Presentation on theme: "Aida Khalatbari Mokaram"— Presentation transcript:
1 Aida Khalatbari Mokaram Volt Slide Deck Iran 2014
2 PAIN Impact of Pain on Life Pain was identified as the reason for 40% impacts quality of life.1Pain was identified as the reason for40%of the visits to physician in primary care.2impacts sleeping, working, socializing with friends and family and accomplishing daily activities.1PAINcauses loss of appetite, weakness feeling and depression.1American Pain Foundation. Treatment Options: A Guide for People Living with Pain. Available at:Mäntyselkä P, Kumpusalo E, Ahonen R, et al. Pain as a reason to visit the doctor: a study in Finnish primary health care. Pain 2001; 89 (2-3):
3 Type of inflammatory process Which NASAID?Factors affecting NSAIDs selection include:1EfficacyType of inflammatory processPrevious and/or currentgastrointestinal pathology of the patientAcute & Chronic useSafetyLlop C, Paredes S, Llor C. Criteria for selecting and using non-steroidal anti-inflammatory drugs in primary health care. Family Practice 2000; 17 (1): 63-5.
4 Voltaren® Effective relieve for majority of pain types Voltaren Basic Prescribing Information Novartis Pharma AG, Basel-Switzerland.
5 Voltaren® : Proven efficacy with high safety profile Superior analgesic efficacy compared to most NSAIDs.1High gastrointestinal safety profile comparedto the majority of NSAIDs.2Bandolier Extra. Evidence-based health care. The OXFORD League Table of Analgesic Efficacy 2003.Which NSAID? Drug and Therapeutics Bulletin, 1987; 25: 81. (commented in The Lancet 1987; p ).
6 Voltaren® : Proven efficacy with high safety profile Voltaren ® is available in wide range of dosage forms which effectively relieve different types of pain.1Voltaren® is considered one of the first choice NSAIDs in the treatment of acute and chronic painful and inflammatory conditions.2Voltaren Basic Prescribing Information Novartis Pharma AG, Basel-Switzerland.Todd PA, Sorkin EM. Diclofenac sodium. A reappraisal of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs 1988; 35 (3):
7 Dougados M et al, Short – Term Efficacy of Rofecoxib and Diclofenac in Acute Shoulder Pain: A Placebo – Controlled Randomized Trial. PLoS Clin Trials 2007; 2 (5): e 24.
8 2. Case JP et al, Lack of Efficacy of Acetaminophen in Treating Symptomatic Knee Osteoarthritis. Arch Intern Med 2003; 163:3. Cannon CP et al, Clinical Trial Design and Patient Demographics of The Multimational Etoricoxib and Diclofenac Arthritis Long-Term (MEDAL) Study Program: Cardiovascular Outcomes with Etoricoxib versus Diclofenac in Patients with Osteoarthritis andRheumatoid arthritis. Am Heart J 2006; 152 (2):
9 4. Bandolier Extra, Evidence-Based Health Care 4. Bandolier Extra, Evidence-Based Health Care. The Oxford League Table of Analgesic Efficacy
10 5. Bandolier. The 2007 Oxford League Table of Analgesic Efficacy. 6. Marenco JL et al, A Multicenter Randomized Double – Blind Study to Compare the Efficacy and Tolerability of Dexketoprofen Trometamol versus Diclofenac in the Symptomatic Treatment of Knee Osteoarthritis, Clin Drug Invest 2000; 19 (4):
11 15. Lu HL, Stastistical Reviewer Briefing Document for the Advisory Committee, available at: Accessed July 25, 2001.16. Singh G et al, celecoxib versus Naproxen and Diclofenac in Osteoarthritis Patients: SUCCESS-1 Study. The American Journal of Medicine 2006; 119 (3):
12 17. Curtis SP et al, Similar Efficacy for Etoricoxib and Diclofenac in Rheumatoid Arthritis Patients in a 174-Week Study. [Poster].18. Cannon CP et al, Cardiovascular Outcomes with in Patients with Osteoarthritis and Rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-Term (MEDAL) Programme: A Randomized Comparison. Lancet 2006; 368 (18):
13 7. Hafele CM, Gyenes V, Daems LN et ol 7. Hafele CM, Gyenes V, Daems LN et ol. Efficacy ond tolerability of diclofenac potassium sachets in acute postoperative dental pain: a placebo-controlled, rondomisad, comparativestudyvs. diclofenac potassium tablets.lnt J Clin Pract (3}: Gan et al, Review Diclofenac: and Update on its Mechanism of Action and safety Profile. Current Medical Reserach & Opinion. 2010; 26(7): Vascular and upper gastrointestinal eff acts of non-steroidal anti-infl ommotory drugs: meta-analyses of individual participant data from randomised trials. The lancet| Presentation Title | Presenter Name | Date | Subject | Business Use Only
14 16. Singh G et al, celecoxib versus Naproxen and Diclofenac in Osteoarthritis Patients: SUCCESS-1 Study. The American Journal of Medicine 2006; 119 (3):
