Doxycycline Monohydrate 150mg Tabs

Manufacturer ZYDUS PHARMACEUTICALS (USA) 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
Tetracycline
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Pregnancy 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 various bacterial infections, including respiratory tract infections, urinary tract infections, skin infections like acne and rosacea, and certain sexually transmitted infections. It works by stopping the growth of bacteria.
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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, consult with 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 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 with a full glass of water (at least 8 ounces) to prevent esophageal irritation.
  • Remain upright for at least 30 minutes (preferably 1 hour) after taking the dose to prevent esophageal irritation.
  • Avoid lying down for at least 30 minutes after taking the dose.
  • Protect skin from sun exposure (wear protective clothing, use sunscreen) as doxycycline can cause severe sunburn (photosensitivity).
  • Avoid taking antacids, iron supplements, or calcium-containing products (like dairy) within 2-3 hours of taking doxycycline, as they can reduce its absorption. Doxycycline monohydrate is less affected by food/dairy than hyclate, but separation is still a good practice for optimal absorption.
  • Complete the full course of medication, even if symptoms improve, to prevent resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: For acne/rosacea: 150 mg once daily. For other infections: 100 mg every 12 hours (initial dose 200 mg, then 100 mg daily or 50 mg every 12 hours depending on severity).
Dose Range: 50 - 200 mg

Condition-Specific Dosing:

Acne vulgaris: 150 mg once daily
Rosacea: 150 mg once daily
Severe infections: 200 mg on first day (100 mg every 12 hours), then 100 mg daily or 50 mg every 12 hours
Gonorrhea (uncomplicated): 100 mg orally twice a day for 7 days
Syphilis (early): 100 mg orally twice a day for 14 days
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Pediatric Dosing

Neonatal: Not established (contraindicated in children < 8 years)
Infant: Not established (contraindicated in children < 8 years)
Child: Contraindicated in children under 8 years due to risk of permanent tooth discoloration and bone growth inhibition. For children 8 years and older (weighing < 45 kg): 4.4 mg/kg/day divided into 2 doses on the first day, then 2.2 mg/kg/day divided into 1 or 2 doses. Max 200 mg/day. For children 8 years and older (weighing â‰Ĩ 45 kg): Adult dose.
Adolescent: Adult dose (typically 100-200 mg/day depending on indication)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed (excreted primarily via feces)
Dialysis: Not significantly removed by hemodialysis; no supplemental dose needed after dialysis.

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.

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 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: Approximately 90-100%
Tmax: 1.5-4 hours
FoodEffect: Absorption of doxycycline monohydrate is minimally affected by food or dairy products, unlike doxycycline hyclate. However, taking with food can reduce gastrointestinal upset.

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 (can be up to 24 hours)
Clearance: Not readily available as a specific rate, but primarily non-renal excretion.
ExcretionRoute: Primarily fecal (via intestinal secretion and bile), with a smaller portion excreted renally.
Unchanged: Approximately 40-60% excreted unchanged in feces; 20-40% in urine.
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Pharmacodynamics

OnsetOfAction: Within hours (bacteriostatic effect)
PeakEffect: Within 2-4 hours (peak plasma concentration)
DurationOfAction: 24 hours (due to long half-life, allowing once-daily dosing for some indications)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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

Important: Antibiotic-Associated Diarrhea

Diarrhea is a common side effect of antibiotics. In rare cases, a severe form of diarrhea called Clostridioides difficile-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.

Raised Pressure in the Brain

This medication can 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 a headache or vision problems, such as blurred vision, double vision, or loss of vision, contact your doctor right away.

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:

Diarrhea
Upset stomach or vomiting
Decreased appetite

Reporting Side Effects

This is not an exhaustive list of potential 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 watery diarrhea or bloody stools (may occur up to 2 months after stopping treatment)
  • New or worsening headache, blurred vision, double vision, or vision loss (signs of increased pressure in the brain)
  • Severe skin rash, blistering, peeling skin, or mouth sores
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems)
  • Unusual bleeding or bruising
  • Severe allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
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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 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 conditions 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 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.

Be aware that this drug can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions that can 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) or other tooth problems. It may also affect bone growth. If you have concerns, discuss them with your doctor. Although this medication is not typically recommended for children under 8, there may be exceptions. Consult with your doctor to determine the best course of treatment.

Tooth discoloration has also been reported in adults, but this condition may be reversible after stopping the medication and undergoing dental cleaning. Consult your doctor if you have concerns.

If you are pregnant or become pregnant while taking this medication, you may be at risk of harming your unborn baby. Inform your doctor immediately if you are pregnant or suspect you may be pregnant.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Esophageal irritation
  • Possible hepatotoxicity or nephrotoxicity (rare with acute overdose)

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. Doxycycline is not significantly removed by hemodialysis.

