what is diclofenac sodium gel used to treat?

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FOR DERMATOLOGIC Utilize Just.  NOT FOR OPHTHALMIC USE.

BOXED WARNING Section

Warning: Gamble OF SERIOUS CARDIOVASCULAR EVENTS

Cardiovascular Thrombotic Events

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This run a risk may occur early in handling and may increase with duration of use.

• Diclofenac Sodium Gel, 3% is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Description

Diclofenac Sodium Gel, 3%, contains the agile ingredient, diclofenac sodium, in a clear, transparent, colorless to slightly xanthous gel base. Diclofenac sodium is a white to slightly yellowish crystalline powder. Information technology is freely soluble in methanol, soluble in ethanol, sparingly soluble in h2o, 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:

Diclofenac Sodium Gel, 3% also contains benzyl alcohol, hydroxyethyl cellulose,  methoxypolyethylene glycol 350, PEG-60 hydrogenated castor oil, and purified h2o.

i one thousand of Diclofenac Sodium Gel, 3% contains xxx mg of the active substance, diclofenac sodium.

CLINICAL PHARMACOLOGY

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 diclofenac sodium gel, iii% is practical topically, diclofenac is absorbed into the epidermis. In a written report in patients with compromised skin (mainly atopic dermatitis and other dermatitic conditions) of the easily, arms or confront, approximately x% of the applied dose (2 grams of 3% gel over 100 cmii) of diclofenac was absorbed systemically in both normal and compromised epidermis afterward 7 days, with four times daily applications.

After topical awarding of ii m diclofenac sodium gel, 3% three times daily for six days to the calf of the leg in good for you subjects, diclofenac could be detected in plasma. Mean bioavailability parameters were AUC0-t nine±19 ng/hr/mL (hateful±SD) with a Cmax of iv±5 ng/mL and a Tmax of 4.five±eight hours. In comparison, a single oral 75 mg dose of diclofenac (Voltaren®)† produced an AUC of 1600 ng/hr/mL. Therefore, the systemic bioavailability later topical application of diclofenac sodium gel, 3% is lower than afterwards oral dosing.

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

Blood drawn at the stop of handling from 60 patients with AK lesions treated with diclofenac sodium gel, 3% in three adequate and well-controlled clinical trials was assayed for diclofenac levels. Each patient was administered 0.5 g of diclofenac sodium gel, 3% twice a twenty-four hours for up to 105 days. There were up to 3 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 beneath xx ng/mL. These data indicate that systemic absorption of diclofenac in patients treated topically with diclofenac sodium gel, iii% is much lower than that occurring subsequently oral daily dosing of diclofenac sodium.

No information is available on the absorption of diclofenac when diclofenac sodium gel, 3% is used under apoplexy.

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 post-obit 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 later oral administration. The minor 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 last plasma half-life is one to ii hours. 4 of the metabolites also have brusque concluding half-lives of i to 3 hours.

INDICATIONS AND USAGE

Diclofenac Sodium Gel, 3% is indicated for the topical treatment of actinic keratoses (AK).  Sun avoidance is indicated during therapy.

CLINICAL STUDIES

Clinical trials were conducted involving a total of 427 patients (213 treated with diclofenac sodium gel, three% and 214 with a gel vehicle). Each patient had no fewer than five AK lesions in a major trunk area, which was defined as one of five 5 cm 10 5 cm regions: scalp, forehead, face, forearm and mitt. Upward to 3 major body areas were studied in whatever patient. All patients were 18 years of age or older (male and female person) with no clinically meaning medical issues 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/pare, fifty% glycolic acrid peel) and hyaluronan-containing cosmetics. Patients were excluded from participation for reasons of known or suspected hypersensitivity to any diclofenac sodium gel, 3% ingredient, pregnancy, allergies to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), or other dermatological conditions which might affect the assimilation of the written report medication. Application of dermatologic products such as sunscreens, cosmetics, and other drug products was not permitted. Patients were instructed to utilize a small amount of diclofenac sodium gel, iii% (approximately 0.5 one thousand) onto the afflicted skin, using their fingers, and gently smoothing the gel over the lesion. In add-on, all patients were instructed to avoid sun exposure. Complete clearing of the AK lesions 30 days subsequently completion of handling was the chief efficacy variable. No long-term patient follow-ups, after the 30-twenty-four hour period assessments, were performed for the detection of recurrence.

