Dosanac Emulsion Gel

White to creamy white cream like gel.
Each 100 g contains: Diclofenac diethylammonium corresponding to Diclofenac sodium 1 g in a base containing a fatty emulsion in an aqueous gel.

Pharmacology: Pharmacodynamics: Diclofenac actions are similar to those of other prototypical nonsteroidal anti-inflammatory agent (NSAIDs). Diclofenac inhibits the synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase; cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), which have been identified to catalyze the formation of prostaglandins in the arachidonic acid pathway. However, the exact mechanisms have not been clearly established.
Pharmacokinetics: When Diclofenac is applied topically, it is absorbed into the epidermis. Diclofenac binds tightly to serum albumin. Diclofenac and its metabolites are excreted in the urine mainly.

For pain relief and inflammation of muscles, tendons and joints.

Dosage used depends on the painful site area. Apply 2-4 g gel (3-6 cm length) 3-4 times daily to the affected parts and gentle massage on the applied area is recommended to ensure drug absorption into the skin.
Maximum total body dose of DOSANAC EMULSION GEL 1% should not exceed 32 g per day.
Lower extremities, including the knees, ankles and feet: Usual dosage: Apply 4 g to the affected knees, ankles and feet 4 times daily.
Maximum dose: 16 g/day to any single joint of lower extremities.
Upper extremities, including the elbows, wrists and hands: Usual dosage: Apply 2 g to the affected elbows, wrists and hands 4 times daily.
Maximum dose: 8 g/day to any single joint of upper extremities.
Dosage in elderly: Safety and efficacy in patients aged 65 years or older are not different from those of younger adults. However, increased sensitivity cannot be identified.
Dosage in children: Safety and efficacy are not established in children. Diclofenac sodium gel should not be used in children.
Dosage in renal impairment: Use with caution in patients with severe renal impairment.
Dosage in hepatic impairment: Use with caution in patients with severe hepatic impairment.

Symptoms: Adverse reactions after oral ingestion of Diclofenac gel are similar to those of oral Diclofenac.
Treatment: It is recommended that the stomach should be emptied by vomiting or lavage. Forced diuresis may be beneficial because the drug is excreted in the urine. In addition, oral activated charcoal may help in reduction of Diclofenac. Absorption provides symptomatic supportive treatment for complications such as renal failure, convulsion, GI irritation and respiratory depression.

Do not use in patients who have hypersensitivity reaction to Diclofenac or any ingredient in the formulation.
Do not use in patients who have hypersensitivity reaction to aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs).
Do not use in pregnant women during the last trimester of pregnancy.

Warnings: This drug may cause an adverse effect of skin. Stop taking this drug and consult a doctor immediately when the symptom occurs.
It is contraindicated in patients with hypersensitivity to this drug, or patients with asthma, urticaria or acute nasal cavity inflammation after taking aspirin or NSAIDs.
It is contraindicated in patients with gastrointestinal hemorrhage or perforation because this drug may increase the risk of gastrointestinal hemorrhage or perforation.
It is contraindicated in patients with severe hepatic or renal diseases.
Prolong use may increase the risk of the platelet aggregation or cardiovascular system like oral route.
Precautions: Do not apply to the eyes, open wounds and mucous membranes.
When DOSANAC EMULSION GEL is applied to relatively large areas of skin over prolonged period of time, the possibility of systemic side effects occurs due to Diclofenac absorption to blood circulation.
Do not eat. DOSANAC EMULSION GEL is for external use only.
Use in Pregnancy: Avoid drug use during pregnancy in the last trimester, unless prescribed by a physician.
Use in the Elderly: Use with caution in elderly patients.

Use in pregnancy: Diclofenac topical gel 1% is classified as pregnancy category C. Safety and efficacy in pregnant women have not been clearly established. Avoid using DOSANAC EMULSION GEL during the third trimester because it may lead to premature closure of the ductus arteriosus and inhibit uterine contractions.
Use in lactation: Excretion in breast milk is unknown. Thus, using DOSANAC EMULSION GEL during breast feeding is not recommended.

Adverse reactions reported during 60-90 days Diclofenac treatment of phase 3 clinical trial.
Cardiovascular: chest pain and hypertension.
CNS: headache, migraine and hypokinesia.
Dermatology: acne, hyperesthesia, photosensitivity reaction, vesiculobullous rash, dry skin, skin carcinoma, application site reaction, contact dermatitis, edema, exfoliation, paresthesia, pruritus, rash and skin ulcer.
Lab test abnormality: increased creatine phosphokinase, hypercholesteremia, hyperglycemia, AST increased, ALT increased and increased creatinine.
Gastrointestinal tract: abdominal pain, diarrhea and dyspepsia.
Musculoskeletal: arthralgia, arthrosis, back pain, and myalgia.
Respiratory: sinusitis, asthma, pneumonia, dyspnea, pharyngitis and rhinitis.
Others: allergic reaction, asthenia, neck pain, eye pain, flu syndrome, infection and conjunctivitis.

Although the systemic absorption of Diclofenac is low, when concomitant oral administration of other NSAIDs, dose of oral NSAIDs should be reduced.

Store below 30°C, protect from light and heat.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.

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