Patient Medication Information: uses, side effects, how to take - Verapamil Hydrochloride Injection USP (Sandoz Canada)
What is Verapamil Hydrochloride Injection USP used for?
- Abnormal heart rhythms
- Rapid heartbeat
How does Verapamil Hydrochloride Injection USP work?
Verapamil hydrochloride Injection USP belongs to a group of medicines known as calcium channel blocker. Calcium channel blockers change the amount of calcium getting into the muscle cells of your heart and blood vessels. This can change the strength and speed at which your heart beats. It also opens up the blood vessels so that blood can be pumped around your body more easily. This helps to lower your blood pressure.
What are the ingredients in Verapamil Hydrochloride Injection USP?
medicinal ingredient: verapamil hydrochloride
non-medicinal ingredients: sodium chloride, hydrochloric acid and/or sodium hydroxide to adjust pH and water for injection. Preservative free.
Verapamil Hydrochloride Injection USP comes in the following dosage forms:
Verapamil Hydrochloride Injection USP is available in 2 mL single use amber vials, boxes of 10.
The chlorobutyl rubber stopper is not made with natural rubber latex
Do not use Verapamil Hydrochloride Injection USP if:
- you are allergic to verapamil hydrochloride or any other ingredients in Verapamil Hydrochloride Injection
Your have any of the following heart conditions:
- left ventricular dysfunction (a weakness to part of the heart that pumps oxygen-rich blood to the rest of the body);
- cardiogenic shock (heart is not able to pump enough blood to the body);
- second or third degree heart block (a type of irregular heart beat and rhythm);
- sick sinus syndrome (heart's natural pacemaker is unable to create normal heartbeats at the normal rate);
- bradycardia (abnormally slow heart beat); or
- atrial flutter or atrial fibrillation (abnormal heart rhythm which is rapid and irregular), and you also have an accessory bypass tract (e.g., Wolff-Parkinson-White and Lown-Ganong-Levine syndromes).
you are breast-feeding while taking this medication.
- you have serious heart disease and are taking beta blockers. You can recognize beta blockers because their medicinal ingredient ends in ‘-lol’.
- you are taking ivabradine, a drug that lowers your heart rate
- you are taking or have recently taken (within the last 2 days) flibanserin, a medicine to treat generalized hypoactive sexual desire disorder (HSDD) in women.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Verapamil Hydrochloride Injection USP. Talk about any health conditions or problems you may have, including if you:
- are pregnant or planning to become pregnant. Verapamil Hydrochloride Injection USP is not recommended during pregnancy.
- are breastfeeding or planning to breastfeed. Verapamil Hydrochloride Injection USP can be passed in your breast milk and is not recommended during breastfeeding.
- have any heart problems.
- have kidney problems.
- have liver problems.
- are taking beta blockers. Verapamil Hydrochloride USP should not be taken with beta blockers as this can cause serious adverse effects.
- have neuromuscular disease (e.g. myasthenia gravis, Lambert-Eaton syndrome, or Duchenne muscular dystrophy).
- have high levels of calcium in your blood.
- are 65 years of age or older.
Other warnings you should know about:
Taking Verapamil Hydrochloride Injection USP can cause the following:
- Hypotension (low blood pressure): This can occur after a single dose and even after several months of treatment. If you develop hypotension, your healthcare professional may reduce your dose of Verapamil Hydrochloride Injection USP.
Heart problems: This includes:
- heart block (a type of irregular heartbeat and rhythm). Verapamil Hydrochloride Injection USP may worsen a first - degree heart block to the second- or third-degree.
- bradycardia (abnormally slow heartbeat); and
- asystole (no electrical activity in the heart and the heart stops beating).
If you develop a heart problem, your healthcare professional may decide to reduce or stop your treatment with Verapamil Hydrochloride Injection USP. A therapy may also be recommended by your healthcare professional to treat the heart problem.
