Adoxa 100mg Tablets

Manufacturer DOAK DERMATOLOGICS 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
Tetracycline antibiotic
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Pharmacologic Class
Tetracycline
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Pregnancy Category
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 medication used to treat a wide range of bacterial infections, including respiratory infections, urinary tract infections, skin infections like acne, 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 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 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 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 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.
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.
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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 dairy products (milk, yogurt, cheese) within 2-3 hours before or after taking doxycycline, as they can interfere with its absorption.
  • Doxycycline can make your skin more sensitive to sunlight (photosensitivity). Use sunscreen, wear protective clothing, and avoid prolonged sun exposure or tanning beds while taking this medication and for several days after stopping it.
  • 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.
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Available Forms & Alternatives

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 twice daily
Dose Range: 50 - 200 mg

Condition-Specific Dosing:

Infection (general): 100 mg every 12 hours on day 1, then 100 mg once daily or 50 mg twice daily for 7-14 days
Acne vulgaris: 50-100 mg once daily or 20 mg twice daily (sub-antimicrobial dose)
Malaria prophylaxis: 100 mg once daily, starting 1-2 days before travel and continuing for 4 weeks after leaving endemic area
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Pediatric Dosing

Neonatal: Not established (generally contraindicated)
Infant: Not established (generally contraindicated)
Child: Generally contraindicated in children under 8 years due to risk of permanent tooth discoloration and enamel hypoplasia. For children 8 years and older: 2-4 mg/kg/day divided every 12-24 hours (max 100-200 mg/day depending on indication).
Adolescent: Same as adult dosing for children 8 years and older, typically 100 mg once or twice daily.
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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 supplemental dose needed.

Hepatic Impairment:

Mild: Caution advised, monitor liver function
Moderate: Caution advised, monitor liver function
Severe: Caution advised, monitor liver function; consider alternative if possible.

Pharmacology

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Mechanism of Action

Doxycycline is a bacteriostatic antibiotic that inhibits bacterial protein synthesis by binding reversibly to the 30S ribosomal subunit, thereby preventing the binding of aminoacyl transfer RNA to the messenger RNA-ribosome complex. This action prevents the addition of new amino acids to the growing peptide chain, thus inhibiting bacterial growth and replication.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 1.5-4 hours
FoodEffect: Food and milk products can decrease absorption, but to a lesser extent than other tetracyclines. For optimal absorption, it is generally recommended to take on an empty stomach, but if GI upset occurs, it can be taken with non-dairy food. Avoid dairy products, antacids, and iron preparations within 2-3 hours of administration.

Distribution:

Vd: 0.7 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (low concentrations in CSF), but can cross inflamed meninges.

Elimination:

HalfLife: 16-22 hours
Clearance: Not typically reported as a single rate; primarily eliminated unchanged.
ExcretionRoute: Primarily fecal (via bile and intestinal secretion), with a significant portion also excreted renally.
Unchanged: Approximately 40% renal, 60% fecal
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Pharmacodynamics

OnsetOfAction: Rapid absorption, antibacterial effects within hours of administration.
PeakEffect: Correlates with Tmax (1.5-4 hours).
DurationOfAction: Due to its relatively long half-life, once-daily dosing is often effective after an initial loading dose.

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 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 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, 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 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 side effects, contact your doctor if they bother you or do not go away:

Diarrhea
Stomach upset 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 or watery diarrhea, especially if it lasts for a long time or contains blood/mucus (could be C. difficile infection).
  • Severe skin rash, blistering, or peeling skin.
  • Yellowing of the skin or eyes (jaundice), dark urine, or severe stomach pain (signs of liver problems).
  • Unusual bleeding or bruising.
  • Severe headache with blurred vision, double vision, or vision loss (signs of increased pressure in the brain, pseudotumor cerebri).
  • Signs of a new infection (e.g., fever, sore throat, vaginal yeast infection).
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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, 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 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.

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.

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 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 affect tooth development. Additionally, bone growth may be impacted 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 for more information.

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

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Liver toxicity (rare with acute overdose)
  • Renal toxicity (rare with acute overdose)

What to Do:

In case of suspected overdose, seek immediate medical attention or call a Poison Control Center at 1-800-222-1222. Treatment is generally supportive and symptomatic.

Drug Interactions

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Contraindicated Interactions

  • Isotretinoin (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.
  • Warfarin: Potentiation of anticoagulant effect (monitor INR).
  • Penicillins: Tetracyclines can interfere with the bactericidal action of penicillins (avoid concomitant use if possible).
  • Oral contraceptives: Reduced efficacy of oral contraceptives (advise backup method, though evidence is mixed).
  • Barbiturates (e.g., phenobarbital), Carbamazepine, Phenytoin: Decreased doxycycline half-life due to enzyme induction.
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Moderate Interactions

  • Methotrexate: Increased methotrexate toxicity (monitor for adverse effects).
  • Digoxin: Increased digoxin levels (monitor digoxin levels).

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 or if prolonged therapy is anticipated.

Timing: Prior to initiation of therapy if clinically indicated.

Renal function tests (RFTs)

Rationale: To assess baseline renal function, though doxycycline generally does not require dose adjustment in renal impairment.

Timing: Prior to initiation of therapy if clinically indicated.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily during acute treatment, periodically for chronic conditions.

Target: Resolution of infection symptoms, improvement in condition.

Action Threshold: Lack of improvement or worsening symptoms warrants re-evaluation of diagnosis and treatment.

Signs of superinfection (e.g., oral candidiasis, C. difficile-associated diarrhea)

Frequency: Throughout therapy and for several weeks post-treatment.

Target: Absence of new infections.

Action Threshold: Development of new or worsening symptoms (e.g., severe diarrhea, white patches in mouth) requires investigation and appropriate treatment.

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Symptom Monitoring

  • Gastrointestinal upset (nausea, vomiting, diarrhea)
  • Photosensitivity (severe sunburn-like reaction)
  • Esophageal irritation/ulceration (chest pain, difficulty swallowing)
  • Headache, blurred vision, or other signs of pseudotumor cerebri (idiopathic intracranial hypertension)
  • Skin rash or other hypersensitivity reactions
  • Vaginal yeast infection (in females)

Special Patient Groups

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Pregnancy

Doxycycline is classified as Pregnancy Category D. It should generally be avoided during pregnancy, especially during the second and third trimesters, due to the potential for permanent discoloration of deciduous teeth (yellow-gray-brown) and inhibition of bone growth in the fetus.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, but risk of tooth discoloration is lower than in later trimesters.
Second Trimester: High risk of permanent tooth discoloration and enamel hypoplasia in the fetus; potential for inhibition of bone growth.
Third Trimester: High risk of permanent tooth discoloration and enamel hypoplasia in the fetus; potential for inhibition of bone growth.
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Lactation

Doxycycline is excreted into breast milk (Lactation Risk L3 - Moderate Risk). While some sources consider it compatible for short-term use, potential for tooth staining and inhibition of bone growth in the nursing infant exists. The decision to breastfeed during doxycycline therapy should weigh the potential risks to the infant against the benefits of treatment for the mother.

Infant Risk: Potential for permanent tooth discoloration and inhibition of bone growth, though absorption by the infant from breast milk is generally low. Monitor infant for diarrhea, candidiasis, and tooth discoloration.
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Pediatric Use

Doxycycline is generally contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia. In specific severe or life-threatening infections (e.g., Rocky Mountain spotted fever, anthrax) where other drugs are contraindicated or ineffective, the benefits may outweigh the risks, even in younger children.

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Geriatric Use

No specific dose adjustment is typically required for elderly patients. However, caution should be exercised in patients with pre-existing hepatic impairment. Elderly patients may be more susceptible to adverse effects such as photosensitivity or gastrointestinal upset.

Clinical Information

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Clinical Pearls

  • Doxycycline is unique among tetracyclines for its primary elimination via the GI tract, making it a preferred tetracycline for patients with renal impairment as no dose adjustment is needed.
  • High risk of photosensitivity; patients must be counselled on strict sun protection measures.
  • To prevent esophageal irritation and ulceration, advise patients to take the medication with a full glass of water and remain upright for at least 30 minutes (preferably 1 hour) after administration.
  • Effective against a broad spectrum of bacteria, including atypical organisms (e.g., Mycoplasma pneumoniae, Chlamydia trachomatis) and some parasites (e.g., malaria prophylaxis).
  • At sub-antimicrobial doses (e.g., 20 mg twice daily or 40 mg once daily extended-release), doxycycline exhibits anti-inflammatory properties and is used for conditions like rosacea without significant antibacterial effects.
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Alternative Therapies

  • Other tetracyclines (e.g., minocycline, tetracycline)
  • Macrolides (e.g., azithromycin, erythromycin) for atypical infections
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for certain bacterial infections
  • Beta-lactam antibiotics (e.g., penicillins, cephalosporins) depending on the specific pathogen and infection site.
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Cost & Coverage

Average Cost: Varies widely for generic (e.g., $10-$50) per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generic formulations; brand names may be Tier 3 or higher.
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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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.