Drugs Details

Drugs Info of Pennsaid, Solaraze, Voltaren Topical
Drugs Details
  • Drugs Type  : Multum
  • Date : 14th Jul 2015 08:01 am
  • Brand Name : Pennsaid, Solaraze, Voltaren Topical
  • Generic Name : diclofenac topical (Pronunciation: dye KLOE fen ak TOP ik al)
Descriptions

Solaraze® (diclofenac sodium) Gel, 3%, contains the active ingredient, diclofenac sodium, in a clear, transparent, colorless to slightly yellow gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, slightly soluble in acetone, and partially insoluble in ether. The chemical name for diclofenac sodium is:

Sodium [o-(2,6-dichloranilino) phenyl] acetate

Diclofenac sodium has a molecular weight of 318.13.

The CAS number is CAS-15307-79-6. The structural formula is represented below:

 

Solaraze® (diclofenac sodium) Illustration

Solaraze® Gel also contains benzyl alcohol, hyaluronate sodium, polyethylene glycol monomethyl ether, and purified water.

1 g of Solaraze® (diclofenac sodium) Gel contains 30 mg of the active substance, diclofenac sodium.

What are the possible side effects of diclofenac topical (Pennsaid, Solaraze, Voltaren Topical)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • chest pain, slurred speech, problems with vision or balance, and feeling weak or...

Read All Potential Side Effects and See Pictures of Solaraze »

What are the precautions when taking diclofenac sodium (Solaraze)?

Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), liver disease, stomach/intestine problems (such as bleeding, ulcers), heart disease (such as previous heart attack), high blood pressure, stroke, recent heart bypass surgery (CABG), swelling (edema, fluid...

Indications

Solaraze® (diclofenac sodium) Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.

Dosage Administration

Solaraze® Gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Solaraze® Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. The recommended duration of therapy is from 60 days to 90 days. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. Lesions that do not respond to therapy should be carefully re-evaluated and management reconsidered.

How Supplied

Available in tubes of 100 g (NDC 10337-803-01). Each gram of gel contains 30 mg of diclofenac sodium.

Storage

Store at controlled room temperature 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F). Protect from heat. Avoid freezing.

Side Effects

Of the 423 patients evaluable for safety in adequate and well-controlled trials, 211 were treated with Solaraze® drug product and 212 were treated with a vehicle gel. Eighty-seven percent (87%) of the Solaraze®-treated patients (183 patients) and 84% of the vehicle-treated patients (178 patients) experienced one or more adverse events (AEs) during the studies. The majority of these reactions were mild to moderate in severity and resolved upon discontinuation of therapy.

Of the 211 patients treated with Solaraze®, 172 (82%) experienced AEs involving skin and the application site compared to 160 (75%) vehicle-treated patients. Application site reactions (ASRs) were the most frequent AEs in both Solaraze®-and vehicle-treated groups. Of note, four reactions, contact dermatitis, rash, dry skin and exfoliation (scaling) were significantly more prevalent in the Solaraze® group than in the vehicle-treated patients.

Eighteen percent of Solaraze®-treated patients and 4% of vehicle-treated patients discontinued from the clinical trials due to adverse events (whether considered related to treatment or not). These discontinuations were mainly due to skin irritation or related cutaneous adverse reactions.

Table 1 below presents the AEs reported at an incidence of > 1% for patients treated with either Solaraze® Gel or vehicle (60- and 90-day treatment groups) during the phase 3 studies.

Table 1. Adverse Events Reported ( > 1% in Any Treatment Group) During Solaraze® Phase 3 Clinical Trials Incidences for 60-Day and 90-Day Treatments

