Doxycycline Hyclate 100mg DR Tb

Manufacturer ALEMBIC PHARMACEUTICALS 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
Protein synthesis inhibitor (30S ribosomal subunit)
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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?

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. This delayed-release tablet is designed to reduce stomach upset.
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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 has instructed 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.
After taking your medication, do not lie down for a period of time to reduce the risk of throat irritation. Ask your pharmacist for guidance on how long to 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.
You may 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 the medication with hot applesauce.
If you mix the medication with applesauce, swallow it 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.
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.
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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, even with delayed-release formulation.
  • 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 absorption.
  • Avoid excessive sun exposure or artificial UV light (tanning beds) while taking this medication and for several days after, as it can cause severe sunburn (photosensitivity). Use sunscreen and wear protective clothing.
  • Complete the full course of medication as prescribed, even if symptoms improve, to prevent recurrence of infection and development of antibiotic resistance.
  • If you are taking oral contraceptives, use an additional non-hormonal birth control method (like condoms) while taking doxycycline and for 7 days after, as doxycycline may reduce the effectiveness of birth control pills.

Dosing & Administration

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Adult Dosing

Standard Dose: 100 mg once or twice daily, depending on indication
Dose Range: 50 - 200 mg

Condition-Specific Dosing:

mostInfections: 100 mg every 12 hours on day 1, then 100 mg once daily or 50 mg every 12 hours
severeInfections: 100 mg every 12 hours
gonorrhea: 100 mg orally twice daily for 7 days (uncomplicated)
syphilis: 100 mg orally twice daily for 14 days (early) or 28 days (late/latent)
chlamydia: 100 mg orally twice daily for 7 days
malariaProphylaxis: 100 mg once daily, starting 1-2 days before travel, continuing for 4 weeks after return
acneVulgaris: 20 mg twice daily or 50 mg once daily (subantimicrobial dose)
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Pediatric Dosing

Neonatal: Not established (contraindicated in children < 8 years due to tooth discoloration and bone effects, unless benefits outweigh risks in severe/life-threatening infections like anthrax or Rocky Mountain spotted fever)
Infant: Not established (contraindicated in children < 8 years)
Child: For children 8 years and older (and weighing < 45 kg): 4.4 mg/kg/day divided into 1-2 doses. Max 200 mg/day. For children 8 years and older (and weighing â‰Ĩ 45 kg): Adult dose.
Adolescent: Adult dose (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 (primarily eliminated via GI tract)
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis; no supplemental dose needed.

Hepatic Impairment:

Mild: Adjustment not typically needed
Moderate: Use with caution; monitor for signs of hepatotoxicity. Dose reduction may be considered in severe cases.
Severe: Use with caution; monitor for signs of hepatotoxicity. Dose reduction may be considered.

Pharmacology

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Mechanism of Action

Doxycycline is a broad-spectrum tetracycline antibiotic that inhibits bacterial protein synthesis by reversibly binding to the 30S ribosomal subunit, thereby preventing the attachment of aminoacyl-tRNA to the ribosomal acceptor site. This action prevents the addition of amino acids to the growing peptide chain, leading to bacteriostatic effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100% (oral)
Tmax: 1.5-4 hours (for delayed-release formulations, may be slightly longer than immediate-release)
FoodEffect: Absorption is not significantly affected by food or milk, unlike other tetracyclines. However, dairy products, antacids, and iron preparations can impair absorption due to chelation.

Distribution:

Vd: 0.75 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (poor penetration into CSF, but increases with inflamed meninges)

Elimination:

HalfLife: 16-22 hours (can be up to 24 hours)
Clearance: Not available (primarily non-renal excretion)
ExcretionRoute: Fecal (via intestinal secretion) and renal (glomerular filtration)
Unchanged: Approximately 40% excreted unchanged in urine, 20-40% in feces.
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Pharmacodynamics

OnsetOfAction: Rapid (therapeutic concentrations achieved within hours)
PeakEffect: Within 2-4 hours of administration
DurationOfAction: 24 hours (allows for once-daily dosing for many indications)

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

Important Antibiotic-Related Side Effect:

Diarrhea is a common side effect of antibiotics. However, a rare but severe form called C. diff-associated diarrhea (CDAD) may occur. This condition can lead to life-threatening bowel problems. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately. Before treating diarrhea, consult with your doctor.