Consummate Clearance of Actinic Keratosis Lesions 30 Days Post-Handling (all locations)

	Diclofenac Sodium Gel, iii%	Vehicle	p-value
Written report one 90 days treatment	27/58 (47%)	11/59 (19%)	<0.001
Study 2 90 days treatment	18/53 (34%)	ten/55 (18%)	0.061
Study 3 60 days treatment	15/48 (31%)	5/49 (10%)	0.021
30 days treatment	vii/49 (14%)	2/49 (4%)	0.221

Complete Clearance of Actinic Keratosis Lesions 30 Days Post-Treatment (by location)

	Scalp	Brow	Confront	Arm/Forearm	Dorsum of Hand
Study 1 xc days handling
Diclofenac Sodium Gel, iii%	1/4 (25%)	17/30 (57%)	9/17 (53%)	4/12 (33%)	half-dozen/16 (38%)
Vehicle	3/9 (33%)	eight/24 (33%)	5/17 (29%)	four/12 (33%)	0/14 (0)
p-value	0.7646	0.0908	0.1682	ane.000	0.0650
Study 2 90 days treatment
Diclofenac Sodium Gel, three%	2/6 (33%)	9/19 (47%)	4/v (80%)	v/8 (63%)	i/17 (6%)
Vehicle	0/4 (0)	6/22 (27%)	two/eight (25%)	0/five (0)	3/xvi (19%)
p-value	0.4235	0.1870	0.0727	0.0888	0.2818
Study 3 60 days treatment
Diclofenac Sodium Gel, iii%	3/7 (43%)	xiii/31 (42%)	10/19 (53%)	0/i (0)	2/8 (25%)
Vehicle	0/6 (0)	5/36 (14%)	2/13 (15%)	0/two (0)	ane/9 (eleven%)
p-value	0.2271	0.0153	0.0433	-	0.4637
xxx days treatment
Diclofenac Sodium Gel, 3%	2/5 (40%)	4/29 (xiv%)	3/14 (21%)	0/0 (0)	0/nine (0)
Vehicle	0/5 (0)	2/29 (7%)	ii/eighteen (xi%)	0/1 (0)	one/9 (xi%)
p-value	0.2299	0.3748	0.4322	-	0.6521
All data combined
Diclofenac Sodium Gel, 3%	8/22 (36%)	43/109 (39%)	26/55 (47%)	nine/21 (43%)	ix/50 (xviii%)
Vehicle	3/24 (thirteen%)	21/111 (19%)	xi/56 (20%)	iv/twenty (20%)	5/48 (10%)
p-value	0.0903	0.0013	0.0016	0.2043	0.3662

CONTRAINDICATIONS

Diclofenac Sodium Gel, 3% is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol and/or polyethylene glycol monomethyl ether 350.

Diclofenac Sodium Gel, 3% is contraindicated in the following patients:
- In the setting of coronary artery bypass graft (CABG) surgery.

WARNINGS

Fetal Toxicity
Premature Closure of Fetal Ductus Arteriosus:
Avoid use of NSAIDs, including Diclofenac Sodium Gel, iii%, in meaning women at about 30 weeks gestation and after. NSAIDs including Diclofenac Sodium Gel, 3%, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.

Oligohydramnios/Neonatal Renal Impairment:
Utilize of NSAIDs, including Diclofenac Sodium Gel, iii%, at almost 20 weeks gestation or afterward in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, afterwards days to weeks of treatment, although oligohydramnios has been infrequently reported as soon every bit 48 hours after NSAID initiation. Oligohydramnios is ofttimes, merely not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as substitution transfusion or dialysis were required.

If NSAID handling is necessary betwixt near 20 weeks and 30 weeks gestation, limit Diclofenac Sodium Gel, 3% use to the lowest constructive dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if Diclofenac Sodium Gel, 3% handling extends beyond 48 hours. Discontinue Diclofenac Sodium Gel, three% if oligohydramnios occurs and follow upwards according to clinical practise [meet PRECAUTIONS; Pregnancy].

