Adoxa 50mg Tablets

Manufacturer PHARMADERM 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 various bacterial infections, including skin infections like acne, 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 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 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.
To minimize the risk of throat irritation, do not lie down after taking your medication. 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 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 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 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, calcium supplements, or dairy products within 2-3 hours of taking doxycycline, as they can interfere with absorption.
  • Avoid prolonged exposure to sunlight or tanning beds, as doxycycline can make your skin more sensitive to the sun (photosensitivity). Use sunscreen and wear protective clothing.
  • 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.
  • If you are taking oral contraceptives, use an additional non-hormonal birth control method during treatment and for 7 days after, as doxycycline may reduce their effectiveness.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 50 mg orally once or twice daily, depending on indication. For most infections, 100 mg orally every 12 hours on day 1, then 100 mg daily or 50 mg every 12 hours. For acne/rosacea, 50 mg once or twice daily.
Dose Range: 50 - 200 mg

Condition-Specific Dosing:

Acne Vulgaris: 50 mg orally once or twice daily
Rosacea: 50 mg orally once or twice daily
General Infections: 100 mg orally every 12 hours on day 1, then 100 mg daily or 50 mg every 12 hours
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Pediatric Dosing

Neonatal: Not established (contraindicated due to dental discoloration)
Infant: Not established (contraindicated due to dental discoloration)
Child: Not recommended for children under 8 years of age due to permanent tooth discoloration and bone growth inhibition. For children 8 years and older: 2-4 mg/kg/day divided every 12-24 hours (max 200 mg/day).
Adolescent: Same as adult dosing for adolescents 8 years and older, typically 50-100 mg daily or BID.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed (doxycycline is primarily eliminated via non-renal routes)
Dialysis: Not significantly removed by hemodialysis; no supplemental dose needed.

Hepatic Impairment:

Mild: No specific adjustment, use with caution
Moderate: Use with caution; monitor for signs of hepatotoxicity
Severe: Use with caution; monitor for signs of hepatotoxicity. Consider dose reduction if severe impairment.

Pharmacology

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Mechanism of Action

Doxycycline is a 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 is primarily bacteriostatic.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 1.5-4 hours
FoodEffect: Absorption is not significantly affected by food or milk, but it can be impaired by antacids containing aluminum, calcium, or magnesium, and by iron preparations.

Distribution:

Vd: 0.7 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 non-renal excretion.
ExcretionRoute: Primarily fecal (via intestinal secretion) and renal (glomerular filtration).
Unchanged: Approximately 40% excreted unchanged in urine and feces.
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Pharmacodynamics

OnsetOfAction: Within hours (bacteriostatic effect)
PeakEffect: Within 2-4 hours (peak plasma concentration)
DurationOfAction: 24 hours (due to long half-life, allows for once or twice daily dosing)

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, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of pancreatitis (pancreas problems), such as:
+ Severe stomach pain
+ Severe back pain
+ 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 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 or accompanied by stomach pain, cramps, or watery, bloody stools (a condition called C. diff-associated diarrhea, or CDAD, which can lead to life-threatening bowel problems)

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

Additional Serious Side Effects

Raised pressure in the brain has been reported with this medication, which may resolve after stopping the drug. However, in some cases, vision loss may occur and may be permanent. If you experience a headache or vision problems, such as blurred vision, double vision, or loss of vision, seek medical attention right away.

Common Side Effects

Most people taking this medication do not experience severe side effects. However, some common side effects may occur, including:

Diarrhea
Upset stomach or vomiting
Decreased appetite

If these side effects bother you or do not resolve, 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 watery diarrhea or bloody stools (may be a sign of C. difficile infection)
  • New or worsening skin rash, blistering, or peeling skin
  • Severe stomach pain, nausea, or vomiting
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
  • Unusual tiredness or weakness
  • Severe headache, blurred vision, or double vision (signs of increased pressure in the brain)
  • Swelling of the face, lips, tongue, or throat (allergic reaction)
  • Difficulty breathing or swallowing
  • Vaginal itching or discharge (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 breast-feeding or plan to breast-feed, as you may need to avoid doing so while taking this medication.

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to ensure it is safe for you to take this medication with your other medications and health conditions.

Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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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.

There is a risk of severe skin reactions associated with this medication, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions that can 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 a condom, to prevent pregnancy.

In children under 8 years old, this medication may cause permanent tooth discoloration (yellow-gray brown) or affect bone growth. If taken during pregnancy, it may also cause tooth discoloration in the unborn baby. These changes are irreversible. Other tooth problems have been reported in children taking this medication. Discuss any concerns 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.

In some cases, adults have also experienced tooth discoloration, which has been reported to reverse after stopping the medication and undergoing dental cleaning. Discuss any concerns with 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
  • Liver damage (rare with acute overdose)
  • Renal toxicity (rare)

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is generally supportive, including gastric lavage if recent ingestion, and symptomatic management.

Drug Interactions

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Major Interactions

  • Isotretinoin (increased risk of pseudotumor cerebri)
  • Acitretin (increased risk of pseudotumor cerebri)
  • Penicillins (tetracyclines may interfere with the bactericidal action of penicillin)
  • Oral Contraceptives (may decrease efficacy of oral contraceptives, leading to breakthrough bleeding or pregnancy)
  • Warfarin (potentiates anticoagulant effect)
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Moderate Interactions

  • Antacids (containing aluminum, calcium, magnesium - decrease doxycycline absorption)
  • Iron preparations (decrease doxycycline absorption)
  • Bismuth subsalicylate (decrease doxycycline absorption)
  • Barbiturates (e.g., phenobarbital - decrease doxycycline half-life)
  • Carbamazepine (decrease doxycycline half-life)
  • Phenytoin (decrease doxycycline half-life)
  • Methotrexate (may increase methotrexate toxicity)

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 those on prolonged therapy.

Timing: Before initiating therapy for prolonged use or in at-risk patients.

Renal function tests (RFTs)

Rationale: To assess baseline renal function, though doxycycline does not require dose adjustment in renal impairment, it's good practice for overall patient assessment.

Timing: Before initiating therapy for prolonged use or in at-risk patients.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily/as needed

Target: Resolution of infection symptoms or improvement in condition (e.g., acne)

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

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

Frequency: Daily/as needed

Target: Absence or mild, manageable side effects

Action Threshold: Severe GI distress, severe rash, signs of candidiasis, or vision changes warrant immediate evaluation and potential discontinuation.

Intracranial pressure (for headache, blurred vision)

Frequency: As needed, if symptoms arise

Target: Normal vision and absence of headache

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

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Symptom Monitoring

  • Severe diarrhea (may indicate C. difficile infection)
  • New or worsening rash (photosensitivity, allergic reaction)
  • Difficulty swallowing or painful swallowing (esophageal irritation/ulceration)
  • Yellowing of skin or eyes (liver dysfunction)
  • Unusual bleeding or bruising (rare, but possible effect on coagulation)
  • Severe headache, blurred vision, or double vision (pseudotumor cerebri)
  • Vaginal itching or discharge (yeast infection)

Special Patient Groups

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Pregnancy

Category D. Doxycycline can cause permanent discoloration of teeth (yellow-gray-brown) and reversible inhibition of bone growth in the fetus. Avoid during pregnancy, especially during the second and third trimesters when tooth development is occurring.

Trimester-Specific Risks:

First Trimester: Potential for skeletal and dental effects, though less pronounced than later trimesters. Risk of teratogenicity is generally low.
Second Trimester: Significant risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia in the developing fetus. Reversible inhibition of bone growth.
Third Trimester: Significant 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 is generally low and calcium in milk may chelate the drug, there is a theoretical risk of dental staining and inhibition of bone growth in the nursing infant. Use with caution; consider alternative antibiotics or temporary interruption of breastfeeding, especially for prolonged therapy.

Infant Risk: L3 (Moderate risk). Potential for tooth discoloration and inhibition of bone growth, though absorption by the infant is likely reduced due to chelation with calcium in milk. Monitor infant for diarrhea, candidiasis, and tooth discoloration.
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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 and older should be carefully weighed against the benefits, especially for long-term use.

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Geriatric Use

Generally well-tolerated in elderly patients. No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to adverse effects such as esophageal irritation or photosensitivity. Monitor renal and hepatic function if pre-existing conditions exist.

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) to minimize the risk of esophageal irritation and ulceration.
  • Educate patients about photosensitivity and advise them to use sunscreen and protective clothing when exposed to sunlight.
  • Remind patients to avoid dairy products, antacids, and iron supplements within 2-3 hours of taking doxycycline due to chelation and reduced absorption.
  • Doxycycline is a preferred tetracycline in patients with renal impairment because it is primarily eliminated via non-renal routes.
  • For acne or rosacea, low-dose doxycycline (e.g., 20 mg BID or 40 mg once daily extended-release) is often used for its anti-inflammatory properties rather than its antimicrobial effect, minimizing resistance risk.
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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)
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin - for susceptible infections)
  • For acne: topical retinoids, benzoyl peroxide, oral isotretinoin, other oral antibiotics (e.g., erythromycin, clindamycin)
  • For rosacea: topical metronidazole, azelaic acid, brimonidine, oral isotretinoin
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Cost & Coverage

Average Cost: $20 - $100+ per 30 tablets (generic 50mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generic formulations; higher tiers for brand names.
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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 this 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 overdose, including the medication taken, the amount, and the time it occurred.