Doxycycline Monohydrate 75mg Caps

Manufacturer RANBAXY PHARMACEUTICALS 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, Tetracycline; Anti-inflammatory (for sub-antimicrobial doses)
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Pharmacologic Class
Tetracycline antibiotic
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Pregnancy Category
D
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FDA Approved
Jan 1967
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Doxycycline is an antibiotic that works by stopping the growth of bacteria. It's used to treat many types of infections, and at lower doses, it can also help reduce inflammation for conditions like acne and rosacea.
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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 prescription 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 also important to avoid taking your medication at the same time as milk, dairy products, or other foods that contain calcium, as this may reduce the effectiveness of the medication. If you have any questions, consult with your doctor or pharmacist.

Additional Tips

Drink plenty of non-caffeinated liquids, unless your doctor has advised you to limit your fluid intake. Avoid taking certain medications or supplements within 2 hours of taking your prescribed medication, including:

Bismuth (Pepto-Bismol)
Calcium
Iron
Magnesium
Zinc
Multivitamins with minerals
Colestipol
Cholestyramine
Didanosine
Antacids

Take your medication with a full glass of water and avoid lying down after taking it to minimize the risk of throat irritation. Ask your pharmacist how long you should wait before lying down after taking your medication.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Do not store it in a bathroom. Check the expiration date and do not take the medication if it is outdated or 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. 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 to make up for a missed dose.
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Lifestyle & Tips

  • Take with a full glass of water (at least 8 ounces) to prevent irritation of the esophagus.
  • Remain upright for at least 30 minutes (preferably 1 hour) after taking the medication to prevent esophageal irritation.
  • Avoid taking antacids, iron supplements, calcium supplements, or laxatives containing magnesium or aluminum within 2-3 hours of taking doxycycline, as they can reduce its absorption.
  • Protect yourself from the sun: Doxycycline can make your skin more sensitive to sunlight (photosensitivity). Use sunscreen, wear protective clothing, and avoid prolonged sun exposure or tanning beds.
  • If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.
  • Complete the full course of medication as prescribed, even if you start feeling better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: 75 mg orally once daily or 75 mg orally twice daily
Dose Range: 75 - 150 mg

Condition-Specific Dosing:

Acne Vulgaris (moderate to severe): 75 mg orally once daily or 75 mg orally twice daily
Rosacea (inflammatory lesions): 75 mg orally once daily (often as 20 mg BID or 45 mg once daily modified release, but 75mg can be used for more severe cases or off-label)
Specific Infections (e.g., mild community-acquired pneumonia, sinusitis): 75 mg orally twice daily (often 100mg BID is standard, but 75mg can be used for step-down or milder cases)
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Pediatric Dosing

Neonatal: Not established (contraindicated in children < 8 years)
Infant: Not established (contraindicated in children < 8 years)
Child: Not established (contraindicated in children < 8 years due to permanent tooth discoloration and bone growth inhibition). For children > 8 years and weighing < 45 kg: 2.2 mg/kg orally every 12 hours. For children > 8 years and weighing >= 45 kg: Adult dose.
Adolescent: Adult dose (typically 75 mg once or twice daily depending on indication)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: Not significantly removed by hemodialysis; no dose adjustment needed. Consider potential for increased photosensitivity.

Hepatic Impairment:

Mild: Caution advised; monitor for adverse effects.
Moderate: Caution advised; monitor for adverse effects.
Severe: Caution advised; monitor for adverse effects. Use with extreme caution due to potential for hepatotoxicity.

Pharmacology

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Mechanism of Action

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

Absorption:

Bioavailability: 90-100%
Tmax: 1.5-4 hours
FoodEffect: Food, including dairy products, has a minimal effect on the absorption of doxycycline monohydrate, unlike other tetracyclines. However, taking with food can reduce gastrointestinal upset.

Distribution:

Vd: 0.7 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (penetrates CSF poorly, but levels are higher in inflamed meninges)

Elimination:

HalfLife: 16-22 hours
Clearance: Not available
ExcretionRoute: Primarily via feces (biliary excretion and subsequent enterohepatic recirculation followed by fecal excretion); a smaller portion is excreted renally.
Unchanged: Approximately 40% (renal), 60% (fecal)
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Pharmacodynamics

OnsetOfAction: Within hours (antibacterial effect)
PeakEffect: Within 2-4 hours (plasma concentration)
DurationOfAction: 24 hours (due to long half-life, allowing once-daily dosing for some 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or eyes
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe stomach upset or vomiting
Chest pain or pressure, or a rapid heartbeat
Difficulty urinating or changes in urine output
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak
Throat irritation or difficulty 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.

Additional Important Warnings

C. diff-associated diarrhea (CDAD) may occur during or after antibiotic treatment, which can lead to a life-threatening bowel condition. If you experience 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, contact your doctor right away.

Other Possible Side Effects

Not everyone will experience side effects, and many people may only have mild symptoms. However, if you notice any of the following side effects or if they bother you or persist, contact your doctor:

Diarrhea, stomach upset, 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 watery diarrhea or bloody stools (may be a sign of C. difficile infection)
  • New or worsening headache, blurred vision, or double vision (signs of increased pressure in the brain, pseudotumor cerebri)
  • Severe skin rash, blistering, or peeling skin
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems)
  • Unusual bruising or bleeding
  • Swelling of the face, lips, tongue, or throat; difficulty breathing (signs of allergic reaction)
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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 doing so while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (including 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 adjust the dosage of any medication without first consulting your doctor.
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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.

Be aware that this medication can make you more susceptible to sunburn. Take necessary precautions when exposed to the sun, and consult your doctor if you experience unusual sunburn or sensitivity.