- Liver problems: This includes an increase of certain liver enzymes that can result in the injury or death of liver cells. Your healthcare professional will monitor your liver enzyme levels throughout treatment. If you develop any liver problems, your healthcare professional may reduce your dose of Verapamil Hydrochloride Injection USP.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Monitoring and testing: If you are prescribed Verapamil Hydrochloride Injection USP, your healthcare professional may conduct various tests depending on your health and the other medicines you take. This includes blood tests, blood pressure checks, and electrocardiogram tests (used to evaluate your heart). Your healthcare professional will interpret your results and may adjust your dose or stop your treatment with Verapamil Hydrochloride Injection USP.
Driving and using machines: Verapamil Hydrochloride Injection USP may affect your ability to react. This may be more likely to occur at the start of your treatment and when your dose is raised. You should not drive or use machines until you know how Verapamil Hydrochloride Injection USP affects you.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Verapamil Hydrochloride Injection USP:
alcohol.
- almotriptan, a medicine used to treat acute migraine headaches.
- anesthetics, medicines used to prevent pain during surgery.
- antiarrhythmics, medicines used to treat or prevent irregular heartbeats (e.g., disopyramide, flecainide, and quinidine).
- anticoagulants, medicines used to prevent blood clotting (e.g., dabigatran, rivaroxaban, apixaban, and edoxaban).
- anticonvulsants also known as antiepileptics, medicines used to prevent epilepsy or seizures (e.g., carbamazepine and phenytoin).
- antidepressants, medicines used to treat depression (e.g., tranquilizers, tricyclic antidepressants, and imipramine).
- antidiabetics, medicines used to treat diabetes (e.g., glibenclamide and metformin).
- anti-gout agents, medicine used to treat chronic gout (e.g., colchicine and sulfinpyrazone).
antihypertensive agents, medicines used to treat high blood pressure:
- alpha blockers (e.g., terazosin and prazosin);
- beta blockers (e.g., propranolol, metoprolol, atenolol, and timolol);
vasodilators;
Serious Drug Interactions
- ivabradine, a medicine used to treat chronic heart failure by lowering the heart rate. Do not take Verapamil Hydrochloride Injection USP if you are taking ivabradine.
flibanserin, a medicine used to treat a condition known as hypoactive sexual desire disorder (HSDD) in women. Do not take Verapamil Hydrochloride Injection USP if you are taking or have recent taken (within 2 days) discontinuing flibanserin. In addition, if you plan to start taking flibanserin, you must wait at least 2 weeks after your last dose of Verapamil Hydrochloride Injection USP.
- angiotensin-converting enzyme (ACD) inhibitors; and
- diuretics (e.g., hydrochlorothiazide).
- anti-infectives, medicines used to prevent or treat infections (e.g., clarithromycin, erythromycin, rifampicin, and telithromycin).
- antineoplastics, medicines used to treat cancer (e.g., doxorubicin).
- anxiolytics, medicines typically used to treat anxiety, insomnia, and seizures (e.g., benzodiazepines, buspirone, and midazolam).
- aspirin (acetylsalicylic acid), a non-steroidal anti-inflammatory agent (NSAIDS) used to reduce pain and swelling.
- barbiturates, medicines used to relax the body and help with sleeping (e.g., phenobarbital)
- cardiac glycosides, medicines used to treat heart failure and certain heartbeats problems (e.g., digitoxin and digoxin).
- cimetidine, a medicine used to treat heartburn and certain types of stomach ulcers.
- grapefruit juice.
- HIV antiviral agents, medicines used to treat HIV infection (e.g., ritonavir).
- immunosuppressive agents, medicines used to treat autoimmune diseases (e.g., cyclosporine, everolimus, sirolimus, and tacrolimus).
- lipid metabolism regulators, medicines used to lower the amount of cholesterol in the blood and prevent coronary heart disease (e.g., atorvastatin, simvastatin, and lovastatin).
- lithium, a medicine used to treat bipolar disorder.
- neuromuscular blocking agents, medicines used to cause muscle relaxation (e.g., atracurium).
- St. John’s wort, an herbal medicine commonly used to treat depression and mood disorders.
- theophylline, a medicine used to relieve symptoms of asthma.
