Minolira 105mg Tablets

Manufacturer EPI HEALTH Active Ingredient Minocycline Extended-Release Tablets(mi noe SYE kleen) Pronunciation mi noe SYE kleen
It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Tetracycline Antibiotic; Anti-acne Agent
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Pharmacologic Class
Tetracycline (Protein Synthesis Inhibitor)
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Pregnancy Category
D
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FDA Approved
May 2007
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Minolira is an antibiotic medication used to treat moderate to severe acne. It works by reducing the bacteria on the skin and decreasing 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 with your prescription and follow the instructions closely.

Take your medication as directed, swallowing the tablets or capsules whole. Do not chew or crush them.
Drink a full glass of water with each dose.
If you have trouble swallowing the medication, check with your doctor to see if you can break the tablet in half. However, do not break the tablet unless your doctor or pharmacist says it is okay to do so.
Continue taking your medication even if your symptoms improve.
Take your medication at the same time every day to establish a routine.
You can take your medication with or without food. If it upsets your stomach, try taking it with food.
However, do not take your medication with products that contain iron or antacids that have aluminum, calcium, or magnesium. Talk to your doctor or pharmacist if you have questions about other medications or supplements you are taking.
Drink plenty of non-caffeinated fluids throughout the day, unless your doctor advises you to limit your fluid intake.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom.
Protect your medication from heat and light.
When you no longer need your medication, dispose of it properly.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember.
However, if it is almost time for your next dose, skip the missed dose and go back to your regular 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 the tablet with a full glass of water to prevent irritation of the esophagus.
  • Do not lie down for at least 30 minutes after taking the medication to prevent esophageal irritation.
  • Avoid taking antacids, iron supplements, or dairy products within 2-3 hours before or after taking Minolira, as they can interfere with absorption.
  • Protect your skin from the sun (wear protective clothing, use sunscreen) as this medication can make your skin more sensitive to sunlight.
  • This medication may cause dizziness; avoid driving or operating machinery until you know how it affects you.
  • If you are taking oral contraceptives, use an additional non-hormonal birth control method while on minocycline, as it may reduce the effectiveness of birth control pills.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 105 mg orally once daily
Dose Range: 105 - 105 mg

Condition-Specific Dosing:

Acne Vulgaris: 105 mg orally once daily
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Pediatric Dosing

Neonatal: Not established (Contraindicated in children under 8 years)
Infant: Not established (Contraindicated in children under 8 years)
Child: Not established (Contraindicated in children under 8 years)
Adolescent: For patients 12 years and older: 105 mg orally once daily
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but monitor for adverse effects.
Moderate: Use with caution; monitor for adverse effects. Dose reduction may be considered if accumulation occurs.
Severe: Use with caution; monitor for adverse effects. Dose reduction may be considered if accumulation occurs.
Dialysis: Minocycline is not significantly removed by hemodialysis. Use with caution and monitor for adverse effects.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Use with caution; monitor for adverse effects. Dose reduction may be considered.
Severe: Use with caution; monitor for adverse effects. Dose reduction may be considered.

Pharmacology

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Mechanism of Action

Minocycline 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 primarily bacteriostatic. It also exhibits anti-inflammatory properties relevant to its use in acne.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100%
Tmax: Approximately 3.5 hours (for extended-release formulation)
FoodEffect: Food does not significantly affect the absorption of minocycline extended-release tablets.

Distribution:

Vd: Approximately 0.7 L/kg
ProteinBinding: Approximately 70-75%
CnssPenetration: Limited (but can cross blood-brain barrier, especially when meninges are inflamed, and can cause pseudotumor cerebri)

Elimination:

HalfLife: Approximately 11-22 hours
Clearance: Not readily available for specific ER formulation, but generally lower than other tetracyclines due to longer half-life.
ExcretionRoute: Renal (approximately 10-30%) and fecal (biliary excretion and enterohepatic recirculation)
Unchanged: Approximately 10-30% (renal)
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Pharmacodynamics

OnsetOfAction: Within hours (antibacterial effect); clinical improvement for acne may take weeks to months.
PeakEffect: Peak plasma concentrations reached in approximately 3.5 hours.
DurationOfAction: Once daily dosing due to long half-life and extended-release formulation.

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: 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, or swelling of the mouth, face, lips, tongue, or throat.
Pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Kidney problems: inability to pass urine, changes in urine output, blood in the urine, or significant weight gain.
Lupus-like symptoms: rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
Fever, chills, or sore throat.
Unexplained bruising or bleeding, or feeling extremely tired or weak.
Changes in hearing.
Joint pain or swelling.
Muscle pain or weakness.
Ringing in the ears.
Seizures.
Shortness of breath.
Chest pain.
Abnormal heartbeat.
Swelling.
Darkening of nail, skin, eye, scar, tooth, or gum color.
Mouth irritation or mouth sores.
Burning, numbness, or tingling sensations.
Redness or white patches in the mouth or throat.
Rectal or genital irritation.
Vaginal itching or discharge.

