Apo-Doxycycline Modified Release: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-DOXYCYCLINE MODIFIED RELEASE is used for the treatment of bumps and pimples caused by rosacea (roh-ZAY-she-ah) in adults. This medication should not be used for any other reason than that which it is prescribed.

APO-DOXYCYCLINE MODIFIED RELEASE contains an antibacterial ingredient called doxycycline, and it should be used exactly as directed by your healthcare professional. Misuse or overuse of APO-DOXYCYCLINE MODIFIED RELEASE could lead to the growth of bacteria that will not be killed by doxycycline. This means that APO-DOXYCYCLINE MODIFIED RELEASE or other medicines that contain doxycycline may not work for you in the future. Do not share your medicine.

What it does:

APO-DOXYCYCLINE MODIFIED RELEASE has anti-inflammatory properties that reduce the bumps and pimples caused by rosacea.

When it should not be used:

• If you are allergic to the medicinal ingredient in APO-DOXYCYCLINE MODIFIED RELEASE, or allergic to any medicinal ingredients known as tetracyclines, including doxycycline and minocycline.
• If you are allergic to any of the ingredients in APO-DOXYCYCLINE MODIFIED RELEASE (see What the important nonmedicinal ingredients are:).

• If you are pregnant or nursing. Low levels of tetracyclines are released in human breast milk.

• In infants and children under 8 years of age.

• If you have myasthenia gravis (a chronic disease which can cause muscle weakness).
• APO-DOXYCYCLINE MODIFIED RELEASE should not be used to treat infections.

What the medicinal ingredient is:

APO-DOXYCYCLINE MODIFIED RELEASE capsules contain the active ingredient doxycycline (as doxycycline monohydrate).

What the important nonmedicinal ingredients are:

Each APO-DOXYCYCLINE MODIFIED RELEASE capsule contains ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, dibutyl sebacate, ethylcellulose, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, red iron oxide, shellac, talc, titanium oxide and yellow iron oxide.

What dosage forms it comes in:

APO-DOXYCYCLINE MODIFIED RELEASE is available in modified-release capsules containing 40 mg of doxycycline (as doxycycline monohydrate). Each capsule contains two types of tablets; the immediate-release component contain 35 mg of doxycycline and the second component contains 5 mg of doxycycline.

WARNINGS AND PRECAUTIONS

BEFORE you use APO-DOXYCYCLINE MODIFIED RELEASE talk to your doctor or pharmacist if:

• You are allergic to any of the ingredients in APO-DOXYCYCLINE MODIFIED RELEASE.
• You are pregnant, planning to become pregnant or if you are breastfeeding.
• You have been diagnosed with myasthenia gravis (a chronic disease which can cause muscle weakness).
• You have difficulty swallowing, or medical conditions such as a narrowing or blockage in your esophagus (passage from your mouth to stomach).
• You have liver or kidney problems.
• You have or have recently had a yeast or fungus infection in your mouth or vagina.
• You are taking other prescription medications or other medications, including medications purchased without a prescription, such as vitamin or mineral supplements.
• You have had a gastrectomy or gastric bypass surgery.
• You spend time in sunlight or artificial sunlight (such as a tanning bed). APO-DOXYCYCLINE MODIFIED RELEASE may increase the severity of sunburns. Avoid sunlight or exposure to artificial UV light. Use a good sunscreen (SPF 15 or higher) and wear protective clothing, such as a hat or sunglasses.

Tell your doctor or pharmacist right away and stop taking APO-DOXYCYCLINE MODIFIED RELEASE if:

• If you develop a hypersensitivity (allergic) reaction which may include symptoms such as difficulty in breathing, fast heartbeat, dizziness, itching, rash, and skin blistering.
• At the first sign of oversensitivity of skin to light/sunlight/Ultra Violet light or skin redness.
• If you develop diarrhea during the course of taking APO-DOXYCYCLINE MODIFIED RELEASE.

INTERACTIONS WITH THIS MEDICATION

IMPORTANT: PLEASE READ

Drugs that may interact with APO-DOXYCYCLINE MODIFIED RELEASE include:

• A medication for hypertension, quinipril.
• Blood thinners (oral anticoagulants). Your doctor may need to change your anticoagulant dose.
• Oral retinoids, such as isotretinoin and acitretin.
• Medications that treat infections, such as penicillin and rifampicin.
• Medications that treat seizures, such as barbiturates, carbamazepine and diphenylhydantoin.
• Chronic alcohol abuse may cause APO-DOXYCYCLINE MODIFIED RELEASE to break down more quickly and make the medication less effective.
• Proton pump inhibitors (to reduce stomach acidity) such as omeprazole, pantoprazole, rabeprazole.
• Antacids and dairy products (that contain aluminum, zinc, calcium or magnesium), and iron preparations, activated charcoal, chlostyramine, bismuth chelates and subsalicylate may reduce the absorption of the medicinal ingredient in APO-DOXYCYCLINE MODIFIED RELEASE.
• Products that contain iron should be taken at a different time than APO-DOXYCYCLINE MODIFIED RELEASE.
• The use of APO-DOXYCYCLINE MODIFIED RELEASE may reduce the effectiveness of birth control pills (oral contraceptives).
• Some anesthetics/inhalants (e.g. methoxyflurane).
• Some medications for diabetes (e.g. sulfonylureas)

PROPER USE OF THIS MEDICATION

Usual adult dose

APO-DOXYCYCLINE MODIFIED RELEASE should be taken once daily in the morning, on an empty stomach. It is recommended that the capsule be swallowed with a full glass of water to avoid potential irritation to the esophagus (passage from mouth to stomach).

Antacids (containing calcium, aluminum, magnesium or zinc), iron preparations, activated charcoal, cholestyramine, bismuth chelates and sucralfate and foods or drinks containing calcium such as dairy products and calcium containing fruit juices should only be taken at least 2-3 hours after taking APO-DOXYCYCLINE MODIFIED RELEASE.

Overdose:

Do not take more capsules than your doctor has told you to. Taking more than the prescribed dose may increase the chance of side effects.

Missed Dose:

If you miss a dose of APO-DOXYCYCLINE MODIFIED RELEASE, skip that dose and take the next dose at your regular time. Do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Common side effects include diarrhea, headache, nausea, and abdominal pain. Some people may experience soreness in the nose or throat (nasopharyngitis), sinus infection or an increase in blood pressure (hypertension). These side effects are generally mild and do not usually cause patients to stop taking APO-DOXYCYCLINE MODIFIED RELEASE

If you experience symptoms such as severe (watery or bloody) diarrhea, fever, abdominal pain or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this happens, stop taking the drug and call your healthcare professional immediately.

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

This is not a complete list of side effects. A complete listing of adverse events that have been reported is contained in the Product Monograph supplied to your doctor and pharmacist. For any unexpected effects while taking APO-DOXYCYCLINE MODIFIED RELEASE, contact your doctor or pharmacist.

IMPORTANT: PLEASE READ

HOW TO STORE IT

Store: APO-DOXYCYCLINE MODIFIED RELEASE capsules at controlled room temperature 15°C to 30°C in tight, light resistant containers.

Keep out of reach and sight of children.

Do not take APO-DOXYCYCLINE MODIFIED RELEASE capsules after the expiry date.

Reporting Side Effects

MORE INFORMATION

If you want more information about APO-DOXYCYCLINE MODIFIED RELEASE:

• Talk to your healthcare professional

  • Find the full product monograph that is prepared for healthcare professionals and includes this Part III: Consumer 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 http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last revised: MAR 13, 2024