Doxycycline Hyc 100mg Tabs

Manufacturer ACTAVIS 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
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 infections. It works by stopping the growth of bacteria. It can also be used to prevent malaria and treat conditions like severe acne and rosacea.
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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-rich 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 to minimize 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 (at least 8 ounces) to prevent irritation of the esophagus.
  • Remain upright for at least 30 minutes (or preferably 1 hour) after taking the medication 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 interfere with absorption.
  • Avoid excessive exposure to sunlight or artificial UV light (e.g., tanning beds) while taking this medication and for several days after, as it can cause severe sunburn (photosensitivity). Use sunscreen and wear protective clothing.
  • 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.
  • 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.

Dosing & Administration

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Adult Dosing

Standard Dose: 100 mg every 12 hours for most infections
Dose Range: 20 - 200 mg

Condition-Specific Dosing:

Severe infections (e.g., anthrax, plague): 200 mg initially, then 100 mg every 12 hours
Uncomplicated gonococcal infections: 100 mg orally twice daily for 7 days
Syphilis (early): 100 mg orally twice daily for 14 days
Syphilis (late latent or tertiary): 100 mg orally twice daily for 28 days
Malaria prophylaxis: 100 mg orally once daily, starting 1-2 days before travel and continuing for 4 weeks after return
Acne vulgaris (anti-inflammatory): 20 mg orally twice daily or 40 mg once daily (delayed-release)
Rosacea (anti-inflammatory): 20 mg orally twice daily or 40 mg once daily (delayed-release)
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Pediatric Dosing

Neonatal: Not established (contraindicated due to teeth discoloration and bone effects)
Infant: Not established (contraindicated due to teeth discoloration and bone effects)
Child: Not recommended for children under 8 years of age due to permanent teeth discoloration and bone growth inhibition. For children 8 years and older: 2-4 mg/kg/day divided into 1-2 doses, max 200 mg/day (or 100 mg/day for chronic use).
Adolescent: Same as adult dosing for those 8 years and older, typically 100 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: 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. Dose reduction may be considered in severe cases.
Severe: Use with caution; monitor for signs of hepatotoxicity. Dose reduction may be considered.

Pharmacology

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Mechanism of Action

Doxycycline is a bacteriostatic antibiotic that inhibits bacterial protein synthesis by binding reversibly 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: 90-100%
Tmax: 2-3 hours
FoodEffect: Absorption is not significantly affected by food or milk, unlike other tetracyclines, but dairy products, antacids, and iron preparations can impair absorption due to chelation. It is recommended to take with a full glass of water to prevent esophageal irritation.

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 (primarily non-renal excretion)
ExcretionRoute: Primarily fecal (via intestinal secretion), with a smaller portion excreted renally.
Unchanged: Approximately 40% renally, significant portion via intestinal secretion.
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Pharmacodynamics

OnsetOfAction: Rapid (within hours for antibacterial effect)
PeakEffect: 2-3 hours (correlates with Tmax)
DurationOfAction: 24 hours (due to long half-life, allowing 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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting
Chest pain or pressure, or a fast heartbeat
Difficulty urinating or changes in urine output
Fever, chills, or sore throat; unexplained bruising or bleeding; or feeling extremely tired or weak
Throat irritation or trouble 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, bloody, or watery (may be a sign of C. diff-associated diarrhea, a potentially life-threatening condition)

If you experience any of these symptoms, contact your doctor right away. Additionally, if you develop stomach pain, cramps, or severe diarrhea while taking this medication, seek medical attention immediately.

Rare but Serious Side Effect: Raised Pressure in the Brain

In some cases, this medication may cause increased pressure in the brain, which can lead to loss of vision. If you experience a headache or vision problems, such as blurred vision, double vision, or loss of vision, contact your doctor immediately.

Other Side Effects

Most people experience few or no side effects while taking this medication. However, some common side effects include:

Diarrhea
Upset stomach or vomiting
* Decreased appetite

If you experience any of these side effects or any other symptoms that concern you, contact your doctor. They can help you manage your symptoms and determine the best course of action.

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor or report them to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe headache, blurred vision, or double vision (signs of increased pressure in the brain)
  • Severe skin rash, blistering, or peeling
  • Severe diarrhea that is watery or bloody (may be a sign of C. difficile infection)
  • Yellowing of the skin or eyes, dark urine, unusual tiredness (signs of liver problems)
  • Signs of a new infection (e.g., fever, sore throat, vaginal itching or discharge)
  • Difficulty swallowing, painful swallowing, or chest pain (signs of 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 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 be sure 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 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 conditions that can affect multiple 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 contraception, 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 other tooth problems. It may also affect bone growth. If you have concerns, discuss them with your doctor. Additionally, if taken during certain stages of pregnancy, this medication may cause tooth discoloration in the unborn baby, which is permanent.

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 has been reported to reverse after stopping the medication and undergoing dental cleaning. If you have questions or concerns, discuss them with 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, with very high doses)
  • Kidney damage (rare, with very high doses)

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; gastric lavage may be considered if ingestion is recent.

