Doxycycline Hyc 100mg Caps

Manufacturer SUN 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; Protein synthesis inhibitor
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Pregnancy Category
Category D
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FDA Approved
Apr 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, urinary tract infections, respiratory infections, and certain sexually transmitted diseases. It works by stopping the growth of bacteria. It's also used for conditions like acne and rosacea, and to prevent malaria.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most out of your medication, follow these guidelines:

Take your medication exactly as directed by your doctor. Read all the information provided and follow the instructions carefully.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Some medications need to be taken with food or 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 calcium-rich foods, as this may reduce its 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

Administration Instructions

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.

Storage and Disposal

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 has not been stored properly.

Missing 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 one.
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Lifestyle & Tips

  • Take with a full glass of water to prevent irritation of the esophagus.
  • Remain upright for at least 30 minutes (preferably 1 hour) after taking the dose.
  • Avoid taking with dairy products, antacids, iron supplements, or multivitamins containing these minerals within 2-3 hours of your dose, as they can reduce absorption.
  • Avoid excessive exposure to sunlight 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 you start to feel better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: 100 mg every 12 hours for most infections
Dose Range: 20 - 200 mg

Condition-Specific Dosing:

General Infections: 100 mg every 12 hours on day 1, then 100 mg once daily or 50 mg every 12 hours
Severe Infections: 100 mg every 12 hours
Acne Vulgaris: 50-100 mg once daily or 20 mg twice daily (subantimicrobial dose)
Rosacea (inflammatory lesions): 20 mg twice daily or 40 mg once daily (delayed-release)
Malaria Prophylaxis: 100 mg once daily, starting 1-2 days before travel, continuing for 4 weeks after leaving endemic area
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Pediatric Dosing

Neonatal: Not established (contraindicated due to tooth discoloration and bone growth effects)
Infant: Not established (contraindicated due to tooth discoloration and bone growth effects)
Child: Children 8 years and older: 4.4 mg/kg/day divided into 1-2 doses (max 200 mg/day). For severe infections, up to 4.4 mg/kg/day divided every 12 hours (max 100 mg/dose).
Adolescent: Same as adult dosing for children 8 years and older, considering weight and severity.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed (primarily eliminated via non-renal routes)
Dialysis: No adjustment needed; not significantly removed by hemodialysis or peritoneal dialysis.

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: No specific adjustment recommended, but use with caution.
Severe: Use with caution; monitor for signs of hepatotoxicity. Doxycycline is primarily eliminated via the GI tract, but severe hepatic impairment could theoretically affect its metabolism/excretion.

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 may slightly decrease absorption but generally not to a clinically significant extent for most formulations, though it's often recommended to avoid dairy/antacids/iron within 2-3 hours for maximal absorption.

Distribution:

Vd: 0.7 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (poor penetration into CSF, but increases with meningeal inflammation)

Elimination:

HalfLife: 16-22 hours (range 12-24 hours)
Clearance: Not readily available as a specific rate, but primarily via fecal excretion.
ExcretionRoute: Fecal (via bile) and urinary excretion (minor route).
Unchanged: Approximately 40% excreted unchanged in urine and feces.
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Pharmacodynamics

OnsetOfAction: Rapid (within hours for antibacterial effect)
PeakEffect: Within 2-4 hours (plasma concentration)
DurationOfAction: 24 hours (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
+ 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
Fast heartbeat
Difficulty urinating or changes in urine output
Fever, chills, or sore throat
Unexplained bruising or bleeding
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

Important: Antibiotic-Associated 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. This condition can lead to a life-threatening bowel problem. If you experience stomach pain, cramps, or loose, 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 may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor:

Diarrhea
Upset stomach
Vomiting
* Decreased appetite

Reporting Side Effects

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 or watery diarrhea, especially if it contains blood or mucus (could be C. difficile infection)
  • New or worsening abdominal pain
  • Severe skin rash, blistering, or peeling
  • Unusual bruising or bleeding
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Persistent headache, blurred vision, or vision changes (signs of increased intracranial pressure)
  • 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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if 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 easy sunburning, inform your doctor promptly.

Be aware that this medication can cause severe skin reactions, 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 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 can turn teeth yellow-gray brown. This change is permanent. Additionally, this medication may affect bone growth and cause other tooth problems 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 has been reported to reverse after stopping the medication and undergoing dental cleaning. If you have questions or concerns, talk to 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
  • Esophageal ulceration (if not taken with water/upright)
  • Possible hepatotoxicity or nephrotoxicity (rare with acute overdose)

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive; gastric lavage may be considered if ingestion is recent. Hemodialysis is not effective.

