Lofibra Capsules
Name: Lofibra Capsules
- Lofibra Capsules 67 mg
- Lofibra Capsules 200 mg
- Lofibra Capsules dosage
- Lofibra Capsules weight loss
- Lofibra Capsules and weight loss
Lofibra Capsules Description
LOFIBRA® [Fenofibrate capsules (micronized)] is a lipid regulating agent available as capsules for oral administration. The chemical name for fenofibrate is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:
The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions.
Each 67 mg LOFIBRA® contains the following inactive ingredients: croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, D&C Red #28, FD&C Blue #1, FD&C Red #40, titanium dioxide and gelatin.
Each 134 mg LOFIBRA® contains the following inactive ingredients: croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, D&C Red #28, FD&C Blue #1, titanium dioxide and gelatin.
Each 200 mg LOFIBRA® contains the following inactive ingredients: croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, FD&C Red #40, D&C Red #28, FDA/E172 yellow iron oxide, titanium dioxide and gelatin.
Adverse Reactions
CLINICAL
Adverse events reported by 2% or more of patients treated with fenofibrate during the double-blind, placebo-controlled trials, regardless of causality, are listed in the table below. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.
| * Dosage equivalent to 200 mg LOFIBRA® [Fenofibrate capsules (micronized)] † Significantly different from Placebo | ||
| BODY SYSTEM Adverse Event | Fenofibrate*(N=439) | PLACEBO (N=365) |
| BODY AS A WHOLE | ||
| Abdominal Pain | 4.6% | 4.4% |
| Back pain | 3.4% | 2.5% |
| Headache | 3.2% | 2.7% |
| Asthenia | 2.1% | 3.0% |
| Flu Syndrome | 2.1% | 2.7% |
| DIGESTIVE | ||
| Liver Function Tests Abnormal | 7.5%† | 1.4% |
| Diarrhea | 2.3% | 4.1% |
| Nausea | 2.3% | 1.9% |
| Constipation | 2.1% | 1.4% |
| METABOLIC AND NUTRITIONAL DISORDERS | ||
| SPGT Increased | 3.0% | 1.6% |
| Creatine Phosphokinase Increased | 3.0% | 1.4% |
| SGOT Increased | 3.4%† | 0.5% |
| RESPIRATORY | ||
| Respiratory Disorder | 6.2% | 5.5% |
| Rhinitis | 2.3% | 1.1% |
Additional adverse events reported during postmarketing surveillance or by three or more patients in placebo-controlled trials or reported in other controlled or open trials, regardless of causality are listed below.
BODY AS A WHOLE: Accidental injury, allergic reaction, chest pain, cyst, fever, hernia, infection, malaise, pain (unspecified), and photosensitivity reaction.
CARDIOVASCULAR SYSTEM: Angina pectoris, arrhythmia, atrial fibrillation, cardiovascular disorder, coronary artery disorder, electrocardiogram abnormal, extrasystoles, hypertension, hypotension, migraine, myocardial infarct, palpitation, peripheral vascular disorder, phlebitis, tachycardia, varicose vein, vascular disorder, vasodilatation, venous thromboembolic events (deep vein thrombosis, pulmonary embolus) and ventricular extrasystoles.
DIGESTIVE SYSTEM: Anorexia, cholecystitis, cholelithiasis, colitis, diarrhea, duodenal ulcer, dyspepsia, eructation, esophagitis, flatulence, gamma glutamyl transpeptidase, gastritis, gastroenteritis, gastrointestinal disorder, increased appetite, liver fatty deposit, nausea, nausea and vomiting, peptic ulcer, rectal disorder, rectal hemorrhage, tooth disorder, and vomiting.
ENDOCRINE SYSTEM: Diabetes mellitus.
HEMIC AND LYMPHATIC SYSTEM: Anemia, ecchymosis, eosinophilia, leukopenia, lymphadenopathy, and thrombocytopenia.
LABORATORY INVESTIGATIONS: Alkaline phosphatase increased, bilirubin increased, blood urea nitrogen increased, serum creatinine increased, gamma glutamyl transpeptidase increased, lactate dehydrogenase increased, SGOT and SGPT increased.
METABOLIC AND NUTRITIONAL DISORDERS: Creatinine increased, edema, gout, hyperuricemia, hypoglycemia, peripheral edema, weight gain, and weight loss.
MUSCULOSKELETAL SYSTEM: Arthralgia, arthritis, arthrosis, bursitis, joint disorder, leg cramps, myalgia, myasthenia, myositis, rhabdomyolysis and tenosynovitis.
NERVOUS SYSTEM: Anxiety or nervousness, depression, dizziness, dry mouth, hypertonia, insomnia, libido decreased, neuralgia, paresthesia, somnolence and vertigo.
RESPIRATORY SYSTEM: Allergic pulmonary alveolitis, asthma, bronchitis, cough increased, dyspnea, laryngitis, pharyngitis, pneumonia, and sinusitis.
SKIN AND APPENDAGES: Acne, alopecia, contact dermatitis, eczema, fungal dermatitis, herpes simplex, herpes zoster, maculopapular rash, nail disorder, photosensitivity reaction, pruritus, rash, skin disorder, skin ulcer, sweating, and urticaria.
SPECIAL SENSES: Abnormal vision, amblyopia, cataract specified, conjunctivitis, ear pain, eye disorder, otitis media, and refraction disorder.
UROGENITAL SYSTEM: Cystitis, dysuria, gynecomastia, kidney function abnormal, prostatic disorder, unintended pregnancy, urinary frequency, urolithiasis, and vaginal moniliasis.