Läs upp


Den här webbplatsen använder så kallade cookies. Cookies är små textfiler som lagras i din dator och sparar information om olika val som du gjort på en webbsida – t ex språk, version och statistik – för att du inte ska behöva göra dessa val en gång till. Tekniken är etablerad sedan många år tillbaka och används idag på väldigt många webbplatser på Internet.

Du kan när som helst ändra cookieinställningarna för denna webbplats.

FASS logotyp

Peka på symbolerna och beteckningarna till vänster för en förklaring.


Sök apotek med läkemedlet i lager

Sök lagerstatus

Naprosyn® Entero


Enterotablett 250 mg
(vit, rund, kupad, märkt "NPR EC 250" på ena sidan)

Antiflogistikum med analgetisk och antipyretisk effekt

Aktiv substans:
ATC-kod: M01AE02
Läkemedel från Pharmanovia omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?


Miljöpåverkan (Läs mer om miljöpåverkan)


Miljörisk: Användning av naproxen har bedömts medföra låg risk för miljöpåverkan.
Nedbrytning: Naproxen bryts ned långsamt i miljön.
Bioackumulering: Naproxen har låg potential att bioackumuleras.

Läs mer

Detaljerad miljöinformation

PEC/PNEC =0.59/0.64 = 0.92 for Naproxen which means that the phrase 'Use of the medicine has been considered to

result in low environmental risk.' is used for Level 1 and 2.

The PEC is based on the following data:

A = 11893.6 kg Naproxen (use data from Läkemedelsstatistik AB, LSAB, 2010)

PEC = 1.5 × 10–6 × 11893.6 × (100–67) = 0.59 μg/l

Ecotoxicological studies: [5]

Green alga (Desmodesmus subspicatus):

ErC50 72 h =39 000 μg/l (OECD 201)

NOEC 72 h = 3 900 μg/l (OECD 201)

Water-flea (Daphnia magna):

EC50 48 h = 37 000 μg/l (OECD 202)

Water-flea chronic (Ceriodaphnia dubia):

chronic NOEC 192 h = 32 μg/l (Environment Canada Method)

Rainbow trout (Oncorhynchus mykiss):

LC50 96 h = 52 000 μg/l (OECD 203)


NOEC = 30 000 μg/l (toxicity control in inherent biodegradation test)

The PNEC is based on the following data:

The PNEC is based on the lower of two chronic NOECs available (water-flea, Ceriodaphnia) and 50 is the assessment factor used.

PNEC = 32/50 = 0.64 μg/l


Naproxen is not readily biodegradable, however, it is inherently biodegradable and actual, measured elimination rates in various sewage works range from 0% to >99%, with a median of approximately 67%. Moreover, naproxen in surface waters is short-lived, due to biodegradation and photolysis in superficial layers (which is not included in the above PEC calculation). A surface water half-life in late summer in Switzerland at ~47° N was determined at 14 days. Hence, naproxen is rapidly degraded in sewage works and surface waters and is nonpersistent. [5]


Naproxen has no significant bioaccumulation potential, with measured logD values below 1.1 at pH 6.5–7.4.


Subsequent to oral application, naproxen shows rapid uptake, very high bioavailability (~99%) and equally high plasma protein binding. The plasma half-life is around 14 (12–15) h, longer in older people. Approximately 30% of absorbed naproxen undergoes Phase I metabolism through 6-O-demethlyation in liver microsomes, which is mediated by cytochrome P450 (CYP) enzyme isoforms CYP2C9 and CYP1A2. Both the approximately 70% native and the 30% 6-O-desmethyl naproxen subsequently undergo Phase II metabolism by conjugation. Excretion of naproxen in man is mainly (≥95%) by urinary pathway in the form of glucuronic acid or other conjugates of native and 6-O-desmethyl naproxen. [3, 4]

Identification and characterisation

CAS number

26159-34-2 Naproxen sodium [1]

22204-53-1 Naproxen acid [2]

Molecular weight

252.24 Naproxen sodium [1]

Brand name

Naprosyn, Naprosyn Entero

Stability/degradation (Naproxen acid)

Ready biodegradability

not readily, literature; readily, own data [5]

Inherent biodegradability

10% 13 d, >60% 17 d, 98% 28 d; OECD 302C [2]

Other degradation information

~67 (0–99)% removal/biodegradation in sewage works, literature [5]

surface waters (Aug–Oct, Switzerland) = 14 d [6]


90% 72 h, algal medium, algal light cabinet, OECD 201 [5]


no hydrolysable bonds

Accumulation/adsorption (Naproxen acid)

logPow (pH < 2.18!)

3.18 [2]

logD (pH 6.5)

0.98–1.06 [7]

logD (pH 7.4)

0.23–0.33 [8, 9]


<=727 pH sensitive QSAR


no significant sorption in actual sewage works [10]


<10; <80 pH sensitive QSAR

Physico-chemical properties

Aqueous solubility

250000 mg/l Naproxen-Na 15.9 mg/l Naproxen acid [2]

Dissociation constant, pKa

4.15 Naproxen acid [2]

Melting point

255 °C [2]

Vapour pressure


Boiling point



3.39*E–10 atm*m3/mol QSAR Naproxen acid

Ecotoxicological data (Naproxen acid)

Algal growth inhibition

31.82 mg/l 72h EbC50 ISO8692 Pseudokirchneriella subcap. [11]


21/39 mg/l 72h Eb/rC50 OECD201 Desmodesmus subspicatus [5]


3.9 mg/l 72h NOEC OECD 201 D. subspicatus [5]