15 Voltaren® proved safety in the special populations Elimination rate of Voltaren ® (Diclofenac Sodium) from plasma after the first 24 hours was the same in the patients with the highest degree of renal dysfunction as in the healthy subjects.1The pharmacokinetic parameters ofVoltaren® are not markedly altered inpatients with mild to moderate degreesof hepatic impairment.2Stierlin H, Faigle JW, Colombi A. Pharmacokinetics of Diclofenac Sodium (Voltaren) And Metabolites in Patients with Impaired Renal Function. Scandinavian Journal of Rheumatology 1978; 7 (22):Catalano MA. Worldwide Safety Experience with Diclofenac. The American Journal of Medicine 1986; 80 (4B):
16 4. Worldwide 2012 IMS. MICI'- M1A. 5. Case JP, Baliunas AJ, Block JA Lack of ERicacy of Acetaminophen in Treating Symptomatic Knee Osteoarthritis. Arch Intern Med. 2003;163: Acute Pain Management: Scientific Evidence. Chapter 6. Administration of systemic analgesic drugs Gan TJ. Review Diclofenac: an update on its mechanism of action and safety profile. Current Medical Research & Opinion ; 26(7}:| Presentation Title | Presenter Name | Date | Subject | Business Use Only
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
19 VOLTAREN®Important note: Before prescribing, please consult full prescribing information. Presentation: Enteric coated tablets 25 mg and 50 mg diclofenac sodium EC, Sustained -release tablets 75 mg diclofenac sodium SR, Extended-release tablets 100 mg diclofenac sodium ER. Indications / Potential uses: • Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis including spondylarthritis.• Painful syndromes of the vertebral column.• Non-articular rheumatism. • Painful posttraumatic and postoperative inflammation and swelling, e.g. following dental or orthopaedic surgery. • Painful and/or inflammatory gynaecological conditions, e.g. primary dysmenorrhoea or adnexitis.• Acute attacks of gout (Enteric coated tablets).• As an adjunct in acute painful inflammatory infections of the ear, nose or throat, e.g. pharyngotonsillitis, otitis (Enteric coated tablets).In keeping with standard therapeutic principles, the underlying disease should be treated with specific therapy as appropriate. Fever alone is not an indication. Dosage and Administration: As a general recommendation, the dose should be individually adjusted, and the lowest effective dose should be given for the shortest possible period of time. The Voltaren Enteric coated / Voltaren Retard / Voltaren SR tablets should be swallowed with liquid, preferably before meals; they must not be divided or chewed. Adults Enteric coated tablets. The starting dose for Voltaren Enteric coated Tablets is usually 100–150 mg/day. In milder cases and for long-term therapy 75–100 mg/day are normally sufficient. The total daily amount is generally given in 2–3 divided doses. In the treatment of primary dysmenorrhoea, the daily dosage should be adapted to the individual patient’s requirements; the usual range is 50–150 mg/day. Treatment should be started at 50–100 mg/day and, if necessary, may gradually be increased over the course of several menstrual cycles to a maximum of 200 mg/day. Treatment should be started on appearance of the first symptoms and continued for a few days, depending on the symptoms. Voltaren SR tablets The usual daily dose of Voltaren SR is 100–150 mg, i.e. two 75 mg Voltaren SR tablets. In milder cases and for long-term therapy, one 75 mg or one 100 mg tablet per day is normally sufficient. If symptoms are most pronounced at night or in the morning, the tablets should preferably be taken in the evening. The Voltaren SR tablets should be swallowed whole with liquid, preferably with meals. Voltaren must not be given to children under 1 year of age. Voltaren 50 mg Enteric coated tablets is not recommended for use in children due to their high content of active substance. Voltaren 25 mg Enteric coated tablets may be used in these patients. Voltaren SR 75 mg and Voltaren Extended-release 100 mg tablets are not suitable for children and adolescents. Contraindications: • Known hypersensitivity to diclofenac, to sodium metabisulphite or other excipients. • Active gastric or intestinal ulcer, bleeding or perforation. • Last trimester of pregnancy. • Severe hepatic, renal or cardiac failure.