Loflam Side effects

• Side effects of Loflam in details
• Loflam contraindications
• Loflam reviews

Side effects of Loflam in details

Gastrointestinal: The most commonly-observed adverse events are gastrointestinal in nature.

Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Cardiovascular and Cerebrovascular: Edema, HTN and cardiac failure have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with an increased risk of arterial thrombotic events.

The majority of adverse reactions reported have been reversible and of a minor nature. The most frequent are gastrointestinal disorders, in particular dyspepsia, abdominal pain, nausea and diarrhea, and occasional occurrence of dizziness. Edema, HTN and cardiac failure have been reported in association with NSAID treatment.

Investigations: Abnormal hepatic enzyme and serum creatinine levels have also been reported.

Other adverse reactions reported less commonly include: Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.

Hepatic: Abnormal liver function, hepatitis and jaundice.

Neurological and Special Senses: Visual disturbances, optic neuritis, headaches, paresthesia, reports of aseptic meningitis with symptoms eg, stiff neck, headache, nausea, vomiting, fever or disorientation, depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.

Hematological: Agranulocytosis, aplastic anemia and hemolytic anemia.

Dermatological: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). Photosensitivity.

If serious adverse reactions occur, Loflam should be withdrawn.

The following is a table of adverse reactions reported during clinical studies and after authorization, grouped by system-organ class and estimated frequencies.

Loflam contraindications

Hypersensitivity to Loflam or any of the excipients of Loflam. Not to be given to those patients who have history of: Shock (cerebrovascular accident); heart attack (myocardial infarction); coronary artery bypass graft; congestive heart failure (CHF) NYHA II-IV.

Active or history of recurrent peptic ulcer/hemorrhage (≥2 distinct episodes of proven ulceration or bleeding).

Patients who have previously shown hypersensitivity reactions (eg, asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other NSAIDs. Severe heart failure, hepatic failure and renal failure.

History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Use in Children: There are no clinical data in children and therefore it is not recommended for use in children <18 years.

Use in Pregnancy: Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the fetal cardiovascular system (risk of closure of the ductus arteriosus) and on the possible risk of persistent pulmonary hypertension (HTN) of the new born, use in the last trimester of pregnancy is contraindicated. The regular use of NSAIDs during the last trimester of pregnancy may decrease uterine tone and contraction. The onset of labor may be delayed and the duration increased with an increased bleeding tendency in both mother and child. NSAIDs should not be used during the first 2 trimesters of pregnancy or labor unless the potential benefit to the patient outweighs the potential risk to the fetus.

Animal studies indicate that there was no evidence of teratogenesis in rats although the systemic exposure was low and in rabbits, treatment with Loflam (10 mg/kg/day) resulted in a series of morphological changes in some fetuses.

Loflam should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used.

References

1. DailyMed. "MELOXICAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. European Chemicals Agency - ECHA. "Aceclofenac: 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).
3. European Chemicals Agency - ECHA. "2H-1,2-Benzothiazine-3-carboxamide, 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-, 1,1-dioxide: The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness.". https://echa.europa.eu/ (accessed September 17, 2018).

Reviews

User reports

Consumer reviews

Information checked by Dr. Sachin Kumar, MD Pharmacology