Gemfibrozil
_DAVA(67253-741-50)_REV1.jpg "Gemfibrozil")
Loading...Gemfibrozil Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
1. Because of chemical, pharmacological, and clinical similarities between Gemfibrozil and clofibrate, the adverse findings with clofibrate in two large clinical studies may also apply to Gemfibrozil. In the first of those studies, the Coronary Drug Project, 1000 subjects with previous myocardial infarction were treated for five years with clofibrate. There was no difference in mortality between the clofibrate-treated subjects and 3000 placebo-treated subjects, but twice as many clofibrate-treated subjects developed cholelithiasis and cholecystitis requiring surgery. In the other study, conducted by the World Health Organization (WHO), 5000 subjects without known coronary heart disease were treated with clofibrate for five years and followed one year beyond. There was a statistically significant (44%) higher age-adjusted total mortality in the clofibrate-treated group than in a comparable placebo-treated control group during the trial period. The excess mortality was due to a 33% increase in non-cardiovascular causes, including malignancy, post-cholecystectomy complications, and pancreatitis. The higher risk of clofibrate-treated subjects for gallbladder disease was confirmed.
Because of the more limited size of the Helsinki Heart Study, the observed difference in mortality from any cause between the Gemfibrozil and placebo groups is not statistically significantly different from the 29% excess mortality reported in the clofibrate group in the separate WHO study at the nine year follow-up (see CLINICAL PHARMACOLOGY). Noncoronary heart disease related mortality showed an excess in the group originally randomized to Gemfibrozil primarily due to cancer deaths observed during the open-label extension.
During the five year primary prevention component of the Helsinki Heart Study, mortality from any cause was 44 (2.2%) in the Gemfibrozil group and 43 (2.1%) in the placebo group; including the 3.5 year follow-up period since the trial was completed, cumulative mortality from any cause was 101 (4.9%) in the Gemfibrozil group and 83 (4.1%) in the group originally randomized to placebo (hazard ratio 1:20 in favor of placebo). Because of the more limited size of the Helsinki Heart Study, the observed difference in mortality from any cause between the Gemfibrozil and placebo groups at Year-5 or at Year-8.5 is not statistically significantly different from the 29% excess mortality reported in the clofibrate group in the separate WHO study at the nine year follow-up. Noncoronary heart disease related mortality showed an excess in the group originally randomized to Gemfibrozil at the 8.5 year follow-up (65 Gemfibrozil versus 45 placebo noncoronary deaths).
The incidence of cancer (excluding basal cell carcinoma) discovered during the trial and in the 3.5 years after the trial was completed was 51 (2.5%) in both originally randomized groups. In addition, there were 16 basal cell carcinomas in the group originally randomized to Gemfibrozil and 9 in the group originally randomized to placebo (p=0.22). There were 30 (1.5%) deaths attributed to cancer in the group originally randomized to Gemfibrozil and 18 (0.9%) in the group originally randomized to placebo (p=0.11). Adverse outcomes, including coronary events, were higher in Gemfibrozil patients in a corresponding study in men with a history of known or suspected coronary heart disease in the secondary prevention component of the Helsinki Heart Study (see CLINICAL PHARMACOLOGY).
A comparative carcinogenicity study was also done in rats comparing three drugs in this class: fenofibrate (10 and 60 mg/kg; 0.3 and 1.6 times the human dose, respectively), clofibrate (400 mg/kg; 1.6 times the human dose), and Gemfibrozil (250 mg/kg; 1.7 times the human dose). Pancreatic acinar adenomas were increased in males and females on fenofibrate; hepatocellular carcinoma and pancreatic acinar adenomas were increased in males and hepatic neoplastic nodules in females treated with clofibrate; hepatic neoplastic nodules were increased in males and females treated with clofibrate; hepatic neoplastic nodules were increased in males and females treated with Gemfibrozil while testicular interstitial cell (Leydig cell) tumors were increased in males on all three drugs.
2. A gallstone prevalence substudy of 450 Helsinki Heart Study participants showed a trend toward a greater prevalence of gallstones during the study within the Gemfibrozil treatment group (7.5% versus 4.9% for the placebo group, a 55% excess for the Gemfibrozil group). A trend toward a greater incidence of gallbladder surgery was observed for the Gemfibrozil group (17 versus 11 subjects, a 54% excess). This result did not differ statistically from the increased incidence of cholecystectomy observed in the WHO study in the group treated with clofibrate. Both clofibrate and Gemfibrozil may increase cholesterol excretion into the bile leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Gemfibrozil therapy should be discontinued if gallstones are found. Cases of cholelithiasis have been reported with Gemfibrozil therapy.
3. Since a reduction of mortality from coronary heart disease has not been demonstrated and because liver and interstitial cell testicular tumors were increased in rats, Gemfibrozil should be administered only to those patients described in the INDICATIONS AND USAGE section. If a significant serum lipid response is not obtained, Gemfibrozil should be discontinued.
4. Concomitant Anticoagulants – Caution should be exercised when warfarin is given in conjunction with Gemfibrozil. The dosage of warfarin should be reduced to maintain the prothrombin time at the desired level to prevent bleeding complications. Frequent prothrombin determinations are advisable until it has been definitely determined that the prothrombin level has stabilized.
5. The concomitant administration of Gemfribrozil with simvastatin is contraindicated (see CONTRAINDICATIONS and PRECAUTIONS). Concomitant therapy with Gemfibrozil and an HMG-CoA reductase inhibitor is associated with an increased risk of skeletal muscle toxicity manifested as rhabdomyolysis, markedly elevated creatine kinase (CPK) levels, and myoglobinuria, leading in a high proportion of cases to acute renal failure and death. IN PATIENTS WHO HAVE HAD AN UNSATISFACTORY LIPID RESPONSE TO EITHER DRUG ALONE, THE BENEFIT OF COMBINED THERAPY WITH GEMFIBROZIL AND an HMG-CoA REDUCTASE INHIBITOR DOES NOT OUTWEIGH THE RISKS OF SEVERE MYOPATHY, RHABDOMYOLYSIS, AND ACUTE RENAL FAILURE (see PRECAUTIONS, Drug Interactions). The use of fibrates alone, including Gemfibrozil, may occasionally be associated with myositis. Patients receiving Gemfibrozil and complaining of muscle pain, tenderness or weakness should have prompt medical evaluation for myositis, including serum creatine-kinase level determination. If myositis is suspected or diagnosed, Gemfibrozil therapy should be withdrawn.
