Pitalo 1mg Tablet 10 ‘S

Description

About

{{Product}} is a lipid-lowering medication that is prescribed in the management of hypercholesterolemia. Hypercholesterolemia indicates an increased level of plasma cholesterol that is mainly low-density lipoprotein (LDL). The presence of LDL may be characterized along with the presence of Triglycerides (TAGs) and low levels of good cholesterol i.e. high-density lipoprotein (HDL).

 {{Product}} belongs to the class “Statins” which work by blocking the production of cholesterol by liver enzyme -HMG CoA Reductase. By this mechanism, statins play a role in reducing the risk of cardiovascular diseases like atherosclerosis, stroke, and heart attack. If {{product}] is prescribed to you, the doctor will advise you to take it along with a proper diet which helps reduce the bad cholesterol (LDL) and increase good cholesterol (HDL). You’ll be advised to refrain from diets that can oppose the effects of Pitalo 1mg Tablet 10 ‘S such as fatty and fried food. 

{{Product}} is usually prescribed along with the cardiovascular disease managing drugs and to those who are at risk of developing cardiovascular diseases such as people with Type 2 Diabetes. The bad cholesterol-reducing ability of statins has potentially reduced the mortality rate due to cardiovascular diseases. Specifically, Pitalo 1mg Tablet 10 ‘S among the statins has shown more efficacy in LDL reduction and HDL enhancement that is good for heart health. 

Indications

{{Product}} is indicated to treat and prevent the following:

• Hyperlipidemia – high levels of cholesterol in the blood
• Dyslipidemia – abnormal levels of cholesterol in the blood that can be too high or too low
• Heterozygous familial hypercholesterolemia in pediatrics (8 years old) – an inherited disease in which there is a higher than normal count of LDL in the blood by birth. 
• As adjunctive treatment with the diet to reduce bad cholesterol (LDL), triglycerides, apolipoprotein B, and increasing good cholesterol (HDL)
• As an adjunct to minimize the risk of cardiovascular diseases in vulnerable populations

How Does Pitalo 1mg Tablet 10 ‘S Work

The lipid-lowering action is carried out by the upregulation of LDL receptors thereby reducing LDL in circulation.  {{Product}} competitively inhibits the HMG CoA reductase enzyme which has a rate-limiting role in the pathway of cholesterol biosynthesis. The inhibition of this enzyme reduces the production of mevalonic acid. This action increases the number of LDL receptors on the liver cells which means there will be more endogenous binding of LDL resulting in its reduction from the bloodstream. 

{{Product}} also enhances endothelial functions by exerting its protective effect on the blood vessels. This effect is independent of the lipid-lowering mechanism and hence significant for the management of oxidative stress and atherosclerosis. 

How To Use Pitalo 1mg Tablet 10 ‘S

{{Product}} should be taken with a diet that has a low saturated fat content. The dose of Pitalo 1mg Tablet 10 ‘S is varied from 1 mg to 4mg once daily through the oral route and can be taken any time in a day irrespective of food. But make sure you take the dose at the same time of the day as you had taken the previous day. The dose of Pitalo 1mg Tablet 10 ‘S should not be increased for more than 4mg a day as there is a risk of developing myopathy (skeletal muscles movement disorder) as a side effect. 

Dosage

Form and strength

Tablet to be taken orally (by mouth)

• 1mg
• 2mg

Adult Dose

The general dose of {{product} ranges from 1 mg to 4 mg once a day. However, 2mg once daily is the recommended starting dose that can be exceeded to 4mg once daily depending on the patient’s profile and response to the drug. The healthcare providers will assess the plasma lipid levels following four weeks of the treatment to achieve the goal of therapy.

Hyperlipidemia and Dyslipidemia 

{{Product}} is prescribed as an adjunct to the diet in primary hyperlipidemia and mixed dyslipidemia, to lower the level of Apo-B, Triglycerides, and LDL along to enhance good cholesterol (HDL) in blood.

Other Considerations 

• Patients with active kidney disease or who are renal compromised should have 1 mg of starting dose of Pitalo 1mg Tablet 10 ‘S to be taken once daily. The maximum dose in a renal compromised patient is 2mg once daily. 
• The dose should not go above 1mg per day if the patient has to co-administer Pitalo 1mg Tablet 10 ‘S along with erythromycin. 
• If the patient has to co-administer Rifampin along with Pitalo 1mg Tablet 10 ‘S, the recommended dose is 2mg per that should not be exceeded. 

2mg once daily is the recommended starting dose that may exceed 4 mg once daily as per the treatment requirement. 

Pediatric Dose

{{Product}} should be given to the children who are 8 years or older. The recommended starting dose for Heterozygous familial hypercholesterolemia is 2mg per day. 4 mg per day is the maximum recommended dose in children. 

Pregnancy And Lactation 

{{Product}} lies in pregnancy category X, which shows that it is contraindicated in pregnancy because Pitalo 1mg Tablet 10 ‘S may harm the fetus (teratogenic). If Pitalo 1mg Tablet 10 ‘S is taken by breastfeeding mothers, it has the potential to disturb the lipid metabolism of infants. 

Contraindications

• People with active liver disease and elevated liver enzymes such as transaminases should not take Pitalo 1mg Tablet 10 ‘S. 
• {{Product}} should be immediately discontinued if there is hepatic injury or diagnosis of hepatic illnesses like jaundice. 
• You should not take Pitalo 1mg Tablet 10 ‘S if you are hypersensitive to any of the excipients or active ingredients. 
• If you are or may become pregnant, you should avoid using {{prodcut}} as it produces teratogenic effects. {{Product}} is also released in breast milk and may cause side effects in infants, so it is not safe to use {[product}} by breastfeeding mothers. 
• Alcoholics are at risk of developing serious live diseases while taking Pitalo 1mg Tablet 10 ‘S. Usage of alcohol should be avoided during the treatment. 
• People with hypothyroidism (low thyroid hormone production by the thyroid gland) may suffer from muscle problems that may lead to myopathy and muscle damage. So {{product}] should be avoided underactive hypothyroidism. 

Precautions

• If you are an alcoholic, had liver or kidney disease in the past, you should inform your healthcare provider before starting {{product} intake. 
• Inform your doctor if you are about to have a dental procedure or any other surgery before starting Pitalo 1mg Tablet 10 ‘S therapy. 
• Daily intake of alcohol makes the individuals vulnerable to liver diseases who are taking Pitalo 1mg Tablet 10 ‘S along. 
• Exceeding the dose of more than 4mg once daily develops a potential risk of serious muscle problems.  So the dose of {[product}} should never be administered more than 4mg per day. 
• If you are taking Erythromycin, Pitalo 1mg Tablet 10 ‘S should not be taken more than 1 mg once daily. 
• If you are on Rifampin, 2mg once daily should remain the maximum dose of {[product} as there is a risk of developing toxicity and serious side effects. 
• People who are prone to develop myopathy (weakness and dysfunction of the skeletal muscle fibers) should be cautiously treated with Pitalo 1mg Tablet 10 ‘S. This population includes geriatrics, people with renal impairment, and hypothyroidism.
• The levels of transaminase (liver enzyme) should be assessed before and after starting the treatment with Pitalo 1mg Tablet 10 ‘S.
• {{Product}} may raise the fasting serum glucose levels. Maintaining a lifestyle by diabetics lessens the chances of elevation of glucose levels during the treatment with Pitalo 1mg Tablet 10 ‘S.
• Other cholesterol lowing agents such as Colestipola and Cholestyramine prevent complete absorption of Pitalo 1mg Tablet 10 ‘S so these drugs should be taken with 1 to 4 hours of the gap between administration of {{product}
• {{Product}} should be taken daily at the same time as per the previous dose so that its efficacy is not compromised. 
• Clinical parameters like Prothrombin time (PT) and INR should be monitored during the intake of warfarin along with Pitalo 1mg Tablet 10 ‘S as there are chances of bleeding with the concomitant use of these two drugs. 

Interactions With Other Medications

Following medicines increase the risk of developing myopathy (skeletal muscles disease characterized with pain and weakness) and rhabdomyolysis (muscle dysfunction) upon concurrent administration of Pitalo 1mg Tablet 10 ‘S:

• Niacin (Vitamin B3) 
• Fenofibrate
• Gemfibrozil 
• Immunosuppressants (Cyclosporin)
• Antivirals (e.g. Atazanavir, Lopinavir) 
• Rifampicin
• Erythromycin
• Diltiazem
• Enalapril
• Itraconazole
• Colchicin 

These drugs increase the plasma concentrations of Pitalo 1mg Tablet 10 ‘S and can make an individual prone to develop side effects of Pitalo 1mg Tablet 10 ‘S.

Some drugs can make Pitalo 1mg Tablet 10 ‘S less available to pose beneficial effects. Those include:

• Ritonavir
• Ezetimibe
• Itraconazole
• Digoxin

Adverse Effects

Common Adverse Effects

• Back pain
• Constipation
• Myalgia (Muscular pain)
• Diarrhea
• Pain in the extremities 

These adverse effects may subside upon completion of therapy. 

Potential Adverse Effects 

• Stomach upsets
• Fatigue
• Jaundice 
• Angioedema (skin reaction likely to urticaria)
• Elevated fasting blood glucose levels
• Muscle Problems like Spasms, Myopathy, and Rhabdomyolysis, leading to renal failure
• Elevated hepatic enzymes 

Rare Adverse Effects

• Nasopharyngitis 
• Joint Pain
• Peripheral neuropathy
• Diseases of the respiratory disorder 
• Amnesia
• Confusion

How To Cope With Some Of The Adverse Effects

• Back pain – Intake of over-the-counter pain killers such as paracetamol manages back pain. Using a heating pad helps soothe the muscles and gives relief from pain. You should also try resting on a firm mattress to deal with back pain. 
• Myalgia – Gentle exercise of the muscles, taking pain killers and icing the effective muscle tissue help reduce myalgia (Muscle pain). You should also avoid lifting heavy weights and vigorous activities. 
• Diarrhea – Intake of a good amount of water, Oral rehydration salt, and semi-solid food helps fight diarrhea. You should also avoid the consumption of caffeine, alcohol, and spicy food. 
• Constipation – Drinking plenty of water, taking a rich fiber diet, exercising, and mild laxatives are beneficial in treating constipation.

Key Facts About Pitalo 1mg Tablet 10 ‘S

• {{Product}} is reduces blood cholesterol, mainly triglycerides and low-density lipoprotein (LDL) which is bad cholesterol and therefore is given in patients with mixed dyslipidemia and hypercholesterolemia. 
• The efficacy of Pitalo 1mg Tablet 10 ‘S in good cholesterol i.e. increasing high-density lipoprotein (HDL) makes it a significant adjunct for the treatment and prevention of serious heart diseases. 
• {{Product}} has the potential to elevate liver enzymes. So the treatment with Pitalo 1mg Tablet 10 ‘S requires monitoring of hepatic profile after certain intervals. 

FAQs

• ARE THERE ANY DIETARY LIMITATIONS ASSOCIATED WITH THE USAGE OF {{PRODUCT?

Yes. Treatment with Pitalo 1mg Tablet 10 ‘S is followed by the diet having low-fat content. Your dietician or consultant will refrain you from eating a certain food, mainly food that induces bad cholesterol production in the body such as fast food and processed food. 

• ARE THERE ANY SPECIAL DOSING INSTRUCTIONS?

{{Product}} should be taken as per the doctor’s recommendation. {{Product}} is usually taken 1 – 4 mg once a day. However, the time of taking the dose should not be shuffled so that Pitalo 1mg Tablet 10 ‘S may act effectively.  

• DO LIFESTYLE CHANGES AID IN THE TREATMENT?

Yes. Intake of healthy food such as vegetables; fruits; whole grains; protein-rich diet, smoke, ng, and alcohol cessation, and dedicated exercise helps lower bad cholesterol from your body and thereby reduce the need for medication. 

• IS THERE ANY SPECIFIC MONITORING REQUIRED DURING THE TREATMENT?

As Pitalo 1mg Tablet 10 ‘S can potentially increase liver enzymes so hepatic monitoring is advised after 4 weeks of the treatment. The next doses are decided as per the lipid profile and if there are any deviations in normal physiology, doses are decided accordingly.

• I AM ON WARFARIN, DO I NEED ANY SPECIFIC MONITORING?

Although there are no significant interactions between Warfarin and Pitalo 1mg Tablet 10 ‘S, parameters like Prothrombin time and INR should be monitored during the treatment as there is a risk of bleeding associated with Warfarin due to its antiplatelet effect. {{Product}}, on the other hand, is a potent lipid-lowering drug. 

• WHAT ARE THE STORAGE CONDITIONS OF {{PRODUCT}}?

{{Product}} should be stored at room temperature from 15 to 30 °C. Protect it from moisture, light, and direct exposure to the sun.

• WHAT TO DO IF A DOSE IS MISSED?

As Pitalo 1mg Tablet 10 ‘S is taken once daily at all doses, you can take it as soon as you remember that you have missed the dose. But make sure the dose is not doubled.

• DOES ALCOHOL CONSUMPTION HARM AN INDIVIDUAL WHO IS TAKING {{PRODUCT}}?

Yes. {{Product}} has the potential to elevate liver enzymes. If you use it along with the intake of alcohol, you are at high risk of developing liver diseases, even renal failure. 

• CAN A BREASTFEEDING MOTHER TAKE {{PRODUCT}}?

{{Product}} is contraindicated to use in pregnant or breastfeeding ladies as it crosses the placenta and is released in breast milk as well. The infant is at risk of developing myopathy and rhabdomyolysis – serious side effects of Pitalo 1mg Tablet 10 ‘S characterized with muscle problems.