseo de Roxas
Makati City.

Drug Description

FORMULATION:
Each film-coated tablet contains;
Levocetirizine hydrochloride ………… 5 mg

Indications and dosage.

INDICATIONS
Allergic Rhinitis
Levocetirizine is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) in adults and children 6 years of age and older.
Chronic Idiopathic Urticaria
Levocetirizine is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.

DOSAGE AND ADMINISTRATION
Adults and Children 12 Years of Age and Older
The recommended dose of Levocetirizine is 5 mg once daily in the evening. Some patients may be adequately controlled by 2.5 mg once daily in the evening.

Children 6 to 11 Years of Age
The recommended dose of Levocetirizine is 2.5 mg (1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults.
Dose Adjustment for Renal and Hepatic Impairment

In adults and children 12 years of age and older with:
 Mild renal impairment (creatinine clearance [CLcr] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended;
 Moderate renal impairment (CLcr = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended;
 Severe renal impairment (CLcr = 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 (CLcr < 10 mL/min) and patients undergoing hemodialysis should not receive Levocetirizine.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

Elderly
Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Patients with renal impairment below).
Adult patients with renal impairment
The dosing intervals must be individualised according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed.

The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula:
Dosing Adjustments for Patients with Impaired Renal Function:

Preferred Term (WHOART)

Placebo (n =771)

Levocetirizine 5 mg (n = 935)

 

 

 

Headache

25 (3.2 %)

24 (2.6 %)

 

 

 

Somnolence

11 (1.4 %)

49 (5.2 %)

 

 

 

Mouth dry

12 (1.6%)

24 (2.6%)

 

 

 

Fatigue

9 (1.2 %)

23 (2.5 %)

 

 

 


In pediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his body weight. There are no specific data for children with renal impairment.

Patients with hepatic impairment
No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended.

Side effects and drug interactions.

UNDESIRABLE EFFECTS
In therapeutic studies in women and men aged 12 to 71 years, 15.1% of the patients in the levocetirizine 5 mg group had at least one adverse drug reaction compared to 11.3% in the placebo group.
In therapeutic trials, the drop out rate due to adverse events was 1.0% (9/935) with levocetirizine 5 mg and 1.8% (14/771) with placebo.
Clinical therapeutic trials with levocetirizine included 935 subjects exposed to the drug at the recommended dose of 5 mg daily. From this pooling, following incidence of adverse drug reactions were reported at rates of 1 % or greater (common: >1/100, <1/10) under levocetirizine 5 mg or placebo:

[140- age (years)] x weight (kg) CL = (x 0.85 for women) 72 x serum creatinine (mg/dl)
Dosing Adjustments for Patients with Impaired Renal Function:

 

[140- age (years)] x weight (kg)

 

CL  =

 

 

(x 0.85 for women)

 

 

 

72 x serum creatinine (mg/dl)

 

Dosing Adjustments for Patients with Impaired Renal Function:

 

 

 

 

 

 

Group

 

Creatinine clearance (ml/min)

Dosage and frequency

Normal

 

>80

 

5 mg once daily

 

 

 

 

 

Mild

 

50 – 79

5 mg once daily

Moderate

 

30 – 49

5 mg once every 2 days

 

 

 

 

 

Severe

 

< 30

 

5 mg once every 3 days

End-stage renal disease -

 

< 10-

 

Contra-indicated

Patients undergoing dialysis

 

 

 

 

 

 

 

 

 


Further uncommon incidences of adverse reactions (uncommon >1/1000, <1/100) like asthenia or abdominal pain were observed.
The incidence of sedating adverse drug reactions such as somnolence, fatigue, and asthenia was altogether more common (8.1 %) under levocetirizine 5 mg than under placebo (3.1%).
Methyl parahydroxybenzoate and propyl parahydroxybenzoate can cause allergic reactions (possibly delayed).
In addition to the adverse reactions reported during clinical studies and listed above, very rare cases of the following adverse drug reactions have been reported in post-marketing experience.

Cardiac disorders:
Palpitations

Eyes disorders:
Visual disturbances

Hepatobiliary disorders:
Hepatitis

Immune system disorders:
Hypersensitivity including anaphylaxis

Respiratory, thoracic and mediastinal disorders:
Dyspnoea

Gastrointestinal disorders:
Nausea

Skin and subcutaneous tissue disorders:
Angioneurotic oedema, pruritus, rash, urticaria

Investigations:
Weight increased, abnormal liver function tests

DRUG INTERACTIONS
Drug interaction studies have been performed with racemic cetirizine.
Antipyrine, Azithromycin, Cimetidine, Erythromycin, Ketoconazole, Theophylline and Pseudoephedrine Pharmacokinetic interaction studies performed with racemic cetirizine demonstrated that cetirizine did not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole, and cimetidine. There was a small decrease (~16%) in the clearance of cetirizine caused by a 400 mg dose of theophylline. It is possible that higher theophylline doses could have a greater effect.

Warnings and precautions

Pregnancy and lactation:
For levocetirizine no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant or lactating women.

WARNINGS AND PRECAUTIONS
Precaution is recommended with intake of alcohol. Due to the lack of data in this population, the administration of the product to infants and toddlers aged less than 2 years is not recommended.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

INTERACTIONS WITH OTHER MEDICAMENTS
No interaction studies have been performed with levocetirizine (including no studies with CYP3A4 inducers); studies with the racemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions (with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam). A small decrease in the clearance of cetirizine (16%) was observed in a multiple dose study with theophylline (400 mg once a day); while the disposition of theophylline was not altered by concomitant cetirizine administration.
The extent of absorption of levocetirizine is not reduced with food, although the rate of absorption is decreased. In sensitive patients the simultaneous administration of cetirizine or levocetirizine and alcohol or other CNS depressants may have effects on the central nervous system, although it has been shown that the racemate cetirizine does not potentiate the effect of alcohol.

Overdosage and Contraindications

Overdosage Symptoms
Symptoms of overdose may include drowsiness in adults and initially agitation and restlessness, followed by drowsiness in children.
Man