Doxycycline Hyc 75mg Tabs

Manufacturer AJANTA PHARMA LIMITED 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
Tetracycline antibiotic
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Pharmacologic Class
Protein synthesis inhibitor (30S ribosomal subunit)
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Pregnancy Category
Category D
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FDA Approved
Apr 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, 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 for malaria prevention and to treat severe acne or rosacea.
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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 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 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 foods that contain calcium, as this may reduce the effectiveness of the medication. 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 continue with 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 (8 ounces) to prevent esophageal irritation.
  • Remain upright for at least 30 minutes (preferably 1 hour) after taking to prevent esophageal irritation.
  • Avoid lying down for at least 30 minutes after taking.
  • Avoid antacids, iron supplements, calcium supplements, and laxatives containing magnesium for 2-3 hours before or after taking doxycycline.
  • Avoid excessive sun exposure and use sunscreen and protective clothing, as doxycycline can cause severe sunburn (photosensitivity).
  • Do not take expired doxycycline, as it can cause kidney damage (Fanconi syndrome).

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For general infections: 100 mg every 12 hours on day 1, then 100 mg once daily or 50 mg every 12 hours. For acne/rosacea (subantimicrobial dose): 20 mg twice daily or 40 mg once daily (modified-release). Doxycycline Hyc 75mg is often used for specific indications like acne or certain infections.
Dose Range: 20 - 200 mg

Condition-Specific Dosing:

Acne/Rosacea (subantimicrobial): 20 mg twice daily or 40 mg once daily (modified-release). 75mg may be used as an alternative low-dose regimen.
Acute infections: 100 mg every 12 hours on day 1, then 100 mg once daily or 50 mg every 12 hours.
Severe infections: 100 mg every 12 hours.
Malaria prophylaxis: 100 mg once daily, starting 1-2 days before travel and continuing for 4 weeks after return.
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Pediatric Dosing

Neonatal: Not established (contraindicated in children < 8 years due to tooth discoloration and bone growth effects, unless benefits outweigh risks in severe/life-threatening infections like anthrax or Rocky Mountain spotted fever).
Infant: Not established (contraindicated in children < 8 years).
Child: Generally contraindicated in children < 8 years. For children â‰Ĩ 8 years and < 45 kg: 2.2 mg/kg every 12 hours on day 1, then 2.2 mg/kg once daily or 1.1 mg/kg every 12 hours. For children â‰Ĩ 8 years and â‰Ĩ 45 kg: Adult dose.
Adolescent: Adult dose.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed (primarily eliminated via feces).
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.
Severe: Use with caution; monitor for signs of hepatotoxicity. Consider lower doses if necessary, though specific guidelines are lacking.

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, ultimately inhibiting bacterial growth and replication.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 1.5-4 hours
FoodEffect: Absorption is not significantly affected by food or milk, unlike other tetracyclines, but it can be reduced by antacids containing aluminum, calcium, or magnesium, and by iron preparations.

Distribution:

Vd: 0.7 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (penetrates CSF poorly, but levels are higher in inflamed meninges)

Elimination:

HalfLife: 16-22 hours (can be up to 24 hours)
Clearance: Not available (primarily non-renal excretion)
ExcretionRoute: Primarily excreted unchanged in feces (via bile) and urine.
Unchanged: Approximately 40% in urine, 60% in feces.
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Pharmacodynamics

OnsetOfAction: Rapid (within hours for antibacterial effect)
PeakEffect: Within 2-4 hours (plasma concentration)
DurationOfAction: 24 hours (allows for 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 medical attention immediately:

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
Diarrhea, especially if it is severe, watery, or bloody (a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD, may occur)

Important: If you experience any of the above symptoms, contact your doctor right away. Additionally, if you have stomach pain, cramps, or severe diarrhea, seek medical attention immediately.

Other Potential Side Effects

Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Diarrhea
Upset stomach or vomiting
Decreased appetite

Reporting 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, or double vision (signs of increased pressure in the brain)
  • Severe or watery diarrhea, especially if it contains blood or mucus (signs of C. difficile infection)
  • Severe skin rash or blistering (signs of severe skin reaction)
  • Yellowing of skin or eyes, dark urine, severe stomach pain (signs of liver problems)
  • Difficulty swallowing, chest pain, or severe heartburn (signs of esophageal irritation)
  • Unusual bruising or bleeding
  • Signs of allergic reaction (hives, swelling of face/lips/tongue/throat, difficulty breathing)
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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. Be sure to describe the allergic reaction and its symptoms.
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.

