Allersoothe

Main information

  • Trade name:
  • Allersoothe 25 mg Film coated tablet
  • Dosage:
  • 25 mg
  • Pharmaceutical form:
  • Film coated tablet
  • Units in package:
  • Blister pack, Al-Amber PVC/PVDC blister in a cardboard carton, 20 tablets
  • Class:
  • Restricted
  • Prescription type:
  • Restricted
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Harika Drugs Pvt Ltd

Documents

Localization

  • Available in:
  • Allersoothe 25 mg Film coated tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • 1. Treatment of allergic conditions including some allergic reactions to drugs, urticaria and allergic contact dermatitis, and allergic reactions to insect bites and stings 2. Relief of excessive secretion in the upper respiratory tract as a result of hayfever and allergic rhinitis 3. Anti-emetic for vomiting from various causes including post-operative vomiting, irradiation sickness, drug induced nausea and motion sickness 4. Sedation - for short term use under the advice of a doctor or pharmacist, Do not use for more than 7-10 consecutive days 5. Promethazine has sedative effects and can be used in the symptomatic management of measles and chickenpox. 6. Promethazine can be used as a pre-anaesthetic medication for the prevention and control of post-operative vomiting.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 12121
  • Authorization date:
  • 15-06-2005
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

Data Sheet

Allersoothe

Promethazinehydrochloride10mg and25mg tablets

Promethazinehydrochloride5mg/5mLElixir

Presentation

Allersoothe 10mg tabletsarelightblue,round,biconvex,film-coatedtablets.Theycontain

10 mg promethazine hydrochloride.

Allersoothe 25mg tabletsarelightblue,round,biconvex,film-coatedtablets.Theycontain

25 mg promethazine hydrochloride.

Allersoothe Elixirisa clear,orange,syrupyliquidwithbanana andvanillaflavour.Each 5mL

ofthe elixircontains5mg ofpromethazine hydrochloride.

Uses

Actions

Promethazine,a phenothiazine derivative,isa long actingantihistaminewith mild atropine-

like anticholinergiceffectsand someanti-serotonin effects.Because ofitsmarkedeffecton

the centralnervoussystem(CNS),itactsasananti-emetic,hypnotic,tranquiliseranda

potentiatorofanaesthetics,hypnotics,sedativesand analgesics.The antihistamine action

hasbeenreportedto lastforbetween 4 and 12hours.

Pharmacokinetics

Promethazine iswellabsorbed afteroraldosingwith peakplasmaconcentrationsbeing

reached 2-3 hoursafteradministration.Duetohighfirstpassmetabolismin the liverthere is

lowsystemicbioavailabilityafteroraladministration.Itiswidelydistributed in thebody,

enteringthe brain andcrossing theplacenta.Itishighlybound toplasmaproteins(76-93%).

Promethazine undergoesextensive metabolismand isslowlyexcreted via urine andbile,

mainlyasmetabolites.Elimination half-livesof5-14 hourshave beenreported.

Phenothiazinespassintobreastmilkatlowconcentrations.

Indications

1.Treatmentofallergicconditionsincludingsomeallergicreactionsto drugs,urticaria and

allergiccontactdermatitis,andallergicreactionsto insectbitesand stings

2.Reliefofexcessivesecretion in theupperrespiratorytractasaresultofhayfeverand

allergicrhinitis

3.Anti-emeticforvomitingfromvariouscausesincludingpost-operative vomiting,irradiation

sickness,drug induced nausea andmotion sickness

4.Sedation-forshorttermuse undertheadvice ofa doctororpharmacist,Do notusefor

morethan7-10consecutive days

5.Promethazine hassedative effectsandcanbe usedin thesymptomaticmanagementof

measlesandchickenpox.

6.Promethazine can be used asapre-anaestheticmedicationfortheprevention and

controlofpost-operative vomiting.

DosageandAdministration

Allersoothe should notbe used inchildren lessthan two yearsofage.

Thedosage variesaccordingtothecondition being treatedandthe patient'sresponse.

Allergic disorders

Children 2-5 yearsofage:5-15 mg(5-15 mL)asasingle doseatnightor5mg(5 mL)2-3

timesdaily.