Rare but Serious Side Effect:

Raised pressure in the brain has been reported with this medication. Although this condition usually resolves after stopping the medication, it can sometimes lead to permanent vision loss. If you experience headaches or vision problems, such as blurred vision, double vision, or loss of vision, contact your doctor immediately.

Other Possible Side Effects:

Most people do not experience severe side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Diarrhea, stomach upset, or vomiting
* Decreased appetite

Reporting Side Effects:

This list is not exhaustive, and you may experience other 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, watery diarrhea or bloody stools (may indicate C. difficile infection)
  • Difficulty swallowing, painful swallowing, or chest pain (signs of esophageal irritation)
  • Severe headache, blurred vision, double vision, or vision loss (signs of benign intracranial hypertension)
  • Yellowing of skin or eyes, dark urine, persistent nausea/vomiting (signs of liver problems)
  • Severe skin rash, blistering, peeling skin, or swelling of face/tongue/throat (signs of severe allergic reaction)
  • Unusual bruising or bleeding, persistent sore throat, fever (signs of blood dyscrasias)
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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 allergic reaction and its symptoms.
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 (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 it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug. Do not exceed the recommended 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.

Be aware that this drug can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions. These reactions can be life-threatening and may also affect internal organs. 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 and unborn babies exposed to this medication during certain stages of pregnancy, there is a risk of tooth discoloration, which may be permanent. This can result in yellow-gray brown teeth. Other tooth problems and effects on bone growth have also been reported in these individuals. If you have concerns, discuss them with your doctor.

Generally, this medication is not recommended for children under 8 years old, but 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 typically resolves after stopping the medication and undergoing dental cleaning. If you have questions or concerns, consult 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
  • Possible liver or kidney damage (with very high doses)

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive; gastric lavage may be considered if ingestion is recent.

Drug Interactions

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Major Interactions

  • Antacids (containing aluminum, calcium, magnesium): Decreased doxycycline absorption.
  • Iron preparations: Decreased doxycycline absorption.
  • Bismuth subsalicylate: Decreased doxycycline absorption.
  • Oral retinoids (e.g., isotretinoin, acitretin): Increased risk of pseudotumor cerebri (benign intracranial hypertension).
  • Penicillins: Tetracyclines may interfere with the bactericidal action of penicillins. Avoid concomitant use.
  • Live bacterial vaccines (e.g., oral typhoid vaccine): Doxycycline may reduce the therapeutic effect of the vaccine.
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Moderate Interactions

  • Warfarin: May potentiate anticoagulant effects (monitor INR).
  • Oral contraceptives: May reduce efficacy of oral contraceptives (advise backup contraception).
  • Barbiturates (e.g., phenobarbital), Carbamazepine, Phenytoin: May decrease doxycycline half-life due to enzyme induction.
  • Methotrexate: May increase methotrexate toxicity (monitor).
  • Ergot alkaloids: Increased risk of ergotism (theoretical, but caution advised).
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Minor Interactions

  • Digoxin: May increase digoxin levels (monitor).

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

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

Timing: Prior to initiating long-term therapy.

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

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

Timing: Prior to initiating therapy, especially in patients with known renal issues.

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Routine Monitoring

Liver function tests (LFTs)

Frequency: Periodically, especially during prolonged therapy (e.g., >2-3 weeks) or in patients with hepatic impairment.

Target: Within normal limits

Action Threshold: Significant elevation (e.g., >3x ULN) may warrant dose reduction or discontinuation.

Complete Blood Count (CBC)

Frequency: Periodically during prolonged therapy.