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

Serious Skin Reactions, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS).
Drug Rash with Eosinophilia and Systemic Symptoms (Apparel)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such every bit Diclofenac Sodium Gel, 3%. Some of these events take 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 Apparel 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. Information technology is important to note that early manifestations of hypersensitivity, such equally fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are nowadays, discontinue Diclofenac Sodium Gel, 3% and evaluate the patient immediately.

Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased gamble of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available information, it is unclear that the gamble for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred past NSAID use appears to be similar in those with and without known CV disease or take a chance factors for CV illness. However, patients with known CV illness or risk factors had a higher accented incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began every bit early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an agin CV event in NSAID-treated patients, employ the lowest constructive dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should exist informed nigh the symptoms of serious CV events and the steps to have if they occur.

There is no consistent evidence that concurrent utilise of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such every bit diclofenac, increases the risk of serious gastrointestinal (GI) events.

Status Post Coronary Artery Featherbed Graft (CABG) Surgery
Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of hurting in the first 10 to xiv days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG.

Post-MI Patients
Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the mail service-MI menstruum were at increased risk of reinfarction, CV-related death, and all-cause bloodshed beginning in the starting time week of treatment. In this aforementioned accomplice, the incidence of death in the first year mail MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of expiry declined somewhat afterwards the first year post-MI, the increased relative gamble of death in NSAID users persisted over at to the lowest degree the next four years of follow-up.

Avert the apply of diclofenac sodium gel, 3% in patients with a recent MI unless the benefits are expected to outweigh the take a chance of recurrent CV thrombotic events. If diclofenac sodium gel, 3% is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Heart Failure and Edema
The Coxib and traditional NSAID Trialists' Collaboration meta-analysis of randomized controlled trials demonstrated an approximately ii-fold increase in hospitalizations for centre failure in COX-two selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for eye failure, and expiry.

Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Apply of diclofenac may blunt the CV effects of several therapeutic agents used to treat these medical atmospheric condition [due east.1000., diuretics, ACE inhibitors, or angiotensin receptor blockers (ARBs)].

Avoid the use of diclofenac sodium gel, 3% in patients with astringent middle failure unless the benefits are expected to outweigh the chance of worsening heart failure. If diclofenac sodium gel, 3% is used in patients with severe middle failure, monitor patients for signs of worsening heart failure.

PRECAUTIONS

Full general
Diclofenac sodium gel, three% should be used with caution in patients with active gastrointestinal ulceration or bleeding and astringent renal or hepatic impairments. Diclofenac sodium gel, 3% should non be applied to open pare wounds, infections, or exfoliative dermatitis. It should non be immune to come up in contact with the optics.

The safety of the concomitant apply of sunscreens, cosmetics or other topical medications and diclofenac sodium gel, iii% is unknown.

Data for Patients

Fetal Toxicity
If handling with Diclofenac Sodium Gel, 3% is needed for a meaning adult female between about 20 to 30 weeks gestation, advise her that she may need to exist monitored for oligohydramnios, if handling continues for longer than 48 hours. Inform pregnant women to avoid use of Diclofenac Sodium Gel, 3% and other NSAIDs starting at 30 weeks gestation considering of the take chances of the premature closing of the fetal ductus arteriosus [encounter WARNINGS; Fetal Toxicity, PRECAUTIONS; Pregnancy].

In clinical studies, localized dermal side furnishings such every bit contact dermatitis, exfoliation, dry peel and rash were found in patients treated with diclofenac sodium gel, 3% at a higher incidence than in those with placebo.

Patients should sympathize the importance of monitoring and follow-upward 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 diclofenac sodium gel, 3% may be interrupted until the status subsides. Exposure to sunlight and the utilise of sunlamps should exist avoided.

Safety and efficacy of the utilise of diclofenac sodium gel, 3% together with other dermal products, including cosmetics, sunscreens, and other topical medications on the area being treated, accept not been studied.

Serious Skin Reactions, including Wearing apparel
Advise patients to stop taking Diclofenac Sodium Gel, three% immediately if they develop any type of rash or fever and to contact their healthcare provider as before long as possible [see WARNINGS, Serious Skin Reactions].

Cardiovascular Thrombotic Events
Advise patients to exist warning for the symptoms of cardiovascular thrombotic events, including breast pain, shortness of breath, weakness, or slurring of speech, and to report whatever of these symptoms to their health care provider immediately.

