Doxycycline Monohydrate 150mg Caps

Manufacturer STRIDES 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
D
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FDA Approved
Jun 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, such as acne, urinary tract infections, respiratory infections, and certain sexually transmitted diseases. It works by stopping the growth of bacteria. It can also be used to prevent malaria.
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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 to you and follow the instructions closely. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.

Some medications work best when taken with food or on an empty stomach. Check with your pharmacist to determine the best way to take your medication. It's generally recommended to avoid taking this medication at the same time as milk, dairy products, or other calcium-rich foods, as this may reduce its effectiveness. If you have any questions, consult with your doctor or pharmacist.

Additional Guidelines

Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Avoid taking certain medications or supplements within 2 hours of taking this medication, including:
+ Bismuth (Pepto-Bismol)
+ Calcium
+ Iron
+ Magnesium
+ Zinc
+ Multivitamins with minerals
+ Colestipol
+ Cholestyramine
+ Didanosine
+ 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 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 to make up for a missed one.
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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 30-60 minutes after taking the dose to prevent esophageal irritation.
  • Avoid taking antacids, iron supplements, calcium supplements, or dairy products within 2-3 hours before or after your doxycycline dose, as they can interfere with absorption.
  • Avoid excessive sun exposure and use sunscreen (SPF 30+) 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 antibiotic resistance and ensure the infection is fully treated.
  • If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double doses.

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: 50 mg once daily or 20 mg twice daily (subantimicrobial dose)
Malaria Prophylaxis: 100 mg once daily, starting 1-2 days before travel, continuing for 4 weeks after return
Lyme Disease: 100 mg twice daily for 10-21 days
Rosacea: 20 mg twice daily or 40 mg once daily (delayed-release)
Anthrax (post-exposure): 100 mg twice daily for 60 days
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Pediatric Dosing

Neonatal: Not established (contraindicated due to tooth discoloration and bone effects)
Infant: Not established (contraindicated due to tooth discoloration and bone effects)
Child: Children > 8 years and weighing < 45 kg: 4.4 mg/kg/day divided into 2 doses on day 1, then 2.2 mg/kg/day divided into 1-2 doses. Max 100 mg/day. For severe infections, up to 4.4 mg/kg/day. Children > 8 years and weighing â‰Ĩ 45 kg: Adult dose.
Adolescent: Adult dose (if > 8 years old)
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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 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. Dosage reduction may be considered, but not well-defined.

Pharmacology

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Mechanism of Action

Doxycycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by reversibly binding to the 30S ribosomal subunit, thereby preventing the attachment of aminoacyl-tRNA to the ribosomal acceptor site. This action prevents the addition of new amino acids to the growing peptide chain, leading to bacteriostatic effects.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 1.5-4 hours
FoodEffect: Food (especially dairy products, calcium, iron, magnesium, aluminum-containing antacids) can decrease absorption, but less so than other tetracyclines. Doxycycline monohydrate is generally less affected by food than doxycycline hyclate. It is recommended to take with food or milk if GI upset occurs, but avoid dairy/antacids/iron within 2-3 hours of dose.

Distribution:

Vd: 0.7 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (increases with meningeal inflammation)

Elimination:

HalfLife: 16-22 hours (can be up to 24 hours)
Clearance: Not readily available, but primarily non-renal.
ExcretionRoute: Fecal (via intestinal secretion) and urinary (renal filtration).
Unchanged: Approximately 40% excreted unchanged in urine, 60% in feces.
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Pharmacodynamics

OnsetOfAction: Variable, depends on infection type and site. Antibacterial effects begin rapidly after therapeutic concentrations are reached.
PeakEffect: Achieved at Tmax (1.5-4 hours).
DurationOfAction: Due to its long half-life, allows for once or twice daily dosing.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention 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 help 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
Diarrhea, especially if it is severe or accompanied by stomach pain, cramps, or bloody stools (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 immediately. Additionally, if you develop a headache or eyesight problems, such as blurred vision, double vision, or loss of vision, seek medical attention right away, as raised pressure in the brain (a rare but potentially serious side effect) may occur.

Common Side Effects

Most people taking this medication do not experience severe side effects. However, some may encounter mild or moderate side effects, including:

Diarrhea
Upset stomach or vomiting
* Decreased appetite

If any of these side effects bother you or persist, contact your doctor for guidance.

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, double vision (signs of increased pressure in the brain)
  • Severe skin rash, blistering, peeling skin
  • Severe stomach pain, watery or bloody diarrhea (may be a sign of C. difficile infection)
  • Yellowing of the skin or eyes (jaundice), dark urine, unusual tiredness (signs of liver problems)
  • Difficulty swallowing, painful swallowing, or chest pain (signs of esophageal irritation)
  • Unusual bleeding or bruising
  • Signs of a new infection (fever, sore throat, chills)
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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 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.

