Doxycycline Mono 40mg DR Capsules

Doxycycline Mono 40mg DR Capsules (Oracea) is a sub-antimicrobial dose of doxycycline. Its mechanism of action in rosacea is believed to be primarily due to its anti-inflammatory properties rather than its antimicrobial effects. It inhibits matrix metalloproteinases (MMPs), which are enzymes implicated in the pathogenesis of rosacea by contributing to inflammation and tissue degradation. It also has anti-collagenase activity and can reduce inflammatory mediators.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting
Chest pain or pressure, or a rapid heartbeat
Difficulty urinating or changes in urine output
Fever, chills, or sore throat; unexplained bruising or bleeding; or feeling extremely tired or weak
Throat irritation or trouble swallowing
Muscle or joint pain
Rapid breathing
Flushing
Severe dizziness or fainting
Changes in skin color
Vaginal itching or discharge
Diarrhea (common with antibiotics), especially if severe, watery, or bloody (may be a sign of C. diff-associated diarrhea, a potentially life-threatening condition)

If you experience any of these symptoms, call your doctor right away. Additionally, be aware that:

C. diff-associated diarrhea (CDAD) may occur during or after antibiotic treatment, which can lead to a life-threatening bowel condition. Seek medical help if you have stomach pain, cramps, or severe diarrhea.
Raised pressure in the brain has been reported with this medication, which may cause headaches or vision problems (such as blurred vision, double vision, or loss of vision). If you experience any of these symptoms, contact your doctor immediately.

Other Possible Side Effects

Most people do not experience severe side effects, but some may occur. If you notice any of the following symptoms, contact your doctor if they bother you or do not go away:

Diarrhea, upset stomach, or vomiting
Decreased appetite

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking any of the following medications: Acitretin, Isotretinoin, or a Penicillin.
* If you are breast-feeding or plan to breast-feed, as you may need to avoid doing so while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are on long-term treatment with this drug, your doctor may recommend regular blood tests to monitor your condition.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and lab personnel that you are taking this drug. Do not exceed the recommended duration of treatment, as this may increase the risk of a second infection.

You may be more susceptible to sunburn while taking this medication, so take necessary precautions when exposed to the sun. If you experience unusual sunburn or sensitivity, inform your doctor promptly.

Be aware that this drug can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions that can affect internal organs. These reactions can be life-threatening, so seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

If you are using birth control pills or other hormone-based contraceptives, note that this medication may reduce their effectiveness. Consider using an additional form of birth control, such as condoms, to prevent pregnancy.

In children under 8 years old, this medication may cause permanent tooth discoloration (yellow-gray brown) or other tooth problems. It may also affect bone growth in these individuals. If you have concerns, discuss them with your doctor. Although this medication is not typically recommended for children under 8, there may be exceptions; consult with your doctor to determine the best course of treatment.

Tooth discoloration has also been reported in adults, but this condition may be reversible after stopping the medication and undergoing dental cleaning. Consult your doctor if you have concerns.

If you are pregnant or become pregnant while taking this medication, you may be at risk of harming your unborn baby. Inform your doctor immediately if you are pregnant or suspect you may be pregnant.

• Isotretinoin (increased risk of pseudotumor cerebri/benign intracranial hypertension)
• Oral retinoids (e.g., acitretin, tretinoin) (increased risk of pseudotumor cerebri/benign intracranial hypertension)
• Penicillins (tetracyclines may interfere with the bactericidal action of penicillin)

• Antacids containing aluminum, calcium, or magnesium (decreased doxycycline absorption)
• Iron preparations (decreased doxycycline absorption)
• Bismuth subsalicylate (decreased doxycycline absorption)
• Oral contraceptives (potential for decreased efficacy of oral contraceptives, though evidence is mixed)
• Warfarin (potential for increased anticoagulant effect)
• Barbiturates (e.g., phenobarbital) (decreased doxycycline half-life)
• Carbamazepine (decreased doxycycline half-life)
• Phenytoin (decreased doxycycline half-life)
• Methoxyflurane (potential for fatal renal toxicity)

• Cholestyramine (may decrease doxycycline absorption)

• Photosensitivity (sunburn-like reaction)
• Gastrointestinal upset (nausea, diarrhea, abdominal pain)
• Headache
• Vaginal candidiasis (yeast infection)
• Esophageal irritation/ulceration (if not taken with sufficient water or if lying down too soon after dose)
• Dizziness/lightheadedness
• Blurred vision or visual disturbances (rare, suggestive of pseudotumor cerebri)

Category D. Doxycycline can cause permanent discoloration of teeth (yellow-gray-brown) and reversible inhibition of bone growth if administered during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years). Use only if the potential benefit justifies the potential risk to the fetus.

Doxycycline is excreted in breast milk. While the amount is generally low and absorption by the infant may be limited due to chelation with calcium in milk, there is a theoretical risk of tooth discoloration and inhibition of bone growth in the nursing infant. The manufacturer recommends that a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and reversible inhibition of bone growth. Safety and efficacy for rosacea have not been established in pediatric patients.

No specific dose adjustment is generally required for elderly patients. However, elderly patients may be more susceptible to adverse effects such as photosensitivity or gastrointestinal irritation. Use with caution and monitor for adverse reactions.

• This specific 40mg DR formulation of doxycycline is designed for its anti-inflammatory effects in rosacea, not for its antimicrobial activity. It's crucial to emphasize this to patients to manage expectations and prevent misuse.
• Always instruct patients to take the capsule with a full glass of water and remain upright for at least 30-60 minutes to minimize the risk of esophageal irritation or ulceration.
• Advise strict sun protection (sunscreen, protective clothing) due to the photosensitivity risk, even with this lower dose.
• Remind patients about the importance of avoiding antacids, iron, and dairy products around the time of dosing to ensure proper absorption.
• Clinical improvement for rosacea may take several weeks to become apparent, so encourage patient adherence and patience.

• Topical metronidazole (cream, gel, lotion)
• Topical azelaic acid (gel, foam, cream)
• Topical ivermectin (cream)
• Brimonidine topical gel (for erythema)
• Oxymetazoline topical cream (for erythema)
• Oral antibiotics (e.g., other tetracyclines, macrolides) at higher doses for more severe inflammatory rosacea (though not preferred for long-term use due to resistance concerns)
• Laser or light therapy (for erythema and telangiectasias)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.