Center Failure and Edema
Propose patients to be alert for the symptoms of congestive heart failure including shortness of jiff, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur.

Drug Interactions

Specific interaction studies betwixt diclofenac sodium gel, three% and other topical or oral agents were not performed.

Oral Nonsteroidal Anti-Inflammatory Drugs
Although low, in that location is systemic exposure to diclofenac following labeled use of diclofenac sodium gel, iii%. Therefore, concomitant administration of diclofenac sodium gel, 3% with oral NSAIDS or aspirin may result in increased NSAID adverse effects.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In that location did not appear to be any increase in drug-related neoplasms post-obit daily topical applications of diclofenac sodium gel for 2 years at concentrations up to 0.035% diclofenac sodium and two.v% hyaluronate sodium in albino mice. (Annotation: diclofenac sodium gel, three% contains three% 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/twenty-four hour period (iii 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/twenty-four hour period in females (25% and 83%, respectively, of the estimated systemic human exposure).

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

Diclofenac was not genotoxic in in vitro betoken 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 diclofenac sodium gel, 3%. Diclofenac sodium showed no evidence of harm of fertility subsequently oral handling with four mg/kg/solar day (7 times the estimated systemic human exposure) in male or female rats.

* Based on body expanse and assuming 10% bioavailability following topical application of two k diclofenac sodium gel, 3% per solar day (1 mg/kg diclofenac sodium).

Pregnancy:

Take chances Summary
Use of NSAIDs, including Diclofenac Sodium Gel, three%, can crusade fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment from 20 weeks of gestation, and premature closure of the fetal ductus arteriosus from 30 weeks of gestation. Because of these risks, limit dose and duration of Diclofenac Sodium Gel, iii% use between near 20 and 30 weeks of gestation, and avoid Diclofenac Sodium Gel, 3% utilize at about 30 weeks of gestation and afterwards in pregnancy (run into WARNINGS; Fetal Toxicity).

Oligohydramnios/Neonatal Renal Impairment
Utilise of NSAIDs at about 20 weeks gestation or after in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.

Premature Closure of Fetal Ductus Arteriosus
Utilize of NSAIDs, including Diclofenac Sodium Gel, iii%, at nigh 30 weeks gestation or subsequently in pregnancy increases the chance of premature closure of the fetal ductus arteriosus.

Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the get-go or 2d trimesters of pregnancy are inconclusive. In the full general U.Southward. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to iv% for major malformations, and 15% to 20% for pregnancy loss.

In fauna reproduction studies, no evidence of teratogenicity was observed in mice, rats, or rabbits given diclofenac during the period of organogenesis at doses at to the lowest degree 15 times, the maximum recommended human dose (MRHD) of Diclofenac Sodium Gel, 3% (See Fauna Data).

Based on published brute information, prostaglandins have been shown to accept an of import function in endometrial vascular permeability, blastocyst implantation, and decidualization, and administration of prostaglandin synthesis inhibitors such as diclofenac sodium, resulted in increased pre- and post-implantation loss. Prostaglandins as well have been shown to have an of import 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.

The safety of diclofenac sodium gel, 3% has not been established during pregnancy.

Clinical Considerations
Fetal/Neonatal Adverse Reactions
Premature Closure of Fetal Ductus Arteriosus:
Avoid use of NSAIDs in women at about xxx weeks gestation and later in pregnancy, because NSAIDs, including Diclofenac Sodium Gel, 3%, can cause premature closure of the fetal ductus arteriosus (see WARNINGS; Fetal Toxicity).

Oligohydramnios/Neonatal Renal Impairment
If an NSAID is necessary at near 20 weeks gestation or subsequently in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If Diclofenac Sodium Gel, 3% handling extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue Diclofenac Sodium Gel, three% and follow upwards co-ordinate to clinical do (meet WARNINGS; Fetal Toxicity).

Data
Man Data
Premature Closure of Fetal Ductus Arteriosus:
Published literature reports that the use of NSAIDs at nigh xxx weeks of gestation and later in pregnancy may crusade premature closure of the fetal ductus arteriosus.

