Cefazolina Mylan may be available in the countries listed below.
Cefazolin sodium salt (a derivative of Cefazolin) is reported as an ingredient of Cefazolina Mylan in the following countries:
International Drug Name Search
Revertor may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Atipamezole hydrochloride (a derivative of Atipamezole) is reported as an ingredient of Revertor in the following countries:
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Pravastatina Merck may be available in the countries listed below.
Pravastatin is reported as an ingredient of Pravastatina Merck in the following countries:
International Drug Name Search
Pharex Ciprofloxacin may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Pharex Ciprofloxacin in the following countries:
International Drug Name Search
Kohakusanin may be available in the countries listed below.
Prednisolone 21-(sodium succinate) (a derivative of Prednisolone) is reported as an ingredient of Kohakusanin in the following countries:
International Drug Name Search
Mazetol may be available in the countries listed below.
Carbamazepine is reported as an ingredient of Mazetol in the following countries:
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Izosept may be available in the countries listed below.
Povidone-Iodine is reported as an ingredient of Izosept in the following countries:
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Fluca may be available in the countries listed below.
Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Fluca in the following countries:
Fluorometholone is reported as an ingredient of Fluca in the following countries:
International Drug Name Search
Albezon may be available in the countries listed below.
Beclometasone 17α,21-dipropionate (a derivative of Beclometasone) is reported as an ingredient of Albezon in the following countries:
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Rec.INN
D07AC07
0001524-88-5
C24-H33-F-O6
436
Adrenal cortex hormone, glucocorticoid
Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11ß,16α)-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Rec.INN
R06AX21
0014504-73-5
C26-H32-N2-O8
500
Antiallergic agent
Antihistaminic agent
1(3H)-Isobenzofuranone, 7-amino-4,5,6-triethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl)-
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Lisinopril Germed may be available in the countries listed below.
Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Lisinopril Germed in the following countries:
International Drug Name Search
Calcefor Lch may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Calcefor Lch in the following countries:
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Erilin may be available in the countries listed below.
Sildenafil citrate (a derivative of Sildenafil) is reported as an ingredient of Erilin in the following countries:
International Drug Name Search
Inton A may be available in the countries listed below.
Interferon alfa Interferon alfa-2b (Arg-23; His-34) (a derivative of Interferon alfa) is reported as an ingredient of Inton A in the following countries:
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Rec.INN
J01MA18
0127045-41-4
C16-H15-F-N2-O4
318
Antibacterial: Gyrase inhibitor
(S)-10-(1-Aminocyclopropyl)-9-fluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]-[1,4]benzoxacin-6-carbonsäure (IUPAC)
(-)-(3$iS$R)-10-(1-Aminocyclopropyl)-9-fluoro-2,3-dihydro-3-methyl-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid (WHO)
7H-Pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid, 10-(1-aminocyclopropyl)-9-fluoro-2,3-dihydro-3-methyl-7-oxo-, (S)- (CAS)
7H-Pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid, 2,3-dihydro-10-(1-aminocyclopropyl)-9-fluoro-3-methyl-7-oxo-, (S)-
International Drug Name Search
Glossary
| CAS | Chemical Abstracts Service |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| WHO | World Health Organization |
Elobact may be available in the countries listed below.
Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Elobact in the following countries:
International Drug Name Search
Fluconazolo Teva may be available in the countries listed below.
Fluconazole is reported as an ingredient of Fluconazolo Teva in the following countries:
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Evolux may be available in the countries listed below.
Risperidone is reported as an ingredient of Evolux in the following countries:
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Framenco may be available in the countries listed below.
Chlorzoxazone is reported as an ingredient of Framenco in the following countries:
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Airmax may be available in the countries listed below.
Salbutamol is reported as an ingredient of Airmax in the following countries:
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Acidum Folicum Leciva may be available in the countries listed below.
