Doxycycline Hyc 50mg Tabs

Manufacturer ALEMBIC Active Ingredient Doxycycline Tablets and Capsules(doks i SYE kleen) Pronunciation doks-i-SYE-kleen HYE-klate
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, Antimalarial, Anti-inflammatory (for acne/rosacea)
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Pharmacologic Class
Tetracycline antibiotic
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Pregnancy Category
Category D
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FDA Approved
Jul 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 bacterial infections, such as urinary tract infections, acne, gonorrhea, and chlamydia. It works by stopping the growth of bacteria. It can also be used 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 feeling 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-containing foods, 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 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.
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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 reduce its absorption.
  • Avoid excessive exposure to sunlight or artificial UV light (e.g., tanning beds) and use sunscreen (SPF 30+) and protective clothing, as doxycycline can cause severe sunburn (photosensitivity).
  • If you experience stomach upset, you may take it with food, but avoid dairy products.
  • Complete the full course of medication as prescribed, even if you feel better, to prevent antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: 50 mg once or twice daily (for acne/rosacea) or 100 mg once or twice daily (for infections)
Dose Range: 50 - 200 mg

Condition-Specific Dosing:

Acne Vulgaris: 50 mg once or twice daily
Rosacea: 20 mg twice daily or 40 mg once daily (delayed-release)
Bacterial Infections (general): 100 mg every 12 hours on day 1, then 100 mg once daily or 50 mg every 12 hours
Malaria Prophylaxis: 100 mg once daily, starting 1-2 days before travel and continuing for 4 weeks after return
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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: Not recommended for children under 8 years of age due to risk of permanent tooth discoloration and enamel hypoplasia. For children 8 years and older: 2.2 mg/kg body weight divided into two doses on day 1, then 2.2 mg/kg body weight once daily or 1.1 mg/kg body weight every 12 hours. Max 100 mg/dose.
Adolescent: Same as adult dosing for children 8 years and older, generally 100 mg once or twice daily depending on indication.
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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 adjustment needed.

Hepatic Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution. Monitor for signs of hepatotoxicity.

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 leads to bacteriostatic effects. It also exhibits anti-inflammatory properties, particularly at sub-antimicrobial doses, by inhibiting matrix metalloproteinases and other inflammatory mediators.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 1.5-4 hours
FoodEffect: Absorption is not significantly affected by food or milk, unlike other tetracyclines, but dairy products, antacids, and iron preparations can impair absorption. It is recommended to take with food or milk if gastric irritation occurs, but avoid dairy/antacids/iron within 2-3 hours of dose.

Distribution:

Vd: 0.75 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (achieves therapeutic levels in CSF only when meninges are inflamed)

Elimination:

HalfLife: 16-22 hours (range 12-24 hours)
Clearance: Not available (primarily non-renal excretion)
ExcretionRoute: Primarily fecal (via bile) and renal excretion. A significant portion is excreted unchanged in the feces.
Unchanged: Approximately 40% renally, 60% fecally
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Pharmacodynamics

OnsetOfAction: Within hours (antibacterial effect)
PeakEffect: Within 2-4 hours (plasma concentration)
DurationOfAction: 24 hours (due to long half-life, allowing once-daily dosing for many indications)

Safety & Warnings

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Side Effects

Serious 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 experience 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
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 Clostridioides difficile-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.

Raised Pressure in the Brain

This medication may 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 headaches or vision problems, such as blurred vision, double vision, or loss of vision, contact your doctor immediately.

Other Side Effects

Most people do not experience significant side effects or only have mild side effects. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Diarrhea
Upset stomach
Vomiting
* Decreased appetite

Reporting Side Effects

If you have questions about side effects or want to report any 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)
  • Severe skin rash, blistering, or peeling skin
  • Severe headache, blurred vision, or vision changes (signs of increased intracranial pressure)
  • Yellowing of the skin or eyes (jaundice), dark urine, or severe stomach pain (signs of liver problems)
  • Swelling of the face, lips, tongue, or throat; difficulty breathing (signs of allergic reaction)
  • 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. 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 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.

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 multiple 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. 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 it may reverse after stopping the medication and undergoing dental cleaning. Consult your doctor if you have concerns.

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
  • Esophageal ulceration (if not taken with enough water/upright)
  • Liver toxicity (rare with acute overdose)
  • Kidney toxicity (rare with acute overdose)

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is generally supportive, including gastric lavage if recent ingestion, and symptomatic management. Doxycycline is not significantly removed by hemodialysis.

