Cetimed 10mg Medochemie Medicine Treatment of allergic rhinitis (1 blister x 10 tablets)

ATC code: R06AE07

Cetirizine is a metabolite in humans of hydroxyzine; This is a powerful and selective antihistamine on peripheral H1 receptors. Studies on cohesion with in vitro receptors show that Cetirizine has no significant affinity other than receptors H1.

In addition to the H1 receptor resistance, Cetirizine can also be allergic to 10 mg or twice a day, Cetirizine inhibits the binding of inflammatory cells in the late stage, especially eosinophilia in the skin and conjunctiva in allergens exposed to allergens.

Clinical and safety effect

Studies on healthy volunteers show that Cetirizine dihydrochloride at a dose of 5 and 10 mg significantly reduces the edema and rosy reactions due to the very high concentration of histamine in the skin; However, the correlation with the efficiency is not established.

In a six -week study, with a restraint with a placebo over 186 patients with allergic rhinitis and at the same time, mild to medium asthma, Cetirizine dihydrochloride 10 mg, once a day improved rhinitis symptoms and does not change the coordination function.

This study supports the safety of the use of Cetirizine dihydrochloride for patients allergies to mild to moderate asthma.

In a must -and -high -doses of high doses of Cetirizine dihydrochloride, 60 mg in 7 days does not cause significant QT range.

With daily dose Cetirizine dihydrochloride 10 mg has shown to improve the symptoms of chronic allergic rhinitis and seasonal di rhinitis.

Pediatric population

In a 35 -day study of children from 5 to 12 years old, there is no tolerance for antihistamine (anti -edema and rosy) effects of Cetirizine; After using many doses of cetirizine, when the drug is stopped, the symptoms on the skin recover the normal reaction with histamine within 3 days.

Pharmacokinetics

absorption

After drinking, Cetirizine absorbed quickly; The peak concentration of plasma in a stable state is about 0.3 µg/ml and is achieved within about 1 hour after taking the medication.

The level of Cetirizine absorption is not reduced by food although the absorption speed has decreased.

Distribution

Cetirizine is connected to plasma proteins about 93%; However, Cetirizine does not change protein cohesion with warfarin.

Expression distribution volume is 0.5 l/kg.

Metabolism

Cetirizine is less metabolized in the liver.

Elimination

About 2/3 of the dose is excreted in the form of unchanged urine.

There is no cetirizine accumulation after taking a dose of 10 mg once a day in 10 days.

Selling waste time of plasma is about 10 hours and this time will last in patients with renal failure.

linear

Cetirizine has linear pharmacokinetics at the dose from 5 mg to 60 mg.

pharmacokinetics in special subjects

Race

The pharmacokinetic distribution such as the concentration of the medication in plasma and the area under the curve is the same in the healthy, black and white male volunteer.

Elderly patients

Research on drug use conducted on 16 elderly people with daily doses of 10 mg once a day recorded a 50% increase in waste time and 40% decreased clearance compared to healthy adults; The decreased clearance in the elderly may be related to the impaired renal function.

Children

Cetirizine's waste sale time is about 6 hours in children from 6 to 12 years old and 5 hours in children 2 to 6 years old; In infants and children from 6 months to 24 months, the sale time is only 3.1 hours.

Patients with renal failure

There is no difference in pharmacokinetics in patients with mild kidney failure compared to you volunteering for normal kidney function.

In patients with average renal impairment, tripled waste time and 70% decreased clearance compared to you volunteering for normal kidney function; Therefore, it is necessary to adjust the dose suitable for patients with renal impairment average to severe. Cetirizine is poorly eliminated by hemons.

Do not prescribe drugs for patients with severe end -stage renal impairment or appointment of hemolysis.

Patients with liver failure

Patients with chronic liver failure (such as liver cell disease, bile stasis and cirrhosis due to cholestasis), at a dose of 10 mg or 20 mg once a day, the half -life increased by 50% and the clearance decreased by 40% compared to healthy people; Therefore, it is necessary to consider adjusting the dose in patients with liver failure.

