Minolira 135mg 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
Antibiotic, Anti-inflammatory (for acne)
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Pharmacologic Class
Tetracycline antibiotic
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Pregnancy Category
Category D
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FDA Approved
Sep 2013
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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 stopping the growth of bacteria that cause acne and 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 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 been instructed to break your tablets in half, make sure you are using a product that can be broken in half. If you are unsure, consult your doctor.
Continue taking your medication as prescribed, even if your symptoms improve.
Take your medication at the same time every day.
You can take your medication with or without food. If it causes stomach upset, take it with food.
However, do not take your medication at the same time as products that contain iron or antacids with aluminum, calcium, or magnesium. Consult your doctor or pharmacist for guidance.
Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids to stay hydrated.

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.

Missing a Dose

If you miss a dose, take it as soon as you remember.
If it is 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 dose.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily. Do not crush, chew, or break the extended-release tablet.
  • Can be taken with or without food, but take with a full glass of water to prevent esophageal irritation.
  • Avoid lying down for at least 30 minutes after taking to prevent esophageal irritation.
  • Avoid excessive sun exposure and use sunscreen (SPF 30 or higher) and protective clothing, as this medication can make your skin more sensitive to the sun.
  • Avoid taking antacids, iron supplements, or products containing calcium (like dairy) within 2-3 hours of taking Minolira, as they can reduce its absorption.
  • If you are taking oral contraceptives, use an additional non-hormonal birth control method while on Minolira and for 7 days after, as it may reduce the effectiveness of birth control pills.
  • Do not give this medication to children under 8 years old due to the risk of permanent tooth discoloration and effects on bone growth.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 135 mg once daily
Dose Range: 135 - 135 mg

Condition-Specific Dosing:

moderate-to-severe acne vulgaris: 135 mg once daily
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Pediatric Dosing

Neonatal: Not established (Contraindicated in children under 8 years due to tooth discoloration and bone growth effects)
Infant: Not established (Contraindicated in children under 8 years due to tooth discoloration and bone growth effects)
Child: Not established (Contraindicated in children under 8 years due to tooth discoloration and bone growth effects)
Adolescent: 135 mg once daily (for patients 12 years and older with moderate-to-severe acne vulgaris)
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but monitor for adverse effects.
Moderate: Use with caution; consider lower doses or extended dosing intervals. Monitor for adverse effects.
Severe: Use with caution; consider lower doses or extended dosing intervals. Monitor for adverse effects.
Dialysis: Minocycline is not significantly removed by hemodialysis. Use with caution and monitor for adverse effects.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: Use with caution; monitor for adverse effects. Dose adjustment may be necessary.
Severe: Use with caution; monitor for adverse effects. Dose adjustment may be necessary.

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 leads to bacteriostatic effects. In the context of acne, minocycline also exhibits anti-inflammatory properties by inhibiting neutrophil chemotaxis and lipase activity of Propionibacterium acnes.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100%
Tmax: Approximately 3.5 hours (for extended-release formulation)
FoodEffect: Food (high-fat meal) may decrease Cmax and AUC slightly, but is not considered clinically significant for the extended-release formulation. Can be taken with or without food.

Distribution:

Vd: Approximately 1.2 L/kg
ProteinBinding: Approximately 70-75%
CnssPenetration: Yes (achieves therapeutic concentrations in CSF)

Elimination:

HalfLife: Approximately 11-22 hours (extended-release)
Clearance: Not readily available for extended-release, but generally lower than other tetracyclines due to longer half-life.
ExcretionRoute: Renal (4-15% unchanged) and fecal/biliary (major route for metabolites and some unchanged drug)
Unchanged: 4-15% (renal)
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Pharmacodynamics

OnsetOfAction: Within hours (antibacterial effect); weeks to months for full therapeutic effect in acne.
PeakEffect: Not directly applicable for acne treatment, but peak plasma concentrations reached in ~3.5 hours.
DurationOfAction: 24 hours (due to extended-release formulation and long half-life, allowing once-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 pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Fever, chills, or sore throat
Unexplained bruising or bleeding
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
Changes in nail, skin, eye, scar, tooth, or gum color to a darker shade
Mouth irritation or mouth sores
Burning, numbness, or tingling sensations
Redness or white patches in the mouth or throat
Rectal irritation
Genital irritation
Vaginal itching or discharge

Antibiotic-Associated Diarrhea

Diarrhea is a common side effect of antibiotics. In rare cases, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to a life-threatening bowel problem. 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 fatal cases, have been reported with this medication. If you notice any signs of liver problems, such as dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor right away.

