Amoclave may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoclave in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Amoclave in the following countries:
International Drug Name Search
Fentolamina may be available in the countries listed below.
Fentolamina (DCIT) is known as Phentolamine in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Rec.INN
P03AA05
0000137-26-8
C6-H12-N2-S4
240
Antiseptic
Disinfectant
Antifungal agent
Insecticide
Bis(dimethylthiocarbamoyl)disulfide
Thioperoxydicarbonic diamide ([(H₂N)C(S)]₂S₂), tetramethyl-
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 |
Captopril-ratiopharm may be available in the countries listed below.
Captopril is reported as an ingredient of Captopril-ratiopharm in the following countries:
International Drug Name Search
Ibuprofen Grindeks may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Ibuprofen Grindeks in the following countries:
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Benecid may be available in the countries listed below.
Probenecid is reported as an ingredient of Benecid in the following countries:
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Tanvimil B6 may be available in the countries listed below.
Pyridoxine hydrochloride (a derivative of Pyridoxine) is reported as an ingredient of Tanvimil B6 in the following countries:
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Amoxicillina + Acido clavulanico DOC may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicillina + Acido clavulanico DOC in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Amoxicillina + Acido clavulanico DOC in the following countries:
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Folerin may be available in the countries listed below.
Loratadine is reported as an ingredient of Folerin in the following countries:
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Atenolol-CT may be available in the countries listed below.
Atenolol is reported as an ingredient of Atenolol-CT in the following countries:
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Humex fournier may be available in the countries listed below.
Benzalkonium chloride (a derivative of Benzalkonium) is reported as an ingredient of Humex fournier in the following countries:
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Furozin may be available in the countries listed below.
Carpronium Chloride is reported as an ingredient of Furozin in the following countries:
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In the US, Cefixime (cefixime systemic) is a member of the drug class third generation cephalosporins and is used to treat Bladder Infection, Bronchitis, Gonococcal Infection - Disseminated, Gonococcal Infection - Uncomplicated, Kidney Infections, Otitis Media, Pneumonia, Sinusitis, STD Prophylaxis, Tonsillitis/Pharyngitis, Upper Respiratory Tract Infection and Urinary Tract Infection.
US matches:
Rec.INN
J01DD08
0079350-37-1
C16-H15-N5-O7-S2
453
Antibacterial: Cephalosporin
(Z)-7-[2-(2-Aminothiazol-4-yl)-2-(carboxymethoxyimino)acetamido]-3-vinyl-3-cephem-4-carboxylic acid
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| 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 |
Trinitrine Merck may be available in the countries listed below.
Nitroglycerin is reported as an ingredient of Trinitrine Merck in the following countries:
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Melitrast may be available in the countries listed below.
Iosarcol is reported as an ingredient of Melitrast in the following countries:
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Barigraf may be available in the countries listed below.
Barium Sulfate is reported as an ingredient of Barigraf in the following countries:
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Lovastatina Ratiopharm may be available in the countries listed below.
Lovastatin is reported as an ingredient of Lovastatina Ratiopharm in the following countries:
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Lansoprazole-Winthrope may be available in the countries listed below.
Lansoprazole is reported as an ingredient of Lansoprazole-Winthrope in the following countries:
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Trosec may be available in the countries listed below.
Trospium Chloride is reported as an ingredient of Trosec in the following countries:
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Enalapril Best may be available in the countries listed below.
Enalapril is reported as an ingredient of Enalapril Best in the following countries:
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Acti Méthoxine may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfadimethoxine is reported as an ingredient of Acti Méthoxine in the following countries:
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Anzief may be available in the countries listed below.
Allopurinol is reported as an ingredient of Anzief in the following countries:
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Alfuzosin Mylan may be available in the countries listed below.
Alfuzosin hydrochloride (a derivative of Alfuzosin) is reported as an ingredient of Alfuzosin Mylan in the following countries:
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Eunoctin may be available in the countries listed below.
Nitrazepam is reported as an ingredient of Eunoctin in the following countries:
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Adglim may be available in the countries listed below.
Glimepiride is reported as an ingredient of Adglim in the following countries:
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Lastet may be available in the countries listed below.
Etoposide is reported as an ingredient of Lastet in the following countries:
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Irazem may be available in the countries listed below.
Aripiprazole is reported as an ingredient of Irazem in the following countries:
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Metoprololsuccinat AL may be available in the countries listed below.
