Doxycycline Hyclate 150mg DR Tb

Manufacturer SOLCO HEALTHCARE 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
Antibiotic
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Pharmacologic Class
Tetracycline Antibiotic
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Pregnancy Category
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 that treats many different kinds of bacterial infections, such as infections of the lungs, urinary tract, eyes, and skin. It works by stopping the growth of bacteria. It can also be used to treat severe acne, 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 steps:

1. Follow Your Doctor's Orders: Take your medication exactly as prescribed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Continue Taking as Directed: Even if you start to feel better, continue taking your medication as directed by your doctor or healthcare provider.
3. Food and Medication: 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.
4. Avoid Interactions with Calcium: It's best to avoid taking your medication at the same time as milk, dairy products, or other calcium-containing products, as this may reduce the medication's effectiveness. If you have questions, consult with your doctor or pharmacist.
5. Stay Hydrated: Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
6. Avoid Certain Medications and Supplements: Do not take the following medications or supplements within 2 hours of taking your medication: bismuth (Pepto-Bismol), calcium, iron, magnesium, zinc, multivitamins with minerals, colestipol, cholestyramine, didanosine, or antacids.
7. Take with Water: Take your medication with a full glass of water.
8. Avoid Lying Down: 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.
9. Swallow Whole: Swallow your medication whole, without chewing or crushing it.
10. Special Instructions for Tablets: If your doctor instructs you to break your tablet, you can do so. You can 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 with hot applesauce, and swallow the mixture immediately. Do not store the mixture for later use.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture.
Keep your medication in a dry place, away from the bathroom.
Do not take your medication if it is outdated or has not been stored properly.

What to Do if You Miss a Dose

Take a missed dose 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.
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Lifestyle & Tips

  • Take with a full glass of water (at least 8 ounces) to prevent irritation of the esophagus.
  • Remain upright for at least 30 minutes (preferably 1 hour) after taking the medication to prevent esophageal irritation and ulceration.
  • Avoid taking with dairy products (milk, yogurt, cheese), antacids (e.g., Tums, Maalox), iron supplements, or multivitamins containing minerals. If necessary, separate administration by at least 2-3 hours.
  • Avoid prolonged exposure to sunlight or tanning beds, as doxycycline can make your skin more sensitive to the sun (photosensitivity). Use sunscreen and wear protective clothing.
  • Complete the full course of medication as prescribed, even if symptoms improve, to prevent antibiotic resistance and recurrence of infection.
  • Do not share this medication with others, even if they have similar symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: 150 mg orally once daily (for certain indications like rosacea, acne, or specific infections)
Dose Range: 100 - 200 mg

Condition-Specific Dosing:

General Infections: 100 mg orally every 12 hours on day 1, then 100 mg orally once daily or 50 mg orally every 12 hours. For severe infections, 100 mg orally every 12 hours.
Rosacea (delayed-release): 150 mg orally once daily or 40 mg (30 mg immediate-release, 10 mg delayed-release) orally once daily.
Malaria Prophylaxis: 100 mg orally once daily, starting 1-2 days before travel to endemic area, continuing daily during travel and for 4 weeks after leaving.
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Pediatric Dosing

Neonatal: Not established (generally contraindicated due to tooth discoloration)
Infant: Not established (generally contraindicated due to tooth discoloration)
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., Rocky Mountain Spotted Fever, Anthrax): 2.2 mg/kg orally every 12 hours on day 1, then 2.2 mg/kg orally once daily or 1.1 mg/kg orally every 12 hours. Max 100 mg/dose.
Adolescent: For children 8 years and older: 2.2 mg/kg orally every 12 hours on day 1, then 2.2 mg/kg orally once daily or 1.1 mg/kg orally every 12 hours. Max 100 mg/dose. For severe infections, up to 4.4 mg/kg/day (max 200 mg/day). For acne/rosacea, adult dosing may apply.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed (excretion is primarily non-renal)
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis; no supplemental dose needed.

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: Use with caution; monitor for signs of hepatotoxicity.
Severe: Use with caution; monitor for signs of hepatotoxicity. Consider lower doses or alternative agents if possible.

