Doxycycline Hyclate 200mgdr Tabs

Manufacturer SOLCO Active Ingredient Doxycycline Delayed-Release Tablets(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
Tetracycline antibiotic
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Pharmacologic Class
Tetracycline
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Pregnancy Category
Category D
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FDA Approved
May 2005
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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, severe acne, intestinal infections, eye infections, gonorrhea, chlamydia, and others. It works by stopping the growth of bacteria. This specific form is a delayed-release tablet, meaning it releases the medicine slowly over time.
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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 steps:

1. Follow Your Doctor's Orders: Take your medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully. Continue taking your medication as prescribed, even if you start to feel better.
2. Food and Drink: 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 generally recommended to avoid taking your medication at the same time as milk, dairy products, or other foods high in calcium, as this may reduce its effectiveness.
3. Stay Hydrated: Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
4. Avoid Interactions: 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, or antacids.
5. Taking Your Medication:
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. Alternatively, you can 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 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 to make up for a missed one.
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Lifestyle & Tips

  • Take with a full glass of water (at least 8 ounces) to prevent irritation of the esophagus.
  • Remain in an upright position (sitting or standing) for at least 30 minutes, and preferably 1 hour, after taking the medication to prevent esophageal irritation.
  • 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.
  • Protect yourself from the sun: Doxycycline can make your skin more sensitive to sunlight (photosensitivity). Use sunscreen, wear protective clothing, and avoid prolonged sun exposure or tanning beds.
  • Complete the entire course of medication as prescribed, even if you start feeling better. Stopping early can lead to resistant bacteria.
  • If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.

Dosing & Administration

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Adult Dosing

Standard Dose: 200 mg once daily for 7-10 days (for certain infections) or 100-200 mg once daily (for acne/rosacea)
Dose Range: 100 - 200 mg

Condition-Specific Dosing:

severeInfections: 200 mg initially, then 100 mg once daily or 100 mg every 12 hours (if not delayed-release formulation)
acneVulgaris: 100 mg once daily or 200 mg once daily (delayed-release)
rosacea: 40 mg once daily (sub-antimicrobial dose, not 200mg DR)
malariaProphylaxis: 100 mg once daily (not 200mg DR)
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Pediatric Dosing

Neonatal: Not established (contraindicated)
Infant: Not established (contraindicated)
Child: Contraindicated in children under 8 years of age due to risk of permanent tooth discoloration and bone growth inhibition. For children 8 years and older: 2 mg/kg once daily or 100 mg once daily, up to 200 mg/day depending on indication.
Adolescent: Same as adult dosing for children 8 years and older, typically 100-200 mg once daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: Not significantly removed by hemodialysis; no supplemental dose needed.

Hepatic Impairment:

Mild: Caution advised; monitor for adverse effects.
Moderate: Caution advised; monitor for adverse effects.
Severe: Caution advised; monitor for adverse effects. Consider lower doses or alternative agents if possible.

Pharmacology

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Mechanism of Action

Doxycycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by reversibly binding to the 30S ribosomal subunit, thereby preventing the binding of aminoacyl-tRNA to the mRNA-ribosome complex. This action is primarily bacteriostatic.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 2-4 hours (for delayed-release formulation)
FoodEffect: Food and milk products may slightly decrease absorption but are often recommended to reduce gastrointestinal irritation. Absorption is less affected by food than other tetracyclines.

Distribution:

Vd: 0.7 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (unless meninges are inflamed)

Elimination:

HalfLife: 16-22 hours
Clearance: Not readily available, but primarily non-renal.
ExcretionRoute: Primarily fecal (via biliary excretion and reabsorption), with some renal excretion.
Unchanged: Approximately 40% excreted unchanged in urine and feces.
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Pharmacodynamics

OnsetOfAction: Within hours (antibacterial effect)
PeakEffect: Not directly applicable for antibacterial effect; peak plasma concentrations reached in 2-4 hours.
DurationOfAction: 24 hours (due to long half-life, allowing 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, 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-Related Side Effect:

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. Do not treat diarrhea without consulting your doctor first.

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, seek medical attention immediately.

Other Possible Side Effects:

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor:

Diarrhea
Upset stomach
Vomiting
* Decreased appetite

Reporting 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 occurs weeks after stopping the medication (could be C. difficile infection).
  • Severe headache, blurred vision, double vision, or vision loss (signs of increased pressure in the brain).
  • New or worsening rash, blistering, or peeling skin.
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems).
  • Difficulty swallowing, chest pain, or severe heartburn.
  • Signs of an allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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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.

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 issues with your doctor and pharmacist. They will help 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 to ensure your safety.
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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 precautions when exposed to sunlight. If you experience unusual sunburn or sensitivity, inform your doctor.

There is a risk of severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions, which 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. Typically, 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.

Tooth discoloration has also been reported in adults, but this condition may be reversible after stopping the medication and undergoing dental cleaning. Consult with 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. Immediately contact your doctor if you are pregnant or suspect you may be pregnant.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Esophageal irritation
  • 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. Hemodialysis is not effective.