6. Cataracts – Subcapsular bilateral cataracts occurred in 10%, and unilateral in 6.3%, of male rats treated with Gemfibrozil at 10 times the human dose.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Gemfibrozil (Gemfibrozil tablets, USP) is indicated as adjunctive therapy to diet for:
- Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of Gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia.
- Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with Gemfibrozil. In some patients with high triglyceride levels, treatment with Gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL- CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.
In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for Gemfibrozil and placebo subgroups (see Table I).
The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
History
There is currently no drug history available for this drug.
Other Information
Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg Gemfibrozil. Each tablet also contains calcium stearate, microcrystalline cellulose, hydroxypropyl cellulose, Opadry white, polysorbate 80, sodium starch glycolate, colloidal silicon dioxide, and pregelatinized starch. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula:
The empirical formula is C 15H 22O 3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°-61° C. Gemfibrozil is a white solid which is stable under ordinary conditions.
Sources
Gemfibrozil Manufacturers
-
Blenheim Pharmacal, Inc.
![Gemfibrozil Tablet, Film Coated [Blenheim Pharmacal, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Gemfibrozil | Blenheim Pharmacal, Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Northwind Pharmaceuticals, Llc
Gemfibrozil | Northwind Pharmaceuticals, Llc
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Kaiser Foundation Hospitals
Gemfibrozil | Kaiser Foundation Hospitals
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Kaiser Foundation Hospitals
Gemfibrozil | Kaiser Foundation Hospitals
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Contract Pharmacy Services-pa
Gemfibrozil | Contract Pharmacy Services-pa
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Global Pharmaceuticals, Division Of Impax Laboratories Inc.
Gemfibrozil | Global Pharmaceuticals, Division Of Impax Laboratories Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
State Of Florida Doh Central Pharmacy
Gemfibrozil | State Of Florida Doh Central Pharmacy
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
State Of Florida Doh Central Pharmacy
Gemfibrozil | State Of Florida Doh Central Pharmacy
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Physicians Total Care, Inc.
Gemfibrozil | Physicians Total Care, Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
State Of Florida Doh Central Pharmacy
Gemfibrozil | State Of Florida Doh Central Pharmacy
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Hikma Pharmaceutical
Gemfibrozil | Hikma Pharmaceutical
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
West-ward Pharmaceutical Corp
Gemfibrozil | West-ward Pharmaceutical Corp
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Contract Pharmacy Services-pa
Gemfibrozil | Contract Pharmacy Services-pa
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Major Pharmaceuticals
Gemfibrozil | Major Pharmaceuticals
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Rebel Distributors Corp
Gemfibrozil | Rebel Distributors Corp
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Remedyrepack Inc.
Gemfibrozil | Remedyrepack Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Remedyrepack Inc.
Gemfibrozil | Remedyrepack Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Remedyrepack Inc.
Gemfibrozil | Remedyrepack Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Udl Laboratories, Inc.
Gemfibrozil | Mylan Institutional Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Camber Pharmaceuticals
Gemfibrozil | Universal
DIRECTIONS FOR TEAT DIPPING
FOR PRE-MILKING:
After teats have been properly cleaned, dip each quarter in undiluted PROTEAT iodine teat dip. Allow product to stay on teats 30 seconds, then wipe dry with a clean towel. Examine each quarter with strip cup before applying milking unit.
FOR POST-MILKING:
Use as is; do not dilute. Immediately after milking dip entire teat in undiluted PROTEAT and allow to air dry. Make a fresh solution if the dip becomes visibly cloudy or dirty. PROTEAT is formulated for use as an aid in reducing the spread of organisms which may cause mastitis. For further information regarding good sanitary practice in the milking parlor, consult your Universal representative.
-
Exelan Pharmaceuticals, Inc.
Gemfibrozil | Exelan Pharmaceuticals, Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Pd-rx Pharmaceuticals, Inc.
Gemfibrozil | Macleods Pharmaceuticals Limited
2.1 Dosing in Mild to Moderate Alzheimer's DiseaseThe recommended starting dosage of donepezil hydrochloride tablets are 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride tablets in patients with mild to moderate Alzheimer’s disease is 10 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks.
2.2 Dosing in Moderate to Severe Alzheimer's DiseaseThe recommended starting dosage of donepezil hydrochloride tablets are 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride tablets in patients with moderate to severe Alzheimer’s disease is 23 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. A dose of 23 mg per day should not be administered until patients have been on a daily dose of 10 mg for at least 3 months.
2.3 Administration InformationDonepezil hydrochloride tablets should be taken in the evening, just prior to retiring. Donepezil hydrochloride tablets can be taken with or without food. The donepezil hydrochloride tablets 23 mg tablet should not be split, crushed, or chewed.
-
Golden State Medical Supply, Inc.
Gemfibrozil | Golden State Medical Supply, Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
West-ward Pharmaceutical Corp
Gemfibrozil | West-ward Pharmaceutical Corp
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Caraco Pharmaceutical Laboratories, Ltd.
Gemfibrozil | Caraco Pharmaceutical Laboratories, Ltd.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Mckesson Contract Packaging
Gemfibrozil | Mckesson Contract Packaging
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Med-health Pharma, Llc
Gemfibrozil | Med-health Pharma, Llc
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Aphena Pharma Solutions – Tennessee, Inc.
Gemfibrozil | Aphena Pharma Solutions - Tennessee, Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Dispensing Solutions, Inc.
Gemfibrozil | Dispensing Solutions, Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Bryant Ranch Prepack
Gemfibrozil | Bryant Ranch Prepack
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Remedyrepack Inc.
