Doxycycline Hyc 20mg Tablets

Manufacturer LARKEN LABORATORIES, INC. 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
Adjunctive treatment for chronic periodontitis; Anti-inflammatory agent
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Pharmacologic Class
Tetracycline (sub-antimicrobial dose); Matrix metalloproteinase inhibitor (MMP inhibitor)
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Pregnancy Category
D
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FDA Approved
Sep 1998
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Doxycycline 20mg is a medication used to help treat gum disease (periodontitis). Unlike higher doses of doxycycline, this low dose primarily works by reducing inflammation and preventing the breakdown of gum tissue, rather than acting as a strong antibiotic. It helps improve the health of your gums when used along with professional dental cleaning.
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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

Some medications should 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 best to avoid taking your medication at the same time as milk, dairy products, or other calcium-rich foods, 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 dosing 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 each dose with a full glass of water (at least 8 ounces) to prevent irritation of the esophagus.
  • Remain upright (sitting or standing) for at least 30 minutes after taking the medication to prevent esophageal irritation.
  • Take the medication at least one hour before your morning and evening meals.
  • Avoid taking antacids, iron supplements, or dairy products (milk, yogurt, cheese) within 2-3 hours of taking doxycycline, as they can interfere with absorption.
  • Protect your skin from the sun. Doxycycline can make your skin more sensitive to sunlight, leading to severe sunburn. Use sunscreen (SPF 30 or higher), wear protective clothing, and limit sun exposure.
  • Complete the full course of treatment as prescribed by your doctor, even if your symptoms improve.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg twice daily
Dose Range: 20 - 20 mg

Condition-Specific Dosing:

chronicPeriodontitis: 20 mg orally twice daily, 12 hours apart, for up to 9 months. Should be taken at least one hour prior to the morning and evening meals.
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Pediatric Dosing

Neonatal: Not established; Contraindicated due to risk of permanent tooth discoloration and bone growth inhibition.
Infant: Not established; Contraindicated due to risk of permanent tooth discoloration and bone growth inhibition.
Child: Not established; Contraindicated for children under 8 years due to risk of permanent tooth discoloration and bone growth inhibition.
Adolescent: Not established for this specific indication (periodontitis); Generally, higher doses of doxycycline are used for antimicrobial indications in adolescents, but 20mg is sub-antimicrobial.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: Doxycycline is not significantly removed by hemodialysis. No dosage adjustment needed.

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 therapy if possible.

Pharmacology

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Mechanism of Action

At sub-antimicrobial doses (20 mg), doxycycline inhibits the activity of collagenase (matrix metalloproteinases or MMPs), enzymes implicated in the breakdown of connective tissue in periodontal disease. It also reduces the production of inflammatory mediators. This action is independent of its antimicrobial effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100%
Tmax: 2-4 hours
FoodEffect: Food and dairy products can slightly decrease absorption, but doxycycline hyclate is often taken with food to minimize gastrointestinal irritation. It should be taken at least one hour prior to meals for optimal absorption in the context of periodontitis treatment.

Distribution:

Vd: Approximately 0.7 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited penetration into the cerebrospinal fluid (CSF) in the absence of meningeal inflammation.

Elimination:

HalfLife: 16-22 hours
Clearance: Not readily available as a single rate; primarily eliminated via non-renal routes (fecal excretion via bile).
ExcretionRoute: Fecal (via bile) and renal
Unchanged: Significant portion excreted unchanged.
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Pharmacodynamics

OnsetOfAction: Clinical effects on periodontal parameters may take weeks to months to become evident with chronic dosing.
PeakEffect: Sustained with chronic dosing for anti-inflammatory/MMP inhibition.
DurationOfAction: Related to half-life, allowing for 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-Related Side Effect:

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 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.

Rare but Serious Side Effect:

Raised pressure in the brain has been reported with this medication. In most cases, this condition resolves on its own after stopping the medication. However, in some instances, 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, seek medical attention right away.

Other Possible Side Effects:

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following:

Diarrhea
Upset stomach
Vomiting
* Decreased appetite

If you're concerned about any side effects or if they persist or worsen, contact your doctor for guidance. 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, especially with blurred vision or vision changes (could be a sign of increased pressure in the brain).
  • Severe skin rash, blistering, or peeling (may indicate a serious skin reaction).
  • Severe or persistent diarrhea, especially if it contains blood or mucus (could be a sign of C. difficile infection).
  • Yellowing of the skin or eyes (jaundice), dark urine, or unusual tiredness (signs of liver problems).
  • Difficulty or pain when 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 allergic reaction you experienced, including any symptoms that occurred.
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 nursing while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you 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 to ensure your safety.
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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.

Be aware that this medication can increase your sensitivity to the sun, making you more prone to sunburn. Take necessary precautions when spending time outdoors, and inform your doctor if you experience excessive sunburn while taking this medication.

There is a risk of severe skin reactions associated with this drug, 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 birth control methods, 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. This change is irreversible. Additionally, there is a risk of other tooth problems and potential effects on bone growth. If you have concerns, discuss them with your doctor.

While 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, talk to your doctor.

If you are pregnant or become pregnant while taking this medication, there is a risk of harm to the unborn baby. If you are pregnant or suspect you may be pregnant, contact your doctor immediately.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Photosensitivity
  • Potentially renal or hepatic toxicity at very high doses.

