Doxycycline Monohydrate 50mg Tabs

Manufacturer LANNETT 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 urinary tract infections, acne, gum disease, chlamydia, and certain skin 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 ensure you get the most out of your medication, follow these guidelines:

Take your medication exactly as directed by your doctor. Read all the information provided and follow the instructions carefully.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
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 best to avoid taking your medication at the same time as milk, dairy products, or other calcium-containing foods, as this may reduce its 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 or supplements within 2 hours of taking your prescribed medication:
Bismuth (Pepto-Bismol)
Calcium
Iron
Magnesium
Zinc
Multivitamins with minerals
Colestipol
Cholestyramine
Didanosine
Antacids

Administration Instructions

Take your medication with a full glass of water.
Avoid lying 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.

Storage and Disposal

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.

Missing 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 (8 ounces) to prevent esophageal irritation. Remain upright for at least 30 minutes (preferably 1 hour) after taking, especially before bedtime.
  • Avoid lying down for at least 30 minutes after taking.
  • Avoid taking antacids, iron supplements, or products containing calcium (like milk or dairy products) within 2-3 hours before or after taking doxycycline, as they can reduce its absorption.
  • Protect yourself from the sun and artificial UV light (tanning beds) while taking this medication and for several days after, as it can make your skin much more sensitive to sunlight (photosensitivity). Use sunscreen, wear protective clothing, and avoid prolonged sun exposure.
  • Complete the full course of medication as prescribed, even if you start feeling better. Stopping early can lead to resistant bacteria.
  • If you are taking oral contraceptives, use an additional non-hormonal birth control method (like condoms) while taking doxycycline and for 7 days after, as it may reduce the effectiveness of birth control pills.

Dosing & Administration

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Adult Dosing

Standard Dose: 50 mg to 100 mg orally every 12 hours or 100 mg orally once daily, depending on indication.
Dose Range: 50 - 200 mg

Condition-Specific Dosing:

Acne Vulgaris (moderate to severe): 50 mg orally once daily or 20 mg orally twice daily (sub-antimicrobial dose)
Rosacea: 20 mg orally twice daily or 40 mg once daily (modified-release, sub-antimicrobial dose)
Lyme Disease (early): 100 mg orally twice daily for 10-21 days
Chlamydia trachomatis: 100 mg orally twice daily for 7 days
Malaria Prophylaxis: 100 mg orally once daily, starting 1-2 days before travel and continuing for 4 weeks after leaving endemic area
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Pediatric Dosing

Neonatal: Not recommended due to risk of tooth discoloration and enamel hypoplasia.
Infant: Not recommended for children under 8 years due to risk of tooth discoloration and enamel hypoplasia.
Child: For children 8 years and older: 2-4 mg/kg/day orally divided every 12-24 hours, up to a maximum of 100 mg/dose or 200 mg/day. For severe infections, up to 4 mg/kg/day.
Adolescent: Same as adult dosing for adolescents 8 years and older and weighing >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 or peritoneal dialysis. No dose adjustment needed.

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: No specific adjustment recommended, but use with caution.
Severe: Use with caution; monitor for signs of hepatotoxicity. Doxycycline is primarily eliminated via non-renal pathways, but hepatic impairment could theoretically affect its elimination.

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 attachment 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: 1.5-4 hours
FoodEffect: Absorption is not significantly affected by food or milk, unlike other tetracyclines. However, absorption can be impaired by antacids containing aluminum, calcium, or magnesium, and by iron preparations.

Distribution:

Vd: 0.7 L/kg (widely distributed into body tissues and fluids, including CSF, pleural fluid, ascitic fluid, synovial fluid, and saliva)
ProteinBinding: 80-95%
CnssPenetration: Limited (penetrates CSF poorly, but levels are higher in inflamed meninges)

Elimination:

HalfLife: 16-22 hours (can be prolonged in severe renal impairment, but this does not necessitate dose adjustment due to non-renal elimination)
Clearance: Not available (primarily non-renal excretion)
ExcretionRoute: Primarily excreted in feces via intestinal secretion and bile; a smaller portion is excreted in urine.
Unchanged: Approximately 40% (renal), 60% (fecal)
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Pharmacodynamics

OnsetOfAction: Rapid (antibacterial effects begin shortly after achieving therapeutic concentrations)
PeakEffect: Within 2-4 hours (corresponds to Tmax)
DurationOfAction: Sustained therapeutic levels due to long half-life, allowing 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, or a 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
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 C. diff-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 Possible Side Effects

Like all medications, this drug may cause side effects. Many people do not experience side effects or only have mild ones. If you are bothered by any of the following side effects or if they 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 headache, blurred vision, double vision, or vision loss (signs of pseudotumor cerebri)
  • Severe skin rash, blistering, or peeling (signs of severe skin reaction)
  • Yellowing of skin or eyes, dark urine, severe stomach pain (signs of liver problems)
  • Severe watery diarrhea or bloody stools (signs of C. difficile infection)
  • Difficulty swallowing, painful swallowing, or chest pain (signs of esophageal irritation)
  • Unusual bleeding or bruising
  • Signs of a new infection (e.g., fever, sore throat, persistent cough)
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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. Never start, stop, or change 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 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 necessary precautions when exposed to the sun. If you experience excessive sunburn, inform your doctor.