Folic Acid is reported as an ingredient of Acidum Folicum Leciva in the following countries:
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Gabapentin Aristo may be available in the countries listed below.
Gabapentin is reported as an ingredient of Gabapentin Aristo in the following countries:
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Triagynon may be available in the countries listed below.
Ethinylestradiol is reported as an ingredient of Triagynon in the following countries:
Levonorgestrel is reported as an ingredient of Triagynon in the following countries:
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Ciprofloxacina Winthrop may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Ciprofloxacina Winthrop in the following countries:
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Practil 21 may be available in the countries listed below.
Desogestrel is reported as an ingredient of Practil 21 in the following countries:
Ethinylestradiol is reported as an ingredient of Practil 21 in the following countries:
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Betarevin may be available in the countries listed below.
Betahistine dihydrochloride (a derivative of Betahistine) is reported as an ingredient of Betarevin in the following countries:
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Cilaxoral may be available in the countries listed below.
Sodium Picosulfate monohydrate (a derivative of Sodium Picosulfate) is reported as an ingredient of Cilaxoral in the following countries:
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Enalapril Maleate Generics may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Enalapril Maleate Generics in the following countries:
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Trisulin 80/420 may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfadiazine sodium (a derivative of Sulfadiazine) is reported as an ingredient of Trisulin 80/420 in the following countries:
Trimethoprim is reported as an ingredient of Trisulin 80/420 in the following countries:
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Calciform may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Calciform in the following countries:
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Pergolide Mesilate may be available in the countries listed below.
Pergolide Mesilate (BANM) is known as Pergolide in the US.
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Glossary
| BANM | British Approved Name (Modified) |
Premil may be available in the countries listed below.
Repaglinide is reported as an ingredient of Premil in the following countries:
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Lamcoin may be available in the countries listed below.
Clofazimine is reported as an ingredient of Lamcoin in the following countries:
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Fomépizole AP-HP may be available in the countries listed below.
Fomepizole sulfate (a derivative of Fomepizole) is reported as an ingredient of Fomépizole AP-HP in the following countries:
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Fluorouracil Aeon may be available in the countries listed below.
Fluorouracil is reported as an ingredient of Fluorouracil Aeon in the following countries:
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Cefurox may be available in the countries listed below.
Cefuroxime is reported as an ingredient of Cefurox in the following countries:
Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Cefurox in the following countries:
Cefuroxime sodium salt (a derivative of Cefuroxime) is reported as an ingredient of Cefurox in the following countries:
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Rec.INN
0006272-74-8
C21-H35-Cl-N2-O3
398
Antiseptic
Pharmaceutic aid: Surfactant
Pyridinium, 1-[2-oxo-2-[[2-[(1-oxododecyl)oxy]ethyl]amino]ethyl]-, chloride
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Ibuprofen Abbott may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Ibuprofen Abbott in the following countries:
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Feverein may be available in the countries listed below.
Nimesulide is reported as an ingredient of Feverein in the following countries:
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Clinmas may be available in the countries listed below.
Clindamycin is reported as an ingredient of Clinmas in the following countries:
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Piroxicam F.T. Pharma may be available in the countries listed below.
Piroxicam is reported as an ingredient of Piroxicam F.T. Pharma in the following countries:
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Boby may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Piperonyl Butoxide is reported as an ingredient of Boby in the following countries:
Pyrethrin I is reported as an ingredient of Boby in the following countries:
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Ucerax Tablets 25 mg.
Hydroxyzine hydrochloride 25 mg.
For excipients, see 6.1.
Film-coated tablets.
Ucerax is indicated to assist in the management of anxiety.
Ucerax is indicated to assist in the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and in atopic and contact dermatosis in adults and children.
Adults:
Anxiety.
50 mg/day in 3 separate administrations of 12.5-12.5-25mg. In more severe cases, doses up to 300mg/day can be used.
Pruritus.
Starting dose of 25 mg at night, increasing as necessary to 25 mg three or four times daily.