Drug Interactions

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Major Interactions

  • Isotretinoin (increased risk of pseudotumor cerebri)
  • Live bacterial vaccines (e.g., BCG, typhoid oral - decreased efficacy)
  • Methoxyflurane (increased risk of nephrotoxicity)
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Moderate Interactions

  • Antacids (aluminum, calcium, magnesium), iron preparations, bismuth subsalicylate, zinc supplements (decreased doxycycline absorption due to chelation)
  • Oral contraceptives (potential for decreased efficacy, though evidence is mixed)
  • Warfarin (potentiates anticoagulant effect)
  • Barbiturates, carbamazepine, phenytoin (decreased doxycycline half-life due to enzyme induction)
  • Penicillins (may interfere with bactericidal action of penicillins)

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: To establish baseline and identify pre-existing hepatic impairment, though severe hepatotoxicity is rare.

Timing: Prior to initiation, especially in patients with pre-existing liver disease.

Renal function tests (RFTs)

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

Timing: Prior to initiation, if clinically indicated.

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Routine Monitoring

Signs and symptoms of C. difficile-associated diarrhea (CDAD)

Frequency: Throughout therapy and for several weeks post-therapy

Target: Absence of severe diarrhea, abdominal pain, fever

Action Threshold: If severe, persistent diarrhea occurs, discontinue doxycycline and initiate appropriate therapy.

Photosensitivity reaction

Frequency: Throughout therapy

Target: Absence of severe sunburn-like reactions

Action Threshold: Advise patients to avoid excessive sun exposure and use sunscreen. Discontinue if severe reaction occurs.

GI upset (nausea, vomiting, esophageal irritation)

Frequency: Throughout therapy

Target: Tolerance of medication

Action Threshold: Advise taking with food (non-dairy) and a full glass of water, remaining upright for at least 30 minutes after dose. Consider dose reduction or alternative if severe.

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Symptom Monitoring

  • Diarrhea (especially severe or bloody)
  • Abdominal pain
  • Fever
  • Skin rash or severe sunburn
  • Nausea
  • Vomiting
  • Difficulty swallowing or chest pain (suggesting esophageal irritation)
  • Headache, blurred vision, diplopia (signs of pseudotumor cerebri, rare)

Special Patient Groups

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Pregnancy

Contraindicated in pregnancy (Category D). Doxycycline can cause permanent discoloration of teeth (yellow-gray-brown) and reversible inhibition of bone growth in the fetus when administered during the second and third trimesters. It should only be used if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for teratogenicity cannot be excluded. Risk of tooth discoloration and bone effects is lower than in later trimesters but still a concern.
Second Trimester: High risk of permanent tooth discoloration (yellow-gray-brown) and reversible inhibition of bone growth in the fetus.
Third Trimester: High risk of permanent tooth discoloration (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 with caution for short-term use, potential risks to the infant include tooth discoloration and inhibition of bone growth (theoretical, as absorption by infant is low), and alteration of gut flora. Monitor infant for diarrhea or candidiasis. Use with caution, especially for prolonged courses.

Infant Risk: Low to moderate. Theoretical risk of tooth discoloration and bone growth inhibition, but systemic absorption by the infant from breast milk is generally low. Monitor for GI upset (diarrhea, 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. In children 8 years and older, use with caution and only when other antibiotics are not appropriate or effective.

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Geriatric Use

No specific dose adjustment is generally needed based on age alone. However, elderly patients may be more susceptible to adverse effects such as photosensitivity or C. difficile-associated diarrhea. Monitor renal and hepatic function, and ensure adequate hydration to prevent esophageal irritation.

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 prevent esophageal irritation and ulceration.
  • Educate patients thoroughly about photosensitivity and the importance of sun protection.
  • Remind patients to separate doxycycline from dairy products, antacids, iron, and other mineral supplements by at least 2-3 hours.
  • Doxycycline is a good option for patients with renal impairment as it is primarily eliminated non-renally.
  • Subantimicrobial doses (e.g., 20 mg BID or 40 mg once daily delayed-release) are used for inflammatory conditions like rosacea and acne, leveraging its anti-inflammatory properties without significant antibacterial effects, thus reducing resistance risk.
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Alternative Therapies

  • Other tetracyclines (e.g., minocycline, tetracycline)
  • Macrolides (e.g., azithromycin, erythromycin - for some respiratory or skin infections)
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin - for certain severe infections)
  • Beta-lactam antibiotics (e.g., penicillins, cephalosporins - depending on the specific infection and susceptibility)
  • Clindamycin (for certain skin and soft tissue infections)
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Cost & Coverage

Average Cost: $10 - $100+ per 30 capsules (generic)
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'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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.