Antibiotic-Related Diarrhea

Diarrhea is a common side effect of antibiotics. However, a severe form called C. diff-associated diarrhea (CDAD) can occur, which may lead to life-threatening bowel problems. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately. Do not treat diarrhea without consulting your doctor.

Liver Problems

Liver problems, including life-threatening cases, have been reported with this medication. If you notice any of the following symptoms, contact your doctor right away: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.

Raised Brain Pressure

Raised pressure in the brain has been reported with this medication, which may lead to loss of eyesight. If you experience headaches or eyesight problems, such as blurred vision, double vision, or loss of eyesight, contact your doctor immediately.

Thyroid Cancer

Cases of thyroid cancer have been reported with long-term use of this medication. If you notice lasting hoarseness, a neck mass, or trouble breathing or swallowing, contact your doctor right away.

Severe Skin Reactions

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur with this medication. These reactions can be life-threatening and may affect other organs. If you experience any of the following symptoms, seek medical help immediately: red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Side Effects

Most people do not experience severe side effects, and many have only minor or no side effects at all. 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, or vomiting.
Decreased appetite.
Dizziness, drowsiness, tiredness, or weakness.

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 or https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe headache, especially with blurred vision or double vision (signs of increased pressure in the brain)
  • Yellowing of the skin or eyes, dark urine, or pale stools (signs of liver problems)
  • Severe skin rash, blistering, or peeling (signs of serious skin reactions)
  • Unusual bleeding or bruising, persistent sore throat, or fever (signs of blood problems)
  • Severe dizziness or lightheadedness
  • Severe stomach pain, nausea, or vomiting
  • Joint pain, swelling, or stiffness (signs of drug-induced lupus-like syndrome)
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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. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you are currently taking any of the following medications: Acitretin, Isotretinoin, or a Penicillin.
If you are pregnant or think you might be pregnant. Do not take this medication if you are pregnant.
If you are trying to conceive or father a child.
* If you are breastfeeding or plan to breastfeed. You may need to avoid breastfeeding while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (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. 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. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor. Additionally, this medication may interfere with certain laboratory tests, so it is crucial to notify all 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 secondary infection. When taking this medication, be cautious when exposed to sunlight, as it may increase your susceptibility to sunburn. If you experience unusual sunburn, inform your doctor promptly.

In children under 8 years old, this medication may cause permanent tooth discoloration, resulting in a yellow-gray-brown color. If this occurs, the discoloration will be irreversible. Discuss this risk with your doctor. This medication is not approved for use in children under 12 years old, so consult with your doctor to determine the best course of treatment.

Children under 8 years old should not be given this medication. Although rare, tooth discoloration has also been reported in adults, which typically resolves after discontinuing the medication and undergoing dental cleaning. Consult your doctor if you have concerns.

When taking this medication, the effectiveness of birth control pills and other hormone-based contraceptives may be reduced. To prevent pregnancy, use an additional form of birth control, such as a condom, in conjunction with your regular birth control method.

If you are pregnant or become pregnant while taking this medication, immediately contact your doctor, as it may pose a risk to the unborn baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Dizziness

What to Do:

In case of overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is generally supportive and symptomatic.

Drug Interactions

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Contraindicated Interactions

  • Isotretinoin (increased risk of pseudotumor cerebri)
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Major Interactions

  • Oral Anticoagulants (e.g., Warfarin - may potentiate anticoagulant effect)
  • Penicillins (may interfere with bactericidal action of penicillin)
  • Oral Contraceptives (may reduce efficacy of oral contraceptives, leading to breakthrough bleeding or pregnancy)
  • Ergot Alkaloids (theoretical increased risk of ergotism, though less documented for minocycline)
  • Methotrexate (may increase methotrexate toxicity)
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Moderate Interactions

  • Antacids containing aluminum, calcium, or magnesium (decreased minocycline absorption)
  • Iron preparations (decreased minocycline absorption)
  • Bismuth subsalicylate (decreased minocycline absorption)
  • Cholestyramine (decreased minocycline absorption)
  • Digoxin (may increase digoxin levels in some patients)
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Minor Interactions

  • Zinc supplements (potential for reduced minocycline absorption)

Monitoring

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Baseline Monitoring

Liver function tests (ALT, AST, bilirubin)

Rationale: To establish baseline and identify pre-existing hepatic impairment, especially for long-term therapy.