Raised Brain Pressure

Raised pressure in the brain has been reported with this medication, which may lead to loss of eyesight. If you experience a headache 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, may occur with this medication. These reactions can be life-threatening and may affect other body organs. If you experience any signs, such as 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, seek medical help immediately.

Other Side Effects

Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:

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 or vision changes (e.g., blurred vision, double vision, loss of vision) - seek immediate medical attention.
  • Severe dizziness or vertigo.
  • Yellowing of the skin or eyes, dark urine, severe stomach pain, or persistent nausea/vomiting (signs of liver problems).
  • Unusual bleeding or bruising, persistent sore throat, or fever (signs of blood problems).
  • New or worsening joint pain, muscle aches, or fatigue (signs of drug-induced lupus-like syndrome).
  • Severe skin rash, blistering, or peeling.
  • Blue-gray discoloration of skin, nails, or gums (can be permanent).
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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. Be sure to describe the allergic reaction you experienced, including any symptoms.
If you are currently taking any of the following medications: Acitretin, isotretinoin, or a penicillin.
If you are pregnant or think you may be pregnant. Note that this medication is not recommended during pregnancy.
If you are planning to become pregnant 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. 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. 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 cause increased sensitivity to sunburn. If you experience unusual sunburn, inform your doctor.

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 not fade. 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 reverses after stopping the medication and undergoing dental cleaning. Consult your doctor if you have concerns.

When taking this medication, birth control pills and other hormone-based contraceptives may be less effective. To prevent pregnancy, use an additional form of birth control, such as a condom. If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Dizziness
  • Lightheadedness

What to Do:

In case of overdose, call your poison control center at 1-800-222-1222. Seek immediate medical attention. Treatment is supportive; gastric lavage may be indicated if ingestion is recent.

Drug Interactions

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Contraindicated Interactions

  • Isotretinoin (increased risk of pseudotumor cerebri)
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Major Interactions

  • Oral Retinoids (e.g., acitretin, tretinoin, adapalene, tazarotene) - increased risk of pseudotumor cerebri.
  • Antacids containing aluminum, calcium, or magnesium (decreased minocycline absorption)
  • Iron preparations (decreased minocycline absorption)
  • Bismuth subsalicylate (decreased minocycline absorption)
  • Penicillins (tetracyclines may interfere with the bactericidal action of penicillin)
  • Warfarin (potentiates anticoagulant effect)
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Moderate Interactions

  • Oral Contraceptives (may decrease efficacy of oral contraceptives, leading to breakthrough bleeding or pregnancy)
  • Ergot alkaloids (theoretical increased risk of ergotism)
  • Methoxyflurane (may result in fatal renal toxicity)
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Minor Interactions

  • Dairy products (decreased minocycline absorption, though less significant for minocycline than other tetracyclines)

Monitoring

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Baseline Monitoring

Liver function tests (ALT, AST, bilirubin)

Rationale: To establish baseline and identify pre-existing hepatic impairment, as minocycline can cause hepatotoxicity.

Timing: Prior to initiation of therapy.

Renal function tests (BUN, creatinine)

Rationale: To establish baseline and identify pre-existing renal impairment, as minocycline is partially renally eliminated and can exacerbate renal dysfunction.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC) with differential

Rationale: To establish baseline, especially for long-term therapy, due to rare reports of hematologic abnormalities.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically, especially with prolonged therapy (e.g., every 3-6 months) or if symptoms of liver dysfunction occur.

