Gala P30
Gala P30 Uses, Dosage, Side Effects, Food Interaction and all others data.
Gala P30 is a preparation of Gala P30 which is a member of the newest class of oral antidiabetic agent called thiazolidinediones. It depends on the presence of Insulin for its mechanism of action. Gala P30 decreases Insulin resistance in the periphery and in the liver, resulting in increased Insulin dependent glucose disposal and decreased hepatic glucose output. It also improves abnormality in lipid metabolism by activating peroxisome proliferator activated receptor gamma (PPAR-γ).
Gala P30 enhances cellular responsiveness to insulin, increases insulin-dependent glucose disposal, and improves impaired glucose homeostasis. In patients with type 2 diabetes mellitus, these effects result in lower plasma glucose concentrations, lower plasma insulin concentrations, and lower HbA1c values.
Significant fluid retention leading to the development/exacerbation of congestive heart failure has been reported with pioglitazone - avoid its use in patients in heart failure or at risk of developing heart failure. There is some evidence that pioglitazone may be associated with an increased risk of developing bladder cancer. Gala P30 should not be used in patients with active bladder cancer and should be used with caution in patients with a history of bladder cancer.
| Trade Name | Gala P30 |
| Availability | Prescription only |
| Generic | Pioglitazone |
| Pioglitazone Other Names | Pioglitazona, Pioglitazone, Pioglitazonum |
| Related Drugs | Farxiga, metformin, Trulicity, Lantus, Victoza, Tresiba, Levemir |
| Type | Tablet |
| Formula | C19H20N2O3S |
| Weight | Average: 356.439 Monoisotopic: 356.119463206 |
| Protein binding | Pioglitazone is >99% protein-bound in human plasma - binding is primarily to albumin, although pioglitazone has been shown to bind other serum proteins with a lower affinity. The M-III and M-IV metabolites of pioglitazone are >98% protein-bound (also primarily to albumin). |
| Groups | Approved, Investigational |
| Therapeutic Class | Thiazolidinedione Group |
| Manufacturer | Kinesis Pharmaceuticals Pvt Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Gala P30 is used for an adjunct to diet and exercise to improve glycaemic control in patients with type II diabetes (NIDDM). Gala P30 is used for monotherapy and also used for use in combination with sulphonylurea, Metformin or Insulin when diet and exercise plus the single agent does not result in adequate glycaemic control.
Gala P30 is also used to associated treatment for these conditions: Diabetes, Diabetic Neuropathies, Type 2 Diabetes Mellitus
How Gala P30 works
Gala P30 is a selective agonist at peroxisome proliferator-activated receptor-gamma (PPARγ) in target tissues for insulin action such as adipose tissue, skeletal muscle, and liver. Activation of PPARγ increases the transcription of insulin-responsive genes involved in the control of glucose and lipid production, transport, and utilization. Through this mechanism, pioglitazone both enhances tissue sensitivity to insulin and reduces the hepatic production of glucose (i.e. gluconeogenesis) - insulin resistance associated with type 2 diabetes mellitus is therefore improved without an increase in insulin secretion by pancreatic beta cells.
Dosage
Gala P30 dosage
Gala P30 can be taken once daily without regard to meals. The management of antidiabetic therapy should be individualized. Gala P30 monotherapy may be initiated at 15 mg or 30 mg once daily dosages in patients not adequately controlled with diet and exercise alone. For patients who respond inadequately to the initial dose of Gala P30, the dose can be increased up to 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered.
Maximum recommended daily dose of Gala P30 should not exceed 45 mg since doses higher than 45 mg have not been studied in placebo controlled clinical studies. Besides, no placebo controlled clinical studies of more than 30 mg once daily have been conducted in combination therapy.
Side Effects
The overall incidence and types of adverse events reported in placebo controlled clinical trials of Gala P30 monotherapy at doses of 7.5 mg, 15 mg, 30 mg or 45 mg once daily are upper respiratory tract infection (13.2%), headache (9.1%), sinusitis (6.3%), myalgia (5.4%), tooth disorder (5.3%), and pharyngitis (5.1%).
