Doryx Mpc 60mg Tablets

Manufacturer MAYNE PHARMA Active Ingredient Doxycycline Delayed-Release Tablets(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
Jun 1967
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Doxycycline is an antibiotic that treats various bacterial infections. Doryx MPC 60mg is a specific formulation often used to treat the bumps and redness of rosacea, a skin condition. It works by reducing inflammation.
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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 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 medication's effectiveness. If you have questions, consult with your doctor or pharmacist.
Drink plenty of non-caffeinated liquids, unless your doctor has advised you to limit your fluid intake.

Interactions with Other Medications and Substances

Do not take the following medications or substances within 2 hours of taking your 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.
After taking your medication, do not lie down for a period of time, as this can help reduce the risk of throat irritation. Ask your pharmacist for guidance on how long to wait before lying down.

Swallowing and Handling Your Medication

Swallow your medication whole; do not chew or crush it.
If your doctor instructs you to break the tablet, you may do so.
You may also sprinkle the contents of the tablet onto applesauce, but be careful not to crush the pellets. Do not chew, crush, or damage the contents of the tablet.
Do not mix the medication with hot applesauce.
If you mix the medication with applesauce, swallow it immediately and do not store it for later use.

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 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.
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Lifestyle & Tips

  • Take the tablet whole with a full glass of water to prevent esophageal irritation. Do not crush, chew, or break the tablet.
  • Remain upright for at least 30 minutes (preferably 1 hour) after taking the medication to prevent esophageal irritation.
  • Avoid excessive exposure to sunlight or artificial UV light (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.
  • Avoid taking antacids, iron supplements, calcium supplements, or dairy products within 2-3 hours of taking Doryx MPC, as they can interfere with absorption.
  • If you are taking oral contraceptives, consider using a backup birth control method, as doxycycline may potentially reduce their effectiveness (though evidence is weak).

Dosing & Administration

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Adult Dosing

Standard Dose: 60 mg once daily for inflammatory lesions of rosacea
Dose Range: 60 - 60 mg

Condition-Specific Dosing:

rosacea: 60 mg once daily (Doryx MPC 60mg is specifically indicated for this)
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Pediatric Dosing

Neonatal: Not established (contraindicated due to tooth discoloration and bone growth inhibition)
Infant: Not established (contraindicated due to tooth discoloration and bone growth inhibition)
Child: Not recommended for children under 8 years of age due to tooth discoloration and bone growth inhibition, except for severe or life-threatening infections (e.g., anthrax, Rocky Mountain spotted fever) where benefits outweigh risks. Dosing for such cases is typically 2.2 mg/kg/dose every 12 hours.
Adolescent: For adolescents â‰Ĩ 8 years of age, dosing is similar to adults, typically 100 mg every 12-24 hours for infections, or 60 mg once daily for rosacea.
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment typically needed.
Moderate: No dose adjustment typically needed.
Severe: No dose adjustment typically needed, as doxycycline is primarily eliminated via non-renal pathways.
Dialysis: Not significantly removed by hemodialysis. No supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Use with caution; monitor for adverse effects. Dose adjustment may be considered in severe cases.
Severe: Use with caution; monitor for adverse effects. Dose adjustment may be considered.

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 binding of aminoacyl tRNA to the mRNA-ribosome complex. This action is bacteriostatic. In the context of rosacea, doxycycline also exhibits anti-inflammatory properties by inhibiting matrix metalloproteinases (MMPs), lipase activity, and nitric oxide synthase, independent of its antimicrobial effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100% (oral)
Tmax: 2-3 hours (for standard formulations); Doryx MPC (delayed-release) may have a slightly delayed Tmax.
FoodEffect: Absorption is generally not significantly affected by food or milk for doxycycline, unlike other tetracyclines. However, Doryx MPC is designed to be taken with or without food, but taking with food may reduce gastrointestinal irritation.

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
Clearance: Not readily available, but primarily non-renal.
ExcretionRoute: Primarily fecal (via bile and direct intestinal secretion); minor renal excretion.
Unchanged: Approximately 40% (fecal), 10-20% (renal)
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Pharmacodynamics

OnsetOfAction: Variable, depending on indication (e.g., antimicrobial effects within hours, anti-inflammatory effects for rosacea may take weeks)
PeakEffect: Variable
DurationOfAction: 24 hours (due to long half-life, allows once-daily dosing)

Safety & Warnings

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Side Effects

Serious 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
Fast 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

Important: Antibiotic-Associated Diarrhea

Diarrhea is a common side effect of antibiotics. However, 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, seek medical attention right away.

Other Side Effects

Most people do not experience significant side effects or only have mild side effects. 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
Vomiting
* Decreased appetite

Reporting Side Effects

If you have questions about side effects or want to report any side effects, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects 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 persistent diarrhea, especially if bloody or watery (may indicate C. difficile infection)
  • Severe skin rash, blistering, or peeling (signs of severe skin reactions like SJS/TEN)
  • Yellowing of the skin or eyes (jaundice), dark urine, or severe stomach pain (signs of liver problems)
  • Signs of an allergic reaction (e.g., hives, difficulty breathing, swelling of face/lips/tongue/throat)
  • New or worsening muscle weakness or difficulty swallowing (rare, but possible in patients with myasthenia gravis)
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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 nursing 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 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 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.

This drug can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions that may 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 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. Similarly, 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 may be at risk of harming the unborn baby. Contact your doctor immediately to discuss the potential risks and necessary precautions.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Liver toxicity (rare)
  • Renal toxicity (rare)

What to Do:

There is no specific antidote for doxycycline overdose. Treatment is symptomatic and supportive. Gastric lavage may be considered if ingestion is recent. Dialysis is not effective in removing doxycycline. Call 1-800-222-1222 (Poison Control Center) immediately.