Metoprolol succinate and tartrate (a derivative of Metoprolol) is reported as an ingredient of Metoprololsuccinat AL in the following countries:
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In the US, Methysergide Maleate is a member of the drug class antimigraine agents and is used to treat Cluster Headaches and Migraine.
Methysergide Maleate (BANM) is known as Methysergide in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
Axerophthol may be available in the countries listed below.
Retinol acetate (a derivative of Retinol) is reported as an ingredient of Axerophthol in the following countries:
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Cefuroxima Generis may be available in the countries listed below.
Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Cefuroxima Generis in the following countries:
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Ilube may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Acetylcysteine is reported as an ingredient of Ilube in the following countries:
Hypromellose is reported as an ingredient of Ilube in the following countries:
International Drug Name Search
Penicillin V Potassium (USAN) is also known as Phenoxymethylpenicillin (Rec.INN)
International Drug Name Search
Glossary
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Findeclin may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Findeclin in the following countries:
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Regtin may be available in the countries listed below.
Sulfamethoxazole is reported as an ingredient of Regtin in the following countries:
Trimethoprim is reported as an ingredient of Regtin in the following countries:
International Drug Name Search
Ampicillin Trihydrous may be available in the countries listed below.
Ampicillin trihydrate (a derivative of Ampicillin) is reported as an ingredient of Ampicillin Trihydrous in the following countries:
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Bacbutol may be available in the countries listed below.
Ethambutol is reported as an ingredient of Bacbutol in the following countries:
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Mesalazine Teva may be available in the countries listed below.
Mesalazine is reported as an ingredient of Mesalazine Teva in the following countries:
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Bipéridys may be available in the countries listed below.
Domperidone is reported as an ingredient of Bipéridys in the following countries:
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Labocton may be available in the countries listed below.
Pefloxacin mesilate (a derivative of Pefloxacin) is reported as an ingredient of Labocton in the following countries:
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Glandinon may be available in the countries listed below.
Dinoprost is reported as an ingredient of Glandinon in the following countries:
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Ftorocort may be available in the countries listed below.
Triamcinolone 16α,17α-acetonide (a derivative of Triamcinolone) is reported as an ingredient of Ftorocort in the following countries:
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H.C.T. may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of H.C.T. in the following countries:
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APC Apotex may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of APC Apotex in the following countries:
Paracetamol is reported as an ingredient of APC Apotex in the following countries:
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Kobalnon may be available in the countries listed below.
Teprenone is reported as an ingredient of Kobalnon in the following countries:
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Analsik may be available in the countries listed below.
Diazepam is reported as an ingredient of Analsik in the following countries:
Metamizole is reported as an ingredient of Analsik in the following countries:
International Drug Name Search
Renitab may be available in the countries listed below.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Renitab in the following countries:
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Trileptin may be available in the countries listed below.
Oxcarbazepine is reported as an ingredient of Trileptin in the following countries:
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Fluidouche may be available in the countries listed below.
Acetylcysteine is reported as an ingredient of Fluidouche in the following countries:
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Mediolax may be available in the countries listed below.
Bisacodyl is reported as an ingredient of Mediolax in the following countries:
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Paxabel may be available in the countries listed below.
Macrogol 4000 (a derivative of Macrogol) is reported as an ingredient of Paxabel in the following countries:
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Avigilen Vit. E may be available in the countries listed below.
Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Avigilen Vit. E in the following countries:
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Tefamin may be available in the countries listed below.
Aminophylline is reported as an ingredient of Tefamin in the following countries:
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Tervent may be available in the countries listed below.
Terbutaline sulfate (a derivative of Terbutaline) is reported as an ingredient of Tervent in the following countries:
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Euform may be available in the countries listed below.
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Euform in the following countries:
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Coromert may be available in the countries listed below.
Flunarizine is reported as an ingredient of Coromert in the following countries:
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Fiblast may be available in the countries listed below.
Trafermin is reported as an ingredient of Fiblast in the following countries:
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Facilpart may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Oxytocin is reported as an ingredient of Facilpart in the following countries:
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Rojamin may be available in the countries listed below.
Cyanocobalamin is reported as an ingredient of Rojamin in the following countries:
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Flucinom may be available in the countries listed below.