The maximum single dose in adults should not exceed 200mg whereas the maximum daily doses should not exceed 300mg.
Children:
Children aged from 12 months to 6 years: 1mg/kg/day up to 2.5mg/kg/day in divided doses.
Children aged over 6 years:1mg/kg/day up to 2mg/kg/day in divided doses.
The dosage should be adjusted according to the patient's response to therapy.
In the elderly, it is advised to start with half the recommended dose due to the prolonged action.
In patients with hepatic dysfunction, it is recommended to reduce the daily dose by 33%.
Dosage should be reduced in patients with moderate or severe renal impairment due to decreased excretion of its metabolite cetirizine.
Ucerax is contra-indicated in patients with a history of hypersensitivity to any of its constituents, to cetirizine, to other piperazine derivatives, to aminophylline, or to ethylenediamine.
Ucerax is contra-indicated during pregnancy and lactation.
Ucerax is contra-indicated in patients with porphyria.
Ucerax film-coated tablets 25 mg tablets contain lactose. Patients with rare hereditiary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose mal-absorption should not take this medicine.
Ucerax should be administered cautiously in patients with increased potential for convulsions.
Young children are more susceptible to develop adverse events related to the central nervous system (see section 4.8). In children, convulsions have been more frequently reported than in adults.
Because of its potential anticholinergic effects, Ucerax should be used cautiously in patients suffering from glaucoma, bladder outflow obstruction, decreased gastro-intestinal motility, myasthenia gravis, or dementia.
Dosage adjustments may be required if Ucerax is used simultaneously with other central nervous system depressant drugs or with drugs having anticholinergic properties (see section 4.5).
The concomitant use of alcohol and Ucerax should be avoided (see section 4.5).
Caution is needed in patients who have a known predisposing factor to cardiac arrhythmia, or who are concomitantly treated with a potentially arrhythmogenic drug.
In patients with pre-existing prolonged QT intervals, use of alternative treatments is to be considered.
In the elderly, it is advised to start with half the recommended dose due to a prolonged action.
Ucerax dosage should be reduced in patients with hepatic dysfunction and in patients with moderate or severe renal impairment (see section 4.2).
The treatment should be stopped at least 5 days before allergy testing or methacholine bronchial challenge, to avoid effects on the test results.
Patients should be informed that Ucerax may potentiate the effects of barbiturates, other CNS depressants or drugs having anticholinergic properties.
Alcohol also potentiates the effects of Ucerax.
Ucerax antagonizes the effects of betahistine, and of anticholinesterase drugs.
The treatment should be stopped at least 5 days before allergy testing or methacholine bronchial challenge, to avoid effects on the test results.
Simultaneous administration of Ucerax with monoamine oxidase inhibitors should be avoided.
Ucerax counteracts the epinephrine pressor action.
In rats, hydroxyzine antagonised the anticonvulsant action of phenytoin.
Cimetidine 600 mg bid has been shown to increase the serum concentrations of hydroxyzine by 36% and to decrease peak concentrations of the metabolite cetirizine by 20%.
Ucerax is an inhibitor of cytochrome P450 2D6 (Ki: 3.9 µM ; 1.7 µg/ml) and may cause at high doses drug-drug interactions with CYP2D6 substrates.
Ucerax has no inhibitory effect at 100 µM on UDP-glucuronyl transferase isoforms 1A1 and 1A6 in human liver microsomes. It inhibits cytochrome P450 2C9/C10, 2C19 and 3A4 isoforms at concentrations (IC50 : 19 to 140 µM ; 7 to 52 µg/ml) well above peak plasma concentrations. The metabolite cetirizine at 100 µM has no inhibitory effect on human liver cytochrome P450 (1A2, 2A6, 2C9/C10, 2C19, 2D6, 2E1 and 3A4) and UDP-glucuronyl transferase isoforms. Therefore, Ucerax is unlikely to impair the metabolism of drugs which are substrates for these enzymes.
