Patient Medication Information: uses, side effects, how to take - Metoprolol Tartrate Injection USP (Omega Laboratories)
ABOUT THIS MEDICATION
What the medication is used for:
Metoprolol Tartrate Injection USP is used alone or in combination with another medicine for the following conditions:
to help to protect the heart after a heart attack (myocardial
infarction)
What it does:
Metoprolol Tartrate Injection USP is a beta-blocker. It helps to control high blood pressure or other heart-related problems.
When it should not be used:
You should not be treated with Metoprolol Tartrate Injection USP if you:
are allergic to metoprolol, to any of the other ingredients in
Metoprolol Tartrate Injection USP or to another beta-blocker
have breathlessness, difficulty breathing when lying down,
swelling of the feet or legs (signs of a heart disorder)
- have a slow or irregular heartbeat
have sudden and oppressive chest pain (sign of heart
attack)
have very poor blood circulation in your limbs (for
example, very cold, pale hands or feet, or pain in your leg muscles when you walk)
- have low blood pressure
have non-treated tumor of the medulla of the adrenal
glands (pheochromocytoma)
have asthma or had history of difficulty breathing with
wheezing or coughing
- have severe skin problems
suffer from severe drop in blood pressure, dizziness, fast
heartbeat, rapid and shallow breathing, cold clammy skin (signs of a heart disorder named cardiogenic shock).
What the medicinal ingredient is:
metoprolol tartrate.
What the nonmedicinal ingredients are:
Metoprolol Tartrate Injection USP contains: sodium chloride
What dosage forms it comes in:
Metoprolol Tartrate Injection USP 1 mg / mL, in a 5 mL single use vial.
BEFORE you use Metoprolol Tartrate Injection USP talk to your doctor or pharmacist if you:
- have heart, liver or kidney disease
- have high or low levels of sugar in the blood (diabetes)
- are at risk for serious allergic reactions
- have chest pain when you are at rest
- have poor blood circulation in your limbs (for example, very cold, pale hands or feet, or pain in your leg muscles when you walk)
have a tumor of the medulla or of the adrenal glands
(pheochromocytoma), you would require an additional treatment to Metoprolol Tartrate Injection USP
- have an overactive thyroid gland
- have respiratory disease such as asthma, or sometimes get breathlessness and wheezing
- have a severe syndrome named oculomucocutaneous syndrome whose signs include severe conjunctivitis (red, irritated and watery eye), skin rash and ear infection
are pregnant, or intend to become pregnant. Metoprolol
Tartrate Injection USP should not be used during pregnancy. Your doctor will discuss with you the potential risks of taking Metoprolol Tartrate Injection USP during pregnancy
- are breast feeding. If your doctor decides that you must continue to take Metoprolol Tartrate Injection USP you should stop breast-feeding as Metoprolol Tartrate Injection USP passes into breast milk
- are under 18 years old.
If you need to undergo an operation where an anesthetic is used, tell your anesthetic professional that you are taking Metoprolol Tartrate Injection USP.
Driving and using machines: If you experience dizziness, tiredness or blurred vision during your treatment with Metoprolol Tartrate Injection USP, do not drive, use machinery, or perform other tasks that need full attention until you know how you respond to Metoprolol Tartrate Injection USP. Drinking alcohol may increase tiredness.
WARNINGS AND PRECAUTIONS
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal and non- prescription medicines. Some other medicines may interact with Metoprolol Tartrate Injection USP. These include:
- medicines used to treat high blood pressure,
medicines used to treat chest pain (angina) (e.g.
nitroglycerin),
medicines used to treat irregular heartbeat (e.g.
amiodarone, propafenone, quinidine,
disopyramidetocainide, procainamide,
ajmalineamiodarone, flecainide, digitalis glycosides such as digoxin, lidocaine),
- anaesthetics, medicines used during surgical operations,
adrenaline or similar substances (sympathomimetics),
which are found in some eye and nose drops, and in some cough medicines or remedies for the common cold (e.g. noradrenaline, isoprenaline, ephedrine, phenylephrine, phenylpropanolamine, and xanthine derivatives),
insulin, or medicines used to treat high levels of sugar in
the blood (diabetes),
medicines used to relieve pain or inflammation (non-
steroidal anti-inflammatory drugs such as COX-2 inhibitors),
- antibiotics (e.g. rifampicin),
- antivirals (e.g. ritonavir),
antihistamines used to treat hay fever (e.g.
diphenhydramine),
medicines used to treat malaria (e.g. hydroxychloroquineor
quinine),
antipsychotic medicines (e.g. thioridazine, chlorpromazine,
fluphenazine, haloperidol),
antidepressants (e.g. fluoxetine, paroxetine, fluvoxamine,
sertraline, clomipramine, desipramine or bupropion),
MOA Inhibitors and adrenergic neuron blockers (e.g.
reserpine or guanethidine),
- antifungals (e.g. terbinafine),
ergot alkaloids, used in the prevention and
treatment of migraine headaches,
- dipyridamole, used to reduce the risk of blood clots,
- alcohol.