Flutamide is reported as an ingredient of Flucinom in the following countries:
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Efrin may be available in the countries listed below.
Phenylephrine hydrochloride (a derivative of Phenylephrine) is reported as an ingredient of Efrin in the following countries:
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Efedrina Cloridrato Monico may be available in the countries listed below.
Ephedrine hydrochloride (a derivative of Ephedrine) is reported as an ingredient of Efedrina Cloridrato Monico in the following countries:
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Asmavent may be available in the countries listed below.
Budesonide is reported as an ingredient of Asmavent in the following countries:
International Drug Name Search
Bicarbonato de Sodio may be available in the countries listed below.
Sodium Bicarbonate is reported as an ingredient of Bicarbonato de Sodio in the following countries:
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Bufabron may be available in the countries listed below.
Theophylline is reported as an ingredient of Bufabron in the following countries:
International Drug Name Search
Alprazolam Calox may be available in the countries listed below.
Alprazolam is reported as an ingredient of Alprazolam Calox in the following countries:
International Drug Name Search
Gabbroral may be available in the countries listed below.
Paromomycin is reported as an ingredient of Gabbroral in the following countries:
Paromomycin sulfate (a derivative of Paromomycin) is reported as an ingredient of Gabbroral in the following countries:
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Inseac may be available in the countries listed below.
Ranitidine is reported as an ingredient of Inseac in the following countries:
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Mecater may be available in the countries listed below.
Procaterol hydrochloride (a derivative of Procaterol) is reported as an ingredient of Mecater in the following countries:
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Tyason may be available in the countries listed below.
Ceftriaxone disodium salt (a derivative of Ceftriaxone) is reported as an ingredient of Tyason in the following countries:
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Micos may be available in the countries listed below.
Econazole is reported as an ingredient of Micos in the following countries:
Econazole nitrate (a derivative of Econazole) is reported as an ingredient of Micos in the following countries:
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Jurnista may be available in the countries listed below.
Hydromorphone hydrochloride (a derivative of Hydromorphone) is reported as an ingredient of Jurnista in the following countries:
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Adenosine Triphosphate Disodium may be available in the countries listed below.
Adenosine Triphosphate Disodium (JAN) is also known as Adenosine Triphosphate
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
Colircusi Atropine may be available in the countries listed below.
Atropine sulfate (a derivative of Atropine) is reported as an ingredient of Colircusi Atropine in the following countries:
International Drug Name Search
Enalapril Farmedic may be available in the countries listed below.
Enalapril is reported as an ingredient of Enalapril Farmedic in the following countries:
International Drug Name Search
Budesonide PCH may be available in the countries listed below.
Budesonide is reported as an ingredient of Budesonide PCH in the following countries:
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Gluconsan K2.5 may be available in the countries listed below.
Potassium Gluconate is reported as an ingredient of Gluconsan K2.5 in the following countries:
International Drug Name Search
Cétirizine Winthrop may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Cétirizine Winthrop in the following countries:
International Drug Name Search
Carboplatin Amphar may be available in the countries listed below.
Carboplatin is reported as an ingredient of Carboplatin Amphar in the following countries:
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Intobac may be available in the countries listed below.
Tobramycin sulfate (a derivative of Tobramycin) is reported as an ingredient of Intobac in the following countries:
International Drug Name Search
Alacetan may be available in the countries listed below.
Naproxen sodium salt (a derivative of Naproxen) is reported as an ingredient of Alacetan in the following countries:
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Isalopan may be available in the countries listed below.
Alcloxa is reported as an ingredient of Isalopan in the following countries:
International Drug Name Search
In the US, Cormax (clobetasol topical) is a member of the drug class topical steroids and is used to treat Anal Itching, Atopic Dermatitis, Dermatitis, Lichen Planus, Lichen Sclerosus, Necrobiosis Lipoidica Diabeticorum and Psoriasis.
US matches:
Clobetasol 17α-propionate (a derivative of Clobetasol) is reported as an ingredient of Cormax in the following countries:
International Drug Name Search
Trima-Kel may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfamethoxazole is reported as an ingredient of Trima-Kel in the following countries:
Trimethoprim is reported as an ingredient of Trima-Kel in the following countries:
International Drug Name Search
Thalamonal may be available in the countries listed below.
Droperidol is reported as an ingredient of Thalamonal in the following countries:
Fentanyl citrate (a derivative of Fentanyl) is reported as an ingredient of Thalamonal in the following countries:
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Cerotor may be available in the countries listed below.
Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Cerotor in the following countries:
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Roxid may be available in the countries listed below.
Roxithromycin is reported as an ingredient of Roxid in the following countries:
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Amodiaquine Hydrochloride may be available in the countries listed below.
Amodiaquine Hydrochloride (BANM) is also known as Amodiaquine (Rec.INN)
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Rilmazafone Hydrochloride may be available in the countries listed below.
Rilmazafone Hydrochloride (JAN) is also known as Rilmazafone (Rec.INN)
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Prozef may be available in the countries listed below.
Cefprozil monohydrate (a derivative of Cefprozil) is reported as an ingredient of Prozef in the following countries:
International Drug Name Search
Cisplatin Hospira may be available in the countries listed below.
Cisplatin is reported as an ingredient of Cisplatin Hospira in the following countries:
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Gobbicaina may be available in the countries listed below.
Lidocaine hydrochloride monohydrate (a derivative of Lidocaine) is reported as an ingredient of Gobbicaina in the following countries:
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Trisiston may be available in the countries listed below.
Ethinylestradiol is reported as an ingredient of Trisiston in the following countries:
Levonorgestrel is reported as an ingredient of Trisiston in the following countries:
International Drug Name Search
Xalatan 0.005% w/v eye drops solution.
100 ml eye drops solution contains 0.005 g latanoprost.
One drop contains approximately 1.5 micrograms latanoprost.
Excipient: Benzalkonium chloride 0.02% w/v is included as a preservative.
For a full list of excipients, see section 6.1.
Eye drops, solution.
The solution is a clear colourless liquid.
Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension.
Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma.
Recommended dosage for adults (including the elderly):
Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if Xalatan is administered in the evening.
The dosage of Xalatan should not exceed once daily since it has been shown that more frequent administration decreases the intraocular pressure lowering effect.
If one dose is missed, treatment should continue with the next dose as normal.
As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop.
Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
Paediatric population:
Xalatan eye drops may be used in paediatric patients at the same posology as in adults. No data are available for preterm infants (less than 36 weeks gestational age). Data in the age group < 1 year (4 patients) are very limited (see Section 5.1).
Known hypersensitivity to any component in Xalatan.
Xalatan may gradually change eye colour by increasing the amount of brown pigment in the iris. Before treatment is instituted, patients should be informed of the possibility of a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia.
This change in eye colour has predominantly been seen in patients with mixed coloured irides, i.e. blue-brown, grey-brown, yellow-brown and green-brown. In studies with latanoprost, the onset of the change is usually within the first 8 months of treatment, rarely during the second or third year, and has not been seen after the fourth year of treatment. The rate of progression of iris pigmentation decreases with time and is stable for five years. The effect of increased pigmentation beyond five years has not been evaluated. In an open 5-year latanoprost safety study, 33% of patients developed iris pigmentation (see 4.8). The iris colour change is slight in the majority of cases and often not observed clinically. The incidence in patients with mixed colour irides ranged from 7 to 85%, with yellow-brown irides having the highest incidence. In patients with homogeneously blue eyes, no change has been observed and in patients with homogeneously grey, green or brown eyes, the change has only rarely been seen.
The colour change is due to increased melanin content in the stromal melanocytes of the iris and not to an increase in number of melanocytes. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may become more brownish. No further increase in brown iris pigment has been observed after discontinuation of treatment. It has not been associated with any symptom or pathological changes in clinical trials to date.
Neither naevi nor freckles of the iris have been affected by treatment. Accumulation of pigment in the trabecular meshwork or elsewhere in the anterior chamber has not been observed in clinical trials. Based on 5 years clinical experience, increased iris pigmentation has not been shown to have any negative clinical sequelae and Xalatan can be continued if iris pigmentation ensues. However, patients should be monitored regularly and if the clinical situation warrants, Xalatan treatment may be discontinued.
There is limited experience of Xalatan in chronic angle closure glaucoma, open angle glaucoma of pseudophakic patients and in pigmentary glaucoma. There is no experience of Xalatan in inflammatory and neovascular glaucoma, inflammatory ocular conditions, or congenital glaucoma. Xalatan has no or little effect on the pupil, but there is no experience in acute attacks of closed angle glaucoma. Therefore, it is recommended that Xalatan should be used with caution in these conditions until more experience is obtained.
