Details for: ENALAPRILAT INJECTION USP
Company: STERIMAX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02388499 | ENALAPRILAT INJECTION USP | ENALAPRILAT | 1.25 MG / ML | SOLUTION | INTRAVENOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Enalaprilat Injection, USP is used for:
- reducing high blood pressure
When blood pressure is high, the workload of the heart and arteries increases so that over time, these organs may not function as they should. In turn, this could lead to damage of the "vital organs": brain - heart - kidneys, and result in stroke, heart failure, heart attack, blood vessel disease or kidney disease.
If your physician has recommended a particular diet, for instance - less salt - follow the diet carefully. This could help your medicine to better control your blood pressure. Your physician may also recommend weight loss. Do follow these suggestions.
What it does
Enalaprilat Injection, USP is part of a class of medicines known as angiotensin converting enzyme (ACE) inhibitors. They lower blood pressure by specifically blocking a naturally occurring substance called angiotensin II. Angiotensin II normally tightens your blood vessels. Enalaprilat Injection, USP allows them to relax and therefore help lower high blood pressure.
Enalaprilat Injection, USP is an active substance of enalapril produced during metabolism and is used in the treatment of high blood pressure.
This medicine does not cure high blood pressure, but does help control it. You may have to take high blood pressure medicine for life.
Keep your regular appointments with your physician, even if you feel well. High blood pressure may not be easily recognized by you, because you may not "feel any symptoms"; but your physician can measure your blood pressure very easily, and check how the medicine is controlling it.
Read the following information carefully. If you need any explanations, or further information, ask your physician or pharmacist.
When it should not be used
Do not take Enalaprilat Injection, USP if you:
- are allergic to enalaprilat or any other component of Enalaprilat Injection, USP (see What the non-medicinal ingredients are).
- have a history of swelling of the face, lips, tongue, throat; or sudden difficulty breathing or swallowing.
- have been diagnosed with swelling of the face, lips, tongue, throat; or sudden difficulty breathing or swallowing due to genetic factors or unknown reasons (please refer to Side Effects and What to do About Them).
- are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
What the medicinal ingredient is
Each millilitre of Enalaprilat Injection, USP contains 1.25 mg enalaprilat.
What the non-medicinal ingredients are
Each millilitre of Enalaprilat Injection, USP contains the following non-medicinal ingredients: sodium chloride 6.2 mg to adjust tonicity, sodium hydroxide to adjust pH (to approximately 7.0), water for injection, q.s.; with benzyl alcohol 9 mg, as preservative.
What dosage form it comes in
Enalaprilat Injection, USP 1.25 mg/mL in vials containing 1 and 2 mL.
Warnings and precautions
Serious Warnings and Precautions
Enalaprilat Injection, USP should not be used during pregnancy. If you discover that you are pregnant while taking Enalaprilat Injection, USP, stop the medication and please contact your physician as soon as possible.
This medicine may not be suitable for certain people. BEFORE you use Enalaprilat Injection, USP talk to your doctor, nurse or pharmacist if:
- You have previously taken Enalaprilat Injection, USP or other medication of the same type - Angiotensin Converting Enzyme (ACE) inhibitors such as enalapril, lisinopril, captopril, and you were allergic or reacted badly to it, particularly if you experienced swelling of the face, lips, tongue, or throat, or had sudden difficulty breathing or swallowing. These are symptoms of conditions called hereditary angioedema or idiopathic angioedema.
- You should not take this medicine if you have been diagnosed with hereditary angioedema or idiopathic angioedema (angioedema of unknown cause).
- Dizziness or drowsiness may occasionally occur when taking medication to lower blood pressure. Therefore, before you perform tasks which may require special attention (driving a car or operating dangerous machinery), wait until you know how you respond to your medicine.
- You should be aware that black patients are at increased risk of these types of reactions to ACE inhibitors.
- You are pregnant, breast feeding or thinking of becoming pregnant. Taking Enalaprilat Injection, USP during pregnancy can cause injury and even death to your developing baby. This medicine should not be used during pregnancy. If you become pregnant while taking Enalaprilat Injection, USP, stop the medication and report to your physician as soon as possible. It is possible that Enalaprilat Injection, USP passes into breast milk. You should not breast feed while taking Enalaprilat Injection, USP
- You suffer from low blood pressure (you may notice this as faintness or dizziness, especially when standing).
- You are undergoing dialysis.
- You have any of these conditions:
- diabetes
- heart or blood vessel disease
- liver disease
- kidney disease
- You are receiving gold (sodium aurothiomalate) injections.
- You are taking "water pills" or potassium supplements.
- You use potassium containing salt substitutes with your food.
