Apo-Diltiaz Tz: Uses, Side Effects and Dosage

What the medication is used for:

APO-DILTIAZ TZ is used for:

• the treatment of mild to moderate high blood pressure.
• the management of effort associated angina (chest pain)

APO-DILTIAZ TZ should normally be used in those patients in whom treatment with other blood pressure reduction medications has been ineffective, or have been associated with unacceptable side effects.

What it does:

APO-DILTIAZ TZ belongs to the group of drugs called “calcium channel blockers” or “calcium antagonists”. APO-DILTIAZ TZ relaxes the arteries, thereby lowering blood pressure.

APO-DILTIAZ TZ reduces the amount of oxygen that your heart muscle needs. This helps control chest pain.

When it should not be used:

Do not use APO-DILTIAZ TZ if:

• You are pregnant or plan to become pregnant.

• You are breastfeeding.
• You have a known allergy to diltiazem or to any of the non-medicinal ingredients
• You have very low blood pressure (<90 mmHg systolic).
• You have heart rhythm disorders in the absence of a pacemaker
• You have severe heart failure with fluid in the lungs.
• You are taking a medicine called dantrolene used for severe muscle spasms or severe fever.

What the medicinal ingredient is:

Diltiazem Hydrochloride

What the nonmedicinal ingredients are:

APO-DILTIAZ TZ 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain the following nonmedicinal ingredients: Carboxymethylcellulose Sodium, Eudragit, Methylcellulose, Microcrystalline Cellulose and Talc.

The empty capsule shells contain the non medicinal ingredients gelating, titanium dioxide and the following colouring agents:

• 120 mg: FD&C blue#1, FD&C red#3
• 180 mg: FD&C green#3
• 240 mg: FD&C blue#1, FD&C red#3, FD&C green #3
• 300 mg: FD&C blue #1, FD&C red#3
• 360 mg; FD&C green#3

What dosage forms it comes in:

Capsules: 120 mg, 180 mg, 240 mg, 300 mg and 360 mg.

Before you use APO-DILTIAZ TZ talk to your doctor or pharmacist if:

• You have a known allergy to diltiazem or any of the non-medicinal ingredients in APO-DILTIAZ TZ
• You have very low blood pressure
• You have ever had a bad or unusual reaction to any drug containing diltiazem in the past
• You have heart, liver or kidney disease
• You had a recent heart attack
• You have high blood sugar or diabetes
• You are 65 years or older

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines. Additional monitoring of your dose or condition may be needed if you are taking other drugs.

The following may interact with APO-DILTIAZ TZ:

• Antifungal medications with a name ending in azole;
• Medications used to control the immune system such as cyclosporine;
• Certain antibiotics should not be taken with APO-DILTIAZ TZ such as erythromycin, rifampin. Check with your pharmacist if you are not sure;
• Sleeping pills such as benzodiazepines (midazolam; triazolam);
• Other blood pressure medications; alpha antagonists, beta-blockers;
• Heart medications; Amiodarone, digoxin, digitalis, flecainide, nifedipine, propafenone, quinidine, verapamil;
• Anaesthetics;
• Lithium and imipramine used for some types of mental illness;
• Drugs that dilate the blood vessels: short and long acting nitrates;
• Medications used to control seizures: carbamazepine, phenobarbital, phenytoin;
• Warfarin used as anticoagulant;
• Cholesterol lowering medications: statins;
• Theophylline used for breathing problems;
• Terfenadine or ranitidine used for allergies;

ABOUT THIS MEDICATION

WARNINGS AND PRECAUTIONS

INTERACTIONS WITH THIS MEDICATION

• Medications used to control stomach ulcers such as cimetidine will increase the effects of APO-DILTIAZ TZ
• Multivitamins with minerals (calcium-containing products).
• Drugs to treat inflammation: Corticosteroids, methylprednisolone.
• Dantrolene used for severe muscle spasms or severe fever.

Alcohol may cause low blood pressure and dizziness when you go from lying or sitting to standing up. This can especially occur after the first dose and when the dose is increased. Tell your doctor if you experience dizziness, lightheadedness, fainting, decreased blood pressure or increased heart rate.

Grapefruit juice when consumed too often while taking APO-DILTIAZ TZ may cause headache, irregular heartbeat, edema (swelling), unexplained weight gain, and chest pain. Tell your doctor if this happens to you. Your doctor may recommend that grapefruit juice be avoided if this happens to you.

-Do not miss doses or take extra doses, unless your doctor tells you. If you are not clear about the directions, ask your doctor or pharmacist.

Take APO-DILTIAZ TZ exactly as your doctor tells you. APO-DILTIAZ TZ is taken once a day about the same time every day.

DO NOT chew or crush APO-DILTIAZ TZ capsules.

Usual Adult Dose:

High blood pressure

Usual starting doses: 180 to 240 mg once a day.

120 mg a day may be used in some patients.

Maximum dose: 360 mg a day.

Angina

Dosage should be individualized.

Starting dose: 120 mg to 180 mg once a day. Dose may be slowly (over 7 to 14 days) increased up to 360 mg a day. Always follow your doctor’s instructions.

Overdose:

Missed Dose:

If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule.

Side effects may include:

• Headache, dizziness, malaise;
• Nausea (feeling like vomiting);
• Flushing (facial redness) or feeling unusually warm;
• Unusual tiredness and weakness;
• Upset stomach.

APO-DILTIAZ can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

PROPER USE OF THIS MEDICATION

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

This is not a complete list of side effects. For any unexpected effects while taking APO-DILTIAZ TZ, contact your doctor or pharmacist.

Store APO-DILTIAZ TZ capsules at room temperature (15-30°C). Avoid excessive humidity. Keep out of sight and reach of children.

HOW TO STORE IT

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products in the Canada Vigilance Program by one of the following 3 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 Report Form and the adverse reaction reporting guidelines are available on the MedEffect^TM Canada Web site at www.healthcanada.gc.ca/medeffect

NOTE: Should you require information related to the management of the side effects, please contact your health care professional. The Canada Vigilance program does not provide medical advice.

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex’s Drug Information Service at:

1-800-667-4708

This leaflet can also be found at:

http://www.apotex.ca/products.

Last revised: November 10, 2014

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