Daphnia acute immobilisation

37 mg/l 48h EC50 OECD 202 Daphnia magna [5]


10 mg/l 48h NOEC OECD 202 D. magna [5]


0.032 mg/l 8d NOEC ECM Ceriodaphnia dubia chronic [12]

Fish acute toxicity

52 mg/l 96h LC50 OECD 203 Oncorhynchus mykiss [5]


32 mg/l 96h NOEC OECD 203 O. mykiss [5]

Micro-organism inhibition

30 mg/l 14d NOEC OECD302C activated sludge [5]

Aquatic macrophytes inhibition

24.2 mg/l 7d EC50 Lemn a, Naproxen-Na [5]

PBT/vPvB Assessment

P: Freshwater half-life

14 d, based on measured half-life in Swiss lake [6]

Sediment half-life

d, based on

Persistence criteria fulfilled?

not P

B: BCF (experimental)


alternatively, base or acid?


alternatively, logDOW(p H 7)

0.329387, logDow < 3 [7, 8, 9]

Bioaccumulation criteria fulfilled?

no significant bioaccumulation potential

T: chronic NOEC < 0.01 mg/l?

no data on T

CMR substance?

n not CMR [1, 2]

Endocrine-disrupting effects?

no data on ED

T criteria fulfilled?

no or incomplete data on T criteria

PBT Assessment:

not PBT

Initial PEC according to fass.se

Annual use in Sweden, A:

11893.6 kg/a [information from LIF 2010]



Excretion as parent

70 % (if not filled in/unknown, 100% is assumed by default)

Excretion as metabolite 1

30 %, with 100 % pharmacological activity compared to parent

Excretion total, E:

100 %, calculated as pharmacological activity of parent

Removal rate in STP, R:

67 %, based on literature data [5]

PEC = 1.5*10E–6*A*(E/100)*(100–R) =

0.5887 μg/l

Initial PNEC according to EU TGD

Lowest ecotox effect value, LEEV:

0.032 mg/l chronic NOEC Ceriodaphnia

Assessment factor, AF:

50 chronic NOECs for algae and daphnids available


0.64 μg/l

PEC/PNEC ratio

0.920 0.1 <PEC/PNEC <= 1

PBT Assessment

not PBT


1. F. Hoffmann-La Roche Ltd (2005): Safety Data Sheet for Naproxen sodium, 19.12.2005.

2. F. Hoffmann-La Roche Ltd (2004): Safety Data Sheet for Naproxen, 20.12.2004.

3. Hradman JG, Limbird LE, Molinoff PB, Ruddon RW, Goodman Gilman A (1996): Goodman & Gilman’s The Pharmacological Basis of Therapeutics, 9th ed. McGraw-Hill, New York.

4. Miners JO, Coulter S, Tukey RH, Veronese ME, Birkett DJ (1996): Cytochromes P450, 1A2 and 2C9 are responsible for the human hepatic O-demethylation of R- and S-naproxen. Biochem Pharmacol 51(8):1003–1008.

5. Straub JO, Stewart KM (2007): Deterministic and Probabilistic Acute-Based Environmental Risk Assessment for Naproxen for Western Europe. Environ Toxicol Chem 26(4): 795–806.

6. Tixier C, Singer HP, Oellers J, Müller SR (2003): Occurrence and fate of carbamazepine, clofibric acid, diclofenac, ibuprofen, ketoprofen and naproxen in surface waters. Environ Sci Technol 37(6):1061–1068.

7. ACD/logD Suite (1997): Results of titrometric and shake-flask measurements on selected drugs compared to ACD/logD predictions. Poster, AAPS, Boston, Nov 1997,


8. Perlovich GL, Kurkov SV, Kinchin AN, Bauer-Brandl A (2004): Solvation and hydration characteristics of ibuprofen and acetylsalicylic acid. AAPS Pharm Sci 6(1):1–9.

9. Zhu C, Jiang L, Chen T–M, Hwang K–K. 2002. A comparative study of artificial membrane permeability assay for high throughput profiling of drug absorption potential. Eur J Med Chem 37:399–407.

10. Joss A, Alder AC, Felis E, Gödel A, Herrmann N, Hoffmann B, Löffler D, McArdell CS, Siegrist H, Ternes T, Zabczynski S, Clara M, Kreuzinger N, Strenn B (2005): fate of pharmaceuticals, hormones and fragrances in full scale wastewater treatment; are predictions based on lab-scale experiments reliable? Presentation, 15th SETAC Europe Annual Conference, Lille. // Joss A, Carballa M, Kreuzinger N, Siegrist H, Zabczynski S (2006): Wastewater treatment. In Ternes TA, Joss A, eds (2006): Human Pharmaceuticals, Hormones and Fragrances; The challenge of micropollutants in urban water management. IWA Publishing, London, pp. 243–292.

11. Isidori M, Lavorgna M, Nardelli A, Parelly A, Previtera L, Rubino M (2005) Ecotoxicity of naproxen and its phototransformation products. Sci Tot Envir 346: 87–98.

12. Brun GL, Bernier M, Losier R, Doe K, Jackman P, Lee H-B (2006): Pharmaceutically active compounds in Atlantic Canadian sewage treatment plant effluents and receiving waters, and potential for environmental effects as measured by acute and chronic aquatic toxicity. Environ Toxicol Chem 25(8): 2163–2176.


ND = no data; QSAR = QSAR-modelled (EPISuite, SPARC, ACD Solaris); AMC = average measured concentration; ECM = Environment Canada method; NC = nominal concentration; SC = saturation concentration.