Target: Within normal limits

Action Threshold: Significant abnormalities (e.g., leukopenia, thrombocytopenia) may warrant investigation or discontinuation.

INR (if on warfarin)

Frequency: More frequently when initiating or discontinuing doxycycline, or changing dose.

Target: Therapeutic range for indication

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

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Symptom Monitoring

  • Signs of C. difficile-associated diarrhea (severe diarrhea, abdominal pain, fever)
  • Signs of esophageal irritation/ulceration (dysphagia, odynophagia, chest pain)
  • Signs of photosensitivity (severe sunburn, rash after sun exposure)
  • Signs of benign intracranial hypertension (severe headache, blurred vision, diplopia, papilledema)
  • Signs of hypersensitivity reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • Signs of liver dysfunction (yellowing eyes/skin, dark urine, persistent nausea/vomiting)

Special Patient Groups

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Pregnancy

Category D. Doxycycline can cause permanent tooth discoloration (yellow-gray-brown) and reversible inhibition of bone growth in the fetus when administered during pregnancy. Use only if the potential benefit justifies the potential risk to the fetus, particularly in severe or life-threatening conditions where safer alternatives are ineffective or contraindicated.

Trimester-Specific Risks:

First Trimester: Potential for tooth discoloration and bone effects, though less pronounced than later trimesters.
Second Trimester: Significant risk of permanent tooth discoloration and reversible inhibition of bone growth.
Third Trimester: Significant risk of permanent tooth discoloration and reversible inhibition of bone growth.
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Lactation

Excreted into breast milk. While the amount transferred is small and calcium in milk may chelate the drug, leading to minimal infant exposure, the potential for tooth discoloration and inhibition of bone growth in the infant remains a theoretical concern, especially with long-term use. The American Academy of Pediatrics considers tetracyclines usually compatible with breastfeeding for short-term use. Monitor infant for diarrhea or candidiasis. Use with caution, especially for prolonged courses.

Infant Risk: L3 (Moderate risk - use with caution). Potential for tooth discoloration and inhibition of bone growth, though low due to calcium binding in milk. Monitor for GI upset 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 reversible inhibition of bone growth. Use in this age group is generally reserved for severe or life-threatening infections (e.g., anthrax, Rocky Mountain spotted fever) where the benefits outweigh the risks and alternative therapies are not suitable.

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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 C. difficile infection. Monitor renal and hepatic function, though doxycycline's primary non-renal elimination makes it a favorable option in renal impairment.

Clinical Information

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Clinical Pearls

  • Doxycycline hyclate is more prone to causing esophageal irritation/ulceration than doxycycline monohydrate. The delayed-release formulation helps mitigate this, but taking with plenty of water and remaining upright is still crucial.
  • Despite being a tetracycline, doxycycline's absorption is less affected by food and dairy compared to other tetracyclines, but it's still best to avoid co-administration with antacids, iron, or calcium.
  • It is a first-line treatment for many atypical infections (e.g., Mycoplasma, Chlamydia, Rickettsia, Lyme disease) and certain parasitic infections (e.g., malaria prophylaxis).
  • Photosensitivity is a common and significant side effect; counsel patients extensively on sun protection.
  • The subantimicrobial dose (20 mg twice daily or 50 mg once daily) is used for inflammatory lesions of rosacea and acne, acting as an anti-inflammatory rather than an antibiotic, and has a lower risk of resistance development.
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Alternative Therapies

  • Azithromycin (for Chlamydia, certain respiratory infections)
  • Amoxicillin (for Lyme disease, certain bacterial infections)
  • Ceftriaxone (for Gonorrhea, certain bacterial infections)
  • Macrolides (e.g., erythromycin, clarithromycin for atypical pneumonias)
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin for various bacterial infections)
  • Other tetracyclines (e.g., minocycline, tetracycline)
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Cost & Coverage

Average Cost: $20 - $100+ per 30 tablets (generic 100mg DR)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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 for more information. 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 details about what was taken, the amount, and the time it occurred.