Reactine duo nebenwirkungen

Reactine, Tabletten is an antihistamine medicine that helps the symptoms of allergies.

Studies with radiolabeled cetirizine administration in the rat have demonstrated insignificant penetration into the brain. Although the animal studies are not indicative of any adverse effects during pregnancy at clinically relevant doses, such studies are not always predictive of a human response. Autoradiographic studies have shown negligible penetration into the brain.

Only 1 metabolite has been identified in humans – the product of oxidative dealkylation of the terminal carboxymethyl group. The high bioavailability associated with generally low inter-subject variation in blood levels is attributable primarily to low first-pass metabolism. In vivo and ex vivo animal models have shown insignificant anticholinergic and antiserotonergic effects.

The incidence of somnolence in fixed dose studies was 6% for placebo, 11% at 5 mg and 13.7% at 10 mg. Cetirizine did not cause exacerbation of asthma symptoms.

Drug Interactions: No clinically significant drug interactions have been found with theophylline, pseudoephedrine, cimetidine, erythromycin and ketoconazole.

It does not produce anticholinergic effects.

Toxicity

Oral LD50 (rat): 365 mg/kg; Intraperitoneal LDLO (mouse): 138 mg/kg; Oral TDLO (rat): 50 mg/kg; Oral TDLO (mouse): 0.1 mg/kg . There is no evidence that tolerance to the antihistaminic effects of cetirizine occurs or that cetirizine has any abuse potential or dependency liability.

Objective measurements to evaluate the effects of cetirizine on the CNS at doses up to 20 mg showed no significant effects on daytime drowsiness, reaction times, mental alertness, objective CNS depression and various other tests of cognitive function as compared to placebo.

Specific ECG studies in healthy volunteers at doses up to 60 mg/day (3 times the maximum clinically studied dose) for 1 week did not prolong QTc intervals nor was there any evidence of QTc prolongation in clinical trials which included ECG evaluations.

Cetirizine given at the maximum clinically studied dose of 20 mg daily did not prolong the QTc when given in combination with either ketoconazole 400 mg daily or erythromycin 50 mg q8h for 10 days.

In most people it is non-sedating, so they take it in the morning. However it's best to take Reactine, Tabletten only for as long as you need to.

The elimination half-life of Reactine, Tabletten ranges from 6.5 to 10 hours in healthy adults, with a mean across studies of approximately 8.3 hours.

The most common adverse reactions were headache and somnolence. His work focuses on medication policy development, formulary strategy, and optimizing patient care through drug utilization review. Use of cetirizine in nursing mothers is not recommended, unless directed otherwise by a physician.

Children: Unless directed otherwise by a physician, cetirizine should not be administered to children below 12 years of age since its safety and effectiveness in this age group has not yet been established.

Occupational Hazards: Activities Requiring Mental Alertness: Studies using objective measurements have shown no effect of cetirizine hydrochloride on cognitive function, motor performance or sleep latency.

You should know that Reactine, Tabletten may make you drowsy.

Stopping Reactine, Tabletten suddenly can result in unbearable itching. Nonmedicinal ingredients: cornstarch, hydroxypropyl methylcellulose, lactose, magnesium stearate, polyethylene glycol, povidone and titanium dioxide.

Lower incidence of sedation, headache, dry mouth, and gastrointestinal disturbances may occur. In vitro receptor binding studies have demonstrated no detectable affinity of cetirizine for histamine receptors other than the H1 receptors. Reactine, Tabletten should be used during pregnancy only if clearly needed. The use of cetirizine in nursing mothers is not recommended .

Precaution

Caution should be exercised when driving a car or operating a heavy machinery.

There was no difference by gender or by body weight with regard to the incidence of adverse reactions.

Occasional instances of transient, reversible hepatic transaminase elevations have occurred during cetirizine therapy, without evidence of jaundice, hepatitis or other clinical findings.

The following events were observed infrequently (equal to or less than 1%), in 3 982 patients who received cetirizine in U.S.

trials, including an open study of 6 months’ duration; a causal relationship with cetirizine administration has not been established.

Application Site: application site reaction, injection site inflammation.

Autonomic Nervous System: anorexia, urinary retention, flushing, saliva increased.

Cardiovascular: palpitation, tachycardia, hypertension, arrhythmia, cardiac failure.

CNS and Peripheral Nervous System: parasthesia, confusion, hyperkinesia, hypertonia, migraine, tremor, vertigo, cramps legs, ataxia, dysphonia, coordination abnormal, hyperesthesia, hypoesthesia, myelitis, paralysis, ptosis, speech disorder, twitching, visual field defect.

Endocrine: thyroid disorder.

Gastrointestinal: appetite increased, dyspepsia, abdominal pain, diarrhea, flatulence, constipation, vomiting, stomatitis ulcerative, tongue disorder, tooth caries, aggravated stomatitis, tongue discoloration, tongue edema, gastritis, hemorrhage rectum, hemorrhoids, melena, hepatic function abnormal.

Genitourinary: polyuria, urinary tract infection, cystitis, dysuria, hematuria, urine abnormal.

Hearing and vestibular: earache, tinnitus, deafness, ototoxicity.

Metabolic/Nutritional: thirst, edema, dehydration, diabetes mellitus.

Musculoskeletal: myalgia, arthralgia, bone disorder, arthrosis, tendon disorder, arthritis, muscle weakness.

Psychiatric: insomnia, nervousness, depression, emotional lability, concentration impaired, anxiety, depersonalization, paroniria, thinking abnormal, agitation, amnesia, libido decreased, euphoria.

Resistance Mechanism: healing impaired, herpes simplex, infection, infection fungal, infection viral.

Respiratory: epistaxis, rhinitis, coughing, respiratory disorder, bronchospasm, dyspnea, upper respiratory tract infection, hyperventilation, sinusitis, sputum increased, bronchitis, pneumonia.

Reproductive: dysmenorrhea, menstrual disorder, breast pain female, intermenstrual bleeding, leukorrhea, menorrhagia, pregnancy unintended, vaginitis, testes disorder.

Recticuloendothelial: lymphadenopathy.

Skin: pruritus, rash, skin disorder, skin dry, urticaria, acne, dermatitis, rash erythematous, sweating increased, alopecia, angioedema, furunculosis, bullous eruption, eczema, hyperkeratosis, hypertrichosis, photosensitivity reaction, photosensitivity toxic reaction, rash maculopapular, seborrhea, purpura.

Special Senses: taste perversion, taste loss, parosmia.

Vision: eye abnormality, vision abnormal, eye pain, conjunctivitis, xerophthalmia, glaucoma, ocular hemorrhage.

Body as a Whole: weight increase, back pain, malaise, pain, chest pain, fever, asthenia, edema generalized, edema periorbital, edema peripheral, rigors, edema legs, face edema, hot flushes, abdomen enlarged, allergic reaction, nasal polyp.

Weight gain was reported as an adverse event in 0.4% of cetirizine patients in placebo-controlled trials.

Carcinogenesis and mutagenesis: In a 2-year carcinogenicity study in rats, cetirizine was not shown to be carcinogenic at dietary doses up to 20 mg/kg (approximately 15 times the maximum recommended daily oral dose in adults). There is no known specific antidote to cetirizine.