Kempo Side effects

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Side effects of Kempo in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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In clinical trials, Kempo was evaluated for safety in 7152 individuals, including 4488 patients with OA, RA or chronic low back pain (approximately 600 patients with OA or RA were treated for one year or longer).

The following drug-related adverse experiences were reported in clinical studies in patients with OA, RA, or chronic low back pain treated for up to 12 weeks. These occurred in ≥1% of patients treated with Kempo and at an incidence greater than placebo: Asthenia/fatigue, dizziness, lower extremity edema, hypertension, dyspepsia, heartburn, nausea, headache, ALT increased, AST increased.

The adverse experience profile was similar in patients with OA or RA treated with Kempo for one year or longer.

In the MEDAL Study, an endpoint driven CV outcomes trial involving 23,504 patients, the safety of Kempo 60 or 90 mg daily was compared to diclofenac 150 mg daily in patients with OA or RA (mean duration of treatment was 20 months). In this large trial, only serious adverse events and discontinuations due to any adverse events were recorded. The rates of confirmed thrombotic cardiovascular serious adverse events were similar between Kempo and diclofenac. The incidence of discontinuations for hypertension-related adverse events was less than 3% in each treatment group; however, Kempo 60 and 90 mg demonstrated significantly higher rates of discontinuations for these events than diclofenac. The incidence of congestive heart failure adverse events (discontinuations and serious events) and the incidence of discontinuations due to edema occurred at similar rates on Kempo 60 mg compared to diclofenac; however, the incidences for these events were higher for Kempo 90 mg compared to diclofenac. The incidence of discontinuations due to atrial fibrillation was higher for Kempo compared to diclofenac.

The EDGE and EDGE II studies compared the GI tolerability of Kempo 90 mg daily (1.5 to 3 times the doses recommended for OA) and diclofenac 150 mg daily in 7111 patients with OA (EDGE Study; mean duration of treatment 9 months) and 4086 patients with RA (EDGE II; mean duration of treatment 19 months). In each of these studies, the adverse experience profile on Kempo was generally similar to that reported in the phase IIb/III placebo-controlled clinical studies; however, hypertension and edema-related adverse experiences occurred at a higher rate on Kempo 90 mg than on diclofenac 150 mg daily. The rate of confirmed thrombotic cardiovascular serious adverse events occurring in the two treatment groups was similar.

In a combined analysis of phase IIb to V clinical studies of 4 weeks duration or longer (excluding the MEDAL Program Studies), there was no discernible difference in the rate of confirmed thrombotic cardiovascular serious adverse events between patients receiving Kempo ≥30 mg or non-naproxen NSAIDs. The rate of these events was higher in patients receiving Kempo compared with those receiving naproxen 500 mg twice daily.

In a clinical study for ankylosing spondylitis, patients were treated with Kempo 90 mg once daily for up to 1 year (N=126). The adverse experience profile in this study was generally similar to that reported in chronic studies in OA, RA and chronic low back pain.

In a clinical study for acute gouty arthritis, patients were treated with Kempo 120 mg once daily for eight days. The adverse experience profile in this study was generally similar to that reported in the combined OA, RA, and chronic low back pain studies.

In initial clinical studies for acute analgesia, patients were treated with Kempo 120 mg once daily for one to seven days. The adverse experience profile in these studies was generally similar to that reported in the combined OA, RA, and chronic low back pain studies.

In the additional clinical studies for acute post-operative pain associated with dental and abdominal gynecological surgeries including 1222 patients treated with Kempo (90 mg or 120 mg), the adverse experience profile was generally similar to that reported in the combined OA, RA, and chronic low back pain studies.

In the combined studies for acute post-operative dental pain, the incidence of post-dental extraction alveolitis (dry socket) reported in patients treated with Kempo was similar to that of patients treated with active comparators.

Post-Marketing Experience: The following adverse reactions have been reported in post-marketing experience: Blood and Lymphatic System Disorders: Thrombocytopenia.

Immune System Disorders: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions including shock.

Metabolism and Nutrition Disorders: Hyperkalemia.

Psychiatric Disorders: Anxiety, insomnia, confusion, hallucinations, depression, restlessness.

Nervous System Disorders: Dysgeusia, somnolence.

Eye Disorders: Blurred vision.

Cardiac Disorders: Congestive heart failure, palpitations, angina, arrhythmia.

Vascular Disorders: Hypertensive crisis.

Respiratory, Thoracic and Mediastinal Disorders: Bronchospasm.

Gastrointestinal Disorders: Abdominal pain, oral ulcers, peptic ulcers including perforation and bleeding (mainly in elderly patients), vomiting, diarrhea.

Hepatobiliary Disorders: Hepatitis, jaundice, hepatic failure.

Skin and Subcutaneous Tissue Disorders: Angioedema, pruritus, erythema, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, fixed drug eruption.

Renal and Urinary Disorders: Renal insufficiency, including renal failure.

Kempo contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Known hypersensitivity to any excipients of Kempo; active peptic ulceration or gastrointestinal bleeding; severe hepatic dysfunction (Child-Pugh score >9); estimated CrCl <30 mL/min; developed signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs); inflammatory bowel disease; cardiovascular disease; congestive heart failure (NYHA II-IV); hypertension in which blood pressure has not been adequately controlled; established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (including patients who have recently undergone coronary artery bypass graft surgery or angioplasty).

Use in pregnancy: The use of Kempo, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive.

No clinical data on exposed pregnancies are available for Kempo. Studies in animals have shown reproductive toxicity. The potential for human risk in pregnancy is unknown. Kempo, as with other medicinal products inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester. Kempo is contraindicated in pregnancy. If a woman becomes pregnant during treatment, Kempo must be discontinued.

Reproductive studies conducted in rats have demonstrated no evidence of developmental abnormalities at doses up to 15 mg/kg/day [approximately 1.5 times the human dose (90 mg) based on systemic exposure]. At doses approximately 2 times the adult human exposure (90 mg) based on systemic exposure, a low incidence of cardiovascular malformations and increases in post-implantation loss were observed in Kempo-treated rabbits. No developmental effects were seen at systemic exposure of approximately equal to or less than the daily human dosage (90 mg). However, there was a decrease in embryo/foetal survival at exposures ≥1.5 times the human exposure. Animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women.

Use in lactation: It is not known whether Kempo is excreted in human milk. Kempo is excreted in the milk of lactating rats. Women who use Kempo must not breastfeed.

Use in children: Kempo is contraindicated in children <16 years. Safety and effectiveness of Kempo in pediatric patients have not been established and should not be given to them.


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References

  1. European Chemicals Agency - ECHA. "2,3'-Bipyridine, 5-chloro-6'-methyl-3-(4-(methylsulfonyl)phenyl)-: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
  2. NCIt. "Etoricoxib: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
  3. NIST. "5-Chloro-6'-methyl-3-[4-(methylsulfonyl)phenyl]-2,3'-bipyridine". http://www.nist.gov/srd/nist1a.cfm (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Kempo are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Kempo. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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