Doxycycline Hyclate 100mg Inj, 1 Vl

Manufacturer ZYDUS PHARMACEUTICALS (USA) Active Ingredient Doxycycline Injection(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 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
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 that fights bacteria in your body. It's used to treat many different types of infections, including skin, urinary tract, respiratory, and sexually transmitted infections. When given as an injection, it's usually for more serious infections or when you can't take medicine by mouth.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a specified period.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Avoid prolonged exposure to natural or artificial sunlight (e.g., tanning beds) while taking this medication and for several days after stopping, as it can cause severe sunburn (photosensitivity). Use sunscreen and wear protective clothing.
  • Report any new or worsening diarrhea, especially if severe or bloody, as it could be a sign of a serious infection (C. difficile).
  • Report any unusual headaches, blurred vision, or dizziness immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 200 mg on the first day (100 mg every 12 hours) by intravenous infusion. Maintenance: 100 mg to 200 mg per day (100 mg once daily or 100 mg every 12 hours) by intravenous infusion.
Dose Range: 100 - 200 mg

Condition-Specific Dosing:

Severe Infections: 200 mg per day (100 mg every 12 hours) by intravenous infusion.
Anthrax (inhalation, post-exposure): 100 mg every 12 hours for 60 days.
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Pediatric Dosing

Neonatal: Not established (generally contraindicated due to tooth discoloration and bone effects).
Infant: Not established (generally contraindicated due to tooth discoloration and bone effects).
Child: For children 8 years of age and older (and weighing less than 45 kg): Initial: 4.4 mg/kg on the first day (2.2 mg/kg every 12 hours) by intravenous infusion. Maintenance: 2.2 mg/kg per day (1.1 mg/kg every 12 hours) by intravenous infusion. For severe infections, up to 4.4 mg/kg per day. For children 8 years of age and older (and weighing 45 kg or more): Adult dose.
Adolescent: Adult dose (100 mg to 200 mg per day).
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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 non-renal routes).
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis; no supplemental dose needed.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: Use with caution; monitor for signs of hepatotoxicity.
Severe: Use with caution; monitor for signs of hepatotoxicity. Doxycycline is concentrated in the liver and excreted in bile.

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 binding 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: Not applicable (IV administration). Oral bioavailability is high (90-100%).
Tmax: Not applicable (IV administration). Peak plasma concentrations are achieved rapidly after IV infusion.
FoodEffect: Not applicable (IV administration).

Distribution:

Vd: Approximately 0.75 L/kg (widely distributed into body tissues and fluids, including pleural fluid, peritoneal fluid, synovial fluid, and saliva).
ProteinBinding: Approximately 80-95%
CnssPenetration: Limited (low concentrations in CSF, but increases in the presence of inflamed meninges).

Elimination:

HalfLife: 16-24 hours (can be prolonged in severe hepatic impairment).
Clearance: Approximately 0.6-0.8 mL/min/kg.
ExcretionRoute: Primarily excreted unchanged in the feces via intestinal secretion and in the urine.
Unchanged: Approximately 40% in urine, 60% in feces.
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Pharmacodynamics

OnsetOfAction: Rapid (achieves therapeutic concentrations quickly after IV infusion).
PeakEffect: Within 1-2 hours after completion of infusion.
DurationOfAction: Sustained therapeutic levels due to long half-life, 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 medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of pancreatitis (pancreas problems), 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 or difficulty 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. However, in rare cases, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) may occur. This condition can lead to life-threatening bowel problems. 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 headaches or vision problems, such as blurred vision, double vision, or loss of vision, contact your doctor right away.

Other Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. 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 an exhaustive 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 skin rash or blistering
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Persistent nausea or vomiting
  • Severe abdominal pain
  • Severe, watery, or bloody diarrhea
  • Unusual headache, vision changes (blurred vision, double vision, loss of vision), or dizziness
  • Signs of allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
  • Injection site pain, redness, or swelling that worsens
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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 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 existing 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.

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 can cause permanent tooth discoloration, turning teeth yellow-gray brown. This effect can also occur in unborn babies if the mother takes the drug during certain stages of pregnancy. Other tooth problems and impaired bone growth may also occur in these individuals. 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.

Adults may also experience tooth discoloration, but this effect is usually reversible 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
  • Hepatotoxicity (rare)
  • Renal toxicity (rare)

What to Do:

There is no specific antidote. Treatment is symptomatic and supportive. Doxycycline is not effectively removed by hemodialysis. Call 1-800-222-1222 (Poison Control Center) immediately.

