Doxycycline Hyclate 200mg DR Tabs

Manufacturer TEVA PHARMACEUTICALS USA 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
Antibiotic, Tetracycline
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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
Jan 1970
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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 diseases. It works by stopping the growth of bacteria. This delayed-release tablet is designed to release the medicine slowly to help 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 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 well.

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 advises 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, as this can help 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 can do so.
You can also sprinkle the contents of the tablet onto 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 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 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'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 before or after taking doxycycline, as they can reduce its absorption.
  • Avoid excessive exposure to sunlight or artificial UV light (tanning beds) and use sunscreen (SPF 30+) and protective clothing, as doxycycline can cause severe sunburn (photosensitivity).
  • Do not lie down immediately after taking the medication.
  • Complete the full course of medication as prescribed, even if symptoms improve, to prevent resistance and recurrence of infection.
  • 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 certain infections or as a loading dose, or 100 mg every 12 hours for more severe infections.
Dose Range: 100 - 200 mg

Condition-Specific Dosing:

General Infections: 200 mg on the first day (as 100 mg every 12 hours), followed by 100 mg daily. For more severe infections, 100 mg every 12 hours.
Anthrax (post-exposure prophylaxis): 100 mg every 12 hours for 60 days.
Malaria Prophylaxis: 100 mg once daily, starting 1-2 days before travel, continuing daily during travel, and for 4 weeks after leaving the malarious area.
Uncomplicated Gonorrhea: 100 mg orally twice daily for 7 days (as part of combination therapy).
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Pediatric Dosing

Neonatal: Not established (generally contraindicated due to tooth discoloration and bone growth effects)
Infant: Not established (generally contraindicated)
Child: Generally not recommended for children under 8 years of age due to risk of permanent tooth discoloration and enamel hypoplasia. If used for severe or life-threatening infections (e.g., anthrax, Rocky Mountain spotted fever) where benefits outweigh risks: 2.2 mg/kg body weight divided into two doses on the first day, followed by 2.2 mg/kg given as a single daily dose or divided into two doses on subsequent days. Max 100 mg/dose.
Adolescent: Same as adult dosing for children weighing over 45 kg.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed (doxycycline is primarily eliminated via non-renal pathways)
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. Dose reduction may be considered, but specific guidelines are lacking.

Pharmacology

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Mechanism of Action

Doxycycline is a broad-spectrum tetracycline antibiotic. It exerts its bacteriostatic effect by inhibiting bacterial protein synthesis. It reversibly binds to the 30S ribosomal subunit, blocking the binding of aminoacyl-tRNA to the mRNA-ribosome complex, thereby preventing the addition of new amino acids to the growing peptide chain.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100% (oral)
Tmax: 2-4 hours (for delayed-release formulations, may be slightly longer than immediate-release)
FoodEffect: Absorption is not significantly affected by food or milk, but it's recommended to take with plenty of water to reduce esophageal irritation. Dairy products, antacids, and iron preparations can impair absorption.

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
Clearance: Not readily available, but primarily non-renal.
ExcretionRoute: Fecal (via intestinal secretion) and renal (glomerular filtration). Approximately 40% excreted in urine and 60% in feces.
Unchanged: High percentage (primarily eliminated unchanged)
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Pharmacodynamics

OnsetOfAction: Rapid (within hours for antibacterial effect)
PeakEffect: Correlates with Tmax (2-4 hours)
DurationOfAction: 24 hours (due to long half-life, allowing once-daily dosing)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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, seek medical attention right away.

Other Side Effects

Most people do not experience significant side effects or only have mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

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 headache with blurred vision or vision changes (signs of increased intracranial pressure)
  • Severe, watery diarrhea or bloody stools (may be a sign of C. difficile infection)
  • New or worsening skin rash, blistering, or peeling skin
  • Yellowing of the skin or eyes (jaundice)
  • Unusual bruising or bleeding
  • Severe stomach pain or cramping
  • Difficulty swallowing or painful swallowing
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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 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, over-the-counter, natural products, and vitamins) and health problems 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.
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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.

Be aware that this medication can increase your sensitivity to the sun, making you more prone to sunburn. Take necessary precautions when spending time outdoors, and inform your doctor if you experience any unusual sunburn or sensitivity.

There is a risk of severe skin reactions associated with this medication, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can be life-threatening and may also affect internal organs. Seek immediate medical attention if you experience any 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 birth control methods, you should be aware that this medication may reduce their effectiveness. Consider using an additional form of birth control, such as a condom, to prevent pregnancy.

