Minolira 135mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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).
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Isotretinoin (increased risk of pseudotumor cerebri)
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)
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)
Minor Interactions
- Dairy products (decreased minocycline absorption, though less significant for minocycline than other tetracyclines)
Monitoring
Baseline Monitoring
Rationale: To establish baseline and identify pre-existing hepatic impairment, as minocycline can cause hepatotoxicity.
Timing: Prior to initiation of therapy.
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.
Rationale: To establish baseline, especially for long-term therapy, due to rare reports of hematologic abnormalities.
Timing: Prior to initiation of therapy.
Routine Monitoring
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.
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.
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.
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
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:
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.
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.
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
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.
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)