Description

Composition:
Each Speedex-NS tablet contains:
Diclofenac potassium: 50mg
Paracetamol: 325mg
Serratiopeptidisae: 10mg
 
Dosage form:
Tablets
 
ATC classification:
Analgesic and anti-inflammatory
 
Description: 
Speedex-NS tablets are formulated with drugs that potentiate the activity of each other in providing faster relief from pain, inflammation, spasms due to trauma or injury or due to any other inflammatory conditions. Paracetamol is the analgesic and antipyretic component of Speedex-NS that potentiates the analgesic effect of Diclofenac potassium, the NSAID component of Speedex-NS. Serratiopeptidase, the enzyme component of Speedex-NS not only has anti-inflammatory, analgesic action but also aids in healing of the hematoma associated with the injuries and dissolves the dead tissue surrounding the injured area. These three components have been complexated with β- cyclodextrins to enhance bioavailability of the drug and to minimize the gastric mucosa irritability that occurs with analgesics.
 
Pharmacological action:
Paracetamol shows analgesic effect by elevating pain threshold which is thought to be attained by inhibiting nitric oxide pathway mediated by a variety of neurotransmitter receptors including N-methyl-D aspartate (NMDA) and substance P. It shows antipyretic activity by inhibiting the synthesis and release of prostaglandin in the central nervous system, thereby inhibiting prostaglandin-mediated effects on the heat-regulating center in the anterior hypothalamus.
It is absorbed rapidly mainly from the small intestine producing peak plasma levels after 15-20 minutes following oral dosing.  Its systemic bioavailability is dose-dependent and ranges from 70 to 90%. Food delays oral absorption. It is rapidly and widely distributed throughout the body with a volume of distribution of approximately 0.9L/kg and is eliminated from plasma with a half life of approximately 2 hours. It is extensively metabolised predominantly in the liver, the major metabolites being the sulphate and glucuronide conjugates which are excreted in urine.
Diclofenac acts by inhibitng the enzyme, cyclooxygenase (COX), an early component of the arachidonic acid cascade that results in the formation of prostaglandins, thromboxanes and prostacyclin.  Prostaglandins are produced at sites of injury or damage causing pain and inflammation. Diclofenac by blocking the effect of COX enzymes, reduce the prostaglandin formation, which means pain and inflammation are eased. The potassium salt of diclofenac is rapidly absorbed and has faster onset of action.
Serratiopeptidase is a proteolytic enzyme that reduces swelling by the process of decreasing the amount of fluid in the tissues, thinning the fluid, and by facilitating the drainage of fluid formed from inflammation and injury. It dissolves the dead tissue surrounding the injured area, breaks down insoluble protein by products of blood coagulation and promotes healing. This finds its usefulness in suppressing post-operative hematoma. It modifies cell-surface adhesion molecules thereby preventing inflammatory cells from reaching the site of inflammation. It exerts analgesia by inhibiting the release of pain-inducing amines like bradykinin from inflamed tissues. After oral administration, Serratiopeptidase is absorbed from intestinal tract and reaches circulation in an enzymatically active form.
 
Indications:
Speedex-NS is indicated in the following conditions
• Severe muscoskeletal pain due to trauma or injury
• Sprain and strains
• Dental pain and in associated conditions like pericoronitis, gingivitis, pulpitis, dental abscess, molar impaction.
• Post operative inflammation
• Post surgical edema
• Post traumatic edema
• Cervical pain
• Lower back pain or sprain
• Muscle spasms
• Pain and inflammation due to ankylosing spondylitis and spondyloarthritis
• Pain due to osteoarthritis, rheumatoid arthritis and gout attacks
• Pain and inflammation due to sports injuries
 
Dosage and Administration:
Adults: 1 tablet 2-3 times daily
 
Contraindications:
¬ Speedex-NS is contraindicated in patients with hypersensitivity or idiosyncrasy to any of its ingredients and NSAIDs
¬ In patients with GI bleeding, moderate to severe renal impairment and acute porphyria
¬ Diclofenac containing formulations should only be initiated after careful consideration for patients with significant risk factors for cardiovascular events (eg, hypertension, hyperlipidaemia, diabetes mellitus, and smoking).
 
Side effects:
The common adverse effects are:
Nausea, heartburn, diarrhea, headache, dizziness, fluid and salt retention, edema feet, high blood pressure, flatulence, constipation, abdominal pain and loss of appetite.
Discontinue use if any hypersensitivity reactions such as rash or redness occur.
 
Warnings and Precautions:
General:
¬ Inform your doctor if you are on any pain killers/NSAIDs.
¬ Fluid retention and edema have been observed in some patients taking Speedex-NS. Therefore it should be used with caution in patients with fluid retention or congestive heart failure and other related cardio vascular conditions.
¬ Speedex-NS might increase the risk of serious cardiovascular events or intestinal bleeding. Ensure that you fully discuss the potential risks with your physician before beginning treatment.
¬ If you suffer from liver disease and gastrointestinal disorders, ensure that you make your physician aware of this before treatment begins, in order for your physician to determine whether or not this medicine is safe and suitable for you.
¬ Precaution to be exercised in patients with: Gastrointestinal bleeding, history of peptic ulceration, cerebrovascular bleeding, ulcerative colitis, Crohn’s disease, systematic lupus erythromatosus (SLE), porphyria, hematopoietic or coagulation disorders, Raynaud’s phenomenon.
¬ Long term use of NSAIDs is likely to cause renal damage.
Drug Interactions:
¬ The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; however occasional doses have no significant effect.
¬ Diclofenac may increase the plasma concentrations of lithium & digoxin. Concomitant use of diclofenac & diuretics may inhibit the activity of diuretics. The activity of anticoagulants may be enhanced when used concomitantly with diclofenac. It may increase toxicity of drugs like cyclosporine. NSAIDs may diminish anti-hypertensive action of ACE-inhibitors.
Pregnancy and Lactation:
¬ This formulation should not be used in the third trimester of pregnancy.
¬ Not recommended even in first two trimesters of pregnancy and also during lactation period since safety in pregnant women or nursing mothers has not been established
Pediatric use:
Safety and efficacy of Speedex-NS in pediatric patients has not been established.
 
References:
Diclofenac- https://pubchem.ncbi.nlm.nih.gov/compound/diclofenac#section=Drug-and-Medication-Information
Paracetamol-https://pubchem.ncbi.nlm.nih.gov/compound/acetaminophen#section=Top
Serratiopeptidase: A systematic review of the existing evidence
http://e-lactancia.org/media/papers/SerratiopeptidasaEficcia-IntJouSurg2013.pdf
Role of Serratiopeptidase in Enzyme Therapy
https://www.ijsr.net/archive/v6i7/ART20175186.pdf
 
Disclaimer:

• Information provided above is for reference purpose only and has been compiled for use by healthcare practitioners. Please consult your physician to understand how the product affects you, its dosages, side-effects and further information.
• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indications prescribed by your physician.
• Every effort has been made to ensure that the information provided by Pharma Synth Formulations Ltd. (‘PSFL’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. PSFL does not endorse drugs, diagnose patients or recommend therapy and is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. PSFL does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.