Diclofenac Sodium, Capsaicin

Generic Name: diclofenac sodium, capsaicin

Over-the-Counter (OTC)

Brand Names:

Lextol

Purpose Topical Analgesic

Overview

Purpose Topical Analgesic

Uses

1 INDICATIONS AND USAGE Diclofenac sodium topical solution, USP is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). ( 1 )

Dosage

2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. The recommended dose is 40 drops on each painful knee, 4 times a day. ( 2 ) Apply diclofenac sodium topical solution to clean, dry skin. ( 2.1 ) Dispense diclofenac sodium topical solution 10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread diclofenac sodium topical solution evenly around front, back and sides of the knee. Repeat this procedure until 40 drops have been applied and the knee is completely covered with solution. ( 2.1 ) Wash hands completely after administering the product.

Side Effects

When using this product do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help. Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported. If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.

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 increased the 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 This is not a face cream. Do not apply to the face. Do not use if allergic to chili peppers or if past allergic reaction to capsaicin. Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin. Do not bandage tightly. Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and cause a burning sensation. Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns. When using this product do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help. Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported. If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately. This is not a face cream. Do not apply to the face. Do not use if allergic to chili peppers or if past allergic reaction to capsaicin. Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin. Do not bandage tightly. Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and cause a burning sensation. Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.

Pregnancy

8.1 Pregnancy Risk Summary Use of NSAIDs, including diclofenac sodium, 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 use between about 20 and 30 weeks of gestation, and avoid diclofenac sodium use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations , Data ).

Storage

Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Frequently Asked Questions

What is Diclofenac Sodium, Capsaicin used for?

1 INDICATIONS AND USAGE Diclofenac sodium topical solution, USP is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). ( 1 )

What are the side effects of Diclofenac Sodium, Capsaicin?

When using this product do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help. Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported. If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.

Can I take Diclofenac Sodium, Capsaicin during pregnancy?

8.1 Pregnancy Risk Summary Use of NSAIDs, including diclofenac sodium, 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 use between about 20 and 30 weeks of gestation, and avoid diclofenac sodium use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations , Data ).

What are the important warnings for Diclofenac Sodium, Capsaicin?

Warnings For external use only This is not a face cream. Do not apply to the face. Do not use if allergic to chili peppers or if past allergic reaction to capsaicin. Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin. Do not bandage tightly. Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and cause a burning sensation. Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns. When using this product do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help. Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported. If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately. This is not a face cream. Do not apply to the face. Do not use if allergic to chili peppers or if past allergic reaction to capsaicin. Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin. Do not bandage tightly. Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and cause a burning sensation. Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of 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.