- You are taking a medicine that contains aliskiren, such as Rasilez, used to lower blood pressure. The combination with Enalaprilat Injection, USP is not recommended.
- You are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.
You should also inform your physician or pharmacist if you have recently suffered from excessive vomiting or diarrhea.
If you have diabetes and are taking oral medicines to treat diabetes or insulin, you should closely monitor for low blood glucose levels, especially during the first month of treatment with Enalaprilat Injection, USP.
If you have to undergo any dental or other surgery, inform the dentist or the physician in charge that you are taking this medicine.
Remember - This medicine is prescribed for the particular condition that you have. Do not give this medicine to other people, nor use it for any other condition.
Enalaprilat Injection, USP is not for use in children. Do not use outdated medicine.
Interactions with this medication
Do not take any other medicines unless you have discussed the matter with your physician or pharmacist. Certain medications tend to increase your blood pressure, for example, non-prescription preparations for appetite control, asthma, colds, coughs, hay fever and sinus problems, or may also react badly with Enalaprilat Injection, USP.
Your physician or pharmacist also needs to know if you are taking any other medication, whether on prescription or otherwise. It is particularly important to inform your physician or pharmacist if you are taking:
- Diuretics or "water pills"; any other medicines to reduce blood pressure.
- Diabetes medicine and/or insulin.
- Potassium-containing medicines, potassium supplements.
- Salt substitutes that contain potassium, as these may lead to increased levels of potassium in the blood which can be serious. In these cases, your physician may need to adjust the dosage of Enalaprilat Injection, USP or monitor your blood level of potassium.
- Lithium (a drug used to treat a certain kind of depression).
- Certain pain and arthritis medicines, including gold therapy and nonsteroidal anti-inflammatory drugs.
The following may also interact with Enalaprilat Injection, USP:
- Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. Rasilez), or angiotensin receptor blockers (ARBs).
Proper use of this medication
Usual Dose
Your physician will determine the best dosing regimen for you based on your specific condition and blood pressure readings. The usual dose of Enalaprilat Injection, USP is 1.25 mg given every 6 hours by intravenous infusion.
Your physician will determine if and when you should convert from Enalaprilat Injection, USP to enalapril tablets. When this is appropriate, the usual initial dose of enalapril tablets is 5 mg once a day.
Overdose
In case of an overdose, contact your physician or pharmacist immediately so that medical attention may be given promptly. The most likely symptom would be a feeling of lightheadedness or dizziness due to a sudden or excessive drop in blood pressure.
Side effects and what to do about them
Along with its intended action, any medication, including Enalaprilat Injection, USP, may cause side effects. Most people do not experience any problem when taking these medicines; but if you notice any of the following, have other side effects or if the condition persists or worsens, seek medical attention.
- Dry cough, sore throat.
- The initial dose may cause a greater fall in blood pressure than will occur following continued treatment. You may notice this as faintness or dizziness and it may help to lie down. If concerned, please consult your physician or pharmacist.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Fatigue | ✔ | ||
| Dizziness/fainting/Lightheadedness, especially following exercise, and/or when it is hot and you have lost a lot of water by sweating | ✔ | ||
| Low blood pressure | ✔ | ||
| Headache | ✔ | ||
| Rash/Itching | ✔ | ||
| Nausea/vomiting/diarrhea | ✔ | ||
| Lasting cough | ✔ | ||
| Chest pain | ✔ | ||
| Shortness of breath | ✔ | ||
| Uncommon | |||
| Allergic reactions/Angioedema (sudden difficulty in breathing or swallowing, swelling of face, eyes, lips, tongue and/or throat, hands or feet) | ✔ | ||
| Flu-like symptoms (fever, malaise, muscle pain, rash, itching, abdominal pain, nausea, vomiting, diarrhea, jaundice, loss of appetite) | ✔ | ||
| Liver impairment such as jaundice, dark/brown urine | ✔ | ||
| Abdominal pain | ✔ | ||
| Low blood sugars in diabetic patients | ✔ | ||
| Loss of appetite | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Enalaprilat Injection, USP, contact your doctor or pharmacist.
How to store
Store vials between 15 and 30°C. Protect from light. Multi-dose vial: discard 28 days after initial puncture.
Once diluted, solution should be used within 24 hours.
Keep all medicines out of reach of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full Product Monograph, prepared for
health professionals can be found at:
http://www.sterimaxinc.com
or by contacting the sponsor, SteriMax Inc., at:
1-877-546-7667
1-2735 Matheson Blvd E
Mississauga, ON L4W 4M8
This leaflet was prepared by SteriMax Inc.
Last revised: February 18, 2014