Gemfibrozil | Remedyrepack Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Gemfibrozil | Merle Norman Cosmetics, Inc
Directions
· Apply liberally 15 minutes before sun exposure
· Reapply at least every 2 hours
· Use a water resistant sunscreen if swimming or sweating
· Sun Protection Measures. Spending time in the sun increases your risk of skin
cancer and early skin aging. To decrease this risk, regularly use a sunscreen
with broad spectrum SPF of 15 or higher and other sun protection measures
including:
· limit time in the sun, especially from 10 a.m. - 2 p.m.
· wear long-sleeve shirts, pants, hats, and sunglasses
· Children under 6 months: Ask a doctorInactive Ingredients
Water (Aqua), Cyclopentasiloxane, Clyclohexasiloxane, Isododecane, Alcohol Denat., Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Acrylates/Dimethicone Copolymer, Silica, Acrylates Copolymer, Sodium Myristoyl Glutamate, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Disteardimonium Hectorite, Caprylyl Glycol, Aluminum Oxide, Stearic Acid, Propylene Glycol, Propylene Carbonate, Tetrasodium EDTA, Methylisothiazolinone,
May Contain: Iron Oxides, Titanium Dioxide, Triethoxycaprylylsilane -
Golden State Medical Supply, Inc.
Gemfibrozil | Golden State Medical Supply, Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Remedyrepack Inc.
Gemfibrozil | Remedyrepack Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
A-s Medication Solutions Llc
Gemfibrozil | A-s Medication Solutions Llc
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Unit Dose Services
Gemfibrozil | Unit Dose Services
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see ). CLINICAL PHARMACOLOGY
-
Major Pharmaceuticals
Gemfibrozil | Major Pharmaceuticals
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Northstar Rxllc
Gemfibrozil | Northstar Rxllc
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Aidarex Pharmaceuticals Llc
Gemfibrozil | Aidarex Pharmaceuticals Llc
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
American Health Packaging
Gemfibrozil | American Health Packaging
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Apotex Corp.
Gemfibrozil | Sun Pharmaceutical Industries, Inc.
There is no fixed dosage regimen for the management of type 2 diabetes with Repaglinide.
The patient’s blood glucose should be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood glucose-lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels are of value in monitoring the patient’s longer term response to therapy.
Short-term administration of Repaglinide may be sufficient during periods of transient loss of control in patients usually well controlled on diet.
Repaglinide doses are usually taken within 15 minutes of the meal but time may vary from immediately preceding the meal to as long as 30 minutes before the meal.
Starting Dose
For patients not previously treated or whose HbA1c is < 8%, the starting dose should be 0.5 mg with each meal. For patients previously treated with blood glucose-lowering drugs and whose HbA1c is ≥8%, the initial dose is 1 or 2 mg with each meal preprandially (see previous paragraph).
Dose Adjustment
Dosing adjustments should be determined by blood glucose response, usually fasting blood glucose. Postprandial glucose levels testing may be clinically helpful in patients whose pre-meal blood glucose levels are satisfactory but whose overall glycemic control (HbA1c) is inadequate. The preprandial dose should be doubled up to 4 mg with each meal until satisfactory blood glucose response is achieved. At least one week should elapse to assess response after each dose adjustment.
The recommended dose range is 0.5 mg to 4 mg taken with meals. Repaglinide may be dosed preprandially 2, 3, or 4 times a day in response to changes in the patient’s meal pattern. The maximum recommended daily dose is 16 mg.
Patient Management
Long-term efficacy should be monitored by measurement of HbA1c levels approximately every 3 months. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia or hyperglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy including hypoglycemia. When hypoglycemia occurs in patients taking a combination of Repaglinide and a thiazolidinedione, the dose of Repaglinide should be reduced.
Patients Receiving Other Oral Hypoglycemic Agents
When Repaglinide is used to replace therapy with other oral hypoglycemic agents, Repaglinide may be started on the day after the final dose is given. Patients should then be observed carefully for hypoglycemia due to potential overlapping of drug effects. When transferred from longer half-life sulfonylurea agents (e.g., chlorpropamide) to repaglinide, close monitoring may be indicated for up to one week or longer.
Combination Therapy
If Repaglinide monotherapy does not result in adequate glycemic control, a thiazolidinedione may be added. If thiazolidinedione monotherapy does not provide adequate control, Repaglinide may be added. The starting dose and dose adjustments for Repaglinide combination therapy is the same as for Repaglinide monotherapy. The dose of each drug should be carefully adjusted to determine the minimal dose required to achieve the desired pharmacologic effect. Failure to do so could result in an increase in the incidence of hypoglycemic episodes. Appropriate monitoring of FPG and HbA1c measurements should be used to ensure that the patient is not subjected to excessive drug exposure or increased probability of secondary drug failure.
-
Preferred Pharmaceuticals, Inc
Gemfibrozil | Preferred Pharmaceuticals, Inc
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
State Of Florida Doh Central Pharmacy
Gemfibrozil | State Of Florida Doh Central Pharmacy
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
State Of Florida Doh Central Pharmacy
Gemfibrozil | State Of Florida Doh Central Pharmacy
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
St Marys Medical Park Pharmacy
Gemfibrozil | St Marys Medical Park Pharmacy
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Aphena Pharma Solutions – Tennessee, Llc
Gemfibrozil | Aphena Pharma Solutions - Tennessee, Llc
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Cardinal Health
Gemfibrozil | Cardinal Health
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Blu Pharmaceuticals, Llc
Gemfibrozil | Blu Pharmaceuticals, Llc
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Proficient Rx Lp
Gemfibrozil | Citra Labs
Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.
-
Clinical Solutions Wholesale
Gemfibrozil | Clinical Solutions Wholesale
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Blu Pharmaceuticals, Llc
Gemfibrozil | Blu Pharmaceuticals, Llc
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Cardinal Health
Gemfibrozil | Cardinal Health
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
-
Avpak
Gemfibrozil | Foshan Nanhai Jinxiong Toys C O., Ltd
Directions
Rub a dime sized drop into hands. For children under 6 use under adult supervision. -
Dava Pharmaceuticals, Inc.