Drug Interactions

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Major Interactions

  • Antacids containing aluminum, calcium, or magnesium (may decrease doxycycline absorption if given orally, but less relevant for IV form, still caution with oral co-administration)
  • Iron preparations (may decrease doxycycline absorption if given orally, less relevant for IV form)
  • Bismuth subsalicylate (may decrease doxycycline absorption if given orally, less relevant for IV form)
  • Oral retinoids (e.g., isotretinoin, acitretin) - increased risk of pseudotumor cerebri (benign intracranial hypertension)
  • Penicillins (tetracyclines may interfere with the bactericidal action of penicillins; avoid concomitant use)
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Moderate Interactions

  • Warfarin and other anticoagulants (doxycycline may potentiate anticoagulant effects; monitor INR/PT)
  • Barbiturates (e.g., phenobarbital), phenytoin, carbamazepine (may decrease doxycycline half-life by inducing hepatic enzymes)
  • Oral contraceptives (may decrease efficacy of oral contraceptives; advise backup contraception)
  • Methotrexate (may increase methotrexate toxicity due to displacement from protein binding or reduced renal elimination)
  • Live bacterial vaccines (e.g., typhoid vaccine) - doxycycline may reduce the therapeutic effect of the vaccine
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Minor Interactions

  • Digoxin (may increase digoxin levels in some patients due to altered gut flora)
  • Ergot alkaloids (theoretical risk of increased ergot toxicity)

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To establish baseline hematologic status and monitor for potential blood dyscrasias with prolonged therapy.

Timing: Prior to initiation of therapy, especially for prolonged courses.

Liver Function Tests (LFTs)

Rationale: To establish baseline hepatic function and monitor for potential hepatotoxicity, especially in patients with pre-existing hepatic impairment or on prolonged therapy.

Timing: Prior to initiation of therapy, especially for prolonged courses or in at-risk patients.

Renal Function Tests (Creatinine, BUN)

Rationale: To establish baseline renal function, although doxycycline is not primarily renally eliminated, it's good practice for antibiotic therapy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Signs of Superinfection (e.g., C. difficile-associated diarrhea, candidiasis)

Frequency: Daily during therapy and for several weeks post-therapy.

Target: Absence of new or worsening symptoms.

Action Threshold: Development of severe diarrhea, oral thrush, or vaginal yeast infection; discontinue doxycycline and initiate appropriate treatment.

Intracranial Pressure (ICP) / Pseudotumor Cerebri symptoms (e.g., headache, blurred vision, papilledema)

Frequency: Periodically, especially in patients with pre-existing conditions or on concomitant medications that increase ICP.

Target: Absence of symptoms.

Action Threshold: Development of symptoms; discontinue doxycycline and refer for neurological evaluation.

Injection Site Reactions (e.g., phlebitis, pain, erythema)

Frequency: Daily during IV infusion.

Target: Absence of significant local reactions.

Action Threshold: Significant pain, swelling, or redness at infusion site; consider slowing infusion rate, changing site, or discontinuing IV.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Photosensitivity (severe sunburn-like reaction)
  • Headache
  • Blurred vision
  • Dizziness
  • Injection site pain/redness/swelling
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)

Special Patient Groups

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Pregnancy

Doxycycline is contraindicated in pregnancy (Category D). It can cause permanent discoloration of teeth (yellow-gray-brown) and reversible 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 tooth discoloration and bone growth inhibition if exposure occurs during tooth and bone development.
Second Trimester: High risk of permanent tooth discoloration and enamel hypoplasia, and reversible inhibition of bone growth.
Third Trimester: High risk of permanent tooth discoloration and enamel hypoplasia, and reversible inhibition of bone growth.
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Lactation

Doxycycline is excreted into breast milk. While the amount transferred is generally low and absorption by the infant is limited due to chelation with calcium in milk, the potential for tooth discoloration and inhibition of bone growth in the infant exists. The American Academy of Pediatrics considers tetracyclines compatible with breastfeeding for short-term use. Use with caution, monitor infant for diarrhea or candidiasis. L3 (Moderately Safe).

Infant Risk: Low risk for short-term use, but theoretical risk of tooth discoloration and bone effects with prolonged or repeated exposure. Monitor for diarrhea, candidiasis (thrush, diaper rash).
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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. Use in this age group should be reserved for severe or life-threatening conditions where the benefits outweigh the risks (e.g., anthrax, Rocky Mountain spotted fever).

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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 as photosensitivity or gastrointestinal disturbances. Monitor renal and hepatic function, and hydration status.

Clinical Information

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Clinical Pearls

  • IV doxycycline must be infused slowly (over 1-4 hours) to minimize the risk of phlebitis and other injection site reactions. Rapid infusion can cause severe irritation.
  • Ensure adequate hydration during therapy to prevent esophageal irritation (though less common with IV, still a general tetracycline precaution).
  • Doxycycline is effective against a broad spectrum of bacteria, including atypical organisms (Mycoplasma, Chlamydia), spirochetes (Lyme disease), and rickettsiae.
  • Unlike other tetracyclines, doxycycline does not accumulate significantly in patients with renal impairment, making it a preferred tetracycline in this population.
  • Always check for pregnancy status before initiating doxycycline in women of childbearing potential due to its Category D status.
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Alternative Therapies

  • Azithromycin (for atypical pneumonia, some STIs)
  • Levofloxacin (for respiratory tract infections, skin infections)
  • Ceftriaxone (for some STIs, severe bacterial infections)
  • Amoxicillin/Clavulanate (for some skin and respiratory infections)
  • Clindamycin (for some skin and soft tissue infections, anaerobic infections)
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Cost & Coverage

Average Cost: $50 - $200 per 100mg vial (estimated)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure your safety and the safety of others, never share your medication with anyone, and do not take medication prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it was taken, to ensure you receive appropriate care.