Oligohydramnios/Neonatal Renal Impairment:
Published studies and postmarketing reports describe maternal NSAID employ at most 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal damage. These adverse outcomes are seen, on average, later on days to weeks of treatment, although oligohydramnios has been infrequently reported as shortly as 48 hours after NSAID initiation. In many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug. In that location have been a limited number of case reports of maternal NSAID apply and neonatal renal dysfunction without oligohydramnios, some of which were irreversible. Some cases of neonatal renal dysfunction required treatment with invasive procedures, such equally exchange transfusion or dialysis.

Methodological limitations of these postmarketing studies and reports include lack of a control group; limited information regarding dose, elapsing, and timing of drug exposure; and concomitant use of other medications. These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAID use. Because the published safe information on neonatal outcomes involved more often than not preterm infants, the generalizability of certain reported risks to the full-term infant exposed to NSAIDs through maternal employ is uncertain.

Animal Data
Reproductive studies performed with diclofenac sodium alone at oral doses up to xx mg/kg/day (15 times the estimated systemic man exposure*) in mice, 10 mg/kg/day (15 times the estimated systemic man exposure) in rats, and 10 mg/kg/day (30 times the estimated systemic human exposure) in rabbits take revealed no evidence of teratogenicity despite the consecration 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 bulwark in mice and rats.

* Based on trunk area and assuming ten% bioavailability following topical awarding of 2 g diclofenac sodium gel, 3% per day  (i mg/kg diclofenac sodium).

Labor and Delivery

The furnishings of diclofenac on labor and commitment in significant 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 belatedly 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. Diclofenac sodium gel, 3% should not be used by children.

Geriatric Employ

Of the 211 subjects treated with diclofenac sodium gel, 3% 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 betwixt these subjects and younger subjects, and other reported clinical experience has non identified differences in responses between the elderly and younger patients, merely greater sensitivity of some older individuals cannot exist ruled out.

Agin REACTIONS

Of the 423 patients evaluable for safe in adequate and well-controlled trials, 211 were treated with diclofenac sodium gel, iii% drug product and 212 were treated with a vehicle gel. Lxxx-seven percent (87%) of the diclofenac sodium gel, 3%-treated patients (183 patients) and 84% of the vehicle-treated patients (178 patients) experienced i 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 diclofenac sodium gel, 3%, 172 (82%) experienced AEs involving pare and the application site compared to 160 (75%) vehicle-treated patients. Awarding site reactions (ASRs) were the about frequent AEs in both diclofenac sodium gel, 3%-and vehicle-treated groups. Of annotation, four reactions, contact dermatitis, rash, dry pare and exfoliation (scaling) were significantly more prevalent in the diclofenac sodium gel, three% grouping than in the vehicle-treated patients.

Eighteen percent of diclofenac sodium gel, 3%-treated patients and iv% of vehicle-treated patients discontinued from the clinical trials due to agin events (whether considered related to treatment or not). These discontinuations were mainly due to pare irritation or related cutaneous adverse reactions.

Table 1 below presents the AEs reported at an incidence of >1% for patients treated with either diclofenac sodium gel, 3% or vehicle (lx- and 90-24-hour interval treatment groups) during the stage 3 studies.

Table 1. Adverse Events Reported (>i% in Whatever Treatment Group) During Diclofenac Sodium Gel, 3% Stage three Clinical Trials Incidences for threescore-Day and 90-Day Treatments

