Details for: APO-DOXYLAMINE/B6
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02413248 | APO-DOXYLAMINE/B6 | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 10 MG; 10 MG | TABLET (DELAYED-RELEASE) | ORAL |
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
The management of nausea and vomiting of pregnancy. APO-DOXYLAMINE/B6 can be used during any trimester of pregnancy.
What it does
and anti-vomiting action of two different ingredients: doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6).
When it should not be used
You should not be given APO- DOXYLAMINE/B6 if you:
- are allergic to APO-DOXYLAMINE/B6 or to any of the nonmedicinal ingredients;
- have any of the following conditions: risk of asthmatic attack, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, bladder-neck obstruction;
- are receiving a monoamine oxidase inhibitor (MAOIs)
What the medicinal ingredient is
The medicinal ingredients of APO-DOXYLAMINE/B6 are doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6).
What the non-medicinal ingredients are
Non-medicinal ingredients are as follows: magnesium stearate, mannitol, methacrylic acid copolymer, sodium hydroxide, talc, triethyl citrate.
What dosage form it comes in
APO-DOXYLAMINE/B6 (doxylamine succinate, pyridoxine hydrochloride) delayed release tablets, 10mg/10 mg: white to off white coloured, round shaped, biconvex coated tablets engraved with “APO” on one side and “10 over 10” on the other side. Each delayed release tablet contains doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg
Warnings and precautions
APO-DOXYLAMINE/B6 may cause somnolence. Caution must be exercised in activities requiring mental alertness such as driving a car or operating heavy machinery. Until you know how you will react to this medication, do not drive or operate machinery.
APO-DOXYLAMINE/B6 may pass into breast milk and unusual excitement, irritability or sedation (sleepiness) may occur in the infant. Nursing mothers treated with APO-DOXYLAMINE/B6 should not breastfeed or the use of APO-DOXYLAMINE/B6 during lactation should be avoided.
Interactions with this medication
Deeper somnolence could be produced if APO- DOXYLAMINE/B6 is taken in combination with alcohol or other drugs such as drugs for cough or colds, pain killers or sleep aids.
You should tell your doctor if you are taking or have recently taken any medications (prescription or non-prescription) or natural/herbal products, especially:
- a monoamine oxidase inhibitor (MAOIs) [e.g., linezolid (an antibiotic), methylene blue (a diagnostic dye)]
- antimuscarinic drugs (used in treating a variety of conditions such as disorders of the bowel, bladder or respiratory systems, Parkinson's disease, certain heart conditions and insomnia).
- alcohol and other central nervous system depressants, such as drugs for anxiety, seizures, mental illness, and allergies, sleeping pills, anesthetics (used for surgery), certain pain medications.
Proper use of this medication
APO-DOXYLAMINE/B6 is a delayed-release formulation that works best when taken 4 to 6 hours before needed and should be taken on a daily basis. If taken with food, it may take longer to feel a relief of symptoms.
Usual dose
APO-DOXYLAMINE/B6 should be taken as prescribed by your doctor or healthcare professional.
- Take two APO- DOXYLAMINE/B6 delayed release tablets at bedtime to control nausea and vomiting occurring in the morning.
- Take 1 tablet in the morning and,
- Take 1 tablet mid-afternoon to control your symptoms throughout the day.
Your doctor or healthcare professional may adjust the dosing schedule according to your condition.
Do not stop taking APO-DOXYLAMINE/B6 on your own. Always consult your doctor or healthcare professional. They will gradually reduce your dose when stopping APO-DOXYLAMINE/B6 treatment to prevent a sudden return of nausea and vomiting.
This drug is specifically prescribed for you and your actual state of health. Do not give it to others, even if they have the same symptoms, and you yourself must not use it for any other condition than the one for which it was prescribed.
Tablets should not be crushed or split.
Missed Dose
If you forget to take a dose of APO-DOXYLAMINE/B6, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not try to make up for a missed dose by taking a double dose.
Overdose
If you suspect an accidental overdose, seek medical attention immediately. Do not wait for any signs or symptoms to appear before seeking medical attention, as they may not occur immediately.
Signs and symptoms of overdosage are restlessness, dryness of mouth, dilated pupils, sleepiness, dizziness, mental confusion and rapid heartbeat.
Side effects and what to do about them
Like all medications, APO-DOXYLAMINE/B6 can cause some side effects. You may not experience any of them. For most patients, these side effects are likely to be minor and temporary. However, some may be serious. Some of these side effects may be dose-related. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.
If you experience an allergic reaction (including skin rash, hives, swelling, trouble breathing) or any severe or unusual side effects, seek immediate emergency medical assistance.
Side effects associated with APO-DOXYLAMINE/B6 are: somnolence, dizziness, nervousness, stomach pain, headache, diarrhea, irritability, or insomnia.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| None | |||
| Very Rare | |||
| Disorientation | ✔ | ||
| Difficulty urinating | ✔ | ||
| Irregular heartbeat | ✔ | ||
| Seizures | ✔ | ||
How to store
Keep your APO-DOXYLAMINE/B6 tablets in a safe place where children cannot reach them
APO-DOXYLAMINE/B6 tablets should be stored at room temperature (15°C - 25°C). Protect from moisture.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (www.healthcanada.gc.ca/medeffect);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. 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.apotex.ca/ products or by contacting the
sponsor, DISpedia, Apotex’s Drug Information
Service, at: 1-800-667-4708.This leaflet was prepared
by Apotex Inc., Toronto, Ontario, M9L 1T9.
If you wish to enroll in the Doxylamine Succinate
and Pyridoxine Hydrochloride Delayed Release
Tablets Surveillance Program, please call 1-800-667-
4708.
Last revised: November 22, 2017