Diclostream

What Is Diclostream?

Diclostream (diclofenac sodium 1.5% solution and menthol 10% topical liquid kit) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat signs and symptoms of osteoarthritis of the knee(s).

What Are Side Effects of Diclostream?

Side effects of Diclostream include:

• application site reactions (dryness, redness, swelling, small cysts, numbness and tingling, itching, widening blood vessels, acne, and hives),
• diarrhea,
• indigestion/heartburn,
• nausea,
• gas (flatulence),
• abdominal pain, and
• fluid retention (edema)

Dosage for Diclostream

For the relief of the signs and symptoms of osteoarthritis of the knee(s), the recommended dose of Diclostream is 40 drops per knee, 4 times a day.

Diclostream In Children

Safety and effectiveness of Diclostream in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Diclostream?

Diclostream may interact with other medicines such as:

• anticoagulants,
• antiplatelet agents (e.g., aspirin),
• selective serotonin reuptake inhibitors (SSRIs),
• serotonin norepinephrine reuptake inhibitors (SNRIs),
• angiotensin converting enzyme (ACE) inhibitors,
• angiotensin receptor blockers (ARBs),
• beta-blockers,
• diuretics,
• digoxin,
• lithium,
• methotrexate,
• cyclosporine,
• other nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates, and
• pemetrexed

Tell your doctor all medications and supplements you use.

Diclostream During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Diclostream. Use of NSAIDs, including Diclostream, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Diclostream, in pregnant women starting at 30 weeks of gestation (third trimester). Diclostream may pass into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Diclostream (diclofenac sodium 1.5% solution and menthol 10% topical liquid kit) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

 

Diclostream Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using this medicine and seek emergency medical attention if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Also call your doctor at once if you have:

• a skin rash, no matter how mild;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• liver problems--nausea, diarrhea, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Serious side effects may be more likely in older adults.

Common side effects may include:

• skin dryness, redness, itching, or rash;
• blistering or hardening of the treated skin;
• numbness, tingling, burning pain;
• acne;
• flushing (sudden warmth, redness, or tingly feeling);
• stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting; or
• dizziness.

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 entire detailed patient monograph for Diclostream (Diclofenac Sodium 1.5% Solution and Menthol 10% Topical Liquid)

 

Diclostream Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Cardiovascular Thrombotic Events [see WARNING AND PRECAUTIONS]
• GI Bleeding, Ulceration and Perforation [see WARNING AND PRECAUTIONS]
• Hepatotoxicity [see WARNING AND PRECAUTIONS]
• Hypertension [see WARNING AND PRECAUTIONS]
• Heart Failure and Edema [see WARNING AND PRECAUTIONS]
• Renal Toxicity and Hyperkalemia [see WARNING AND PRECAUTIONS]
• Anaphylactic Reactions [see WARNING AND PRECAUTIONS]
• Serious Skin Reactions [see WARNING AND PRECAUTIONS]
• Hematologic Toxicity [see WARNING AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to diclofenac sodium topical solution of 911 patients treated between 4 and 12 weeks (mean duration of 49 days) in seven Phase 3 controlled trials, as well as exposure of 793 patients treated in an open-label study, including 463 patients treated for at least 6 months, and 144 patients treated for at least 12 months. The population mean age was approximately 60 years, 89% of patients were Caucasians, 64% were females, and all patients had primary osteoarthritis. The most common adverse events with diclofenac sodium topical solution were application site skin reactions. These events were the most common reason for withdrawing from the studies.

Application Site Reactions

In controlled trials, the most common treatment-related adverse events in patients receiving diclofenac sodium topical solution were application site skin reactions. Application site reactions were characterized by one or more of the following: dryness, erythema, induration, vesicles, paresthesia, pruritus, vasodilation, acne, and urticaria. The most frequent of these reactions were dry skin (32%), contact dermatitis characterized by skin erythema and induration (9%), contact dermatitis with vesicles (2%) and pruritus (4%). In one controlled trial, a higher rate of contact dermatitis with vesicles (4%) was observed after treatment of 152 subjects with the combination of diclofenac sodium topical solution and oral diclofenac. In the open label uncontrolled long-term safety study, contact dermatitis occurred in 13% and contact dermatitis with vesicles in 10% of patients, generally within the first 6 months of exposure, leading to a withdrawal rate for an application site event of 14%.