  60-day Treatment 90-day Treatment
Solaraze® (%) Gel Vehicle (%) Solaraze® (%) Gel Vehicle (%)
N=48 N=49 N=114 N=114
BODY AS A WHOLE 21 20 20 18
Abdominal Pain 2 0 1 0
Accidental Injury 0 0 4 2
Allergic Reaction 0 0 1 3
Asthenia 0 0 2 0
Back Pain 4 0 2 2
Chest Pain 2 0 1 0
Chills 0 2 0 0
Flu Syndrome 10 6 1 4
Headache 0 6 7 6
Infection 4 6 4 5
Neck Pain 0 0 2 0
Pain 2 0 2 2
CARDIOVASCULAR SYSTEM 2 4 3 1
Hypertension 2 0 1 0
Migraine 0 2 1 0
Phlebitis 0 2 0 0
DIGESTIVE SYSTEM 4 0 6 8
Constipation 0 0 0 2
Diarrhea 2 0 2 3
Dyspepsia 2 0 3 4
METABOLIC AND NUTRITIONAL DISORDERS 2 8 7 2
Creatine Phosphokinase Increased 0 0 4 1
Creatinine Increased 2 2 0 1
Edema 0 2 0 0
Hypercholesteremia 0 2 1 0
Hyperglycemia 0 2 1 0
SGOT Increased 0 0 3 0
SGPT Increased 0 0 2 0
MUSCULOSKELETAL SYSTEM 4 0 3 4
Arthralgia 2 0 0 2
Arthrosis 2 0 0 0
Myalgia 2 0 3 1
NERVOUS SYSTEM 2 2 2 5
Anxiety 0 2 0 1
Dizziness 0 0 0 4
Hypokinesia 2 0 0 0
RESPIRATORY SYSTEM 8 8 7 6
Asthma 2 0 0 0
Dyspnea 2 0 2 0
Pharyngitis 2 8 2 4
Pneumonia 2 0 0 1
Rhinitis 2 2 2 2
Sinusitis 0 0 2 0
SKIN AND APPENDAGES 75 86 86 71
Acne 0 2 0 1
Application Site Reaction 75 71 84 70
Acne 0 4 1 0
Alopecia 2 0 1 1
Contact Dermatitis 19 4 33 4
Dry Skin 27 12 25 17
Edema 4 0 3 0
Exfoliation 6 4 24 13
Hyperesthesia 0 0 3 1
Pain 15 22 26 30  
Paresthesia 8 4 20 20
Photosensitivity Reaction 0 2 3 0
Pruritus 31 59 52 45
Rash 35 20 46 17
Vesiculobullous Rash 0 0 4 1
Contact Dermatitis 2 0 0 0
Dry Skin 0 4 3 0
Herpes Simplex 0 2 0 0
Maculopapular Rash 0 2 0 0
Pain 2 2 1 0
Pruritus 4 6 4 1
Rash 2 10 4 0
Skin Carcinoma 0 6 2 2
Skin Nodule 0 2 0 0
Skin Ulcer 2 0 1 0
SPECIAL SENSES 2 0 4 2
Conjunctivitis 2 0 4 1
Eye Pain 0 2 2 0
UROGENITAL SYSTEM 0 0 4 5
Hematuria 0 0 2 1
OTHER 0 0 0 3
Procedure 0 0 0 3

Skin and Appendages Adverse Events Reported for Solaraze® at Less Than 1 % Incidence in the Phase 3 Studies: skin hypertrophy, paresthesia, seborrhea, urticaria, application site reactions (skin carcinoma, hypertonia, skin hypertrophy lacrimation disorder, maculopapular rash, purpuric rash, vasodilation).

Adverse Reactions Reported for Oral Diclofenac Dosage Form (not topical Solaraze® Gel): *Incidence greater than 1% marked with asterisk.

Body as a Whole: abdominal pain or cramps*, headache*, fluid retention*, abdominal distention*, malaise, swelling of lips and tongue, photosensitivity, anaphylaxis, anaphylactoid reactions, chest pain.

Cardiovascular: hypertension, congestive heart failure, palpitations, flushing, tachycardia, premature ventricular contractions, myocardial infarction, hypotension.

Digestive: diarrhea*, indigestion*, nausea*, constipation*, flatulence*, liver test abnormalities*, PUB*, i.e., peptic ulcer, with or without bleeding and/or perforation, or bleeding without ulcer, vomiting, jaundice, melena, esophageal lesions, aphthous stomatitis, dry mouth and mucous membranes, bloody diarrhea, hepatitis, hepatic necrosis, cirrhosis, hepatorenal syndrome, appetite change, pancreatitis with or without concomitant hepatitis, colitis, intestinal perforation.

Hemic and Lymphatic: hemoglobin decrease, leukopenia, thrombocytopenia, eosinophilia, hemolytic anemia, aplastic anemia, agranulocytosis, purpura, allergic purpura, bruising.

Metabolic and Nutritional Disorders: azotemia, hypoglycemia, weight loss.

Nervous System: dizziness*, insomnia, drowsiness, depression, diplopia, anxiety, irritability, aseptic meningitis, convulsions, paresthesia, memory disturbance, nightmares, tremor, tic, abnormal coordination, disorientation, psychotic reaction.