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 laboratory personnel that you are taking this drug. Do not exceed the recommended 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 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 birth control methods, 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.

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 may also experience tooth discoloration, which may be reversible after stopping the medication and undergoing dental cleaning. Discuss any concerns 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 Poison Control at 1-800-222-1222. Treatment is generally supportive.

Drug Interactions

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Major Interactions

  • Isotretinoin, Acitretin, Tretinoin (oral): 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.
  • Penicillins: May interfere with the bactericidal action of penicillin (antagonistic effect).
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Moderate Interactions

  • Antacids (aluminum, calcium, magnesium), Iron supplements, Bismuth subsalicylate, Zinc supplements: Decreased absorption of doxycycline due to chelation. 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 (monitor INR).
  • Barbiturates (e.g., Phenobarbital), Carbamazepine, Phenytoin: May decrease doxycycline half-life due to enzyme induction.
  • Methotrexate: May increase methotrexate levels (monitor for toxicity).
  • Ergot alkaloids: Theoretical increased risk of ergotism.
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Minor Interactions

  • Cholestyramine: May decrease doxycycline absorption (separate administration).

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease, as doxycycline can rarely cause hepatotoxicity.

Timing: Before initiating therapy, if clinically indicated.

Renal function tests (creatinine, BUN)

Rationale: To assess baseline renal function, though dosage adjustment is not typically needed for renal impairment, it's good practice.

Timing: Before initiating therapy, if clinically indicated.

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Routine Monitoring

INR (International Normalized Ratio)

Frequency: Regularly, as clinically indicated

Target: Therapeutic range for patient's condition

Action Threshold: If INR increases significantly, consider doxycycline as a contributing factor and adjust warfarin dose.

Signs of pseudotumor cerebri (benign intracranial hypertension)

Frequency: Throughout therapy, especially if co-administered with retinoids

Target: N/A

Action Threshold: Headache, blurred vision, diplopia, papilledema. Discontinue doxycycline immediately.

Signs of C. difficile-associated diarrhea (CDAD)

Frequency: Throughout and after therapy

Target: N/A

Action Threshold: Persistent diarrhea, abdominal pain, fever. Discontinue doxycycline and initiate appropriate treatment.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Esophageal irritation/dysphagia
  • Photosensitivity (severe sunburn-like reaction)
  • Headache
  • Blurred vision
  • Dizziness
  • Rash
  • Vaginal yeast infection
  • Oral thrush

Special Patient Groups

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Pregnancy

Doxycycline is 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.

Trimester-Specific Risks:

First Trimester: Potential for skeletal and limb abnormalities, though less established than dental effects. 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, 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 for short-term use. Monitor infant for diarrhea, candidiasis, or tooth discoloration. Use with caution, especially for prolonged courses.

Infant Risk: L3 - Moderate risk. Potential for tooth discoloration and inhibition of bone growth, though unlikely with typical short-term use due to low milk levels and calcium binding. Monitor infant for GI upset 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 inhibition of bone growth. In children > 8 years, use with caution and only when other antibiotics are not suitable, and for the shortest duration possible. Dosing is weight-based for children < 45 kg.

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Geriatric Use

No specific dosage adjustment is generally required based on age alone. However, elderly patients may be more susceptible to adverse effects such as esophageal irritation or C. difficile infection. Monitor renal and hepatic function, and ensure adequate hydration.

Clinical Information

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Clinical Pearls

  • Doxycycline monohydrate is generally associated with less esophageal irritation and GI upset compared to doxycycline hyclate, making it a preferred formulation for some patients.
  • Always advise patients to take doxycycline with a full glass of water and remain upright for at least 30-60 minutes to minimize the risk of esophageal ulceration.
  • Photosensitivity is a common side effect; counsel patients on sun protection (sunscreen, protective clothing, avoiding peak sun hours).
  • Despite being a tetracycline, doxycycline is primarily eliminated via non-renal routes, making it a suitable option for patients with renal impairment without dose adjustment.
  • Doxycycline has anti-inflammatory properties at sub-antimicrobial doses (e.g., 20 mg BID or 40 mg once daily delayed-release), which are utilized in conditions like rosacea and acne without significant antibacterial effects.
  • Be aware of the potential for benign intracranial hypertension (pseudotumor cerebri), especially when co-administered with retinoids. Counsel patients on symptoms like headache and visual disturbances.
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Alternative Therapies

  • Minocycline (another tetracycline, similar spectrum but higher risk of dizziness/vertigo)
  • Azithromycin (for some respiratory/skin infections, STIs)
  • Amoxicillin (for Lyme disease, some respiratory infections)
  • Ciprofloxacin (for anthrax, some severe infections)
  • Clindamycin (for skin/soft tissue infections, acne)
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Cost & Coverage

Average Cost: $20 - $100+ per 30 capsules (150mg)
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's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.