DICLOFENAC SODIUM gel

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

diclofenac sodium (UNII: QTG126297Q) (diclofenac - UNII:144O8QL0L1)

Dostępny od:

Preferred Pharmaceuticals Inc.

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Diclofenac sodium gel is indicated for the topical treatment of actinic keratoses (AK). Diclofenac sodium gel is contraindicated in the following patients: Risk Summary Use of NSAIDs, including diclofenac sodium gel, can cause premature closure of the 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 diclofenac sodium gel use between about 20 and 30 weeks of gestation and avoid diclofenac sodium gel use at about 30 weeks of gestation and later in pregnancy. Oligohydramnios/Neonatal Renal Impairment 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. Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including diclofenac sodium gel, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, no evidence of malformations was observed in mice, rats, or rabbits given diclofenac during the period of organogenesis at doses at least 15 times, the maximum recommended human dose (MRHD) of diclofenac sodium gel (see Data) . Based on published animal data, prostaglandins have been shown to have an important role 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 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. The background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including diclofenac sodium gel, can cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment If after careful consideration of alternative treatment options for actinic keratoses, an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If diclofenac sodium gel treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue diclofenac sodium gel and follow up according to clinical practice. Labor or Delivery There are no studies on the effects of diclofenac sodium gel during labor or delivery. In animal studies, NSAIDS, including diclofenac, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data Premature Closure of Fetal Ductus Arteriosus Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Published studies and postmarketing reports describe maternal NSAID use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon 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. There have been a limited number of case reports of maternal NSAID use and neonatal renal dysfunction without oligohydramnios, some of which were irreversible. Some cases of neonatal renal dysfunction required treatment with invasive procedures, such as exchange transfusion or dialysis. Methodological limitations of these postmarketing studies and reports include lack of a control group; limited information regarding dose, duration, 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 safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to NSAIDs through maternal use is uncertain. Animal Data The multiples provided in this labeling are based on an MRHD that assumes 10% bioavailability following topical application of 2 g diclofenac sodium gel per day (1 mg/kg diclofenac sodium). Reproductive studies performed with diclofenac sodium alone at oral doses up to 20 mg/kg/day (15 times the MRHD based on body surface area (BSA) comparisons) in mice, 10 mg/kg/day (15 times the MRHD based on BSA comparisons) in rats, and 10 mg/kg/day (30 times the MRHD based on BSA comparisons) in rabbits have revealed no evidence of malformations 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. Risk Summary Data from published literature cases with oral preparations of diclofenac indicate the presence of small amounts of diclofenac in human milk. There are no data on the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for diclofenac sodium gel and any potential adverse effects on the breastfed infant from the diclofenac sodium gel or from the underlying maternal condition. Data One woman treated orally with a diclofenac salt, 150 mg/day, had a milk diclofenac level of 100 mcg/L, equivalent to an infant dose of about 0.03 mg/kg/day. Diclofenac was not detectable in breast milk in 12 women using diclofenac (after either 100 mg/day orally for 7 days or a single 50 mg intramuscular dose administered in the immediate postpartum period). The systemic bioavailability after topical application of diclofenac sodium gel is lower than after oral dosing [see Clinical Pharmacology (12.3)] . Female Infertility Based on the mechanism of action, the use of prostaglandin mediated NSAIDs, including diclofenac sodium gel, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women [see Clinical Pharmacology (12.1)] . 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, including diclofenac sodium gel, in women who have difficulties conceiving or who are undergoing investigation of infertility. Actinic keratoses is not a condition seen within the pediatric population. diclofenac sodium gel should not be used by children. Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see Warnings and Precautions (5.4, 5.5, 5.6, 5.9, 5.14)]. Of the 211 subjects treated with diclofenac sodium gel in controlled clinical trials, 143 subjects were 65 years of age and over. Of those 143 subjects, 55 subjects were 75 years of age 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.

Podsumowanie produktu:

Each gram of Diclofenac Sodium Topical Gel, 3% contains 30 mg of diclofenac sodium, USP. Diclofenac Sodium Gel, 3% is available as follows: Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from heat. Avoid freezing.

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
www.glenmarkpharma-us.com/medguides
Diclofenac Sodium (dye-KLOE-fen-ak SOE-dee-um)
Gel
What is the most important information I should know about diclofenac
sodium gel and medicines called
Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
o
with increasing doses of NSAIDs
o
with longer use of NSAIDs
Do not take or use NSAIDs right before or after a heart surgery called
a “coronary artery bypass graft
(CABG)”. Avoid taking NSAIDs after a recent heart attack unless your
healthcare provider tells you to. You
may have an increased risk of another heart attack if you take or use
NSAIDs after a recent heart attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
o
anytime during use
o
without warning symptoms
o
that may cause death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What is diclofenac sodium gel?
Diclofenac sodium gel is an NSAID that is used on the skin (topical)
to treat a skin condition called actinic
keratosis. Diclofenac sodium gel is not for use in children.
Do not use diclofenac sodium gel:
•
if you have had an allergic reaction to any of the ingredients in
diclofenac sodium gel. See the end of
this Medication Guide for a

Charakterystyka produktu

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC SODIUM GEL
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DICLOFENAC SODIUM GEL.
DICLOFENAC SODIUM TOPICAL GEL
INITIAL U.S. APPROVAL: 2000
WARNING: RISK OF SERIOUS CARDIOVASCULAR EVENTS AND GASTROINTESTINAL
EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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•
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INDICATIONS AND USAGE
Diclofenac sodium gel is a nonsteroidal anti-inflammatory drug (NSAID)
indicated for the topical treatment
of actinic keratoses (AK). (1)
DOSAGE AND ADMINISTRATION
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•
•
•
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DOSAGE FORMS AND STRENGTHS
Topical gel, 3% (3)
CONTRAINDICATIONS
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•
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WARNINGS AND PRECAUTIONS
•
•
•
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Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious cardiovascular
thrombotic events, including myocardial infarction and stroke, which
can be fatal. This risk may
occur early in treatment and may increase with duration of use. (5.4)
Diclofenac sodium gel is contraindicated in the setting of coronary
artery bypass graft (CABG)
surgery. (4, 5.4)
NSAIDs cause an increased risk of serious gastrointestinal (GI)
adverse events including
bleeding, ulceration, and perforation of the stomach or intestines,
which can be fatal. These
events can occur at any time during use and without warning symptoms.
Elderly patients and
patients with a prior history of peptic ulcer disease and/or GI
bleeding are at greater risk for
serious GI events (5.5)
Use the lowest effective dosage for shortest duration consistent with
the individual patient treatment
goals. (2)
Apply to lesion areas twice daily to adequately cover each lesion. (2)
Use 0.5 g of gel (pea size) on each 5 cm x 5 cm lesion site. (2)
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.
L