Timing: Prior to initiation of therapy, if clinically indicated.

Renal function tests (BUN, creatinine)

Rationale: To establish baseline and identify pre-existing renal impairment, especially for long-term therapy.

Timing: Prior to initiation of therapy, if clinically indicated.

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Routine Monitoring

Signs and symptoms of pseudotumor cerebri (idiopathic intracranial hypertension)

Frequency: Periodically, especially if patient reports headache, blurred vision, diplopia, or papilledema.

Target: Absence of symptoms

Action Threshold: Discontinue drug and refer for neurological evaluation if symptoms occur.

Signs and symptoms of photosensitivity

Frequency: Periodically, especially during sun exposure.

Target: Absence of severe sunburn or rash.

Action Threshold: Advise sun protection; discontinue if severe reaction occurs.

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically, especially during prolonged therapy (e.g., >6 months) or if symptoms of hepatic dysfunction develop.

Target: Within normal limits or stable.

Action Threshold: Elevated levels or symptoms of liver injury warrant discontinuation.

Renal function tests (BUN, creatinine)

Frequency: Periodically, especially during prolonged therapy or in patients with pre-existing renal impairment.

Target: Within normal limits or stable.

Action Threshold: Significant decline in function may require dose adjustment or discontinuation.

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Symptom Monitoring

  • Headache (especially severe or persistent)
  • Blurred vision or other visual disturbances (e.g., diplopia, vision loss)
  • Dizziness or lightheadedness
  • Nausea, vomiting, diarrhea
  • Skin rash, hives, or itching
  • Photosensitivity (severe sunburn with minimal sun exposure)
  • Joint pain or swelling
  • Yellowing of skin or eyes (jaundice)
  • Dark urine, pale stools
  • Unusual fatigue or weakness
  • Sore throat, fever, or unusual bleeding/bruising (signs of blood dyscrasias)

Special Patient Groups

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Pregnancy

Minocycline is Pregnancy Category D. It can cause permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth in the fetus if used during pregnancy. Avoid use during pregnancy unless the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, including tooth discoloration and bone growth inhibition, though risk increases with duration of exposure.
Second Trimester: High risk of permanent tooth discoloration and inhibition of bone growth in the fetus.
Third Trimester: High risk of permanent tooth discoloration and inhibition of bone growth in the fetus.
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Lactation

Minocycline is excreted into breast milk. Due to the potential for serious adverse reactions in the nursing infant (e.g., tooth discoloration, inhibition of bone growth), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Moderate risk (L3). Potential for tooth discoloration, inhibition of bone growth, and theoretical risk of affecting gut flora in the infant.
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Pediatric Use

Minocycline is contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth. Minolira 105mg is indicated for patients 12 years and older.

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Geriatric Use

No specific dose adjustment is generally required based on age alone. However, elderly patients may have reduced renal or hepatic function, which should be considered. Monitor for adverse effects, especially dizziness and gastrointestinal upset.

Clinical Information

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Clinical Pearls

  • Minolira 105mg is an extended-release formulation, designed for once-daily dosing, which may improve adherence compared to immediate-release minocycline.
  • Counsel patients extensively on photosensitivity and the importance of sun protection.
  • Warn patients about potential for dizziness, especially at the start of therapy, and advise caution with driving or operating machinery.
  • Emphasize taking the medication with a full glass of water and remaining upright for at least 30 minutes to prevent esophageal irritation/ulceration.
  • Educate patients about the risk of permanent tooth discoloration, particularly in children under 8 years, and the importance of avoiding the drug in this age group and during pregnancy.
  • Be aware of the rare but serious adverse effects like pseudotumor cerebri (idiopathic intracranial hypertension) and drug-induced lupus-like syndrome; counsel patients on warning signs.
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Alternative Therapies

  • Other oral tetracyclines (e.g., Doxycycline, Tetracycline)
  • Other oral antibiotics for acne (e.g., Erythromycin, Azithromycin, Trimethoprim/Sulfamethoxazole)
  • Topical antibiotics (e.g., Clindamycin, Erythromycin)
  • Topical retinoids (e.g., Tretinoin, Adapalene, Tazarotene)
  • Oral retinoids (e.g., Isotretinoin - for severe, recalcitrant acne)
  • Benzoyl peroxide
  • Hormonal therapies (e.g., Oral contraceptives for female patients)
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Cost & Coverage

Average Cost: $100 - $300+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (for brand name); Tier 1 (for generic minocycline ER)
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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 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 occurred.