Target: Within normal limits

Action Threshold: Significant elevation (e.g., >3x ULN) or signs/symptoms of hepatotoxicity warrant discontinuation.

Renal function tests (BUN, creatinine)

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

Target: Within normal limits

Action Threshold: Significant elevation warrants dose adjustment or discontinuation.

Clinical assessment for adverse effects

Frequency: Regularly throughout therapy (e.g., at follow-up visits)

Target: Absence of significant adverse effects

Action Threshold: Development of severe headache, visual disturbances, dizziness, severe GI upset, rash, or signs of lupus-like syndrome.

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Symptom Monitoring

  • Severe headache
  • Blurred vision or vision changes (suggestive of pseudotumor cerebri)
  • Dizziness or vertigo
  • Nausea, vomiting, diarrhea
  • Skin rash or discoloration (blue-gray pigmentation)
  • Photosensitivity (severe sunburn)
  • Joint pain, muscle aches, fatigue (suggestive of drug-induced lupus)
  • Sore throat, fever, unusual bleeding/bruising (suggestive of hematologic abnormalities)
  • Yellowing of skin or eyes, dark urine, abdominal pain (suggestive of hepatotoxicity)

Special Patient Groups

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Pregnancy

Minocycline is classified as Pregnancy Category D. It should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Tetracyclines can cause permanent discoloration of teeth (yellow-gray-brown) and inhibition of bone growth in the fetus if administered during the second and third trimesters.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for teratogenicity cannot be excluded. Risk of tooth discoloration and bone growth inhibition is primarily in later trimesters.
Second Trimester: High risk of permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth in the fetus.
Third Trimester: High risk of permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth in the fetus.
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Lactation

Minocycline is excreted into breast milk. The American Academy of Pediatrics considers tetracyclines to be compatible with breastfeeding, but caution is advised due to theoretical concerns of tooth discoloration and inhibition of bone growth in the nursing infant. The amount transferred is generally low, but long-term use or use in premature infants should be avoided. Monitor infant for diarrhea, candidiasis, and tooth discoloration.

Infant Risk: L3 (Moderately safe) - Potential for tooth discoloration and inhibition of bone growth in infant, though risk is considered low with typical doses due to low milk concentrations. Monitor infant for adverse effects.
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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. Use in adolescents (12 years and older) for acne is generally considered safe at appropriate doses.

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Geriatric Use

No specific dose adjustment is generally required based on age alone. However, elderly patients may have age-related decreases in renal or hepatic function, which may necessitate dose adjustment or closer monitoring. Increased susceptibility to adverse effects like dizziness/vertigo may occur.

Clinical Information

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Clinical Pearls

  • Minocycline extended-release is often preferred over immediate-release formulations for acne due to its once-daily dosing and potentially lower incidence of vestibular side effects (dizziness, vertigo).
  • Counsel patients extensively on photosensitivity and the importance of sun protection.
  • Warn patients about potential for permanent skin/nail/gum discoloration, especially with long-term use. This is more common with minocycline than other tetracyclines.
  • Educate patients on the symptoms of pseudotumor cerebri (severe headache, vision changes) and the need for immediate medical attention.
  • Minocycline can cause drug-induced lupus erythematosus; monitor for symptoms like arthralgia, myalgia, rash, and fatigue.
  • Ensure patients understand the interaction with antacids, iron, and dairy products to maximize absorption.
  • Emphasize taking the tablet with a full glass of water and remaining upright for at least 30 minutes to prevent esophageal irritation/ulceration.
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Alternative Therapies

  • Doxycycline (oral, extended-release or delayed-release for acne)
  • Sarecycline (oral, for acne)
  • Oral isotretinoin (for severe nodular acne)
  • Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
  • Topical antibiotics (e.g., clindamycin, erythromycin)
  • Benzoyl peroxide (topical)
  • Azelaic acid (topical)
  • Oral contraceptives (for hormonal acne in females)
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Cost & Coverage

Average Cost: Varies widely, typically $200-$600+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (often requires prior authorization for brand name)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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.