Doxycycline Monohydrate 50mg Caps

Manufacturer GAVIS PHARMACEUTICALS Active Ingredient Doxycycline Tablets and Capsules(doks i SYE kleen) Pronunciation doks i SYE kleen
It is used to treat pimples (acne).It is used to treat or prevent bacterial infections.It is used to prevent malaria.It is used to treat swelling of the tissue around the teeth (periodontitis). It is used with scaling and root planing.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antibiotic
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Pharmacologic Class
Tetracycline Antibiotic; Protein Synthesis Inhibitor (30S ribosomal subunit)
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Pregnancy Category
Category D
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FDA Approved
Jan 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 various bacterial infections, including skin infections like acne and rosacea, respiratory infections, urinary tract infections, and certain sexually transmitted infections. 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 get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.

Special Instructions for Taking Your Medication

Some medications need to 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 also important 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 any questions, be sure to ask your doctor or pharmacist.

Additional Tips for Taking Your Medication

Drink plenty of non-caffeinated liquids, unless your doctor has advised you to limit your fluid intake. To avoid interactions with other substances, do not take the following within 2 hours of your medication:
- Bismuth (Pepto-Bismol)
- Calcium
- Iron
- Magnesium
- Zinc
- Multivitamins with minerals
- Colestipol
- Cholestyramine
- Didanosine
- Antacids

Take your medication with a full glass of water, and avoid lying down after taking it to minimize the risk of throat irritation. Ask your pharmacist how long you should wait before lying down after taking your medication.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:
- Store it at room temperature, protected from light
- Keep it in a dry place, away from the bathroom
- Do not take the medication if it is past its expiration date
- Do not take the medication 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. However, if it's close to the time for your next dose, skip the missed dose and return to 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 (or 1 hour if possible) after taking the medication to prevent esophageal irritation.
  • Avoid taking antacids, iron supplements, or dairy products within 2-3 hours before or after taking doxycycline, as they can interfere with its 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 full course of medication as prescribed, even if you start feeling better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • If using for acne/rosacea, it may take several weeks to see full effects.

Dosing & Administration

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Adult Dosing

Standard Dose: For acne/rosacea: 50 mg once or twice daily. For other infections: 100 mg every 12 hours on day 1, then 100 mg once daily or 50 mg every 12 hours.
Dose Range: 50 - 200 mg

Condition-Specific Dosing:

Acne Vulgaris: 50 mg once or twice daily
Rosacea (inflammatory lesions): 50 mg once or twice daily (sub-antimicrobial dose often 20mg BID or 40mg QD, but 50mg is also used)
General Infections (e.g., respiratory, urinary, skin): 100 mg every 12 hours on day 1, then 100 mg once daily or 50 mg every 12 hours for duration of treatment
Malaria Prophylaxis: 100 mg once daily
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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 established for children under 8 years of age. For children 8 years and older: 4.4 mg/kg/day divided into 1-2 doses (max 200 mg/day).
Adolescent: Same as adult dosing for children 8 years and older, typically 100 mg every 12 hours on day 1, then 100 mg once daily or 50 mg every 12 hours.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific adjustment needed, 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 attachment of aminoacyl-tRNA to the ribosomal acceptor site. This action prevents the addition of amino acids to the growing peptide chain, ultimately inhibiting bacterial growth and replication. It also exhibits anti-inflammatory properties at sub-antimicrobial doses.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 1.5-4 hours
FoodEffect: Food and milk products may slightly decrease absorption, but the monohydrate formulation is generally less affected than the hyclate. Taking with food can reduce gastrointestinal upset.

Distribution:

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

Elimination:

HalfLife: 16-22 hours
Clearance: Not readily available as a single rate, but primarily via non-renal routes.
ExcretionRoute: Primarily fecal (via bile) and urinary excretion of unchanged drug.
Unchanged: Approximately 40% excreted in urine and 60% in feces.
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Pharmacodynamics

OnsetOfAction: Within hours (bacteriostatic 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

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ 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
Rapid heartbeat
Difficulty urinating or changes in urine output
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Throat irritation
Difficulty swallowing
Muscle or joint pain
Rapid breathing
Flushing
Severe dizziness or fainting
Changes in skin color
Vaginal itching or discharge
Diarrhea (common with antibiotics), especially if severe or accompanied by:
+ Stomach pain
+ Cramps
+ Watery, bloody, or loose stools
+ Note: Rarely, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) may occur, which can lead to a life-threatening bowel problem. If you experience any of these symptoms, contact your doctor immediately.

Other Possible Side Effects

Most people experience no side effects or only mild ones. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor:

Diarrhea
Upset stomach
Vomiting
Decreased appetite

Reporting Side Effects

This is not an exhaustive list of potential 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 stomach pain, watery or bloody diarrhea (may indicate C. difficile infection)
  • Severe skin rash, blistering, or peeling skin
  • Signs of liver problems (e.g., dark urine, yellowing of skin or eyes, severe nausea/vomiting, loss of appetite)
  • Severe headache, blurred vision, double vision, or vision loss (signs of increased intracranial pressure)
  • Difficulty swallowing or painful swallowing
  • Unusual bleeding or bruising
  • Signs of a new infection (e.g., fever, sore throat, chills)
  • Allergic reaction (e.g., hives, difficulty breathing, swelling of face/lips/tongue/throat)
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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 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.
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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.

Be aware that this medication can increase your sensitivity to the sun, making you more prone to sunburn. Take necessary precautions when exposed to sunlight, 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 conditions. 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 contraception, 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 can cause permanent tooth discoloration, turning teeth yellow-gray brown. Similarly, if taken during certain stages of pregnancy, it can affect the unborn baby's teeth. This tooth discoloration is irreversible. Additionally, this medication may lead to other tooth problems and affect bone growth in these individuals. If you have concerns, discuss them with your doctor.