Drug Interactions

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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., isotretinoin, acitretin) (increased risk of pseudotumor cerebri/intracranial hypertension)
  • Warfarin (enhanced anticoagulant effect)
  • Penicillins (tetracyclines may interfere with the bactericidal action of penicillins)
  • Live bacterial vaccines (e.g., oral typhoid vaccine) (decreased vaccine efficacy)
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Moderate Interactions

  • Barbiturates (e.g., phenobarbital) (decreased doxycycline half-life)
  • Phenytoin (decreased doxycycline half-life)
  • Carbamazepine (decreased doxycycline half-life)
  • Oral contraceptives (potential for decreased contraceptive efficacy, though evidence is weak; advise backup method)
  • Sucralfate (decreased doxycycline absorption)

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: Although primarily non-renally eliminated, baseline assessment is prudent, especially in patients with pre-existing renal impairment or those on prolonged therapy.

Timing: Prior to initiation of prolonged therapy

Hepatic function (ALT, AST, bilirubin)

Rationale: Doxycycline is metabolized in the liver; baseline assessment is prudent, especially in patients with pre-existing hepatic impairment or those on prolonged therapy.

Timing: Prior to initiation of prolonged therapy

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Routine Monitoring

Clinical response to therapy

Frequency: Regularly throughout treatment

Target: Resolution of infection symptoms or improvement in rosacea lesions

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistance, requiring re-evaluation.

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

Frequency: Daily, especially during initial weeks of therapy

Target: Absence or mild, tolerable symptoms

Action Threshold: Severe or persistent GI upset, severe photosensitivity reaction, signs of intracranial hypertension (e.g., severe headache, blurred vision, diplopia), or severe rash (e.g., SJS/TEN) require immediate medical attention and potential discontinuation.

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Symptom Monitoring

  • Gastrointestinal upset (nausea, vomiting, diarrhea)
  • Photosensitivity (severe sunburn-like reaction upon sun exposure)
  • Headache (especially severe or persistent)
  • Blurred vision or double vision (diplopia)
  • Dizziness or lightheadedness
  • Rash or hives
  • Difficulty swallowing or painful swallowing (esophageal irritation)
  • Vaginal yeast infection (in females)
  • Oral thrush

Special Patient Groups

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Pregnancy

Category D. Doxycycline can cause permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia in the fetus if used during the second and third trimesters. It can also cause reversible inhibition of bone growth. Avoid use during pregnancy unless the potential benefit justifies the potential risk to the fetus (e.g., for severe, life-threatening infections where safer alternatives are not available or effective).

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided due to potential for teratogenicity, though risk is lower than later trimesters for dental/bone effects.
Second Trimester: High risk of permanent tooth discoloration and enamel hypoplasia in the fetus; reversible inhibition of bone growth.
Third Trimester: High risk of permanent tooth discoloration and enamel hypoplasia in the fetus; reversible inhibition of bone growth.
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Lactation

L3 (Moderate Risk). Doxycycline is excreted into breast milk. While the amount transferred is generally low and binding to calcium in milk may limit absorption by the infant, there is a theoretical risk of tooth discoloration and inhibition of bone growth in the nursing infant, especially with long-term or repeated use. Short-term use (e.g., <3 weeks) is generally considered compatible by some experts, but monitor the infant for diarrhea, candidiasis, and tooth discoloration. Consider alternative agents or temporary interruption of breastfeeding if prolonged therapy is needed.

Infant Risk: Potential for tooth discoloration, inhibition of bone growth, gastrointestinal upset (diarrhea), and candidiasis (thrush, diaper rash).
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Pediatric Use

Contraindicated in children under 8 years of age for long-term use due to the risk of permanent tooth discoloration (yellow-gray-brown) and reversible inhibition of bone growth. Use in children under 8 should be reserved for severe or life-threatening infections (e.g., anthrax, Rocky Mountain spotted fever) where the benefits outweigh these risks and no safer alternative is available.

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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, and assess for polypharmacy and potential drug interactions.

Clinical Information

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Clinical Pearls

  • Doryx MPC is a delayed-release formulation designed to reduce gastrointestinal irritation and improve tolerability compared to immediate-release doxycycline.
  • Always advise patients to take doxycycline with a full glass of water and remain upright for at least 30 minutes (preferably 1 hour) to prevent esophageal irritation and ulceration.
  • Photosensitivity is a common and significant side effect; counsel patients on strict sun avoidance, protective clothing, and high-SPF sunscreen.
  • Doxycycline's anti-inflammatory properties make it useful for conditions like rosacea, even at sub-antimicrobial doses (e.g., 20mg BID or 40mg once daily, or 60mg once daily for Doryx MPC).
  • Avoid co-administration with antacids, iron, calcium, or dairy products due to chelation and reduced absorption. Separate administration by at least 2-3 hours.
  • Despite its broad-spectrum activity, doxycycline is not effective against viral infections.
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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 certain infections)
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin - for certain infections)
  • For rosacea: topical metronidazole, azelaic acid, ivermectin; oral isotretinoin (severe cases); other oral antibiotics (e.g., azithromycin, metronidazole).
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Cost & Coverage

Average Cost: Varies widely, typically $50 - $300+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 for brand, Tier 1 for 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 details. 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 for clarification. 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 information about the medication taken, the amount, and the time it happened, as this will aid in your care.