Details for: ULTRACAINE D-S
Company: HANSAMED LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 01988557 | ULTRACAINE D-S FORTE INJECTION | EPINEPHRINE; ARTICAINE HYDROCHLORIDE | 0.01 MG / ML; 40 MG / ML | SOLUTION | BLOCK/INFILTRATION |
| 01988530 | ULTRACAINE D-S INJECTION | EPINEPHRINE; ARTICAINE HYDROCHLORIDE | 5 MCG / ML; 40 MG / ML | SOLUTION | BLOCK/INFILTRATION |
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
Ultracaine D-S and Ultracaine D-S Forte are used for the local anaesthesia(freezing) for dental treatments in adults and children 4 years of age and older.
What it does
Ultracaine contains two active ingredients: 1) articaine (local anaesthetic) that causes loss of feeling (freezing) in the gums and surrounding tissues, and 2) epinephrine (adrenaline) that narrows the blood vessels, reduces bleeding, and helps the freezing last longer during dental treatments.
When it should not be used
Ultracaine D-S and Ultracaine D-S Forte should not be used in patients who:
- are allergic to articaine or other similar local anaesthetics ,
- are allergic to sulphites or any of the other ingredients of this medication,
- suffer from severe heart rhythm disorders,
- have a very slow pulse,
- suffer from acute heart failure,
- have very low blood pressure,
- suffer from asthma attacks, which can be triggered by hypersensitivity to the sulphites in this medicine,
- suffer from excessive pressure in your eyes (glaucoma),
- have an overactive thyroid,
- suffer from sudden heart palpitations (tachycardia),
- suffered a heart attack in the last 3 to 6 months,
- underwent coronary artery bypass surgery in the last 3 months,
- take certain heart medications, known as beta blocker medications, such as propranolol,
- suffer from an adrenaline-producing tumour in the adrenal gland,
- have uncontrolled high blood pressure,
- are currently taking certain medications for the treatment of depression and Parkinson’s disease (tricyclic antidepressants, MAO inhibitors).
What the medicinal ingredient is
- articaine HCl, epinephrine (adrenaline)
What the non-medicinal ingredients are
- hydrochloric acid, sodium chloride, sodium metabisulphite, and distilled water
What dosage form it comes in
Ultracaine D-S and Ultracaine D-S Forte are available to the dentist, in single use cartridges containing 1.7 millilitres (mL) of the solution for injection by the dentist.
Ultracaine D-S solution contains 40 milligrams (mg) of articaine HCl and 0.006 mg epinephrine HCl (adrenaline HCl) in each mL. This corresponds to 0.005 mg of epinephrine base in each mL (1:200,000).
Ultracaine D-S Forte solution contains 40 mg of articaine HCl and 0.012 mg epinephrine HCl (adrenaline HCl) in each mL. This corresponds to 0.010 mg of epinephrine base in each mL (1:100,000).
Warnings and precautions
You should talk to your dentist or doctor prior to dental treatment:
- about health problems you have now, or have had in the past,
- about other medicines you take, including medications you can buy without a prescription,
- if you have heart, liver, lung or kidney disease;
- if you have a neurological, or psychiatric disorder,
- you have a deficiency of a specific enzyme (cholinesterase deficiency),
- if you have epilepsy,
- if you are pregnant,
- if you are nursing.
If you are breastfeeding an infant or small child, you may want to pump and discard your breast milk for about 4 hours following the dental treatment involving an injection of Ultracaine D-S, or Ultracaine D-S Forte. This will help minimize the amount of this medication in the breast milk given to your infant or young child.
Recovery from local anaesthesia (freezing) after a dental treatment usually occurs gradually, within minutes to hours after treatment.
Before the freezing has worn off, avoid drinking hot liquids or chewing, because it will be difficult to know if the liquid is too hot, or if you are biting your tongue, inner cheek or lips by mistake.
Interactions with this medication
As with most medicines, interactions with other drugs are possible. Tell your dentist or doctor if you are taking, or have recently taken any other medicines.
For example, the following medications may interact with Ultracaine D-S or Ultracaine D-S Forte:
- certain types of medications, known as “tricyclic” antidepressants or “MAO inhibitors”, for the treatment of depression or Parkinson’s disease,
- certain heart medications, known as beta blockers (such as propranolol),
- oral medicines (pills) for the treatment of diabetes.
Proper use of this medication
Usual Dose
Ultracaine D-S and Ultracaine D-S Forte solutions are only for injection by dental professionals at the time of dental treatment. They are not for intravenous injection.
Your dentist will determine the dose to use. The lowest dosage needed to provide effective freezing should be used. The maximum dose is 7 milligrams of articaine per kilogram of body weight (0.175 ml/kg), for adults and children 4 years old or older.
These medications are not recommended for use in children less than 4 years old.
Overdose
If an excessive quantity of Ultracaine is present in your body, you may experience one or more of the following side effects (likely soon after injection): restlessness, anxiety, confusion, facial reddening, drowsiness, nausea, vomiting, dizziness, difficulty speaking, hearing or seeing (for example, blurred or double vision), muscular weakness, tremor, twitching, difficulty breathing, an increase or decrease in your blood pressure, or heart rhythm disturbances.
Tell your dentist immediately if you have any of the above symptoms, as special monitoring and care may be required to prevent them from becoming more serious side effects.
Side effects and what to do about them
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may include: headache, nausea and vomiting. You may feel temporary tingling or prickling sensations near the area that was frozen (paraesthesia).
Additional side effects in children
Compared to adults, children have an increased risk after a dental procedure of biting their numb area(s) before the freezing has worn off. This could result in injuries to their lips, inner cheeks and /or tongue.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Seek immediate medical assistance |
|---|---|---|---|
| Uncommon (may affect up to 1 in 100 people) | |||
| Rapid heart-beat (tachycardia) | ✔ | ||
| Unknown (frequency cannot be estimated from the available data) | |||
| Numbness in the injected area or face, that does not fade away (hypoaesthesia) | ✔ | ||
| Disturbed sight, taste or sensation of touch in injected area, that does not fade away (paraesthesia) | ✔ | ||
| Heart rhythm disturbances | ✔ | ||
| Increase or decrease in blood pressure | ✔ | ||
| Lowered heart rate (bradycardia), | ✔ | ||
| Visual disorders, nervousness, anxiety, dizziness, difficulty hearing or seeing (for example, blurred or double vision, blindness), drowsiness, convulsions, difficulty breathing. | ✔ | ||
| Wheezing, acute asthma attack (hypersensitivity / allergic reactions) | ✔ | ||
| Inflammation at injection site (including redness, swelling and/or strong itching), with red eyes, runny nose, face and /or throat area swelling, difficulty breathing (hypersensitivity / allergic reactions) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects after a dental treatment involving Ultracaine products, contact your dentist, doctor or pharmacist.
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.hansamed.net
or by contacting the sponsor, Hansamed Ltd, at:
Tel. 1-800-363-2876
This leaflet was prepared by Hansamed Ltd,
Last revised: 27-Jan-2014