Doxycycline Hyc 150mg 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
Antibiotic
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Pharmacologic Class
Tetracycline antibiotic; Protein synthesis inhibitor
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Pregnancy Category
Category D
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FDA Approved
May 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 to prevent malaria and treat severe acne.
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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 need to 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 also important 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 any questions, be sure to ask your doctor or pharmacist.

Additional Tips for Taking Your Medication

Drink plenty of non-caffeinated liquids, unless your doctor has instructed you to limit your fluid intake. To avoid interactions with other substances, 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, or antacids. Take your medication with a full glass of water and avoid lying down after taking it to minimize the risk of throat irritation. Ask your pharmacist how long you should wait before lying down after taking your medication.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Do not store it in a bathroom. Check the expiration date on your medication and do not take it if it is outdated or 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. However, if it's close to the 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 to prevent irritation of the esophagus (food pipe).
  • Remain upright for at least 30 minutes (preferably 1 hour) after taking the medication.
  • Avoid taking with dairy products (milk, cheese, yogurt), antacids, iron supplements, or multivitamins containing minerals (calcium, magnesium, zinc) for at least 2-3 hours before or after your dose, as these can reduce absorption.
  • Avoid excessive sun exposure and use sunscreen (SPF 30 or higher) and protective clothing, as doxycycline can make your skin more sensitive to sunlight (photosensitivity).
  • 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.
  • If you are taking oral contraceptives, consider using a backup birth control method, as doxycycline may reduce their effectiveness (though evidence is weak).

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

Acne vulgaris: 20 mg twice daily or 50 mg once daily (sub-antimicrobial dose)
Malaria prophylaxis: 100 mg once daily, starting 1-2 days before travel, continuing for 4 weeks after leaving endemic area.
Lyme disease: 100 mg twice daily for 10-21 days.
Chlamydia trachomatis: 100 mg twice daily for 7 days.
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Pediatric Dosing

Neonatal: Not established (contraindicated in children < 8 years due to tooth discoloration and bone growth inhibition, 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 weighing < 45 kg: 2.2 mg/kg twice daily on day 1, then 2.2 mg/kg once daily. For severe infections, 2.2 mg/kg twice daily. Max 100 mg/dose. For children â‰Ĩ 8 years and weighing â‰Ĩ 45 kg: Adult dose.
Adolescent: Adult dose (typically 100 mg once or twice daily).
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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 the GI tract, not renally).
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: No specific adjustment recommended, but use with caution.
Severe: No specific adjustment recommended, but use with caution. Monitor for signs of hepatotoxicity.

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 and replication.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 1.5-4 hours
FoodEffect: Food (especially dairy products) and cations (e.g., aluminum, calcium, magnesium, iron) can decrease absorption. It is recommended to take with a full glass of water to prevent esophageal irritation, and avoid dairy/antacids/iron within 2-3 hours.

Distribution:

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

Elimination:

HalfLife: 16-22 hours (single dose); 22-24 hours (multiple doses)
Clearance: Not readily available, but primarily non-renal.
ExcretionRoute: Primarily excreted unchanged in feces (via intestinal secretion) and urine (to a lesser extent).
Unchanged: Approximately 40% in urine, 60% in feces.
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Pharmacodynamics

OnsetOfAction: Variable, depends on infection type; generally within hours for bacteriostatic effect.
PeakEffect: Not directly applicable for bacteriostatic agents; peak plasma concentrations reached within 1.5-4 hours.
DurationOfAction: Plasma concentrations remain above MIC for susceptible organisms for 12-24 hours, 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, or 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, bloody, or watery (see below for more information on diarrhea)

Important Information About 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 a life-threatening bowel problem. If you experience stomach pain, cramps, or severe diarrhea (especially if it is bloody or watery), contact your doctor immediately. Do not treat diarrhea without consulting your doctor first.

Raised Pressure in the Brain

This medication can cause increased pressure in the brain, which may lead to loss of vision. This condition usually resolves after stopping the medication, but in some cases, vision loss 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 Side Effects

Like all medications, this drug can cause side effects. Many people do not experience any side effects or only have mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Diarrhea
Upset stomach or vomiting
* Decreased appetite

Reporting Side Effects

This is not a complete 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 (could be signs of increased pressure in the brain).
  • Severe watery diarrhea or bloody stools, with or without fever and stomach cramps (could be a sign of C. difficile infection).
  • Yellowing of the skin or eyes, dark urine, unusual tiredness (signs of liver problems).
  • Severe skin rash, blistering, peeling, or swelling of the face/throat (signs of a severe allergic reaction or skin reaction).
  • Difficulty swallowing, chest pain, or severe heartburn (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 breastfeeding 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 laboratory 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 contraceptives, 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, turning teeth yellow-gray brown. Similarly, if taken during certain stages of pregnancy, it may affect the unborn baby's teeth. Other tooth problems and impaired bone growth have also been reported in children taking this medication. If you have concerns, discuss them with your doctor.

Generally, this medication is not recommended for children under 8 years old, but 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 typically resolves 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, 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:

In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive and symptomatic. Gastric lavage may be considered if ingestion is recent.