As hydroxyzine is metabolized in the liver, an increase in hydroxyzine blood concentrations may be expected when hydroxyzine is co-administered with other drugs known to be potent inhibitors of liver enzymes.
Animal studies have shown reproductive toxicity.
Hydroxyzine crosses the placental barrier leading to higher fetal than maternal concentrations.
To date, no relevant epidemiological data are available relating to exposure to Ucerax during pregnancy.
In neonates whose mothers received Ucerax during late pregnancy and/or labour, the following events were observed immediately or only a few hours after birth : hypotonia, movement disorders including extrapyramidal disorders, clonic movements, CNS depression, neonatal hypoxic conditions, or urinary retention.
Therefore, Ucerax should not be used during pregnancy.
Ucerax is contra-indicated during lactation. Breast-feeding should be stopped if Ucerax therapy is needed.
Alertness or reaction time may be impaired by Ucerax therefore patients' driving capacity or ability to use machines may be reduced. Concomitant use of Ucerax with alcohol or other sedative drugs should be avoided as it aggravates these effects.
Undesirable effects are mainly related to CNS depressant or paradoxical CNS stimulation effects, to anticholinergic activity, or to hypersensitivity reactions.
A Clinical trials
The following table list the relevant undesirable effects reported in placebo-controlled clinical trials for hydroxyzine and including 735 subjects exposed to hydroxyzine up to 50 mg daily. The frequency has been estimated using the following definitions: very common (
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B Post-marketing experience
The following table lists, per body system, the additional undesirable adverse reactions reported during marketed use of the drug. No frequency can be estimated from post-marketing reporting of events.
Immune system disorders :
Hypersensitivity, anaphylactic shock
Psychiatric disorders :
Agitation, confusion, disorientation, hallucination
Nervous system disorders :
Sedation, tremor, convulsions, dyskinesia
Eye disorders :
Accommodation disorder, vision blurred
Cardiac disorders :
Tachycardia
Vascular disorders :
Hypotension
Respiratory, thoracic and mediastinal disorders :
Bronchospasm
Gastrointestinal disorders :
Vomiting
Skin and subcutaneous tissue disorders :
Pruritus, erythematous rash, maculo-papular rash, urticaria, dermatitis, angioneurotic oedema, sweating increased, fixed drug eruption
Renal and urinary disorders :
Urinary retention
General disorders and administration site conditions :
Malaise, pyrexia
Investigations :
Liver function tests abnormal
Symptoms observed after an important overdose are mainly associated with excessive anticholinergic load, CNS depression or CNS paradoxical stimulation. They include nausea, vomiting, tachycardia, pyrexia, somnolence, impaired pupillary reflex, tremor, confusion, or hallucination. This may be followed by depressed level of consciousness, respiratory depression, convulsions, hypotension, or cardiac arrhythmia. Deepening coma and cardiorespiratory collapse may ensue.
Airway, breathing and circulatory status must be closely monitored with continuous ECG recording and an adequate oxygen supply should be available. Cardiac and blood pressure monitoring should be maintained until the patient is free of symptoms for 24 hours. Patients with altered mental status should be checked for simultaneous intake of other drugs or alcohol and should be given oxygen, naloxone, glucose, and thiamine if deemed necessary.
Norepinephrine or metaraminol should be used if vasopressor is needed. Epinephrine should not be used.
Syrup of ipecac should not be administered in symptomatic patients or those who could rapidly become obtunded, comatose or convulsing, as this could lead to aspiration pneumonitis. Gastric lavage with prior endotracheal intubation may be performed if a clinically significant ingestion has occurred. Activated charcoal may be left in the stomach but there are scant data to support its efficacy.
It is doubtful that hemodialysis or hemoperfusion would be of any value.
There is no specific antidote.
