Doxycycline Monohydrate 100mg Caps

Manufacturer ZYDUS PHARMACEUTICALS (USA) 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
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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 used to treat many different types of bacterial infections, such as acne, urinary tract infections, respiratory infections, and certain sexually transmitted diseases. 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, follow your doctor's instructions carefully. Read all the information provided with your prescription 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

Check with your pharmacist to see if you should take your medication with food or on an empty stomach.
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.
To minimize the risk of throat irritation, do not lie down after taking your medication. Ask your pharmacist how long you should wait before lying down.

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 almost 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 to make up for a missed dose.
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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 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.
  • 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, even if you start feeling better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • If you are taking it for acne, it may take several weeks to see the full benefit.

Dosing & Administration

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Adult Dosing

Standard Dose: 100 mg orally every 12 hours on day 1, then 100 mg orally once daily or 50 mg orally every 12 hours.
Dose Range: 50 - 200 mg

Condition-Specific Dosing:

Severe Infections: 100 mg orally every 12 hours
Acne Vulgaris: 20 mg orally twice daily or 50 mg orally once daily
Malaria Prophylaxis: 100 mg orally once daily, starting 1-2 days before travel and continuing for 4 weeks after return
Lyme Disease: 100 mg orally twice daily for 10-21 days
Chlamydia Trachomatis: 100 mg orally twice daily for 7 days
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Pediatric Dosing

Neonatal: Not established (contraindicated in children < 8 years due to tooth discoloration and enamel hypoplasia)
Infant: Not established (contraindicated in children < 8 years)
Child: For children 8 years and older and weighing less than 45 kg: 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. For children 8 years and older and weighing 45 kg or more: Adult dose.
Adolescent: Adult dose (100 mg orally every 12 hours on day 1, then 100 mg orally once daily or 50 mg orally every 12 hours)
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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: No adjustment needed; not significantly removed by hemodialysis or peritoneal dialysis.

Hepatic Impairment:

Mild: Use with caution; monitor for signs of hepatotoxicity.
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 mRNA-ribosome complex. This action prevents the addition of new amino acids to the growing peptide chain, leading to inhibition of bacterial growth.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 1.5-4 hours
FoodEffect: Food and milk products have a minimal effect on the absorption of doxycycline monohydrate, unlike other tetracyclines. However, absorption may be slightly reduced by antacids containing aluminum, calcium, or magnesium, and by iron preparations.

Distribution:

Vd: 0.75 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (penetrates CSF poorly, but levels increase with inflamed meninges)

Elimination:

HalfLife: 16-22 hours (range 12-24 hours)
Clearance: Not available (primarily non-renal excretion)
ExcretionRoute: Fecal (via intestinal secretion) and urinary excretion (minor route).
Unchanged: Approximately 40% (renal), significant portion via fecal route.
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Pharmacodynamics

OnsetOfAction: Rapid (within hours of first dose)
PeakEffect: Within 2-4 hours of administration
DurationOfAction: 24 hours (allows for once or twice 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 experience 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

Antibiotic-Associated Diarrhea

Diarrhea is a common side effect of antibiotics. In rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. This condition can lead to a life-threatening bowel problem. 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 a headache or vision problems, such as blurred vision, double vision, or loss of vision, contact your doctor right away.

Other Side Effects

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

Diarrhea
Upset stomach
Vomiting
* Decreased appetite

Reporting Side Effects

This is not an exhaustive list of possible 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 persistent diarrhea (especially watery or bloody stools, with or without fever and abdominal cramps) - could be C. difficile infection.
  • Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, unusual tiredness, severe stomach pain, nausea, vomiting.
  • Signs of kidney problems: changes in the amount of urine, swelling in ankles or feet.
  • Severe skin rash, blistering, peeling skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Increased sensitivity to sunlight (severe sunburn, rash).
  • Headache with blurred vision, dizziness, or nausea (signs of benign intracranial hypertension).
  • Difficulty or pain when swallowing, chest pain (esophageal irritation).
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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.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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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 take this medication for longer than prescribed, 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 easy sunburning, inform your doctor promptly.

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions that may affect internal organs. These reactions can be life-threatening. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

If you are using birth control pills or other hormone-based birth control methods, 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 affect bone growth. If taken during pregnancy, it may also cause tooth discoloration in the unborn baby. These changes are irreversible. Other tooth problems have been reported in children taking this medication. Discuss any concerns 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 some cases, adults have also experienced tooth discoloration, which may reverse after stopping the medication and undergoing dental cleaning. Discuss any concerns with your doctor.

If you are pregnant or become pregnant while taking this medication, you may be at risk of harming the unborn baby. Contact your doctor immediately if you are pregnant or suspect you may be pregnant.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Liver damage (rare, but possible with very high doses)

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive; gastric lavage may be considered if ingestion is recent.

