Diclofenac Sodium, Isopropyl Alcohol

Generic Name: diclofenac sodium, isopropyl alcohol

Over-the-Counter (OTC)

Brand Names:

Venngel Ii

Purpose Antiseptic

Overview

Purpose Antiseptic

Uses

1 INDICATIONS AND USAGE Diclofenac sodium topical gel, 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Diclofenac sodium topical gel, 1% has not been evaluated for use on the spine, hip, or shoulder. Diclofenac sodium topical gel, 1% is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. ( 1 ) Diclofenac sodium topical gel, 1% was not evaluated for use on joints of the spine, hip, or shoulder. ( 14.1 )

Dosage

2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ]. Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2.1 ) Lower extremities: Apply the gel (4 g) to the affected area 4 times daily. Do not apply more than 16 g daily to any one affected joint of the lower extremities. ( 2.2 ) Upper extremities: Apply the gel (2 g) to the affected area 4 times daily. Do not apply more than 8 g daily to any one affected joint of the upper extremities. ( 2.3 ) Total dose should not exceed 32 g per day, over all affected joints.

Side Effects

Stop use and ask a doctor if Condition persists for more than 72 hours or gets worse.

Interactions

7 DRUG INTERACTIONS See Table 2 for clinically significant drug interactions with diclofenac. Table 2: Clinically Significant Drug Interactions with Diclofenac Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis.

Warnings

Warnings For External Use Only Flammable, keep away from fire or flame. Do not use • In the eyes or over large areas of the body • Longer than 1 week unless directed by a doctor • With electrocautery procedures Ask a doctor before use if you have Deep or puncture wounds, animal bites, or serious burns. Stop use and ask a doctor if Condition persists for more than 72 hours or gets worse. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Do not use • In the eyes or over large areas of the body • Longer than 1 week unless directed by a doctor • With electrocautery procedures Ask a doctor before use if you have Deep or puncture wounds, animal bites, or serious burns.

Pregnancy

8.1 Pregnancy Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation Risk Summary Use of NSAIDs, including diclofenac sodium topical gel, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including diclofenac sodium topical gel, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of diclofenac sodium topical gel in pregnant women. Human and animal studies indicate that diclofenac crosses the placenta.

Storage

Other Information Store at room temperature Avoid excessive heat

Frequently Asked Questions

What is Diclofenac Sodium, Isopropyl Alcohol used for?

1 INDICATIONS AND USAGE Diclofenac sodium topical gel, 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Diclofenac sodium topical gel, 1% has not been evaluated for use on the spine, hip, or shoulder. Diclofenac sodium topical gel, 1% is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. ( 1 ) Diclofenac sodium topical gel, 1% was not evaluated for use on joints of the spine, hip, or shoulder. ( 14.1 )

What are the side effects of Diclofenac Sodium, Isopropyl Alcohol?

Stop use and ask a doctor if Condition persists for more than 72 hours or gets worse.

Can I take Diclofenac Sodium, Isopropyl Alcohol during pregnancy?

8.1 Pregnancy Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation Risk Summary Use of NSAIDs, including diclofenac sodium topical gel, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including diclofenac sodium topical gel, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of diclofenac sodium topical gel in pregnant women. Human and animal studies indicate that diclofenac crosses the placenta.

What are the important warnings for Diclofenac Sodium, Isopropyl Alcohol?

Warnings For External Use Only Flammable, keep away from fire or flame. Do not use • In the eyes or over large areas of the body • Longer than 1 week unless directed by a doctor • With electrocautery procedures Ask a doctor before use if you have Deep or puncture wounds, animal bites, or serious burns. Stop use and ask a doctor if Condition persists for more than 72 hours or gets worse. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Do not use • In the eyes or over large areas of the body • Longer than 1 week unless directed by a doctor • With electrocautery procedures Ask a doctor before use if you have Deep or puncture wounds, animal bites, or serious burns.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.