	sixty-day Handling		90-mean solar day Treatment
	Diclofenac Sodium Gel, iii% (%) N=48	Gel Vehicle (%) North=49	Diclofenac Sodium Gel, 3% (%) N=114	Gel Vehicle (%) N=114
BODY AS A WHOLE	21	20	twenty	18
Abdominal Hurting	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	two
Chest Pain	2	0	1	0
Chills	0	ii	0	0
Influenza Syndrome	ten	6	1	iv
Headache	0	vi	7	6
Infection	four	half-dozen	four	5
Neck Hurting	0	0	two	0
Pain	2	0	two	2
CARDIOVASCULAR SYSTEM	2	four	3	1
Hypertension	two	0	ane	0
Migraine	0	2	1	0
Phlebitis	0	2	0	0
DIGESTIVE Organization	4	0	6	8
Constipation	0	0	0	2
Diarrhea	two	0	2	3
Dyspepsia	two	0	3	4
METABOLIC AND NUTRITIONAL DISORDERS	2	viii	7	two
Creatine Phosphokinase Increased	0	0	iv	1
Creatinine Increased	2	2	0	1
Edema	0	2	0	0
Hypercholesteremia	0	2	1	0
Hyperglycemia	0	2	one	0
SGOT Increased	0	0	3	0
SGPT Increased	0	0	2	0
MUSCULOSKELETAL SYSTEM	four	0	iii	four
Arthralgia	2	0	0	2
Arthrosis	2	0	0	0
Myalgia	2	0	3	1
NERVOUS SYSTEM	2	ii	two	5
Anxiety	0	two	0	ane
Dizziness	0	0	0	iv
Hypokinesia	ii	0	0	0
RESPIRATORY Arrangement	viii	8	seven	6
Asthma	2	0	0	0
Dyspnea	2	0	ii	0
Pharyngitis	2	8	2	four
Pneumonia	2	0	0	one
Rhinitis	2	two	2	2
Sinusitis	0	0	2	0
Pare AND APPENDAGES	75	86	86	71
Acne	0	2	0	one
Application Site Reaction	75	71	84	70
Acne	0	four	one	0
Alopecia	2	0	1	1
Contact Dermatitis	19	4	33	4
Dry out Skin	27	12	25	17
Edema	4	0	3	0
Exfoliation	half dozen	4	24	13
Hyperesthesia	0	0	iii	1
Pain	fifteen	22	26	30
Paresthesia	8	4	20	xx
Photosensitivity         Reaction	0	2	3	0
Pruritus	31	59	52	45
Rash	35	20	46	17
Vesiculobullous Rash	0	0	four	ane
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	iv	6	4	ane
Rash	2	10	iv	0
Skin Carcinoma	0	vi	two	ii
Skin Nodule	0	2	0	0
Skin Ulcer	2	0	1	0
SPECIAL SENSES	2	0	4	two
Conjunctivitis	two	0	four	1
Middle Hurting	0	2	2	0
UROGENITAL SYSTEM	0	0	4	5
Hematuria	0	0	ii	1
OTHER	0	0	0	3
Process	0	0	0	3

Pare and Appendages Agin Events Reported for diclofenac sodium gel, iii% at Less Than 1% Incidence in the Phase 3 Studies: skin hypertrophy, paresthesia, seborrhea, urticaria, application site reactions (peel carcinoma, hypertonia, skin hypertrophy lacrimation disorder, maculopapular rash, purpuric rash, vasodilation).

Adverse Reactions Reported for Oral Diclofenac Dosage Course (not topical diclofenac sodium gel, 3%):
*Incidence Greater than 1% marked with asterisk.

Body equally a Whole: abdominal pain or cramps*, headache*, fluid retentiveness*, abdominal distention*, malaise, swelling of lips and tongue, photosensitivity, anaphylaxis, anaphylactoid reactions, breast hurting.

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.due east., 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, abdominal 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, hygienic meningitis, convulsions, paresthesia, retention 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 haemorrhage.

To report SUSPECTED ADVERSE REACTIONS contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Due to the depression systemic assimilation of topically-applied diclofenac sodium gel, iii%, overdosage is unlikely. There have been no reports of ingestion of diclofenac sodium gel, iii%. In the event of oral ingestion, resulting in significant systemic side effects, it is recommended that the stomach be emptied past 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% poly peptide-bound) remains unproven. In addition to supportive measures, the use of oral activated charcoal may help to reduce the assimilation of diclofenac. Supportive and symptomatic treatment should exist given for complications such as renal failure, convulsions, gastrointestinal irritation and respiratory depression.

DOSAGE AND Assistants

Diclofenac Sodium Gel, 3% is applied to lesion areas twice daily. It is to be smoothed onto the affected pare gently. The amount needed depends upon the size of the lesion site. Assure that enough Diclofenac Sodium Gel, 3% is practical to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x v cm lesion site. The recommended duration of therapy is from threescore days to xc days. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for upward to 30 days post-obit abeyance of therapy. Lesions that do non respond to therapy should exist carefully re-evaluated and direction reconsidered.

