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Diclofenac sodium+Serratiopeptidase information from DrugsUpdate  

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Diclofenac sodium + Serratiopeptidase, a combination of NSAID and therapeutic enzyme, is prescribed for the treatment of pain and inflammation, post-traumatic pain, local relief of pain or inflammation, treatment of pain after radical keratectomy, inflammation due to strabismus surgery, post-photo reflective keratectomy pain and renal colic. Diclofenac sodium + Serratiopeptidase are also given for prophylaxis of intra-operative miosis and actinic keratosis.

Pharmacodynamics

Diclofenac exerts potent anti-inflammatory, anti-pyretic and analgesic activity by inhibition of cyclooxygenase pathway (COX) and thus inhibits biosynthesis of prostaglandin and other pro-inflammatory mediators of pain pathway.

Serratiopeptidase, a bacterial peptide-cleaving enzyme obtained from Serratia marcescens. Serratiopeptidase is also a potent anti-inflammatory agent that exerts fibrinolytic and anti-edematic property. The therapeutic enzyme reduce inflammation and swelling in the affected area.

Pharmacokinetics

After oral/IM or rectal administration, Diclofenac sodium + Serratiopeptidase is rapidly absorbed in the GIT. However, the absorption rate is very slow in enteric-coated formulations. The drug can enter breast milk and synovial fluid after distribution. The plasma protein binding capability of Diclofenac sodium + Serratiopeptidase is about 99%. Diclofenac sodium + Serratiopeptidase is extensively metabolized in the liver and converted into active metabolites. The drug is extensively excreted in urine as glucuronide and sulfate conjugates. The rest of the elimination is via the bile. The terminal half-life of Diclofenac sodium + Serratiopeptidase is about 1-2 hours.

Diclofenac sodium+Serratiopeptidase Indications / Diclofenac sodium+Serratiopeptidase Uses

No information available

Diclofenac sodium+Serratiopeptidase Adverse Reactions / Diclofenac sodium+Serratiopeptidase Side Effects

Diclofenac sodium + Serratiopeptidase can cause serious adverse events including toxic epidermal necrolysis, Stevens-Johnson syndrome and exfoliative dermatitis. Some of the other adverse events of Diclofenac sodium + Serratiopeptidase are dizziness, headache, GI disturbances, peptic ulcers, local irritation/stinging/burning sensation (for ophthalmic and rectal formulations) and pain with tissue damage (for IM injections).

Precautions

Diclofenac sodium + Serratiopeptidase is contraindicated in patients with active GI bleeding or perforations, asthma, renal or hepatic disorders, hypertension, porphyria, peri-operative pain in CABG surgery patients and bleeding disorders.

Special Precautions

No information available

Other Drug Interactions

Diclofenac sodium + Serratiopeptidase should not be taken concomitantly with other NSAIDs, anticoagulants including low-dose/LMW heparin, sucralfate, triamterene, cyclosporine, cholestyramine, colestipol, digoxin, aspirin, methotrexate and lithium.

Other Interactions

Administration of enteric-coated drugs after meals can delay drug absorption.

Dosage

For sprains (Adults):
Consider administration of 75-150 mg/day in divided doses. The maximum daily dose should not exceed 150 mg/day.
For Strains (Adults):
Consider administration of 75-150 mg/day in divided doses. The maximum daily dose should not exceed 150 mg/day.
For Tendinitis (Adults)
Consider administration of 75-150 mg/day in divided doses. The maximum daily dose should not exceed 150 mg/day.
For Pain and inflammation associated with musculoskeletal and joint disorders (Adults):
Consider administration of 75-150 mg/day in divided doses. The maximum daily dose should not exceed 150 mg/day.
For Bursitis (Adults):
Consider administration of 75-150 mg/day in divided doses. The maximum daily dose should not exceed 150 mg/day.
For Acute gout (Adults):
Consider administration of 75-150 mg/day in divided doses. The maximum daily dose should not exceed 150 mg/day.
For treatment of Dysmenorrhoea (Adults):
Consider administration of 75-150 mg/day in divided doses. The maximum daily dose should not exceed 150 mg/day.
 
Intravenous

For Postoperative pain (Adults):
Consider 75 mg of intravenous infusion in 5% glucose or normal saline, administered over 30-120 minutes. The dose can be repeated after 4-6 hours, if needed.
Intramuscular

For Bursitis (Adults):
Consider intramuscular injection of 75 mg, once daily. The IM injection should be injected deeply into the gluteal muscle. The dosage can be increased, if needed.

Intramuscular

For Sprains (Adults):

Consider intramuscular injection of 75 mg, once daily. The IM injection should be injected deeply into the gluteal muscle. The dosage can be increased, if needed.

For Strains (Adults):
Consider intramuscular injection of 75 mg, once daily. The IM injection should be injected deeply into the gluteal muscle. The dosage can be increased, if needed.

For Tendinitis (Adults):
Consider intramuscular injection of 75 mg, once daily. The IM injection should be injected deeply into the gluteal muscle. The dosage can be increased, if needed.

