REACTINE Tablet, Capsule, Syrup (2021)

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Περιεχόμενα

Name of the medicinal product

REACTINE Cetirizine hydrochloride.

Summary product information

Route of Administration Dosage Form/Strength Clinically Relevant Nonmedicinal Ingredients Oral Non-prescription: Film-coated tablets 5 mg, 10 mg Orally disintegrating tablets, 10 mg Soft gelatin ...

Indications and clinical use

Patient Subsets Adults and children 12 years of age and over: REACTINE (cetirizine hydrochloride) is indicated for the fast relief of nasal and non-nasal symptoms associated with seasonal and perennial ...

Contraindications

REACTINE (cetirizine hydrochloride) is contraindicated in those patients with a known hypersensitivity to it, to its parent compound, hydroxyzine, or to piperazine derivatives, in patients who are hypersensitive ...

Warnings and precautions

General Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported very rarely with cetirizine-containing products. This acute pustular eruption may exhibit an early ...

Adverse reactions

Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed ...

Drug interactions

Overview Interaction studies with REACTINE and alcohol or diazepam indicate that at therapeutic doses, REACTINE does not increase alcohol-induced or diazepam-induced impairment of motor and mental performance. ...

Dosage and administration

Recommended Dosage and Dosage Adjustment The recommended initial dose of REACTINE (cetirizine hydrochloride) is 5 to 10 mg, depending on symptom severity, given as a single daily dose, with or without ...

Overdosage

Overdose has been reported with REACTINE (cetirizine hydrochloride). Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with symptoms that could suggest an anticholinergic ...

Action and clinical pharmacology

Mechanism of Action REACTINE (cetirizine hydrochloride), an active human metabolite of hydroxyzine, is a histamine H1 receptor antagonist anti-allergic compound; its principal effects are mediated via ...

Storage and stability

Recommended storage: Store between 15°-30°C. REACTINE Allergy Liquid Gels (cetirizine hydrochloride capsules, 10 mg): Store at temperatures between 15°-30°C. Avoid high humidity and excessive heat ...

Dosage forms, composition and packaging

REACTINE (cetirizine hydrochloride) Film-coated Scored Tablet: 5, 10, and 20 mg of cetirizine hydrochloride. The 20 mg tablets are only available by prescription. For commercial use, tablet packaging: ...

Pharmaceutical information

Drug Substance Proper Name: cetirizine hydrochloride (USP) cetirizine dihydrochloride (Ph. Eur.) Chemical Name: (RS)- 2(2- (4-[4-chlorphenyl)phenylmethyl]- 1-piperazinyl)ethoxy) acetic acid, dihydrochloride ...

Detailed pharmacology

ANIMAL PHARMACOLOGY REACTINE (cetirizine hydrochloride) has been shown to be a potent H1 antagonist in 14 animal studies carried out to evaluate the antihistaminic activity of the drug in vivo. The selectivity ...

Clinical trials

Randomized, multi-centre, double-blind, placebo-controlled clinical trials have demonstrated the effectiveness of REACTINE in relieving the symptoms associated with seasonal allergic rhinitis, perennial ...

Toxicology

Acute Toxicity Studies 1. Rodents REACTINE (cetirizine hydrochloride) was administered orally or intravenously to 10 fasted animals/sex/dose level. Clinical signs, food consumption, and mortality were ...

Marketing authorization holder

McNeil Consumer Healthcare, division of Johnson & Johnson Inc., 88 McNabb Street, Markham, Canada, L3R 5L2

Submission control number

246339

Date of revision

March 18, 2021

References

1. Aaronson D, Boggs P, Bronsky E, Goldberg S, Hawrylko E, Kaiser HB, Klein G, Leonardy JG, Mansmann H. Placebo- controlled comparison of cetirizine and hydroxyzine in chronic urticaria. Scientific exhibit. ...

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