Respiratory: epistaxis, asthma, laryngeal edema, dyspnea, hyperventilation, edema of pharynx.

Skin and Appendages: rash*, pruritus*, alopecia, urticaria, eczema, dermatitis, bullous eruption, erythema multiforme major, angioedema, Stevens-Johnson syndrome, excess perspiration, exfoliative dermatitis.

Special Senses: tinnitus*, blurred vision, taste disorder, reversible and irreversible hearing loss, scotoma, vitreous floaters, night blindness, amblyopia.

Urogenital: nephrotic syndrome, proteinuria, oliguria, interstitial nephritis, papillary necrosis, acute renal failure, urinary frequency, nocturia, hematuria, impotence, vaginal bleeding.

Interactions

Specific interaction studies between Solaraze® Gel and other topical or oral agents were not performed.

Oral Nonsteroidal Anti-Inflammatory Drugs

Although low, there is systemic exposure to diclofenac following labeled use of Solaraze® Gel. Therefore, concomitant administration of Solaraze® Gel with oral NSAIDS or aspirin may result in increased NSAID adverse effects.

Warnings

As with other NSAIDs, anaphylactoid reactions may occur in patients without prior exposure to diclofenac. Diclofenac sodium should be given with caution to patients with the aspirin triad. The triad typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs.

Precautions

General

Solaraze® (diclofenac sodium) Gel should be used with caution in patients with active gastrointestinal ulceration or bleeding and severe renal or hepatic impairments. Solaraze® should not be applied to open skin wounds, infections, or exfoliative dermatitis. It should not be allowed to come in contact with the eyes.

The safety of the concomitant use of sunscreens, cosmetics or other topical medications and Solaraze® is unknown.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There did not appear to be any increase in drug-related neoplasms following daily topical applications of diclofenac sodium gel for 2 years at concentrations up to 0.035% diclofenac sodium and 2.5% hyaluronate sodium in albino mice. (Note: Solaraze® contains 3% diclofenac sodium.) When administered orally for 2 years, diclofenac showed no evidence of carcinogenic potential in rats given diclofenac sodium at up to 2 mg/kg/day (3 times the estimated systemic human exposure*), or in mice given diclofenac sodium at up to 0.3 mg/kg/day in males and 1 mg/kg/day in females (25% and 83%, respectively, of the estimated systemic human exposure).

A photococarcinogenicity study with up to 0.035% diclofenac in the Solaraze® vehicle gel was conducted in hairless mice at topical doses up to 2.8 mg/ kg/day. Median tumor onset was earlier in the 0.035% group (Solaraze® contains 3% diclofenac sodium).

Diclofenac was not genotoxic in in vitro point mutation assays in mammalian mouse lymphoma cells and Ames microbial test systems, or when tested in mammalian in vivo assays including dominant lethal and male germinal epithelial chromosomal studies in mice, and nucleus anomaly and chromosomal aberration studies in Chinese hamsters. It was also negative in the transformation assay utilizing BALB/3T3 mouse embryo cells.

Fertility studies have not been conducted with Solaraze® Gel. Diclofenac sodium showed no evidence of impairment of fertility after oral treatment with 4 mg/kg/day (7 times the estimated systemic human exposure) in male or female rats.

Pregnancy

Teratogenic Effects: Pregnancy Category B

The safety of Solaraze® (diclofenac sodium) Gel has not been established during pregnancy. However, reproductive studies performed with diclofenac sodium alone at oral doses up to 20 mg/kg/day (15 times the estimated systemic human exposure*) in mice, 10 mg/kg/day (15 times the estimated systemic human exposure) in rats, and 10 mg/kg/day (30 times the estimated systemic human exposure) in rabbits have revealed no evidence of teratogenicity despite the induction of maternal toxicity. In rats, maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival.

Diclofenac has been shown to cross the placental barrier in mice and rats. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy unless the benefits to the mother justify the potential risk to the fetus. Because of the risk to the fetus resulting in premature closure of the ductus arteriosus, diclofenac should be avoided in late pregnancy.

Labor and Delivery

The effects of diclofenac on labor and delivery in pregnant women are unknown. Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), use of diclofenac during late pregnancy should be avoided and, as with other nonsteroidal anti-inflammatory drugs, it is possible that diclofenac may inhibit uterine contractions and delay parturition.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from diclofenac sodium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Actinic keratoses is not a condition seen within the pediatric population. Solaraze® should not be used by children.