HOW SUPPLIED

Bachelor in tubes of 100 thousand and l thou. Each gram of gel contains 30 mg of diclofenac sodium.

100 grand tube – NDC 0115-1483-61
50 g tube – NDC 0115-1483-56

Storage: Shop at 20º to 25ºC (68º to 77ºF); excursions permitted betwixt 15º to 30ºC (59º to 86ºF) [run into USP Controlled Room Temperature]. Protect from heat. Avoid freezing.

†Voltaren® is a registered trademark of Novartis.

Manufactured past:
Tolmar, Inc.
Fort Collins, CO 80526

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

04006125 Rev. ane 05/21

Medication Guide
Diclofenac (dye kloe' fen ak) Sodium Gel, three%

What is the most important information I should know virtually Diclofenac Sodium Gel, 3% and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
Diclofenac Sodium Gel, 3% is an NSAID medicine that is used on the skin only (topical). Practice not use Diclofenac Sodium Gel, 3% in or on the eyes. NSAIDs tin can crusade serious side effects, including:
•  Increased gamble of a heart attack or stroke that can pb to expiry. This risk may happen early in treatment and may increase:
º with increasing doses of NSAIDs
º  with longer utilize of NSAIDs

Do non take or utilize NSAIDs right before or later a heart surgery chosen a "coronary avenue featherbed graft (CABG)". Avert taking NSAIDs afterwards a recent heart attack, unless your healthcare provider tells y'all to. You may have an increased risk of another heart set on if you have or use NSAIDs later a recent heart assault.

• Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), tum and intestines:
   •  anytime during apply
   •  without warning symptoms
   •  that may cause death

The risk of getting an ulcer or haemorrhage increases with:

• by history of stomach ulcers, or tum or intestinal bleeding with utilize of NSAIDs

• taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs"

• increasing doses of NSAIDs

• longer apply of NSAIDs

• smoking

• drinking alcohol

• older age

• poor health

• advanced liver disease

• bleeding problems

NSAIDs should only exist used:
•   exactly equally prescribed
•   at the everyman dose possible for your treatment
•   for the shortest time needed

What is Diclofenac Sodium Gel, three%?
Diclofenac Sodium Gel, 3% is an NSAID that is used on the peel (topical) to care for a peel condition called actinic keratosis. Diclofenac Sodium Gel, iii% is non for use in children.

Who should non use Diclofenac Sodium Gel, iii%?
Practise not use Diclofenac Sodium Gel, 3%:
•  if you have had an allergic reaction to any of the ingredients in Diclofenac Sodium Gel, 3%. See the end of this Medication Guide for a consummate list of ingredients in Diclofenac Sodium Gel, three%.
•  right before or later heart bypass surgery.

Before using Diclofenac Sodium Gel, 3%, tell your healthcare provider about all of your medical weather condition, including if you:
•   have liver or kidney problems
•   have high blood force per unit area
•   take asthma
•   are pregnant or programme to become pregnant. Taking NSAIDS at most 20 weeks of pregnancy or later may harm your unborn baby. If y'all demand to accept NSAIDs for more two days when you are between twenty and 30 weeks of pregnancy, your healthcare provider may demand to monitor the amount of fluid in your womb effectually your infant. You should not take NSAIDs after virtually thirty weeks of pregnancy.
•   are breastfeeding or plan to breastfeed.Y'all and your healthcare provider should decide if yous will use Diclofenac Sodium Gel, 3% or breastfeed. You lot should not exercise both.

Tell your healthcare provider about all of the medicines you have, including prescription or over-the-counter medicines, vitamins, or herbal supplements. NSAIDs and some other medicines tin can interact with each other and crusade serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

How should I use Diclofenac Sodium Gel, 3%?
•   Use Diclofenac Sodium Gel, 3% exactly as your healthcare provider tells you to use information technology.
•   Apply Diclofenac Sodium Gel, 3% 2 times a day.
•   Use enough Diclofenac Sodium Gel, 3% to embrace each skin lesion and gently rub in.
•   Diclofenac Sodium Gel, 3% may be used for 60 to 90 days.  You may not see comeback of skin lesions for upwards to 30 days later stopping treatment.  See your healthcare provider if lesions do non answer to treatment.
 •   Wash your easily after applying Diclofenac Sodium Gel, 3%.

