Doxycycline Monohydrate 75mg Tabs

Manufacturer HERITAGE Active Ingredient Doxycycline Tablets and Capsules(doks i SYE kleen) Pronunciation doks-i-SYE-kleen
It is used to treat pimples (acne).It is used to treat or prevent bacterial infections.It is used to prevent malaria.It is used to treat swelling of the tissue around the teeth (periodontitis). It is used with scaling and root planing.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antibiotic
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Pharmacologic Class
Tetracycline antibiotic
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Pregnancy Category
Category D
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FDA Approved
Jun 1967
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Doxycycline is an antibiotic used to treat many different types of bacterial infections, such as skin infections, respiratory infections, urinary tract infections, and sexually transmitted diseases. It can also be used for certain conditions like severe acne or rosacea, and to prevent malaria.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most out of your medication, follow these guidelines:

Take your medication exactly as directed by your doctor. Read all the information provided and follow the instructions carefully.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling better.
Some medications need to be taken with food or 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 calcium-rich foods, as this may reduce its effectiveness. If you have questions, consult 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 or supplements within 2 hours of taking your prescribed medication:
Bismuth (Pepto-Bismol)
Calcium
Iron
Magnesium
Zinc
Multivitamins with minerals
Colestipol
Cholestyramine
Didanosine
Antacids

Taking Your Medication Safely

Take your medication with a full glass of water.
Avoid lying down after taking your medication, as this can increase the risk of throat irritation. Ask your pharmacist how long you should 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 has not been stored properly.
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take with a full glass of water (at least 8 ounces) to prevent irritation of the esophagus. Do not lie down for at least 30 minutes (preferably 1 hour) after taking.
  • Avoid taking antacids, iron supplements, calcium supplements, or dairy products within 2-3 hours before or after taking doxycycline, as they can reduce its absorption.
  • Avoid excessive sun exposure and use sunscreen (SPF 30 or higher) and protective clothing, as doxycycline can make your skin more sensitive to sunlight (photosensitivity).
  • Complete the full course of medication as prescribed, even if you start to feel better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • If you are taking this medication for acne or rosacea, it may take several weeks to see the full benefit.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For general infections: 100 mg every 12 hours on day 1, then 100 mg once daily or 50 mg every 12 hours. For rosacea (Oracea): 20 mg twice daily or 40 mg once daily (30 mg immediate release and 10 mg delayed release). For 75mg specific formulation (e.g., Acticlate): 75 mg once daily or 75 mg every 12 hours depending on infection severity.
Dose Range: 50 - 200 mg

Condition-Specific Dosing:

Acne vulgaris (moderate to severe): 50-100 mg once or twice daily
Rosacea (inflammatory lesions): 20 mg twice daily or 40 mg once daily (Oracea), or 75 mg once daily (Acticlate)
Lyme disease: 100 mg twice daily for 10-21 days
Malaria prophylaxis: 100 mg once daily, starting 1-2 days before travel and continuing for 4 weeks after return
Community-acquired pneumonia: 100 mg twice daily
Uncomplicated gonorrhea: 100 mg twice daily for 7 days
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Pediatric Dosing

Neonatal: Not established (contraindicated due to tooth discoloration and bone effects)
Infant: Not established (contraindicated due to tooth discoloration and bone effects)
Child: For children >8 years and weighing <45 kg: 2.2 mg/kg every 12 hours on day 1, then 2.2 mg/kg once daily or 1.1 mg/kg every 12 hours. Max 100 mg/dose. For children >8 years and weighing â‰Ĩ45 kg: Adult dose.
Adolescent: Adult dose (if >8 years old)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed (excreted primarily via GI tract)
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis; no dose adjustment needed. However, monitor for adverse effects.

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: Use with caution; monitor for increased serum levels and adverse effects.
Severe: Use with caution; monitor for increased serum levels and adverse effects. Consider dose reduction if accumulation occurs.