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 benign intracranial hypertension (pseudotumor cerebri).
  • Penicillins: May interfere with the bactericidal action of penicillin (avoid concomitant use).
  • Warfarin: May potentiate anticoagulant effects (monitor INR).
  • Methotrexate: May increase methotrexate toxicity (monitor for adverse effects).
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Moderate Interactions

  • Barbiturates (e.g., phenobarbital): Decreased doxycycline half-life and serum levels.
  • Carbamazepine: Decreased doxycycline half-life and serum levels.
  • Phenytoin: Decreased doxycycline half-life and serum levels.
  • Oral contraceptives: May reduce efficacy of oral contraceptives (advise backup contraception).
  • Cholestyramine: Decreased doxycycline absorption.
  • Digoxin: May increase digoxin levels in some patients.
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Minor Interactions

  • Sucralfate: Decreased doxycycline absorption (separate administration by at least 2 hours).

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: Although primarily non-renally eliminated, baseline assessment is prudent, especially in patients with pre-existing renal impairment or those on prolonged therapy.

Timing: Prior to initiation of therapy

Hepatic function (ALT, AST, bilirubin)

Rationale: Doxycycline can rarely cause hepatotoxicity; baseline assessment is important, especially in patients with pre-existing liver disease.

Timing: Prior to initiation of therapy

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Routine Monitoring

Signs of superinfection (e.g., oral 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.

Intracranial pressure (for headache, blurred vision, papilledema)

Frequency: Periodically, especially if co-administered with retinoids or in patients with predisposing factors.

Target: Absence of symptoms

Action Threshold: New onset or worsening of symptoms suggestive of intracranial hypertension; discontinue doxycycline and seek ophthalmologic evaluation.

Complete Blood Count (CBC)

Frequency: Periodically, especially with prolonged therapy (>2-3 months)

Target: Within normal limits

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

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Symptom Monitoring

  • Photosensitivity (severe sunburn-like reaction)
  • Esophageal irritation (dysphagia, odynophagia, chest pain)
  • Gastrointestinal upset (nausea, vomiting, diarrhea)
  • Vaginal yeast infection
  • Headache, blurred vision, diplopia (signs of intracranial hypertension)
  • Rash or other allergic reactions
  • Signs of liver injury (fatigue, dark urine, jaundice, abdominal pain)
  • Signs of C. difficile infection (severe diarrhea, abdominal cramps, fever)

Special Patient Groups

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Pregnancy

Category D. Doxycycline crosses the placenta. Use is generally contraindicated during pregnancy due to the risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia in the fetus, as well as reversible inhibition of bone growth. Use only if the potential benefit justifies the potential risk to the fetus (e.g., life-threatening infections where safer alternatives are ineffective or contraindicated).

Trimester-Specific Risks:

First Trimester: Risk of fetal malformations is low, but potential for tooth and bone effects exists throughout pregnancy.
Second Trimester: Significant risk of permanent tooth discoloration and enamel hypoplasia, and inhibition of bone growth.
Third Trimester: Significant risk of permanent tooth discoloration and enamel hypoplasia, and inhibition of bone growth.
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Lactation

L3 (Moderately Safe). Doxycycline is excreted into breast milk. While the amount transferred is generally low and calcium in milk may chelate the drug, theoretical concerns exist regarding tooth discoloration and bone effects in the nursing infant, especially with long-term or repeated use. Short-term use is generally considered compatible with breastfeeding, but monitor the infant for diarrhea, candidiasis, or rash. Consider alternative antibiotics if prolonged therapy is needed.

Infant Risk: Low to moderate risk of tooth discoloration or bone effects with short-term use; higher risk with prolonged or repeated exposure. Monitor for GI upset (diarrhea, thrush).
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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 have age-related decline in renal or hepatic function, which should be considered. Monitor for adverse effects, particularly GI upset and photosensitivity.

Clinical Information

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Clinical Pearls

  • Doxycycline is a versatile antibiotic used for a wide range of infections, including respiratory, urinary, skin, and sexually transmitted infections, as well as Lyme disease, Rocky Mountain spotted fever, cholera, and malaria prophylaxis.
  • It is also used for its anti-inflammatory properties in conditions like acne vulgaris and rosacea at sub-antimicrobial doses (e.g., 20 mg BID or 40 mg once daily delayed-release).
  • Always advise patients to take doxycycline with a full glass of water and to remain upright for at least 30 minutes to prevent esophageal irritation and ulceration.
  • Emphasize strict sun protection due to high photosensitivity risk.
  • Unlike other tetracyclines, doxycycline's absorption is less affected by food and dairy, but chelation with polyvalent cations (calcium, magnesium, iron, aluminum) still occurs, so separation from these products is crucial.
  • It is a preferred agent for community-acquired MRSA skin infections in some regions, and for atypical pneumonia (Mycoplasma, Chlamydia).
  • Despite being a tetracycline, its elimination is primarily non-renal, making it a suitable option for patients with renal impairment.
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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., levofloxacin, moxifloxacin) for certain bacterial infections
  • Beta-lactam antibiotics (e.g., amoxicillin, cephalexin) depending on the specific infection and susceptibility
  • For acne/rosacea: topical retinoids, topical antibiotics, oral isotretinoin (for severe acne), other oral antibiotics (e.g., azithromycin, minocycline).
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (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 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 consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.