Literature data indicate that, in the presence of severe, life-threatening, intractable anticholinergic effects unresponsive to other agents, a therapeutic trial dose of physostigmine may be useful. Physostigmine should not be used just to keep the patient awake. If cyclic antidepressants have been coingested, use of physostigmine may precipitate seizures and intractable cardiac arrest. Also avoid physostigmine in patients with cardiac conduction defects.
Hydroxyzine is a psycholeptic and anxiolytic agent (ataractic).
ATC code is N05B B01
The active substance, hydroxyzine dihydrochloride, is a diphnylmethane derivative, chemically unrelated to the phenothiazines, reserpine, meprobamate or benzodiazepines.
Mechanism of action
Hydroxyzine is a first generation antihistamine that crosses extensively the blood/brain barrier and has a high affinity for histaminic receptors into the brain, thereby producing sedative-anxiolytic effects.
Pharmacodynamic effects
Antihistaminic and bronchodilatator activities have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine at therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity. Wheal and flare reduction have been demonstrated in adult healthy volunteers and in children after intradermal injections of histamine or antigens. Hydroxyzine has also revealed its efficacy in relieving pruritus in various forms of urticaria, eczema and dermatitis.
Hydroxyzine was studied in eight patients with primary biliary cirrhosis. All had abnormal liver biochemistry tests, all had biopsies compatible with primary cirrhosis, and seven of eight had positive tests for antimitochodrial antibodies. The patients received a single dose of hydroxyzine (0.7mg/kg – mean does 43.9 ± 6.6 mg).
In these subjects with hepatic dysfunction secondary to primary cirrhosis, total body clearance was approximately 66% that of normal subjects (8.65 ± 7.46 ml/min/kg versus 10 ml/min/kg for normal subjects). The half-life was increased to 37 hours and the serum concentrations of the carboxylic metabolite, cetirizine (500.4 ± 302.0 mg/ml), were higher than in young patients with a normal liver function. As hydroxyzine elimination is impaired in patients with hepatic dysfunction, daily dose or dose frequency should be reduced in patients with impaired liver function.
EEG recordings in healthy volunteers show an anxiolytic-sedative profile. Anxiolytic effect was confirmed in patients by the use of various classical psychometric tests. Polysomnographic recordings in anxious and insomniac patients have evidenced an increase in total sleep time, a reduction of total time of night awakenings and a reduction of sleep latency either after single or repeated daily doses of 50 mg. A reduction of the muscular tension was demonstrated in anxious patients at a daily dose of 3 x 50 mg. No memory deficiency has been observed. No withdrawal signs or symptoms have appeared after 4-week treatment in anxious patients.
Onset of action
The antihistaminic effect begins approximately after 1 hour with oral pharmaceutical forms. The sedative effect starts after 5-10 minutes with oral liquid and after 30-45 minutes with tablets.
Hydroxyzine has a weak affinity for muscarinic receptors.
Absorption
Hydroxyzine is rapidly absorbed from the gastro-intestinal tract. The peak plasma level (Cmax) is reached approximately two hours after oral intake. After single oral doses of 25 mg and 50 mg in adults, Cmax concentrations are typically 30 and 70 ng/ml, respectively. The rate and extent of exposure to hydroxyzine is very similar when given as tablet or as a syrup. Following repeat administration once a day, concentrations are increased by 30%. The oral bioavailability of hydroxyzine with respect to intramuscular (IM) administration is about 80%. After a single 50 mg IM dose, Cmax concentrations are typically 65 ng/ml.
Distribution
Hydroxyzine is widely distributed in the body and generally more concentrated in the tissues than in plasma. The apparent volume of distribution is 7 to 16 l/kg in adults. Hydroxyzine enters the skin following oral administration. Skin concentrations of hydroxyzine are higher than serum concentrations, following both single and multiple administration. Hydroxyzine crosses the blood-brain and placental barriers leading to higher fetal than maternal concentrations.