There are limited study data on the use of Xalatan during the peri-operative period of cataract surgery. Xalatan should be used with caution in these patients.
Xalatan should be used with caution in patients with a history of herpetic keratitis, and should be avoided in cases of active herpes simplex keratitis and in patients with a history of recurrent herpetic keratitis specifically associated with prostaglandin analogues.
Reports of macular oedema have occurred (see 4.8) mainly in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema (such as diabetic retinopathy and retinal vein occlusion). Xalatan should be used with caution in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.
In patients with known predisposing risk factors for iritis/uveitis, Xalatan can be used with caution.
There is limited experience from patients with asthma, but some cases of exacerbation of asthma and/or dyspnoea were reported in post marketing experience. Asthmatic patients should therefore be treated with caution until there is sufficient experience, see also 4.8.
Periorbital skin discolouration has been observed, the majority of reports being in Japanese patients. Experience to date shows that periorbital skin discolouration is not permanent and in some cases has reversed while continuing treatment with Xalatan.
Latanoprost may gradually change eyelashes and vellus hair in the treated eye and surrounding areas; these changes include increased length, thickness, pigmentation, number of lashes or hairs and misdirected growth of eyelashes. Eyelash changes are reversible upon discontinuation of treatment.
Xalatan contains benzalkonium chloride, which is commonly used as a preservative in ophthalmic products. Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy, may cause eye irritation and is known to discolour soft contact lenses. Close monitoring is required with frequent or prolonged use of Xalatan in dry eye patients, or in conditions where the cornea is compromised. Contact lenses may absorb benzalkonium chloride and these should be removed before applying Xalatan but may be reinserted after 15 minutes (see section 4.2 Posology and Method of Administration).
Paediatric population
Efficacy and safety data in the age group < 1 year (4 patients) are very limited (see Section 5.1). No data are available for preterm infants (less than 36 weeks gestational age).
In children from 0 to < 3 years old that mainly suffers from PCG (Primary Congenital Glaucoma), surgery (e.g. trabeculotomy/goniotomy) remains the first line treatment.
Long-term safety in children has not yet been established.
Definitive drug interaction data are not available.
There have been reports of paradoxical elevations in intraocular pressure following the concomitant ophthalmic administration of two prostaglandin analogues. Therefore, the use of two or more prostaglandins, prostaglandin analogues or prostaglandin derivatives is not recommended.
Paediatric population
Interaction studies have only been performed in adults.
Pregnancy
The safety of this medicinal product for use in human pregnancy has not been established. It has potential hazardous pharmacological effects with respect to the course of pregnancy, to the unborn or the neonate. Therefore, Xalatan should not be used during pregnancy.
Lactation
Latanoprost and its metabolites may pass into breast milk and Xalatan should therefore not be used in nursing women or breast feeding should be stopped.
In common with other eye preparations, instillation of eye drops may cause transient blurring of vision. Until this has resolved, patients should not drive or use machines.
The majority of adverse events relate to the ocular system. In an open 5-year latanoprost safety study, 33% of patients developed iris pigmentation (see 4.4). Other ocular adverse events are generally transient and occur on dose administration.
Adverse events are categorized by frequency as follows: very common (
Infections and Infestations:
Not known: Herpetic keratitis
Eye Disorders:
Very common: Increased iris pigmentation; mild to moderate conjunctival hyperaemia eye irritation (burning grittiness, itching, stinging and foreign body sensation); eyelash and vellus hair changes (increased length, thickness, pigmentation and number) (vast majority of reports in Japanese population).
Common: transient punctate epithelial erosions, mostly without symptoms; blepharitis; eye pain.
Uncommon: Eyelid oedema: dry eye; keratitus; vision blurred; conjunctivitis.
Rare: Iritis/uveitis (the majority of reports in patients with concomitant predisposing factors); macular oedema; symptomatic corneal oedema and erosions; periorbital oedema; misdirected eyelashes sometimes resulting in eye irritation; extra row of cilia at the aperture of the meibomian glands (distichiasis).
Not known: iris cyst
Nervous System Disorders:
Not known: Headache, Dizziness.
Cardiac Disorders:
Very rare: Aggravation of angina in patients with pre-existing disease.
Not known: Palpitations.