Drug Interactions

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Major Interactions

  • Oral retinoids (e.g., isotretinoin, acitretin): Increased risk of pseudotumor cerebri (benign intracranial hypertension).
  • Live bacterial vaccines (e.g., oral typhoid vaccine): Doxycycline may reduce the therapeutic effect of the vaccine.
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Moderate Interactions

  • Antacids (containing aluminum, calcium, magnesium), iron preparations, bismuth subsalicylate, zinc supplements: Decreased absorption of doxycycline. Separate administration by at least 2-3 hours.
  • Warfarin: May potentiate anticoagulant effect (increased INR). Monitor INR closely.
  • Oral contraceptives: May decrease efficacy of oral contraceptives (though evidence is weak, advise backup contraception).
  • Barbiturates (e.g., phenobarbital), carbamazepine, phenytoin: May decrease doxycycline half-life due to enzyme induction, leading to subtherapeutic levels. Consider increasing doxycycline dose.
  • Penicillins: Tetracyclines are bacteriostatic and may interfere with the bactericidal action of penicillins. Avoid concomitant use when bactericidal action is required (e.g., acute streptococcal infections).
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Minor Interactions

  • Methotrexate: May increase methotrexate toxicity (though less common with doxycycline than other tetracyclines).

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: Although rare, hepatotoxicity can occur, especially with high doses or prolonged therapy.

Timing: Prior to initiation, especially in patients with pre-existing hepatic impairment.

Renal function tests (BUN, creatinine)

Rationale: While not renally eliminated, baseline assessment is good practice.

Timing: Prior to initiation.

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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 symptoms.

Action Threshold: If symptoms occur, evaluate and treat appropriately; consider discontinuing doxycycline.

Photosensitivity reaction

Frequency: Throughout therapy.

Target: Absence of severe sunburn-like reactions.

Action Threshold: Advise patients to avoid excessive sun exposure and use sunscreen. Discontinue if severe reaction occurs.

GI symptoms (e.g., esophageal irritation, nausea, vomiting)

Frequency: Throughout therapy.

Target: Minimal or no GI distress.

Action Threshold: Advise taking with plenty of water and remaining upright. If severe, consider alternative or discontinue.

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Symptom Monitoring

  • Severe headache, blurred vision, diplopia, vision loss (signs of pseudotumor cerebri)
  • Severe abdominal pain, watery or bloody diarrhea, fever (signs of C. difficile infection)
  • Yellowing of skin or eyes, dark urine, unusual fatigue (signs of liver problems)
  • Severe skin rash, blistering, peeling (signs of severe cutaneous adverse reactions)
  • Difficulty swallowing, chest pain, heartburn (signs of esophageal irritation)

Special Patient Groups

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Pregnancy

Category D. Doxycycline crosses the placenta. Use during pregnancy, especially during the second and third trimesters, can cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth in the fetus. Should only be used if the potential benefit justifies the potential risk to the fetus (e.g., life-threatening infections like anthrax, or severe rickettsial infections where alternative treatments are less effective or contraindicated).

Trimester-Specific Risks:

First Trimester: Limited data, but potential for teratogenicity cannot be excluded. Risk of tooth discoloration and bone effects is lower than in later trimesters but still a concern.
Second Trimester: High risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia in the developing teeth of the fetus. Reversible inhibition of bone growth.
Third Trimester: High risk of permanent tooth discoloration and enamel hypoplasia. Reversible inhibition of bone growth.
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Lactation

L3 (Moderately Safe). Doxycycline is excreted into breast milk in small amounts. While the amount absorbed by the infant is generally low due to chelation with calcium in milk, there is a theoretical risk of tooth discoloration and inhibition of bone growth in the nursing infant. The American Academy of Pediatrics considers tetracyclines compatible with breastfeeding with caution. Monitor infant for diarrhea, candidiasis, or rash. Short-term use is generally considered acceptable; long-term or repeated use should be avoided if possible.

Infant Risk: Low to moderate. Theoretical risk of tooth staining and enamel hypoplasia, and reversible inhibition of bone growth. GI upset (diarrhea, candidiasis) in 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 enamel hypoplasia, and reversible inhibition of bone growth. In severe or life-threatening infections (e.g., anthrax, Rocky Mountain spotted fever) where other drugs are contraindicated or ineffective, the benefits may outweigh these risks. For children â‰Ĩ 8 years, dosing is weight-based.

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Geriatric Use

No specific dose adjustment is generally needed 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 concerns exist, although doxycycline is primarily non-renally eliminated.

Clinical Information

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Clinical Pearls

  • Always advise patients to take doxycycline with a full glass of water and remain upright for at least 30 minutes (preferably 1 hour) to minimize the risk of esophageal irritation and ulceration.
  • Educate patients about photosensitivity and the importance of sun protection (sunscreen, protective clothing).
  • Remind patients to avoid dairy products, antacids, and iron supplements within 2-3 hours of taking doxycycline due to chelation and reduced absorption.
  • Doxycycline is a preferred agent for many tick-borne diseases (e.g., Lyme disease, Rocky Mountain spotted fever) and certain atypical bacterial infections (e.g., Mycoplasma, Chlamydia).
  • Unlike other tetracyclines, doxycycline does not accumulate significantly in patients with renal impairment, making it a safer choice for those with kidney disease.
  • The 20 mg dose (Oracea) is a sub-antimicrobial dose used for rosacea, acting primarily through anti-inflammatory mechanisms rather than antibacterial.
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Alternative Therapies

  • Azithromycin (for Chlamydia, certain respiratory infections)
  • Amoxicillin (for Lyme disease, certain bacterial infections)
  • Ceftriaxone (for Lyme disease, certain bacterial infections)
  • Macrolides (e.g., erythromycin, clarithromycin for atypical pneumonia)
  • Fluoroquinolones (e.g., levofloxacin for respiratory/urinary infections)
  • Minocycline (another tetracycline, often used for acne)
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ 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'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.