Doxycycline Mono 40mg Drcapsules

Manufacturer MAYNE PHARMA Active Ingredient Doxycycline Capsules (Rosacea)(doks i SYE kleen) Pronunciation doks-i-SYE-kleen
It is used to treat rosacea.
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Drug Class
Anti-acne agent; Tetracycline antibiotic (sub-antimicrobial dose)
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Pharmacologic Class
Tetracycline
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Pregnancy Category
Category D
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FDA Approved
May 2006
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Doxycycline Mono 40mg Drcapsules is a low-dose form of an antibiotic that is used to treat rosacea, a skin condition causing redness and bumps. At this low dose, it works mainly by reducing inflammation, not by killing bacteria, which helps to improve your skin's appearance.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.

Special Instructions for Taking Your Medication

Some medications should be taken with food, while others should be taken on an empty stomach. Check with your pharmacist to determine the best way to take your medication.
It's best to avoid taking your medication at the same time as milk, dairy products, or other foods that contain calcium, as this may reduce the medication's effectiveness. If you have questions, consult with your doctor or pharmacist.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Important Interactions to Avoid

Do not take the following medications within 2 hours of taking your prescribed medication: bismuth (Pepto-Bismol), calcium, iron, magnesium, zinc, multivitamins with minerals, colestipol, cholestyramine, didanosine, or antacids.
Take your medication with a full glass of water.
After taking your medication, do not lie down for a period of time to reduce the risk of throat irritation. Ask your pharmacist for guidance on how long to wait before lying down.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Do not take your medication if it is past its expiration date or if it has not been stored properly.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take this medication exactly as prescribed, usually once daily in the morning.
  • Take with a full glass of water (at least 8 ounces) to prevent irritation of the esophagus.
  • Remain upright (do not lie down) for at least 30 minutes after taking the capsule.
  • Take on an empty stomach, at least 1 hour before or 2 hours after meals.
  • Avoid taking antacids, iron supplements, or dairy products within 2-3 hours of your dose, as they can interfere with absorption.
  • Protect yourself from the sun: Doxycycline can make your skin more sensitive to sunlight (photosensitivity). Use sunscreen, wear protective clothing, and limit sun exposure.
  • Do not share this medication with others, even if they have similar symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: 40 mg (as Doxycycline Monohydrate) once daily in the morning
Dose Range: 40 - 40 mg

Condition-Specific Dosing:

rosacea: 40 mg once daily in the morning
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Pediatric Dosing

Neonatal: Not established (Contraindicated in children under 8 years)
Infant: Not established (Contraindicated in children under 8 years)
Child: Not established (Contraindicated in children under 8 years due to risk of tooth discoloration and bone growth effects)
Adolescent: Not established for rosacea indication. If used for other indications in adolescents >8 years, dosing is typically weight-based.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment generally needed
Moderate: No dosage adjustment generally needed
Severe: No dosage adjustment generally needed
Dialysis: Doxycycline is not significantly removed by hemodialysis. No dosage adjustment generally needed.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects
Moderate: Use with caution; monitor for adverse effects
Severe: Use with caution; monitor for adverse effects

Pharmacology

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Mechanism of Action

At the 40 mg delayed-release dose, doxycycline primarily exerts anti-inflammatory effects rather than antimicrobial action. It inhibits matrix metalloproteinases (MMPs), particularly collagenase, and reduces inflammatory cytokines and reactive oxygen species, which are implicated in the pathogenesis of rosacea. At higher doses, doxycycline acts as a broad-spectrum antibiotic by inhibiting bacterial protein synthesis through reversible binding to the 30S ribosomal subunit.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 60% (for 40mg DR formulation)
Tmax: 2-3 hours
FoodEffect: Should be taken on an empty stomach (at least 1 hour before or 2 hours after meals) for optimal absorption and to minimize esophageal irritation.

