Doryx 200mg DR Tablets

Manufacturer MAYNE 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
Category D
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FDA Approved
Mar 2005
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Doryx is an antibiotic that treats bacterial infections like pneumonia, acne, and certain skin infections. It works by stopping the growth of bacteria. It's also used to prevent malaria and treat some sexually transmitted infections.
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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

Take your medication with food or on an empty stomach, as directed by your pharmacist. Some medications may not work as well when taken with certain foods or products.
Avoid taking your medication at the same time as milk, dairy products, or other foods that contain calcium, as this may reduce its effectiveness. If you have questions, consult 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.
Take your medication with a full glass of water to help prevent throat irritation.
Do not lie down after taking your medication. Ask your pharmacist how long you should wait before lying down.

Swallowing Your Medication

Swallow your medication whole. Do not chew or crush it.
If your doctor instructs you to break the tablet, you may do so. However, be careful not to crush the pellets inside the tablet.
You may sprinkle the contents of the tablet onto applesauce, but be careful not to crush or damage the pellets. Do not mix the medication with hot applesauce, and swallow the mixture immediately. 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.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember.
If it is 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 or ulceration.
  • Avoid taking antacids, iron supplements, calcium supplements, or dairy products within 2-3 hours before or after taking Doryx, as they can interfere with absorption.
  • Avoid excessive exposure to sunlight or artificial UV light (e.g., tanning beds) while taking this medication and for several days after stopping, as it can cause severe sunburn (photosensitivity). Use sunscreen and wear protective clothing.
  • If you are taking oral contraceptives, use an additional non-hormonal birth control method (like condoms) while on Doryx and for 7 days after, as Doryx may reduce the effectiveness of birth control pills.
  • Complete the full course of medication as prescribed, even if you feel better, to prevent the infection from returning and to reduce the development of antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: 200 mg once daily or 100 mg every 12 hours, depending on indication.
Dose Range: 100 - 200 mg

Condition-Specific Dosing:

Severe Infections: 200 mg on first day (loading dose), then 100 mg once daily or 50 mg every 12 hours.
Acne Vulgaris (moderate to severe): 100 mg once daily or 50 mg twice daily. For Doryx 200mg, often 200mg once daily for severe cases or specific regimens.
Rosacea: 20 mg twice daily or 40 mg once daily (sub-antimicrobial dose, not Doryx 200mg strength). For Doryx 200mg, higher doses for inflammatory lesions.
Syphilis (early): 100 mg twice daily for 14 days.
Lyme Disease: 100 mg twice daily for 10-21 days.
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Pediatric Dosing

Neonatal: Not established (contraindicated in children < 8 years old).
Infant: Not established (contraindicated in children < 8 years old).
Child: For children 8 years of age and older (weighing < 45 kg): 4.4 mg/kg/day in 1 or 2 divided doses. For children weighing â‰Ĩ 45 kg: Adult dose (100-200 mg/day).
Adolescent: Adult dose (100-200 mg/day).
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: Use with caution; monitor for signs of hepatotoxicity.
Moderate: Use with caution; monitor for signs of hepatotoxicity.
Severe: Use with caution; monitor for signs of hepatotoxicity. Dose adjustment generally not specified, but close monitoring is advised.

Pharmacology

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Mechanism of Action

Doxycycline is a tetracycline 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 is bacteriostatic.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100%
Tmax: 2-3 hours (for delayed-release formulations, may be slightly longer than immediate-release)
FoodEffect: Food and milk products have a minimal effect on the absorption of doxycycline, unlike other tetracyclines. However, Doryx DR should be taken with adequate fluid to reduce the risk of esophageal irritation.

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 as a specific rate, but primarily eliminated via fecal excretion and renal excretion.
ExcretionRoute: Fecal (via bile) and renal (glomerular filtration)
Unchanged: Approximately 40-60% excreted unchanged in urine and feces.
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Pharmacodynamics

OnsetOfAction: Variable, depends on infection type and site; generally within hours for bacteriostatic effect.
PeakEffect: Correlates with Tmax (2-3 hours).
DurationOfAction: 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 medical attention immediately:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Chest pain or pressure, or a fast 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
Trouble swallowing
Muscle or joint pain
Rapid breathing
Flushing
Severe dizziness or fainting
Changes in skin color
Vaginal itching or discharge
Diarrhea, especially if it is severe, watery, or bloody (see below for more information on diarrhea)

Important Information About Diarrhea

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) may occur. CDAD can happen during or after treatment with antibiotics and may lead to a life-threatening bowel problem. If you experience stomach pain, cramps, or severe diarrhea (watery or bloody stools), contact your doctor immediately. Before treating diarrhea, consult with your doctor.

Raised Pressure in the Brain

This medication can cause increased pressure in the brain, which usually resolves after stopping the medication. 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.

Other Side Effects

Like all medications, this drug can cause side effects. Many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:

Diarrhea
Upset stomach or vomiting
* Decreased appetite

This is not a complete list of possible side effects. If you have questions or concerns about side effects, talk to 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 with blurred vision or double vision (signs of increased pressure in the brain)
  • Severe, watery diarrhea or bloody stools (may occur up to 2 months after stopping treatment)
  • New or worsening skin rash, blistering, or peeling skin
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems)
  • Difficulty or pain when swallowing, or heartburn that doesn't go away
  • Unusual bleeding or bruising
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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.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your other medications and health conditions.