Adverse Events Common To The NSAID Class

In controlled trials, subjects treated with diclofenac sodium topical solution experienced some adverse events associated with the NSAID class more frequently than subjects using placebo (constipation, diarrhea, dyspepsia, nausea, flatulence, abdominal pain, edema; see Table 1). The combination of diclofenac sodium topical solution and oral diclofenac, compared to oral diclofenac alone, resulted in a higher rate of rectal hemorrhage (3% vs. less than 1%), and more frequent abnormal creatinine (12% vs. 7%), urea (20% vs. 12%), and hemoglobin (13% vs. 9%), but no difference in elevation of liver transaminases.

Table 1 lists all adverse reactions occurring in 1% of patients receiving diclofenac sodium topical solution, where the rate in the diclofenac sodium topical solution group exceeded placebo, from seven controlled studies conducted in patients with osteoarthritis. Since these trials were of different durations, these percentages do not capture cumulative rates of occurrence.

Table 1: Adverse reactions occurring in ≥1% of patients treated with Diclofenac Sodium Topical Solution in placebo and oral diclofenac-controlled trials.

Treatment Group:	Diclofenac SodiumTopical Solution N=911	Topical Placebo N=332
Adverse Reaction*	N (%)	N (%)
Dry Skin (Application Site)	292 (32)	17 (5)
Contact Dermatitis (Application Site)	83 (9)	6 (2)
Dyspepsia	72 (8)	13 (4)
Abdominal Pain	54 (6)	10 (3)
Flatulence	35 (4)	1 (<1)
Pruritus (Application Site)	34 (4)	7 (2)
Diarrha	33 (4)	7 (2)
Nausea	33 (4)	3 (1)
Pharyngitis	40 (4)	13 (4)
Constipation	29 (3)	1 (<1)
Edema	26 (3)	0
Rash (Non-Application Site)	25 (3)	5 (2)
Infection	25 (3)	8 (2)
Ecchymosis	19 (2)	1 (<1)
Dry Skin (Non-Application Site)	19 (2)	1 (<1)
Contact Dermatitis, vesicles (Application Site)	18 (2)	0
Paresthesia (Non-Application Site)	14 (2)	3 (<1)
Accidental Injury	22 (2)	7 (2)
Pruritus (Non-Application Site)	15 (2)	2 (<1)
Sinusitis	10 (1)	2 (<1)
Halitosis	11 (1)	1 (<1)
Application Site Reaction (not otherwise specified)	11 (1)	3 (<1)
*Preferrred Term according to COSTART

Post-marketing Experience

In non-U.S. post-marketing surveillance, the following adverse reactions have been reported during post-approval use of diclofenac sodium topical solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: abdominal pain, accidental injury, allergic reaction, asthenia, back pain, body odor, chest pain, edema, face edema, halitosis, headache, lack of drug effect, neck rigidity, pain

Cardiovascular: palpitation, cardiovascular disorder

Digestive: diarrhea, dry mouth, dyspepsia, gastroenteritis, decreased appetite, mouth ulceration, nausea, rectal hemorrhage, ulcerative stomatitis

Metabolic and Nutritional: creatinine increased

Musculoskeletal: leg cramps, myalgia

Nervous: depression, dizziness, drowsiness, lethargy, paresthesia, paresthesia at application site

Respiratory: asthma, dyspnea, laryngismus, laryngitis, pharyngitis

Skin and Appendages: At the Application Site: contact dermatitis, contact dermatitis with vesicles, dry skin, pruritus, rash; Other Skin and Appendages

Adverse Reactions: eczema, rash, pruritus, skin discoloration, urticaria

Read the entire FDA prescribing information for Diclostream (Diclofenac Sodium 1.5% Solution and Menthol 10% Topical Liquid)