- fingolimod, a medicine used to treat multiple sclerosis
Aldesleukin, a medicine used to treat a kidney cancer, or
other medicines that may cause a decrease in blood pressure
Usual dose:
Metoprolol Tartrate Injection USP is used for the emergency treatment of heart attacks. It is only used by an experienced health care provider under circumstances where resuscitation and monitoring equipment is available.
Overdose:
If you think you, or a person you are caring for have taken too much Metoprolol Tartrate Injection USP, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Some of the effects of an overdose of Metoprolol Tartrate Injection USP are: an abnormally slow heartbeat or an irregular heartbeat, very low blood pressure, breathlessness, difficulty breathing when lying down, swelling of the feet, loss of consciousness, blue discoloration of the lips, tongue, skin, seizures, nausea and vomiting, sudden and oppressive chest pain and death.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like other medications, Metoprolol Tartrate Injection USP may cause some side effects. These side effects may be minor and temporary. However, some may be serious and need medical attention.
Side effects may include: sleep disturbance, fatigue and tiredness especially with activity, headache, dry mouth, nausea and vomiting, diarrhea or constipation and abdominal pain, numbness, a tingling sensation in the extremities, signs of paresthesia, increased sensitivity of the skin to sun, sweating, hair loss, increased weight, and lower back pain.
Based on your health history, your doctor should take blood tests for as long as you are being treated with Metoprolol Tartrate Injection USP. They may monitor:
- blood sugar
- heart, liver, kidney and thyroid function
- how Metoprolol Tartrate Injection USP is affecting other medications that you are taking.
PROPER USE OF THIS MEDICATION
INTERACTIONS WITH THIS MEDICATION
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking the drug and get immediate medical help | ||
Only if severe | In all cases | |||
| Common | Low Blood Pressure: feeling of lightheadedness or fainting especially when getting up from a lying or sitting position | ✓ | ||
| Chest Pain | ✓ | |||
Bronchospasm: Difficulty breathing with wheezing or coughing | ✓ | |||
Heart Failure: Shortness of breath, leg swelling and tiredness especially with activity | ✓ | |||
| Uncommon | Edema: ankle swelling | ✓ | ||
Slow or irregular heartbeat (palpitations) | ✓ | |||
New or Worsening Psoriasis: Skin rash (in the form of itchy rash, thickened patches of red/silver skin). | ✓ | |||
Allergic Reaction: rash, hives, swelling of the face, throat, lips, difficulty swallowing or breathing | ✓ | |||
Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✓ | |||
Sexuality: Abnormal curvature of the penis | ✓ | |||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking the drug and get immediate medical help | ||
Only if severe | In all cases | |||
Change in sex drive Change in ability to achieve or maintain an erection | ✓ ✓ | |||
Hallucinations: see or hear things that are not there | ✓ | |||
| Depression: feel sad, loss of interest in usual activities changes in sleep and eating patterns | ✓ | |||
Change in personality and confusion | ✓ | |||
Visual Disturbance: blurred vision, dry or irritated eyes | ✓ | |||
Hearing Disturbance: noises, reduced or loss of hearing | ✓ | |||
Parasthesia: Colder than usual hands or feet | ✓ | |||
| Gangrene; toes or fingers cold to the touch, discoloured and painful | ✓ | |||
Kidney Disorder: change in frequency of urination, swelling of extremities, fatigue, skin rash, itching, nausea, vomiting | ✓ | |||
High Blood Pressure: Headaches, vision disorders, nausea and vomiting | ✓ | |||
Blood clots: swelling, pain and redness in an arm or leg that can be warm to touch. | ✓ | |||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
Symptom / effect You may develop sudden chest pain, difficulty breathing and heart palpitations Decreased Platelets: bruising, bleeding, fatigue and weakness Retroperitoneal fibrosis: lower back pain, kidney failure (low or no urine produced), high blood pressure, blood clot in the legs (See Blood Clots above) Arthritis: stiff sore joints Oculomuco- cutaneous Syndrome: red, irritated and watery eyes, skin rash and ear infection | Talk with your doctor or pharmacist | Stop taking the drug and get immediate medical help | |||
Only if severe | In all cases | ||||
| ✓ | |||||
| ✓ | |||||
| ✓ | |||||
| ✓ | |||||
This is not a complete list of side effects. For any unexpected effects while taking Metoprolol Tartrate Injection USP contact your doctor or pharmacist.
HOW TO STORE IT
Store Metoprolol Tartrate Injection USP between 15-30°C. Protect from heat and light.:
Keep all medicines out of the reach and sight of children.
REPORTING SIDE EFFECTS
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. | |||
MORE INFORMATION
If you want more information about Metoprolol Tartrate 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 sponsor’s website www.omegapharma.ca or by calling 1-800-363-0584.
Omega Laboratories Limited,
11177 Hamon
Montreal, Canada
H3M 3E4