Children 6-12 yearsofage:10-25 mg(10-25mL)asasingle doseatnightor10mg(10mL)

2-3 timesdaily

Children over12 yearsand adults: 25-75mgasasingledose atnightor10-20 mg2-3 times

daily.

Sedation

Give asa single dose atnight.

Children 2-5 years:5-15 mg(5-15 mL)

Children 6-12 yearsofage:10-25 mg(10-25mL)

Children over12 yearsand adults:25-75 mg

Travelsickness

Tobetakenthe nightbeforetraveland repeatedafter6-8 hoursonthefollowingdayif

required.

Children 2-5 yearsofage:5mg (5mL)

Children 6-12 yearsofage:10mg (10mL)

Children over12 yearsand adults:25mg

Nausea andvomiting

Children 2-5 yearsofage:5 mg(5 mL)very4-6hoursto amaximumdailydose of15mg(15

mL).

Children 6-12 yearsofage:10mg (10mL)every4-6hourstoamaximumdailydose of20

mg(20mL)

Children over12 yearsand adults:25mg every4-6 hoursto amaximumdailydose of100

mg.

Contraindications

Patientswith hypersensitivityto promethazine,substanceswith a similarchemical

structureortoanyoftheexcipients.

Patientswho areallergictosodiumbenzoate.

Newborn and prematureinfants

Children under2yearsofage

Womenwho are breastfeeding

Patientswho have received highdosesofotherCNSdepressantsand/orare

comatose

Allersoothe should notbegiven forjaundiceinduced byotherphenothiazine

derivatives..

Allersoothe should beavoided in patientswho have been takingmonoamine oxidase

inhibitorswithin the previous14 days.

WarningsandPrecautions

Caution isadvised in patientswith:

Cardiovasculardisease

Impairedhepaticfunction

Impairedrenalfunction orrenalfailure

Acute orchronicrespiratoryimpairment

Epilepsy-epilepticpatientsmayexperience increased severityofconvulsions

Hypertensive crisis

Narrow-angle glaucoma

Stenosing pepticulcer

Symptomaticprostatichypertrophy

Bladderneckobstruction

Pyloroduodenalobstruction

Promethazine maycause drowsinessandmayincreasethe effectsofalcohol.Drowsiness

maycontinuethefollowing day.Thoseaffectedshould notdrive oroperate machinery.

Alcoholshould be avoided.

Solardermatitishasbeen reportedfollowingoraldosesofpromethazine in patientswith

eczema oratendencytorheumatism.

QTintervalprolongationhasbeenreported with phenothiazines.

Useduring Pregnancyand Lactation

CategoryC

Promethazine hascaused ormaybesuspected ofcausing,harmfuleffectsonthe human

foetusorneonatewithoutcausing malformations.Theseeffectsmaybereversible.When

promethazine hasbeengiven in highdosesduring late pregnancy,ithascaused prolonged

neurologicaldisturbancesin theinfant.Promethazine should onlybe used duringpregnancy

ifthepotentialbenefitstothepatientouweigh thepotentialriskstothefoetus.

Available evidence suggeststhatthe amountexcretedin breastmilkisverylow.However,

therearerisksofneonatalirritabilityand excitement.Itshouldnotbe used unlessthe

physician considersitessential.

Children

Children mayexperience paradoxicalexcitation.

Use ofpromethazine in children and adolescentswith signandsymptomssuggestive of

Reye'ssyndrome should be avoided.

Promethazine should notbe usedin childrenunder2yearsofagedie tothe potentialfor

fatalrespiratorydepression.

Caution should beexercised when administeringpromethazine to childrenduetothe

potentialforcentralandobstructive apnoea andreduced arousal.Excessive dosagesmay

resultinhalluconations,convulsionsand suddendeath.

Elderlypatients

Theelderlymayexperience paradoxicalexcitation.

Theelderlyaremorelikelyto have CNSdepressive side effectsincludingconfusion andare

moresusceptible totheanti-muscariniceffectsof anti-histaminesincluding hypotension.

Effects onability todriveandusemachines

PatientsreceivingAllersootheforthefirsttimeshould notbeincontrolofvehiclesor

machineryforthefirstfewdaysuntilitisestablished thattheyare notreacting tothe central

nervouseffectsofthemedicine and do notsufferfromdisorientation,confusion ordizziness.