Remember, do not 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 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 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 other tooth problems. It may also affect bone growth. 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 if you experience any changes in tooth color.

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 damage (rare with acute overdose)
  • Kidney damage (rare with acute overdose)

What to Do:

There is no specific antidote. Treatment is symptomatic and supportive. Gastric lavage may be considered if ingestion is recent. Dialysis is not effective in removing doxycycline. Call 911 or Poison Control at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Isotretinoin (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 contraceptives (may reduce efficacy of oral contraceptives, leading to breakthrough bleeding or pregnancy)
  • Warfarin (potentiates anticoagulant effect, increased INR)
  • Penicillins (tetracyclines may interfere with the bactericidal action of penicillin)
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Moderate Interactions

  • Barbiturates (e.g., phenobarbital) (decreased doxycycline half-life)
  • Phenytoin (decreased doxycycline half-life)
  • Carbamazepine (decreased doxycycline half-life)
  • Methotrexate (may increase methotrexate toxicity due to competition for renal excretion)
  • Live bacterial vaccines (e.g., typhoid vaccine) (may reduce vaccine efficacy)
  • Ergot alkaloids (theoretical increased risk of ergotism)
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Minor Interactions

  • Digoxin (may increase digoxin levels in some patients due to altered gut flora)

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.

Timing: Prior to initiating therapy if clinically indicated.

Renal function tests (BUN, creatinine)

Rationale: To assess baseline renal function, though doxycycline is primarily non-renally excreted, it's good practice for overall patient assessment.

Timing: Prior to initiating therapy if clinically indicated.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily to weekly, depending on infection severity and duration of treatment.

Target: Resolution of signs and symptoms of infection/condition.

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

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

Frequency: Daily, especially during initial therapy.

Target: Absence or mild, tolerable adverse effects.

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

INR (for patients on warfarin)

Frequency: More frequently (e.g., 2-3 times per week) during co-administration and after discontinuation.

Target: Therapeutic INR range for the patient's indication.

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

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Symptom Monitoring

  • Severe headache
  • Blurred vision or vision changes (signs of pseudotumor cerebri)
  • Severe or persistent diarrhea (may indicate C. difficile-associated diarrhea)
  • New or worsening rash (may indicate hypersensitivity reaction or photosensitivity)
  • Difficulty swallowing or painful swallowing (esophageal irritation/ulceration)
  • Yellowing of skin or eyes, dark urine, abdominal pain (signs of liver dysfunction)

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.

Trimester-Specific Risks:

First Trimester: Potential for skeletal abnormalities, though less studied than later trimesters.
Second Trimester: Known to cause permanent discoloration of teeth (yellow-gray-brown) and reversible inhibition of bone growth in the fetus.
Third Trimester: Known to cause permanent discoloration of teeth (yellow-gray-brown) and reversible inhibition of bone growth in the fetus.
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Lactation

Doxycycline is excreted into breast milk. While generally considered compatible for short-term use by some experts due to low levels in milk and low oral bioavailability in infants, caution is advised. Long-term or repeated use should be avoided.

Infant Risk: Potential for tooth discoloration and inhibition of bone growth in the nursing infant, though the risk is considered low with typical therapeutic doses due to calcium binding in milk and low infant absorption. Monitor for diarrhea or candidiasis in the infant.
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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 considered and only when other drugs are contraindicated or ineffective.

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Geriatric Use

No specific dose adjustment is generally required based on age alone. However, elderly patients may be more susceptible to adverse effects, particularly gastrointestinal disturbances and photosensitivity. Monitor renal and hepatic function if clinically indicated.

Clinical Information

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Clinical Pearls

  • Always instruct patients to take Doryx 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.
  • Advise patients to avoid dairy products, antacids, and iron supplements within 2-3 hours of taking doxycycline to ensure proper absorption.
  • Doxycycline is a good option for patients with renal impairment as it is primarily eliminated non-renally.
  • Be aware of the potential for C. difficile-associated diarrhea, which can occur even weeks after discontinuation.
  • For acne, lower sub-antimicrobial doses (e.g., Oracea) are available to reduce resistance and side effects, but Doryx 200mg is used for more severe inflammatory acne or other infections.
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Alternative Therapies

  • Other tetracyclines (e.g., minocycline, tetracycline)
  • Macrolides (e.g., azithromycin, erythromycin - for some infections)
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin - for some infections)
  • Beta-lactam antibiotics (e.g., amoxicillin, cephalexin - for some infections)
  • For acne: topical retinoids, benzoyl peroxide, oral retinoids (isotretinoin), other oral antibiotics (e.g., azithromycin, trimethoprim/sulfamethoxazole)
  • For rosacea: topical metronidazole, azelaic acid, ivermectin cream, oral sub-antimicrobial dose doxycycline (Oracea).
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Cost & Coverage

Average Cost: Varies widely, typically $100 - $500+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (brand), Tier 1 (generic)
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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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.