What should I avoid while using Diclofenac Sodium Gel, 3%?
•   Avoid spending time in sunlight or artificial light, such every bit tanning beds or sunlamps. Diclofenac Sodium Gel, 3% can make your peel sensitive to sunlight and the lite from tanning beds and sunlamps.
•   You lot should avert applying Diclofenac Sodium Gel, 3% to open pare wounds, pare infections, or peeling skin.

What are the possible side furnishings of Diclofenac Sodium Gel, 3%?
Diclofenac Sodium Gel, 3% and other NSAIDs can cause serious side effects, including:
See "What is the most of import information I should know about Diclofenac Sodium Gel, iii% and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
•   new or worse loftier claret force per unit area
•   eye failure
•   liver problems including liver failure
•   kidney issues including kidney failure
•   low cerise blood cells (anemia)
•   life-threatening skin reactions
•   life-threatening allergic reactions

Other side effects of NSAIDs include: tummy hurting, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.
Go emergency aid right away if you get whatever of the post-obit symptoms:
•   shortness of breath or trouble animate
•   chest pain
•   weakness in one part or side of your body
•   slurred speech
•   swelling of the face or throat

Stop using Diclofenac Sodium Gel, three% and call your healthcare provider right abroad if you go any of the post-obit symptoms:

•   nausea
•   more tired or weaker than usual
•   diarrhea
•   itching
•   your skin or eyes expect yellowish
•   indigestion or stomach pain
•   influenza-similar symptoms
•   vomit claret
•   there is blood in your bowel motion or it is black and sticky similar tar
•   unusual weight gain
•   pare rash or blisters with fever
•   swelling of the artillery, legs, hands and anxiety

Application site skin reactions are common with Diclofenac Sodium Gel, three% and include: skin redness, itching, rash, dry skin, scaling, and peeling.

If Diclofenac Sodium Gel, three% is accidentally taken past mouth, call your healthcare provider or get medical aid right away.
These are not all the possible side effects of NSAIDs. For more than data, ask your healthcare provider or pharmacist nearly NSAIDs.
Phone call your doc for medical communication nearly side effects. You may report side furnishings to FDA at 1-800-FDA-1088.

Other information almost NSAIDs
Aspirin is an NSAID merely it does not increase the risk of a heart attack. Aspirin tin cause haemorrhage in the brain, stomach, and intestines. Aspirin can too cause ulcers in the stomach and intestines.
Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than ten days.

How should I store Diclofenac Sodium Gel, 3%?
•   Store Diclofenac Sodium Gel, 3% at twenty° to 25°C (68° to 77°F); excursions permitted betwixt 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
•   Go along Diclofenac Sodium Gel, iii% abroad from heat. Avoid freezing Diclofenac Sodium Gel, iii%.
Keep Diclofenac Sodium Gel, three% and all medicines out of the reach of children.

General information nigh the safe and effective use of Diclofenac Sodium Gel, 3%
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Diclofenac Sodium Gel, three% for a condition for which it was not prescribed. Do non requite Diclofenac Sodium Gel, 3% to other people, even if they have the aforementioned symptoms that you have. It may harm them.
If you would like more information about Diclofenac Sodium Gel, 3%, talk with your healthcare provider. You can inquire your pharmacist or healthcare provider for data virtually Diclofenac Sodium Gel, 3% that is written for wellness professionals.

What are the ingredients in Diclofenac Sodium Gel, 3%?
Active ingredient: diclofenac sodium
Inactive ingredient: benzyl alcohol,  hydroxyethyl cellulose, methoxypolyethylene glycol 350, PEG-lx hydrogenated castor oil, and purified water.

To report SUSPECTED ADVERSE REACTIONS contact Amneal Pharmaceuticals at one-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by:Tolmar, Inc.,Fort Collins, CO 80526
Distributed by:Amneal Pharmaceuticals LLC,Bridgewater, NJ 08807

This Medication Guide has been canonical past the U.South. Nutrient and Drug Administration.
Issued: 05/2021

04006125 Rev. 1 05/21

Packet LABEL.Primary DISPLAY Panel

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Source: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8aadab37-9068-45a8-ac9a-8ad87d163b68&type=display

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