Drug Interactions

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Major Interactions

  • Antacids (aluminum, calcium, magnesium): Decreased doxycycline absorption.
  • Iron preparations: Decreased doxycycline absorption.
  • Bismuth subsalicylate: Decreased doxycycline absorption.
  • Oral retinoids (e.g., isotretinoin): Increased risk of pseudotumor cerebri (benign intracranial hypertension).
  • Penicillins: Tetracyclines may interfere with the bactericidal action of penicillins.
  • Warfarin: May potentiate anticoagulant effects (monitor INR).
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Moderate Interactions

  • Barbiturates (e.g., phenobarbital): Decreased doxycycline half-life.
  • Carbamazepine: Decreased doxycycline half-life.
  • Phenytoin: Decreased doxycycline half-life.
  • Oral contraceptives: May reduce efficacy of oral contraceptives (advise backup method).
  • Methotrexate: May increase methotrexate toxicity (monitor).
  • Live bacterial vaccines (e.g., typhoid vaccine): May reduce efficacy of vaccine.
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Minor Interactions

  • Cholestyramine: May decrease 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, as doxycycline is metabolized in the liver.

Timing: Prior to initiation, if clinically indicated.

Renal function tests (RFTs)

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

Timing: Prior to initiation, if clinically indicated.

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Routine Monitoring

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

Frequency: Throughout therapy and for several weeks post-therapy

Target: Absence of new infections

Action Threshold: If symptoms occur, discontinue doxycycline and initiate appropriate therapy.

INR (International Normalized Ratio)

Frequency: Regularly, especially when co-administered with warfarin

Target: Therapeutic range for indication

Action Threshold: Adjust warfarin dose as needed to maintain target INR.

Photosensitivity reaction

Frequency: Daily patient assessment

Target: Absence of severe sunburn-like reactions

Action Threshold: Advise sun protection; discontinue if severe reaction occurs.

Esophageal irritation/ulceration

Frequency: Daily patient assessment

Target: Absence of dysphagia, odynophagia, retrosternal pain

Action Threshold: Advise proper administration (upright, full glass of water); discontinue if severe symptoms occur.

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Symptom Monitoring

  • Diarrhea (especially severe or persistent, suggestive of C. difficile)
  • Nausea, vomiting, abdominal pain
  • Photosensitivity (severe sunburn, rash after sun exposure)
  • Esophageal irritation (difficulty swallowing, painful swallowing, chest pain)
  • Headache, blurred vision (signs of benign intracranial hypertension)
  • Yellowing of skin/eyes, dark urine (signs of liver dysfunction)
  • New or worsening infection symptoms

Special Patient Groups

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Pregnancy

Category D. Doxycycline can cause permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia, and reversible inhibition of bone growth in the fetus when administered during pregnancy. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for tooth discoloration and bone growth effects, though less pronounced than later trimesters.
Second Trimester: Significant risk of permanent tooth discoloration and enamel hypoplasia, and reversible inhibition of bone growth.
Third Trimester: Significant risk of permanent tooth discoloration and enamel hypoplasia, and reversible inhibition of bone growth.
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Lactation

Doxycycline is excreted into breast milk. While the amount is generally low and calcium in milk may chelate the drug, potential risks to the infant include tooth discoloration and inhibition of bone growth. The American Academy of Pediatrics considers tetracyclines compatible with breastfeeding with caution. Use with caution; monitor infant for diarrhea, candidiasis, and potential tooth staining (though unlikely with typical exposure).

Infant Risk: L3 (Moderate risk)
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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, and reversible inhibition of bone growth. In children 8 years and older, use with caution and only when other antibiotics are not appropriate or effective.

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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 superinfections. Monitor renal and hepatic function if clinically indicated.

Clinical Information

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Clinical Pearls

  • Doxycycline monohydrate is generally better tolerated gastrointestinally than doxycycline hyclate.
  • Always advise patients to take with a full glass of water and remain upright for at least 30 minutes to prevent esophageal ulceration.
  • Emphasize sun protection due to photosensitivity.
  • Unlike other tetracyclines, doxycycline can be used in patients with renal impairment without dose adjustment.
  • It is a common choice for Lyme disease, Rocky Mountain spotted fever, and malaria prophylaxis.
  • For acne, low-dose doxycycline (e.g., 20 mg twice daily or 50 mg once daily) is often used for its anti-inflammatory properties rather than its antimicrobial effect.
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Alternative Therapies

  • Azithromycin (for chlamydia, respiratory infections)
  • Amoxicillin (for Lyme disease, respiratory infections)
  • Ceftriaxone (for Lyme disease, certain STIs)
  • Minocycline (another tetracycline, often used for acne)
  • Erythromycin (for certain atypical infections)
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Cost & Coverage

Average Cost: Varies widely (e.g., $20 - $100+) per 30 capsules (100mg)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.