Gemfibrozil | Dava Pharmaceuticals, Inc.
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
-
Teva Pharmaceuticals Usa Inc
Gemfibrozil | Glenmark Pharmaceuticals Inc., Usa
2.1 General Dosing ConsiderationsRash: There are suggestions, yet to be proven, that the risk of severe, potentially life-threatening rash may be increased by (1) coadministration of lamotrigine with valproate, (2) exceeding the recommended initial dose of lamotrigine, or (3) exceeding the recommended dose escalation for lamotrigine. However, cases have occurred in the absence of these factors [see Boxed Warning]. Therefore, it is important that the dosing recommendations be followed closely.
The risk of nonserious rash may be increased when the recommended initial dose and/or the rate of dose escalation for lamotrigine is exceeded and in patients with a history of allergy or rash to other AEDs.
It is recommended that lamotrigine not be restarted in patients who discontinued due to rash associated with prior treatment with lamotrigine, unless the potential benefits clearly outweigh the risks. If the decision is made to restart a patient who has discontinued lamotrigine, the need to restart with the initial dosing recommendations should be assessed. The greater the interval of time since the previous dose, the greater consideration should be given to restarting with the initial dosing recommendations. If a patient has discontinued lamotrigine for a period of more than 5 half-lives, it is recommended that initial dosing recommendations and guidelines be followed. The half-life of lamotrigine is affected by other concomitant medications [see Clinical Pharmacology (12.3)].
Lamotrigine Added to Drugs Known to Induce or Inhibit Glucuronidation:
Because lamotrigine is metabolized predominantly by glucuronic acid conjugation, drugs that are known to induce or inhibit glucuronidation may affect the apparent clearance of lamotrigine. Drugs that induce glucuronidation include carbamazepine, phenytoin, phenobarbital, primidone, rifampin, estrogen-containing oral contraceptives, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Valproate inhibits glucuronidation. For dosing considerations for lamotrigine in patients on estrogen-containing contraceptives and atazanavir/ritonavir, see below and Table 13. For dosing considerations for lamotrigine in patients on other drugs known to induce or inhibit glucuronidation, see Table 1, Table 2, Table 5- 6, and Table 13.Target Plasma Levels for Patients With Epilepsy or Bipolar Disorder:
A therapeutic plasma concentration range has not been established for lamotrigine. Dosing of lamotrigine should be based on therapeutic response [see Clinical Pharmacology (12.3)].Women Taking Estrogen-Containing Oral Contraceptives:Starting Lamotrigine in Women Taking Estrogen-Containing Oral Contraceptives:
Although estrogen-containing oral contraceptives have been shown to increase the clearance of lamotrigine [see Clinical Pharmacology (12.3)], no adjustments to the recommended dose-escalation guidelines for lamotrigine should be necessary solely based on the use of estrogen-containing oral contraceptives. Therefore, dose escalation should follow the recommended guidelines for initiating adjunctive therapy with lamotrigine based on the concomitant AED or other concomitant medications (see Table 1, 5 and 7). See below for adjustments to maintenance doses of lamotrigine in women taking estrogen-containing oral contraceptives.Adjustments to the Maintenance Dose of Lamotrigine In Women Taking Estrogen-Containing Oral Contraceptives:
(1) Taking Estrogen-Containing Oral Contraceptives: In women not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], the maintenance dose of lamotrigine will in most cases need to be increased, by as much as 2-fold over the recommended target maintenance dose to maintain a consistent lamotrigine plasma level.
(2) Starting Estrogen-Containing Oral Contraceptives: In women taking a stable dose of lamotrigine and not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], the maintenance dose will in most cases need to be increased by as much as 2-fold to maintain a consistent lamotrigine plasma level. The dose increases should begin at the same time that the oral contraceptive is introduced and continue, based on clinical response, no more rapidly than 50 to 100 mg/day every week. Dose increases should not exceed the recommended rate (see Table 1 or Table 5) unless lamotrigine plasma levels or clinical response support larger increases. Gradual transient increases in lamotrigine plasma levels may occur during the week of inactive hormonal preparation (pill-free week), and these increases will be greater if dose increases are made in the days before or during the week of inactive hormonal preparation. Increased lamotrigine plasma levels could result in additional adverse reactions, such as dizziness, ataxia, and diplopia. If adverse reactions attributable to lamotrigine consistently occur during the pill-free week, dose adjustments to the overall maintenance dose may be necessary. Dose adjustments limited to the pill-free week are not recommended. For women taking lamotrigine in addition to carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], no adjustment to the dose of lamotrigine should be necessary.
(3) Stopping Estrogen-Containing Oral Contraceptives: In women not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], the maintenance dose of lamotrigine will in most cases need to be decreased by as much as 50% in order to maintain a consistent lamotrigine plasma level. The decrease in dose of lamotrigine should not exceed 25% of the total daily dose per week over a 2-week period, unless clinical response or lamotrigine plasma levels indicate otherwise [see Clinical Pharmacology (12.3)]. In women taking lamotrigine in addition to carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], no adjustment to the dose of lamotrigine should be necessary.
Women and Other Hormonal Contraceptive Preparations or Hormone Replacement Therapy: The effect of other hormonal contraceptive preparations or hormone replacement therapy on the pharmacokinetics of lamotrigine has not been systematically evaluated. It has been reported that ethinylestradiol, not progestogens, increased the clearance of lamotrigine up to 2-fold, and the progestin-only pills had no effect on lamotrigine plasma levels. Therefore, adjustments to the dosage of lamotrigine in the presence of progestogens alone will likely not be needed.
Patients Taking Atazanavir/Ritonavir:
While atazanavir/ritonavir does reduce the lamotrigine plasma concentration, no adjustments to the recommended dose-escalation guidelines for lamotrigine should be necessary solely based on the use of atazanavir/ritonavir. Dose escalation should follow the recommended guidelines for initiating adjunctive therapy with lamotrigine based on concomitant AED or other concomitant medications (see Tables 1, 2, and 5). In patients already taking maintenance doses of lamotrigine and not taking glucuronidation inducers, the dose of lamotrigine may need to be increased if atazanavir/ritonavir is added, or decreased if atazanavir/ritonavir is discontinued [see Clinical Pharmacology (12.3)].