Distribution:

Vd: Approximately 0.7 L/kg
ProteinBinding: 80-90%
CnssPenetration: Limited (increases with meningeal inflammation)

Elimination:

HalfLife: 18-22 hours
Clearance: Not available (primarily renal and fecal excretion)
ExcretionRoute: Renal and fecal (unchanged drug)
Unchanged: Approximately 40% (renal), 20-40% (fecal)
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Pharmacodynamics

OnsetOfAction: Clinical improvement for rosacea is gradual, typically observed within 3-4 weeks of initiation.
PeakEffect: Continued improvement may be seen over 12-16 weeks of treatment.
DurationOfAction: Effects persist as long as treatment is continued.

Safety & Warnings

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Side Effects

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 fast 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 it's severe, bloody, or watery (may be a sign of C. diff-associated diarrhea, a potentially life-threatening condition)

If you experience any of these symptoms, contact 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 severe bowel problem. If you have stomach pain, cramps, or severe diarrhea, contact your doctor immediately.
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, seek medical attention right away.

Other Possible Side Effects

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

Diarrhea, upset stomach, or vomiting
Decreased appetite

This is not a comprehensive list of all 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe headache or vision changes (e.g., blurred vision, double vision, loss of vision) – seek immediate medical attention.
  • Severe diarrhea (especially if watery or bloody) or stomach cramps.
  • New or worsening rash, hives, or severe itching.
  • Signs of a yeast infection (e.g., white patches in mouth, vaginal itching or discharge).
  • Difficulty swallowing or painful swallowing, chest pain (may indicate esophageal irritation).
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Before Using This Medicine

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, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking any of the following medications: Acitretin, Isotretinoin, or a Penicillin.
* If you are breastfeeding or plan to breastfeed, as you may need to avoid breastfeeding while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

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 prescribed 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 increased sensitivity to the sun, inform your doctor promptly.

There is a risk of severe skin reactions associated with this medication, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can be life-threatening and may also affect internal organs. 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 contraception, note that this medication may reduce their effectiveness. Consider using an additional form of birth control, such as a condom, to prevent pregnancy.

In children under 8 years old, this medication may cause permanent tooth discoloration (yellow-gray brown). Similarly, if taken during certain stages of pregnancy, it may affect the unborn baby's teeth. Other tooth problems and impaired bone growth have also been reported in these individuals. If you have concerns, discuss them with your doctor.

Generally, this medication is not recommended for children under 8 years old, except in exceptional circumstances. Consult your doctor to determine the best course of treatment.

Adults may also experience tooth discoloration, but this typically reverses after stopping the medication and undergoing dental cleaning. Consult your doctor if you have any concerns.

If you are pregnant or become pregnant while taking this medication, you should contact your doctor immediately, as it may harm the unborn baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea

What to Do:

In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. Treatment is symptomatic and supportive.

Drug Interactions

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Contraindicated Interactions

  • Isotretinoin (increased risk of pseudotumor cerebri)
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Major Interactions

  • Antacids (containing aluminum, calcium, magnesium) - decreased doxycycline absorption
  • Iron preparations - decreased doxycycline absorption
  • Bismuth subsalicylate - decreased doxycycline absorption
  • Oral retinoids (e.g., acitretin, tretinoin) - increased risk of pseudotumor cerebri
  • Penicillins - tetracyclines may interfere with the bactericidal action of penicillins
  • Live bacterial vaccines (e.g., oral typhoid vaccine, cholera vaccine) - reduced vaccine efficacy
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Moderate Interactions

  • Oral contraceptives - potential for reduced efficacy (though evidence is weak and controversial)
  • Warfarin - potentiation of anticoagulant effect (monitor INR)
  • Methotrexate - increased methotrexate toxicity (monitor for adverse effects)
  • Ergot alkaloids - increased risk of ergotism
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Minor Interactions

  • Barbiturates (e.g., phenobarbital) - decreased doxycycline half-life
  • Carbamazepine - decreased doxycycline half-life
  • Phenytoin - decreased doxycycline half-life

Monitoring

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Baseline Monitoring

Clinical assessment of rosacea symptoms

Rationale: To establish baseline severity and guide treatment.

Timing: Prior to initiation of therapy

Liver function tests (LFTs)

Rationale: Although doxycycline is minimally metabolized by the liver, caution is advised in patients with hepatic impairment.

