Diclofenac topical

Diclofenac topical is an over-the-counter and prescription medication used for treating the symptoms of actinic keratosis, osteoarthritis, acute pain, and arthritis pain.

• Diclofenac topical is available under the following different brand names: Flector Transdermal Patch, Voltaren Gel, Pennsaid topical solution, Solaraze Gel, Licart, Voltaren Arthritis Pain

Adult and pediatric dosage

Gel

• diclofenac sodium
• 1% (Voltaren Gel, Voltaren Arthritis Pain [OTC])
• 3% (Solaraze Gel)

Patch

• diclofenac epolamine
• 1.3% (180mg) (Flector)

Topical solution (Pennsaid)

• diclofenac sodium
• 1.5% (16.05mg/mL; dropper bottle)
• 2% (20mg/pump actuation)

Topical system

• diclofenac epolamine
• 1.3% (Licart)

Actinic Keratosis

Adult dosage

• Solaraze gel: Apply a thin layer to the affected skin every 12 hours for 60-90 days

Osteoarthritis

Adult dosage

Voltaren gel

• Apply 2 g (upper extremities)/4 g (lower extremities) every 6 hours.
• Not to exceed 8 g/day to any single joint of (upper) extremities; 16 g/day to any single joint of (lower extremities)
• Pennsaid topical solution
  • 1.5%: Apply 40 drops on each painful knee four times a day; dispense 10 drops at a time either directly onto the knee or first into hand and then spread evenly to the front, sides, and back of the knee; repeat procedure until 40 drops have been applied
  • 2%: Apply 40 mg (2 pump actuation) on each painful knee twice a day; dispense 40 mg at a time directly into the palm and then apply evenly to the front, sides, and back of the knee

Acute Pain

Adult dosage

• Flector patch: 1 patch every 12 hours applied on the most painful area
• Licart topical system
  • Apply 1 topical system to the most painful area once daily

Pediatric dosage

• Children below 6 years
  • Safety and efficacy not established
• Children above 6 years
  • Flector patch: 1 patch every 12 hours applied on the most painful area

Arthritis Pain

Adult dosage

Voltaren Arthritis Pain gel 

• Apply to the affected area(s) four times a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Diclofenac topical include:

• heartburn,
• gas,
• stomach pain,
• nausea,
• vomiting,
• diarrhea,
• constipation,
• headache,
• dizziness,
• drowsiness,
• stuffy nose,
• itching,
• increased sweating,
• increased blood pressure, and
• skin redness, itching, dryness, scaling, or peeling where the medication was applied.

Serious side effects of Diclofenac topical include:

• chest pain spreading to the jaw or shoulder,
• sudden numbness or weakness on one side of the body,
• slurred speech,
• shortness of breath,
• skin rash, no matter how mild,
• swelling,
• rapid weight gain,
• severe headache,
• blurred vision,
• pounding in the neck or ears,
• little or no urination,
• nausea,
• diarrhea,
• upper right-side stomach pain,
• tiredness,
• itching,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes,
• pale skin,
• dizziness,
• cold hands and feet,
• bloody or tarry stools,
• coughing up blood, and
• vomit looking like coffee grounds.

Rare side effects of Diclofenac topical include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Diclofenac topical has severe interactions with no other drugs.
• Diclofenac topical has serious interactions with the following drugs:
  • aminolevulinic acid oral
  • aminolevulinic acid topical
  • methyl aminolevulinate
• Diclofenac topical has moderate interactions with the following drugs:
  • atogepant
  • axitinib
  • deferasirox
  • finerenone
  • isavuconazonium sulfate
  • ivacaftor
  • lomitapide
  • midazolam intranasal
  • mifepristone
  • tazemetostat
  • tinidazole
• Diclofenac topical has minor interactions with at least 24 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to diclofenac, aspirin other NSAIDs, or any ingredient
• CABG perioperative period
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
• Flector patch: Use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns, or wounds

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Diclofenac topical?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Diclofenac topical?”

Cautions

• If pregnant or breast-feeding, ask a health professional before use; it is especially important not to use diclofenac at 20 weeks or later in pregnancy unless directed to do so by a doctor; may cause problems in the unborn child or complications during delivery
• Long-term administration of NSAIDs resulted in renal papillary necrosis and other renal injuries; renal toxicity was also seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion
• Risks of: cardiovascular thrombotic events; GI bleeding & ulceration; hepatotoxicity (with Na-salt)
• Anemia has occurred in NSAID-treated patients
• Diclofenac is associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma
• May lead to new-onset or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events; coadministration with angiotensin-converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs
• Randomized controlled trials demonstrated an ~2-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients
• Increases in serum potassium concentration reported with the use of NSAIDs, even in some patients without renal impairment; patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state
• Diclofenac may cause premature closure of the fetal ductus arteriosus; avoid the use of NSAIDs in pregnant women starting at 30 weeks of gestation (third trimester) (see Pregnancy)
• The pharmacological activity of diclofenac in reducing inflammation, and possibly fever, may diminish the utility of these diagnostic signs in detecting infections
• GI bleeding, hepatotoxicity and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically
• Even used diclofenac contains a large amount of diclofenac epolamine (as much as 170 mg); potential therefore exists for a small child or pet to suffer serious adverse effects from chewing or ingesting a new or used drug; store and keep out of the reach of children and pets
• Avoid contact of diclofenac with eyes and mucosa
• Concomitant use of oral and topical NSAIDs may result in a higher rate of hemorrhage, more frequent abnormal creatinine, urea, and hemoglobin
• NSAIDs can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and may occur without warning

Drug reaction with eosinophilia and systemic symptoms (DRESS)

• Drug Reaction reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
• Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
• Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
• Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately

Pregnancy and Lactation

• Use of NSAIDs can cause premature closure of fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment
• Because of these risks, limit dose and duration of use between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy
• Use of NSAIDs at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of fetal ductus arteriosus
• Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment
• Data from observational studies regarding other potential embryofetal risks of NSAID use in women in first or second trimesters of pregnancy are inconclusive
• In animal reproduction studies, no evidence of malformations was observed in mice, rats, or rabbits given during the period of organogenesis at doses up to approximately 0.6, 0.6, and 1.3 times, respectively, the maximum recommended human dose (MRHD) of 162 mg diclofenac sodium via topical application, despite the presence of maternal and fetal toxicity at these doses
• In rats, increased incidences of skeletal anomalies and maternal toxicity were also observed at this dose; drug administered orally to both male and female rats before mating and throughout the mating period, and during gestation and lactation in females produced embryotoxicity at doses approximately 3 and 7 times, respectively, the topical exposure from the MRHD 
• Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization
• In animal studies, administration of prostaglandin synthesis inhibitors resulted in an increased pre-and post-implantation loss; prostaglandins also have been shown to have an important role in fetal kidney development
• In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses

Reproductive potential

• Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some
• Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation
• Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation; consider withdrawal of NSAIDs in women who have difficulties conceiving or who are undergoing investigation of infertility
• Published studies in adult male rodents report that diclofenac, at clinically relevant doses, can produce adverse effects on male reproductive tissues; the impact of these findings on male fertility is not clear

Lactation

• Data from published literature reports with oral preparations of diclofenac indicate the presence of small amounts of diclofenac in human milk
• There are no data on effects on the breastfed infant, or effects on milk production; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for drug and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition