Doryx 75mg DR Tablets

Manufacturer WARNER Active Ingredient Doxycycline Delayed-Release Tablets(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
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?

Doryx is an antibiotic that can treat certain infections. It's also used at a lower dose to help reduce inflammation and redness from skin 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 to you 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 medication: bismuth (Pepto-Bismol), calcium, iron, magnesium, zinc, multivitamins with minerals, colestipol, cholestyramine, didanosine, or antacids.

Taking Your Medication Safely

Take your medication with a full glass of water.
Do not lie 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.
Swallow your medication whole; do not chew or crush it.
If your doctor instructs you to break your tablet, you can do so. You can also sprinkle the contents of the tablet on applesauce, but be careful not to crush the pellets. Do not chew, crush, or damage the contents of the tablet.
Do not mix your medication with hot applesauce. If you do mix it with applesauce, swallow the mixture immediately and do not store it for later use.

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.
Check with your pharmacist or doctor if you have any questions about storing or disposing of your medication.

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 continue with 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.
  • Remain upright for at least 30 minutes (preferably 1 hour) after taking the medication to prevent esophageal irritation.
  • 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).
  • Do not take antacids, iron supplements, or products containing calcium (like dairy) within 1-2 hours before or after taking Doryx, as they can interfere with absorption. Doryx DR is less affected by food/dairy than other forms, but separation is still a good practice.
  • 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 your regular schedule. Do not double dose.
  • Complete the full course of medication as prescribed, even if your symptoms improve, to prevent resistance and ensure full treatment.

Dosing & Administration

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Adult Dosing

Standard Dose: 75 mg once daily
Dose Range: 75 - 75 mg

Condition-Specific Dosing:

Acne Vulgaris: 75 mg once daily
Rosacea (inflammatory lesions): 75 mg once daily
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Pediatric Dosing

Neonatal: Not established (contraindicated due to tooth discoloration)
Infant: Not established (contraindicated due to tooth discoloration)
Child: Not established (contraindicated for children under 8 years due to tooth discoloration and bone growth effects)
Adolescent: For adolescents â‰Ĩ 8 years and weighing â‰Ĩ 45 kg, adult dosing may apply. For those < 45 kg, 2.2 mg/kg/day in 1-2 divided doses, up to 100 mg/day. Doryx 75mg DR is generally not indicated for pediatric use.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: Doxycycline is not significantly removed by hemodialysis. No dose adjustment needed.

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: Use with caution; monitor for adverse effects
Severe: Use with caution; monitor for adverse effects

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. It also exhibits anti-inflammatory properties, particularly at sub-antimicrobial doses (e.g., 20 mg twice daily or 40 mg once daily extended-release), by inhibiting matrix metalloproteinases (MMPs) and other inflammatory mediators.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100%
Tmax: 2-3 hours (for delayed-release formulations)
FoodEffect: Absorption of Doryx DR is not significantly affected by food, including dairy products, unlike immediate-release doxycycline.

Distribution:

Vd: 0.7 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (increases with meningeal inflammation)

Elimination:

HalfLife: 16-22 hours
Clearance: Not readily available, but primarily renal and fecal excretion.
ExcretionRoute: Renal (30-60%) and fecal/biliary (40-70%)
Unchanged: Approximately 40-60% (renal) and 20-40% (fecal)
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Pharmacodynamics

OnsetOfAction: Within hours for antimicrobial effect; anti-inflammatory effects may take weeks.
PeakEffect: 2-3 hours (plasma concentration); clinical effect varies by indication.
DurationOfAction: 24 hours (due to long half-life, allows once-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 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 or 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, call your doctor right away. Additionally, be aware that:

C. diff-associated diarrhea (CDAD) may occur during or after antibiotic treatment, which can lead to a potentially life-threatening bowel problem. If you have 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, seek medical attention right away.

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, upset stomach, or vomiting
* Decreased appetite

This is not an exhaustive list of 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 headache, especially if accompanied by blurred vision or double vision (could indicate increased pressure in the brain).
  • Severe diarrhea that is watery or bloody (could be a sign of C. difficile infection).
  • Severe skin rash, blistering, or peeling (could indicate a severe allergic reaction).
  • Yellowing of the skin or eyes, dark urine, or severe stomach pain (signs of liver problems).
  • Difficulty swallowing or chest pain (signs of esophageal irritation).
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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. 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 conditions 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 dose 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 be sure 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 contraception, 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 other tooth problems. It may also affect bone growth. If you have concerns, discuss them with your doctor. Additionally, if taken during certain stages of pregnancy, this medication may cause tooth discoloration in the unborn baby, which is permanent.

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. If you have questions or concerns, discuss them 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 toxicity (rare)
  • Kidney toxicity (rare)

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222. Treatment is generally supportive, including gastric lavage if recent ingestion.