Geriatric Use

Of the 211 subjects treated with Solaraze® in controlled clinical studies, 143 subjects were 65 and over. Of those 143 subjects, 55 subjects were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

OverDose

Due to the low systemic absorption of topically-applied Solaraze® Gel, overdosage is unlikely. There have been no reports of ingestion of Solaraze®. In the event of oral ingestion, resulting in significant systemic side effects, it is recommended that the stomach be emptied by vomiting or lavage. Forced diuresis may theoretically be beneficial because the drug is excreted in the urine. The effect of dialysis or hemoperfusion in the elimination of diclofenac (99% protein-bound) remains unproven. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption of diclofenac. Supportive and symptomatic treatment should be given for complications such as renal failure, convulsions, gastrointestinal irritation and respiratory depression.

ContrainDications

Solaraze® (diclofenac sodium) Gel is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 350 and/or hyaluronate sodium.

Clinical Pharamacology

The mechanism of action of diclofenac sodium in the treatment of actinic keratoses (AK) is unknown. The contribution to efficacy of individual components of the vehicle has not been established.

Pharmacokinetics

Absorption

When Solaraze® is applied topically, diclofenac is absorbed into the epidermis. In a study in patients with compromised skin (mainly atopic dermatitis and other dermatitic conditions) of the hands, arms or face, approximately 10% of the applied dose (2 grams of 3% gel over 100 cm2) of diclofenac was absorbed systemically in both normal and compromised epidermis after seven days, with four times daily applications.

After topical application of 2 g Solaraze® three times daily for six days to the calf of the leg in healthy subjects, diclofenac could be detected in plasma. Mean bioavailability parameters were AUC0-t 9±19 ng/hr/mL (mean±SD) with a Cmax of 4±5 ng/mL and a Tmax of 4.5±8 hours. In comparison, a single oral 75 mg dose of diclofenac (Voltaren®)† produced an AUC of 1600 ng/hr/mL. Therefore, the systemic bioavailability after topical application of Solaraze® is lower than after oral dosing.

Comparative bioavailability studies have not been conducted between available diclofenac topical products (gels containing 1 - 3% diclofenac) which have different dosing regimens. A cross-study evaluation of the data indicates that diclofenac is more bioavailable when applied to diseased skin and less bioavailable when applied to intact skin.

Blood drawn at the end of treatment from 60 patients with AK lesions treated with Solaraze® in three adequate and well-controlled clinical trials was assayed for diclofenac levels. Each patient was administered 0.5 g of Solaraze® Gel twice a day for up to 105 days. There were up to three 5 cm X 5 cm treatment sites per patient on the face, forehead, hands, forearm, and scalp. Serum concentrations of diclofenac were, on average, at or below 20 ng/mL. These data indicate that systemic absorption of diclofenac in patients treated topically with Solaraze® is much lower than that occurring after oral daily dosing of diclofenac sodium.

No information is available on the absorption of diclofenac when Solaraze® is used under occlusion.

Distribution

Diclofenac binds tightly to serum albumin. The volume of distribution of diclofenac following oral administration is approximately 550 mL/kg.

Metabolism

Biotransformation of diclofenac following oral administration involves conjugation at the carboxyl group of the side chain or single or multiple hydroxylations resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, however to a much smaller extent than diclofenac. Metabolism of diclofenac following topical administration is thought to be similar to that after oral administration. The small amounts of diclofenac and its metabolites appearing in the plasma following topical administration makes the quantification of specific metabolites imprecise.

Elimination

Diclofenac and its metabolites are excreted mainly in the urine after oral dosing. Systemic clearance of diclofenac from plasma is 263±56 mL/min (mean±SD). The terminal plasma half-life is 1-2 hours. Four of the metabolites also have short terminal half-lives of 1-3 hours.

