Doryx Mpc 120mg Tablets

Manufacturer MAYNE PHARMA Active Ingredient Doxycycline Delayed-Release Tablets(doks i SYE kleen) Pronunciation DOR-iks EM-Pee-See (for Doryx MPC); doks-i-SYE-kleen (for Doxycycline)
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
Jan 1967
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Doryx MPC is an antibiotic used to treat various bacterial infections, including certain skin conditions like acne and rosacea. It works by stopping the growth of bacteria. It's a delayed-release tablet, which means it's designed to release the medicine slowly in your body to help reduce stomach upset.
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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 exactly. 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 instructed you to limit your fluid intake.

Important Interactions to Avoid

Do not take the following medications 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.
After taking your medication, do not lie down for a period of time to reduce the risk of throat irritation. Ask your pharmacist for specific guidance on how long to wait before lying down.

Swallowing 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 with a full glass of water (at least 8 ounces) to prevent esophageal irritation and ulceration.
  • Remain upright for at least 30 minutes (preferably 1 hour) after taking the dose to prevent esophageal irritation.
  • Take with food or milk if stomach upset occurs, as Doryx MPC is formulated to be taken with food.
  • Avoid excessive exposure to sunlight or artificial UV light (tanning beds) while taking this medication and for several days after stopping it, as it can cause severe sunburn (photosensitivity). Use sunscreen and wear protective clothing.
  • Avoid taking antacids, iron supplements, calcium supplements, or laxatives containing magnesium or aluminum within 2-3 hours of taking Doryx MPC, as they can interfere with absorption. If you must take them, separate the doses.
  • Do not crush, chew, or break the tablets; swallow them whole.
  • Complete the full course of medication as prescribed, even if symptoms improve, to prevent antibiotic resistance and recurrence of infection.

Dosing & Administration

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Adult Dosing

Standard Dose: 120 mg once daily
Dose Range: 120 - 120 mg

Condition-Specific Dosing:

Acne Vulgaris (moderate to severe): 120 mg once daily
Rosacea (inflammatory lesions): 120 mg once daily
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Pediatric Dosing

Neonatal: Not established (contraindicated due to teeth discoloration)
Infant: Not established (contraindicated due to teeth discoloration)
Child: Not recommended for children under 8 years due to risk of permanent tooth discoloration and enamel hypoplasia. For children 8 years and older, dosing is typically 2-4 mg/kg/day divided into 1-2 doses, up to adult dose, for specific indications.
Adolescent: For adolescents 8 years and older, dosing is typically 2-4 mg/kg/day divided into 1-2 doses, up to adult dose. For acne/rosacea, 120 mg once daily may be used if appropriate for weight/age.
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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: No adjustment needed; not significantly removed by hemodialysis or peritoneal dialysis.

Hepatic Impairment:

Mild: Use with caution
Moderate: Use with caution; monitor for signs of hepatotoxicity. Dose reduction may be considered.
Severe: Use with caution; monitor for signs of hepatotoxicity. Dose reduction may be considered.

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 transfer RNA to the messenger RNA-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: 2-4 hours (for delayed-release formulations)
FoodEffect: Absorption is not significantly affected by food or milk for Doryx MPC, which is designed to minimize gastrointestinal upset when taken with food. However, other doxycycline formulations may have reduced absorption with dairy products or antacids.

Distribution:

Vd: 0.7 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (poor penetration into CSF unless meninges are inflamed)

Elimination:

HalfLife: 16-22 hours
Clearance: Not available (primarily non-renal excretion)
ExcretionRoute: Primarily fecal (via intestinal secretion and bile), with a smaller portion excreted renally.
Unchanged: Approximately 40-60% (fecal), 20-30% (renal)
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Pharmacodynamics

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

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
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 may 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 symptoms. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Diarrhea
Upset stomach
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 or watery diarrhea, especially if persistent or bloody (may indicate C. difficile infection)
  • New or worsening headache, blurred vision, or vision loss (may indicate pseudotumor cerebri/idiopathic intracranial hypertension)
  • Severe skin rash, blistering, or peeling (may indicate severe skin reaction)
  • Yellowing of the skin or eyes (jaundice), dark urine, or severe stomach pain (signs of liver problems)
  • Unusual bruising or bleeding
  • Signs of a new infection (e.g., fever, sore throat, chills) that do not improve
  • Swelling of the face, lips, tongue, or throat; difficulty breathing (signs of allergic reaction)
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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 breast-feeding or plan to breast-feed, as you may need to avoid doing so while taking this medication.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

with your doctor and pharmacist. They will help determine whether it is safe for you to take this medication in combination with your other medications and health conditions. Never 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 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. This can also occur in unborn babies if the medication is taken during certain stages of pregnancy. Other tooth problems and effects on bone growth have 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 concerns, discuss them with your doctor.

