Dilsave (Dronedarone) 400mg – 10 tablet

Dronedarone Information

What is this drug used for?

• It is used to treat certain types of abnormal heartbeats.

Possible side effects

Dronedarone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Diarrhea.
• Upset stomach or throwing up.
• Feeling tired or weak.
• Belly pain.

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
• Slow heartbeat.
• A heartbeat that does not feel normal.
• Dizziness.
• Heart failure has happened with this drug, as well as heart failure that has gotten worse in people who already have it. Sometimes, this has been deadly. Tell your doctor if you have heart disease. Call your doctor right away if you have shortness of breath, a big weight gain, a heartbeat that is not normal, or swelling in the arms or legs that is new or worse.
• Kidney problems like kidney failure have happened in people taking this drug. Most of the time, these effects have gone back to normal when this drug was stopped and with care. Call your doctor right away if you have a change in the amount of urine passed.

Medication Safety Issues

Geriatric Patients: High-Risk Medication:

Storage and Stability

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Adverse Reactions

>10%:

Cardiovascular: Prolonged Q-T interval on ECG (Bazett; 28% [placebo: 19%]; defined as >450 msec in males or >470 msec in female)

Renal: Increased serum creatinine (51%; increased >10%; occurred 5 days after initiation)

1% to 10%:

Cardiovascular: Bradycardia (3%)

Dermatologic: Allergic dermatitis (≤5%), dermatitis (≤5%), eczema (≤5%), pruritus (≤5%), skin rash (≤5%; described as generalized, macular, maculopapular, erythematous)

Gastrointestinal: Diarrhea (9%), nausea (5%), abdominal pain (4%), dyspepsia (2%), vomiting (2%)

Neuromuscular & skeletal: Weakness (7%)

<1%, postmarketing, and/or case reports: Acute hepatic failure (requiring transplant), anaphylaxis, angioedema, atrial flutter (with 1:1 atrioventricular conduction), cardiac failure (new or worsened), dysgeusia, hepatic injury, hyperbilirubinemia, hypersensitivity angiitis, increased blood urea nitrogen, increased liver enzymes, interstitial pulmonary disease, pneumonitis, pulmonary fibrosis, skin photosensitivity, vasculitis