Clinical Studies

Clinical trials were conducted involving a total of 427 patients (213 treated with Solaraze® and 214 with a gel vehicle). Each patient had no fewer than five AK lesions in a major body area, which was defined as one of five 5 cm X 5 cm regions: scalp, forehead, face, forearm and hand. Up to three major body areas were studied in any patient. All patients were 18 years of age or older (male and female) with no clinically significant medical problems outside of the AK lesions and had undergone a 60-day washout period from disallowed medications (masoprocol, 5-fluorouracil, cyclosporine, retinoids, trichloroacetic acid/lactic acid/peel, 50% glycolic acid peel) and hyaluronan-containing cosmetics. Patients were excluded from participation for reasons of known or suspected hypersensitivity to any Solaraze® ingredient, pregnancy, allergies to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), or other dermatological conditions which might affect the absorption of the study medication. Application of dermatologic products such as sunscreens, cosmetics, and other drug products was not permitted. Patients were instructed to apply a small amount of Solaraze® Gel (approximately 0.5 g) onto the affected skin, using their fingers, and gently smoothing the gel over the lesion. In addition, all patients were instructed to avoid sun exposure. Complete clearing of the AK lesions 30 days after completion of treatment was the primary efficacy variable. No long-term patient follow-ups, after the 30-day assessments, were performed for the detection of recurrence.

Complete Clearance of Actinic Keratosis Lesions 30 Days Post-Treatment (all locations)
  Solaraze® Gel Vehicle p-value
Study 1 90 days treatment 27/58 (47%) 11/59 (19%) < 0.001
Study 2 90 days treatment 18/53 (34%) 10/55 (18%) 0.061
Study 3 60 days treatment 15/48 (31%) 5/49 (10%) 0.021
30 days treatment 7/49 (14%) 2/49 ( 4%) 0.221
Complete Clearance of Actinic Keratosis Lesions 30 Days Post- Treatment (by location)
  Scalp Forehead Face Arm/Forearm Back of Hand
Study 1 - 90 days treatment
Solaraze® 1/4 (25%) 17/30 (57%) 9/17 (53%) 4/12 (33%) 6/16 (38%)
Vehicle 3/9 (33%) 8/24 (33%) 5/17 (29%) 4/12 (33%) 0/14 (0)
p-value 0.7646 0.0908 0.1682 1.000 0.0650
Study 2 - 90 days treatment
Solaraze® 2/6 (33%) 9/19 (47%) 4/5 (80%) 5/8 (63%) 1/17 (6%)
Vehicle 0/4 (0) 6/22 (27%) 2/8 (25%) 0/5 (0) 3/16 (19%)
p-value 0.4235 0.1870 0.0727 0.0888 0.2818
Study 3 - 60 days treatment
Solaraze® 3/7 (43%) 13/31 (42%) 10/19 (53%) 0/1 (0) 2/8 (25%)
Vehicle 0/6 (0) 5/36 (14%) 2/13 (15%) 0/2 (0) 1/9(11%)
p-value 0.2271 0.0153 0.0433 - 0.4637
30 days treatment
Solaraze® 2/5 (40%) 4/29 (14%) 3/14 (21%) 0/0 (0) 0/9 (0)
Vehicle 0/5 (0) 2/29 (7%) 2/18(11%) 0/1 (0) 1/9(11%)
p-value 0.2299 0.3748 0.4322 - 0.6521
All data combined
Solaraze® 8/22 (36%) 43/109 (39%) 26/55 (47%) 9/21 (43%) 9/50 (18%)
Vehicle 3/24 (13%) 21/111 (19%) 11/56(20%) 4/20 (20%) 5/48 (10%)
p-value 0.0903 0.0013 0.0016 0.2043 0.3662

 

Patient Information

In clinical studies, localized dermal side effects such as contact dermatitis, exfoliation, dry skin and rash were found in patients treated with Solaraze® at a higher incidence than in those with placebo.

Patients should understand the importance of monitoring and follow-up evaluation, the signs and symptoms of dermal adverse reactions, and the possibility of irritant or allergic contact dermatitis. If severe dermal reactions occur, treatment with Solaraze® may be interrupted until the condition subsides. Exposure to sunlight and the use of sunlamps should be avoided.

Safety and efficacy of the use of Solaraze® together with other dermal products, including cosmetics, sunscreens, and other topical medications on the area being treated, have not been studied.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

DICLOFENAC 3% - TOPICAL

 

(dye-KLOE-fen-ak)

 

COMMON BRAND NAME(S): Solaraze

 

USES: This medication is used to treat a certain skin condition (actinic keratoses). Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID).

 

HOW TO USE: This medication is for use on the skin only. Wash and dry your hands before applying the medication. Gently apply enough medication to cover the affected skin well as directed by your doctor, usually 2 times daily. This medication is usually applied for 60 to 90 days. Wash your hands after using, unless you are using this medication to treat the hands.

The dosage is based on your medical condition and response to treatment.