If you are pregnant or become pregnant while taking this medication, there is a risk of harm to the unborn baby. If you are pregnant or suspect you may be pregnant, contact your doctor immediately.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Liver damage (rare, with very high doses)

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center. Call 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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Contraindicated Interactions

  • Isotretinoin (risk of pseudotumor cerebri)
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Major Interactions

  • Antacids (containing aluminum, calcium, magnesium): Decreased doxycycline absorption.
  • Iron preparations: Decreased doxycycline absorption.
  • Bismuth subsalicylate: Decreased doxycycline absorption.
  • Warfarin: May potentiate anticoagulant effect (monitor INR).
  • Penicillins: May interfere with the bactericidal action of penicillin (avoid concomitant use).
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Moderate Interactions

  • Oral contraceptives: May reduce efficacy of oral contraceptives (though evidence is controversial, advise backup contraception).
  • Barbiturates (e.g., phenobarbital): May decrease doxycycline half-life.
  • Carbamazepine: May decrease doxycycline half-life.
  • Phenytoin: May decrease doxycycline half-life.
  • Methotrexate: May increase methotrexate toxicity (rare, but monitor).
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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, given potential for hepatotoxicity.

Timing: Prior to initiation in patients with hepatic impairment or prolonged therapy.

Renal function tests (RFTs)

Rationale: To assess baseline renal function, though dose adjustment is generally not needed, it's good practice for overall patient assessment.

Timing: Prior to initiation in patients with renal impairment or prolonged therapy.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily/as needed

Target: Improvement in infection/condition

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

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

Frequency: Daily/as needed

Target: Absence or mild, tolerable effects

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

INR (if on warfarin)

Frequency: Regularly, especially at initiation and dose changes

Target: Therapeutic range for warfarin

Action Threshold: INR outside target range requires warfarin dose adjustment.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Photosensitivity (severe sunburn-like reaction)
  • Rash
  • Headache (especially severe, persistent, or with vision changes, suggestive of pseudotumor cerebri)
  • Vaginal yeast infection (candidiasis)
  • Oral thrush
  • Signs of superinfection (e.g., new or worsening diarrhea, fever, abdominal cramps, pus or blood in stool - suggestive of C. difficile-associated diarrhea)

Special Patient Groups

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Pregnancy

Doxycycline is classified as Pregnancy Category D. It should not be used in pregnant women unless the potential benefits outweigh the risks. Tetracyclines can cause permanent discoloration of teeth (yellow-gray-brown) and enamel hypoplasia in the fetus if used during the second and third trimesters. They can also cause reversible inhibition of bone growth.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for teratogenicity cannot be completely ruled out. Generally avoided.
Second Trimester: Risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia in the fetus. Reversible inhibition of bone growth.
Third Trimester: Risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia in the fetus. Reversible inhibition of bone growth.
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Lactation

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. The American Academy of Pediatrics considers tetracyclines to be compatible with breastfeeding with caution. Monitor the infant for diarrhea, candidiasis, and potential tooth discoloration (though unlikely with typical short-term use).

Infant Risk: L3 (Moderate concern - potential for tooth discoloration and bone growth inhibition, though absorption by infant is limited).
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Pediatric Use

Doxycycline is generally contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia. It may also cause reversible inhibition of bone growth. Use in children under 8 is only considered in severe or life-threatening conditions where other drugs are ineffective or contraindicated (e.g., anthrax, Rocky Mountain spotted fever).

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Geriatric Use

No specific dose adjustment is generally required for elderly patients. However, elderly patients may be more susceptible to adverse effects, particularly gastrointestinal disturbances and photosensitivity. Monitor renal and hepatic function, although doxycycline is primarily eliminated non-renally.

Clinical Information

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Clinical Pearls

  • Always advise patients to take doxycycline with a full glass of water and to remain upright for at least 30 minutes (preferably 1 hour) to minimize the risk of esophageal irritation and ulceration.
  • Emphasize the importance of sun protection (sunscreen, protective clothing) due to significant photosensitivity risk.
  • Educate patients about potential drug interactions, especially with antacids, iron, calcium, and dairy products, and advise separating administration times.
  • Doryx MPC is a delayed-release formulation designed to be taken with food to improve tolerability and reduce GI upset, unlike some other doxycycline formulations.
  • Doxycycline is a common cause of drug-induced esophageal injury if not taken correctly.
  • Despite being a tetracycline, doxycycline is generally safe for use in patients with renal impairment due to its primary non-renal elimination.
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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 infections)
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin - for susceptible infections)
  • For acne/rosacea: Topical retinoids, topical antibiotics (e.g., clindamycin, metronidazole), oral isotretinoin (for severe acne), other oral antibiotics (e.g., azithromycin, trimethoprim/sulfamethoxazole).
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Cost & Coverage

Average Cost: $100 - $300 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand), Tier 1 (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 this medication, don't hesitate to discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.