Drug Interactions

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Contraindicated Interactions

  • Isotretinoin (risk of pseudotumor cerebri)
  • Acitretin (risk of pseudotumor cerebri)
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Major Interactions

  • Antacids containing aluminum, calcium, or magnesium (decreased doxycycline absorption)
  • Iron preparations (decreased doxycycline absorption)
  • Bismuth subsalicylate (decreased doxycycline absorption)
  • Oral retinoids (e.g., tretinoin, adapalene, tazarotene) (increased risk of pseudotumor cerebri)
  • Penicillins (tetracyclines may interfere with the bactericidal action of penicillins)
  • Warfarin (enhanced anticoagulant effect)
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Moderate Interactions

  • Barbiturates (e.g., phenobarbital) (decreased doxycycline half-life)
  • Carbamazepine (decreased doxycycline half-life)
  • Phenytoin (decreased doxycycline half-life)
  • Oral contraceptives (decreased efficacy of oral contraceptives, increased risk of breakthrough bleeding)
  • Methotrexate (increased methotrexate toxicity due to displacement from protein binding or reduced renal clearance)
  • Cyclosporine (increased cyclosporine levels)
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Minor Interactions

  • Cholestyramine (decreased doxycycline absorption)

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: To establish baseline in patients with pre-existing hepatic impairment or for prolonged therapy.

Timing: Prior to initiation of therapy if indicated.

Renal function tests (RFTs)

Rationale: To establish baseline in patients with pre-existing renal impairment, though dose adjustment is typically not needed.

Timing: Prior to initiation of therapy if indicated.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily/as clinically indicated

Target: Resolution of infection symptoms or improvement in skin condition.

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistance.

Adverse effects (e.g., GI upset, photosensitivity, headache, rash)

Frequency: Daily/as clinically indicated

Target: Absence or mild, tolerable side effects.

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

Complete Blood Count (CBC)

Frequency: Periodically for prolonged therapy (e.g., > 3 months)

Target: Within normal limits.

Action Threshold: Significant abnormalities may indicate bone marrow suppression (rare).

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Symptom Monitoring

  • Severe diarrhea (may indicate C. difficile-associated diarrhea)
  • New or worsening headache, blurred vision, double vision, or vision loss (signs of pseudotumor cerebri)
  • Severe skin rash, blistering, or peeling (signs of severe cutaneous adverse reactions like SJS/TEN)
  • Yellowing of skin or eyes, dark urine, persistent nausea/vomiting (signs of hepatotoxicity)
  • Severe sunburn reaction (photosensitivity)
  • Difficulty swallowing, chest pain, or irritation (esophageal irritation)

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.

Trimester-Specific Risks:

First Trimester: Potential for skeletal and limb abnormalities, though data are limited and conflicting. Generally avoided.
Second Trimester: High risk of permanent tooth discoloration (enamel hypoplasia) and inhibition of bone growth in the fetus.
Third Trimester: High risk of permanent tooth discoloration (enamel hypoplasia) and inhibition of bone growth in the fetus.
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Lactation

Doxycycline is excreted into breast milk. While the amount is generally low and calcium in milk may chelate the drug, limiting infant absorption, there is a theoretical risk of tooth discoloration and bone effects in the nursing infant. The American Academy of Pediatrics considers tetracyclines compatible with breastfeeding with caution. Use with caution, monitor infant for diarrhea or candidiasis.

Infant Risk: L3 (Moderately safe) - Low risk of adverse effects, but theoretical risk of tooth discoloration and inhibition of bone growth. Monitor infant for diarrhea, candidiasis, or rash.
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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 reversible inhibition of bone growth. Use in children 8 years and older should be carefully weighed against the benefits, especially for long-term use.

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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, although doxycycline's primary non-renal excretion makes it a safer option for renal impairment compared to other tetracyclines.

Clinical Information

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Clinical Pearls

  • Doxycycline monohydrate is generally better tolerated gastrointestinally than doxycycline hyclate and is less affected by food/dairy, making it a preferred formulation for many patients.
  • Always advise patients to take with a full glass of water and 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 does not accumulate significantly in patients with renal impairment, making it a suitable choice for this population.
  • For acne and rosacea, lower doses (e.g., 20 mg twice daily or 40 mg once daily extended-release) are often used for their anti-inflammatory effects, rather than their antimicrobial effects, to minimize resistance and side effects.
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Alternative Therapies

  • Other tetracyclines (e.g., minocycline, tetracycline)
  • Macrolides (e.g., azithromycin, erythromycin) for certain infections
  • Beta-lactam antibiotics (e.g., penicillins, cephalosporins) for susceptible bacterial infections
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for susceptible bacterial infections
  • Topical or oral retinoids (for acne/rosacea)
  • Topical antibiotics (for acne/rosacea)
  • Metronidazole (for rosacea)
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Cost & Coverage

Average Cost: $30 - $150 per 30 tablets
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.