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 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 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 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 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 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)
  • Kidney damage (rare)

What to Do:

Seek immediate medical attention or call a poison control center. Call 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Oral retinoids (e.g., isotretinoin, acitretin): Increased risk of pseudotumor cerebri (intracranial hypertension).
  • Penicillins: Tetracyclines may interfere with the bactericidal action of penicillin. Avoid concomitant use.
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Moderate Interactions

  • Antacids (aluminum, calcium, magnesium), iron preparations, bismuth subsalicylate, zinc supplements: Decreased doxycycline absorption. Separate administration by at least 2-3 hours.
  • Oral contraceptives: May decrease efficacy of oral contraceptives (though evidence is mixed, advise backup contraception).
  • Warfarin: May potentiate anticoagulant effect (increased INR). Monitor INR closely.
  • Barbiturates (e.g., phenobarbital), carbamazepine, phenytoin: May decrease doxycycline half-life due to enzyme induction.
  • Methotrexate: May increase methotrexate toxicity (tetracyclines can reduce renal clearance of methotrexate).
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Minor Interactions

  • Cholestyramine: May decrease doxycycline absorption.

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: To establish baseline and identify pre-existing hepatic impairment, as doxycycline can rarely cause hepatotoxicity.

Timing: Prior to initiation, especially in patients with known liver disease.

Renal function tests (Cr, BUN)

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

Timing: Prior to initiation.

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Routine Monitoring

INR (International Normalized Ratio)

Frequency: Regularly, especially when initiating or discontinuing doxycycline

Target: Therapeutic range for warfarin

Action Threshold: If INR is outside target range, adjust warfarin dose as needed.

Signs of intracranial hypertension (pseudotumor cerebri)

Frequency: Periodically, especially if headache, blurred vision, or diplopia occur

Target: Not applicable

Action Threshold: Discontinue doxycycline and refer for ophthalmologic evaluation if symptoms develop.

Signs of C. difficile-associated diarrhea (CDAD)

Frequency: Throughout therapy and for several weeks after

Target: Not applicable

Action Threshold: Discontinue doxycycline and initiate appropriate therapy if CDAD is suspected.

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Symptom Monitoring

  • Severe headache
  • Blurred vision
  • Diplopia (double vision)
  • Nausea
  • Vomiting
  • Diarrhea (especially severe or persistent)
  • Abdominal pain
  • Photosensitivity (severe sunburn-like reaction)
  • Esophageal irritation (heartburn, difficulty swallowing, chest pain)
  • Rash
  • Signs of allergic reaction (hives, swelling, difficulty breathing)

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. Use only if the potential benefit justifies the potential risk to the fetus (e.g., life-threatening infections like anthrax).

Trimester-Specific Risks:

First Trimester: Potential for skeletal and dental effects, though less pronounced than in later trimesters. Generally avoided.
Second Trimester: Significant risk of permanent tooth discoloration and inhibition of bone growth.
Third Trimester: Significant risk of permanent tooth discoloration and inhibition of bone growth.
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Lactation

Doxycycline is excreted into breast milk. While some sources suggest it may be compatible for short-term use due to low levels in milk and poor oral absorption by the infant, the potential for tooth discoloration and inhibition of bone growth in the nursing infant remains a concern. The American Academy of Pediatrics considers tetracyclines to be compatible with breastfeeding, but caution is advised. Monitor infant for diarrhea, candidiasis, and tooth discoloration. Consider alternative antibiotics if possible, especially for long-term therapy.

Infant Risk: L3 (Moderate risk - potential for tooth discoloration and bone growth inhibition, but generally considered compatible for short-term use by some experts due to low levels in milk and poor oral absorption by infant).
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Pediatric Use

Generally contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and reversible inhibition of bone growth. In severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted fever) where other drugs are ineffective or contraindicated, the benefits may outweigh these risks.

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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 to gastrointestinal irritation or photosensitivity. Monitor for adverse effects and ensure adequate hydration.

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.
  • Counsel patients extensively on photosensitivity; advise strict sun avoidance, protective clothing, and high-SPF sunscreen.
  • Doxycycline is unique among tetracyclines for its minimal renal excretion, making it a preferred choice for patients with renal impairment.
  • The 75mg strength is often used for subantimicrobial dosing in conditions like rosacea or acne, or for specific infection regimens where lower doses are effective.
  • Despite its classification, some experts consider short-term use in breastfeeding compatible due to low infant exposure, but caution and monitoring are essential.
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Alternative Therapies

  • Other tetracyclines (e.g., minocycline, tetracycline)
  • Macrolides (e.g., azithromycin, erythromycin) for certain infections (e.g., atypical pneumonia, chlamydia)
  • Beta-lactam antibiotics (e.g., penicillins, cephalosporins) for susceptible bacterial infections
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for susceptible bacterial infections
  • Topical or oral retinoids, benzoyl peroxide, topical antibiotics for acne/rosacea (non-antibiotic alternatives)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (75mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 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's a good idea 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.