Medication: diclofenac
diclofenac sodium
Voltaren - anti-inflamatory
Breastfeeding:
Data taken from Medications and Mothers Milk (Hale 2017 online access).
Because of the very high plasma binding (99.7%), very little drug is available to pass into breastmilk, hence no m/p ratio has been determined. The half-life is very short (1.1 hours) and the mother could be advised to feed just before taking the tablet to minimise transfer further as the medication may be taken in short acute doses or on an as required regime. Nonsteroidal drugs, as a class, are often transferred into breastmilk at very low levels hence their widespread use for immediate post-partum pain.
Diclofenac is preferable to naproxen in mothers with babies less than 6 weeks’ old. Naproxen has a half-life of 12–15 hours, an m/p ratio of 0.01 and plasma protein binding of 99.7%, and the relative infant dose is 3.3%. The longer half-life is of marginally more concern in younger babies. One case of a 7-day- old baby with prolonged bleeding, haemorrhage and acute anaemia has been reported by Hale and LactMed. Original paper in Spanish (Fidalgo et al. 1989).
Breastfeeding:
Data taken from Medications and Mothers Milk (Hale 2017 online access).
Because of the very high plasma binding (99.7%), very little drug is available to pass into breastmilk, hence no m/p ratio has been determined. The half-life is very short (1.1 hours) and the mother could be advised to feed just before taking the tablet to minimise transfer further as the medication may be taken in short acute doses or on an as required regime. Nonsteroidal drugs, as a class, are often transferred into breastmilk at very low levels hence their widespread use for immediate post-partum pain.
Diclofenac is preferable to naproxen in mothers with babies less than 6 weeks’ old. Naproxen has a half-life of 12–15 hours, an m/p ratio of 0.01 and plasma protein binding of 99.7%, and the relative infant dose is 3.3%. The longer half-life is of marginally more concern in younger babies. One case of a 7-day- old baby with prolonged bleeding, haemorrhage and acute anaemia has been reported by Hale and LactMed. Original paper in Spanish (Fidalgo et al. 1989).
Route & Typical Dose:
Use lowest effective dose for shortest poss duration (regularly review efficacy, risk factors, ongoing need if long-term use). Swallow tabs whole with liquid, do not divide, chew. Admin in 2-3 divided doses, pref before meals. Initially: 75-150 mg/day; long-term: usually 75-100 mg/day. Dysmenorrhoea: 50-100 mg/day at 1st symptom onset, may admin for a few days; may incr over several cycles to max 200 mg/day. CV disease, risk factors, uncontrolled hypertension: may admin ≤ 100 mg/day for > 4 wks only after careful consideration
Can have eye drops
indication/Use:
NSAID (phenylacetic acid derivative). Inflammatory, degenerative rheumatism (RA, OA); acute, chronic pain states with inflammatory component; primary dysmenorrhoea
Mode of Action:
Presentation:
Management/administration considerations/Precautions:
Uncontrolled hypertension, established CV disease (eg CHF, IHD, peripheral arterial disease) (not recommended) or significant risk factors (eg diabetes, hyperlipidaemia), atherosclerotic CV disease history; smoking; hypertension (monitor BP) incl history; fluid retention; heart failure; GI event risk eg alcoholism, history (consider protective agent eg misoprostol, PPI); GI disorder; post-GI surgery; high dose (esp 150 mg/day); prolonged use (monitor LFTs within 8 wks of initiation, FBC); monitor for ATE, GI toxicity, hepatotoxicity signs, symptoms; ulcerative colitis; Crohn's disease; severe dyshaemopoiesis; 1st mth of therapy (skin reaction risk); asthma; seasonal allergic rhinitis, nasal mucosa swelling, other allergy; COPD; chronic respiratory tract infection; hepatic, renal, cardiac impairment; hepatic porphyria; mask infection; haemostatic, coagulation disorder; preop admin (postop bleeding risk); extracellular volume depletion eg major surgery (monitor renal function); galactose intolerance, severe lactase deficiency, glucose-galactose malabsorption (not recommended); low bodyweight; elderly; women attempting to conceive (not recommended); pregnancy (should not use in 1st, 2nd trimester); lactation, children (not recommended)
Side effect/Adverse reations:
Headache; dizziness; vertigo; GI upset, bleed, ulcer; rash, skin eruption; inhibit platelet aggregation; incr LFTs; visual disturbance; hypertension; oedema; hypersensitivity; Kounis syndrome; rare: blood dyscrasia; very rare: SCAR, fulminant hepatitis, hepatic, acute renal failure, colitis, aseptic meningitis, CVA, cardiac failure, MI; others, see full PI
Pregnancy/Breastfeeding: Category- |
C
|
- 1st trimester
Consider alternative - 2nd trimester
Consider alternative - 3rd trimester
Consider alternative - Category
C - Human placental transfer
Yes
Pregnancy SummaryDiclofenac use during the first trimester of pregnancy has not been associated with an increased risk of congenital malformations (1, 2). However, use of non-steroidal anti-inflammatory agents (NSAID) have been associated with an increased risk of spontaneous abortion, but this has not been conclusively confirmed (3, 4).