• Known hypersensitivity to aspirin or other non-steroidal anti- inflammatory drugs (NSAIDs). Warnings / Precautions: • Caution recommended in patients with symptoms/history of gastrointestinal (GI) disease and in elderly because of the risks of GI bleeding or perforation. To be discontinued if these conditions occur. • Combined use with protective agents to be considered in patients with history of ulcer, elderly and those requiring low dose aspirin. • Caution when used concomitantly with corticosteroids, anticoagulants, anti-platelets agents or SSRIs. • Caution recommended in patients with ulcerative colitis or Crohn`s disease. • Caution recommended is patients with asthma, seasonal allergic rhinitis or chronic pulmonary diseases. • Risks of serious allergic reactions. To be discontinued if these conditions occur. • Caution recommended in patients with impaired hepatic function (including porphyria). Monitoring of liver function during prolonged treatment. • Beware of severe fluid retention and edema. • Monitoring of renal function recommended in patients with history of hypertension, impaired cardiac or renal function, extracellular volume depletion, the elderly, patients treated with diuretics or drugs that impact renal function. • Monitoring of blood counts recommended during prolonged treatment. • Monitoring recommended in patients with defect of haemostasis. • Monitoring recommended for elderly. • Avoid use with other systemic NSAIDs including COX-2 inhibitors. • Caution in patients with CV risk factors. • May mask signs and symptoms of infection. Pregnancy and breast-feeding: • Should not be used in the first and second trimester of pregnancy and by breast-feeding mothers. Fertility: • Not recommended to use in women attempting to conceive as it may impair female fertility. Excipients: • Not recommended in patients with galactose or sucrose intolerance (GRT or PRT contain respectively lactose or sucrose).| Presentation Title | Presenter Name | Date | Subject | Business Use Only
20 Interactions: • Monitoring of serum lithium or digoxin levels recommended if used concomitantly. • Caution with concomitant use of diuretics and antihypertensives (e.g. beta blockers, ACE inhibitors), methotrexate, other NSAIDs and corticosteroids, SSRIs. ). • Dose of diclofenac to be reduced in patients receiving ciclosporin. • Monitoring of serum potassium level if used concomitantly with drugs known to cause hyperkalemia (e.g. diuretics, cliclosporin, tacrolimus, trimethoprim. • Interactions with concomitant use of quinolone antibacterials, CYP2C9 inhibitors (e.g. sulfinpyrazone, voriconazole). • Monitoring recommended for patients receiving anticoagulants, anti-platelets agents as well as blood glucose level if used concomitantly with antidiabetics. • Monitoring of phenytoin plasma concentrations is recommended if used concomitantly. Adverse reactions: • Common undesirable effects are: Headache, dizziness, vertigo, nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, decreased appetite, transaminases increased, rash, application site irritation (SUP only). (INJ only): injection site reaction, injection site pain, injection site induration.• Rare undesirable effects are: Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock), somnolence, asthma (including dyspnea), gastritis, gastrointestinal hemorrhage, hematemesis, diarrhea hemorrhagic, melena, gastrointestinal ulcer (with or without bleeding or perforation), hepatitis, jaundice, liver disorder, urticaria, edema. • Very rare undesirable effects are: Thrombocytopenia, leukopenia, anemia (including hemolytic anemia and aplastic anemia), agranulocytosis, angioedema (including face edema), disorientation, depression, insomnia, nightmare, irritability, psychotic disorder, paresthesia, memory impairment, convulsion, anxiety, tremor, meningitis aseptic, dysgeusia, cerebrovascular accident, visual impairment, vision blurred, diplopia, tinnitus, hearing impaired, palpitations, chest pain, cardiac failure, myocardial infarction, hypertension, vasculitis, pneumonitis, colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn’s disease), constipation, stomatitis, glossitis, esophageal disorder, intestinal diaphragm disease, pancreatitis, hepatitis fulminant, hepatic necrosis/ hepatic failure, dermatitis bullous, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, alopecia, photosensivity reaction, purpura, Henoch-Schonlein purpura, pruritus, renal failure acute, hematuria, proteinuria, nephrotic syndrome, tubulointerstitial nephritis, renal papillary necrosis. Packs and prices: Country specific. Legal classification: Country specific.| Presentation Title | Presenter Name | Date | Subject | Business Use Only