Drug Interactions

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Contraindicated Interactions

  • Isotretinoin (increased risk of pseudotumor cerebri)
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Major Interactions

  • Antacids (containing aluminum, calcium, magnesium): Decreased doxycycline absorption.
  • Iron preparations: Decreased doxycycline absorption.
  • Bismuth subsalicylate: Decreased doxycycline absorption.
  • Warfarin: Potentiation of anticoagulant effect (monitor INR).
  • Penicillins: May interfere with the bactericidal action of penicillin (avoid concomitant use).
  • Oral contraceptives: May decrease efficacy of oral contraceptives (advise backup method).
  • Barbiturates (e.g., phenobarbital), Phenytoin, Carbamazepine: May decrease doxycycline half-life and efficacy.
  • Methotrexate: May increase methotrexate toxicity (monitor for adverse effects).
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Moderate Interactions

  • Digoxin: May increase digoxin levels (monitor).
  • Ergot alkaloids: Theoretical risk of increased ergot toxicity.
  • Live bacterial vaccines (e.g., typhoid vaccine): May reduce vaccine efficacy.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: To assess baseline hepatic function, especially if prolonged therapy or pre-existing liver disease.

Timing: Prior to initiation of therapy (if indicated).

Renal function tests (RFTs)

Rationale: To assess baseline renal function, though dose adjustment is typically not needed.

Timing: Prior to initiation of therapy (if indicated).

Complete Blood Count (CBC)

Rationale: To assess baseline hematologic status, especially for prolonged therapy.

Timing: Prior to initiation of therapy (if indicated).

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Routine Monitoring

Clinical response to therapy

Frequency: Daily/as needed

Target: Resolution of infection/symptoms

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

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

Frequency: Daily

Target: Absence or mild, tolerable symptoms

Action Threshold: Severe GI upset, severe headache, blurred vision, rash, or signs of C. difficile infection require immediate evaluation.

INR (if on warfarin)

Frequency: Regularly, as per warfarin monitoring guidelines

Target: Therapeutic range for warfarin

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

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Symptom Monitoring

  • Severe or persistent diarrhea (may indicate C. difficile-associated diarrhea)
  • Severe headache, blurred vision, diplopia, or vision loss (may indicate benign intracranial hypertension/pseudotumor cerebri)
  • Severe skin rash or blistering (photosensitivity or severe cutaneous adverse reactions)
  • Difficulty swallowing, chest pain, or heartburn (esophageal irritation/ulceration)
  • Signs of allergic reaction (e.g., hives, swelling, difficulty breathing)
  • Signs of liver dysfunction (e.g., jaundice, dark urine, persistent nausea/vomiting)

Special Patient Groups

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Pregnancy

Doxycycline is classified as Pregnancy Category D. It should be avoided during pregnancy, especially during the second and third trimesters, due to the risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia in the fetus. It can also cause reversible inhibition of bone growth.

Trimester-Specific Risks:

First Trimester: Potential for skeletal and dental effects, though less pronounced than later trimesters. Generally avoided.
Second Trimester: High risk of permanent tooth discoloration and enamel hypoplasia in the fetus. Reversible inhibition of bone growth.
Third Trimester: High risk of permanent tooth discoloration and enamel hypoplasia in the fetus. Reversible inhibition of bone growth.
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Lactation

Doxycycline is excreted into breast milk. While the amount transferred is generally low and binding to calcium in milk may limit absorption by the infant, the American Academy of Pediatrics considers it compatible with breastfeeding for short-term use. However, caution is advised, and the infant should be monitored for potential adverse effects.

Infant Risk: L3 (Moderately safe). Potential risks include theoretical tooth discoloration (though less likely with short-term exposure), diarrhea, and candidiasis in the infant. Benefits to the mother should outweigh potential risks to 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 enamel hypoplasia, as well as reversible inhibition of bone growth. Use in children 8 years and older should be carefully considered and limited to situations where other agents are ineffective or contraindicated.

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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 such as gastrointestinal disturbances or photosensitivity. Monitor renal and hepatic function if prolonged therapy is anticipated, although doxycycline's primary non-renal elimination makes it relatively safe in renal impairment.

Clinical Information

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Clinical Pearls

  • Always instruct patients to take doxycycline with a full glass of water and to remain upright for at least 30-60 minutes to prevent esophageal irritation and ulceration.
  • Advise patients about significant photosensitivity and the need for strict sun protection (sunscreen, protective clothing, avoiding peak sun hours).
  • Remind patients to avoid concomitant use of antacids, iron, calcium, and dairy products within 2-3 hours of taking doxycycline due to chelation and reduced absorption.
  • Be aware of the risk of benign intracranial hypertension (pseudotumor cerebri), especially in young, obese females, and counsel patients to report severe headache or vision changes immediately.
  • Doxycycline is unique among tetracyclines for its primary non-renal elimination, making it a preferred tetracycline in patients with renal impairment.
  • Despite its broad-spectrum activity, doxycycline is a bacteriostatic agent. Ensure appropriate duration of therapy to prevent relapse.
  • Counsel female patients on the potential for decreased efficacy of oral contraceptives and the need for a backup birth control method.
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Alternative Therapies

  • Other tetracyclines (e.g., minocycline, tetracycline)
  • Macrolides (e.g., azithromycin, erythromycin - for certain infections like chlamydia)
  • Beta-lactam antibiotics (e.g., penicillin, amoxicillin - for susceptible bacterial infections)
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin - for specific bacterial infections)
  • Clindamycin (for anaerobic infections or skin/soft tissue infections)
  • Topical retinoids or oral isotretinoin (for severe acne, but contraindicated with doxycycline)
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Cost & Coverage

Average Cost: $50 - $300+ per 30 tablets (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 is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 the medication taken, the amount, and the time it happened.