Doxycycline Monohydrate 100mg Tabs

Manufacturer LANNETT 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; Protein synthesis inhibitor
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Pregnancy Category
Category D
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FDA Approved
Jul 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, including skin infections, respiratory infections, urinary tract infections, and certain sexually transmitted infections. It works by stopping the growth of bacteria.
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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 to feel better.
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 calcium-rich foods, as this may reduce its effectiveness. If you have any 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 or supplements within 2 hours of taking your prescribed medication:
Bismuth (Pepto-Bismol)
Calcium
Iron
Magnesium
Zinc
Multivitamins with minerals
Colestipol
Cholestyramine
Didanosine
Antacids

Administration Instructions

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.

Storage and Disposal

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.

Missing a Dose

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

  • Take with a full glass of water (8 ounces) to prevent esophageal irritation.
  • Remain upright for at least 30 minutes (preferably 1 hour) after taking the dose to prevent esophageal irritation.
  • Avoid taking antacids, iron supplements, or products containing calcium (like milk or dairy products) within 2 hours before or after 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.
  • Complete the full course of medication, even if you start to feel better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • 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.

Dosing & Administration

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Adult Dosing

Standard Dose: 100 mg every 12 hours on day 1, then 100 mg once daily or 50 mg every 12 hours for subsequent days, depending on infection severity.
Dose Range: 50 - 200 mg

Condition-Specific Dosing:

severeInfections: 100 mg every 12 hours
acneVulgaris: 20 mg twice daily or 50 mg once daily
malariaProphylaxis: 100 mg once daily, starting 1-2 days before travel and continuing for 4 weeks after return
gonorrhea: 100 mg twice daily for 7 days (as part of combination therapy)
syphilis: 100 mg twice daily for 14 days (early) or 28 days (late latent/tertiary)
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Pediatric Dosing

Neonatal: Not established (contraindicated in children < 8 years due to tooth discoloration and enamel hypoplasia)
Infant: Not established (contraindicated in children < 8 years)
Child: Contraindicated in children < 8 years. For children 8 years and older: 4.4 mg/kg/day divided into 1-2 doses on day 1, then 2.2 mg/kg/day divided into 1-2 doses. Max 100 mg/dose.
Adolescent: Same as adult dosing for children 8 years and older, if weight allows.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: Doxycycline is minimally removed by hemodialysis or peritoneal dialysis. No dosage adjustment is necessary.

Hepatic Impairment:

Mild: No specific adjustment, use with caution.
Moderate: No specific adjustment, use with caution.
Severe: No specific adjustment, use with caution. Monitor for signs of hepatotoxicity.

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.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 1.5-4 hours
FoodEffect: Food and milk products have a minimal effect on the absorption of doxycycline monohydrate, unlike other tetracyclines. However, antacids containing aluminum, calcium, or magnesium, and iron preparations can impair absorption.

Distribution:

Vd: 0.75 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (achieves therapeutic levels in CSF only when meninges are inflamed)

Elimination:

HalfLife: 16-22 hours
Clearance: Not readily available, but primarily via non-renal routes.
ExcretionRoute: Primarily excreted unchanged in the feces via intestinal secretion and in the urine.
Unchanged: Approximately 40% (renal), 60% (fecal)
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Pharmacodynamics

OnsetOfAction: Rapid (within hours for bacteriostatic effect)
PeakEffect: Correlates with Tmax (1.5-4 hours)
DurationOfAction: Due to its long half-life, once-daily or twice-daily dosing is effective.

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 immediate medical attention:

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 and 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, 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 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 immediately.

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 right away.
Raised intracranial pressure (pressure in the brain) has been reported with this medication, which may cause headaches, vision problems, or even permanent vision loss. If you experience headaches, blurred vision, double vision, or loss of vision, seek medical attention immediately.

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following:

Diarrhea, stomach upset, or vomiting
Decreased appetite

If you experience any of these side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for guidance.

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor or report them to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe diarrhea (watery or bloody stools), which may occur up to several months after stopping the medication (could be C. difficile infection).
  • New or worsening headache, blurred vision, or vision changes (could be signs of increased pressure in the brain).
  • Severe skin rash, blistering, or peeling skin.
  • Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, persistent nausea/vomiting, severe stomach pain).
  • Signs of allergic reaction (e.g., hives, difficulty breathing, swelling of face/lips/tongue/throat).
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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 existing 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 unusual sunburn or sensitivity, inform your doctor promptly.

This drug can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions that may affect internal organs. These reactions can be life-threatening. 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) or affect tooth development. Additionally, it may impact 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 years old, 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 for more information.