Biotransformation
Hydroxyzine is extensively metabolized. The formation of the major metabolite cetirizine, a carboxylic acid metabolite (approximately 45% of the oral dose), is mediated by alcohol dehydrogenase. This metabolite has significant peripheral H1-antagonist properties. An elimination half-life for cetirizine of about 20 hours has been reported. The other metabolites identified include a N-dealkylated metabolite, and an O-dealkylated metabolite with a plasma half-life of 59 hours. These pathways are mediated principally by CYP3A4/5.
Elimination
Across studies, the half life (t½) of hydroxyzine in adults is 12 ± 5 hrs (range 7 – 20 hrs). Across studies the apparent plasma clearance (CL/F) of hydroxyzine is 14 ± 4 ml/min/kg (range 9.4-17.5 ml/min/kg).
The apparent total body clearance calculated across studies is 13 ml/min/kg. Only 0.8% of the dose is excreted unchanged in urine. The major metabolite cetirizine is excreted mainly unchanged in urine (25% and 16 % of the hydroxyzine oral and IM dose, respectively).
After a single dose of 50 mg hydroxyzine, the Cmax of cetirizine (261 ng/ml) was comparable to that after a single dose of 10 mg cetirizine (282 ng/ml) but the AUC was similar to that after a single dose of 20 mg cetirizine.
Special population
Elderly patients
The pharmacokinetics of hydroxyzine was investigated in 9 healthy elderly subjects (69.5 ± 3.7 years) following a single 0.7 mg/kg oral dose. The elimination half-life of hydroxyzine was prolonged to 29± 10 hrs (range 20-53 hrs) and the apparent volume of distribution was increased to 22 ± 6 l/kg (range 13 -31 l/kg). In view of the longer t½ and of the prolonged Pharmacodynamic effect (suppression of the wheal and flare response to histamine), it is advised to start with half the recommended dose (see section 4.2).
Paediatric patients
The pharmacokinetics of hydroxyzine was evaluated in 12 paediatric patients aged 1 to 14 years (mean 6.1 ± 4.6 yrs) with severe atopic dermatitis. A 0.7 mg/kg single dose of hydroxyzine was administered orally. The mean peak serum concentration was 47 ± 17 ng/ml and occurred at a mean time of 2.0 ± 0.9h after the dose. The mean plasma clearance was higher than in adults (32 ± 11 ml/min/kg). The half-life was shorter than in adults and increased with age from 4 hrs at 1 year of age to 11 hrs at 14 years of age. No data was available regarding the metabolite cetirizine.
Like in adults, the antipruritic effect lasted longer than anticipated for the half-life as pruritus was significantly suppressed from 1 to 24 hrs post-dose with>85% suppression from 2 to 12 hrs.
Dosage should be adjusted in paediatric population (see section 4.2).
Hepatic impairment
Hydroxyzine was studied in eight patients with primary biliary cirrhosis. All had abnormal liver biochemistry tests, all had biopsies compatible with primary cirrhosis, and seven of eight had positive tests for antimitochodrial antibodies. The patients received a single dose of hydroxyzine (0.7mg/kg – mean does 43.9 ± 6.6 mg).
In these subjects with hepatic dysfunction secondary to primary cirrhosis, total body clearance was approximately 66% that of normal subjects (8.65 ± 7.46 ml/min/kg versus 10 ml/min/kg for normal subjects). The half-life was increased to 37 hours and the serum concentrations of the carboxylic metabolite, cetirizine (500.4 ± 302.0 mg/ml), were higher than in young patients with a normal liver function. As hydroxyzine elimination is impaired in patients with hepatic dysfunction, daily dose or dose frequency should be reduced in patients with impaired liver function (see section 4.2).