Patients With Hepatic Impairment:Experience in patients with hepatic impairment is limited. Based on a clinical pharmacology study in 24 subjects with mild, moderate, and severe liver impairment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)], the following general recommendations can be made. No dosage adjustment is needed in patients with mild liver impairment. Initial, escalation, and maintenance doses should generally be reduced by approximately 25% in patients with moderate and severe liver impairment without ascites and 50% in patients with severe liver impairment with ascites. Escalation and maintenance doses may be adjusted according to clinical response.
Patients With Renal Impairment:Initial doses of lamotrigine should be based on patients' concomitant medications (see Tables 1-3 or Table 5); reduced maintenance doses may be effective for patients with significant renal impairment [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)]. Few patients with severe renal impairment have been evaluated during chronic treatment with lamotrigine. Because there is inadequate experience in this population, lamotrigine should be used with caution in these patients.
Discontinuation Strategy: Epilepsy:For patients receiving lamotrigine in combination with other AEDs, a re-evaluation of all AEDs in the regimen should be considered if a change in seizure control or an appearance or worsening of adverse reactions is observed.
If a decision is made to discontinue therapy with lamotrigine, a step-wise reduction of dose over at least 2 weeks (approximately 50% per week) is recommended unless safety concerns require a more rapid withdrawal [see Warnings and Precautions (5.8)].
Discontinuing carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation should prolong the half-life of lamotrigine; discontinuing valproate should shorten the half-life of lamotrigine.
Bipolar Disorder:In the controlled clinical trials, there was no increase in the incidence, type, or severity of adverse reactions following abrupt termination of lamotrigine. In clinical trials in patients with bipolar disorder, 2 patients experienced seizures shortly after abrupt withdrawal of lamotrigine. However, there were confounding factors that may have contributed to the occurrence of seizures in these patients with bipolar disorder. Discontinuation of lamotrigine should involve a step-wise reduction of dose over at least 2 weeks (approximately 50% per week) unless safety concerns require a more rapid withdrawal [see Warnings and Precautions (5.8)].
2.2 Epilepsy - Adjunctive TherapyThis section provides specific dosing recommendations for patients older than 12 years and patients aged 2 to 12 years. Within each of these age-groups, specific dosing recommendations are provided depending upon concomitant AEDs or other concomitant medications (see Table 1 for patients older than 12 years and Table 2 for patients aged 2 to 12 years). A weight-based dosing guide for patients aged 2 to 12 years on concomitant valproate is provided in Table 3.
Patients Older Than 12 Years:Recommended dosing guidelines are summarized in Table 1.
Table 1. Escalation Regimen for Lamotrigine in Patients Older Than 12 Years With EpilepsyIn Patients TAKING Valproatea
In Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidoneb, or Valproatea
In Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb and NOT TAKING Valproatea
Weeks 1 and 2
25 mg every other day
25 mg every day
50 mg/day
Weeks 3 and 4
25 mg every day
50 mg/day
100 mg/day (in 2 divided doses)
Week 5 onward to maintenance
Increase by 25 to 50 mg/day every 1 to 2 weeks
Increase by 50 mg/day every 1 to 2 weeks
Increase by 100 mg/day every 1 to 2 weeks.
Usual Maintenance Dose
100 to 200 mg/day with valproate alone
100 to 400 mg/day with valproate and other drugs that induce glucuronidation (in 1 or 2 divided doses)
225 to 375 mg/day (in 2 divided doses)
300 to 500 mg/day (in 2 divided doses)
a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see Drug Interactions (7), Clinical Pharmacology (12.3)].
b Drugs that induce lamotrigine glucuronidation and clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see Dosage and Administration (2.1), Drug Interactions (7), Clinical Pharmacology (12.3)].
Patients Aged 2 to 12 Years:Recommended dosing guidelines are summarized in Table 2.
Lower starting doses and slower dose escalations than those used in clinical trials are recommended because of the suggestion that the risk of rash may be decreased by smaller starting doses and slower dose escalations. Therefore, maintenance doses will take longer to reach in clinical practice than in clinical trials. It may take several weeks to months to achieve an individualized maintenance dose. Maintenance doses in patients weighing less than 30 kg, regardless of age or concomitant AED, may need to be increased as much as 50%, based on clinical response.
Table 2. Escalation Regimen for Lamotrigine in Patients Aged 2 to 12 Years With EpilepsyIn Patients TAKING Valproatea
In Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidoneb, or Valproatea
In Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb and NOT TAKING Valproatea
Weeks 1 and 2
0.15 mg/kg/day in 1 or 2 divided doses, rounded down to the nearest whole tablet (see Table 3 for weight based dosing guide)
0.3 mg/kg/day in 1 or 2 divided doses, rounded down to the nearest whole tablet
0.6 mg/kg/day in 2 divided doses, rounded down to the nearest whole tablet
Weeks 3 and 4
0.3 mg/kg/day in 1 or 2 divided doses, rounded down to the nearest whole tablet (see Table 3 for weight based dosing guide)
0.6 mg/kg/day in 2 divided doses, rounded down to the nearest whole tablet
1.2 mg/kg/day in 2 divided doses, rounded down to the nearest whole tablet
Week 5 onward to maintenance
The dose should be increased every 1 to 2 weeks as follows: calculate 0.3 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose
The dose should be increased every 1 to 2 weeks as follows: calculate 0.6 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose
The dose should be increased every 1 to 2 weeks as follows: calculate 1.2 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose
Usual Maintenance Dose
1 to 5 mg/kg/day (maximum 200 mg/day in 1 or 2 divided doses) 1 to 3 mg/kg/day with valproate alone
4.5 to 7.5 mg/kg/day (maximum 300 mg/day in 2 divided doses)
5 to 15 mg/kg/day (maximum 400 mg/day in 2 divided doses)
Maintenance dose in patients less than 30 kg
May need to be increased by as much as 50%, based on clinical response
May need to be increased by as much as 50%, based on clinical response
May need to be increased by as much as 50%, based on clinical response
Note: Only whole tablets should be used for dosing.
a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see Drug Interactions (7), Clinical Pharmacology (12.3)].
b Drugs that induce lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see Dosage and Administration (2.1), Drug Interactions (7), and Clinical Pharmacology (12.3)].