Do not apply the medication in or around the eyes, open skin wounds, or infected/scraped/burned skin. If you do get the medication in those areas, flush with plenty of water.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Tell your doctor if your condition persists or worsens. It may take up to 30 days after finishing the medication for the skin to completely heal.

Consumer Overview Side Effect

SIDE EFFECTS: Rash, scaling, dry skin, swelling, or itching may occur at the application site. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling of the ankles/feet/hands, sudden/unexplained weight gain, unusual tiredness, signs of kidney problems (such as change in the amount of urine).

Other medications similar to this medication may rarely cause serious bleeding from the stomach or intestines. Also, related drugs have rarely caused blood clots to form, causing heart attacks and strokes. If you notice any of the following rare but very serious side effects, stop using this medication and get medical help right away: black/bloody stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain, chest/jaw/left arm pain, shortness of breath, unusual sweating, sudden vision changes, weakness on one side of the body, trouble speaking, confusion.

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Solaraze (diclofenac sodium) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), liver disease, stomach/intestine problems (such as bleeding, ulcers), heart disease (such as previous heart attack), high blood pressure, stroke, recent heart bypass surgery (CABG), swelling (edema, fluid retention), diabetes, blood disorders (such as anemia), bleeding/clotting problems, growths in the nose (nasal polyps).

Kidney problems can sometimes occur with the use of NSAID medications, including diclofenac. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have any unusual change in the amount of urine.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medicine may rarely cause stomach bleeding. Daily use of alcohol and tobacco while using this medicine may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink.

Your condition may get worse when exposed to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Wear protective clothing when outdoors. Ask your doctor if you should use sunscreen along with this medication.

Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding, kidney problems and worsening heart problems.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

It is unknown if this form of diclofenac passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), cidofovir, corticosteroids (such as dexamethasone, prednisone), lithium, methotrexate, "water pills" (diuretics such as furosemide).

This medication may increase the risk of bleeding when used with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen, naproxen, or ketorolac). These drugs are similar to diclofenac and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, change in the amount of urine, slow/shallow breathing.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count, liver and kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all regular medical and laboratory appointments.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Patient Detailed Side Effect

Brand Names: Pennsaid, Solaraze, Voltaren Topical

Generic Name: diclofenac topical (Pronunciation: dye KLOE fen ak TOP ik al)

  • What is diclofenac topical (Solaraze)?
  • What are the possible side effects of diclofenac topical (Solaraze)?
  • What is the most important information I should know about diclofenac topical (Solaraze)?
  • What should I discuss with my healthcare provider before using diclofenac topical (Solaraze)?
  • How should I use diclofenac topical (Solaraze)?
  • What happens if I miss a dose (Solaraze)?
  • What happens if I overdose (Solaraze)?
  • What should I avoid while using diclofenac topical (Solaraze)?
  • What other drugs will affect diclofenac topical (Solaraze)?
  • Where can I get more information?

What is diclofenac topical (Solaraze)?

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Diclofenac topical 1% gel (Voltaren Topical) is used to treat joint pain in the hands, wrists, elbows, knees, ankles, or feet caused by osteoarthritis. This medication may not be effective in treating arthritis pain elsewhere in the body.

Diclofenac topical 1.5% solution (Pennsaid) is used to treat pain in the knees caused by osteoarthritis. This medication may not be effective in treating arthritis pain elsewhere in the body.

Diclofenac topical 3% gel (Solaraze) is used to treat warty overgrowths of skin (actinic keratoses) on sun-exposed areas of the body.

Diclofenac topical may also be used for purposes not listed in this medication guide.

What are the possible side effects of diclofenac topical (Solaraze)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • chest pain, slurred speech, problems with vision or balance, and feeling weak or short of breath;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • pale or yellowed skin, dark colored urine, confusion;
  • swelling or rapid weight gain, urinating less than usual or not at all;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

  • mild nausea, stomach pain, upset stomach;
  • diarrhea, gas; or
  • mild itching, dryness, redness, scaling, or other skin irritation where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Solaraze (diclofenac sodium) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about diclofenac topical (Solaraze)?

Do not use this medication if you have ever had asthma or a severe allergic reaction caused by aspirin, diclofenac (Cataflam, Voltaren), or another non-steroidal anti-inflammatory drug (NSAID). Do not use diclofenac just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Before using this medication, tell your doctor if you have heart disease, congestive heart failure, high blood pressure, a history of heart attack or stroke, a history of stomach ulcer or bleeding, liver or kidney disease, a blood clotting disorder, asthma, or nasal polyps.