Timing: Consider in patients with pre-existing hepatic impairment

Renal function tests (RFTs)

Rationale: To assess baseline kidney function, though dosage adjustment is generally not needed.

Timing: Consider in patients with pre-existing renal impairment

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Routine Monitoring

Clinical assessment of rosacea symptoms (e.g., inflammatory lesions, erythema)

Frequency: Every 4-8 weeks initially, then as clinically indicated

Target: Reduction in lesion count and erythema

Action Threshold: Lack of improvement or worsening symptoms may warrant re-evaluation of treatment.

Adverse effect monitoring (e.g., GI upset, photosensitivity, headache, candidiasis)

Frequency: At each follow-up visit

Target: Absence or manageable level of side effects

Action Threshold: Persistent or severe adverse effects may require dose adjustment or discontinuation.

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Symptom Monitoring

  • Gastrointestinal upset (nausea, vomiting, diarrhea)
  • Photosensitivity (severe sunburn, rash upon sun exposure)
  • Headache (especially severe or persistent, which could indicate pseudotumor cerebri)
  • Blurred vision or other visual disturbances
  • Dizziness
  • Signs of candidiasis (oral thrush, vaginal yeast infection)
  • Signs of esophageal irritation (dysphagia, odynophagia, chest pain)

Special Patient Groups

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Pregnancy

Doxycycline is classified as Pregnancy Category D. It should be avoided during pregnancy due to the potential for permanent discoloration of deciduous teeth and reversible inhibition of bone growth in the fetus. The benefits of treatment must outweigh the potential risks.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, including tooth discoloration and bone growth effects, though risk is higher with prolonged exposure in later trimesters.
Second Trimester: Increased risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia in the developing teeth of the fetus. Reversible inhibition of bone growth.
Third Trimester: Increased risk of permanent tooth discoloration and enamel hypoplasia. Reversible inhibition of bone growth.
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Lactation

Doxycycline is excreted into breast milk. While the amount transferred at the 40mg sub-antimicrobial dose is low, there is a theoretical risk of tooth discoloration and enamel hypoplasia in the nursing infant. The American Academy of Pediatrics considers tetracyclines compatible with breastfeeding with caution. Use with caution, monitor infant for potential adverse effects (e.g., diarrhea, candidiasis), or consider alternative therapy.

Infant Risk: L3 (Moderately safe). Potential for tooth discoloration and enamel hypoplasia, though risk is low with short-term use of low doses. GI upset and candidiasis are also theoretical risks.
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Pediatric Use

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 in pediatric patients have not been established.

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Geriatric Use

No specific dosage adjustment is generally required in elderly patients. However, geriatric patients may be more susceptible to adverse effects, particularly gastrointestinal disturbances. Monitor closely for side effects.

Clinical Information

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Clinical Pearls

  • Doxycycline 40mg delayed-release (e.g., Oracea) is specifically formulated to provide sub-antimicrobial concentrations, primarily leveraging its anti-inflammatory properties for rosacea treatment, thereby minimizing the risk of antibiotic resistance.
  • Emphasize strict adherence to administration instructions: take on an empty stomach with a full glass of water, and remain upright for at least 30 minutes to prevent esophageal irritation and ulceration.
  • Counsel patients extensively on photosensitivity and the importance of sun protection (sunscreen, protective clothing, avoiding peak sun hours).
  • Inform patients that clinical improvement for rosacea is gradual and may take several weeks to months.
  • This formulation is not intended for the treatment of bacterial infections.
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Alternative Therapies

  • Topical metronidazole (cream, gel, lotion)
  • Topical azelaic acid (cream, gel, foam)
  • Topical ivermectin (cream)
  • Topical brimonidine (gel) for erythema
  • Oral isotretinoin (for severe, refractory cases, off-label for rosacea)
  • Laser and light-based therapies
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Cost & Coverage

Average Cost: Varies widely (e.g., $300-$1000+) per 30 capsules (for brand Oracea)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 for brand (Oracea); Tier 1 for generic doxycycline (other formulations)
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General Drug Facts

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 your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.