Renal impairment
The pharmacokinetics of hydroxyzine was studied in 8 severe renally impaired subjects (Creatinine clearance: 24 ± 7 ml/min). The extent of exposure (AUC) to hydroxyzine was not altered in a relevant manner while that to the carboxylic metabolite, cetirizine, was increased. This metabolite is not removed efficiently by hemodialysis. In order to avoid any important accumulation of the cetirizine metabolite following multiple doses of hydroxyzine, the daily dose of hydroxyzine should be reduced in subjects with impaired renal function (see section 4.2).
There is no pre-clinical data of relevance to the subscriber additional to that noted in other sections of this SPC.
Lactose monohydrate.
Microcrystalline cellulose
Magnesium stearate
Anhydrous colloidal silica
Purified water
Opadry® Y-1-7000 containing:
Titanium dioxide
Hydroxypropylmethylcellulose 2910 5cP
Macrogol 400.
None.
5 years.
Keep container in the outer pack.
Aluminium foil / PVC blister packs containing 25, 30, 50 or 60 tablets.
Not applicable.
UCB Pharma Limited
208 Bath Road
Slough
Berkshire
SL1 3WE
PL 00039/0538
16 August 2001
August 2010
Clariget may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Clariget in the following countries:
International Drug Name Search
In the US, Amiloride (amiloride systemic) is a member of the drug class potassium-sparing diuretics and is used to treat Ascites, Edema, Heart Failure and High Blood Pressure.
US matches:
UK matches:
Rec.INN
C03DB01
0002609-46-3
C6-H8-Cl-N7-O
229
Potassium-sparing diuretic agent
Pyrazinecarboxamide, 3,5-diamino-N-(aminoiminomethyl)-6-chloro-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| SPC | Summary of Product Characteristics (UK) |
| USAN | United States Adopted Name |
Avlocardyl may be available in the countries listed below.
Propranolol is reported as an ingredient of Avlocardyl in the following countries:
Propranolol hydrochloride (a derivative of Propranolol) is reported as an ingredient of Avlocardyl in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
C05AD03,D04AB04,N01BA05,R02AD01
0000094-09-7
C9-H11-N-O2
165
Anesthetic, local
Benzoic acid, 4-amino-, ethyl ester
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| WHO | World Health Organization |
Fluconazol Ur may be available in the countries listed below.
Fluconazole is reported as an ingredient of Fluconazol Ur in the following countries:
International Drug Name Search
Paranausine may be available in the countries listed below.
Dimenhydrinate is reported as an ingredient of Paranausine in the following countries:
International Drug Name Search
Fluconazole Dakota Pharm may be available in the countries listed below.
Fluconazole is reported as an ingredient of Fluconazole Dakota Pharm in the following countries:
International Drug Name Search
In the US, Baros is a member of the drug class miscellaneous GI agents.
Dimeticone is reported as an ingredient of Baros in the following countries:
Sodium Bicarbonate is reported as an ingredient of Baros in the following countries:
International Drug Name Search
Rinogutt may be available in the countries listed below.
Tramazoline hydrochloride (a derivative of Tramazoline) is reported as an ingredient of Rinogutt in the following countries:
International Drug Name Search
Alapril may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Alapril in the following countries:
Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Alapril in the following countries:
International Drug Name Search
Bentylol may be available in the countries listed below.
Dicycloverine hydrochloride (a derivative of Dicycloverine) is reported as an ingredient of Bentylol in the following countries:
International Drug Name Search
Talion may be available in the countries listed below.
Bepotastine besilate (a derivative of Bepotastine) is reported as an ingredient of Talion in the following countries:
International Drug Name Search
Isoniazida may be available in the countries listed below.
Isoniazid is reported as an ingredient of Isoniazida in the following countries:
International Drug Name Search
Folidar may be available in the countries listed below.
Calcium Folinate is reported as an ingredient of Folidar in the following countries:
International Drug Name Search
Bétaméthasone Biogaran may be available in the countries listed below.
Betamethasone is reported as an ingredient of Bétaméthasone Biogaran in the following countries:
International Drug Name Search