Preceptic safety data

Prelise clinical data shows that there are no special dangers in people based on common studies on safety pharmacological pharmacology, repetitive dose toxicity, gene poisoning, cancer, reproductive toxicity.

Prelopisologically -clinical results are only observed at exposure levels that are considered to exceed the maximum exposure level of humans, which shows little related to clinical use.

Caution when used

in the treatment dose proved that there was no clinical interaction with alcohol (for blood concentration in blood is 0.5 g/1); However, patients should be cautious to use drugs simultaneously with food and alcoholic beverages.

Patients with liver failure with kidney failure should consult a physician before use; If necessary, the dose for this object can be redefined.

Be cautious when using drugs for epilepsy patients or patients at risk of convulsions.

Cetirizine dihydrochloride may increase the risk of urinary retention, so patients with factors affecting urinary retention due to spinal damage or prostate enlargement need to be cautious when taking the drug.

Itching and/or jute may occur after the drug stops; Even if those symptoms do not appear before the beginning of treatment; In some cases, these symptoms may become serious and repeat treatment requirements; These symptoms will end when they start treatment with Cetirizine dihydrochloride.

Antihistamine anti -hypersensitivity drugs inhibit skin allergies; Therefore, before performing these tests, patients should stop the drug 3 days in advance for the central nervous system to return to normal state.

The form of Cetimed 10mg film -making tablets does not allow the appropriate dose adjustment for children under 6 years old; Therefore, it is not recommended to use Cetimed 10mg for children under 6 years old.

excipients

In the composition of lactose-containing drug formula, patients with rare genetic diseases in galactose, decreased lactose or reduced absorption of glucose-galactose should not be taken.

In the formula of the drug containing propylene glycol 0.25 mg in each tablet (200 mg) is equivalent to 0.25mg/200mg.

Use drugs for women during pregnancy and lactation

Pregnant women

Animal research does not see directly or indirectly harmful to pregnancy, the development of embryos, fetus, during and after birth; However, clinical data is limited in the use of Cetirizine Hydrochloride in humans, so pregnant women should not take the drug and use only drugs when really necessary.

breastfeeding women

Cetirizine Hydrochloride is excreted in breast milk with a concentration of 25% to 90% of the measured concentration in plasma depending on the sampling time after taking the drug; Breastfeeding women should not take the drug and only take the drug when really necessary.

The effect of the drug on driving and operating machinery

Research on healthy volunteers with a dose of 20 to 25 mg/kg/day without any clinical manifestations affecting the ability to drive and operate machinery; However, patients should not overdose recommended and should consider the ability to respond to the drug. In the process of using drugs, patients need kidneys to drive or operate machinery because of unwanted effects on the central nervous system that can occur such as drowsiness, dizziness and headache affecting these activities.

Drug interaction

There is no significant interaction between Cetirizine dihydrochloride and other drugs recorded in pharmacokinetic and pharmacokinetic studies.

In fact, there is no evidence that pharmacokinetic interaction when using cetirizine and other drugs such as pseudoepherine, theophyllline (at a dose of 400 mg/ day). In theoophyllline multi -dose study (every 400 mg dose once a day) and Cetirizine dihydrochloride has seen a slight decrease (16%) of the clearance of Cetirizine Hydrochloride; Meanwhile, the webyline's distribution level is not affected when used simultaneously with Cetirizine dihydrochloride.

The absorbing food of Cetirizine Dihydrochloride although the absorption rate decreases by 1 hour.

For patients with sensitivity, simultaneous use of Cetirizine dihydrochloride with food and alcoholic beverages or other central neurological inhibitors will increase the impact on the nervous system that is impaired alertness and active ability.

Mutual medicine

Due to the lack of studies on the cavalry of the drug, Cetimed 10mg is not mixed with other drugs.