Pharmacology

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Mechanism of Action

Doxycycline is a bacteriostatic 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 prevents the addition of new amino acids to the growing peptide chain, leading to inhibition of bacterial growth and replication.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100%
Tmax: 2-4 hours (for standard formulations; DR may vary slightly)
FoodEffect: Absorption of doxycycline is not significantly affected by food, unlike other tetracyclines. However, dairy products, antacids containing aluminum, calcium, or magnesium, and iron preparations can chelate doxycycline and significantly impair its absorption. Delayed-release formulations may be designed to mitigate some GI upset when taken with food.

Distribution:

Vd: 0.7 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (low concentrations in CSF, but increases with meningeal inflammation)

Elimination:

HalfLife: 16-22 hours (can be prolonged in severe hepatic impairment)
Clearance: Not readily quantifiable as it's primarily non-renal excretion.
ExcretionRoute: Primarily fecal (via bile), with a smaller portion excreted renally (glomerular filtration).
Unchanged: Approximately 40% excreted unchanged in urine and feces.
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Pharmacodynamics

OnsetOfAction: Rapid (antibacterial effects within hours)
PeakEffect: Correlates with Tmax (2-4 hours)
DurationOfAction: Due to its long half-life, 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 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 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 headaches 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, consult 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, blurred vision, or vision changes (could be signs of increased pressure in the brain, pseudotumor cerebri).
  • Severe diarrhea that is watery or bloody (could be a sign of C. difficile infection).
  • Yellowing of the skin or eyes, dark urine, or severe stomach pain (signs of liver problems).
  • New or worsening rash, hives, swelling of the face/lips/tongue, or difficulty breathing (signs of an allergic reaction).
  • Severe sunburn or skin blistering after sun exposure.
  • Sore throat, fever, or other signs of a new infection (superinfection).
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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 disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to ensure it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or adjust the dosage 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 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.

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 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 a condom, 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 years old, there may be exceptions. Consult with your doctor to determine the best course of treatment.

In rare cases, adults may also experience tooth discoloration, which 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 the 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
  • Hepatotoxicity (rare, 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

  • Oral retinoids (e.g., isotretinoin, acitretin): Increased risk of pseudotumor cerebri (benign intracranial hypertension).
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Major Interactions

  • Antacids (aluminum, calcium, magnesium), iron preparations, bismuth subsalicylate, zinc supplements: Form insoluble chelates, significantly reducing doxycycline absorption. Separate administration by at least 2-3 hours.
  • Barbiturates (e.g., phenobarbital), carbamazepine, phenytoin: Induce hepatic enzymes, increasing doxycycline metabolism and decreasing its half-life and efficacy.
  • Warfarin and other anticoagulants: Doxycycline may potentiate the anticoagulant effect by interfering with vitamin K synthesis or displacing protein-bound anticoagulants. Monitor INR closely.
  • Penicillins: Tetracyclines are bacteriostatic and may interfere with the bactericidal action of penicillins. Avoid concurrent use if possible.
  • Live bacterial vaccines (e.g., oral typhoid vaccine): Doxycycline may reduce the therapeutic effect of the vaccine.
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Moderate Interactions

  • Oral contraceptives: May reduce efficacy of oral contraceptives (though evidence is controversial, advise backup contraception).
  • Methotrexate: Doxycycline may increase methotrexate levels due to competition for renal tubular secretion.
  • Ergot alkaloids: Theoretical risk of increased ergot toxicity.
  • Cyclosporine: Doxycycline may increase cyclosporine levels.

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: To assess baseline kidney health, though doxycycline is primarily non-renally excreted, it's good practice for antibiotic use.

Timing: Prior to initiation, especially in patients with pre-existing renal conditions.

Hepatic function (ALT, AST, bilirubin)

Rationale: To assess baseline liver health, as doxycycline can rarely cause hepatotoxicity, particularly with high doses or in patients with pre-existing liver disease.

Timing: Prior to initiation, especially in patients with pre-existing hepatic conditions.