Maternal use of NSAID in late pregnancy has been associated with an increased risk of premature closure of the ductus arteriosus (5-7), persistent pulmonary hypertension of the newborn (8), nephrotoxicity (9) and oligohydramnios (10, 11). A case report has suggested topical use of diclofenac may reach the fetal circulation and induce fetal ductus constriction (12). Therefore, the use of all oral and topical NSAID preparations (except for low dose aspirin) are not recommended during pregnancy. Women exposed to diclofenac in late pregnancy may consider fetal circulation monitoring via fetal echocardiography (13).
Short term use of diclofenac eye drops is unlikely to cause adverse effects, as systemic absorption is expected to be minimal. If diclofenac eye drops is the medicine of choice, to minimise systemic absorption, apply digital pressure against the inner corner of the eye (over the tear duct) for one to two minutes and blot away excess drops (14).
- Excreted into milk
Yes - Milk to plasma ratio
Unknown - Relative infant dose
Unknown - Recommendation
Safe to use
Breastfeeding SummarySmall amounts of diclofenac are excreted into breast milk. As diclofenac has a relatively short half-life and is highly bound to plasma proteins, infants exposed to the medicine via breast milk are unlikely to experience harmful effects. Diclofenac is safe to use during breastfeeding.
Contraindications:
Gastric, duodenal ulcer; GI bleed, perforation; severe hepatic impairment; renal, severe cardiac failure; CABG periop pain; aspirin, NSAID induced asthma, angioedema, urticaria, allergy; pregnancy (3rd trimester)
Interactions:
Lithium; digoxin; diuretics; antihypertensives eg ACE inhibitors, ARBs (monitor renal function), β-blockers; other NSAIDs incl COX-2 inhibitors, aspirin; corticosteroids; antiplatelets; anticoagulants incl warfarin; SSRIs; antidiabetics eg metformin (monitor BGL); methotrexate (± 24 hrs); ciclosporin; tacrolimus; quinolones; other drugs impacting renal function; ACE inhibitor/ ARB + anti-inflammatory (NSAID or COX-2 inhibitor) + thiazide (monitor serum creatinine); K sparing drugs incl trimethoprim; CYP2C9 inhibitors (eg sulfinpyrazone, voriconazole), inducers (eg rifampicin); phenytoin
Useful resources or guidelines:
https://www-mimsonline-com-au.ezproxy2.acu.edu.au/Search/AbbrPI.aspx?ModuleName=Product%20Info&searchKeyword=Diclofenac+sodium&PreviousPage=~/Search/QuickSearch.aspx&SearchType=&ID=85040001_2
https://thewomenspbmg-org-au.ezproxy2.acu.edu.au/medicines/diclofenac/
https://go.drugbank.com/drugs/DB00586
https://thewomenspbmg-org-au.ezproxy2.acu.edu.au/medicines/diclofenac/
https://go.drugbank.com/drugs/DB00586