Indications
Romerol Tablet is used for:
Type 2 Diabetes Mellitus
Adult Dose
Type 2 Diabetes Mellitus
Initial 4 mg PO qDay or divided q12hr
If inadequate response afer 8-12 weeks, may increase dose to 8 mg PO qDay or divided q12hr
Monitor: ALT at start of treatment, qMonth for 12 months then q3Months thereafter
Dosage Modifications
Active liver disease (ALT >2.5 x ULN): Do not inititate rosiglitazone
Child Dose
Renal Dose
Renal impairment: No dosage adjustments required
Administration
Contra Indications
Hypersensitivity to rosiglitazone
Diabetic ketoacidosis
Heart failure NYHA class III-IV
Active liver disease: do not start rosiglitazone if ALT >2.5 x ULN
Precautions
Congestive heart failure risk
Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients.
Fluid retention, which may exacerbate or lead to heart failure, may occur; combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk of other cardiovascular effects
If ALT >3 x ULN stop treatment; if 1.5-3 x normal, retest qWeek until normal or 3 x normal and need to discontinue
Not for use in diabetes mellitus type 1;
Thiazolidinediones, which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin; dose-related edema and weight gain may occur
When used in combination with other hypoglycemic agents, a dose reduction of concomitant agent may be necessary to reduce risk of hypoglycemia
Associated with rare cases of new onset or worsening of macular edema
May result in ovulation in some premenopausal anovulatory women; ensure adequate contraception
Increased risk of fractures of upper arm, hand, or foot in female patients
Dose-related decreases in hemoglobin and hemocrit reported
Lactation: Unsafe
Pregnancy-Lactation
Pregnancy
Limited data in pregnant women are not sufficient to determine drug- associated risk for major birth defects or miscarriage; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy
Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
Animal data
In animal reproduction studies, no adverse developmental effects observed when drug was administered to pregnant rats and rabbits during organogenesis at exposures up to 4 times the maximum recommended human dose (MRHD) of 8 mg daily
Reproductive potential of patients
Discuss potential for unintended pregnancy with premenopausal women as therapy may result in ovulation in some anovulatory women
Lactation
There are no data on presence of rosiglitazone in human milk, effects on breastfed infant, or on milk production; drug is present in rat milk; however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk; developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on breastfed infant or the underlying maternal condition
Interactions
Side Effects
Side effects of Rosiglitazone :
>10%
Increased LDL-cholesterol
Increased HDL-cholesterol
Increased total cholesterol
1-10%
Edema
Hypertension
Heart failure/congestive heart failure
Myocardial ischemia
Diarrhea
Upper respiratory tract infection
Frequency Not Defined
Accidental injury
Anemia
Back pain
Fatigue
Headache
Hypoglycemia
Myalgia
Sinusitis
Weight gain
Mode of Action
Lowers glucose by improving target cell response to insulin without increasing pancreatic cell secretion; activates nuclear peroxisome proliferator-activated receptor gamma, which influences the production of gene products involved in glucose and lipid metabolism
Note
Romerol 2mg Tablet generic name is Rosiglitazone. Romerol 2mg Tablet is manufactured by Drug International Ltd.Romerol is availble in all over Bangladesh.
Mes BD drug index information on Romerol Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.