Table 3. The Initial Weight-Based Dosing Guide for Patients Aged 2 to 12 Years Taking Valproate (Weeks 1 to 4) With EpilepsyIf the patient’s weight is
Give this daily dose, using the most appropriate combination of lamotrigine 2-mg and 5-mg tablets
Greater than
And less than
Weeks 1 and 2
Weeks 3 and 4
6.7 kg
14 kg
2 mg every other day
2 mg every day
14.1 kg
27 kg
2 mg every day
4 mg every day
27.1 kg
34 kg
4 mg every day
8 mg every day
34.1 kg
40 kg
5 mg every day
10 mg every day
Usual Adjunctive Maintenance Dose for EpilepsyThe usual maintenance doses identified in Tables 1 and 2 are derived from dosing regimens employed in the placebo-controlled adjunctive trials in which the efficacy of lamotrigine was established. In patients receiving multidrug regimens employing carbamazepine, phenytoin, phenobarbital, or primidone without valproate, maintenance doses of adjunctive lamotrigine as high as 700 mg/day have been used. In patients receiving valproate alone, maintenance doses of adjunctive lamotrigine as high as 200 mg/day have been used. The advantage of using doses above those recommended in Tables 1 - 4 has not been established in controlled trials.
2.3 Epilepsy - Conversion From Adjunctive Therapy to MonotherapyThe goal of the transition regimen is to attempt to maintain seizure control while mitigating the risk of serious rash associated with the rapid titration of lamotrigine.
The recommended maintenance dose of lamotrigine as monotherapy is 500 mg/day given in 2 divided doses.
To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations for lamotrigine should not be exceeded [see Boxed Warning].
Conversion From Adjunctive Therapy With Carbamazepine, Phenytoin, Phenobarbital, or Primidone to Monotherapy With LamotrigineAfter achieving a dose of 500 mg/day of lamotrigine using the guidelines in Table 1, the concomitant enzyme-inducing AED should be withdrawn by 20% decrements each week over a 4-week period. The regimen for the withdrawal of the concomitant AED is based on experience gained in the controlled monotherapy clinical trial.
Conversion from Adjunctive Therapy With Valproate to Monotherapy With LamotrigineThe conversion regimen involves the 4 steps outlined in Table 4.
Table 4. Conversion From Adjunctive Therapy With Valproate to Monotherapy With Lamotrigine in Patients Aged 16 Years and Older With EpilepsyLamotrigine
Valproate
Step 1
Achieve a dose of 200 mg/day according to guidelines in Table 1.
Maintain established stable dose.
Step 2
Maintain at 200 mg/day.
Decrease dose by decrements no greater than 500 mg/day/week to 500 mg/day and then maintain for 1 week.
Step 3
Increase to 300 mg/day and maintain for 1 week.
Simultaneously decrease to 250 mg/day and maintain for 1 week.
Step 4
Increase by 100 mg/day every week to achieve maintenance dose of 500 mg/day.
Discontinue.
Conversion from Adjunctive Therapy With Antiepileptic Drugs Other Than Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate to Monotherapy With LamotrigineNo specific dosing guidelines can be provided for conversion to monotherapy with lamotrigine with AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate.
2.4 Bipolar DisorderThe goal of maintenance treatment with lamotrigine is to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Indications and Usage (1)]. Patients taking lamotrigine for more than 16 weeks should be periodically reassessed to determine the need for maintenance treatment.
Adults
The target dose of lamotrigine is 200 mg/day (100 mg/day in patients taking valproate, which decreases the apparent clearance of lamotrigine, and 400 mg/day in patients not taking valproate and taking either carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitor lopinavir/ritonavir that increase the apparent clearance of lamotrigine). In the clinical trials, doses up to 400 mg/day as monotherapy were evaluated; however, no additional benefit was seen at 400 mg/day compared with 200 mg/day [see Clinical Studies (14.2)]. Accordingly, doses above 200 mg/day are not recommended.
Treatment with lamotrigine is introduced, based on concurrent medications, according to the regimen outlined in Table 5. If other psychotropic medications are withdrawn following stabilization, the dose of lamotrigine should be adjusted. For patients discontinuing valproate, the dose of lamotrigine should be doubled over a 2-week period in equal weekly increments (see Table 6). For patients discontinuing carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation, the dose of lamotrigine should remain constant for the first week and then should be decreased by half over a 2-week period in equal weekly decrements (see Table 6). The dose of lamotrigine may then be further adjusted to the target dose (200 mg) as clinically indicated.
If other drugs are subsequently introduced, the dose of lamotrigine may need to be adjusted. In particular, the introduction of valproate requires reduction in the dose of lamotrigine [see Drug Interactions (7), Clinical Pharmacology (12.3)].
To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of lamotrigine should not be exceeded [see Boxed Warning].
Table 5. Escalation Regimen for Lamotrigine in Patients With Bipolar DisorderIn Patients TAKING Valproatea
In Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidoneb, or Valproatea
In Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb and NOT TAKING Valproatea
Weeks 1 and 2
25 mg every other day
25 mg daily
50 mg daily
Weeks 3 and 4
25 mg daily
50 mg daily
100 mg daily, in divided doses
Week 5
50 mg daily
100 mg daily
200 mg daily, in divided doses
Week 6
100 mg daily
200 mg daily
300 mg daily, in divided doses
Week 7
100 mg daily
200 mg daily
up to 400 mg daily, in divided doses
a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see Drug Interactions (7), Clinical Pharmacology (12.3)].
b Drugs that induce lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see Dosage and Administration (2.1), Drug Interactions (7), and Clinical Pharmacology (12.3)].