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 can cause permanent tooth discoloration, turning teeth yellow-gray brown. This effect can also occur in unborn babies if the mother takes the medication during certain stages of pregnancy. Additionally, this medication may affect tooth development and bone growth in these individuals. 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 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 concerns, consult your doctor.

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
  • Esophageal ulceration
  • Hepatotoxicity (rare)
  • Renal toxicity (rare)

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive; gastric lavage may be considered if ingestion is recent. Activated charcoal may be administered. Hemodialysis is not effective.

Drug Interactions

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Contraindicated Interactions

  • Isotretinoin (increased risk of pseudotumor cerebri)
  • Acitretin (increased risk of pseudotumor cerebri)
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Major Interactions

  • Antacids (containing aluminum, calcium, magnesium): Decreased doxycycline absorption
  • Iron preparations (oral): Decreased doxycycline absorption
  • Bismuth subsalicylate: Decreased doxycycline absorption
  • Warfarin: Potentiation of anticoagulant effect (monitor INR)
  • Penicillins: May interfere with the bactericidal action of penicillin (avoid concomitant use if possible)
  • Live bacterial vaccines (e.g., oral typhoid vaccine): May reduce vaccine efficacy
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Moderate Interactions

  • Oral contraceptives: Theoretical reduction in efficacy (evidence is weak, but advise backup contraception)
  • Barbiturates (e.g., phenobarbital): Decreased doxycycline half-life
  • Carbamazepine: Decreased doxycycline half-life
  • Phenytoin: Decreased doxycycline half-life
  • Methoxyflurane: Increased risk of nephrotoxicity

Monitoring

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Baseline Monitoring

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease or those on long-term therapy, due to rare risk of hepatotoxicity.

Timing: Prior to initiation of therapy if clinically indicated.

Renal function (BUN, creatinine)

Rationale: To assess baseline renal function, though dose adjustment is generally not needed for doxycycline in renal impairment.

Timing: Prior to initiation of therapy if clinically indicated.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily/as clinically indicated

Target: Resolution of infection/symptoms

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistance.

Adverse effects (e.g., GI upset, photosensitivity, headache, rash)

Frequency: Daily/as clinically indicated

Target: Absence or mild, tolerable side effects

Action Threshold: Severe or persistent adverse effects warrant dose adjustment or discontinuation.

INR (if on warfarin)

Frequency: Regularly, especially upon initiation or discontinuation of doxycycline

Target: Therapeutic range for warfarin

Action Threshold: INR outside target range requires warfarin dose adjustment.

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Symptom Monitoring

  • Severe diarrhea (may indicate C. difficile infection)
  • New or worsening headache, blurred vision, or diplopia (may indicate pseudotumor cerebri)
  • Severe skin rash or blistering (may indicate severe cutaneous adverse reactions)
  • Yellowing of skin or eyes, dark urine, persistent nausea/vomiting (signs of liver dysfunction)
  • Increased sensitivity to sunlight (photosensitivity)

Special Patient Groups

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Pregnancy

Doxycycline is classified as Pregnancy Category D. It should be avoided 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.

Trimester-Specific Risks:

First Trimester: Potential for skeletal and limb abnormalities, though data are conflicting and risk appears low.
Second Trimester: Significant risk of permanent tooth discoloration (enamel hypoplasia) and inhibition of bone growth.
Third Trimester: Significant risk of permanent tooth discoloration (enamel hypoplasia) and inhibition of bone growth.
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Lactation

Doxycycline is excreted into breast milk. While the amount transferred is generally low and binding to calcium in milk may limit absorption by the infant, the potential for tooth discoloration and inhibition of bone growth in the nursing infant remains a concern, especially with long-term or repeated use. The American Academy of Pediatrics considers tetracyclines compatible with breastfeeding with caution. LactMed rates it L3 (moderate risk).

Infant Risk: Moderate risk. Potential for tooth discoloration and inhibition of bone growth, though absorption by infant is limited. Monitor infant for diarrhea, candidiasis, and rash.
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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. Use in children < 8 years only when other drugs are contraindicated or ineffective, such as for anthrax or Rocky Mountain spotted fever. For children > 8 years, dosing is weight-based.

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Geriatric Use

Generally well-tolerated in geriatric patients. No specific dose adjustment is typically required based on age alone, but monitor for age-related decreases in renal or hepatic function and potential for increased photosensitivity or gastrointestinal upset.

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 30-60 minutes to prevent esophageal irritation and ulceration.
  • Emphasize strict sun protection due to significant photosensitivity risk.
  • Doxycycline monohydrate is generally better tolerated gastrointestinally than doxycycline hyclate and its absorption is less affected by food/dairy.
  • Unlike other tetracyclines, doxycycline does not accumulate significantly in patients with renal impairment, making it a preferred tetracycline in this population.
  • For acne and rosacea, the anti-inflammatory effects at sub-antimicrobial doses are key, not just the antibacterial action.
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Alternative Therapies

  • Other tetracyclines (e.g., minocycline, tetracycline)
  • Macrolides (e.g., azithromycin, erythromycin - for certain infections)
  • Beta-lactam antibiotics (e.g., penicillins, cephalosporins - for susceptible infections)
  • Topical antibiotics (e.g., clindamycin, erythromycin - for acne/rosacea)
  • Topical anti-inflammatory agents (e.g., metronidazole, azelaic acid - for rosacea)
  • Oral retinoids (e.g., isotretinoin - for severe acne, but contraindicated with doxycycline)
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Cost & Coverage

Average Cost: $15 - $50 per 30 capsules (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.