Cetirizine Mylan 10 mg 7 Tablets

Cetirizine Mylan 10 mg 7 Tablets - Antihistamine Drug

What is Cetirizine Antihistamine?

Cetirizine Mylan 7 Coated Tablets 10 mg is an antihistamine drug indicated in adults and children from 6 years of age for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and also for the symptomatic treatment of chronic idiopathic urticaria.

Contraindications

Hypersensitivity to the active substance or to any of the excipients or to hydroxyzine or to any derivative of piperazine. Patients with severe renal impairment with creatinine clearance below 10 ml / min.

Dosage

Posology in children aged 6 to 12 years: 5 mg twice a day (half tablet twice a day). Adults and children over 12 years of age: 10 mg once daily (one tablet). Elderly people: The data do not suggest the need for dose reduction in elderly people with normal renal function. Pediatric population The use of the film-coated tablet formulation is not recommended in children under 6 years of age as this formulation does not allow for adequate dose adjustment. Patients with moderate to severe renal impairment: Dosing intervals should be individualized based on 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 required. CLcr (ml / min) can be obtained from the serum creatinine value (mg / dl) using the following formula:

Dosage adjustment for adults with impaired renal function

In pediatric patients with renal impairment, the dose will need to be individually adjusted taking into account the patient's renal clearance, age and body weight. Patients with hepatic impairment: No dose adjustment is required in patients with hepatic impairment only. Patients with hepatic and renal impairment: dosage adjustment is recommended (see above "Patients with moderate to severe renal impairment"). Method of administration: The tablets should be taken with a glass of liquid.

storage

This medicine does not require any special storage conditions.

Warnings

At therapeutic doses, there was no evidence of clinically significant interactions with alcohol (for blood alcohol levels of 0.5 g / l). However, caution is advised in case of concomitant alcohol intake. Caution should be exercised in patients with predisposing factors for urinary retention such as spinal cord injury, prostatic hyperplasia) as cyherizine may increase the risk of urinary retention. Caution is advised in epileptic patients and in patients at risk for seizures. Pediatric population The use of the film-coated tablet formulation is not recommended in children below 6 years of age as this formulation does not allow for appropriate dose adjustment. Allergic skin tests are inhibited by antihistamines therefore a wash out period (3 days) is required before performing them. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take cetirizine film-coated tablets.

Interactions

For the drug kinetic, drug dynamic and tolerability profile of cetirizine, no interactions with this antihistamine are expected. Indeed, neither pharmacodynamic nor significant pharmacokinetic interactions were reported in drug-drug interaction studies, in particular with pseudoephedrine or theophylline (400 mg / day). The extent of absorption of cetirizine is not reduced by food, although the rate of absorption is decreased.

Side effects

Clinical studies have shown that cetirizine at the recommended dosage has minor CNS undesirable effects, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been observed. Although cetirizine is a selective inhibitor of peripheral H1 receptors and is relatively free of anticholinergic activity, rare cases of micturition difficulties, eye accommodation disorders and dry mouth have been reported. There have been reports of abnormal liver function with liver enzyme elevations accompanied by elevated bilirubin, most of which resolved following discontinuation of cetirizine dihydrochloride. a) Clinical trials In the context of double-blind controlled clinical trials or clinical pharmacology studies, in which the effects of cetirizine versus placebo or other antihistamines at the recommended dosage (10 mg per day for cetirizine) were compared for which Quantitative safety data are available, more than 3200 subjects were treated with cetirizine. Based on these data, the following adverse events were reported in placebo-controlled trials with an incidence of 1.0% or greater with cetirizine 10 mg:

Although statistically the incidence of somnolence was more common with cetirizine than with placebo, it was mild to moderate in the majority of cases. Further studies in which objective tests have been carried out have shown that usual daily activities are not compromised at the recommended daily dose in young healthy volunteers. Adverse reactions with an incidence of 1% or greater in children aged 6 months to 12 years, in placebo-controlled clinical trials or clinical pharmacology studies, are:

b) Post-marketing experience To the adverse events encountered in clinical trials, listed in the previous paragraph, the isolated cases of the following adverse reactions reported in post-marketing experience should be added. Undesirable effects are described by MedDRA system organ class and frequency estimated based on post marketing experience. Frequencies are defined as follows: very common (> 1/10), common (> 1/100 to <1/10); uncommon (> 1 / 1,000 to <1/100), rare (> 1 / 0,000 to <1 / 1,000), very rare (<1 / 10,000), not known (cannot be estimated from the available data). Blood and lymphatic system disorders: Very rare: thrombocytopenia Immune system disorders: Rare: hypersensitivity Very rare: anaphylactic shock Metabolism and nutrition disorders: Not known: increased appetite Psychiatric disorders: Uncommon: agitation Rare: aggression, confusion, depression , hallucinations, insomnia Very rare: tic Not known: suicidal thoughts Nervous system disorders: Uncommon: paraesthesia Rare: convulsions Very rare: dysgeusia, dyskinesia, dystonia, syncope, tremor Not known: amnesia, memory impairment Eye disorders: Very rare: accommodation disorder, blurred vision, oculorotation Ear and labyrinth disorders: Not known: dizziness Cardiac disorders: Rare: tachycardia Gastrointestinal disorders: Uncommon: diarrhea Hepatobiliary disorders: Rare: impaired liver function (elevation of transaminases, phosphatase alkaline, gamma (GT and bilirubin) Skin and tea disorders subcutaneous: Uncommon: pruritus, rash Rare: urticaria Very rare: angioneurotic edema, fixed drug eruption Renal and urinary disorders: Very rare: dysuria, enuresis Not known: urinary retention General disorders and administration site conditions: Uncommon : asthenia, malaise Rare: edema Investigations: Rare: weight gain Reporting of adverse reactions Reporting suspected adverse reactions occurring after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product . Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Overdose

Symptoms observed following an overdose of cetirizine are mainly associated with central nervous system effects or with effects that may suggest anticholinergic activity. Following a dose of at least 5 times the recommended daily dose, the following adverse events have been reported: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor and urinary retention. A specific antidote to cetirizine is not known. In the event of an overdose, symptomatic or supportive treatment is recommended. Following recent ingestion, gastric lavage is recommended. Cetirizine is not effectively removed by dialysis.

Pregnancy and breastfeeding

Pregnancy Very few clinical data on exposed pregnancies are available for cetirizine. Animal studies do not show direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Prescribing to pregnant women should be done with caution. Breastfeeding Cetirizine is excreted in breast milk at concentrations representing 0.20 - 0.90 compared to those measured in plasma, depending on the sampling time after administration. Therefore, caution should be used when prescribing Cetirizine Mylan Generics to breastfeeding women.

Active principles

Each film-coated tablet contains 10 mg cetirizine dihydrochloride. Excipient with known effect: Each film-coated tablet contains 74.3 mg of lactose monohydrate. For the full list of excipients, see section 6.1.

Excipients

Tablet core: Lactose monohydrate Pregelatinised maize starch Povidone K29 / 32 Magnesium stearate. Tablet coating: Talc Titanium dioxide (E171) Hypromellose 5cP (E464) Macrogol 400.

Format

Cetirizine is sold in packs of 7 coated tablets of 10 mg.