How to take Verapamil Hydrochloride Injection USP:
Verapamil hydrochloride Injection USP will be administered by a healthcare professional
Usual dose:
Adult
Initial Dose: 5 to 10 mg (0.075 to 0.15 mg/kg body weight) given as an IV bolus over at least 2 minutes.
Repeat Dose: 10 mg (0.15 mg/kg body weight) 30 minutes after the first dose if the initial response is not adequate. An optimal interval for subsequent IV doses has not been determined and should be individualized for each patient.
Older Patients (65 years or older):
The dose should be administered over at least 3 minutes to minimize the risk of untoward drug effects.
Children
Initial Dose:
0 to 1 year: 0.1 to 0.2 mg/kg body weight (usual single dose range 0.75 to 2 mg) should be administered as an IV bolus over at least 2 minutes under continuous ECG monitoring.
1 to 15 years: 0.1 to 0.3 mg/kg body weight (usual single dose range 2 to 5 mg) should be administered as an IV bolus over at least 2 minutes. Do not exceed 5 mg.
Repeat Dose:
0 to 1 year: 0.1 to 0.2 mg/kg body weight (usual single dose range 0.75 to 2 mg) 30 minutes after the first dose if the initial response is not adequate (under continuous ECG monitoring). An optimal interval for subsequent doses has not been determined and should be individualized for each patient.
1 to 15 years: 0.1 to 0.3 mg/kg body weight (usual single dose range 2 to 5 mg) 30 minutes after the first dose if the initial response is not adequate. An optimal interval for subsequent doses has not been determined and should be individualized for each patient. Do not exceed 10 mg as a single dose.
Oral treatment should replace intravenous therapy as soon as possible, when the physician wishes to continue treatment with verapamil hydrochloride. Duration of treatment will depend on the underlying cause and history of recurrence.
Overdose:
If you think you, or a person you are caring for, have taken too much Verapamil hydrochloride Injection USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed dose:
Your healthcare professional will ensure that this product is administered properly, and doses are not missed.
What are possible side effects from using Verapamil Hydrochloride Injection USP?
These are not all the possible side effects you may have when taking Verapamil Hydrochloride Injection USP. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of Verapamil Hydrochloride Injection USP may include constipation and headaches. Check with your healthcare professional if you are concerned by any of the above side effects.
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| COMMON | |||
| Hypotension (low blood pressure): dizziness, fainting, light- headedness, blurred vision, nausea, vomiting, or fatigue (may occur when you go from lying or sitting to standing up). | ✓ | ||
Edema: unusual swelling of the arms, hands, legs, feet and ankles, face or airway passages. | ✓ | ||
| Heart failure (heart does not pump blood as well as it should): shortness of breath, difficult breathing, fatigue, weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, or reduced ability to exercise. | ✓ | ||
| Heart block (a type of irregular heartbeat and rhythm): feeling lightheaded, fainting, dizziness, shortness of breath, difficult breathing, nausea, or fatigue. | ✓ | ||
Bradycardia (abnormally slow heartbeat) | ✓ | ||
| UNCOMMON | |||
| Angioedema and Severe Allergic Reaction (anaphylaxis): swelling of the face, eyes, lips, tongue or throat, difficulty swallowing or breathing, nausea or vomiting, wheezing, rash, hives itching, fever, abdominal cramps, chest discomfort or tightness | ✓ | ||
Muscle problems: joint pain, muscle cramps, or muscle weakness. | ✓ | ||
| Seizures | ✓ | ||
Skin disorders: rash, painful red lumps, itchiness, sweating, redness, pain in joints, or pain in muscles. | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Liver problems: feeling of discomfort, fever, right upper abdominal pain, jaundice (yellowing of the skin or whites | |||
| of eyes), dark urine, or light-coloured stools. | |||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Keep out of reach and sight of children.
Store between 15°C and 30°C. Protect from light.
The chlorobutyl rubber stopper is not made with natural rubber latex
If you want more information about Verapamil hydrochloride Injection USP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.