Pain and inflammation associated with musculoskeletal and joint disorders (Adults):

Consider intramuscular injection of 75 mg, once daily. The IM injection should be injected deeply into the gluteal muscle. The dosage can be increased, if needed.

For Acute gout (Adults)
Consider intramuscular injection of 75 mg, once daily. The IM injection should be injected deeply into the gluteal muscle. The dosage can be increased, if needed.

Dysmenorrhoea (Adults):

Consider intramuscular injection of 75 mg, once daily. The IM injection should be injected deeply into the gluteal muscle. The dosage can be increased, if needed.

For Renal colic (Adults):

Consider intramuscular injection of 75 mg, once daily. The IM injection should be injected deeply into the gluteal muscle. The dosage can be increased, if needed.

Intravenous
For Prophylaxis of postoperative pain (Adults):
Consider administration of 25-50 mg IV infusion, post-surgery, over 15-60 minutes followed by 5 mg/hr. The maximum daily dose should not exceed 150 mg.
Ophthalmic

For Postoperative ocular inflammation (Adults):
As 0.1% sodium formulation, instil one drop of Diclofenac sodium + Serratiopeptidase in the affected eye(s), four times a day. The dosage should be started within 24 hrs, post-surgery. The treatment should be continued up to 4 weeks.

For Prophylaxis of intra-operative miosis (Adults):
As 0.1% sodium formulation, instil one drop of Diclofenac sodium + Serratiopeptidase in the affected eye(s), four times a day. The dosage should be administered within two hours before surgery.
For Post-photorefractive keratectomy pain (Adults):
As 0.1% sodium formulation, instil one drop of Diclofenac sodium + Serratiopeptidase in the affected eye(s), two times before surgery and one drop at 5 minutes interval after surgery. The dosage should be continued every 2-5 hours, post-surgery. The treatment should be continued up to 24 hours.

For Seasonal allergic conjunctivitis (Adults):
As 0.1% sodium formulation, instil one drop of Diclofenac sodium + Serratiopeptidase at least four times in the affected eye(s).
For Pain and discomfort after radial keratotomy (Adults):
As 0.1% sodium formulation, instil one drop of Diclofenac sodium + Serratiopeptidase one drop before surgery and one drop immediately post-surgery. Then administer one drop of Diclofenac sodium + Serratiopeptidase four times daily for up to two days.
Control of inflammation after argon laser trabeculoplasty (Adults):
As 0.1% sodium formulation, instil one drop of Diclofenac sodium + Serratiopeptidase one drop two hours before surgery and one drop immediately post-surgery for seven days.
For Inflammation and discomfort after strabismus surgery (Adults):
As 0.1% sodium formulation, instil one drop of Diclofenac sodium + Serratiopeptidase  four times/week then followed by thrice daily in the second week. The treatment should be lowered to twice daily in the third week, and as needed in the fourth week.
For Pain after accidental trauma (Adults):
As 0.1% sodium, instil one drop of Diclofenac sodium + Serratiopeptidase four times a day for up to two days.
As Topical/Cutaneous

For Local symptomatic relief of pain and inflammation (Adults):
As 0.1% sodium gel, apply Diclofenac sodium + Serratiopeptidase, thrice or four times a day onto the affected area.
For Osteoarthritis (Adults)
As 1.6% sodium solution, apply 20-40 drops of Diclofenac sodium + Serratiopeptidase onto the affected area, four times a day.
For Actinic keratoses (Adults):
Apply 3% gel of Diclofenac sodium + Serratiopeptidase, twice daily for 60-90 days.

Rectal formulations

For Post-operative pain (Adults):
Apply 75-150 mg/day of Diclofenac sodium + Serratiopeptidase (25, 50, 100 mg rectal suppositories). The maximum daily dose should not exceed 150 mg/day.
For Post-operative pain (Pediatrics):
For children, 6-12 years of age, administer 1-2 mg/kg/day in divided doses, not more than four days. The available pediatric dose rectal formulations are 12.5 mg and 25 mg suppositories.

Food(before/after)

Diclofenac sodium + Serratiopeptidase should be taken with food. Take the drug immediately after meals to avoid GI disturbances.

List of Contraindications

Diclofenac sodium+Serratiopeptidase and Pregnancy

USFDA pregnancy category B. If used in the first trimester of pregnancy, Diclofenac sodium + Serratiopeptidase may not cause harm to an unborn foetus. Before Diclofenac sodium + Serratiopeptidase treatment, the patient should discuss with the physician, if they are planning for a pregnancy. 
USFDA pregnancy category C. Diclofenac sodium + Serratiopeptidase may be or may not be harmful to an unborn baby. Consult a physician if you are in gestation or planning to have a baby during Diclofenac sodium + Serratiopeptidase treatment.

Diclofenac sodium+Serratiopeptidase and Lactation

Nursing mothers should consult a physician before taking Diclofenac sodium + Serratiopeptidase tablets

Diclofenac sodium+Serratiopeptidase and Children

No information available

Diclofenac sodium+Serratiopeptidase and Geriatic

No information available

Diclofenac sodium+Serratiopeptidase and Other Contraindications

No information available

Storage

Store at 15-30°C.

Lab interference

Store at 15-30°C.

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