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, or magnesium (decreased doxycycline absorption)
  • Iron preparations (decreased doxycycline absorption)
  • Bismuth subsalicylate (decreased doxycycline absorption)
  • Oral retinoids (e.g., tretinoin, adapalene, tazarotene) (increased risk of pseudotumor cerebri)
  • Penicillins (tetracyclines may interfere with the bactericidal action of penicillins)
  • Warfarin (potentiates anticoagulant effect, monitor INR)
  • Live bacterial vaccines (e.g., oral typhoid vaccine) (may reduce vaccine efficacy)
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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, advise backup method)
  • Methotrexate (increased methotrexate toxicity, monitor)
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Minor Interactions

  • Dairy products (less significant with delayed-release formulations, but still advise separation by 1-2 hours)

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: To establish baseline in patients with pre-existing hepatic impairment or for prolonged therapy.

Timing: Prior to initiation of therapy if indicated.

Renal function tests (RFTs)

Rationale: To establish baseline in patients with pre-existing renal impairment, though dose adjustment is generally not needed.

Timing: Prior to initiation of therapy if indicated.

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Routine Monitoring

Clinical response (e.g., improvement in acne/rosacea lesions)

Frequency: Weekly to monthly, depending on indication and patient progress.

Target: Reduction in lesion count, decreased inflammation.

Action Threshold: Lack of improvement or worsening of condition may require re-evaluation of therapy.

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

Frequency: At each follow-up visit, and instruct patient to report immediately.

Target: Absence or mild, tolerable side effects.

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

Intracranial pressure (ICP) symptoms (e.g., severe headache, blurred vision, diplopia)

Frequency: Patient education at initiation, instruct to report immediately.

Target: Absence of symptoms.

Action Threshold: Presence of symptoms requires immediate medical evaluation and discontinuation.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Photosensitivity (severe sunburn-like reaction)
  • Headache (especially severe or persistent)
  • Blurred vision
  • Diplopia (double vision)
  • Dizziness
  • Difficulty swallowing
  • Esophageal irritation/ulceration (chest pain, heartburn)
  • Rash
  • Vaginal yeast infection
  • Oral thrush

Special Patient Groups

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Pregnancy

Doxycycline is classified as Pregnancy Category D. It should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Tetracyclines can cause permanent discoloration of teeth (yellow-gray-brown) and reversible inhibition of bone growth in the fetus.

Trimester-Specific Risks:

First Trimester: Potential for skeletal abnormalities and tooth bud effects, though less data than later trimesters.
Second Trimester: Significant risk of permanent tooth discoloration (yellow-gray-brown) and reversible inhibition of bone growth.
Third Trimester: Significant risk of permanent tooth discoloration (yellow-gray-brown) and reversible inhibition of bone growth, especially during the latter half of pregnancy.
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Lactation

Doxycycline is excreted into breast milk. While the amount transferred is small and chelation with calcium in milk may reduce absorption by the infant, there is a theoretical risk of tooth discoloration and inhibition of bone growth in the nursing infant. The American Academy of Pediatrics considers tetracyclines to be compatible with breastfeeding with caution. Use with caution, or consider an alternative, especially for long-term use.

Infant Risk: L3 (Moderate risk) - Potential for tooth discoloration and inhibition of bone growth in the infant, though unlikely with short-term use due to low milk levels and calcium binding.
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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 these risks.

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Geriatric Use

No specific dose adjustment is generally required for elderly patients. However, elderly patients may be more susceptible to adverse effects such as photosensitivity and gastrointestinal irritation. Monitor for these effects.

Clinical Information

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Clinical Pearls

  • Doryx 75mg DR is specifically formulated for once-daily dosing and is often used for inflammatory lesions of rosacea and acne, leveraging its anti-inflammatory properties at sub-antimicrobial doses.
  • Unlike immediate-release doxycycline, Doryx DR's absorption is less affected by food and dairy products, but taking it with a full glass of water and remaining upright for at least 30 minutes is still crucial to prevent esophageal irritation.
  • Emphasize strict sun protection due to significant photosensitivity risk.
  • Counsel patients on the signs and symptoms of increased intracranial pressure (severe headache, vision changes) and C. difficile-associated diarrhea, which require immediate medical attention.
  • Doxycycline is a broad-spectrum antibiotic, but its use for acne/rosacea at lower doses aims to minimize antimicrobial resistance while still providing anti-inflammatory benefits.
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Alternative Therapies

  • Other tetracyclines (e.g., minocycline, tetracycline)
  • Macrolides (e.g., erythromycin, azithromycin) for certain infections or if tetracyclines are contraindicated
  • Topical antibiotics (e.g., clindamycin, erythromycin) for acne/rosacea
  • Topical retinoids (e.g., tretinoin, adapalene) for acne
  • Benzoyl peroxide for acne
  • Oral isotretinoin for severe acne
  • Metronidazole (topical or oral) for rosacea
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Cost & Coverage

Average Cost: $100 - $300 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (generic usually Tier 1 or 2, brand Tier 3 or higher)
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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 your 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 medication taken, the amount, and the time it happened.