Generally, this medication is not recommended for children under 8 years old, except in specific circumstances. Consult with your doctor to determine the best course of treatment.

In some cases, adults have also experienced tooth discoloration, which has been reported to reverse after stopping the medication and undergoing dental cleaning. If you have concerns, discuss them with your doctor.

If you are pregnant or become pregnant while taking this medication, it is essential to inform your doctor immediately, as it may harm the unborn baby.
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Overdose Information

Overdose Symptoms:

  • Severe nausea
  • Vomiting
  • Diarrhea
  • Signs of liver or kidney toxicity (rare at typical overdose levels)

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive, including gastric lavage if appropriate, and symptomatic management.

Drug Interactions

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Major Interactions

  • Antacids (containing aluminum, calcium, magnesium): Decreased doxycycline absorption.
  • Iron preparations (oral): Decreased doxycycline absorption.
  • Bismuth subsalicylate: Decreased doxycycline absorption.
  • Oral retinoids (e.g., Isotretinoin, Acitretin): Increased risk of pseudotumor cerebri (benign intracranial hypertension).
  • Penicillins: May antagonize the bactericidal effect of penicillin (due to bacteriostatic action of doxycycline).
  • Live bacterial vaccines (e.g., Typhoid, Cholera): May decrease vaccine efficacy.
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Moderate Interactions

  • Oral Contraceptives: May decrease efficacy of oral contraceptives (though evidence is weak and controversial).
  • Warfarin: May enhance anticoagulant effect (monitor INR).
  • Methotrexate: May increase methotrexate toxicity.
  • Ergot alkaloids: Increased risk of ergotism.
  • Barbiturates, Carbamazepine, Phenytoin: May decrease doxycycline half-life due to enzyme induction.
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Minor Interactions

  • Digoxin: May increase digoxin levels in some patients (rare).

Monitoring

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Baseline Monitoring

Liver Function Tests (LFTs)

Rationale: To establish baseline in patients with pre-existing hepatic impairment or those at risk for hepatotoxicity.

Timing: Prior to initiation, if indicated.

Renal Function Tests (RFTs)

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

Timing: Prior to initiation, 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, candidiasis)

Frequency: Daily/As needed

Target: Absence or mild, manageable symptoms

Action Threshold: Severe GI upset, severe photosensitivity reaction, signs of C. difficile infection, or other intolerable side effects warrant re-evaluation.

INR (if on warfarin)

Frequency: Regularly, especially at initiation or dose change

Target: Therapeutic range for indication

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

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Heartburn/Esophageal irritation
  • Photosensitivity (severe sunburn-like reaction)
  • Rash
  • Headache
  • Blurred vision or visual disturbances (signs of pseudotumor cerebri)
  • Vaginal yeast infection (candidiasis)
  • Oral thrush

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 inhibition of bone growth in the fetus.

Trimester-Specific Risks:

First Trimester: Potential for skeletal and limb abnormalities, though data are limited and conflicting. Generally avoided.
Second Trimester: High risk of permanent tooth discoloration (enamel hypoplasia) and inhibition of bone growth in the fetus.
Third Trimester: High risk of permanent tooth discoloration (enamel hypoplasia) and inhibition of bone growth in the fetus.
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Lactation

Doxycycline is excreted into breast milk. While generally considered compatible with breastfeeding for short-term use (L3), caution is advised. Long-term or repeated use should be avoided due to theoretical concerns of tooth discoloration and bone growth effects in the infant.

Infant Risk: Low to moderate risk for short-term use. Theoretical risk of tooth discoloration and inhibition of bone growth in the infant, though actual reported cases are rare. Monitor infant for diarrhea or 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 inhibition of bone growth. Use in children 8 years and older should be carefully weighed against potential risks.

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Geriatric Use

No specific dose adjustment is generally required for elderly patients. However, caution should be exercised in patients with pre-existing hepatic impairment. Elderly patients may be more susceptible to adverse effects like esophageal irritation or photosensitivity.

Clinical Information

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Clinical Pearls

  • Always advise patients to take doxycycline with a full glass of water and to remain upright for at least 30 minutes to minimize the risk of esophageal irritation and ulceration.
  • Educate patients thoroughly about photosensitivity and the importance of sun protection (sunscreen, protective clothing, avoiding peak sun hours).
  • Remind patients to avoid dairy products, antacids, and iron supplements for several hours before and after taking doxycycline to ensure optimal absorption.
  • For acne/rosacea, emphasize that the effects are often anti-inflammatory rather than purely antimicrobial at lower doses, and it may take weeks to see improvement.
  • Doxycycline is a good option for patients with renal impairment as it is primarily eliminated non-renally.
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Alternative Therapies

  • Other tetracyclines (e.g., Minocycline, Tetracycline)
  • Macrolide antibiotics (e.g., Azithromycin, Erythromycin, Clarithromycin) for susceptible infections
  • Fluoroquinolone antibiotics (e.g., Ciprofloxacin, Levofloxacin) for susceptible infections
  • Beta-lactam antibiotics (e.g., Penicillins, Cephalosporins) for susceptible infections
  • For acne: Topical retinoids, topical antibiotics (e.g., clindamycin, erythromycin), benzoyl peroxide, oral isotretinoin (for severe acne).
  • For rosacea: Topical metronidazole, azelaic acid, ivermectin cream.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$100+ per 30 capsules (50mg)
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.