Toxicity
The oral TDLo observed in mice is 24 mg/kg for 4 days and for rats is 3 mg/kg for 6 days.
One instance of overdose was reported during clinical trials with pioglitazone in which a patient took an oral dose of 120mg daily for four days, followed by 180mg daily for seven days - this patient did not report any adverse clinical symptoms during this time. In the event of overdosage, employ symptomatic and supportive measures according to the patient's clinical status.
Precaution
Gala P30 exerts its antihyperglycaemic effect only in the presence of Insulin. Therefore, it should not be used in Type 1 diabetes or for the treatment of diabetic ketoacidosis. Gala P30 should be used with caution in case of combination antidiabetic therapy and hepatic insufficiency. Liver enzyme should be monitored regularly.
Interaction
Administration of thiazolidinediones with an oral contraceptive containing ethinyl oestradiol and norethindrone reduces the plasma concentration of both hormones by approximately 30% which could result in loss of contraception.
Food Interaction
- Take with or without food. Food delays drug absorption, but not to a clinically significant extent.
[Moderate] GENERALLY AVOID: Alcohol may cause hypoglycemia or hyperglycemia in patients with diabetes.
Hypoglycemia most frequently occurs during acute consumption of alcohol.
Even modest amounts can lower blood sugar significantly, especially when the alcohol is ingested on an empty stomach or following exercise.
The mechanism involves inhibition of both gluconeogenesis as well as the counter-regulatory response to hypoglycemia.
Episodes of hypoglycemia may last for 8 to 12 hours after ethanol ingestion.
By contrast, chronic alcohol abuse can cause impaired glucose tolerance and hyperglycemia.
Moderate alcohol consumption generally does not affect blood glucose levels in patients with well controlled diabetes.
A disulfiram-like reaction (e.g., flushing, headache, and nausea) to alcohol has been reported frequently with the use of chlorpropamide and very rarely with other sulfonylureas.
MANAGEMENT: Patients with diabetes should avoid consuming alcohol if their blood glucose is not well controlled, or if they have hypertriglyceridemia, neuropathy, or pancreatitis.
Patients with well controlled diabetes should limit their alcohol intake to one drink daily for women and two drinks daily for men (1 drink = 5 oz wine, 12 oz beer, or 1.5 oz distilled spirits) in conjunction with their normal meal plan.
Alcohol should not be consumed on an empty stomach or following exercise.
Gala P30 Hypertension interaction
[Moderate] Thiazolidinediones can cause dose-related edema.
Therapy with thiazolidinediones should be administered cautiously in patients at risk for congestive heart failure as well as those with fluid overload or other conditions that may be adversely affected by excess fluid such as hypertension.
Patients should be monitored for signs and symptoms of heart failure such as dyspnea, swelling of legs or ankles, and weight gain.
Gala P30 Drug Interaction
Moderate: insulin glargine, insulin glargine, pregabalinUnknown: aspirin, aspirin, ubiquinone, dapagliflozin, omega-3 polyunsaturated fatty acids, canagliflozin, sitagliptin, empagliflozin, metoprolol, metoprolol, semaglutide, dulaglutide, liraglutide, cyanocobalamin, ascorbic acid, ergocalciferol, cholecalciferol
Gala P30 Disease Interaction
Major: CHF, type I diabetesModerate: bladder cancer, edema, liver disease, macular edema, premenopausal anovulation, weight gainMinor: anemia
Volume of Distribution
The average apparent volume of distribution of pioglitazone is 0.63 ± 0.41 L/kg.
Elimination Route
Following oral administration of pioglitazone, peak serum concentrations are observed within 2 hours (Tmax) - food slightly delays the time to peak serum concentration, increasing Tmax to approximately 3-4 hours, but does not alter the extent of absorption. Steady-state concentrations of both parent drug and its primary active metabolites are achieved after 7 days of once-daily administration of pioglitazone. Cmax and AUC increase proportionately to administered doses.
Half Life
The mean serum half-life of pioglitazone and its metabolites (M-III and M-IV) range from 3-7 hours and 16-24 hours, respectively.
Clearance
The apparent clearance of orally administered pioglitazone is 5-7 L/h.
Elimination Route
Approximately 15-30% of orally administered pioglitazone is recovered in the urine. The bulk of its elimination, then, is presumed to be through the excretion of unchanged drug in the bile or as metabolites in the feces.
Pregnancy & Breastfeeding use
Pregnancy: There are no adequate and well controlled studies in pregnant women. Gala P30 should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Lactation: It is not known whether Gala P30 is secreted in human milk. As many drugs are excreted in human milk, it should not be administered to a lactating women.
Contraindication
Gala P30 is contraindicated in patients with known hypersensitivity to any of its components.
Storage Condition
Store at 25° C.
Innovators Monograph
You find simplified version here Gala P30
Gala P30 contains Pioglitazone see full prescribing information from innovator Gala P30 Monograph, Gala P30 MSDS, Gala P30 FDA label
FAQ
What is Gala P30 used for?
Gala P30 is a medicine used to treat type 2 diabetes. Type 2 diabetes is an illness where the body doesn't make enough insulin, or the insulin that it makes doesn't work properly.
How safe is Gala P30?
Gala P30 is usually safe to take for a long time. Your doctor will give you regular tests to check whether it's safe for you to continue taking it.
How long does it take Gala P30 to work?
Gala P30 controls type 2 diabetes but does not cure it. It may take 2 weeks for your blood sugar to decrease and 2 to 3 months for you to feel the full effect of Gala P30.
What is the mechanism of action of Gala P30?
Gala P30 selectively stimulates the nuclear receptor peroxisome proliferator-activated receptor gamma and to a lesser extent PPAR-α.
What are the common side effects of Gala P30?
The common side effects of Gala P30 are include:
- Blurred vision or other changes in vision.
- flushed, dry skin.
- fruit-like breath odor.
- headache.
- increased thirst.
- increased urination.
- muscle pain or soreness.
- problems with your teeth.
Is Gala P30 safe during pregnancy?
This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Gala P30 is rated "C" by the Food and Drug Administration (FDA). This means that risks to the fetus cannot be ruled out.
Is Gala P30 safe during breastfeeding?
Gala P30 is unlikely to pass into breastmilk in clinically important amounts. However, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
Can I drink alcohol with Gala P30?
Yes, you can drink alcohol while taking Gala P30. However, it's best to drink no more than 2 units a day. Drinking more than this can increase your risk of low blood sugar.
Can I drive after taking Gala P30?
Gala P30 will not normally affect your ability to drive or use machines but take care if you experience abnormal vision.
What is the best time to take Gala P30?
Follow your doctor's instructions when taking this medicine. You'll usually take Gala P30 once a day. You can take it at any time, for example in the morning or in the evening. Try to take it at the same time every day.
How long does Gala P30 stay in my system?
The mean serum half-life of Gala P30 and total Gala P30 ranges from 3 to 7 hours and 16 to 24 hours, respectively.
Is Gala P30 bad for kidneys?
The pharmacokinetic properties of Gala P30 are ideally suited for patients with renal insufficiency.
Does Gala P30 cause heart failure?
Gala P30 induced heart failure is known in patients with underlying heart disease, but is not well documented in patients with normal left ventricular function.
When should I stop taking Gala P30?
Gala P30 can cause or worsen congestive heart failure. You should not use this medicine if you have severe or uncontrolled heart failure. Stop using this medicine and call your doctor at once if you have shortness of breath unusual tiredness, swelling, or rapid weight gain.
Is Gala P30 bad for your liver?
Gala P30 has been associated with only rare instances of clinically apparent liver injury.
Who should not take Gala P30?
This medicine may cause or make heart failure worse. Tell your doctor if you have had heart failure. Do not take Gala P30 and glimepiride if you have moderate to severe heart failure or any signs of heart failure.
What happen if I overdose of Gala P30?
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
