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diclofenac sodium, isopropyl alcohol
Overview
What is Diclo Gel 1% Pak?
VOLTAREN
GEL (diclofenac sodium topical gel) is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. The chemical name is 2-[(2,6-dichlorophenyl)amino]benzene acetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C
H
Cl
NNaO
, and it has the following chemical structure:
It contains the active ingredient, diclofenac sodium, in an opaque, white gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. Diclofenac sodium is a benzeneacetic acid derivative.
The inactive ingredients in VOLTAREN
GEL include: carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution.
What does Diclo Gel 1% Pak look like?
What are the available doses of Diclo Gel 1% Pak?
VOLTAREN
GEL (diclofenac sodium topical gel), 1%
What should I talk to my health care provider before I take Diclo Gel 1% Pak?
Pregnancy
Infertility
How should I use Diclo Gel 1% Pak?
Use as part of your daily cleansing routine
May be covered with a sterile bandage
What interacts with Diclo Gel 1% Pak?
Sorry No Records found
What are the warnings of Diclo Gel 1% Pak?
Sorry No Records found
What are the precautions of Diclo Gel 1% Pak?
Sorry No Records found
What are the side effects of Diclo Gel 1% Pak?
Sorry No records found
What should I look out for while using Diclo Gel 1% Pak?
VOLTAREN
GEL is contraindicated in the following patients:
What might happen if I take too much Diclo Gel 1% Pak?
Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare
Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
For additional information about overdosage treatment, contact a poison control center (1-800-222-1222).
How should I store and handle Diclo Gel 1% Pak?
Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).Keep tightly closed. Dispense in a tight container, as defined in the USP.Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).Keep tightly closed. Dispense in a tight container, as defined in the USP.VOLTAREN GEL (diclofenac sodium topical gel, 1%) is available in tubes containing 100 grams of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%). 100 grams tube………………………………NDC 63481-684-47 3 Pack (3 Tubes containing 100 g each)……..NDC 63481-684-03 5 Pack (5 Tubes containing 100 g each)……..NDC 63481-684-05 StorageStore at room temperature 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Keep from freezing. Store the dosing card with your VOLTAREN GEL VOLTAREN GEL (diclofenac sodium topical gel, 1%) is available in tubes containing 100 grams of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%). 100 grams tube………………………………NDC 63481-684-47 3 Pack (3 Tubes containing 100 g each)……..NDC 63481-684-03 5 Pack (5 Tubes containing 100 g each)……..NDC 63481-684-05 StorageStore at room temperature 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Keep from freezing. Store the dosing card with your VOLTAREN GEL VOLTAREN GEL (diclofenac sodium topical gel, 1%) is available in tubes containing 100 grams of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%). 100 grams tube………………………………NDC 63481-684-47 3 Pack (3 Tubes containing 100 g each)……..NDC 63481-684-03 5 Pack (5 Tubes containing 100 g each)……..NDC 63481-684-05 StorageStore at room temperature 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Keep from freezing. Store the dosing card with your VOLTAREN GEL VOLTAREN GEL (diclofenac sodium topical gel, 1%) is available in tubes containing 100 grams of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%). 100 grams tube………………………………NDC 63481-684-47 3 Pack (3 Tubes containing 100 g each)……..NDC 63481-684-03 5 Pack (5 Tubes containing 100 g each)……..NDC 63481-684-05 StorageStore at room temperature 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Keep from freezing. Store the dosing card with your VOLTAREN GEL
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Diclofenac has analgesic, anti-inflammatory, and antipyretic properties.
The mechanism of action of VOLTAREN
GEL, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro. Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Non-Clinical Toxicology
VOLTAREN GEL is contraindicated in the following patients:Topiramate
Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels.
Drugs Metabolized by P450 2D6
The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the caucasian population (about 7 to 10% of Caucasians are so called “poor metabolizers”); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8 fold increase in plasma AUC of the TCA).
In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).
Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be coadministered with another drug known to be an inhibitor of P450 2D6.
Monoamine oxidase inhibitors – see section. Guanethidine or similarly acting compounds; thyroid medication; alcohol, barbiturates and other CNS depressants; and disulfiram – see section.
When amitriptyline is given with anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics, close supervision and careful adjustment of dosages are required.
Hyperpyrexia has been reported when amitriptyline is administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather.
Paralytic ileus may occur in patients taking tricyclic antidepressants in combination with anticholinergic-type drugs.
Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine. Increases in plasma levels of tricyclic antidepressants, and in the frequency and severity of side effects, particularly anticholinergic, have been reported when cimetidine was added to the drug regimen. Discontinuation of cimetidine in well-controlled patients receiving tricyclic antidepressants and cimetidine may decrease the plasma levels and efficacy of the antidepressants.
Caution is advised if patients receive large doses of ethchlorvynol concurrently. Transient delirium has been reported in patients who were treated with one gram of ethchlorvynol and 75 to 150 mg of amitriptyline hydrochloride.
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute 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 as 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 adverse CV event in NSAID-treated patients, use the lowest effective 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 be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious gastrointestinal (GI) events .
Status Post Coronary Artery Bypass Graft (CABG) Surgery
Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 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 post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-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 death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of VOLTAREN GEL in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If VOLTAREN GEL is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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