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

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Esophageal irritation
  • Hepatotoxicity (rare, with very high doses)

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and symptomatic. Gastric lavage may be considered if ingestion is recent. Dialysis 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 (aluminum, calcium, magnesium) - decreased doxycycline absorption
  • Iron preparations - decreased doxycycline absorption
  • Bismuth subsalicylate - decreased doxycycline absorption
  • Oral retinoids (e.g., tretinoin, adapalene) - increased risk of pseudotumor cerebri
  • Penicillins - potential antagonism (avoid concomitant use)
  • Warfarin - increased anticoagulant effect (monitor INR)
  • Live bacterial vaccines (e.g., typhoid vaccine) - decreased vaccine efficacy
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Moderate Interactions

  • Oral contraceptives - potential decreased efficacy (advise backup contraception)
  • Barbiturates (e.g., phenobarbital) - decreased doxycycline half-life
  • Carbamazepine - decreased doxycycline half-life
  • Phenytoin - decreased doxycycline half-life
  • Methotrexate - increased methotrexate toxicity (rare, but possible)
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Minor Interactions

  • Dairy products - minimal effect on monohydrate absorption, but still advise separation by 1-2 hours if possible.

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: To establish baseline and identify pre-existing hepatic impairment, especially for prolonged therapy.

Timing: Before initiating prolonged therapy.

Renal function tests (e.g., BUN, creatinine)

Rationale: To establish baseline, though dose adjustment is generally not needed for renal impairment.

Timing: Before initiating prolonged therapy.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily/as needed

Target: Resolution of infection symptoms

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

Signs of superinfection (e.g., oral thrush, vaginal candidiasis, severe diarrhea)

Frequency: Throughout therapy and for several weeks post-therapy

Target: Absence of new infections

Action Threshold: Presence of new infections requires evaluation and appropriate treatment (e.g., C. difficile infection).

Photosensitivity reaction

Frequency: Daily, especially with sun exposure

Target: Absence of severe sunburn-like rash

Action Threshold: Severe reaction may require discontinuation and protective measures.

Intracranial pressure (for headache/visual disturbances)

Frequency: As symptoms arise

Target: Normal neurological status

Action Threshold: Persistent headache, blurred vision, or papilledema may indicate pseudotumor cerebri and require discontinuation.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Esophageal irritation/ulceration (dysphagia, odynophagia, heartburn)
  • Photosensitivity (severe sunburn-like reaction)
  • Rash
  • Headache
  • Blurred vision or visual disturbances (signs of pseudotumor cerebri)
  • Vaginal yeast infection
  • Oral thrush
  • Signs of C. difficile-associated diarrhea (CDAD) such as severe, persistent diarrhea, abdominal pain, fever.

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 enamel hypoplasia in the fetus, as well as reversible inhibition of bone growth.

Trimester-Specific Risks:

First Trimester: Potential for skeletal and limb abnormalities, though data are conflicting and risk appears low. Still generally avoided.
Second Trimester: Significant risk of permanent tooth discoloration and enamel hypoplasia in the fetus. Reversible inhibition of bone growth.
Third Trimester: Significant risk of permanent tooth discoloration and enamel hypoplasia in the fetus. Reversible inhibition of bone growth.
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Lactation

Doxycycline is excreted into breast milk. While the amount transferred is generally low and calcium in milk may chelate the drug, there is a theoretical risk of tooth discoloration and inhibition of bone growth in the nursing infant. The American Academy of Pediatrics considers tetracyclines compatible with breastfeeding with caution. Use with caution, or consider an alternative if possible, especially for long-term use.

Infant Risk: L3 (Moderate concern). Potential for tooth discoloration and inhibition of bone growth, though risk is considered low with short-term use due to calcium binding in milk. Monitor infant for diarrhea or candidiasis.
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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 enamel hypoplasia, as well as reversible inhibition of bone growth. In children 8 years and older, use with caution and only when other antibiotics are not suitable or effective.

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Geriatric Use

No specific dosage adjustment is generally required based on age alone. However, elderly patients may be more susceptible to adverse effects such as gastrointestinal disturbances or photosensitivity. Monitor renal and hepatic function if prolonged therapy is anticipated, although doxycycline is primarily eliminated non-renally.

Clinical Information

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Clinical Pearls

  • Doxycycline monohydrate is generally better tolerated gastrointestinally than doxycycline hyclate, especially regarding esophageal irritation.
  • Always advise patients to take with a full glass of water and remain upright for at least 30-60 minutes to prevent esophageal ulceration.
  • Emphasize strict sun protection due to high photosensitivity risk.
  • Doxycycline is a preferred agent for Lyme disease, Rocky Mountain spotted fever, and malaria prophylaxis.
  • It is effective against atypical bacteria (e.g., Mycoplasma, Chlamydia) and some protozoa.
  • Despite being a tetracycline, doxycycline's unique elimination pathway means it does not accumulate significantly in renal impairment, making it a safe option for patients with kidney disease.
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Alternative Therapies

  • Azithromycin (for atypical infections, STIs)
  • Amoxicillin (for Lyme disease in children <8 years or pregnant women)
  • Ceftriaxone (for gonorrhea)
  • Clindamycin (for certain skin/soft tissue infections)
  • Macrolides (e.g., erythromycin, clarithromycin)
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin)
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Cost & Coverage

Average Cost: $20 - $100+ per 30 tablets (100mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.