In children under 8 years old, this medication can cause permanent tooth discoloration, turning teeth yellow-gray brown. This can also occur in unborn babies if the mother takes the medication during certain stages of pregnancy. Other tooth problems and effects on bone growth have been reported in children taking this medication. If you have concerns, discuss them with your doctor.

Note that this medication is not typically recommended for children under 8 years old, except in exceptional circumstances. Your doctor will assess the potential benefits and risks of treatment in these cases.

Tooth discoloration has also been reported in adults taking this medication, but this effect is usually reversible after stopping the medication and undergoing dental cleaning. If you have any concerns, consult 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
  • Liver damage (rare)
  • Kidney damage (rare)

What to Do:

Seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222. Treatment is generally supportive and symptomatic. Gastric lavage may be considered if ingestion is recent.

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.
  • Oral contraceptives: May reduce efficacy of oral contraceptives (breakthrough bleeding, unintended pregnancy).
  • Warfarin: Potentiation of anticoagulant effect (monitor INR).
  • Penicillins: May interfere with the bactericidal action of penicillin (avoid concomitant use).
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Moderate Interactions

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

  • Cholestyramine: May reduce doxycycline absorption (separate administration).

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease or for prolonged therapy.

Timing: Before initiating therapy, if clinically indicated.

Renal function tests (RFTs)

Rationale: To assess baseline renal function, though doxycycline is generally safe in renal impairment.

Timing: Before initiating therapy, if clinically indicated.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily/as clinically indicated

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, dizziness)

Frequency: Daily/as clinically indicated

Target: Absence or mild, tolerable symptoms

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

INR (for patients on warfarin)

Frequency: Regularly, especially at initiation and dose changes

Target: Therapeutic range for warfarin

Action Threshold: Elevated INR 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 infection)
  • New or worsening rash, severe sunburn reaction (photosensitivity)
  • Difficulty swallowing, chest pain, or irritation (esophageal irritation)
  • Yellowing of skin or eyes (jaundice, liver dysfunction)

Special Patient Groups

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Pregnancy

Category D. Doxycycline can cause permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia in the fetus if used during the second and third trimesters. It can also cause reversible inhibition of bone growth. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided due to potential for teratogenicity, though risk is lower than later trimesters for dental/bone effects.
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

L3 (Moderately Safe). Doxycycline is excreted into breast milk. While the amount is generally low and calcium in milk may chelate the drug, theoretical concerns exist for tooth discoloration and inhibition of bone growth in the nursing infant, especially with long-term or repeated use. Monitor infant for diarrhea, candidiasis, and tooth discoloration. Short-term use may be acceptable; consider alternative if prolonged therapy is needed.

Infant Risk: Low to moderate risk of tooth discoloration, enamel hypoplasia, or inhibition of bone growth, especially with prolonged exposure. Monitor for GI upset (diarrhea, thrush).
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Pediatric Use

Generally contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration and enamel hypoplasia. However, it may be used in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted fever) where the benefits outweigh the risks. Close monitoring is essential.

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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 esophageal irritation or C. difficile-associated diarrhea. Monitor renal and hepatic function if pre-existing conditions exist.

Clinical Information

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Clinical Pearls

  • Doxycycline Hyclate delayed-release formulations are designed to reduce gastrointestinal irritation, but taking with plenty of water and remaining upright is still crucial.
  • Photosensitivity is a common and potentially severe side effect; advise strict sun protection.
  • Always complete the full course of therapy to prevent antibiotic resistance.
  • Doxycycline is a preferred agent for certain atypical infections (e.g., Mycoplasma, Chlamydia, Rickettsia, Lyme disease).
  • Despite being a tetracycline, doxycycline is generally safe in patients with renal impairment as it is primarily eliminated via non-renal pathways.
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Alternative Therapies

  • Azithromycin (for atypical pneumonia, chlamydia)
  • Amoxicillin (for Lyme disease, certain bacterial infections)
  • Ciprofloxacin (for anthrax, severe infections)
  • Tetracycline (older tetracycline, more GI side effects)
  • Minocycline (another tetracycline, often used for acne, but higher risk of CNS side effects)
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Cost & Coverage

Average Cost: Varies widely ($30 - $300+) per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 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 this medication, consult 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 overdose, including the medication taken, the amount, and the time it occurred.