Table 6. Dosage Adjustments to Lamotrigine In Patients With Bipolar Disorder Following Discontinuation of Psychotropic MedicationsDiscontinuation of Psychotropic Drugs (excluding Valproatea, Carbamazepine, Phenytoin, Phenobarbital or Primidoneb)
After Discontinuation of Valproatea
After Discontinuation of Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb
Current dose of lamotrigine (mg/day) 100
Current dose of lamotrigine (mg/day) 400
Week 1
Maintain current dose of lamotrigine
150
400
Week 2
Maintain current dose of lamotrigine
200
300
Week 3 onward
Maintain current dose of lamotrigine
200
200
a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see Drug Interactions (7), Clinical Pharmacology (12.3)].
b Drugs that induce lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see Dosage and Administration (2.1), Drug Interactions (7), and Clinical Pharmacology (12.3)].
-
Aurobindo Pharma Limited
Gemfibrozil | Aurobindo Pharma Limited
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
OVERDOSAGE
There have been reported cases of overdosage with gemfibrozil. In one case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil. Symptoms reported with overdosage were abdominal cramps, abnormal liver function tests, diarrhea, increased CPK, joint and muscle pain, nausea and vomiting. Symptomatic supportive measures should be taken, should an overdose occur. -
Clinical Solutions Wholesale, Llc
Gemfibrozil | Clinical Solutions Wholesale, Llc
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
![Gemfibrozil Tablet [Northwind Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5d386c38-7522-41a2-abcf-bd27b737286c&name=51655-142-26.jpg)
![Gemfibrozil Tablet, Coated [Kaiser Foundation Hospitals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7632214b-7d22-4edb-af0f-bf9609d371b4&name=Gemfibrozil-02.jpg)
![Gemfibrozil Tablet, Coated [Kaiser Foundation Hospitals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=22ea8379-50aa-4550-98f0-708d6da97e79&name=gemfibrozil-02.jpg)
![Gemfibrozil Tablet, Film Coated [Contract Pharmacy Services-pa]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1c8945d1-2292-4c31-8ba4-19bece8cec8d&name=1c8945d1-2292-4c31-8ba4-19bece8cec8d-02.jpg)
![Gemfibrozil Tablet, Coated [Global Pharmaceuticals, Division Of Impax Laboratories Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0ce067fa-abeb-41a3-9bbe-7956f9a96278&name=gemfibrozil-02.jpg)
![Gemfibrozil Tablet, Film Coated [State Of Florida Doh Central Pharmacy]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fb2df26c-60c6-4aef-986d-242364489717&name=Gemfibrozil600mg(Teva).jpg)
![Gemfibrozil Tablet, Film Coated [State Of Florida Doh Central Pharmacy]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3e286434-895a-41c4-8f7c-9ade565227cf&name=Gemfibrozil600mg(Major).jpg)
![Gemfibrozil Tablet, Film Coated [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7e877a90-e00f-45b2-a8e9-a9f70dfa8927&name=600mgpackagelabel.jpg)
![Gemfibrozil Tablet, Film Coated [State Of Florida Doh Central Pharmacy]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d8ec3de8-7f83-4c29-87cb-3f3ffc2689b8&name=Gemfibrozil600mg(Camber).jpg)
![Gemfibrozil Tablet, Film Coated [Hikma Pharmaceutical]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fe33138d-03ef-443d-9a78-783d4669eda8&name=gemfibrozil-tablets-600-mg-2.jpg)
![Gemfibrozil Tablet, Film Coated [West-ward Pharmaceutical Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=76185935-589d-41ba-a96c-3739eefd6b7a&name=gemfibrozil-tablets-2.jpg)
![Gemfibrozil Tablet, Film Coated [Contract Pharmacy Services-pa]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e2ec8e47-8f4e-44cc-82ff-1d4511d3fadd&name=e2ec8e47-8f4e-44cc-82ff-1d4511d3fadd-02.jpg)
![Gemfibrozil Tablet, Film Coated [Major Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ee012874-1a59-4803-bb72-a9a133218ce7&name=gemfibrozil-tablets-2.jpg)
![Gemfibrozil Tablet, Film Coated [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d709812f-e958-4065-a447-c2c00ddd7677&name=d709812f-e958-4065-a447-c2c00ddd7677-02.jpg)
![Gemfibrozil (Gemfibrozil) Tablet, Film Coated [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0e707c51-fe83-471b-ba39-699ca0bb9514&name=MM2.jpg)
![Gemfibrozil Tablet [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b5c30233-04c2-4fb5-9716-4c876ec0c0ba&name=MM2.jpg)
![Gemfibrozil Tablet [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0a1249c3-00b2-4eba-851b-3e67c8acb64a&name=MM2.jpg)
![Gemfibrozil Tablet, Film Coated [Udl Laboratories, Inc.]](http://www.recallguide.org/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Gemfibrozil Tablet [Camber Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=922bfe8c-4040-4e4f-8b26-751e94def800&name=ProteatLabel.jpg)
![Gemfibrozil Tablet, Film Coated [Exelan Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5c09fe54-697e-4cd5-9a26-7c9c7fa9a864&name=Gemfibrozil.jpg)
![Gemfibrozil Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ecddf11f-5784-4576-a7e6-1b3560c4d2ea&name=image-1.jpg)
![Gemfibrozil Tablet, Film Coated [Golden State Medical Supply, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2911a53a-3f37-4c4b-b424-a6d98e41aab7&name=ae8a6c8f-c1f7-47bb-b1ed-497ab7ed0e57-02.jpg)
![Gemfibrozil Tablet, Film Coated [West-ward Pharmaceutical Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c45cdbdb-414f-4bbf-a643-3a3d9de63a6b&name=gemfibrozil-tablets-2.jpg)