Pharmacology

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Mechanism of Action

Doxycycline is a bacteriostatic antibiotic that inhibits bacterial protein synthesis by reversibly binding to the 30S ribosomal subunit, thereby preventing the attachment of aminoacyl-tRNA to the mRNA-ribosome complex. This action prevents the addition of new amino acids to the growing peptide chain, leading to inhibition of bacterial growth. It also exhibits anti-inflammatory properties at sub-antimicrobial doses (e.g., for rosacea) by inhibiting matrix metalloproteinases and other inflammatory mediators.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100%
Tmax: 1.5-4 hours (oral)
FoodEffect: Food and dairy products can decrease absorption, but less so than other tetracyclines. It is recommended to take with a full glass of water to prevent esophageal irritation.

Distribution:

Vd: 0.7 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (poor penetration into CSF unless meninges are inflamed)

Elimination:

HalfLife: 16-22 hours
Clearance: Not readily available as a specific rate, but primarily non-renal.
ExcretionRoute: Primarily fecal (via bile and direct intestinal secretion); minor renal excretion.
Unchanged: Approximately 40% (fecal), 10-20% (renal)
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Pharmacodynamics

OnsetOfAction: Rapid (antibacterial effects within hours)
PeakEffect: Within 2-4 hours (plasma concentration)
DurationOfAction: 24 hours (due to long half-life, allowing once-daily dosing for many indications)

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 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, bloody, or watery (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.

Additional Serious Side Effects

Raised pressure in the brain (may cause headache or vision problems, such as blurred vision, double vision, or loss of vision)
C. diff-associated diarrhea (may occur during or after treatment, and can lead to a life-threatening bowel condition)

If you experience any of these symptoms, contact your doctor immediately.

Common Side Effects

Most people do not experience severe side effects, but may have minor ones. 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

Reporting 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 stomach pain or watery/bloody diarrhea (may be a sign of C. difficile infection)
  • New or worsening headache, especially with blurred vision, double vision, or vision loss (may be a sign of increased pressure in the brain)
  • Severe skin rash, blistering, or peeling skin
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems)
  • Signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat
  • Unusual bruising or bleeding
  • Joint pain, muscle pain, or weakness
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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 you 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 take this medication for a longer period than prescribed, 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 easy sunburning, 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 birth control methods, 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, turning teeth yellow-gray brown. This can also occur in unborn babies if the mother takes the medication during certain stages of pregnancy. Other tooth problems and effects on bone growth have been reported in children taking this medication. If you have concerns, discuss them with your doctor.

Generally, this medication is not recommended for children under 8 years old, but there may be exceptions. Consult with your doctor to determine the best course of treatment.

In some cases, adults have also experienced tooth discoloration, which has been reported to reverse after stopping the medication and undergoing dental cleaning. If you have questions or concerns, discuss them with your doctor.

This medication may harm an unborn baby if taken during pregnancy. If you are pregnant or become pregnant while taking this medication, contact your doctor immediately.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Esophageal irritation
  • Liver damage (rare)
  • Kidney damage (rare)

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive.

Drug Interactions

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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., isotretinoin, acitretin): Increased risk of pseudotumor cerebri (benign intracranial hypertension).
  • Penicillins: Tetracyclines may interfere with the bactericidal action of penicillins; avoid concomitant use.
  • Warfarin: May potentiate anticoagulant effects; monitor INR closely.
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Moderate Interactions

  • Barbiturates (e.g., phenobarbital): Decreased doxycycline half-life.
  • Carbamazepine: Decreased doxycycline half-life.
  • Phenytoin: Decreased doxycycline half-life.
  • Oral contraceptives: May reduce efficacy of oral contraceptives (controversial, but advise backup method).
  • Methotrexate: May increase methotrexate toxicity (rare, but possible).
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Minor Interactions

  • Dairy products: Decreased doxycycline absorption (less significant than with other tetracyclines, but still advise separation).

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease, as doxycycline is primarily eliminated via the GI tract but can rarely cause hepatotoxicity.

Timing: Prior to initiation, if clinically indicated.

Renal function tests (BUN, creatinine)

Rationale: To assess baseline renal function, though dose adjustment is generally not needed, it's good practice for overall patient assessment.

Timing: Prior to initiation, if clinically indicated.

