Katerzia

Katerzia is a prescription medication used to treat high blood pressure, angina (chest pain) and other conditions caused by coronary artery disease. 

Katerzia belongs to a group of drugs called calcium channel blockers. It dilates (widens) blood vessels and improves blood flow.

This medication comes as an oral suspension (liquid) to be taken once daily. Shake the liquid suspension before measuring your dose using the dosing syringe provided. Take Katerzia at the same time each day with or without food.

Common side effects include edema (swelling), flushing, stomach pain or nausea, and tiredness. Katerzia can also cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how this medication affects you.

Katerzia is a prescription medication used alone or in combination with other medications for the treatment of:

• Hypertension (high blood pressure) in adults and children 6 years and older
• Chronic Stable Angina (chest pain)
• Coronary Artery Disease

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Katerzia. See the "Katerzia Precautions" section.

Common side effects of Katerzia include:

• edema (swelling)
• dizziness
• drowsiness
• tiredness
• stomach pain
• nausea
• flushing (hot or warm feeling in the face)

This is not a complete list of Katerzia side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• nitroglycerin
• simvastatin (brand names Zocor, Simcor, Vytorin)
• ketoconazole (Nizoral)
• itraconazole (Sporanox)
• cyclosporine (Sandimmune)
• tacrolimus (Prograf)
• other blood pressure-lowering medications
• other heart disease medications

This is not a complete list of Katerzia drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Katerzia including:

• Symptomatic hypotension (low blood pressure) is possible, particularly in patients with severe aortic stenosis. However, sudden (acute) hypotension is unlikely. 

• Worsening angina (chest pain) and acute myocardial infarction can develop after starting or increasing the dose of this medication, particularly in patients with severe obstructive coronary artery disease. (

• The dose must be gradually increased in patients with severe hepatic (liver) impairment.

Katerzia can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Do not take Katerzia are allergic to any of its ingredients.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Katerzia there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Katerzia, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Katerzia or to any of its ingredients
• have liver disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Katerzia will harm your unborn baby.

There are no good studies in pregnant women. In studies involving rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). Amlodipine (the active ingredient in Katerzia) has also been shown to prolong both the gestation period and the duration of labor in rats.

Katerzia should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Tell your doctor if you are breastfeeding or planning to breastfeed.

• Limited available data from a published clinical lactation study reports that amlodipine (the active ingredient in Katerzia) is present in human milk. No adverse effects of amlodipine on the breastfed infant have been observed.

Take Katerzia exactly as as prescribed by your healthcare provider.

• Katerzia comes as an oral suspension (liquid). 
• Shake before using.
• Use the dosing syringe provided with your medication to measure your dose.
• Take Katerzia once daily (or as directed) at the same time(s) each day with or without food.
• If you miss a dose, take your regular dose as soon as you remember. Skip the missed dose if you are more than 12 hours late for the dose. Do not take two doses at one time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

High blood pressure:

• The effective antihypertensive oral dose of Katerzia in pediatric patients ages 6 to 17 years of age is 2.5 mg to 5 mg once daily.
• The recommended starting dose for adult hypertension is 5 mg once daily with maximum dose of 10 mg once daily.
• Small, fragile, or elderly patients, or patients with hepatic insufficiency, may be started on 2.5 mg once daily, and this dose may be used when adding Katerzia to other antihypertensive therapy.

Angina:

• The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg once daily, with the lower dose suggested in the elderly and in patients with hepatic insufficiency.
• Most patients will require 10 mg for adequate effect.

Coronary Artery Disease:

• The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily.
• In clinical studies, the majority of patients required 10 mg once daily.

If you take too much Katerzia, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Katerzia in the refrigerator at 2°C to 8°C/36°F to 46°F. Avoid freezing and excessive heat. Protect from light.

Keep this and all medications out of the reach of children.