What to Do:

In case of suspected overdose, immediately contact a poison control center (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is supportive and symptomatic.

Drug Interactions

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Major Interactions

  • Oral retinoids (e.g., isotretinoin, acitretin): Increased risk of pseudotumor cerebri (benign intracranial hypertension).
  • Antacids containing aluminum, calcium, or magnesium; Iron preparations; Bismuth subsalicylate: Can chelate doxycycline, significantly reducing its absorption. Separate administration by at least 2-3 hours.
  • Penicillins: Tetracyclines are bacteriostatic and may interfere with the bactericidal action of penicillins. Avoid concomitant use.
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Moderate Interactions

  • Warfarin: Doxycycline may enhance the anticoagulant effect of warfarin. Monitor INR closely.
  • Barbiturates (e.g., phenobarbital), Carbamazepine, Phenytoin: May decrease the half-life of doxycycline through enzyme induction, potentially reducing its efficacy.
  • Cyclosporine: Doxycycline may decrease plasma concentrations of cyclosporine.
  • Live bacterial vaccines (e.g., oral typhoid vaccine, BCG): Tetracyclines may reduce the therapeutic effect of these vaccines. Avoid administration within 3 days of vaccination.
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Minor Interactions

  • Oral contraceptives: Although controversial, some reports suggest tetracyclines may reduce the efficacy of oral contraceptives. Advise patients to use an alternative or additional method of contraception.

Monitoring

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Baseline Monitoring

Liver Function Tests (LFTs)

Rationale: To establish baseline in patients with pre-existing hepatic impairment or risk factors for liver disease, although severe hepatotoxicity is rare.

Timing: Prior to initiation of therapy if indicated.

Renal Function Tests (RFTs)

Rationale: To establish baseline in patients with pre-existing renal impairment, though doxycycline is generally safe in renal dysfunction.

Timing: Prior to initiation of therapy if indicated.

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Routine Monitoring

Clinical response (e.g., periodontal health, reduction in inflammation)

Frequency: Periodically during treatment (e.g., every 3-6 months)

Target: Improvement in clinical attachment levels, probing depths, and reduction in bleeding on probing.

Action Threshold: Lack of improvement or worsening of condition may warrant re-evaluation of therapy.

Adverse effects monitoring (e.g., GI upset, photosensitivity, candidiasis)

Frequency: Regularly throughout therapy

Target: Absence or mild, manageable side effects.

Action Threshold: Severe or persistent adverse effects warrant dose adjustment or discontinuation.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Photosensitivity (severe sunburn, rash upon sun exposure)
  • Headache (especially severe or persistent, may indicate pseudotumor cerebri)
  • Blurred vision or visual disturbances
  • Vaginal candidiasis (yeast infection)
  • Oral candidiasis (thrush)
  • Difficulty swallowing or painful swallowing (esophageal irritation)
  • Yellowing of skin or eyes (jaundice, indicating liver issues)

Special Patient Groups

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Pregnancy

Category D. Doxycycline should be avoided during pregnancy due to the potential for permanent discoloration of deciduous teeth (yellow-gray-brown) and inhibition of bone growth in the fetus. Weigh the potential benefits against the risks.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though less clearly established than effects in later trimesters.
Second Trimester: High risk of permanent tooth discoloration and enamel hypoplasia in deciduous teeth.
Third Trimester: High risk of permanent tooth discoloration and enamel hypoplasia in deciduous teeth.
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Lactation

L3 (Moderately Safe). Doxycycline is excreted into breast milk. While generally considered compatible with breastfeeding for short-term use, long-term or repeated use should be avoided due to the theoretical risk of tooth discoloration and inhibition of bone growth in the infant. Monitor the infant for diarrhea, candidiasis, or rash.

Infant Risk: Low to moderate; theoretical risk of tooth discoloration and bone growth inhibition with prolonged exposure.
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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. The 20mg dose for periodontitis is not established for pediatric use.

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Geriatric Use

No specific dosage adjustment is generally required for elderly patients. However, monitor for increased susceptibility to adverse effects, particularly gastrointestinal upset and photosensitivity.

Clinical Information

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Clinical Pearls

  • Doxycycline 20mg is a sub-antimicrobial dose, meaning its primary action is anti-inflammatory and matrix metalloproteinase (MMP) inhibition, not direct bacterial killing.
  • It is crucial to take this medication with a full glass of water and remain upright for at least 30 minutes to prevent esophageal irritation and ulceration.
  • Patients should be counselled extensively on photosensitivity and advised to use strict sun protection.
  • Avoid in pregnant women and children under 8 years due to the risk of permanent tooth discoloration and bone growth effects.
  • This formulation is an adjunctive therapy to scaling and root planing for chronic periodontitis, not a standalone treatment.
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Alternative Therapies

  • Scaling and root planing (non-surgical periodontal therapy)
  • Other systemic antibiotics (e.g., amoxicillin + metronidazole, clindamycin) for specific periodontal infections (at higher, antimicrobial doses)
  • Local antimicrobial delivery systems (e.g., Arestin, Atridox) for specific periodontal pockets
  • Periodontal surgery (e.g., flap surgery, bone grafts)
  • Other anti-inflammatory agents (e.g., NSAIDs, though not directly for MMP inhibition in periodontitis)
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Cost & Coverage

Average Cost: Typically low (generic) per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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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's a good idea to check with your pharmacist for more information. 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.