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Routine Monitoring

Signs/symptoms of GI upset (nausea, vomiting, diarrhea)

Frequency: Daily during therapy

Target: Absence or mild, manageable symptoms

Action Threshold: Severe or persistent symptoms; consider discontinuation or alternative.

Photosensitivity (skin redness, sunburn-like reaction)

Frequency: Daily during therapy and for several days post-therapy

Target: Absence of reaction

Action Threshold: Any signs of photosensitivity; advise sun avoidance, protective clothing, sunscreen. May require discontinuation.

Signs/symptoms of C. difficile-associated diarrhea (CDAD)

Frequency: During and up to several weeks post-therapy

Target: Absence of severe diarrhea, abdominal pain, fever

Action Threshold: Persistent, severe diarrhea; test for C. difficile toxin.

INR (if on warfarin)

Frequency: More frequently during co-administration and after discontinuation of doxycycline

Target: Therapeutic range for indication

Action Threshold: INR outside target range; adjust warfarin dose.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Heartburn
  • Dysphagia
  • Esophagitis
  • Photosensitivity (severe sunburn, rash)
  • Headache (especially severe, persistent, or with visual changes, suggestive of pseudotumor cerebri)
  • Vaginal yeast infection (itching, discharge)
  • Oral thrush (white patches in mouth)
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)

Special Patient Groups

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Pregnancy

Contraindicated during pregnancy, especially during the second and third trimesters, due to the risk of permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth in the fetus. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for teratogenicity cannot be excluded. Generally avoided.
Second Trimester: High risk of permanent tooth discoloration and inhibition of bone growth.
Third Trimester: High risk of permanent tooth discoloration and inhibition of bone growth.
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Lactation

Doxycycline is excreted into breast milk. While the amount is generally low and unlikely to cause significant harm to the infant (due to calcium binding in milk limiting absorption), potential for tooth discoloration and inhibition of bone growth remains a theoretical concern. Short-term use may be acceptable, but long-term or repeated use should be avoided. Monitor infant for diarrhea, candidiasis, or rash.

Infant Risk: Low to moderate risk (L3). Potential for tooth staining and bone effects, but absorption by infant is limited. Consider alternative if possible, or monitor infant.
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Pediatric Use

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration and reversible inhibition of bone growth. Use in children >8 years should be carefully weighed against the risks, and only when other antibiotics are not suitable or effective.

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Geriatric Use

No specific dose adjustment is generally needed based on age alone. However, elderly patients may be more susceptible to adverse effects such as photosensitivity and gastrointestinal irritation. Monitor for dehydration and C. difficile infection.

Clinical Information

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Clinical Pearls

  • Always advise patients to take doxycycline with a full glass of water and to remain upright for at least 30 minutes (preferably 1 hour) after administration to prevent esophageal irritation and ulceration.
  • Doxycycline is a common cause of photosensitivity; counsel patients on sun protection (sunscreen, protective clothing, avoiding peak sun hours).
  • Unlike other tetracyclines, doxycycline is primarily eliminated via the GI tract, making it a safer option for patients with renal impairment.
  • The 75mg dose is often used for specific indications like rosacea or certain acne regimens, where lower, sub-antimicrobial doses are effective for their anti-inflammatory properties.
  • Despite the general advice to avoid dairy with tetracyclines, doxycycline's absorption is less affected than other tetracyclines, but separation by 2-3 hours is still prudent for optimal absorption.
  • Be aware of the potential for C. difficile-associated diarrhea, which can occur during or even weeks after therapy.
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Alternative Therapies

  • Minocycline (another tetracycline, often used for acne)
  • Azithromycin (macrolide, for respiratory/skin infections, STIs)
  • Amoxicillin/Clavulanate (penicillin, for various bacterial infections)
  • Cephalexin (cephalosporin, for skin/soft tissue infections)
  • Clindamycin (lincosamide, for skin/soft tissue infections, acne)
  • Erythromycin (macrolide, for rosacea, acne, various infections)
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Cost & Coverage

Average Cost: $50 - $300+ per 30 tablets (75mg or 100mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe and effective treatment, 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 discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.