This drug 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 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). Similarly, if taken during certain stages of pregnancy, it may affect the tooth color of the unborn baby. Other tooth problems and effects on bone growth have also been reported 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 exceptional cases. Your doctor will assess the potential benefits and risks of treatment in these situations.

Adults may also experience tooth discoloration, but this typically reverses after stopping the medication and undergoing dental cleaning. Consult your doctor if you have any concerns.

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 (1-800-222-1222). Treatment is supportive and symptomatic. Gastric lavage may be considered if ingestion is recent.

Drug Interactions

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Major Interactions

  • Isotretinoin (increased risk of pseudotumor cerebri)
  • Acitretin (increased risk of pseudotumor cerebri)
  • Oral Retinoids (e.g., tretinoin, adapalene, tazarotene) (increased risk of pseudotumor cerebri)
  • Live bacterial vaccines (e.g., oral typhoid vaccine) (may reduce vaccine efficacy)
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Moderate Interactions

  • Antacids (aluminum, calcium, magnesium) (decreased doxycycline absorption)
  • Iron preparations (decreased doxycycline absorption)
  • Bismuth subsalicylate (decreased doxycycline absorption)
  • Oral contraceptives (may decrease efficacy of oral contraceptives, leading to breakthrough bleeding or pregnancy)
  • Warfarin (may potentiate anticoagulant effect, increasing bleeding risk)
  • Penicillins (tetracyclines are bacteriostatic and may interfere with the bactericidal action of penicillins; avoid concomitant use if possible)
  • Barbiturates (e.g., phenobarbital) (decreased doxycycline half-life)
  • Carbamazepine (decreased doxycycline half-life)
  • Phenytoin (decreased doxycycline half-life)
  • Rifampin (decreased doxycycline half-life)
  • Methotrexate (may increase methotrexate toxicity due to displacement from protein binding or reduced renal clearance)
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Minor Interactions

  • Digoxin (may increase digoxin levels in some patients due to altered gut flora)

Monitoring

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Baseline Monitoring

Allergy history

Rationale: To identify contraindications or potential hypersensitivity reactions.

Timing: Prior to initiation

Renal function (BUN, creatinine)

Rationale: Although not renally cleared, severe renal impairment can prolong half-life; caution in patients with pre-existing renal disease.

Timing: Prior to initiation (if clinically indicated)

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease, as hepatotoxicity can occur.

Timing: Prior to initiation (if clinically 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 or persistent adverse effects warrant dose adjustment or discontinuation.

INR (if on warfarin)

Frequency: Regularly, especially upon initiation or dose change of doxycycline

Target: Therapeutic range for warfarin

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

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Photosensitivity (severe sunburn-like reaction)
  • Esophageal irritation/ulceration (dysphagia, odynophagia, retrosternal pain)
  • Headache (especially with visual disturbances, suggestive of pseudotumor cerebri)
  • Vaginal yeast infection (candidiasis)
  • Rash
  • Signs of superinfection (e.g., C. difficile-associated diarrhea)

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 may also inhibit 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 fetal harm, though risk of tooth discoloration is lower than in later trimesters.
Second Trimester: High risk of permanent tooth discoloration and enamel hypoplasia in the fetus. Potential for inhibition of bone growth.
Third Trimester: High risk of permanent tooth discoloration and enamel hypoplasia in the fetus. Potential for inhibition of bone growth.
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Lactation

L3 - Moderately safe. Doxycycline is excreted into breast milk in small amounts. While the risk of tooth discoloration in the infant is considered low due to calcium binding in milk, theoretical concerns exist. Monitor breastfed infant for diarrhea, candidiasis, or rash. Short-term use may be acceptable; long-term or repeated use should be avoided if possible.

Infant Risk: Low to moderate risk of tooth discoloration or inhibition of bone growth in the infant, but generally considered low due to calcium binding in milk. Potential for GI upset or candidiasis in infant.
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Pediatric Use

Not recommended for children under 8 years of age due to the risk of permanent tooth discoloration and enamel hypoplasia. In children 8 years and older, use with caution and only when other antibiotics are not suitable 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, particularly gastrointestinal disturbances and photosensitivity. Monitor renal and hepatic function if pre-existing impairment is present.

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 (preferably 1 hour) to minimize the risk of esophageal irritation and ulceration.
  • Emphasize strict sun protection due to high photosensitivity risk.
  • Doxycycline is a preferred agent for many atypical infections (e.g., Mycoplasma, Chlamydia, Rickettsia, Borrelia burgdorferi).
  • Unlike other tetracyclines, doxycycline's absorption is less affected by food and dairy, but still advise separation from antacids, iron, and calcium supplements.
  • Sub-antimicrobial doses (e.g., 20 mg BID or 40 mg once daily modified-release) are used for anti-inflammatory effects in conditions like rosacea and acne, without significant antibacterial activity, thus reducing resistance risk.
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Alternative Therapies

  • Azithromycin (for Chlamydia, Mycoplasma)
  • Erythromycin (for atypical infections)
  • Ciprofloxacin (for certain bacterial infections)
  • Amoxicillin (for Lyme disease in pregnant women or young children)
  • Minocycline (another tetracycline, often used for acne)
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (50mg 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'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 your 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.