![Gemfibrozil Tablet, Film Coated [Caraco Pharmaceutical Laboratories, Ltd.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3dae4466-86f8-4133-84c1-cba8e237ae28&name=gemfibrozil.fig2.jpg)
![Gemfibrozil Tablet, Film Coated [Mckesson Contract Packaging]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=694abc50-a512-423f-9bf0-f8d9ac99f030&name=694abc50-a512-423f-9bf0-f8d9ac99f030-02.jpg)
![Gemfibrozil Tablet, Film Coated [Med-health Pharma, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b57eeb99-679e-4136-80f4-85421e21400b&name=gem600.jpg)
![Gemfibrozil Tablet, Film Coated [Aphena Pharma Solutions – Tennessee, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f4179a86-7f9c-4bbd-b10d-3507c8327dc9&name=43353-772.jpg)
![Gemfibrozil Tablet [Dispensing Solutions, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=244f3a69-8539-46a3-9483-559af1fe17b2&name=NDC66336-0367-XX------INVAGEN.jpg)
![Gemfibrozil Tablet, Film Coated [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bcbb0450-2062-4627-a0a2-11f405df8ea9&name=13901.jpg)
![Gemfibrozil Tablet [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=97d23f30-eecb-4323-b68f-d98e78485dfd&name=MM2.jpg)
![Gemfibrozil Tablet, Film Coated [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=748a9d28-8814-4394-ad7d-0d6ba868b0bc&name=bottle.jpg)
![Gemfibrozil Tablet, Film Coated [Golden State Medical Supply, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3357b98b-fb76-4993-a655-5e307d315d41&name=895335b4-1621-426c-ac43-fc75263580f7-02.jpg)
![Gemfibrozil Tablet [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=774ddddd-8439-4989-a10c-0c1b5632175c&name=MM2.jpg)
![Gemfibrozil Tablet [A-s Medication Solutions Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0d8c8521-06c4-4e15-99c0-12bd8adb5a48&name=3695-0.jpg)
![Gemfibrozil Tablet, Film Coated [Unit Dose Services]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3fb9e3b4-ca71-4bad-a1f0-babed42a29e3&name=50436-6540.jpg)
![Gemfibrozil Tablet, Film Coated [Major Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3c40a933-527d-49e8-81ce-631e9c646000&name=gemfibrozil-tablets-2.jpg)
![Gemfibrozil Tablet [Northstar Rxllc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=75cac02c-56e3-4dfe-b1e2-4ce166b28833&name=gemfibrozil-fig1.jpg)
![Gemfibrozil Tablet, Film Coated [Aidarex Pharmaceuticals Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1b1fa50e-6bb3-40d9-addc-48c37b8e1c49&name=gemfibrozil-tab-600mg-for-apotex-2.jpg)
![Gemfibrozil Tablet, Film Coated [American Health Packaging]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9fa2de4d-a921-48c1-a0b8-48bb579862a1&name=57688690-1ceb-4c4a-b9a0-f8389dedd38b-02.jpg)
![Gemfibrozil Tablet, Film Coated [Apotex Corp.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=457c2638-86cd-4afc-b562-eea925e9d42a&name=repaglinide-50.jpg)
![Gemfibrozil Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=16a775ec-47e7-491f-8c48-319ce43dcd3b&name=483428f4-7df8-43f9-9567-1fdcc4f85bf7-02.jpg)
![Gemfibrozil Tablet, Film Coated [State Of Florida Doh Central Pharmacy]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8967a94c-be50-4018-9e9b-62856c81a6f0&name=Gemfibrozil600mgBluPharma.jpg)
![Gemfibrozil Tablet, Film Coated [State Of Florida Doh Central Pharmacy]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=85c59fe5-5cac-4cf5-915b-2aba2a787765&name=Gemfibrozil600mgMajor.jpg)
![Gemfibrozil Tablet [St Marys Medical Park Pharmacy]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b30c3330-c53d-4fd4-8f96-520087be6261&name=Gemfibrozil.jpg)
![Gemfibrozil Tablet, Film Coated [Aphena Pharma Solutions – Tennessee, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=78ec73e1-6420-467f-8496-042d8d9a1d0b&name=43353-090.jpg)
![Gemfibrozil Tablet, Film Coated [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ade1420f-ccd4-4fef-b105-a0fbfbe9a53b&name=image-01.jpg)
![Gemfibrozil Tablet, Film Coated [Blu Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fdcee21a-097d-4354-bc91-e92cfdffac62&name=gemfibrozil-tablets-usp-600-mg-2.jpg)
![Gemfibrozil Tablet [Proficient Rx Lp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5bcd261e-ebba-4ecb-af22-e5aaeb04499b&name=acd-a-03.jpg)
![Gemfibrozil Tablet [Clinical Solutions Wholesale]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=951b414d-6e87-45f3-a5a4-3241317d941c&name=951b414d-6e87-45f3-a5a4-3241317d941c-02.jpg)
![Gemfibrozil Tablet [Blu Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6704e562-3297-4613-9982-e6bfec67a7e4&name=gemfibrozil-tablets-2.jpg)
![Gemfibrozil Tablet, Film Coated [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fd2817c5-11fd-47f0-8d14-e4e857cbd46a&name=image-02.jpg)
![Gemfibrozil Tablet [Avpak]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=975557bd-aef3-44f2-85c6-b8ffd2474248&name=cars.jpg)
![Gemfibrozil Tablet, Film Coated [Dava Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=75269c5c-8b6f-4496-9a93-1eba4208e1f7&name=gemfib-2.jpg)
![Gemfibrozil Tablet, Film Coated [Teva Pharmaceuticals Usa Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7d032419-4429-4e10-a11f-b8d2f6360835&name=100mg-label.jpg)
![Gemfibrozil Tablet, Film Coated [Aurobindo Pharma Limited]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a68f430e-7c98-4bd9-8902-758706713996&name=gemfibrozil-fig1.jpg)
![Gemfibrozil Tablet [Clinical Solutions Wholesale, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3797ddf0-2ede-4d4d-be7b-a2e83c64c8c5&name=fbfdad8d-figure-02.jpg)
Login To Your Free Account