While the risk of absorbing diclofenac topical into your bloodstream is low, an NSAID may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using diclofenac topical, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Patient Detailed How Take

What should I discuss with my healthcare provider before using diclofenac topical (Solaraze)?

While the risk of absorbing diclofenac topical into your bloodstream is low, an NSAID can cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using diclofenac topical, especially in older adults.

Do not use this medication if you have ever had asthma or a severe allergic reaction caused by aspirin, diclofenac (Cataflam, Voltaren), or another NSAID. Do not use diclofenac just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

To make sure you can safely use diclofenac topical, tell your doctor if you have any of these other conditions:

  • a history of drug allergies;
  • a history of heart attack, stroke, or blood clot;
  • heart disease, congestive heart failure, high blood pressure;
  • a history of stomach ulcer or bleeding;
  • liver or kidney disease;
  • a bleeding or blood clotting disorder; or
  • asthma, or polyps in your nose.

This medication may be harmful to an unborn baby. If you are pregnant, ask your doctor if it is safe for you to use diclofenac topical. Tell your doctor if you become pregnant during treatment.

Diclofenac topical can pass into breast milk and may harm a nursing baby. You should not breast-feed while using diclofenac topical.

How should I use diclofenac topical (Solaraze)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. When treating osteoarthritis, keep using any oral medications your doctor has prescribed.

Do not use diclofenac topical on an open skin wound, or on areas of eczema, infection, skin rash, or burn injury. Do not cover the treated skin with a bandage or expose it to heat from a hot tub, heating pad, sauna, or heated water bed. Heat or bandaging can increase the amount of drug you absorb through your skin and may cause harmful effects.

Wash your hands after applying this medication, unless you are treating the skin on your hands. Do not wear gloves for at least 10 minutes after applying diclofenac topical to the hands.

After you apply diclofenac topical gel, wait at least 10 minutes before dressing and at least 1 hour before you bathe or shower.

To treat actinic keratosis (with Solaraze): Apply enough gel to cover each lesion and rub in gently. Do not apply Solaraze gel more than 2 times daily and never use more than your prescribed dose.

To treat osteoarthritis knee pain (with Pennsaid): Apply the solution only to clean, dry skin. Place 10 drops at a time into your hand and spread the solution over the front, back, and sides of the knee. Apply a total of 40 drops to each affected knee, 4 times per day. You may also drop the medicine directly onto the knee, spreading after every 10 drops.

Wait until the solution is completely dry before covering treated skin with clothing or applying any other skin products, including sunscreen.

To treat osteoarthritis pain (with Voltaren Topical): This medicine is supplied with dosing cards that show you how much gel to use for a 2-gram dose or a 4-gram dose. Squeeze the gel onto this card along the line for your dose. Use no more gel than will fit on the length of your dosing line. Wipe the card directly onto the treatment area and rub gently into the skin.

To treat arthritis pain in the foot, spread the gel out onto all areas of the foot including the toes and soles. When treating the hand, spread the gel out onto all areas of the hand including the fingers and palms.

Store at room temperature away from moisture and heat. Do not freeze.

Patient Detailed Avoid Taking

What happens if I miss a dose (Solaraze)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Solaraze)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using diclofenac topical (Solaraze)?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Do not use cosmetics, sunscreen, lotions, insect repellant, or other medicated skin products on the same area you treat with diclofenac topical.

Avoid getting this medication in your mouth, nose, or eyes. If this does happen, rinse with water.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds) while you are using diclofenac topical.

Avoid taking aspirin, oral (pill form) diclofenac (Cataflam, Voltaren), or other NSAIDs without your doctor's advice. This includes ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others.

Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Aspirin and other medicines similar to diclofenac are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

What other drugs will affect diclofenac topical (Solaraze)?

Tell your doctor about all other medicines you use, especially:

  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • lithium (Eskalith, Lithobid);
  • methotrexate (Rheumatrex, Trexall);
  • a diuretic (water pill);
  • steroids (prednisone and others); or
  • heart or blood pressure medication such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

It is not likely that other drugs you take orally or inject will have an effect on topically applied diclofenac. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about diclofenac topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Rx Scoops
Featured Topics
Advertisements
Copyrights ©2014: Rx Scoops - Designed & Developed By - GOIGI