Respiratory, Thoracic and Mediastinal Disorders:
Rare: Asthma, asthma exacerbation and dyspnoea.
Skin and Subcutaneous Tissue Disorders:
Uncommon: Skin rash.
Rare: Localised skin reaction on the eyelids; darkening of the palpebral skin of the eyelids.
Musculoskeletal and Connective Tissue Disorders:
Not known: Myalgia; Arthralgia.
General Disorders and Administration Site Conditions:
Very rare: Chest pain.
Paediatric Population
In two short term clinical trials (
Apart from ocular irritation and conjunctival hyperaemia, no other ocular side effects are known if Xalatan is overdosed.
If Xalatan is accidentally ingested the following information may be useful: One bottle contains 125 micrograms latanoprost. More than 90% is metabolised during the first pass through the liver. Intravenous infusion of 3 micrograms/kg in healthy volunteers produced mean plasma concentrations 200 times higher than during clinical treatment and induced no symptoms, but a dose of 5.5-10 micrograms/kg caused nausea, abdominal pain, dizziness, fatigue, hot flushes and sweating. In monkeys, latanoprost has been infused intravenously in doses of up to 500 micrograms/kg without major effects on the cardiovascular system.
Intravenous administration of latanoprost in monkeys has been associated with transient bronchoconstriction. However, in patients with moderate bronchial asthma, bronchoconstriction was not induced by latanoprost when applied topically on the eyes in a dose of seven times the clinical dose of Xalatan.
If overdosage with Xalatan occurs, treatment should be symptomatic.
Pharmacotherapeutic group (ATC code): S 01 E E 01
The active substance latanoprost, a prostaglandin F2α analogue, is a selective prostanoid FP receptor agonist which reduces the intraocular pressure by increasing the outflow of aqueous humour. Reduction of the intraocular pressure in man starts about three to four hours after administration and maximum effect is reached after eight to twelve hours. Pressure reduction is maintained for at least 24 hours.
Studies in animals and man indicate that the main mechanism of action is increased uveoscleral outflow, although some increase in outflow facility (decrease in outflow resistance) has been reported in man.
Pivotal studies have demonstrated that Xalatan is effective as monotherapy. In addition, clinical trials investigating combination use have been performed. These include studies that show that latanoprost is effective in combination with beta-adrenergic antagonists (timolol). Short-term (1 or 2 weeks) studies suggest that the effect of latanoprost is additive in combination with adrenergic agonists (dipivalyl epinephrine), oral carbonic anhydrase inhibitors (acetazolamide) and at least partly additive with cholinergic agonists (pilocarpine).
Clinical trials have shown that latanoprost has no significant effect on the production of aqueous humour. Latanoprost has not been found to have any effect on the blood-aqueous barrier.
Latanoprost has no or negligible effects on the intraocular blood circulation when used at the clinical dose and studied in monkeys. However, mild to moderate conjunctival or episcleral hyperaemia may occur during topical treatment.
Chronic treatment with latanoprost in monkey eyes, which had undergone extracapsular lens extraction, did not affect the retinal blood vessels as determined by fluorescein angiography.
Latanoprost has not induced fluorescein leakage in the posterior segment of pseudophakic human eyes during short-term treatment.
Latanoprost in clinical doses has not been found to have any significant pharmacological effects on the cardiovascular or respiratory system.
Paediatric population
The efficacy of Xalatan in paediatric patients
IOP reductions among subjects in the primary congenital/infantile glaucoma (PCG) subgroup were similar between the latanoprost group and the timolol group. The non-PCG (e.g. juvenile open angle glaucoma, aphakic glaucoma) subgroup showed similar results as the PCG subgroup.
The effect on IOP was seen after the first week of treatment (see graph) and was maintained throughout the 12 week period of study, as in adults.
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SE: standard error.
†Adjusted estimate based on an analysis of covariance (ANCOVA) model.
Latanoprost (mw 432.58) is an isopropyl ester prodrug which per se is inactive, but after hydrolysis to the acid of latanoprost becomes biologically active.
The prodrug is well absorbed through the cornea and all drug that enters the aqueous humour is hydrolysed during the passage through the cornea.
Studies in man indicate that the peak concentration in the aqueous humour is reached about two hours after topical administration. After topical application in monkeys, latanoprost is distributed primarily in the anterior segment, the conjunctivae and the eyelids. Only minute quantities of the drug reach the posterior segment.