Drug Interactions

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Contraindicated Interactions

  • Isotretinoin (increased risk of pseudotumor cerebri)
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Major Interactions

  • Antacids (aluminum, calcium, magnesium): Decreased doxycycline absorption
  • Iron preparations: Decreased doxycycline absorption
  • Bismuth subsalicylate: Decreased doxycycline absorption
  • Oral contraceptives: Potential for decreased efficacy of oral contraceptives (though evidence is mixed, advise backup method)
  • Warfarin: Enhanced anticoagulant effect (monitor INR)
  • Penicillins: Potential for antagonism (avoid concomitant use)
  • Live bacterial vaccines (e.g., oral typhoid vaccine): Decreased vaccine efficacy
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Moderate Interactions

  • Barbiturates (e.g., phenobarbital): Decreased doxycycline half-life and plasma levels
  • Phenytoin: Decreased doxycycline half-life and plasma levels
  • Carbamazepine: Decreased doxycycline half-life and plasma levels
  • Methotrexate: Increased methotrexate toxicity (rare, but possible)
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Minor Interactions

  • Digoxin: Increased digoxin levels (rare)

Monitoring

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Baseline Monitoring

Renal and Hepatic Function

Rationale: To assess baseline organ function, especially in patients with pre-existing impairment, though doxycycline is generally safe in renal impairment.

Timing: Before initiating therapy in patients with known or suspected impairment.

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Routine Monitoring

Clinical Response to Therapy

Frequency: Daily to weekly, depending on infection severity and indication

Target: Resolution of symptoms, reduction in infection markers

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

Adverse Effects (e.g., GI upset, photosensitivity, rash)

Frequency: Daily, especially during initial weeks of therapy

Target: Absence or mild, tolerable symptoms

Action Threshold: Severe GI distress, severe photosensitivity reaction, persistent headache, vision changes, or new rash requires evaluation and potential discontinuation.

INR (if on warfarin)

Frequency: Regularly, especially when initiating or discontinuing doxycycline

Target: Therapeutic INR range for indication

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

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Photosensitivity (severe sunburn-like reaction)
  • Headache
  • Blurred vision or vision changes (signs of pseudotumor cerebri)
  • Rash
  • Difficulty swallowing or esophageal irritation
  • Vaginal 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 when administered during pregnancy. Avoid use during pregnancy, especially during the second and third trimesters.

Trimester-Specific Risks:

First Trimester: Potential for tooth discoloration and bone growth effects, though less pronounced than later trimesters. Risk of congenital anomalies is not clearly established.
Second Trimester: High risk of permanent tooth discoloration and reversible inhibition of bone growth.
Third Trimester: High risk of permanent tooth discoloration and reversible inhibition of bone growth.
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Lactation

L3 (Moderate risk). Doxycycline is excreted into breast milk. While the amount is generally small and calcium in milk may chelate it, there is a theoretical risk of tooth discoloration and inhibition of bone growth in the nursing infant. The American Academy of Pediatrics considers tetracyclines compatible with breastfeeding with caution. Monitor infant for diarrhea, candidiasis, and potential tooth staining (though unlikely with short-term use).

Infant Risk: Potential for tooth discoloration and inhibition of bone growth (theoretical, low risk with typical doses and short-term use), gastrointestinal upset, 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 enamel hypoplasia, as well as reversible inhibition of bone growth. Use in children 8 years and older should be carefully weighed against the benefits, especially for long-term therapy.

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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 photosensitivity or gastrointestinal irritation. Monitor renal and hepatic function if comorbidities exist.

Clinical Information

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Clinical Pearls

  • Always advise patients to take doxycycline with a full glass of water and remain upright for at least 30 minutes to prevent esophageal irritation and ulceration.
  • Emphasize strict sun protection due to high photosensitivity risk.
  • Doxycycline is unique among tetracyclines for its minimal renal excretion, making it a preferred choice in patients with renal impairment.
  • Sub-antimicrobial doses (e.g., 20mg BID or 40mg once daily delayed-release) are used for anti-inflammatory effects in conditions like rosacea, without significant antibacterial activity, thus reducing resistance risk.
  • Despite the general advice to avoid dairy with tetracyclines, doxycycline's absorption is less affected, but it's still prudent to separate by 2-3 hours to maximize absorption and minimize GI upset.
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Alternative Therapies

  • Other tetracyclines (e.g., minocycline, tetracycline)
  • Macrolides (e.g., azithromycin, erythromycin) for certain bacterial infections
  • Beta-lactam antibiotics (e.g., penicillins, cephalosporins) for susceptible bacterial infections
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for susceptible bacterial infections
  • Topical or oral retinoids (e.g., tretinoin, isotretinoin) for acne (note interaction with isotretinoin)
  • Metronidazole (for rosacea or certain parasitic infections)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (50mg 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 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 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.