AdverseEffects

CNSEffects

CNSdepressive effectsofpromethazine include sedation andimpaired performance

(impaired driving,poorworkperformance,incoordination,reducedmotorskillsand impaired

information processing).Performancemaybeimpaired in theabsenceofsedation andmay

persistthemorning aftera night-timedose.

Thestimulatoryeffectsofpromethazine mayincludeanxiety,hallucinations,appetite

stimulation,muscle dyskenesiasand activation ofepileptogenicfoci.

Highdosesofpromethazine maycause nervousness,tremor,insomnia,agitation and

irritability.

Anti-cholinergicEffects

Side effectsofpromethazine associated with cholinergicblockade includedrynessofthe

eyes,nose andmouth,blurred vision,urinaryhesitancyand retention,constipation and

tachycardia.

Common Reactions

Gastrointestinal:Drymouth,epigastricdistress,lossofappetite,nausea,vomiting,

constipation,diarrhoea

Nervous system:Sedation,restlessness,dizziness,lassitude,incoordination,fatigue

Ocular:Blurred vision

LessCommon Reactions

Cardiovascular:Tachcardia,bradycardia,faintness

Dermatological:Contactdermatitis(topical),photosensitisation,urticaria,angioneurotic

oedema,pruritus

Haematological:Leucopenia,agranulocytosis,aplasticanemia,thrombocytopenicpurpura

Hepatic:Jaundice

Musculoskeletal:Extrapyramidalsymptoms

Nervous system:Tinnitus,euphoria,nervousness,insomnia,convulsive seizures,oculogyric

crises,excitation,catatonic-like states,hysteria,extrapyramidalsymptoms,tardive

dyskenesia

Respiratory:Marked irregularrespiration

Severe orLife-threateningReactions

Agranulocytosis,anaphylaxis.

Allersoothe Elixercontainssodiumbenzoate which hasbeenreportedtocause

hypersensitivityreactions.

Interactions

Promethazine maycause drowsinessandmayenhance thesedative effectsofCNS

depressantse.g.alcohol,barbiturates,hypnotics,opiod analgesics,anxiolyticsedativesand

neurolepticsandhave additive anti-muscarinicactionswith otheranti-muscarinicdrugse.g.

atropine andtricyclicantidepressants.Interactionsbetween promethazine andmonoamine

oxidase inhibitors(MAOI)andtricyclicantidepressantsmayprolongand intensifytheanti-

cholinergicandCNSdepressive effects.

Overdosage

Themainsignofacute poisonongfromoverdosageisunconsciousnesswhich iscommonly

delayed.Convulsions,hallucinations,delirium,acuteanxiety,psychoticreactions,extreme

hyperaesthesia and hyperalgesiawith extensorplantarresponsesmayalso occur.Anti-

cholinergicactionsmaycause tachycardia,flushed skin,drymouthand sometimesmydriasis

and urinaryretention.

In adultsCNSismorecommonwith drowsiness,coma,convulsions,progressing to

respiratoryfailureorcardiovascularcollapse.

In infantsand children,CNSstimulationpredominatesoverCNSdepression causingataxia,

excitement,tremors,psychoses,hallucinations,convulsionsand possible hyperpyrexiawhich

maybefollowed bydeepeningcomaand cardiorespiratorycollapse.

Aswith otherphenothiazinessymptomatic,supportive therapyisindicated.Maintenance of

adequate ventilation should be instituted ifnecessary.

PharmaceuticalPrecautions

Store below30°C.Protectfromlight.

Medicines Classification

PharmacistOnlyMedicine

Package Quantities

10 mg tablets:OTCblisterpacksof20and 50tablets,dispensing blisterpackof50tablets

25 mg tablets:OTCblisterpacksof20and 50tablets,dispensing blisterpackof50tablets

Elixir:Bottlesof100mL

FurtherInformation

AllersootheTabletscontain lactose andcolour.

Allersoothe Elixircontainssodiumbenzoate asapreservative.Italsocontainscolourand

flavours.

NameandAddress

AFTPharmaceuticalsLtd

POBox33-0232

Takapuna

Auckland

Tel:(09)4880232

Email:customer.service@aftpharm.com

Date ofPreparation

25 March 2013

Document Outline

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EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety