Ranolaz 500 Mg Tablet (15 Tab)

RANOLAZ 500 MG TABLET (15 TAB) by TORRENT PHARMACEUTICALS LTD.

Name

• Brand Name: Ranolaz 500 Tablet ER
• Common/Generic Name: Ranolazine

Composition

Ranolaz 500 Tablet contains Ranolazine 500 mg as its active ingredient.

Uses

Ranolaz 500 Tablet is primarily used for the management of chronic angina (heart-related chest pain). It helps to prevent new attacks of angina by improving blood flow to the heart muscle and making the heart work more efficiently, without significantly altering blood pressure or heart rate. This medication is not intended to stop an acute angina attack once it has started. It can be used alone or in combination with other anti-anginal medications such as beta-blockers or calcium channel blockers.

Dosage and Administration

• Ranolaz 500 Tablet is an extended-release tablet and should be swallowed whole with a glass of water. It should not be chewed, crushed, or broken.
• It can be taken with or without food, usually twice daily at the same time each day, or as prescribed by a doctor.
• The initial adult dosage is typically 500 mg twice a day, which may be adjusted by a doctor, but generally should not exceed 1000 mg twice a day.
• It is crucial to take this medication regularly to achieve the most benefit, even if symptoms improve.

Side Effects

Common Side Effects:

• Constipation
• Dizziness
• Headache
• Nausea or feeling sick
• Tiredness/Weakness
• Lightheadedness

Serious Side Effects (Seek immediate medical attention if experienced):

• Changes in heart rhythm, such as fast, pounding, or uneven heartbeat, severe dizziness, or fainting (may indicate QT prolongation).
• Signs of kidney problems, including changes in the amount of urine, bloody urine, increased thirst, or swelling of the face, fingers, or lower legs.
• Symptoms of a serious allergic reaction, such as breathing problems, wheezing, swelling of the face, lips, mouth, tongue, or throat, or skin rash/hives.

Precautions

• Inform your doctor about any allergies to Ranolazine or any other medications.
• Use with caution in patients with liver disease, kidney disease, or existing heart rhythm problems (like QT prolongation).
• Grapefruit or grapefruit juice should be avoided while taking Ranolaz 500 Tablet, as it can increase the medicine's levels in the blood and potentially lead to serious side effects.
• Alcohol consumption should be avoided as it may cause excessive drowsiness and increase muscle pain, and can affect how quickly the medicine is released.
• Inform your doctor if you are pregnant, planning a pregnancy, or breastfeeding, as Ranolaz may be unsafe during pregnancy and breastfeeding.
• This medicine may cause dizziness or drowsiness; therefore, exercise caution when driving or operating machinery until you know how it affects you.
• Do not stop taking the medicine abruptly, as chest pain may return in a more severe form.
• Avoid taking more than the prescribed dose to prevent overdose symptoms like severe dizziness, confusion, hallucinations, or severe tremor.

Storage

Store in a cool and dry place, away from direct sunlight. Keep out of sight and reach of children. The typical storage temperature is between 10ºC to 25ºC or below 30ºC. Do not store in the bathroom.

What is Ranolaz 500 mg Tablet used for?

Ranolaz 500 mg Tablet is used to treat chronic angina (chest pain) associated with coronary artery disease. It helps prevent episodes of chest pain and can improve your ability to exercise. It is important to note that Ranolaz is not meant to treat a sudden angina attack but rather to prevent future ones.

How does Ranolaz 500 mg Tablet work?

Ranolaz (ranolazine) works by reducing the flow of sodium ions into the heart muscle cells. This action is believed to help in reducing intracellular calcium levels, which in turn decreases tension in the heart wall. This mechanism helps the heart work more efficiently with less oxygen, thereby alleviating angina symptoms. It does so without significantly affecting heart rate or blood pressure.

What is the usual dosage for Ranolaz 500 mg Tablet?

The usual starting dose for adults is 500 mg taken twice daily. Your doctor may increase the dose to 1000 mg twice daily, if needed, based on your clinical symptoms and how well you tolerate the medication. The maximum recommended dose is 1000 mg twice daily. Ranolaz tablets should be swallowed whole; they should not be crushed, broken, or chewed. It can be taken with or without food.

What are the possible side effects of Ranolaz 500 mg Tablet?

Common side effects include dizziness, headache, constipation, and nausea. More serious, but less common, side effects can include changes in heart rhythm (QT prolongation), severe allergic reactions, and kidney problems. If you experience severe dizziness, fainting, a fast or irregular heartbeat, or signs of an allergic reaction (e.g., hives, swelling of the face, lips, tongue, or throat), seek immediate medical attention.

Is Ranolaz 500 mg Tablet safe during pregnancy or breastfeeding?

Regarding pregnancy, there is no controlled data in human pregnancy. Animal studies have shown decreased fetal weight and reduced bone formation at doses higher than recommended for humans. UK guidelines advise against its use during pregnancy unless clearly necessary. For breastfeeding, it is unknown if ranolazine passes into human breast milk, although it has been found in animal milk. It is important to discuss the potential risks and benefits with your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Can Ranolaz 500 mg Tablet be taken with other medications?

Ranolaz can interact with several medications. It is contraindicated with strong CYP3A4 inhibitors (e.g., certain antifungals like ketoconazole, certain antibiotics like clarithromycin, and some HIV medications). For moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil, erythromycin, fluconazole), the maximum dose of ranolazine should be limited to 500 mg twice daily. It also interacts with P-glycoprotein (P-gp) inhibitors and other drugs that prolong the QT interval. It can generally be used with beta-blockers, nitrates, calcium channel blockers, antiplatelet therapy, lipid-lowering therapy, ACE inhibitors, and ARBs. You should also limit the consumption of grapefruit and grapefruit juice while taking Ranolaz, as it can increase the medicine's levels in your blood. Always inform your doctor about all prescription, over-the-counter, herbal, and vitamin supplements you are taking.

What precautions should be taken while taking Ranolaz 500 mg Tablet?

Do not use Ranolaz for sudden, acute chest pain. Inform your doctor if you have a history of liver disease (it is contraindicated in severe liver disease like cirrhosis), kidney problems, or any heart rhythm disorders, especially QT prolongation or a family history of it. Use with caution if you have a low body weight (under 60 kg) or severe heart failure. Ranolaz may cause dizziness or drowsiness, so avoid driving or operating machinery until you know how it affects you. Do not crush, break, or chew the extended-release tablets.

What happens if a dose of Ranolaz 500 mg Tablet is missed?

If you miss a dose of Ranolaz, skip the missed dose and take your next dose at the regularly scheduled time. Do not take a double or extra dose to make up for the missed one.

How should Ranolaz 500 mg Tablet be stored?

Ranolaz tablets should be stored at room temperature, typically between 68°F to 77°F (20°C to 25°C). Keep the medicine in a closed container, away from heat, moisture, and direct light. Do not freeze. Always keep Ranolaz and all other medications out of the reach of children.