There is practically no metabolism of the acid of latanoprost in the eye. The main metabolism occurs in the liver. The half life in plasma is 17 minutes in man. The main metabolites, the 1,2-dinor and 1,2,3,4-tetranor metabolites, exert no or only weak biological activity in animal studies and are excreted primarily in the urine.
Paediatric population
An open-label pharmacokinetic study of plasma latanoprost acid concentrations was undertaken in 22 adults and 25 paediatric patients (from birth to < 18 years of age) with ocular hypertension and glaucoma. All age groups were treated with latanoprost 0.005%, one drop daily in each eye for a minimum of 2 weeks. Latanoprost acid systemic exposure was approximately 2-fold higher in 3 to < 12 year olds and 6-fold higher in children < 3 years old compared with adults, but a wide safety margin for systemic adverse effects was maintained (see section 4.9). Median time to reach peak plasma concentration was 5 minutes post-dose across all age groups. The median plasma elimination half-life was short (< 20 minutes), similar for paediatric and adult patients, and resulted in no accumulation of latanoprost acid in the systemic circulation under steady-state conditions.
The ocular as well as systemic toxicity of latanoprost has been investigated in several animal species. Generally, latanoprost is well tolerated with a safety margin between clinical ocular dose and systemic toxicity of at least 1000 times. High doses of latanoprost, approximately 100 times the clinical dose/kg body weight, administered intravenously to unanaesthetised monkeys have been shown to increase the respiration rate probably reflecting bronchoconstriction of short duration. In animal studies, latanoprost has not been found to have sensitising properties.
In the eye, no toxic effects have been detected with doses of up to 100 micrograms/eye/day in rabbits or monkeys (clinical dose is approximately 1.5 micrograms/eye/day). In monkeys, however, latanoprost has been shown to induce increased pigmentation of the iris.
The mechanism of increased pigmentation seems to be stimulation of melanin production in melanocytes of the iris with no proliferative changes observed. The change in iris colour may be permanent.
In chronic ocular toxicity studies, administration of latanoprost 6 micrograms/eye/day has also been shown to induce increased palpebral fissure. This effect is reversible and occurs at doses above the clinical dose level. The effect has not been seen in humans.
Latanoprost was found negative in reverse mutation tests in bacteria, gene mutation in mouse lymphoma and mouse micronucleus test. Chromosome aberrations were observed in vitro with human lymphocytes. Similar effects were observed with prostaglandin F2α, a naturally occurring prostaglandin, and indicates that this is a class effect.
Additional mutagenicity studies on in vitro/in vivo unscheduled DNA synthesis in rats were negative and indicate that latanoprost does not have mutagenic potency. Carcinogenicity studies in mice and rats were negative.
Latanoprost has not been found to have any effect on male or female fertility in animal studies. In the embryotoxicity study in rats, no embryotoxicity was observed at intravenous doses (5, 50 and 250 micrograms/kg/day) of latanoprost. However, latanoprost induced embryolethal effects in rabbits at doses of 5 micrograms/kg/day and above.
The dose of 5 micrograms/kg/day (approximately 100 times the clinical dose) caused significant embryofoetal toxicity characterised by increased incidence of late resorption and abortion and by reduced foetal weight.
No teratogenic potential has been detected.
Sodium chloride
Benzalkonium chloride
Sodium dihydrogen phosphate monohydrate
Anhydrous disodium phosphate
Water for injections
In vitro studies have shown that precipitation occurs when eye drops containing thiomersal are mixed with Xalatan. If such drugs are used, the eye drops should be administered with an interval of at least five minutes.
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After first opening of container: 4 weeks (for both dropper containers)
Store in a refrigerator (2°C – 8°C).
Keep the bottle in the outer carton in order to protect from light.
After first opening the bottle: do not store above 25oC and use within four weeks.
Dropper container (5 ml) of polyethylene with either a screw cap and tamper evident overcap of polyethylene or with a screw cap and tamper-evident ring
Each dropper container contains 2.5 ml eye drops solution corresponding to approximately 80 drops of solution.
Pack sizes: 1 x 2.5 ml, 3 x 2.5 ml, 6 x 2.5 ml.
Not all pack sizes may be marketed.
No special requirements.
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
PL 00057/1057
16 December 1996/16 December 2006
March 2011
XN 15_0 UK