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Routine Monitoring

Signs of superinfection (e.g., oral thrush, vaginal candidiasis, C. difficile-associated diarrhea)

Frequency: Throughout therapy and for several weeks post-therapy

Target: Absence of new infections

Action Threshold: Development of new or worsening symptoms; consider discontinuation and appropriate treatment.

Photosensitivity reactions (e.g., severe sunburn, rash)

Frequency: Throughout therapy

Target: Absence of severe skin reactions

Action Threshold: Development of severe photosensitivity; advise sun protection, consider discontinuation.

Gastrointestinal upset (nausea, vomiting, esophageal irritation)

Frequency: Throughout therapy

Target: Tolerable GI symptoms

Action Threshold: Persistent or severe GI symptoms; advise taking with food (non-dairy), full glass of water, remaining upright; consider alternative.

Complete Blood Count (CBC)

Frequency: Periodically for prolonged therapy (e.g., >2-3 weeks)

Target: Within normal limits

Action Threshold: Significant abnormalities (e.g., leukopenia, thrombocytopenia); investigate and consider discontinuation.

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Symptom Monitoring

  • Severe headache, blurred vision, diplopia, vision loss (signs of pseudotumor cerebri)
  • Yellowing of skin or eyes, dark urine, abdominal pain (signs of hepatotoxicity)
  • Severe diarrhea, abdominal cramps, fever (signs of C. difficile infection)
  • New or worsening rash, itching, swelling (signs of allergic reaction)
  • Difficulty swallowing, chest pain, heartburn (signs of esophageal irritation)

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 developing fetus. It may also cause reversible inhibition of bone growth. Use only if the potential benefit justifies the potential risk to the fetus (e.g., for life-threatening infections like anthrax or Rocky Mountain Spotted Fever where alternative treatments are not suitable).

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, but tooth discoloration risk is lower than in later trimesters.
Second Trimester: High risk of permanent tooth discoloration and enamel hypoplasia in the fetus.
Third Trimester: High risk of permanent tooth discoloration and enamel hypoplasia in the fetus.
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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, 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 for short-term use. However, caution is advised, and alternative agents may be preferred, especially for long-term therapy.

Infant Risk: Low risk for short-term use; theoretical risk of tooth discoloration and enamel hypoplasia, and inhibition of bone growth. Monitor infant for diarrhea, candidiasis, or rash.
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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. In severe or life-threatening infections (e.g., Rocky Mountain Spotted Fever, Anthrax) where the benefits outweigh the risks and no suitable alternatives exist, it may be used under strict medical supervision. Dosing is weight-based for this age group.

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Geriatric Use

No specific dose adjustment is required based solely on age. However, elderly patients may be more susceptible to adverse effects such as gastrointestinal irritation or photosensitivity. Monitor renal and hepatic function, and consider potential polypharmacy and drug interactions.

Clinical Information

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Clinical Pearls

  • Doxycycline is known for causing esophageal irritation and ulceration. Advise patients to take it with a full glass of water and remain upright for at least 30-60 minutes after administration, especially before bedtime.
  • Photosensitivity is a common side effect. Counsel patients to use sunscreen, wear protective clothing, and avoid prolonged sun exposure or tanning beds while on doxycycline.
  • Unlike other tetracyclines, doxycycline's absorption is less affected by food, but it is still significantly impaired by dairy products, antacids, and iron supplements. Advise patients to separate these by several hours.
  • Doxycycline is a preferred agent for certain atypical infections (e.g., Mycoplasma, Chlamydia, Rickettsia) and for Lyme disease, Rocky Mountain Spotted Fever, and malaria prophylaxis.
  • The delayed-release formulation (DR) is designed to reduce gastrointestinal side effects and may be preferred for patients experiencing significant GI upset with immediate-release forms.
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Alternative Therapies

  • Other tetracyclines (e.g., minocycline, tetracycline)
  • Macrolides (e.g., azithromycin, erythromycin, clarithromycin) for atypical infections or penicillin allergies
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for certain bacterial infections
  • Beta-lactam antibiotics (e.g., penicillins, cephalosporins) depending on the specific bacterial infection and susceptibility.
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Cost & Coverage

Average Cost: Varies widely, typically $30-$150 per 30 tablets
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. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.